The Leading Difference

Anastasia Mironova is the founder of UpLevelMedTech, a leadership development and executive coaching practice focused on shaping the next generation of medtech executives. Anastasia shares her path from joining Medtronic as an MBA intern to building a career across marketing, strategy, sales, and M&A, and the pivotal moment that cemented her purpose. She breaks down the core themes she sees in leaders at every level—team effectiveness, operating with GM-level ownership, and influence without authority—and explains how “leadership by subtraction” and time inventory create the capacity for strategic impact. She also explores how music shaped her leadership through listening, pausing, and performing under pressure. 
 
Guest links: www.uplevelmedtech.com
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPTEpisode 085 - Anastasia Mironova
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to another episode of the Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Anastasia Mironova. Anastasia is the founder of UpLevelMedTech, a leadership development and strategic advisory firm dedicated to shaping the next generation of executives in medtech. Through a blend of executive coaching, strategic advisory, and custom leadership programs, she helps senior leaders and teams elevate their influence, decision-making, and organizational impact. She is a passionate advocate for advancing women in leadership and brings two decades of lived experience navigating corporate growth, career transitions, and motherhood with authenticity and humor.
Known for her relatable approach and her ability to make leadership growth feel both practical and empowering, Anastasia helps leaders show up with clarity and confidence in complex environments. When she's not coaching or facilitating programs, she loves spending time with her husband and daughter, often recharging at a beach somewhere and supporting mentoring initiatives that help women lead boldly and thrive in their careers and lives.
All right. Well, welcome to the show. Thank you so much for being here today. I'm, I'm really excited to speak with you.
[00:01:55] Anastasia Mironova: Thank you for having me. I'm excited also.
[00:01:58] Lindsey Dinneen: Awesome. Well, if you wouldn't mind starting off by just sharing a little bit about you, who you are, your background, and what led you to medtech?
[00:02:08] Anastasia Mironova: Oh my gosh. My name is Anastasia Mironova, and I'm the CEO and founder of UpLevelMedTech. We are the leadership development and executive coaching practice focused specifically on medtech, but I have not grown up around medtech at all. You probably hear that from other guests, I'm assuming, quite a bit. But I was born and raised in Kazakhstan in Central Asia, and I kind of grew up more around music and entrepreneurship and totally did not know anything about medtech. I came to US in early 2000s to do my MBA program, and one of my classmates was, at the time, working for Medtronic.
And when I was finishing my MBA program, she said, "You know, we're hiring for a variety of marketing roles, including an intern, and I was thinking maybe you should apply because you have some of those skills." And I said, "Sure, I, I'm interested." And so the rest is history. I joined as an intern working for Medtronic and eventually worked my way up into product management roles and then global marketing, marketing and strategy, marketing strategy and sales, and then added M&A components to it. So loved it, and I very shortly thereafter, there was a situation that made me completely fall in love with the industry.
And I would say that what I really appreciate about it the most is just how much purpose there is behind it, and that's what really connected me to it, and also just how much innovation is being brought forward because I come from a place that didn't necessarily have a lot of innovation readily available, you know, at the speed that we're producing it here. And so I, I really appreciated that, and that's how I-- that, that was my journey in medtech up until I then became a, an entrepreneur and opened up my own business.
[00:03:51] Lindsey Dinneen: Awesome. Okay, well thank you for sharing. There's so much I wanna dive into, but you said you did grow up around maybe not medtech, but entrepreneurship and leadership and things like that. Do you mind sharing a little bit about that and what maybe intrigued you? Because obviously you've become not only an incredible leader yourself, but you are coaching other leaders too.
[00:04:11] Anastasia Mironova: Yeah, sure. It's, it's a really good question. I grew up around my parents' little, I call it mom-and-pop loving business. That business didn't start until after the wall fell and, and, and all of that, but because the business was so tiny, everybody was involved, and I was very much spending a lot of my time around that. And my mother was my early impact on how I was shaped as a leader later on. Unbeknownst to me, I would say she was what you and I would describe a servant leader today, probably long before that term was coined somewhere in a book or in a business school.
But what it really taught me was one thing, which is you're not bound to any specific functional area. You are in the business of something, whatever your business is. And so it taught me to think more broadly and to think like a business person, and I would say, again, I was very unconscious to that at the time. I was just doing a lot of things, helping out, having fun, sometimes thinking about how I absolutely don't know what I'm doing, you know? But then later on, I became more and more self-aware about the fact that how much that business thinking actually helped me to succeed later on as a leader and, and help other leaders grow.
[00:05:29] Lindsey Dinneen: Yeah, and I'm curious about that aspect. So you, you said it was lovingly a mom-and-pop place, which is wonderful, and, you know, you said sort of everybody was involved, and I feel, feel like that is a very common theme. And so one of the things that I'd be curious to have your take on is something that I discovered owning my own dance studio is there were, there were a lot of moments that were really fun, right?
And you, you got to kinda show up in the community, and you, you had a business, and that's, that's a fun thing to do. But, you know, on any given day, I was everything from the CEO to the janitor, and everything in between. And I think that's a wonderful thing to experience as a leader, but I'm curious as to how that experience probably shaped your own style of leadership beyond being able to observe really good leadership up close and personally. But I'm just kinda curious how that, how, how sort of having a take in all the different aspects of the business may have really helped shape you.
[00:06:27] Anastasia Mironova: Yeah. It, it, it's really kind of fundamental when I think about it, 'cause my mom said exactly the same phrase that you just mentioned. She told me always, "You have to be able to get along with everyone equally and treat everyone equally with respect, whether it's a janitor or your CEO, and your ability to get along with every level of the organization is what's going to shape the success." And, and she was very much modeling that behavior.
But where I feel it shaped me was that when you work in, in medtech in particular, it's very cross-functional, right? So when you work in a particular area, say I was in marketing in early, in early days, I didn't think of myself as a marketeer. And, and what that meant for me is certainly I would focus on what I needed to do and my goals and our functional area imperatives and all of that, but I always was curious about how does the rest of the business work.
And so I didn't think of myself as "I'm a marketing leader." I thought of myself as "I'm a business leader." And when you remain curious in how other aspects of the business work, how it all comes together, what are the macro trends? You know, what do the customers want? How are people compensated? How does the innovation pipeline get shaped? All of those things working together helps early on to make better decisions in your own swim lane.
And it kind of like, it shaped me as a leader because I felt that it helped me to make better decisions in larger context in mind. But also it helped me to relate, to relate to a lot of people in a lot of different functional areas, and not assume what their life was like and what their day-to-day was like, but be curious about it. So I would say that definitely both of those things shape how I saw business as well as people in it, if you will.
[00:08:18] Lindsey Dinneen: Yeah, I love that. I love the idea of curiosity and being willing to have conversations, meet other people, learn different aspects of the business, 'cause you're absolutely right. The only thing it can do is help you better understand your lane in relation to other people's lanes. And I'm wondering if part of that was also learning how to kind of to, to speak the language of other people's areas of expertise a little bit, in the sense of you're probably going to have a little bit of a different explanation for, say an upcoming project you wanna launch, say, like a, a marketing campaign to the CFO than you would maybe an engineer. So I'm curious how you, how that ha- unraveled for you.
[00:08:59] Anastasia Mironova: Oh it was quite a journey. So earlier when, when I first started in medtech, and I was probably on my second role, I had a, a tremendous boss that was very visionary and, and she believed in talent development very much. And she said to me, "You need to go and probably get even more training in influencing and influencing skills." And I was like, "Wow, I would love to do that. I love everything that has to do with human psychology, behavioral, you know, psychology." And so she actually sponsored that, and I was able to do that. And what I quickly found was that the way you position your message and the way you deliver your message and how you influence different people varies drastically.
And that really helped me later on as a leader to advocate for my team. I felt like at minimum, the influencing skills and the ability to relate to different people from different walks of life, it helps you to advocate for yourself and for your own initiatives and for whatever you might be focused on. But for leadership, it definitely helped me to be heard as a leader and advocate for my own team later on.
And I also felt like other leaders were telling me, "You really understand what it's like to be in our shoes," and therefore were more willing to listen to what I had to say. So it's, it's such a counterintuitive thing at times, but I do believe in this concept of it is our job to inform ourselves of our conversation partner and not the other way around. And it, it works. It's very effective.
[00:10:38] Lindsey Dinneen: Yeah, that's, that is, that is incredible and such a great skill set to have and to pass along, and I really love your point about advocating for others as well, in addition to advocating for yourself. And so I know one of the things that you do brilliantly now is to help people who are potentially interested in taking that next step in their own leadership journey, whether they're interested in, you know, going from, let's say, director to VP, VP to C-suite, and things like that.
So I was just wondering if you could share a little bit about how you made this successful for yourself, because you mentioned on, on your LinkedIn profile that you didn't work-- It's not like you were working crazy hours, or you were doing all the right things. And so I'd love to hear about your journey and then how you help others too, through their journeys as well.
[00:11:27] Anastasia Mironova: Yeah, certainly. I'm thinking about back when most of my career happened, probably while I was very much navigating the demands of everything all at once, the demands of young family or having young family at the time, you know, parents and, and everything that we normally have on our plate. And I firmly believe that as a leader, you have to be very, very clean and clear on what your one or two things are that are super strategic in your world that only you can really do and drive, and this is your primary role.
And so one of the ways I did that is I, I definitely was very, very intentional about how I spent my time, and I did a process once a month that had to do with my inventory, time inventory, believe it or not. And I would do it on the plane or, you know, on, on the ride to, to, you know, a, a seminar or something or a meeting, and it really helped me to hone in on these are the things that only I can really ensure to drive, and the rest belongs to my team so that they can shine and they can also, you know, we can be effective together.
One of the things that I find the hardest is that people graduate from execution to that strategic impact, and it's hard to do that. Most of the time when I help my clients, the, the challenge is not the capability. It's not the skill set. I work with tremendously talented people. It's the capacity. It's the creation of that leadership capacity, and that takes what I call leadership by subtraction. You have to subtract something to create that space for your strategic impact, and that's what we work on often together, but that's what really truly helped me to be successful, is leadership by subtraction and inventorying it.
[00:13:20] Lindsey Dinneen: Yeah. Okay, great. Well, yeah, th- that's great because I'd love to learn more about your company now how you work with people, and kind of where you find perhaps some of the, the hardest things as, as you're growing in your career and your leadership responsibilities increase. So what are, what are some of the common things that you see that don't work well as you're trying to continue to grow in your, in that way?
[00:13:46] Anastasia Mironova: For me or for my clients?
[00:13:48] Lindsey Dinneen: Let's talk about for your clients.
[00:13:51] Anastasia Mironova: Okay. So for my clients, I would say there are definitely very common themes as I see it. It's interesting to me because when I first opened up my business, I had this theory that the kind of challenges that people maybe at an individual level will face might be drastically different from those that are faced at the executive level. And I quickly learned that the challenges are all the same. The way they show up in your day-to-day life may be different, but the challenges are all the same, and they have to do oftentimes with three things. Do you really get laser-focused on how effectively you manage your team so that you and your team can elevate?
The second area that's probably by far the most common is, are you operating at that GM level? Even if you're individual contributor, are you thinking from an ownership perspective like an owner would in a business versus a particular title or a particular role in, in honing in on that business, business acumen and the one that crosses all lanes, all company sizes, I would say all teams, all functions is, is influencing skills and presence. How do you show up in a way that honors other people but helps you to move both business and people forward and you have absolutely no authority over them, right? So it's that influence without authority.
These are very, very for like front of mind for a majority of the teams that I work with. And I'd say one of the ways to probably, you know, deal with that or address that is, is definitely to be very intentional about development. So it's not just here and there or, you know, as time permits, but as, as the companies become more intentional about the development, the more capacity they create. I definitely believe that our future is not, not in necessarily having high potential development, but high capacity development.
[00:15:55] Lindsey Dinneen: Hmm. Yeah.
[00:15:56] Anastasia Mironova: If that makes sense.
[00:15:57] Lindsey Dinneen: Yeah. So how, how can we encourage companies to prioritize this? 'Cause I, I agree with you that the development all along the path is really important, and I know a lot of people take very personal ownership of that, and they do a lot of their own you know, training and things like that, and coaching. But, but what about from the perspective of a company? How can we encourage companies to be more involved and to understand the importance of the ROI associated with it, just to be frank?
[00:16:27] Anastasia Mironova: Yeah. Yeah, for sure. And that's the conversation where I would say the CHROs, the people leaders, are now taking a significantly more active role in companies to allow for that conversation to take place and to have a much deeper partnership with the business leaders to be more intentional about development. And I would say what I see is that's the best practice where they partner together and say, "My needs are like this," right? "These are some of my needs on my team, and here's our solutions. And how do we bring these solutions more systematically to all levels so that we can uplevel everybody?" And companies that do do that and have these conversations, then they, they're more disciplined as well as more prioritized around that topic. And where it doesn't become that partnership conversation on the table, it's harder, certainly harder. And I'm being completely frank and candid on that.
[00:17:28] Lindsey Dinneen: Yeah. Yeah, I appreciate that. Yeah. Okay, so one of the things I noticed on LinkedIn is --you have w- several wonderful things. One of them that I really enjoyed was kind of seeing your different book recommendations, so it seems like you are a very avid reader, and also you grew up in a very musical environment, yeah? That's part of your background. So I'd love if you share a little bit about those, and maybe how you think that has helped you as a leader in your career. Just h-how do those things interplay?
[00:18:02] Anastasia Mironova: Oh, you, you, you run a risk of getting me into my soapbox a little bit, but mus- yeah, yeah. Music is big. So I, I went to music school for 10 years and learned to, to play piano. But I probably could write a book about the parallels between music and leadership just for fun of it at someday when I retire and have time, because learning music really taught me a lot about leadership in, in a number of ways.
If you think about medtech and you think about, again, how much of it is very cross-functional, a lot of different groups have to come together, words like alignment come to mind, right, all the time. In music, it's interesting because you have to listen to yourself as you play to make sure that you self-correct. And so that listening, that ability to listen to "How am I coming off right now?" is, is really important, I think, in leadership, particularly today when everything is more about being more inclusive, right, being more diverse in how you build your team. So I would say that listening ability is huge and shaped me as a leader.
And the other one is the power of pause. If you, if you don't pause when you play when you're supposed to, it's just not gonna sound the same. It's not gonna land the same. And so, like that power of pausing to allow for a better response is another huge parallel, particularly in executive levels and like how you show up.
And I would say probably the other one is ability to prep. There is a lot of preparation in leadership. You can attest to that. There's a lot of prep that goes into it. But then there comes the time when you have to go and in high stakes be composed and, and read the room and, and, and get there.
So lots of parallels. I could think of many more, but these are just like the top three that I would say definitely prepared me, again, when it matters, you know? 'Cause I, I think a lot of times in leadership we talk about, you know, culture and engagement, right? And trust, and those are fundamentally unbelievably important. But I oftentimes think that leadership falls apart in those high-pressure moments, right? And music prepared me to deal with that quite a bit, so.
[00:20:23] Lindsey Dinneen: Yeah. Oh, I love that. So I t- I talk about this quite a bit too with s- my background is also in the arts, but on the dance side. I'm a professional ballerina, and, and one of the things that I often talk about is how, yeah, it prepares you for really high-stakes environments where you're gonna go in, and honestly, it doesn't really matter what kind of day you've had, what you, what's going on in your life. You're there to perform, so you have to learn to show up poised and in command and with confidence that may or may not actually exist.
[00:20:56] Anastasia Mironova: Yes, definitely. Definitely. Yeah. Yeah, you have to compartmentalize it all. And even if you make a mistake, which is inevitably that does happen on stage when people are watching and all eyes are on you, and there, lo and behold, you tripped on a note or it didn't land quite there, and you just have to keep going. And I think that that skill is tremendous in leadership.
[00:21:25] Lindsey Dinneen: Yeah, could not agree more. Okay, so you mentioned when you were first telling us a little bit about your story that there was a moment that kind of really made you fall in love with the industry or, or helped you feel fairly passionate about it, and I was just wondering, I always love learning what, what is a moment or a couple of moments that stand out to you as just affirming, "Wow, I am in the right place at the right time"?
[00:21:50] Anastasia Mironova: Yeah, it's, it's a little bit of an emotional story, but I started my career in medtech in a external defibrillation category, which in simple terms, at the time, it wasn't something that was mandatory in schools, stadiums, airports, planes, you know, all these things were now are equipped with a little portable defibrillator wasn't the case. The laws haven't yet been passed, and so we were pretty early days, and we had to fight oftentimes very hard to get one of these into, say, schools.
And so one of our team mem- members on the sales side did that, and later on, I met a six-year-old boy with his mom who survived sudden cardiac arrest in the school that we were able to fight and place the AED in because he collapsed with sudden cardiac arrest. And so we, we brought him to, to our company, and this little human was on stage, you know, alive because so many people carried that part, right? And I just get emotional just talking about it. That was my moment. It was really early on, and I literally just committed to it and never looked back. And I'm so happy that he was there , and then we met many more, you know, throughout the years, but that was my pivotal moment for sure.
[00:23:10] Lindsey Dinneen: Oh, that's such a beautiful story. Thank you for sharing that. I, yeah, that, yeah. I can see why that would get you every time because what an amazing, what an amazing thing to get to... 'Cause, you know, you, you know you're in a good industry doing good things, but when you get to see the impact on a patient, and a little human and to top it all off, oh my gosh, that's, that's beautiful. Yeah.
[00:23:34] Anastasia Mironova: Thank you. Kids, right? And, and, and I've met a few patients since then that have been positively impacted, adults, various ages. And again, it just-- it's such a reminder every time. Even when I now work with my clients and I, you know, would talk to them about whatever their challenges are and work through that, most all of them share that and tell me, " Yesterday I was reminded, you know, because I met-- I went to the hospital, and I met, you know, some, some patients." It's unbelievable. Purpose.
[00:24:05] Lindsey Dinneen: Yeah, exactly. Yeah. Yeah, yeah, absolutely. Well, okay, pivoting the conversation a little bit just for fun, and based on a previous answer, now I'm, I'm wondering if this will be similar, but imagine that you were to be offered a million dollars to teach a master class on anything you want. Could be within your industry, it doesn't have to be. What would you choose to teach?
[00:24:28] Anastasia Mironova: I would choose, I would choose to teach two things. One would be how to not fall apart under pressure, for sure. I would teach that in a heartbeat because I feel like there's just so much to it, and it's fun. It's actually fun. It's very, very learnable, and contrary to people's belief, anybody can learn that. So I would totally teach that. And I would teach it, believe it or not, how to tailor your message. The marketeer in me is still very much alive. I would teach about you can take this one thing that you really need to deliver and deliver it 16 different ways, and this is the one or two ways that it's going to get it landed, whether it's your investor pitch, your initiatives, your budget, your people, whatever you need. There's so much power in that, in tailoring it to the audience, and I have fun doing that, so I would probably teach those two things.
[00:25:27] Lindsey Dinneen: I love that. That's awesome. Okay, and then how do you wish to be remembered after you leave this world?
[00:25:33] Anastasia Mironova: That's a weighty question. Probably in two ways. For me, my most important values are my family, if you haven't guessed that already. So I would want to be remembered that I've spent a lot of really good special moments with my daughter and with my family because I feel like that's, that's what matters at the end of the day. And I would like for all the people whose lives I touch today and throughout my career leave with feeling more clarity, lighter, and just more uplifted after talking to me, and so that I leave them better off than when we started because that's, that's the legacy I want to create. I do believe both leadership as well as our personal life are comprised of those hundreds of very small moments, and that's how I would like to be remembered probably.
[00:26:26] Lindsey Dinneen: Yes, I, I love that. I-- that's a beautiful legacy, yeah. All right, and then final question: What is one thing that makes you smile every time you see or think about it?
[00:26:40] Anastasia Mironova: My daughter's paintings, hands down. So I have a, an artist in the house, which I, I'm not artistically inclined from, from, from a painting perspective. Music, right, not painting. And she paints a lot, and so every time I see something being created, whether it's silly or serious, whatever she- her, her mood is at, it just makes me smile. So it's my, it's my instant instant smile of the day.
[00:27:04] Lindsey Dinneen: Oh, I love that. Yes, I, I love art in general, and very much share the same, you know, idea that there's so much that you can take from what you learn from the discipline of, of being in the arts to where you go in the future. But anyway, that's so much fun to hear, so thank you for sharing. And just in general, thank you so much for being here today. I really appreciate it.
We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support.
I, I loved hearing your stories and your advice, and I appreciate how you're helping the next generation of leaders to succeed. This is such an important industry, and we want people to be successful, so thank you for the work you're doing to change lives for a better world.
[00:28:05] Anastasia Mironova: Oh, thank you, Linds. Thank you for having me. I am really honored. You bring such wonderful guests always, that I look forward to your next episodes as well. Thank you very much for having me. I had so much fun talking to you.
[00:28:16] Lindsey Dinneen: Awesome. Good. Well, thank you, and until next time.
[00:28:20] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Brent Lavin, principal at Ironwood Medtech Partners, shares how he helps early-stage medtech companies build commercial strategies from concept through commercialization and exit. Brent reflects on his path from electrical engineer to launch expert, including lessons learned after seeing how overbuilt product features can complicate V&V and FDA review, and why founders must make early decisions with the end in mind. He discusses common startup pitfalls, the importance of pairing technical innovation with a strong commercial plan, and practical leadership insights on hiring “the right seat,” delegation, and setting clear standards while allowing teams flexibility in execution. 
 
Guest links: https://www.linkedin.com/in/brent-lavin/
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPTEpisode 084 - Brent Lavin
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest Brent Lavin. Brent is currently principal at Ironwood Medtech Partners, where they help build the commercial logic into medtech startup innovation from concept through commercialization and exit. As an engineer turned launch expert, Brent has helped commercialize 20+ 510K PMA products and led the buy side of four M&A transactions, so he knows what buyers value beyond the science. With a diverse background from GE Healthcare to C.R. Bard to BD to now leading Ironwood Medtech Partners, he thrives on helping early-stage companies navigate the complex healthcare landscape and build successful companies.
All right. Brent, welcome to the show. So glad to have you here today.
[00:01:39] Brent Lavin: Yeah, great to be here. Thanks so much for the invite. I appreciate it.
[00:01:42] Lindsey Dinneen: Absolutely. Well, I'd love if you would start by just sharing a little bit about yourself, your background, and what led you to medtech?
[00:01:50] Brent Lavin: Yeah. So, I'm Brent Lavin. I live here in Phoenix, Arizona. I've recently founded Ironwood Medtech Partners, which is my company helping early-stage medtech. But I spent nearly 20 years in strategic medtech, and so I originally came to the industry through the engineering function. I was an electrical engineer in product development and innovation. And after three or four years of that, decided I wanna move over into what was, what is traditionally product management.
And so, through my MBA program and then starting with GE Healthcare, I've spent the last 20 years at this intersection of R&D innovation, strategy, business development, and marketing. And so, really great run. Have been on the buy side of several M&A transactions, and I try to bring all of that experience to the early stage so that, you know, companies as they start out, can be building for the future. And so, it's been a great journey in medtech, and I've loved it so far.
[00:02:46] Lindsey Dinneen: Yeah. Okay, so, so many things to ask about, but I'll, I'll start here. So, all right, so you're sa- you know, as you, you mentioned building towards the future and especially with these young startups that might not have a lot of experience in that particular kind of environment, or they're leading their company for the first time. What are some of the things that you see that maybe are pitfalls to avoid? Just, just like maybe some of the things that you've seen startups struggle with a little bit, and how can we help them mitigate those risks?
[00:03:17] Brent Lavin: Yeah, there is a lot there, but let me just start by saying there is no linear path, and it is a very circular, ongoing process as you work through those early stages. And we call it the fuzzy front end for a very good reason. And sometimes you need to go down paths to realize that's not the right path, and you need to be comfortable with that.
But at the end of the day, one of my goals is to help early-stage companies build with the end in mind because whether you acknowledge it or not, you're making decisions today that are ultimately gonna affect how you commercialize in the future. And so at least being able to make those decisions with your eyes wide open and understanding the trade-offs that are going on. And so for somebody that's been at the very end of that process, I, I can help inform, you know, those early stages so that you make priority decisions and trade-offs, you know, with full-scale information.
[00:04:17] Lindsey Dinneen: Okay. Yeah. Well, I, I love the fact that you highlighted it's not a linear path, and there are a lot of things that go into, of course, the success of a startup. I'm wondering, in, in your role now, what are some of the areas which you see successful startups really thrive in as they're working with, with somebody like you to help make them successful from the start?
[00:04:42] Brent Lavin: Yeah. Thanks for that question. I love working with early-stage founders that are passionate about their technology but especially those that realize where they may need to supplement their technical background with more of a commercial mindset. And so the, the people that work, that I work best with, are open to inputs and consideration of other options as they go through that process because you know, the, the famous saying, "What got you here is not what's going to get you there." And so while technical innovation is, is key that may not lead to an acquisition if you can't tie it to a strong commercial plan.
[00:05:22] Lindsey Dinneen: Mm, mm-hmm. Yeah, so actually this is an area that I'm very curious about even in your own journey is, so you started off with that technical background as an electrical engineer, and I'd love to hear a little bit more about that as well. But maybe if you don't mind sharing a little bit about the transition or the learning process of going from that as a really good base to also being able to understand the full life cycle and how to make something succeed.
[00:05:47] Brent Lavin: Yeah. Well, let me kind of go back to those engineering days and talk a little bit about how I made that pivot from engineering into product management. And to be honest, I didn't know exactly what I was doing at the time, but a-as an engineer, I was working with a product development team where we were creating a project. I was at a s- a contract design manufacturing company, and we were working with an outside company that owned a patent for a laboratory blood culturing instrument.
And so we were their engineering partner, and what I saw firsthand was unfortunately, this customer at the time did not have full insight into the workflow and how the device was used in practice. And so as an engineering team, we frankly overbuilt many options into the product in order to try to s-satisfy everybody. And that seemed attractive at the time, but ultimately when we got to V&V, verification validation, and the FDA review process, it was a real struggle to get this on market.
Now we ultimately did, but the epiphany for me was, I am really good at understanding engineering trade-offs and working with engineering teams to go through the process of evaluating different options. But I also really like working with customers and understanding what moves the needle and what's the difference between a nice to have and a need to have. And so, it was that kind of experience firsthand that led me to say, "I wanna operate at this intersection and really operate in both sides of that equation."
And so ultimately I decided I needed to get an MBA in order to do that. So I left a, a good paying engineering job right after I got married and we moved to Madison and I got my MBA and then, you know, that ultimately led to GE Healthcare and, and then, you know, continued career in medtech. So thanks for asking that question.
[00:07:43] Lindsey Dinneen: Yeah. Well, okay, so your leadership journey, of course, has, has evolved over time as, as often happens, and, and you've gone from leadership positions within other organizations to, of course, now leading your own. And I'd love if you'd just share a little bit about that journey of, of growth and discovery, maybe some, you know, lessons learned along the way.
[00:08:06] Brent Lavin: Yeah. So, let's talk a little bit about kind of my formal leadership in the, you know, corporate structure and organization. I would say, we were chatting beforehand that, you know, I really moved through slowly at the beginning of my leadership from one person to three people to five people. And as an ambitious person, I always felt like that was too slow. And so, but I think it was those foundational aspects of working very closely one-on-one with people, hiring, deciding who to hire, selection, onboarding having crucial conversations about performance management and how to put people in the right seat to be successful, all occurred when my leadership span was frankly smaller than probably I was hoping it would be.
But at the proper time, my leadership expanded very quickly from five to seven and ultimately 22 people within about an 18-month period. And if I had not had those slow steps along the way, I don't think I would've been ready for that and I, I would've struggled. And so, even though my ambition was high, the pace was just right in order to be successful in that.
Now, to your second part of the question of, you know, how do you then transition to this, this new role? That has been a learning experience, and I'm not sure I have it mastered but it is all about influence. And so, you know, leadership, even in a formal organization, while you can be connected on the org chart, ultimately boils down to influence.
And so my goal is to influence early-stage companies to understand the trade-offs that they're making and hopefully help them chart the best path forward for the goal that they have, you know, individually. Every company is built differently, and so I try to channel what their goals are into my recommendations.
[00:10:02] Lindsey Dinneen: Absolutely. So you mentioned something that is brought up often, but I think it's a concept that would be worth diving into, and that's the concept of the right seat, and I would love if you would share a little bit more about your philosophy behind that and how, as a leader too, if you know that there's perhaps somebody who's a great fit for your organization but isn't in the right seat, how do you help make that happen?
[00:10:29] Brent Lavin: Yeah. So this is back to the seminal Jim Collins book. You know, get the right people on the, on the bus and then get them in the right seat, correct? And so I always tried to select the person first and then find the opportunity. And there are times where you need to pivot people. So let me tell a, a quick anecdote about, you know, a situation where we had somebody on my team, and this person had progressed through different product management roles, but this person also had a project management background and was really passionate about project management and brought those skill sets to product management.
But they are different, and that... Her passion was in project management, and so I knew of some upcoming and different opportunities in the organization that would be very project management focused and that, that position was not even on the org chart at the time. But as I had discussions and, and understood that that was becoming a reality, then I turned and, and offered that to the, to the person and ultimately they, they took that new opportunity. And so, it's really understanding really their long-term goals as well as, you know, their strengths, their natural strengths. Not just where they're operating, but what their natural strengths are, and then sometimes even creating an opportunity for them.
[00:11:51] Lindsey Dinneen: Mm-hmm. Yeah. Yeah, and so, okay, so, so you've had kind of, a really cool opportunity to get a really good look into some of these startup companies who, you know, their founders might not be in a place where they're able to necessarily hire a whole bunch of people right away. How can you come in and support them when they're, say, like really young, maybe pre-seed, trying to figure out what the next right step is and, and able to sort of help lead them also in that transition of, you know, perhaps single founder to also a leader of a company?
[00:12:32] Brent Lavin: Yeah. That's a great question, and I'm early in that journey, right? And so, maybe not some specific examples around that, but certainly again, you know, leadership is influence. And you know, I try to understand as a leader of people in a, an organization what everybody's goals are, personal and professional goals are, and then match, you know, again, what I can do to, to their, to their interests.
And so when you talk about, you know, early stage CEOs, sometimes it's just a matter of listening as an unbiased outside observer who has no money in the company. And so, it can just be providing perspective from years of experience and asking insightful questions, you know, even before there's a relationship, a business relationship, between, you know, my company and theirs.
And the goal is to help everybody be successful. Like, I'm a passionate medtech leader that wants, you know, th- these innovations to reach market. And so, people have lifted me up along the way, and if, if I can do that just in, in conversations and mentorship, certainly willing to do that and have done that.
But as, you know, a CEO transitions then into seed and Series A, just providing, you know, again, leadership perspective from, you know, my corporate experience can be helpful. Because ultimately people are not gonna do things exactly the same way that you've done them as an individual contributor, and you have to become comfortable with allowing people, giving people the, the guardrails, and then allowing them to operate in their own style to achieve the results that you've laid out for them.
[00:14:20] Lindsey Dinneen: Hmm. So yeah, and th-that's been something that's been talked about quite a bit is that art of delegating, and how do you give your people the right guardrails without making it so narrow that it feels like you're kind of micromanaging, but you ha- you have to maintain culture and brand, you know, like tone in the way that you speak. So, what are some strategies or tips that you might have for, for a leader who is in the position, needs to delegate? This is maybe a first time. It's a little bit hard to let go of the baby, as it were. So, so how do you help them navigate that?
[00:14:55] Brent Lavin: Ye- yeah, I, I would go back to my own experience where, you know, I probably didn't do this the best the very first time that I had people on my team and was delegating. And I would say that most high achievers struggle with delegation for the first time because people are going to do things in a different way than you did. And I tried to teach my way, but as I grew and expanded and got, you know, mentorship and, and learned through that process, I started to go f- you know, higher o- on the ladder to, you know, values and culture and expectations, to your, to your point before. So, as a leader you have to be consistent and just unending in your communication of expectations, values, and standards, and then hold people to those.
And so I, I say this often. I live in South Chandler, Arizona, and Scottsdale is maybe 40 minutes away. You know, a new leader would say you know, "You gotta go up the 101, you need to take Exit this and that to get to the coffee shop." Where as I grew more comfortable and confident, I would say, "We're gonna meet at this coffee shop in Chandler." And if they wanted to take surface streets and hit all the stoplights, so be it. And so you gotta become comfortable with that. But at the same time, our standard is "We're gonna meet at this coffee shop at 11 o'clock sharp, and I expect you to be there."
[00:16:26] Lindsey Dinneen: That's a great analogy. I love the way you put that. Thanks for sharing it. Yeah, that's-- and that's a really interesting way of thinking about it, is there's, there's many avenues to getting something done correctly and to meet those expectations that you set forth, but there can also be room for creativity on how that's done, how that's accomplished.
[00:16:46] Brent Lavin: Yeah. You know, one of the team values that, that I had with my most recent team was around this idea of, of play to win. And you know, over time, I actually adjusted that with some feedback and some further, you know, kinda study on leadership toward striving for excellence. And so I think the play to win was a little bit narrow in that you can't always control everything around you.
And winning is an outcome that may be dependent on some other factors that, that you can't influence. And so that was a little bit narrow and, and too outcome-focused. But strive- striving for excellence was something that we could talk about daily, and you may not win, but as long as you strive for excellence in whatever we're asking you to do, like that's the standard. And so, that became a lot more robust, I would say, in the conversations that we had around setting and ensuring expectations.
[00:17:45] Lindsey Dinneen: Yes, I love that. Excellence over perfection, especially for those of us who are what I would fondly refer to as a recovering perfectionist. So.
[00:17:53] Brent Lavin: Mm-hmm
[00:17:54] Lindsey Dinneen: I love that.
[00:17:56] Brent Lavin: Yeah, it's a present tense recovering, right? Because we're never fully recovered. But...
[00:18:01] Lindsey Dinneen: That's right. That's right. Absolutely. No, I love that. So just out of pure curiosity, when you were, say, I don't know, seven, eight years old, could you have possibly imagined becoming an engineer and/or doing what you do now, which is so much even more robust?
[00:18:18] Brent Lavin: Oh my gosh, Lindsey, I love this question, because I couldn't, you know? I didn't. I grew up in small town USA and you know, I, I was really focused on it, you know, being the best at any single sport I could play. I, I was just a ball kid and, and but I loved entrepreneurship. And it's funny you say this because I think in high school, you know, they have those like, "What are you gonna do when you grow up?" I wanted to own a sports bar. And yeah, so like I wanted to help serve good food and, and just have a lot of TVs around and and be an entertainment spot.
But I just kind of had that entrepreneurial, you know, itch. And so I, I pretty well knew I was gonna be an engineer just because I was good at technical things, and I loved it. Like, it wasn't work to me. But I didn't even understand what medtech was. And I was 22 years old in my first engineering job. I was six months into the job, and I ended up in the ER on the weekend, and excruciating abdominal pain. And they ran a CT scan, and they found the problem, they relieved the symptoms, they sent me home, and they said, "You need to see the surgeon on Monday morning."
Not really understanding what was going on, but I distinctly remember being in that surgeon's office the next week and seeing the axial image of the CT scan on the light box, like the physical light box back then. And I was fascinated. I was fascinated that they chopped my body like a loaf of bread, and within about 30 seconds they could identify the issue.
And you know, the surgeon said, "Y- you have this recurrent diaphragmatic hernia, and you're gonna be in surgery in two days." And so I was not scared. I was more fascinated than anything, and that is what crystallized, you know, my need to get into, to medtech. I didn't even know it existed, but I said, "I wanna go do that."
And if you fast-forward about five years, there I was working for GE Healthcare, you know, the maker of those CT scanners. And so, I think medtech is really hard. It is not the most glamorous industry. So we all need that why, and for me, again, that Monday morning in the surgeon's office is my why.
[00:20:31] Lindsey Dinneen: Hmm. I love that. Yeah, and I love that that's your why, and sort of a follow-up question to that then is, are there any moments that stand out to you along your journey being in medtech that particularly reinforced to you, since making that decision, say, that you are in the right place at the right time?
[00:20:52] Brent Lavin: Yeah, and, and I don't mind talking about this. I'll tell this other story. About 12 or 13 years ago, I ended up learning that I had an autoimmune condition, and if you fast-forward, I, I was on some pharmaceuticals, and I've recovered, and I'm all back to normal, but I still live with that. But you go to today, and there are neuromodulation solutions that are addressing autoimmune conditions. And so we're now giving patients a choice between a device-based intervention and a pharmaceutical intervention or a pharmaceutical treatment.
And I did not love those pharmaceuticals. They, they had certain side effects and I didn't wanna be on them the rest of my life. Now, I've weaned off of most of them, but patients today are getting an option for a device-based intervention, and so that's what medtech is about. And so when I hear stories of like th- like this, I'm like, "I'm exactly in the right place." And so, there's so much opportunity for us to innovate and impact pa- impact patient lives whether that's ourselves, you know, our family members, or people we may never meet.
[00:22:03] Lindsey Dinneen: Yeah. Yeah, thank you for sharing that story. That's-- it's incredible to see. I think one of the best parts about being in the industry is getting to feel hope on a daily basis, yeah? 'Cause there's always something new coming out. These, like you said, medtech is really hard. There are a lot of really tough days, sometimes very not glamorous, and you just... if you have that why, that helps pull you through those days. But I really love what you touched on there of how those innovations that are coming through, that is reason for hope and just optimism again, especially in a, in a world that needs that really badly.
[00:22:45] Brent Lavin: Yeah, I think it's easy to be cynical about healthcare. But I guess I choose hope. And yes, we have some structural things that we need to work through. Yes, we have a reimbursement climate or regulatory structure. But to me, that's just a great puzzle, and the, the innovations that do have an impact, not only on healthcare patients, but also economics, are the ones that are gonna win. And so I don't mind that it's a high bar, you know? And so, that just means that we need to all be a little bit better, 1% better, and continue to make a difference.
[00:23:20] Lindsey Dinneen: Yeah. No, that's, that's so great. I really love that. Okay, so pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach?
[00:23:41] Brent Lavin: Yeah. I love that you asked this question, and I could go a lot of different directions. I, I think I'm gonna say, you know, I would love to teach the process of structured customer insights. And so I'm thinking back to the whiteboard of an early stage and then throughout the con- the, the journey of a company. But I think there's a big gap between asking questions to learn and asking the best questions that can ultimately influence your business decision. And so it's not only what you're asking, it's how you're asking it, why you're asking it, and then doing the proper follow-up during the conversation in order to learn the true insight.
And so I love baking and I love barbecue, maybe back to my, you know, sports bar dreams. But I think there's a big difference between following the recipe of a baking, you know, process, and doing barbecue, which is very process-oriented and no two things are the same. And so I think we need to approach customer insights a little bit more like barbecue, where you definitely have a goal and a process, but you're willing to adjust and make the changes as you learn in order to affect, you know, the business decisions.
[00:25:06] Lindsey Dinneen: Hmm. Yeah. Okay. I really like that. I also like the illustration of the barbecue analogy. That's, that's fun. So okay, so I do have to ask a follow-up question then. So how did this skill set come about for you? Is this something that you, you learned, say, during observations? Or how did you develop this, this masterclass, shall we say?
[00:25:28] Brent Lavin: Yeah. I, I think it's, some of it's through my own kind of learning in having conducted just hundreds of physician interviews. And I think, again, early in my career, I used to go through a questionnaire step by step and, and I'd get to the end and I'd have a report, but I may not have the insight. And I think as, again, as I became more comfortable with that process, I would, I would take U-turns or I would take the fork in the road, depending on where the physician was going, and continue to learn maybe not something that was on my roadmap, but something I still needed to learn.
And then as I became in- came into leadership, I, I think I just saw it again with early product managers that wanted to follow a recipe and wanted to check a box toward customer insights rather than, again, truly getting in the customer's shoes.
I think one of the most fun things of my job in upstream and innovation marketing is when I can interview enough physicians about a particular narrow procedure or product concept, if I can interview enough of them, s- typically between 20 and 30, depending on how complex, and I can start to think like them. And that's the ultimate of a product manager, is to think like the physician.
Again, it all depends on how complex the procedure is and whatnot, and we should always be striving to learn. But when you can achieve this secondary kinda personality that mirrors what you've heard from all of these conversations, there's nothing better.
[00:27:10] Lindsey Dinneen: Really cool. Okay, excellent. Thank you All right. And then how do you wish to be remembered after you leave this world?
[00:27:19] Brent Lavin: Wow. I haven't thought about this in a while. I think, how do I wanna be remembered? Obviously, you know, for my family by, like, leaving, you know, a good family legacy, and also just, I showed up. I just put my shoulder down, did the best I could, certainly wasn't perfect. But I tried to just do the best with what God gave me, and it happens to be in the medtech world right now. And I think I'm uniquely gifted for where I'm at. But I still wanna make more impact over, you know, the next couple of decades.
[00:27:55] Lindsey Dinneen: Mm, mm-hmm. Yeah, absolutely. Okay, and then final question. What is one thing that makes you smile every time you see or think about it?
[00:28:06] Brent Lavin: Yeah, I, I guess I gotta just go back to my family right now. I got four teenagers, you know, and we're just in an awesome period of life, and I was traveling last week, and just being able to come home, you know, see my wife, see the kids, can't help but smile. So, you know, my two boys are twins, are graduating high school, and those days are, are kinda short, so I'm just trying to soak up every minute of that right now.
[00:28:30] Lindsey Dinneen: That's wonderful. I love that. Well, this has been a really great conversation, Brent. Thank you so much for joining me today. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. I'm grateful for you and for your impact on the industry.
[00:29:07] Brent Lavin: Well, thanks for this conversation. I've really enjoyed it, and I, I can't wait to continue to stay in touch.
[00:29:11] Lindsey Dinneen: Absolutely. Thank you so much.
[00:29:14] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Allison Komiyama, a consultant and senior regulatory strategist at DuVal & Associates and founder of Bluestocking Health, shares her journey from neuroscience and an FDA reviewer role into regulatory affairs and consulting. Allison explains why companies should educate FDA about their device by telling a compelling, respectful story, and discusses why “getting through FDA” is often the starting line. She highlights the post-clearance work of launch, adoption, and promotion while staying within FDA marketing rules. Allison also reflects on leadership, relying on community and advisory boards, her volunteer work, and the moments that affirm her impact when devices reach patients. 
Guest links: https://www.bluestocking.health/ 
Charity supported: Feeding America
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPTEpisode 083 - Allison Komiyama
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Allison Komiyama. Allison is a consultant focused on getting medical devices to market and helping them stay there. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about the regulatory submissions as a faculty member at SDSU Global Campus.
She received her doctorate in neuroscience in 2009, was an FDA reviewer from 2010 to 2011, received her Regulatory Affairs Certification US in 2014, and became a RAPS Fellow in 2024. Throughout her career, she's been actively involved in hundreds of pre-submissions and pre-market submissions for a wide variety of medical device companies.
She recently started a medical device hype company called Bluestocking Health, where she continues to elevate and amplify the message of exciting technologies entering the market. She's also a senior regulatory strategist at DuVal & Associates, where she helps companies navigate the FDA pre-market process. Alright, well, welcome to the show. I'm so glad you're here today.
[00:01:59] Allison Komiyama: Thank you so much. I'm so glad to be here.
[00:02:02] Lindsey Dinneen: Well, I've been looking forward to this conversation very much. I got to meet you, I think it was maybe last fall, and it was after watching a video where I believe you were chopping wood while explaining a medtech concept, I and was like, "I have to meet this person."
[00:02:21] Allison Komiyama: I like that that is how we, we, yeah, that you were introduced to me is through a wood chopping video. But yes, that was me. I love... I am a lumberjill, so yeah.
[00:02:31] Lindsey Dinneen: See? And we will get into this, let's start with just a little intro into who you are, your background, and what led you to medtech.
[00:02:39] Allison Komiyama: Sure. So background's actually biology, neuroscience. Left academia after graduate school and went and worked at FDA. I was just there for a brief period of time, but it was very instrumental in having me understand what I wanted to do with my life. I knew I loved regulatory affairs. I knew that I loved med devices and the intersection of medtech and innovation and regulatory and, and, and, and, and, right? Like, so all the things I was just super excited to be part of this space.
But after leaving FDA, sort of tried to figure out what... You know, did I wanna work at a company? Did I actually wanna be at a specific industry job? Tried that on. Tried that hat on for a little over a year at an IVD company and just sort of missed all the stuff I got to work on at FDA. So I kind of saw it as the second-best thing after FDA is to go into consulting. So really worked with a lot of startups and companies that were bringing their technologies to market, and yeah, never looked back. I did sort of change positions over the years from going from a small consulting company to my own consulting company to a large consulting company, and now I'm sort of back at a, a smaller regulatory law firm. It's not that small, but, you know, 15-some people at DuVal & Associates working with companies that need help with strategy and regulatory support as well.
And also started my passion project, which is Bluestocking Health. It is a medtech hype company, is what I call us. And we really work on helping companies after they've made it through FDA onto what... you know, what does, what does their launch look like? How do they get people to adopt their technologies and not sort of flounder and, and fail, right? So I, I love seeing really cool, nerdy, geeky tech get to market, and I think we all have a sort of inner geek that loves stuff like that, and it's my happy place where I can just kind of talk about those things and share it with patients and caregivers alike.
[00:04:47] Lindsey Dinneen: Amazing. I love that. Yeah, and so much to dive into. But one of the things also I remember, so so I, I watch this video and you're chopping wood, and you're, you're clearly super passionate about medtech. And then I think the next one, were you possibly like baking or doing some sort of maybe chopping?
[00:05:08] Allison Komiyama: Yes. I do flower arranging, so it might've been that one. I, I-- That's a great idea, though. I love to bake. I love protocol, so I think you're onto something. I need to come up with a video maybe where I'm talking about, like, the de novo process and, like, baking a cake or something. So.
[00:05:27] Lindsey Dinneen: Amazing. And you're right, it was flower arranging, and I was thinking at the time, "Is there anything you don't do?"
[00:05:35] Allison Komiyama: Yes. I-- There's a lot of things I don't do or don't even dare to do. Mostly dangerous sports. I, I'm a rower, so I love to row where no one's touching you. You know, like no one... There's no physical contact. You're just in a boat pulling an oar, and it's quiet and peaceful and, you know, also you're working hard. So, but otherwise, yeah, don't want any contact sports in my life. And but there's a lot of things I don't do, of course. I just have a lot of hobbies and things that I enjoy doing.
[00:06:10] Lindsey Dinneen: Okay. So did the idea for Bluestocking Health come from? I mean, I know you explained a little bit about what the company does and who it helps, but first of all, I'm really curious about the name, and second of all, I'm just curious about, yeah, what made you go, "Gosh, this is the right time for this"?
[00:06:27] Allison Komiyama: Yeah, great question. I-- So Bluestockings were... I'll, I'll go first into the origin story 'cause I think it kind of helps explain why I picked up that name. The Bluestockings were a group of mostly women in the 1700s in England who were, you know, kind of tired of sitting around playing card games and, you know, learning new dance routines-- not that there's anything wrong with that-- I love doing all of those things. But they decided they wanted to pursue some more intellectual and intellectually stimulating conversations with people.
So they would invite women and men into their salons to have these conversations, and they would talk about botany and, yeah, science, art, literature, theater, all of the things that sort of sparked their interest. And they would say, you know, "Don't worry about wearing your black stockings," which were, like, the highly fashionable, expensive stockings of the day. They said, "Just come in your blue stockings. It's fine." You know, which were wool and, you know, cheaper.
And I was like, oh, I love that idea of just people getting together, talking about stuff that they find interesting, and having it be like, "Come as you are. Wear your sweats," you know? "Don't worry about getting fancy." And that resonated with me. And so I thought, you know, what I want to build is something similar to what the Bluestockings had, but have it be more medtech or health-focused, and so hence Bluestocking Health was born.
I, yeah, I really... A-as I said earlier, I saw a lot of companies feel like getting through FDA was the finish line, and I s- you know, I would tell them, like, "No, that's kind of the starting line with a lot of what you're going to now need to build." You know? It's-- I, I think historically FDA was seen as, like, the hardest thing to get through, which isn't always the case, right? The, the 510K program is historically very successful with getting devices cleared. You know, FDA does wanna work with you, and that was my narrative and my mantra always was like, you know, "How do you work with FDA to get through FDA?"
And then once you're through FDA, what's next? And I wanted to have those honest conversations, you know, as these companies were considering the product development, their quality system, their regulatory, and, you know, even reimbursement is also part of that post-market conversation. And I wanted them to also think about, "How are you gonna get patients to know about this? Like, what are ways that you can promote yourself and promote what you're doing without misbranding or mislabeling or adulterating anything, right?"
You wanna stay within FDA's regulations and not do anything wrong marketing-wise. But it's also something to get really excited about, and I think we've often forgotten that a lot of these medtech devices do really, really cool things, do really amazing work to help people, help people s- you know, improve their quality of life. Let-- Help them survive, get them to live longer, let kids actually make it to adulthood, right?
So there's so much good that I wanted to amplify that more. I wanted to get people to not just focus on the negative, right? There is, there is a lot of harm that can come from any sort of drug, device, anything, but there's also a lot of good. And so I think especially right now in the world we need more good things to talk about. Not that I wanna, you know, look at everything through rose-colored glasses. But I do think if we can focus on some of the good that's going on in the world and the things that we have in common, what a great conversation to have.
[00:10:14] Lindsey Dinneen: Oh, yeah, I couldn't agree more. And I love the fact that and you're so much fun. You're helping these companies also get excited too, because I think sometimes it's really easy-- I mean, we need to take our industry seriously. It's a serious industry and real life consequences, good and bad, from innovation...
[00:10:29] Allison Komiyama: Yes.
[00:10:30] Lindsey Dinneen: ...But I think you know, we've, we've talked a lot about this recently, even ar- along amongst just some of my colleagues, is like we're gonna take, we're gonna take our actual work very seriously, of course, but we're gonna not take ourselves super seriously. We're gonna have fun. We're gonna celebrate. We're going to each other why we're here and why we're doing this, 'cause otherwise it can get easy to get kind of bogged down in the, the nitty-gritty.
[00:10:52] Allison Komiyama: Oh, it's so easy to spiral. I-- And I feel like a lot of media allows us a-and, and capitalizes on that doom scroll/spiraling of, "Oh gosh, everything's bad." And I wanna be informed, but I also, as you said, I don't wanna take myself that seriously. Like, I have so many hobbies. I laugh a lot. I have really great conversations with people, and I think that's what I, you know... the legacy I wanna le- leave behind is that I made the world a little better than when I started here. And also that I had a lot of joy to share. So yeah.
[00:11:31] Lindsey Dinneen: Okay. So I-I'm curious, going back to your days at the FDA, what are some of the common things that you saw where perhaps there's either a misconception about the process of approval or just mistakes you might have seen that were kind of common that maybe those who are listening who are trying to, you know, get through it as, as easily as possible could benefit from?
[00:11:54] Allison Komiyama: I think one of the biggest misconceptions and it wasn't anyone's fault, was that FDA are the experts in what you're building. And maybe, maybe folks knew that that wasn't the case. You know, they walk in and they know that they're living and breathing their technology and their device day in and day out. They've been building it for years oftentimes. And so to think that FDA understands your patient population, understands the, the sensor technology or whatever technology you're building understands your software, your materials, all, all the various things that go into a s- a pre-market submission, is a terrible assumption to make, right?
Not that you wanna treat FDA like a bunch of dummies, that you're like, "Oh, you guys don't know anything. I'm gonna have to start from, you know, square one here to really walk you through everything." But you definitely want to communicate and be able to tell a really solid story to FDA about what you're building or what you've built, and why you believe it's either safe and effective, or why you believe it's substantially equivalent, or why you believe the benefits outweigh the risks.
And so I think if you can be that storyteller, if you can really walk FDA through what it is you've built, and why you think it should be, you know, allowed to enter interstate commerce, you've w- you know, you, you're already ahead of the game. So I think any company that really is trying to figure out what's that first interaction they're gonna have with FDA, whether it be at a pre-submission or just straight to pre-market submission, right?
They're just gonna file the, the, the 510K or what have you. Really making sure that you've explained your product and they know why you're there. Otherwise, you are going to cause more questions than answers from FDA, and that's a big concern when you have somebody who doesn't understand what you're doing or why you've built it the way you've built it. That can really set you back.
[00:13:56] Lindsey Dinneen: That's great advice. So, so being really prepared to kindly educate while telling the story, but you know, doing so, of course, in a, like you said, a respectful way. But, but having those answers ready, having the narrative really thought out so that you can walk in with that authority, but also explanation and storytelling. Yeah. Okay.
[00:14:19] Allison Komiyama: Exactly. Yeah. It is. I mean, I always my-- I've actually, I have a podcast that I f- a few of my guests recently, they've all been expert or experts in how we tell stories, which I love even just... I mean, how we tell stories to our children is very different to how you tell a story to a colleague at work or, you know, the... and there's a way that, once you know your audience and once you know what it is you're trying to convey, there's a very clean path that you can follow. I'm still working on it. I have to, I have to confess, I am not a great storyteller. I have a tendency to get sidetracked and off topic, probably like what I'm doing right now. But, but you know, bringing it back and, like, what are, what are we trying to do? What are we trying to accomplish? And that I think that storytelling is really valuable when you have FDA as your audience.
[00:15:15] Lindsey Dinneen: So I know, like you said, you have many hobbies and lots of things that keep you occupied, but you also do a lot of volunteering for boards. And I was wondering if you could share just a little bit about some of that experience and what you're passionate about there.
[00:15:29] Allison Komiyama: Yeah. I think I've always been a big fan of volunteering. I think it's one of the ways that I I meet new people, I get involved in s- things that are outside medtech, which I think is extremely valuable. There's so many voices that even if it's not directly in medtech, everyone's impacted by medtech in some way, right? Like I always say, "You're either gonna start in a hospital or end in a hospital, and you're probably gonna go into a hospital at many different times or use a medical device, whether it be on your phone or, well, while you sleep or," you know, for any-- I don't know, there's a million purposes that people use medical devices.
And I wanted to have more voices around me that that are, that are helping humanity, but in a different way. So, one of the boards that's always been near and dear to my heart, of course, my rowing club. I love... It's the oldest women's rowing club in the world. It's called Slack Rowing Club, based here in San Diego, and I help with a lot of the programs, but also fundraising, membership, and just, you know, having this really dynamic group of 400 women that some of them row, some of them are just there to be part of a community and help each other, which is pretty marvelous.
And we do a lot of actually talks. Like we'll have a speaker series and we'll bring in physicians or we'll bring in people who are talking about sleep and perimenopause and menopause or, you know, various topics that definitely impact our our cohort. It, it's actually kind of similar to Bluestockings, like the original Bluestockings, where we'll have someone come in and talk about architecture. Like there's various things. So I love doing that. It's also-- They're-- The members are from like 12 years old to 102 years old. It's pretty amazing, and just, like, this great dynamic group of women who are fun to volunteer with and also sit in a boat with.
The other one that I've joined last year was the International Relief Teams, which works on helping bring some sort of relief to an emergency situation, whether it be floods or fires or famine or war. Like, there's, They partner-- We partner with different organizations that are, like, boots on the ground in those areas to either build houses or get m- meals or get water to where it needs to be in an emergency. So IRT is fantastic. They get, like, one of the highest ratings of nonprofits.
The other one is Indy Medtech. Really cool. That's a very medtech-based one. It's a virtual board, but it is building a community of medtech suppliers and people who are just needing support from each other or you know, either hiring or, "Hey, I have a question. Can someone help answer this 'cause I don't know where to go to get the answer to this?" So really cool, and they, they're doing a podcast as well. I love it.
And then last but not least is the San Diego Regulatory Affairs Network. So I have been in San Diego, moved here back here, I should -- i'm from San Diego-- but moved back here in 2011, 2012, and I joined the San Diego Regulatory Affairs Network. It's the SoCal... Like, there's a similar one in Orange County, the Orange County Regulatory Affairs, so OCRA, and then there's also, of course, RAPS, and there's a Southern California chapter. And it's just a group of regulatory folks that love to meet up, love to support each other. "Hey, I have this job opening coming up. Hey is there a mentee that would like a mentor?"
And so I'm now the VP of programs for that, and once a month we try to have a speaker either virtually or in person. There's gonna be some in-person ones. And I love it. It's just a great way to network, to support each other, and also to learn more cool stuff going on in regulatory. So yeah, that's a smattering of the ones that I'm part of. So, you know, as, as you said, like, it's kind of like they're all over the place, but it definitely makes me feel more connected with humans, with our-- you know, like, and, and not doomscroll. I'm, I'm too busy to doomscroll. So.
[00:19:44] Lindsey Dinneen: That's, that's a good thing, I feel like. So, I love that. Okay. Those are g- those are such cool organizations. Thank you for sharing a bit about them.
[00:19:51] Allison Komiyama: Yeah. Thanks for asking.
[00:19:52] Lindsey Dinneen: Yeah. So all right, I'm curious. Going back, could eight-year-old Allison have ever imagined what you're doing now?
[00:20:02] Allison Komiyama: Never in a million years. Yeah, I think I, I knew I loved biology and bugs and science at a very young age, so I knew that I was probably on that trajectory. But if you asked eight-year-old-- or actually, I-- if you asked five-year-old Alison what she wanted to be, the first was hummingbird, and I did... That did not pan out.
[00:20:29] Lindsey Dinneen: Dang it.
[00:20:29] Allison Komiyama: But and then I would say florist 'cause I love flower arranging, so that is something that I've s- I've kept up with, as you said, like you saw the video of me arranging flowers. I still love doing that. I, I enjoy that creative outlet. But not in regulatory. I didn't really know that regulatory affairs existed as a career especially until I was 26. I mean, which is crazy to think, like I was in grad school, and I took a course on the history of FDA, and I was like, "What is this? This is so exciting, so interesting." And I knew that was something, that something along those lines is what I wanted to do with using my biology and, and neuroscience background, but also how do I maybe get closer to medicine in a certain way? Like, I, I didn't wanna be a medical doctor, but I knew I wanted to help people. Like, I think most people wanna help people. And that was, that was the right pivot for me at that point.
[00:21:32] Lindsey Dinneen: Amazing. So, all right. So you've had a bunch of different leadership positions now over the years. And of course, you have led your own company now a couple different iterations, I suppose, of, of what you've been doing. But what has that leadership journey been like for you, especially perhaps how different it is between working for another company where you might be in a leadership role versus leading yourself and your company?
[00:21:56] Allison Komiyama: Great question. I-- what was it, what's it been like? I would say there's like equal parts fearlessness, excitement, and terror. I don't know, like I-- maybe those are all kind of, of the same like ilk of those, those feelings. My daughter always says, she's like, "I'm nervous and I'm excited," like before she goes on stage in the talent show, and she's like, "I'm nerve-cited." And I, I, I use that a lot now too 'cause, you know, before I give a talk or before I you know, go on a podcast like this, I'm like, "I'm nerve-cited," 'cause it's gonna be something that I haven't done before, right? Every day is a little different and... But it's also exciting to do. I
Yeah. I, I feel like it was not always easy. Like, people are like, "Oh, you made it look so easy and, and just, you know, seamless." And oof, there were moments that I really struggled. It's... You know, there have been times that I really relied on my family, on therapy, on my friends to really help me. And even just, you know, something as simple as I had a friend who made my first website for me. He was like, "You're so busy and stressed," like, "Let me help you." And so I think calling on others and really having people be your community that you've built, right? Like, I think sometimes we try and go it alone, and maybe that's the worst thing to do when you're building something 'cause you really need to rely on others to help you out. And so I've had, you know, I've, I've, I've worked really hard on my network and to build the friends and colleagues that I want to surround myself with, and then I have reached out to them when I knew I need them.
So I, for example, I think with Bluestocking Health, I... When I was-- Before I launched in last year, so September of 2025, I called a bunch of folks that I really trusted to tell me if I was going off course or to also help me build stuff. And my advisory board for Bluestocking Health is amazing. Like, they're not all in regulatory, 'cause that's not what I wanted to build. They're in media. They're in quality system, reimbursement, business strategy. Like, there's such a diverse group of folks that will also help be my sounding board, right?
Like, I had a couple medical doctors that I reached out to that are on the advisory board that I was like, "I'm thinking of doing this. Can you give me, like, your thoughts pro/con?" And they always are so willing to help, right, if they have the time. It's been extremely rewarding. So I would say that leadership journey, again, not the easiest at times, but also when it gets hard calling on those friends to really support me has been really marvelous.
[00:24:49] Lindsey Dinneen: Yeah. You know, that's such an interesting thing because this has come up a lot, especially in the last few episodes and just conversations I've had in the industry of the importance of community and mentorship and surrounding yourself with those good people who you can call and go, "Okay, I have this, I have this, I think maybe crazy idea. What do you think?" Or just, "Hey, life is a little tough right now. Can we just, can we just talk?" So that's...
[00:25:15] Allison Komiyama: Yeah.
[00:25:15] Lindsey Dinneen: ...Really cool.
[00:25:17] Allison Komiyama: Yeah. Absolutely
[00:25:19] Lindsey Dinneen: Yeah. Okay. So as you've gone through your career, and especially within the medtech industry, which seems like you've really just, you know, fell in love with and, and stayed, so that's wonderful. Are there any moments that stand out to you as really affirming that, "Yes, I am in the right place at the right time"?
[00:25:40] Allison Komiyama: I think every clearance De Novo granting that I've ever been part of, even if my name's not on the file, has been one of those moments where, oh, it feels so good. It feels so great to see those companies make it through FDA. And then also, you know, to the next point or d- you know once they are selling and they're, they're helping patients, I've had clients reach out to me and say, "I just got this amazing testimonial from somebody and I wanted to share it with you because you were part of that journey." And oftentimes I'll say, "Can I share that with the FDA reviewer that helped us 'cause they're still there and I really think that they would value that, that piece of information, just that commentary and that validation."
I mean, w- I've had ones where the testimonial was like, "Because of this device, my kid is alive today. My kid would have been-- would have died two years ago if it hadn't been for this product." And like, I even just got chills. Like I-- honestly, it feels like even though I'm not a medical doctor, even though I was, you know, integral maybe in putting their 510K together or their submission together, and I've never touched the device necessarily, I feel so rewarded that it's like, we did it. We did it together, right? And I, I wanna share that with others.
I think that's part of what I'm trying to do with Bluestocking Health is like we all are part of this community, and it's not that we just like clock in and we, you know, do document control or, you know, work on our risk assessments and, you know, clock out for the day. It's like, no, we, we do all help save lives, right? What a, what a powerful thing to be part of and to know that that's, that's something that you helped do. I don't know. I, I-- maybe that sounds again a little too like look how great we are. Like how, you know, look at, look at how amazing this space is, but oh, it is. It 100% is, so.
[00:27:43] Lindsey Dinneen: No, I could not agree with you more. I've, I've always felt the same way of just like, "Okay, I'm, I'm not the scientist, I'm not the engineer, I'm not the regulatory affairs person. I, you know, I play a very small role. I, I help talk about the devices." I sh- you know, the marketing...
[00:27:59] Allison Komiyama: Yes.
[00:28:00] Lindsey Dinneen: ...And that's, you know, that's, that's not the biggest component of bringing these devices to market by any stretch of the imagination. But I do get to play a role, and I think that is the coolest thing ever. Yeah.
[00:28:12] Allison Komiyama: Yeah. Well, and think of-- I mean, I'm gonna be your hype woman for a second because think of all the people who learn about that tech or understand, "Hey, this might be something right for me or my loved one, and if I hadn't learned about it or if I hadn't you know, been exposed to this idea or even knowing that this is in clinical trials, okay, now I'm gonna go look into the clinical trial." Like, that information sharing and even just talking to people or talking to laypeople, like, there's such an important piece of the marketing and the strategy around that, that it's huge. I-- you know, like, directly or indirectly, you've saved a life, right? How cool is that?
[00:28:56] Lindsey Dinneen: Yeah, exactly. How cool is that? It's, it's remarkable. Okay. So, all right. Pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want.
[00:29:09] Allison Komiyama: Ooh, yes.
[00:29:10] Lindsey Dinneen: What would you choose?
[00:29:10] Allison Komiyama: I mean, all of the things in my header, I think at LinkedIn. So I lo- but I'll, I'll give you a real answer in a second. I think, I mean, all of the... I love my creative outlets. So I love flower arranging, I love face painting, I love chopping wood. I love cross-stitch and needlepoint, and my daughter and I just started doing crocheting together. So I feel all of those things are so I... Not that I'm a master in any of those things, but maybe it's being willing to try new things or having that, I don't feel, I don't consider myself to be a totally fearless person, but maybe channeling some of that fearlessness and a willingness to try new things, and where do we find that and how do we kinda overcome some of that activation energy sometimes to get to try those new things?
And I think innovators have that in spades, right? So a lot of the companies that we work with, they're like, "I have an idea, and I don't know if this is gonna work, but I'm gonna go for it." And I think a lot of those cre- it, it's a creative outlet for them as well, right? They're trying something new. And so maybe it's giving people more more support or more confidence that they can try new things. I feel like I don't love change. Like I, I, as a child, I like, I liked the things that just stay the same. But when you look at my arc and my, my origin story, it has been all about very unsettling moments or, you know, like where I was felt, feeling very unsettled or like trying something new, and I'm so grateful for all of those things, and I'm also really grateful that I did it, right?
So a- and again, it came down to a lot of my community, my friends, my family that supported me and said, "Yeah, you can do this," right? Having those hype people to help me. So maybe a masterclass in just like being the hype person for people who wanna try new things and try leadership, right? Or try a new path that they hadn't thought about yet.
[00:31:24] Lindsey Dinneen: Like, I think to your point too, the more that you're willing to do that and kind of step a little bit outside of your comfort zone and have that potential for quote unquote "failure." But, you know, first of all, the more you do that, the more resilient you get, which means it's easier and easier and easier to take those first steps, right, into something new.
[00:31:43] Allison Komiyama: Yes.
[00:31:44] Lindsey Dinneen: But I also think-- I, I often think about it in terms of if you can frame those kinds of moments as "I am exploring, this is an exploration" and not like pass-fail, if you're exploring, there's, there's no chance of failure, right? You can, you can explore something and go, "Ugh, not for me," or you can go, "Oh, I actually love this, but it's hard and I'm gonna have to keep working at it." But I think if you can like kind of maybe take it in a slightly different mental direction, that also helps, you know?
[00:32:13] Allison Komiyama: Ooh, I like that. Yeah. Like reframing. This is not, this is not something that's gonna, you know, end in failure, 'cause I agree with you. You know, I've called it failure in the past where it's like, "I'm gonna try things. If this fails, then I'll go do something else," right, which then it's not really a failure. You learned something. But it is being able to change directions. It is the ability to say, "Okay, I figured out that I something from that, and then what am I, what am I gonna do with that information?" So I love that.
[00:32:48] Lindsey Dinneen: Oh, that'll be a masterclass. I can't wait. okay. And how do you wish to be remembered after you leave this world?
[00:32:55] Allison Komiyama: Oof. I hope I... It's, oof. I, I, I hope to be remembered. Yeah. What does my dash look like? Isn't that what they say? Like, what is the dash between the, the birth year and your the year of your death? I definitely wanna be remembered for, like, what my kids are doing, 'cause I'm pretty proud of, like, how badass both of those girls are. But back to your question. I would like to be remembered as somebody who helped innovators and people who were building in the medtech space to grow their brand, to get their message out there, and to really bring awareness to the benefits of medtech.
I think it's so easy, as I said earlier, it's very easy for us to get caught up in the bad and the negative, and here are the risks, and we really are so nervous about the risks of things, as we should be. We should be a res- risk-averse population. Like, they-- I don't wanna be walking towards something that's gonna cause me harm. And at the same time, there's a lot of benefit to what we're doing, and I think if we can I guess what we were just talking about, reframe a little bit and say, "Yes, there's risk. There's inevitable things that are gonna happen, but here's the potential benefit," and how do we h- in a human way, weigh those things so that we can get other people to also see that this is something that could benefit them.
So it's sharing that message. I wanna know, be, you know, considered somebody who also didn't take herself too seriously, made people laugh. You know, maybe they showed their, their kid a, a video of me doing something silly, but also maybe there's some kid out there that's like, "Oh, she was talking about regulatory affairs. What's that? Maybe I should look into that as a career option." So, yeah, I hope some of it is inspiring to others.
[00:34:48] Lindsey Dinneen: Okay. That's, that's great. And then final question: What's one thing that makes you smile every time you see or think about it?
[00:34:59] Allison Komiyama: I wanna say my kids, but really it's probably hummingbirds. I have never lost the total fascination with hummingbirds. They are so interesting. They're so beautiful. There's a lot of them here in San Diego where I live, and I kid you not, last year, a mother hummingbird built her nest right outside of our front door. And so we'd have-- we told our guests, like, "Come through the, the side gate 'cause do not walk close to, to our sweet hummingbird." And she laid two eggs, and I was able to watch these two little hummingbirds grow and fledge. And I... It was just one of-- again, it makes me smile every time I think about it. Every time I see a hummingbird, I'm like, "That might be our girl that, that had, that had her nest right here." So yeah, I think that whimsy, the, the, the fun and just how gorgeous they are. They always bring... sparks me joy, for sure.
[00:35:58] Lindsey Dinneen: Absolutely. Me too. I adore hummingbirds. One of my favorites. Yeah, love that. Oh my goodness. Well, this has been an amazing conversation. Allison, thank you so much for taking time today to speak with me, and we are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support. Oh my gosh, and just thank you so much for everything you're doing to change lives for a better world. We're grateful for you.
[00:36:42] Allison Komiyama: Thank you. It's so nice to be here. Thank you so much for having me on.
[00:36:45] Lindsey Dinneen: Absolutely. Until next time.
[00:36:49] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Dr. Amel Havkic, founder and Managing Director of EvoMed Consulting and a practicing physician, unpacks why so many amazing medtech solutions never reach the patient bedside, along with advice on how to change that. Driven by frustration from frontline care, Amel built EvoMed to guide companies from development through real-world clinical adoption, and shares how his MBA research became the StarMap framework: seven success factors spanning workflow alignment, implementation friction, ecosystem fit, quality of care, and economic viability. He explains why staying in clinical practice matters as medical knowledge rapidly evolves, offers a real example of digitalization increasing clinician burden, and discusses AI as “augmented intelligence” that supports—not replaces—human decision-making. 
Guest links: https://evomed-consulting.eu/ | https://www.linkedin.com/in/a-havkic/ | https://www.instagram.com/evomed_consulting?igsh=aTlyaGVmeXYybGt3
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPTEpisode 082 - Amel Havkic
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to another episode of the Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome my guest, Amel Havkic. Amel is founder and MD of EvoMed Consulting, Department Head for Weaning and Home Ventilation. Dr. Amel is also a consulting medical director for many companies, apart from being an educator, mentor, author, and currently working physician.
All right. Well thank you so much for being here. Welcome to the show. I'm delighted to talk with you today.
[00:01:23] Amel Havkic: Thank you so much. It's a pleasure being here, and thank you for having me.
[00:01:27] Lindsey Dinneen: Of course. I'd love if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and what led you to medtech.
[00:01:37] Amel Havkic: Okay, so my name is Amel Havkic. I am still a practicing physician. But on top of that, I'm a advisor in medtech. I am in medtech since something like six, seven years, and it actually came from the frustration that I had in everyday work on the patient bedside. I was already consulting some medtech companies on specific topics. And I've seen this huge gap between amazing medtech solutions which, however, for whatever reason, never made it to the bedside. So I ended up, I ended up fund founding EvoMed Consulting consultancy, which helps medtech companies with clinical adoption, pretty much helps them guide from the development all the way to the patient bedside. The solutions really getting adopted, really having an impact. We've had quite some success with this. We've been named best Market Access Consultancy in '25 in medtech. I personally also celebrated recently award for Best Rising Star of the industry. And yeah, all of this came from the idea that I wanted to see a world where no patient is left behind and independent of geography or economy or economic status. Every patient gets the best care imaginable. And yeah, what better way to deliver that than medtech, right?
[00:03:05] Lindsey Dinneen: Yes, that was the perfect plug for medtech right there. That was excellent. So first of all, congratulations on all of your success and these recent achievements. That is really exciting and incredible and I, I know that your motivation goes obviously so much deeper than that, but I love the fact that you're getting recognized and it's, it's nice to have those moments of affirmation, so.
[00:03:31] Amel Havkic: Yes, it is. I said it on the interview, which I got after the, after the award. It's not even about the award itself. It is actually about what I stand for and that is the human side of medtech. I mean, it is technology, but we're still doing it for humans. And as a doctor getting recognized and not as a founder, it is something it, it is a signal. So that's the, I think that's the positive, the good part about it, and that's what makes me proud.
[00:04:03] Lindsey Dinneen: Yeah. Yeah, absolutely. So did you always have an interest in medicine? Did you always think you were gonna go this route?
[00:04:11] Amel Havkic: In medicine, yes. I think as far as I can remember, thinking I wanted to be, I wanted to be a doctor. I was trying to cater to wounded animals as a, as a kid with, I don't know, four or five, six years old. Then I went to med-- no, before I went to med school, I was doing basically nursing school. I grew up in Bosnia, in Sigovina There it's after eighth, eighth grade, you decide what you actually want to do. So I decided I wanted to go into medicine and at that time, Dr. House came out and or house MD in, in the English, English terminology. And I was a huge fan. So that was pretty much my, my route was set from that. I was al also always tech savvy, so if I wouldn't have done medicine, I would've probably done IT. And at one point it kind of merged.
[00:05:09] Lindsey Dinneen: Wow. Okay. All right. So Dr. House, I can totally understand why that became an, an inspiration. Do you have any examples that you could share that are like, is, is the medical world ever as wild as some of those stories on Dr. House?
[00:05:27] Amel Havkic: Oh yes. Oh yes. It is specifically. So besides working in the hospital, I work in a private practice, and funny enough that private practice is focused on difficult to diagnose and rare diseases of, obviously for, for that reason. I was also working in a hospital department, which was working with with or in discovering rare diseases specifically when it comes to, to respiratory diseases. So, yeah, it is like that.
I can share a story of one patient, which came to me because she had thoracic pain every now and then. And it was reoccurring, came again and again. I did an ultrasound, and so she was at a cardiologist, she couldn't find anything. The, the whole thing. And it, I did an ultrasound of the chest and I found a, a little a little mass, which is not supposed to be there. So I sent her to a CT. Funny enough, the CT came back negative because it was so small that you couldn't see it on a ct. However, when you know exactly where to look, you could still like see outlines of it. And then in the, in the discussion came out that she had an endometriosis at one point. So, we said, "Okay, this might be somehow connected." We took a tissue sample, so in the end it was indeed an endometriosis, which got discovered after 20 plus years of or, or 10 years of, chest pain every now and then. So, it's just one of the examples of the, of the, so yeah, it's Dr. House specifically is quite realistic.
[00:06:57] Lindsey Dinneen: Oh my goodness. That is wild. I, wow. Okay. That is, that is really cool. So, so do you also have these these moments, I could just imagine you just feel like you've solved a mystery and you can help this patient and you know exactly how, is that just like the best feeling?
[00:07:13] Amel Havkic: For, for me it is, for me, it is, I always have to describe or, or tell to my assistants in a or, or not assistants, my residents. Please don't misunderstand me. I get excited by this, not because I want the patient to be sick, but because first of all, we find a way to help after so many people could not. And yeah, just for the pure love of the game, so to say.
[00:07:37] Lindsey Dinneen: That's amazing. Okay, so, well, I feel like we can go off on many tangents, but I'll, I'll try to, I'll try to stay focused because I, but I love that. I love that. So you're a practicing physician and you're, you're seeing these instances of medical technology that I imagined isn't getting adopted in the way that you know it should, that would have clients or patient impact. So you're, you're seeing this for a while. So did that lead to direct opportunities to consult for some of these companies that needed a physician's perspective or how did, how did that go from, "Hey, I, I, gosh, I'm seeing this gap" to, "Okay, I know where to go from here."
[00:08:19] Amel Havkic: So, it exactly like that. So I was brought into a medtech company to consult them as a clinical medical expert on, at that point, risks associated to their solution. Of course it makes sense to have someone who is still in the trenches, so to say, because the logic behind certain workflows in hospitals or in healthcare environment is not the same logic that it guy would have when talking workflows similar.
So that's how it started. And then a pattern started emerging. When I did my MBA thesis, I basically took, took these two, these two, that, that gap that I saw and made it a topic of my MBA thesis. I was looking specifically on success factors in healthcare and what makes a solution gets adopted or delivery system healthcare path, what makes it get adopted in the real world and what does not.
And what emerged was basically knowledge graph constellation, so to say, of seven success factors. And that constellation also showed how they're connected with each other, so, and how they interact how they impact one another. So I put that to the, to the to the test, the findings, running multiple times the most profitable hospital unit in basically every hospital I went to, starting my private practice, which got profitable from day one. Consulting clients on the same on the same, framework who were able to triple their, their revenue from 30 to 90 million.
And so on, so forth. And ultimately then just about half a year ago, I made the framework public, and that's the StarMap framework which is the moment when everything kicked off. So everything I I said after all the awards and all the recognition came after I shared what I've been holding back up until that point.
[00:10:25] Lindsey Dinneen: Okay. Alright. Wow. All right. Can you share a little bit about this framework and what makes it so unique and impactful?
[00:10:34] Amel Havkic: So what the eye recognized is that it works because it's basically backwards engineered. I had the benefit of hindsight and had the benefit of seeing the solutions, which really made it to, to the patient bedside. So this is a challenge that many medtech companies, specifically the medtech startups face. You know, they come actually from the other side trying to pick one of the hundreds, if not thousands of ways to to, to navigate, to come to that one point where they want to be.
For me, it was exactly the other way around. I was already where they want to be and was able to backwards and engineer those factors.
And it is, when you think about it or when you read through it, it's almost common sense. Factors like specialization, cooperation and ecosystem fit, workflow alignment, predictability of services. But also implementation, friction digitalization, quality of care, and specifically economic viability. So pretty much a 360 view on the, the, on the solution because when you, when you come to think of it, for something to get adopted in the clinic, there is a lot of different stakeholders involved. So it's not just the doctors, it's not just the clinics, it's the insurance companies, it's the the procurement, IT. Does this at all integrate into my ecosystem and so on so forth as a whole bunch of stakeholders and questions that need to be answered. And the StarMap is the first framework, which basically has a, a structured way of looking through all of these.
[00:12:16] Lindsey Dinneen: Okay. Yeah. So this is, this is a framework that you have, I imagine, developed and refined over time as you've been consulting. So when you first started consulting, what are some of maybe the lessons that you learned in terms of being able to really help these companies succeed?
[00:12:35] Amel Havkic: This is a bit more of a personal one because, I founded a consulting company. So my thought I had, I have no clue about marketing. I have no clue about those things. I'm a doctor, right? So, I imagined that what I should be is a consultant, right? After all, I'm consulting. It turns out that the, the biggest impact I could make, in fact as a doctor, because in the end, that's what I am, it's what is most natural to me, and that is what is bringing most impact to the clients.
And then there's one specific thing which I have, which many other consultants in healthcare, also good consultants, don't have. And it is the fact that I'm still practicing. Fact is that today medical knowledge doubles every 73 days. In theory, that means if you are out of the healthcare delivery for 73 days, your knowledge is almost obsolete. It was way less, it was a few years when I studied. And now it's, it's became so exponentially big. What that means is that if you would take a doctor, and make him a consultant, drag him out of the hospital, he would be an expert for 73 days, and that's where it would stop. And this is the, this is pretty much the, the mindset that I adopted and everyone consulting in the EvoMed is still a practicing, practicing healthcare practitioner. So yeah, that's what makes EvoMed specifically different and that's how I saw the world before and how I see it now.
[00:14:09] Lindsey Dinneen: That's incredible. Okay. Yeah. And, and it makes so much sense that if you're practicing then you're, you're needing to keep up on all that. But just on a very practical level, how do you stay on top of so much new information coming out so regularly? I mean, it's not like, you know, you don't have three major career things going on right now.
[00:14:33] Amel Havkic: Yeah, I think by now it's a flywheel, and luckily I, I am the very, in the, in the very lucky position that my, that my hospital knows and accepts what I'm doing outside of the hospital and also supports this. So, I get updated regularly through through people talking to me, reaching out to me, showing their solutions, asking for my opinion. And on the other side, so, so that's, that's what keeps me updated on a regular. And on the other side, I still I still see the challenges that you would have in a hospital implementing those solutions.
So, recently the one specific thing happened, just as an example. We, I, I was involved or I'm involved in a digitalization pro project of an ICU and of operating room. For that they have now from, from paper, from from paper notes, they're switching to digital. Problem is the paper notes they could fill out within five minutes while the digital have all kinds of mandatory fields. And, and it's kind and, and the time it takes a physician to fill out those, those digital forms is six times...
[00:15:47] Lindsey Dinneen: Hmm.
[00:15:47] Amel Havkic: ...More, so it's 30 minutes roughly if you're fast. So although you would think that something which gets digitalized is automatically better, this specific thing proves that just because someone thought, okay, I need this information, it need, this needs to be mandatory. But because the system maybe doesn't communicate with other parts of the system, legacy systems, legacy data from somewhere, it makes the job of the doctor living hell. So you, you can imagine how it is when you have like one person doing, I don't know, 40, 50, 60 pre-medication a day, and then from like five to 10 minutes pre-medication, it goes to 30 minutes, 60 minutes. That's, that's a problem.
[00:16:31] Lindsey Dinneen: Yeah. So yeah, that is, that's, that is so interesting. It's, it's kind of, I suppose that goes into a lot of innovation. There are sometimes, you know, the things that we think, "Oh, well, this is, this is progress" and, and it might be, but just because you can doesn't mean it's always perhaps the most efficient or we should at least stress test it and decide, you know, how to make it the best it can be. So, all right, what are some, what are some trends and innovations that you're seeing that you're really excited about in terms of the future of medical care?
[00:17:08] Amel Havkic: Well, obviously AI is a, is a great trend. I am really hoping that it'll take the, the proper route. I am, I've, I've been saying this a lot and I will repeat it again. When I say AI in healthcare context, I don't like AI as artificial intelligence, but as augmented intelligence, because what it's supposed to do, it's supposed to support our natural decision making process. And a decision in a high stakes environment like healthcare still needs to be in the hands of humans because there's much more to it than just a simple yes or no, or a statistic, or it's most probable that and that is a trend. So, so that is a technology which has huge potential.
But so far, I must say oftentimes I see it implemented in the wrong way. It's trying to automate certain things either not good enough, or at certain points, or in such a way that it's not a livable in daily life or meets resistance. Specifically in healthcare, it's a very inert system because innovation in healthcare is perhaps dangerous is, it introduces new risks. That's why healthcare evolved to be a very inert system and to resist changes unless those changes are definitely proven to be better than what we have right now.
So as an example, we had IBM Watson Oncology, huge player, huge possibilities. But somehow the, the way that Watson Oncology did things was not the way that clinicians wanted to use it. So in the end, they ended up selling it off. And that is just one example of many, many. So what I would really like to see for the future is AI is augmented intelligence, which really is positioned at the right places in a workflow of healthcare practitioners and help support their decisions rather than trying to automize or making them obsolete.
[00:19:24] Lindsey Dinneen: Yeah, that makes a lot of sense. And it's, it's something that of course we hear a lot about, you know, and, and a lot of times I think that what I've been hearing, exactly like you said is, you know, if it can help, if it can help minimize some workflows or make something more, a process more efficient or those kinds of things, that is great help. But I don't think anyone wants AI to replace the expertise and the hands on learning that you do. And, and you obviously every 73 days, like you said, you're constantly building up your, your knowledge bank. And literally having been in the, in the medical setting for so long, you've, you've gotten to see this play out in real life and AI can't do that. So yeah, that's really interesting.
[00:20:12] Amel Havkic: True. What, what it can do however, is just like every other job, healthcare also has a bell curve. So you have 5% or a percentage of the practitioners who are massive under performers, a percentage which are massive over performers, and then there's an average in the middle. And what, what AI can do is it can help even out the bell curve and move it as far to the expertise side as possible. There's also other repetitive tasks which, which can be taken over. So I do see potential in the, I do see a lot of potential in that technology specifically.
But just as another example in my private practice, I have a. I have a AI scribe. It is specific for medtech. It's not something that I misuse, foreseeable misuse, for all the regulatory people. But it is an AI scribe. Still, most of my colleagues are not using it because they say, "Okay, this does not fit our needs. And it is not that specific scribe that we use." You cannot tweak the way how it gives you the output. It's preset. You can optimize certain things, but you cannot, for instance, train on your on the way you like your letters to look, for example.
Then there's errors. So although you think, "Okay, you save a lot of time typing," right? You add at another point another a few work steps with the solution and ending up being shelved again because it's not really helping. Although from the, from the first glance, on the first glance, you would think, "Okay, this is revolutionary."
[00:21:55] Lindsey Dinneen: Hmm. Yeah. Yeah. Okay that. Yeah. So it's gonna be interesting to see how it evolves and how it becomes hopefully even more useful in the future. So are there any moments that along your journey, either as a physician or even as a consultant, are there any moments that really stand out to you as affirming, "Wow, I am in the right place at the right time."
[00:22:23] Amel Havkic: So it happened on, so speaking of the doctor part, yeah. It happened to me quite often. And I was first thinking of it as having bad luck. But ultimately maybe I was supposed to be there. So for some reason I run on a regular, into, into big car accidents happening. And car accidents or motorcycle accidents or so on, so forth, at least maybe 6, 7, 8 of them through, throughout my life with people really being injured and me being there as a first responder. So, so those were for instance, moments where I thought, "Okay, well, I understand this happens once or twice," but now and, and keeps keeps getting more. It's a bit maybe I wouldn't say well, it, it seems that I am supposed to be there at that time. That's how it feels to me.
On the, the consulting side as well, specifically now that medtech is gaining more traction and more impact, and also with the award recently and similar things happening, that also made me feel like, "Okay, maybe I can with this make impact on more lives than just the lives I treat directly." Because if you manage to help a medtech startup launch a revolutionary idea and then survive and really make it all the way to the market and then thrive there, you impact thousands hundred, thousands, maybe millions of lives. And the, it being accepted the way it is right now is for me as well a similar sign.
[00:24:05] Lindsey Dinneen: That's really cool. Yeah. I, I think, you know, I, I talk about it a lot. My role within medtech industry, you know, is, is small. I don't have that same level of impact at all. I'm, I'm helping, I'm, I'm in marketing, so I'm helping people tell their stories and get the, the word out. But I think getting to even just think about the fact that no matter kind of where you fit into the ecosystem you're helping hopefully impact patients' lives for the better and it's, it's so special getting to feel like even though it's a small role, I got to play a role. Yeah.
[00:24:42] Amel Havkic: It is a, i I wouldn't even downplay it that much to be honest, because if no one hears about the solution, if no one knows that it exists there's more and more and more we're getting overloaded with all kinds of information. So, marketers who help certain things break through and reach the right people are doing their share just as anyone else in the industry is. It's maybe just as important. So yeah, I, I would encourage you to continue what you're doing up until now.
[00:25:12] Lindsey Dinneen: Well, thank you. That's, that's, that is very encouraging. Okay, so, pivoting the conversation a little bit. Just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be within your industry, but it doesn't have to be. What would you choose to teach?
[00:25:31] Amel Havkic: Oh, that's a relatively easy one for me. I would teach clinical adoption masterclass and clinical adoption simply for the reasons we already mentioned. I would really like to help good solutions survive the reality of everyday clinical life.
[00:25:50] Lindsey Dinneen: Amazing.
[00:25:51] Amel Havkic: I think survive is the right, right word for this.
[00:25:54] Lindsey Dinneen: Yes, I think so too, especially in having conversations with startups that are currently in the midst of this and, and trying to navigate the best approaches. So, yeah. That's incredible. Okay. And how do you wish to be remembered after you leave this world?
[00:26:11] Amel Havkic: Well, that's a more difficult one. How do I wish to be remembered? Well, I would like to be the, so I would like to be the guy who everyone thinks left the world a better place than I found it. Maybe, quite short, not that extensive, but the implications are huge. You know, you can make the world better in many different ways. I do have certain skills and talents which naturally got me to where I am today.
But it ultimately doesn't matter how much better the world is after I'm gone as long as it is better and this became clear to me also recently. So, while the, the awards night was going on, my wife couldn't come with me because our kid got sick, so she stayed in a hotel and, but they were watching the live stream and in the amidst of it all, when, when I came up and I went front to get the award, the little one got up, although she was sick and she was like laying in bed all day and couldn't get up. She went to the screen and pointed to the screen. So yeah, ultimately I want also my my daughter to think of me as someone who made this world a better place one way or the other.
[00:27:29] Lindsey Dinneen: Yeah. I love that. That's a beautiful legacy and yeah, you're, you're doing just that, so that's amazing. That is so amazing. Okay. Okay. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:27:48] Amel Havkic: Oh, that's also an easy one for me. It's definitely my daughter, also my wife. It's, yeah, it's an amazing it's, it's amazing just seeing her growing up and develop all of these new skills and all of the new things that you didn't, that she didn't know how to do the day before. Also the way she goes through the world. She's fascinated by everything. Everything around is somehow magical and new and, yeah, so she can just like sit, sit in a, in a baby carriage and look around and everything is so, so awesome. She doesn't even need more. And that makes me remember that we actually should be more, way more, way more aware of the world around us and maybe not so, rushing all the time.
[00:28:39] Lindsey Dinneen: Mm-hmm. Yes. I, I love that. I think I think about this sometimes of the idea of everyday magic, and those are just those moments of, I don't know, a butterfly, you know, flying by and you just see how beautiful its wings are or, you know, nature is, is very much that way for me in general. I, I, you know, you go on a walk and you go, "Oh my gosh, you know, those, those daffodils weren't there yesterday, and how beautiful are these things?" And to me, that's everyday magic.
[00:29:09] Amel Havkic: Well, it, it is, and we, I, I do think that we don't take enough time to appreciate it. With always being busy with what's in the future, where we have to be and what we still have to do, that we maybe forget sometimes to appreciate what's right in front of us.
[00:29:25] Lindsey Dinneen: Yeah. Yeah. I love that. Well, this has been a wonderful conversation. I'm so thankful you joined me today. Thanks for sharing your time and your experience and your stories. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. We're grateful, and I wish you the most amazing continued success.
[00:30:06] Amel Havkic: Thank you so much. It was a pleasure being here and looking forward to part two.
[00:30:12] Lindsey Dinneen: Yeah. There you go. Alright, well thanks again and we'll talk again later.
[00:30:20] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Staci Miller, founder of Gen UX Consulting, shares her winding path from fashion design and psychology to human factors engineering in MedTech. Staci explains what human factors is—through stories from World War II aviation and modern healthcare—and why the FDA now mandates usability work to reduce catastrophic use errors. She breaks down formative versus summative/validation studies, the role of risk documentation (URRA/UFMEA), and why founders should think about usability as early as they think about risk. Staci also opens up about the challenge of starting a second business after losing her first in 2008, how she built Gen UX from $0, and the leadership lessons behind year-over-year growth.
 
Guest links: https://www.genuxconsulting.com/ | https://www.linkedin.com/company/gen-ux-consulting/ 
Charity supported: Feeding America
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPTEpisode 081 - Staci Miller
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Staci Miller. Staci is the founder at Gen UX Consulting. Her expertise is in applying user-focused research to develop innovative solutions, and it's essential to the growth of any technology organization. As a detail-oriented and tenacious executive in human factors engineering and UX design, she has a proven record of elevating the end user experience and achieving targeted client outcomes. She has created innovative medtech and big tech solutions through a comprehensive user-centered development process, leveraging artificial intelligence and industry agnostic design tools to optimize products and services. In her current role with Gen UX, she's a key leader facilitating strategic company growth plans and service offerings while managing the capacity and workflow of the UX HF design team.
Well, Staci, welcome to the show. I'm so excited to talk with you today.
[00:01:49] Staci Miller: Me too. I've been looking forward to it all week, so I'm very excited to be here. And I don't know what the day has in store. I, I know that there was like a, a, a kit that you sent out and I didn't read it on purpose, so everything's gonna be organic.
[00:02:03] Lindsey Dinneen: Perfect. Those are my favorite conversations anyway, so I'll take it and run. Some people I know really love to have the questions ahead of time, and others are just like, "Yeah, I don't want to know. I'm just gonna go off the cuff. Here we go." So, brilliant. All right, well, let's start, if you don't mind, by sharing a little bit about yourself, your background, and what led you to medtech.
[00:02:24] Staci Miller: That is, those are my favorite questions. So, I have a background in fashion design, psychology. I spent most of my classes in cognitive psych, but it wasn't like a difference of degree, it was just psychology. And then I have a master's degree in human factors and ergonomics. So I went the psychology route and the design route. That's kind of my background. So when I graduated my master's degree, through my master's program, I was able to intern for both years and one was in tech, big tech.
I interviewed and landed a, great one year long internship at Samsung, which was actually supposed to be just three months, and I stayed there for a full year. So they kept me through my whole, my whole semester, which is something they don't normally do, which was really fun. I mostly just said, "Hey, can I stay here for the year?" And they're like, "Great, no problem. Sure. We'll figure it out like that seems like a good option. We like you, you like us. Cool. We'll do that."
And my second internship was in medical device at a company called Interface and Analysis. My, that was actually my internship. My second one was at Samsung, so I got to really look in like I, I guess you got the curtain. If you think about Wonderland and Oz and the curtain and being able to pull back the curtain between both industries, what did I like better? I ended up liking medical better, mostly because the research was more structured and not necessarily conversations about, "Yeah, so how do you feel about that? Did you like it?"
Like to me, that's not really. What I would consider the best opportunity to gain data. Data to me, like there has to be like a clear objective as to what you're doing, the whys behind it, and what do you wanna learn. And I found that in, when I worked with engineers in medtech, they definitely had things that they wanted to learn, whereas in tech, they just had so much money. They were like, "Yeah, let's just see what people think about this." And I'm. Okay. And then when I would be really structured and I was working with people who didn't have backgrounds in research, had very strong, very good backgrounds in design, like legitimately awesome, they were leading the research and they were missing the boat.
So the narratives started to be focused on the N of one. This one person said this really interesting thing, so let's base our whole design off of what they said. And I'm like, "Dude, wait a second. Wait a second. All of them said this thing about the design though, and like we have four or five data points about when you ask this question." They're like, "Yeah, but that's not interesting." And I was like, "Okay, keep my mouth shut. I got it. Move on." Like from that moment forward, I, it wasn't like "Staci, don't talk, it was more like this is how we design based on the narratives that we've learned how to, how to research on."
And so it wasn't as I would say-- it wasn't considering the actual 360 view of the user. It was considering the really cool thing that happened this one time that was like totally an outlier. And it happened consistently when I was working in big tech. So I was like, uh, medtech, probably more my speed. And then my first job was at Abbott.
[00:05:39] Lindsey Dinneen: Nice.
[00:05:40] Staci Miller: And I ended up there. Yeah,
[00:05:41] Lindsey Dinneen: Okay, great. Well.
[00:05:42] Staci Miller: Cool.
[00:05:43] Lindsey Dinneen: Lots of questions based on this incredible background. I want to go back a little bit. So fashion design, was this something that you grew up thinking, "Oh, this is what I wanna do and be okay?" Right. All right, so...
[00:05:57] Staci Miller: it's all I ever wanted and I did that. So...
[00:06:00] Lindsey Dinneen: Yeah.
[00:06:02] Staci Miller: That's a, that's a great question. I think that my interest in fashion peaked around when I was 12 years old and during the time, Cindy Crawford and Naomi Campbell, and I was so fascinated by how beautiful these women were. And, and fashion was a thing in the nineties. There was like a lot of Dolce and Gabana around, and I loved it. And I couldn't wait to get my new print of Vogue every, every season. I loved Harper's Bizarre, and I would just pull pictures out of these models and what they were wearing. And then I would start you know, freehanding stuff and things like that. And I think a lot of people do that when they're really interested in clothing and things like that. And if you really think about it, fashion is art that people wear. So I was very attracted to that part of it. And it's all I wanted to do.
So after high school, I went to FIDM and studied fashion design. And right outta FIDM, I started my first company in fashion design, and I was a clothing manufacturer, and we had 500 open doors in the United States and in Canada, and I was hoping to expand, but unfortunately 2008 hit and they hit it hard and fast and I lost most of my managing capital in the year that I think was my tipping point.
So it was the, the year that I finally got a lot of traction and had a lot of repeat business and a lot of new business as well. And a lot of those new businesses just refused orders. Just from the east coast to the west, and it was just tons of money out that wasn't gonna come in. So there was really no way to, make that work after that, like I lost literally all the money I had in my business in like the span of, I would say three, four weeks. It was just mortifyingly scary.
But I was young and people who are young are resilient and they move on and they find a new dream. And it took me a minute, like I didn't really know what the french toast I was gonna do. And I was like, well, I was still planning on staying in fashion and long, short, I was offered a job to do and run production for a one, a different company. So make sure that their goods were produced on time. Deal with the, the timing of all the orders, making sure the product line. So it was basically operations for manufacturing.
And I was super excited about the job and I moved back to my parents' house at the time because things were just that tight financially for me. My parents were like, "Yeah, just, you know, come back, we'll figure it out." And I remember saying to my mom and dad, I'm like, "If this job falls through, do you mind if I just go back to school and stay here?" And they both started to laugh at me like, "Your job is fine, but if the sure why, why not?" And they, they thought it was crazy. And then I ended up back in school. So, they were like, "Whoa, that was really insane," 'cause that was in the end of 2008, starting 2009. And so the company rescinded their offer and they were really like, so sad about it, but they went to a market to sell their clothes and they got zero orders that year or something like close to that. So it was just, it was just a really intense time in the fashion industry and I was looking for jobs and I wasn't getting anywhere.
So I only had an AA, and at the time that really didn't matter, but I went back to school and I'm like, "If I'm going back to school this late in age, I'm getting a master's degree." I had no idea what I was gonna get a master's degree in. I was like. I like clothes and design. We'll figure it out from there like that. And I was like, "Well, maybe I'll be..." this is crazy. But I was thinking about being a lawyer, like a property law lawyer. So, because when you are a designer in clothing, people can just knock you off. And you've seen that happen like pretty much everywhere. And people can just take advantage of your intellectual property and never pay you for it if they change enough of it.
And so I was like, "You know, this would be something I'd probably be good at." So I went back to school thinking I was gonna go into that type of law. I took psychology courses and I took philosophy courses. And philosophy courses really do lean you, get you thinking very specifically about law. That's what philosophy was basically geared towards anyways. And you take these psychology courses and they're about people and how people process information, how people behave based on their behavior and things like that. So I thought the combination would be really good. Well, I ended up not liking, I did like philosophy, but philosophy's "let's think about thinking about it."
And psychology is-- which is great. It's great, but psychology is like more applicable when you're interacting with others. And I found it super fascinating. And then I got really into like cognitive psychology and I'm like, "What the french toast am I gonna do with this? I can't do anything with cognitive psychology. Like I need to make money. I'm a grownup. This isn't ah, I'm gonna study underwater basket weaving and come out and go work in communications at Fox." Like I had to have an actual plan.
So in my college at the time, there were these classes and they were like introductory to what you can do with your degrees. And that's literally where I found human factors. And there weren't very many schools that did it, but I was taking most of my classes at that point in cognitive psychology, which is how people process information, not their feeling based stuff. Like I didn't wanna have conversations with people about their feelings. Get that off of me. Like that's not, that's not my jam. I'm like, "Sorry, you're sad, but I'm not sad and I don't wanna be sad, so I'm gonna keep, keep going."
And I'm like, "How am I gonna work this into my, you know, I love design, I wanna keep that in my background, and how am I gonna, what am I gonna do?" And so the study of human factors really is the intersection of design and research, and how people interact with said products based on the design. And you get to research that. And I'm like, "Sold. Good. I'm, I can do this. This is like this, I didn't even know this thing existed." This is crazy good. And I never looked back.
[00:11:49] Lindsey Dinneen: Yeah.
[00:11:50] Staci Miller: I got into a master's program the next year. I, and because I was in that specific program in San Jose State, that's why it was so easy for me to work for Samsung because it was in my backyard. And that's why it was easy for me to work for Interface Analysis because Tony was the owner of that company. Tony, he was my professor. So he just was like hiring people and I, I answered his response and I was like, "Hey, I, I'm looking for something." Do you like, he didn't say it was his company. He said, "I have a friend looking" and I'm, you know, like when I know I need to make some money, I'm gonna try to hustle up and make some money. So I'm like, "Hey, I'm open to that." He's like, "Why don't you come by my office and we'll talk?" And I was like, "That's weird." He said It was for some other, I'm like, "Sure, no problem." So I go to his office and he offered me an internship right then and there 'cause it was for me. "I just wanted to see who would respond," 'cause you are the only person that responded. I'm like, "Guess you're gonna hire me then."
[00:12:37] Lindsey Dinneen: Amazing. All right. That's great. Thank you so much for that background. And it is so interesting how sometimes our paths are very, very windy to get to where we end up being and we Yeah, exactly. What, what ends up being a really good fit. But, so can you explain a little bit more about human factors, especially, maybe to help folks who have maybe some misconceptions or don't fully understand what it is just in general, but then also relate it specifically to medtech and why it's so important within the medtech industry?
[00:13:11] Staci Miller: I can give you a story that probably would do both. So human factors was, was actually founded pretty recently in our timeline of psychology and understanding people. In World War II, there were a whole bunch of fighter pilots ejecting themselves from planes that caused, even in World War II, millions of dollars to produce and nobody could figure out what the problem was. They checked the planes. The planes were operating correctly. They did psychology, like psychological backgrounds on the people who are fighter pilots. I mean, they have to, to get into the military and to fly those planes, you have to be pretty good under pressure. They interviewed them, they were fine. They didn't have any breakdown of stress, and it wasn't happening on a small scale. This was happening on quite a large scale.
So they, again, they went, they're like, "Okay, okay." Well, the military went back and " Well, it has to be the plane." So they looked through the plane, wasn't the plane, talk to the people, wasn't the people. So then the psychologist started to ask questions. They're like, "Well, if you're saying that it's not the person's emotional state and you're saying it's not the plane, well then what happened? Something had to happen. Something changed. What changed?" It turned out that the engineers had moved the throttle button with the ejection button in the planes.
[00:14:31] Lindsey Dinneen: Oh.
[00:14:31] Staci Miller: So the pilots were originally trained to hit the throttle button on the certain side that the throttle button was in the cockpit. So instead of hitting the throttle, because that was their original training, they hit the ejection button. So they ejected themselves out of the planes, which is why human factors was born. Those little changes that people don't understand about human beings. So when we learn something for the first time, because like even if you think about being a kid or being a baby, or learning a really tough lesson, right? You remember that lesson. And so what happens is that's your default setting. "This is the lesson I've learned. This is how I react." Now for that lesson, it doesn't matter if it's like an emotional exchange or if it's a physical one. So because they were taught where the, the pilots were taught specifically where the throttle was in the first place when they were under attack and they were in a high cognitive loaded space, they went back to their original training.
[00:15:30] Lindsey Dinneen: Mm-hmm.
[00:15:32] Staci Miller: And then the engineers were like, "Well, we told them. We told them." So, so, because they didn't wanna take the blame, right? Nobody wanted to take the blame ruining millions of dollars of planes. So this same type of thing happens in the medical industry. I mean, you can see it pretty easily, right? So you're trained on System X. There's an update, a 510K release to it. The system works differently. Errors are made, people are hurt.
[00:15:57] Lindsey Dinneen: Mm-hmm.
[00:15:58] Staci Miller: That's how it translates to medical. So aviation was a really big part of human factors and it still is to this day. Like NASA used to hire quite a few of my classmates. And I know that Boeing and a lot of those other, even BMW hire people that do what I do for a living and test the responses during drive time. And if you think about it, if you look at a Tesla versus a BMW, those are very different driving experiences. Like I had to relearn how to drive a Tesla, right? And like it has a one pedal situation. So now when I get into regular cars, I'm like, "Wait, what? What am I doing? What? What kind of car is this? Like how do I drive this thing again?" I know that sounds silly, but it, it's true 'cause you kind of just get used to the thing that you have.
And that's exactly why human factors is prevalent in medical device or in aviation or in, you know, like any kind of like navigation systems. The reason the FDA mandated it is because a lot of products were coming to market and there was a very large influx of critical catastrophic errors in hospitals. People were suffering consequences of bad interfaces or lack of instructions on products. I know that there were a lot of intravenous medications given that weren't supposed to be IV medications in like in certain-- yes, you're supposed to inject it, but not. Intravenously and those charged caused people to perish.
So that's when the FDA stepped in and said, "Okay, we were asking you as a favor to do these usability studies, but now officially they're part of your risk requirements and they're part of your requirements to get to market." And I think that happened about the time I graduated grad school, around that time. So about 15, 16 years ago.
[00:17:50] Lindsey Dinneen: Okay. Yeah. Well that's a fascinating story, and I'm sorry that that is the impetus for the results that we have today, but also how incredible that that is something that's being prioritized and mandated now. And I'm wondering too, when a startup company is developing their technology, how soon should they be thinking about human factors, usability, UX/UI.
[00:18:17] Staci Miller: As fast as they're thinking about risk. if you're already thinking about risk at phase zero, that's when you should be thinking about usability and UI and interactions based on user processes, because that's when this kind of conversation really needs to start with regulatory, with your team, with the engineers. So even if you don't have a human factors engineer on staff, like you can find a company that can give you like some fractional support, just, you know, to talk to and to understand what their, what, what their responsibilities are, and what their requirements are to get to market. I have found that a lot of founders don't think that it's a requirement. And I, and I'm really not sure why, but that's been happening a lot lately.
[00:18:59] Lindsey Dinneen: Yeah. So because it's a requirement, because you should be thinking about it from the get go, what are some things that you've seen work really well in terms of, putting together this kind of this testing and whatnot versus things that might seem like they could work. Like perhaps somebody feels that they could maybe do some of this testing themselves. You know, just, just things that maybe people who aren't really familiar with all the regulations would perhaps do, and that could cause problems down the road.
[00:19:32] Staci Miller: So there's a, these are all really great questions and let's, let's unpack the idea of research, right? So some people think that research is finding out if somebody is happy about a product and would use it, like product market fit, right? Some people do marketing for that, and I can, that's the type of research that is not technically human factors, but it is something that Gen UX can do, right? So it's just research. I, I call it like insert white meat or insert protein. We can do the research, right?
So when it comes down to it, there's, I would say that research is split into two buckets, which is UX/UI, which is very popular and people understand that, which is a formative in the FDA guidance and then validation slash summative. So the validation studies are very clean cut. So I'll explain those first. And they are to validate that the user can use the system in its environments safely. So the alpha for that is the user is successful at using this product and the uses, uses and use environments correctly and safely. And this is all based on your risk documentation from your URRA or your UFMEA.
Some people use ADFMEA, which is based on design, and I suggest that they don't use that because that focuses more on the system than it does on the user. And the FDA has really cracked down on that. So if you are a founder and you think you can get just one system, ADFMEA, you are probably already starting off on the wrong foot. Make sure you have your own usability. Because human factors work really focuses on two things in the medical industry.
One, it focuses on helping develop the device while breaking down risks. So if you have mitigations and your system's designed a certain way to avoid a risk, that's very important, and that's really also usability testing. And I can explain this in two ways. I've worked at Meta, I've worked at Samsung, I've worked at a lot of different big tech companies, and I've worked at a lot of medtech companies. So I think that people think that human factors is different than user research, and they're right. Human factors is much harder than user research. And you really actually need a background in research methods and an understanding of how the application of research works. Formatives can be used for two reasons. One, to support the need of the product in use and to check how people are actually using the system in real life.
So sometimes people are really good at thinking-- so engineers are amazing at building systems, right? I can't do what they can do. I'm not gonna pretend like I can. What I can do is help them build it for their end user, because a lot of the times engineers think very differently than the average human being. They're much more educated. Schooling for engineering is extremely difficult. A lot of it's mathematical computations, understanding actual physical properties of things in their environments and how that they work, right? So those are the things that engineers think about all day long. That's fine. I think about the user all day long.
So you can create a system that an engineer thinks that is fine, but then the user is " I don't really know how to use this. What are you talking about?" Right? And so that's what user research informatives avoid. They avoid, they break down risk and they are able to help form the product. So those, those user research studies, like before, let's say phase zero to phase four in a market cycle, if phase five is market release, are for those things. And then as you get later in the cycle, you wanna do more rigid research, that's really breaking down the risk and really focusing on the user interactions within the system and med device. And making sure that they're assessing the risk based on your user, but they're very specific to the user interactions that are critical tasks and higher. Or things that lead up to the critical test and come away.
So like you have to be able to do the steps before, do the thing that's really hard to do, that could hurt somebody and then make sure coming away from them you don't cause any harm either. That's the best way to look at these types of tests. And we do the exact same thing in validation for systems. So, in software you test to see if the software can do the thing that it's supposed to do. When you check that box, the software does the thing and it did it, and we're good to go. You do the same thing with mechanical engineering. The system has this, this range of motion here and this range of motion here, and it doesn't deviate from plus X to plus Y and therefore the system does what it's supposed to say. So you're verifying and validating that the system does what the system is planned to do.
It's really no different in users, it's just that you're dealing with human beings and it's not, it doesn't work the same way, right? Because like people are variables no matter what. And that was really long worded. So there's like tons of different research to do, but if you don't do your summative and you don't do your risk documentation, you're not getting to, you're not gonna get to market approval. Just, there's no way.
[00:24:34] Lindsey Dinneen: Yeah. Thank you. Yeah, that is incredibly helpful insight. And you know, so I wanna go back to, you had this company before, right? So you had already built a business and it was thriving, and then unfortunately life intervened a little bit. When you went to start Gen UX, did you have moments...
[00:24:57] Staci Miller: Of PTSD?
[00:24:58] Lindsey Dinneen: Of, yeah.
[00:25:01] Staci Miller: Yes.
[00:25:01] Lindsey Dinneen: Yeah.
[00:25:02] Staci Miller: Yeah. I had major PTSD. Like I, so the concept of Gen UX was a play on words like, so I'm a Gen Xer, no biggie, but like I think that every Gen Xers, millennials, I feel like both of our generations very much identify with our generation. And I thought it would be kind of a fun play on words to identify to people that are also Gen Xers that, yeah, we do UX work and we're Gen UX, as a Generation X, like it was very important, right? So I kind of came up with that idea, thought it was cute. But at the time I was working for Meta, and Meta had been doing quite a bit of layoffs at the time. Nothing wrong with that, that happens with every company. But I have survived in Medtronic and Abbott and all these other companies. I had survived so many rounds of layoffs. I'm like, "One day my number is gonna be, it's just, it's just gonna happen."
So, we started at Meta internally, really like they, they were very open and honest with people. They're like, "This is when this is gonna happen. We are gonna lay off more people. This is when this round is gonna happen. We're gonna lay off more people, and then this is the final round and this is when we're gonna lay off these people." So each of our groups of things like, so it was like engineers, lawyers, researchers. Like we, we had timelines that we knew if, if it was gonna happen, this is when it was gonna happen, this would be the day.
[00:26:17] Lindsey Dinneen: Yeah.
[00:26:17] Staci Miller: So I started to really think about what that meant, and I'm like, "Okay, well I'm not gonna start looking for jobs right away because I want my severance package." I definitely wanted that 'cause I, and then I wanted a break if I could have it. So I was like, okay. I, in between working at I was working at EDA as a contractor and that was super fun. Like I had my own time kind of, and I enjoyed the work and I got put on other projects whenever they needed me. And it was like, but I was constantly on a project, so I'm like, "I, maybe I'll go into doing IC work by myself" and I'm like, "No, I can't make enough. If I'm gonna do this, I'm gonna build something."
And then I'm like, well, I started to talk to my friends every single one of my friends, including Interface Analysis' owner, Tony Andre was like, "Start your own business, Staci. Start your own consulting firm, just do it. Don't even look back. Just do it. People will end up coming to you because you know how to do this." He's like, he's it's, "You know, the first years they are what they are and everybody knows what that looks like. It's, it's rough. You have, it's like a mental game. You're like, I am gonna do this. And you just have to be consistent and can continue down your path. And more and more people will show up."
And that's been true every year. But that's how GenX was started. And yes, there was this whole trepidation about, "Am I gonna make it? Am I gonna make it through this?" And I was like, "You know what, Stac, you're starting in a recession in your, in your industry. If you can get it done, if you can get two years in and be successful, you're fine." I'm in year three.
[00:27:50] Lindsey Dinneen: Yeah!
[00:27:51] Staci Miller: Yeah, I mean, year three, woohoo. And we're increasing 50% year over year in year three, and I started it with $0. So, and I'm not, I'm not saying like a hundred to 50, like $50 to a hundred, we're, we're talking a couple hundred thousand dollars here, a couple hundred thousand there. But it's modest and I do expect that growth, and I do expect that to continue. And the other thing I think about is becoming very malleable in, in your spaces, like what's working for you and what doesn't work for you. But I feel like that's kind of off topic from what you asked.
But yeah, I had PTSD gave myself at least two years and I'm like, "I can do anything for two years. If it doesn't work out, you know, like I have everything that I have and I can go back into corporate if I need to." And I really, I really was tripping, like just to be nineties about it, I was tripping. Like I was really like, "You know, I don't know." And my husband was like. He was my biggest cheerleader. He was like, "You've gotta do this. He's you're gonna, you're gonna be able to do this. You have something that I don't have. You're really great at networking people like you." I'm like, "Do they really like what?" And he's, " No, people like being around you. You make friends easy and people really do enjoy being around you and they like know that you're smart and you're gonna be able to do this." So, that's how this all started. And yes, I was really freaked out when I first started, but every day when I had bad days, I'm like, "Everything always works itself out."
[00:29:14] Lindsey Dinneen: Yeah.
[00:29:14] Staci Miller: "Have you ever not been in a situation where everything works itself out?" "No. No." So I'm like, "Well, if I, if it doesn't, I'll get a new dream, but I don't-- once you hit this, this year, like year three and you know you're still growing, you don't have to get a new dream, you just keep going and you're like, this dream is happening. I'm gonna keep it going."
[00:29:34] Lindsey Dinneen: Yeah. What was it like building a team? Did you start off as a one-woman show, or did you have support at the beginning? How did that work?
[00:29:43] Staci Miller: So at first, actually my designer's father was working with me and he called me out of the blue and he's " Hey. I have this client, she doesn't have any human factors person working with her, but I know that she needs it and do you wanna talk to her? I know you're not working at Meta," because I put on my, oh. LinkedIn profile Open to Work. So he called me like within two days, like seriously, like people started to call me and that was when I was already like, "I'm gonna do my own thing. I'm just gonna do my own thing." So the universe just brought me a gift, right?
And I met this first client and I started to work with her, and at first everything was super cool. The first year it was great, and I really liked working with her, but she also needed a couple of other things. She needed an IFU and she needed design quality assurance. I'm like, "Check, check. I can get both those things done." So I called my friend Maria, "Hey, do you wanna work with me? She's " Hey. Yeah, totally." Because we had already worked together and we knew each other pretty well. So it wasn't like it was difficult to make that connection. And, and she knows my personality. I know her personality, and I know we both work extremely hard and we have that in common. So I wasn't, never, would I be worried about Maria.
And then I found I wasn't, I didn't even have a designer yet on staff. And I found someone who used to do instructions for use for a different company I worked for. I called him like, "Hey, can you do this?" He's " Yeah, yeah." So I got all that done for this other client. I'm like, "I can do this. I can do this. I can, I can find people." I know so many intelligent people who love what they do and have a fire for it every day. And then the evolution started to happen. And then I asked someone to work with me to do sales, and then they said, "Yes." And then we started to pitch people that I was friends with and knew, and sometimes they said yes, and sometimes they said no.
I think the first year, I think I pitched over like $4 million in business and I got 20,000. No, I got, I got 80,000, something like that. Something, something small and I'm like, "Why am I pitching so much? This is like taking so much time outta my day," that I found someone to work with me. His name was Adam and I still actually work with Adam and he, but he's a big picture guy and he started to work with me a little bit and help me like navigate through some things. Even to this day, we talk and he's not fully, fully, fully on onboarded, but if, if some. Of the clients that he lands do come on board, he will be back on board and he will be working with me again.
And then I had a salesperson this last year and I realized just I needed more of a hunter-gatherer. So like we're just going in a different direction, right? So I had that, and then last year my goal was to bring my designer Maddie on full-time. And I was able to do that too. So everything that I've kind of just said, "I'm gonna do this this year, I've been able to do this year." And I'm not taking this lightly. Like I have a board of directors, which are people who are, have different perspectives on finance because that's my weakest link, I would say. A professor at UCLA, his name's Sean Pat, also a good friend of mine. He's on my board.
And my brother-in-law and my nephew, who is new in his life and on his journey, is on my board as well, and I kind of wanted him on my board so he can see what it looks like to be an entrepreneur and see what growth looks like year over year because he is already working for companies. He's, he's like 25, I think, and he's already being groomed to be in upper management. He's got upper management written all over him as like the, as like people would say in like cute little circles. And then my my brother-in-law, he is one of the CFOs at Mayo Clinic, so these are people who have some in medical, some in finance, some in finance, in medical, just helping me like grow. I throw things past them and they help, you know, make decisions for the year. And they tell me like, they give me feedback and, and work through things that I'm doing and what they think is right, what they don't think is right. And sometimes I listen, sometimes I don't. You know, like...
[00:33:28] Lindsey Dinneen: Well, yeah.
[00:33:29] Staci Miller: Just really depends like where I'm at and what I wanna do and where we wanna grow.
[00:33:34] Lindsey Dinneen: Yeah. Excellent. Okay. So I'm curious, especially within medtech specifically, are there moments that really stand out to you as just affirming, "Oh my goodness, I am in the right place at the right time."
[00:33:49] Staci Miller: Things keep happening, so, every time I speak, like I, I spoke at Project Medtech, people bombarded me. They're like, "We wanna work with you. We wanna work with you. We should talk, we should talk." Anytime I go to a symposium I walk away with two or three leads. People coming up to me, "Oh, do you do this thing? We should really talk. We should really talk." So, just being in the situation like that kind of tells me that I'm in the right direction.
And the other thing is we're growing year over year. If you take a 10,000 foot view of where I was year one versus year three now, very, very different. Extremely different. And like I said, I do have, I do have other consultants that work with me. I don't want you to think it's just like a two person shop. It's not, there's other consultants that work with me but they're as needed. They're not full employees, which I think is really helpful in a situation like this. If you're a founder starting up from scratch and you're not, you don't have, I'm not trying to get angel investors. I'm not trying to get people to push money into my company. I am building it literally from zero to whatever it is that I make.
And so that, that's a, what I would call like a slow burn of, you have to build your foundation, you have to manage to the capital that you do have, and then you, then you go to the next level and you do the same thing and then you do the same thing. And there's a lot of consistency with the business now, and I see a lot of people targeting me for that consistency. And as, as we are growing, like people are engaging with us on a different level, which is exciting to see. That's always exciting.
[00:35:20] Lindsey Dinneen: Yes.
[00:35:20] Staci Miller: That's kind of how I know. Yeah.
[00:35:23] Lindsey Dinneen: I love that. Awesome. Okay, so pivoting the conversation a little bit just for fun.
[00:35:28] Staci Miller: Cool.
[00:35:30] Lindsey Dinneen: Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. Could be within your industry, but it doesn't have to be. What would you choose to teach?
[00:35:40] Staci Miller: That's a great question. I love, I think it's very important when you do what you do for a living to have something that isn't that for yourself. So I, there's very specific ways as to how I unwind at the end of the day. One of those things is cooking. I would totally do a masterclass in being a home chef. Like I'm, I'm not even a chef like that. I've never gone to culinary school, but I absolutely, I make my own breads. I make chutney sometimes when, when I want some. I would do a masterclass on-- I'm not Gordon Ramsey. I'm not Thomas Keller. Here's what it looks like to be a home cook. And here's the, the five things that you actually need. And this is what you should learn how to make first.
Like I remember the first time I was trying to make pasta or something, I boiled the water to death. There was no water left in the pond. Like I didn't even know what I was doing. I, maybe I walked away from it, I don't know, but I destroyed the pot. My mom's " What were you doing?" I was like, "Making pasta." And she's " What, what, what happened? You ruined the pot." I'm like, "I'm not, I just did it wrong." So I would probably do a masterclass in how to just take that first step learning how to make your own food, right? And talk about food 'cause I like food. There you go. That's what I would do.
[00:36:52] Lindsey Dinneen: Love it. I love food and I love talking about it. So, that sounds like a great class.
[00:36:58] Staci Miller: I would do, I would totally do it.
[00:36:59] Lindsey Dinneen: Okay, and then how do you wish to be remembered after you leave this world?
[00:37:07] Staci Miller: This might be dating me, but Roy Orbison who wrote the song, "Pretty Woman" that was also in the movie, "Pretty Woman" wrote that he "just wanted to be remembered." And I thought that was really interesting. And I think that everybody knows that song knows that it's the guy like, I don't know if you know like the artist, but I think even to this day, that song, generationally, people know that song.
I don't know how I wanna be remembered, but this is how I wanna impact the world. So it's kind of like that, but kind of not. I believe that knowledge transfer is the most powerful thing that we have amongst generations. And I want the next generation to be better than me, which is probably, in my opinion, I'm kind of kind of strict about this, probably a tall order, 'cause I'm like very picky. But, I have mentored and, and taught people my craft, and I want them to be better than me so they can mentor people and be better at this craft. So if I leave one mark on this world, it's that I have taught somebody what I know how to do and I expect them to do it better than me.
And I don't mentor just anybody. So if I'm mentoring you is, and I'm putting all this energy into you, you better, you better bring it. And the people that I have worked with and have mentored are doing extremely well in their careers, and that's, that's kind of a thing that I like about, like what we do and how I do it. So I don't know if I would be specifically remembered for that, but I do know that it would move our industry forward and that makes me happy.
[00:38:39] Lindsey Dinneen: I love that. That's a beautiful legacy. All right, and then final question. What is one I know, what is one thing that makes you smile every time you see or think about it?
[00:38:52] Staci Miller: When I see what I'm building or, or how I'm building it in the future and I really go deep within my, my consciousness about this is what I'm gonna do next. This is how I'm gonna do it. This is what makes me feel really alive. I get so excited. I get like goosebumps. I start smiling. I, I'm a big-- I don't know if you do this, Lindsey, but I do this-- I kind of dance around a little bit. Like I dance when I'm making food, I dance and most people dunno that about me.
But I, but my closest friends I remember I was working with this one guy and he looks at me, he's " Do you ever stop dancing?" I'm like, "Nope. Nope, Nope. Gotta dance." So all that stuff like starts to happen. And I just get really excited about the things that I'm trying to build, what I'm trying to master in my own world, what I'm trying to create. And that's what gives me like so much excitement. And then a number two would be my cats, because they're ridiculous and I love them and they give me so much love and they make me smile all the time too.
[00:39:52] Lindsey Dinneen: Oh yes, those are great answers. I love that so much. It is exciting to see. Dreams come true. I can totally understand that answer of getting the, the excitement, the tingles, and then yeah, I, yeah, I, I obviously relate to dancing around all the time, and especially like celebratory dances. They're, my celebratory dances are the goofiest, most ridiculous things you've ever seen, but I'm happy! So.
[00:40:20] Staci Miller: As long as you're happy, that's all that really matters, right? Like that vibe that you're putting out there and the happiness and the giddiness, like the things that I'm building in my mind, like they haven't happened yet, but I'm dancing like they have, you know, because I hope that they do. Like there you go. And I think that's important. I love it.
[00:40:35] Lindsey Dinneen: True embodiment of the vision. I love it. Well, well, Staci, this has been a great conversation. Thank you so much for your insights and your stories, and we are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support. And gosh, I just wish you the most continued success as you work to change lives for a better world.
[00:41:15] Staci Miller: Thank you, thank you. It was so much fun being with you today. I appreciate this and it was so much fun to talk about. And yeah, I can't wait to see you in the next couple weeks too. So we'll see each other soon.
[00:41:26] Lindsey Dinneen: Yay! Sounds good. Well, thanks again and have the best rest of your day.
[00:41:32] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Spencer Jones, Founder of XO Medtech and MedtechVendors.com, shares how frontline nursing experiences led him to patent vascular access innovations and ultimately take devices from idea to FDA clearance and product launch. Spencer walks through learning business fundamentals through accelerators, raising early funding, and building sales and distribution networks, then explains why launching a digital-first, AI-native ecosystem has enabled faster, leaner execution than traditional medtech pathways. Spencer also discusses leadership, clear communication, and why AI adoption is essential to accelerate and de-risk early-stage medtech. 
Guest links: https://www.linkedin.com/in/medtech-innovation/ | www.xomedtech.com | https://medtechvendors.com/ 
Charity supported: Polaris Project
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPTEpisode 080 - Spencer Jones
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and today I'm delighted to welcome to the show Spencer Jones. Spencer is the founder at XO Medtech and MedTechvendors.com. He is an RN, MedTech entrepreneur with 12 years of med device leadership. He's a two time med device CEO with 10 plus patents under his belt and has taken devices from idea to FDA clearance and product launch. Spencer has built sales and distribution networks, led product development teams, and raised over 10 million in VC and Angel Capital. Spencer founded XO MedTech in 2024 to create a digital first medtech ecosystem, deploy AI native tools for medtech operators through medtechvendors.com and cultivate the next generation of medtech innovators.
All right, Spencer, welcome to the podcast. Thanks for being here.
[00:01:43] Spencer Jones: Thank you for having me, Lindsey. I'm very, very excited to be here. Like it's, it's always more fun to be a guest than it is to host the pod, so absolutely thrilled to be a guest on the pod. Thank you for having me.
[00:01:54] Lindsey Dinneen: Of course. Absolutely. Well, yeah, let's just, if you won't, don't mind just sharing a little bit about yourself, your background and what led you to medtech.
[00:02:04] Spencer Jones: Yeah. Born and raised in Arkansas. I've lived, I traveled a ton and lived in Memphis and whatnot, but grew up in a healthcare household. Dad did anesthesia for, what was it, 36 years or something at the same place. So I thought I was gonna be a CRNA, like actually started pre-med. Took chemistry my freshman year while I was, you know, it was just, I got a C and I was like, maybe, maybe med school's not for me.
But but anyways, did the nursing school thing, got out, started working, pretty quickly, knew if you've ever spent any amount of time in frontline healthcare, you just kind of get, it's like a barrage of things that suck. It's just, especially nursing, the devices you're using are commoditized. Like just the workflows are bad. You know, people, it's, healthcare is very broken. Every, it's no secret. Everybody says that. Everybody knows that.
So anyways, I noticed pretty quickly that hey, like why isn't this better? Why can't this be like this? And, you know, kind of had that mindset. And before I could even go through like critical care enough to apply to a CRNA school, ended up patenting some devices in the vascular access space. Really leveraged accelerator programs and the entrepreneurial support organizations that were in my area, in my region to, I call it that get that dirt money, which is like the before the seed, you know, your pre kind of, your pre-seed /seed you know, before the pre-seed money. And, and also like the business training, right? Like I wasn't formally trained on business stuff like that.
So did that. Did the venture capital hamster wheel a little bit, took a, you know, device through class two de novo clearance. Was doing ride-alongs training, sales reps, doing marketing stuff, you know, managing our ip, managing clinical you know, 300 patient RCT that we had to do in the middle of COVID, launched the product and then past couple years, I left, left that company in 2022. Products still on the market and they got, you know, clearance in, in Europe now and et cetera, et cetera. But just been working more in laparoscopic spine or laparoscopic surgery orthopedic spine and then doing some like consulting projects and, and things like that.
And then yeah, XO Medtech and Medtech Vendors that's been. You know, for the past two years, like a big focus. And I know we're gonna talk more about that, but yeah. So it's just been, it's been a great journey. Medtech is one of my --I love it and hate it at the same time, but I wouldn't wanna be doing anything else, frankly. So.
[00:04:17] Lindsey Dinneen: Awesome. That's a great intro. Okay. You were, I really, I enjoyed how you sort of went straight from okay, so, so "I, you know, started the career, started in the industry, and then I, I, you know, got a bunch of patents." What were the ideas for the patents? Where did those come from? If we could just go back, how did that, what was that inspiration like?
[00:04:39] Spencer Jones: Yeah. So I was night shift, med-surg, big, pretty big hospital in Little Rock. It was like one of the, one of the bigger ones in Little Rock, St. Vincent's, which is like CHI, St. Vincent, et cetera. And like one of my patients --well the, the very first one was a dual lumen peripheral IV. A patient has a peripheral IV in, I need to get a blood draw. They're like, "Go stick his other arm." I'm like, "Why can't we get it out of his, you know, IV that's in his, that's in his forearm?" And, and they were like, "Well, you, you know, you don't want to contaminate, you know, the thing." And I was like, "Oh, okay. That kind of makes sense."
And I was like, well, PICC lines have two lumens. So you know, I was like, why couldn't, you know, why couldn't we just have a second lumen on, you know? And I was like, do those exist? And they didn't really exist. There was kind of one that existed, but it was more of like a longer extended dwell peripheral and you know, you kind of needed ultrasound to place it. You didn't really place, you know, normal nurses on the floor weren't gonna place it. And so I kind of, that one was just sheer-- I experienced something that I was like, "Dude, you're kidding me. There's gotta be a better way to do this." You know what I mean?
And you know, kind of similar approach in that one. We, you know, that was the very first one so I was like doing these drawings on note cards and then like meeting with a patent attorney and I was like, did that provisional filing and wrote the patent myself and the claims and all this stuff. And the guy thought I was like, just " Okay, yeah, I'll, I'll file the provisional for you, bro, whatever." Filed the provisional, you know, ended up like going to a different attorney 'cause that guy was kind of just not taking me seriously. And so, ended up going to a different person, filed a non-pro provisional, started raising all this money, and that original attorney reached out later, was like, "Oh, so glad, glad to see blah, blah, blah." I was like, "Yeah, yeah, whatever."
But then the second one, I, which was Safe Break Vascular, had the, it's kind of similar. Patient was like, had patients pulling out their IVs, pulling out lines, you know, and it's a million things. It's, it's walkie talkie, so like Alzheimer's, dementia, memory care type stuff. You, it's TBIs, it's agitation, sundowners. It's, you're coming off medication, you're drowsy, you forget, you're hooked up. You need to go to the bathroom. You trip on it. The nurse trips on the tubing. There's like a million reasons how, you know. Where mechanical force can get applied to an IV line.
And same thing, I was just like, man, like this, it, it feels holding on for dear life is like the wrong approach because skin is only so strong. You get skin tears. Adhesives, you only want them to be so, you know, so, so strong. And it just, you know, it, wrapping it up, then you can't assess the site, you can get infiltration. So it didn't feel like any of the options we had were great. That one, I started to do patent research literally on the floor at the hospital. Like that night. I was like, I, 'cause I knew enough then found someone that had patented it. Like same exact concept. It was a nurse. And design was bad. Like the design, it had springs in it and it was just like not manufacturable and not a good design, but there were like conceptually it was like spot on. And then there were some elements of it that I was like, this would be very useful to have if I was gonna like actually do this.
So me and somebody I'd met, and in accelerator program, we bought the patent from 'em for 20 grand which was a steal of a deal. It was like 10K up front, 10K after 18 months. And yeah. And then we turned around and raised a, you know, million dollar seed round within like, within nine months after acquiring the patent, got into an accelerator, ZeroTo510, shout out to them. But acquired the patent in February. Got it, or March, got into ZeroTo510, April. Went there in May, closed our seed round of a million in December, so it was like a nine month, yeah, ordeal.
[00:08:03] Lindsey Dinneen: Wow. That's okay. That's awesome. I love the story. I love the fact that it was from boots on the ground going, "Okay, I see this problem. There's gotta be a better solution." That's super cool. So. All right, so you have these patents, you're going and you're working with accelerators. Can you tell us a little bit about what that experience was like, especially since you mentioned, you know, you didn't necessarily have the business background, so there was, there was probably a bit of a learning curve to that whole, you know, how do you get your idea from your, your note card drawing to commercialization. So I'd just love to hear about your experience.
[00:08:35] Spencer Jones: Yeah. The, so I did one accelerator before ZeroTo510. It, I basically did two within about a year, a year of each other. It was like back to back to back. But the first one I did, it was industry agnostic. So it was just a lot of like mentorship and lean canvas startup methodology kind of business practice stuff like accounting 101, you know, building financial forecasts and models and like all of that stuff. So I really learned a ton about kind of just non device specific stuff there. Obviously I was learning a ton about device stuff along the way, but then once I got to ZeroTo510, that's when things kind of like really, you know-- and I had, I had won, I won that first accelerator. It was like a competition, and so I had 150K.
And I was like, "Oh wow. So maybe, maybe this is gonna be a career path," 'cause I was still working full-time as a nurse and then I got into the second one. ZeroTo510 was amazing. Allan Daisley was running it. James Bell was like the co-director, I think, and it was like bootcamp. It was like, you know, 8:00 AM to 5:00 PM. It was like sessions and mentor hours and office hours and " Alright, we're done with that. You guys work on this for an hour and a half, we're gonna come back and talk about like the finished product and you better have it done." You know what I mean?
And it was every day. I lived up at this building. It was amazing sponge mode. You know, it was one of those environments where you're just like constantly soaking it in and learning and learning and like you can feel your brain expanding like every day. You know, you wake up excited. And that one was amazing. Met a ton of people that I still work with today. You know, met my co-founder at XO Medtech. Met him at that accelerator. But yeah, it was just, that one was amazing. I was like, life changing. Came back from that and I was like, "This is what I was meant to do." I felt like I you know, found my calling. And so, yeah, shout out to the people there that you know, we're a part of that.
[00:10:20] Lindsey Dinneen: Love it. Excellent. So, okay, so you found your co-founder for XO Medtech, and this is great because I wanted to dive into that. So, so you've, you've now successfully taken like several products to market and of course you have a lot of other great industry experience. What was, how was it different starting XO Medtech and Medtech Vendors than perhaps other things that you'd done in the past?
[00:10:47] Spencer Jones: Yeah. You know, I'm gonna say it was way easier just to be honest. I mean, I mean, you know, I think we, we were doing a lot. We started building XO Medtech in 2022, 2023, and at that time a lot of it was like, it was really focused on the community and the training platform and the resources and kind of all the videos and things that we put in there. Which I still like to this day, will stand on it, that like there, if you're an early stage innovator and you're, you wanna like kind of internally like level yourself up, right? There's no better place than like XO Medtech and the training and inside there to do that, right?
But, but yeah, it was we started doing it at a time when AI was starting to become, like Chat GBT, what was it, four was coming out or whatever. So we started it kind of before the wave and then as we were continuing to build it in like 2023 which was like the meat of us building it. It was like kind of starting to become more of a thing, but we still weren't really using it that much. But then as we really went into kind of like launch and growth mode in 2024, it was just like a huge tailwind and like being able and, and it continues to be.
But like not having to raise, you know, three, four, $5 million to get a business off the ground and to get to a point where you can start selling something is just incredible. I mean, like we are, we are so agile and can move so quickly and, you know, we don't have any investors. We don't want any investors. So like our speed at which we can move is unbelievable. And coming from somewhere where it's " Oh, you wanna put out something for marketing? Route it through the quality management system and like maybe it goes out in two weeks."
You know, we can go from like idea to feature in a week. You know what I mean, you know, let alone like idea to like press release, right? That's 10 minutes if we want to be, right? So really it's just, it's a lot easier and this takes nothing away. There's some incredibly rewarding parts of kind of my, like my medtech journey and stuff like that, like the day we got FDA clearance and, and X, Y, and z whatever date, you know, first sale and getting our first GPO contract. But it's, it's definitely more I would say day to day, just like the exhilarating agility, excitement type stuff that you like, don't really get with with me.
And I'm not, I'm not taking anything away from, I'm still a medtech person through and through and I'm sure at some at some point I'll you know, do another device. We're developing another device at Lapovations, so, in combo spine. So my hands are still in it, but I love, love, love what we do at XO Medtech. It's so much fun.
[00:13:11] Lindsey Dinneen: Awesome. Well, I love hearing that. So tell us a little bit about both XO Medtech and Medtech Vendors and yeah, their, their focuses.
[00:13:21] Spencer Jones: Yeah. So I think, you know, like I said, we started XO Medtech and it's, it's a online community. So think like Skool, like S-K-O-O-L School or Circle, or there's some other Mighty Networks, like one of the-- we use Circle-- but you know, it's whether you're ideation or just like curious about medtech all the way through like series A really, you know, we've got, you know, there's community feed, people are posting. I mean, we posted you know, Project Medtech, you know, event stuff, discounts a lot of exclusive stuff where, I think we added, it was like three or $4,000 worth of discounts. Like just for being like once you join XO Medtech.
But then there's that primary feed people, it's like a massive exchange of value and it's it's not like LinkedIn. There's no promotion. Like we base, we will take your post down if you're like nakedly promoting your own stuff or your services, whatever. The whole point of it is to be massive exchange of value. So you know, "Hey, we did some like really cool testing, ETO sterilization testing on coil tubing to see how it retained its memory. Here's what we found, your pictures," you know what I mean? Just stuff like that where it's like kind of giving people behind the, behind the curtain peaks at your own organizations or that kind of, those, those moments of alpha, those nuggets that you've found and just sharing it so you can have you know, and they're doing the same and everybody's better for it.
But then we have a training course and then some other like mini courses, probably a couple dozen downloadable resources. So these are like, you know, prebuilt, proformas, budget forecasts, you know, IP stuff, due diligence type stuff, like stuff to help you with, get your data room beef, you know, beefed up and looking good. And we do videos. There's some live events every now and then. So, so that was very focused on the founder side, you know what I mean, like the entrepreneur side.
We, you know, my co-founder used to run a med device, venture studio, so like doing like business engineering, business development, engineering, you know, kind of market related stuff for like early stage, largely like clinician and inventors and stuff like that. He used to run a, a, a group that did that. And we knew we wanted to kind of start to do more offerings that kind of for that side of the table, like the CDMO contract manufacturer design and development group side of the table. So we launched, we started building MedTechVendors.com and launched it in 2025, February, 2025. And then did kinda a relaunch with adding some like agentic AI features in I think at the end of the summer last year.
But it, but at its core, I always say this analogy, it's like Angie's List, right? You know, Angie's List, what do they do? Well, it connects people with local pros. Allows them to like, evaluate, engage them really easily, you know, get, get their stuff done quickly from trusted people. You know what I mean? So we have the same approach. We help device teams, and that could be device teams at large, medium, small, or startup organizations or tech transfer offices, whoever we help those device teams find, evaluate, and engage contract manufacturers, CDMOs testing facilities, design and development groups, one man band engineers, whatever through the platform.
We have an an ag agentic AI chat. So like it'll ask you questions about your device. It'll start recommending, "Hey, do you need this? Do you need these types of services? Are you looking for this type of vendor? This type of vendor?" It pre-populates forms. It generates matches for you. You can review each vendor's profile, one click get email intros or request quotes, and we're adding some some really cool additional features around some different like skills that you can run. So, think like a reimbursement skill or market a, you know, different predicate device selection skill, whatever.
And so those are all gonna be like linked up to the to this kind of AI agent. I don't wanna say too much 'cause we're still building it. I'm like really excited about, but there's other things that we're adding to it. The ability to do quote, visualization you know, and trying to make it kind of a, you know, a home away from home, a hub where you can track execution, get things done, engage vendors, and kind of evolve it more laterally in kind of the lifecycle journey. Not just " Hey, I'm looking for a vendor," 'cause that's a very acute point in time in a, you know, in a person's journey. But trying to expand it out to say the period of time when you're doing X and Y and Z and looking for a vendor so we can get some really was sticky, more sticky use and add more value.
So, that was that. And we've started really focusing on some more like intimate, I would say, engagements with CDMOs contract manufacturers focused on giving their sales and marketing teams massive, massive leverage using AI and ai, AI native tools.
[00:17:35] Lindsey Dinneen: Awesome. That's really cool. Yeah. Okay, so going back a little bit to the, to XO Medtech, I know you know you, you mentioned that there's a lot of resources available, but one of the things that I think is super cool, and I would love if you just share a little bit more about this, is you have a course that-- i don't remember the name off the top of my head-- but it's basically sort of Medtech Innovation 101. It's, I think...
[00:18:00] Spencer Jones: Yeah, The Playbook.
[00:18:00] Lindsey Dinneen: Call it like-- The Playbook! And you call it like the MBA for somebody who needs to learn. So can you just share the value of that and sort of what, what made you go, "Okay. I have, you know, the expertise in all these different areas enough to be able to share the journey from start to finish."
[00:18:19] Spencer Jones: Yeah, absolutely. I think like the, the value there partially comes-- I mean, I think speaking about the value, you gotta speak about kind of like why there was a gap there, like how it, why it didn't exist, whatever. There's just a lot of really bad content in medtech. You know, there's a lot of stuff that reads I mean, there's guidance documents, you know, ISO and this and that. Like those are tough reads, right? And then, you know, the, the content around " "here's how you really fundamentally apply these guidance documents and here's how all this fits together."
And it just felt like everything was I don't know what the opposite of like inside baseball is, right? Like that kind of " Hey, here's what you really need to know." Whatever the opposite of that is, is how medtech content felt like to me everywhere. It was just like polished press releases, really, like consulting speak. You know, "You gotta be strategic with your analysis." It's okay "You know, you know, you gotta find your champions." "How do I find them? What do I tell them? You know, how do I engage them?"
So it was just, that was the big gap. So I think the value, what we tried to do with The Playbook was, you know, give, like I said, pre-seed all the way through Series A, the right information, like the right depth, on the right topics in the right order with the right assets, so resources, downloads, all that stuff along the way so that you can go cradle to grave on this, basically be a novice, or we've had people that have launched products and gone through it and they were like, "Holy crap, I wish I would've had this five years ago."
But the whole idea is to basically not make you a supreme expert on any one of those topics. There's 46 different lessons, 47, and like you can get through each one in probably 20 minutes, right, 15 minutes. But not to make you an expert on each individual topic, but to give you like a dangerous level of information on any one, and then make you able to dive deeper on any of them, you know, very quickly and easily. So like when you meet with your, you know, a regulatory consultant or an IP attorney, or go down the list, you are not, they're not saying words you don't know for the most part. You're not paying them $300 an hour or $500 an hour to educate you on definitions and concepts. Right? You're, you're applying principles and evaluating strategy versus " What's that again? Like, how does this, what's the timeline for that?" 'Cause that you know, that's just not good for anybody.
You know, so, so that, that's kinda the main, the main value prop thrust of it. And I just, I frankly didn't think it existed, but proof's in the pudding. Like we've sold it to accelerator programs, we've sold it to hospital, you know, innovation departments. We've sold it to incubators, like trade associations that have like their like kind of innovation arms. It works. Like when people do it, it works.
It's funny-- we can talk about this too-- but like the, you can lead a horse to water thing. It's funny how many people say they want to be entrepreneurs and say they wanna be innovators and really they just want to just yap. And they don't actually wanna put the time in. I'm telling you, it's like crazy how many, you know, fake entrepreneurs there are out there. But it's okay. It's okay. You know, like there has to be, I think there needs to be some cleaving or weaning or calving of the herd to some degree because we've got, I don't know, and maybe we need to develop 'em more, but it's, it is frustrating seeing it firsthand when it's like "You have a really cool device, but you are so uninvestible and you have no interest in being coachable that it just hurts me."
[00:21:30] Lindsey Dinneen: Oh yeah, absolutely. No, I love that you've done that resource and yes, super excited to see hopefully a lot of innovation actually happen and be successful as a result of that. So with, you know, okay, so you have, you have this community now and I'm wondering if there are any moments that kind of stand out to you, maybe as you've built the company, also Medtech Vendors that kind of enforce, "Wow, I am, I am in the right place at the right time."
[00:22:00] Spencer Jones: You know, I definitely-- you know, it's, it's, it's really, there's not, I would say, any huge singular moments. I mean, we've had people like get business from coming on the XO Medtech podcast. You know, we've had people meet new clients, new strategic partners type stuff, like in the XO Medtech community. I mean, I've made a ton of friends in the XO Medtech community, people that I talk to you know, every, every week or two you know, Brad Shirley, I'll mention him. He's fantastic. And like I've learned from him, he's learned from me. We've both learned stuff from the community. I, I, I really do think it's though, it's like it's, you know, those-- whether it's a LinkedIn DM or you know, somebody messaging me in XO and they're like, "Hey, I just went through this lesson. It was like, so good. You know, blah, blah, blah." And I think those little things honestly like power me, power me up, give me juice, give me energy.
You know, and, and like reading, we, we did a ton of, I mean we probably got 30 people that did kind of like a pre- and post- assessment and they gave their feedback on The Playbook so we could refine it like as we were, you know, after launch and all that stuff 'cause we're constantly trying to improve it. And have reading the testimonials and people just being like, yeah, like "This is, this is killer." People that are brand new, people that have been in the industry for 20 years that went through it. I think so, I think, I think it's kinda like a myriad of those things.
I would say some of the stuff on-- and that's on the XO Medtech -- I think some of the stuff on the Medtech Vendor side and what we're doing with, you know, kind of campaigns and the tools that we're developing and the work that we're doing there, like we are fully an AI native organization. Like it, like we, it there is just not at all like a significant amount of people in medtech using AI to like actually do not in their products. I don't care about that. Like I'm talking about like in their day-to-day operations and, and whatnot and like we're trying to change that. And so like in that respect, like we will come out with things, you know, release features, release products, build custom tools for CDMOs and you know, the looks on their faces and like how amazed that they are at X, Y, and Z.
And sometimes it's like stuff where it's hey, I'm like building them a just showing them how to do something with not even a tool that we built and like they're blown away. And anyways, all of that stuff, I feel like, man, like this is where I'm supposed to be because like. We, we've gotta make MedTech a more attractive investment opportunity. We've gotta compress the development cycles and the cost to develop and the time to develop and get things to market. You know, and I look at AI drug discovery for the pharma world as like a huge way that that's happening.
But we have to have that similar type of like, when you to engage with this, it will be good for our ecosystem and industry as a whole, becoming more investible, becoming more cash efficient and all that stuff because you've seen other sectors, you know, software is taking money from early stage medtech, like nobody's business. You know, people are investing AI and you know, I just looked at the annual report from like HSBC, the Venture Report, and like me, early stage medtech funding continues to be down. You know what I mean? So we just gotta do something like, I, I feel like it's an existential, it's an existential issue for early stage medtech to get better at being scrappy and using AI.
[00:25:03] Lindsey Dinneen: And there's so much opportunity there. Yeah, I love that you're helping to promote that. So you've gotten to lead a number of different companies now and through very challenging milestones. And so I'm curious, how has your own leadership philosophy developed over the course of your career so far?
[00:25:24] Spencer Jones: Oh, what a good question. You know, I, I hate to say this, but I've almost gotten more cynical, you know.
[00:25:30] Lindsey Dinneen: Okay.
[00:25:31] Spencer Jones: Well, and it, it's, it's like I try to be very protective of my time and like protective of the time of the people that I work with, right. You know, and that doesn't mean I'm not willing to like go the extra mile and whatnot, but I think it's about respecting people's time. Right? And, and you know, I think honestly my leadership philosophy, I think a lot of it revolves around just like incredibly clear communication and like staying above the fray. No riff-raff, just just executing and moving fast and like keeping expectations really high, because I feel like when you've got complacency, you know, at the top, it just, it like doubles every rung of the ladder lower that you go in the org chart or whatever.
You know, so I think like pace, you know, pace and hyper clear communication, like no subversive or passive aggressive or anything. It's just like straight up, like I'll just exactly tell you if I wasn't happy with something or whatever, but I just, I don't know, like I feel, I feel like you know, leadership style too, like I think, I think it, so much of it boils down to communication for me. It's just like really, really clearly communicating and like making sure that people understand what good work looks like and what a, them doing a good job looks like, and where...
Yeah, I think, I think being clear about expectations, really clearly communicating those expectations around like work product, what it should look like, how fast it should get done, how many updates I need, or how many questions I expect to get as you're doing this, what resources I expect you to expend and explore before you come to me with something you could Google.
Like all of that stuff, but honestly, I, it, it's kind of a tough question thinking in like the more immediate past, just because I feel like there's been such like, almost like a flattening of org charts, frankly, with the way that we're using technology and AI these days where I feel like in the companies I'm operating in right now, like it's mainly just principles and like lower level stuff, like we're either delegating to AI agents or delegating to like VAs that are in a different country or something, you know what I mean? And, and so there's just been a big flattening.
You know, seven years ago, six years ago, I was managing, you know, new grads outta college, two or three at a time, and, you know, having to like, have these kind of like, you know, like brotherly, you know, like talks with, you know, these types of things, " Hey, like you really gotta do this" and like coaching and stuff like that, i, you know, there's a, we have to have that stuff. I'm just not in, in organization and honestly, the organizations I'm in right now in startup world I just feel I don't know. Like I, I feel like we're, I haven't seen that and I, I know a lot of organizations that are small and nimble and whatever, and I feel like the org charts are getting real flat in terms of like people that are getting managed, you know, it's a lot of agents getting managed, frankly.
[00:28:21] Lindsey Dinneen: Yeah. Yeah, yeah. Interesting. Yeah, that, that's a really interesting insight too. But I really do think that to your point of coaching and mentorship and how much of a difference that makes, but especially, I was just on this conversation earlier today of the critical importance I feel that there is about establishing expectations across the board, whether it's your clients, your employees, your coworkers, just making sure that everybody's on the same page is such a critical aspect of, of setting yourself up for success. So yeah, I love that you touched on that 'cause like I said, literally earlier today.
[00:29:00] Spencer Jones: Yeah. And, and can I, can I, quick aside here. It's, it's on topic, but before we move on, I mean, I, I'm not the first person to think this or say this, but I'll, I'll die on this hill. The more you use AI when, when you're using it the right way, right, the better leader and better specifically, the better communicator you'll become, right? Why? So much of interpersonal office drama, bad management, bad leadership is like what we talked about, right? It's poor communication. It's expecting people assumed something or had knowledge they didn't, right? It's not letting them know what you really wanted, what good work looks like, all that stuff.
This is all context engineering, right, which is just a similar to prompt engineering, but context engineering is kind of the other more important piece these days with AI. What do I mean by that? Like I'm gonna give a prompt to a chat. Is it in just like a virgin chat or is it in a project? What context, what documents, skills, reference templates, et cetera, access to code bases does that project have, right? What am I telling it to do? How am I breaking that down? How am I, you know, big, high level goal? What do I want it to do? What does the output need to look like? How deep do I want it to go? Right? Like, how many questions I say, "Ask me like five or six questions" when I'm prompting, right, if I want that, right?
Give, so giving the other person right in that space to say " What questions do you have?" Right? The, the, the best people at context engineering and leveraging AI in that way end up becoming more, better and better and better communicators because it's-- I mean, yes, you're talking to a machine, but at the same way, like those principles a hundred percent apply to good professional communication.
So I'll die on that hill. There's a lot of people that are like brain rott using AI. It's " what's the weather today?" And you know, "how many calories does mayonnaise have?" And those people are not, you know, they're, they're not improving their leadership communication by using app, but the people actually doing it right a hundred percent are,
[00:30:52] Lindsey Dinneen: Yes, I could not agree more. I think that is one of the coolest things that AI has taught me personally is-- to your point, to be a better communicator, to be clearer with the way that I communicate, to avoid assumptions that the other person, say, knows what I'm talking about or, or does have the context behind why I asked the question the way I did, or all those kinds of things. So I, I could not agree with you more. Yeah. And it's exciting to see how it continues to evolve. Okay.
[00:31:22] Spencer Jones: Yeah. And why, real quick, why, like the AI models, especially with the reasoning models and stuff, Opus 4.6, all this stuff, telling them why they're doing something and why doing it, doing a certain task within that project flow is important is proving to be more effective than telling them how. And I think that's something where, you know, you tell someone what to do, they may do it, but if you tell them and make them believe why it's important, they do it that way, they're really gonna do it that way.
[00:31:49] Lindsey Dinneen: Yeah. Love that so much. Okay. All right, so pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want, could be within your industry, but doesn't have to be. What would you choose to teach?
[00:32:05] Spencer Jones: Does this, assume-- I have a question. Does this assume that I'm already I'm already capable and you know, have enough expertise to actually teach this class? Or is it like I choose this topic, I'm now an expert in that and I get to teach it?
[00:32:19] Lindsey Dinneen: I like, I like I like both options, but I'm gonna go with option B because you have a million dollars to play with, right, so you could build up the expertise. Yeah.
[00:32:29] Spencer Jones: You know, I would still say like building AI tools, AI agent systems, you know, skills and subagents and these flows and, and really tactically executing that for medtech. And that that goes from founder, you know, innovator to service provider, reg, quality ,reimbursement, like all the way up through sales and marketing and then like CDMO teams, you know, doing contract manufacturing, doing this. Like I, I just, I'm so passionate about it and I, I just see that there's so much untapped opportunity that that is the thing I think, and, and like we, we are doing that not a masterclass, but like we are working with groups to do some of that. But, I just, it's just so, so, so, so much opportunity to do it.
And I think there's like weird structural reasons why it's not being adopted the same, you know, at the same clip it is in other industries. But you know, medtech's very rules-based game. You know, you've got your guidance docs, you've got your predicate devices, you've got your clinical trial protocols, you've got your stats analysis. You got your, you know, X, Y, Z hospitals get paid a certain way. Like lots of formulas, lots of reference material, lots of guidance docs. You know, it's very kind of rules and order based system in a lot of ways. And biology has its own kind of, prescriptive way that things happen, right?
So I just feel like it's so primed for it. And anyways, I, I just, I wanna see it adopted more so we can see like what's happening with software now, where, you know, the cost to build and, you know, produce and get software to market has com has almost collapsed, but compressed to, you know, from like months, maybe years to, you know, days and weeks and, you know, you got a $200, 250 bucks worth of like software subscriptions, Claude this, that, the other, you can get it done in a week if you, you know, two weeks if you put your mind to
[00:34:21] Lindsey Dinneen: Yeah. Yeah. No, that would be an incredible masterclass. I like it. All right. And then how do you wish to be remembered after you leave this world?
[00:34:30] Spencer Jones: Oof. God, what a good question, Lindsey. You know, I hope to be remembered at all.
[00:34:35] Lindsey Dinneen: Yeah.
[00:34:36] Spencer Jones: You know, 'cause I, I'm definitely one of those people that's " nobody cares, nobody's thinking about you." You know, you may have, I, I mean, I think there's like some healthy main character syndrome that people can have that gives 'em confidence, but at the end of the day, no one cares. They're just, everyone's thinking about themselves. But if I am remembered, which I hope to be I wanna be viewed as like someone that was, I'd say, loved their family was a good dad, good husband. I would say brought people joy, was like fun to be around, but like from a interested in other people sense, you know, you know, genuinely cared about people.
But I would say that on the professional side, like somebody that you know, would like consistently just delivered an absurd amount of value whether it was, you know, running a business or coaching and developing people at a company or working on behalf of clients or trying to make a positive change. I would say impactful and valuable, you know, with the work that I'm doing. That's, that's, that's how I wanna be remembered.
I mean, we don't have big, I don't wanna be a unicorn billion dollar company. No, we have no desire to do that. We don't even have a, a desire to get acquired at any point. We're not raising money, you know, we've, we've deliberately chosen to bootstrap it. You know, we frankly just wanna employ really awesome smart people that we work with, you know, pay everybody well. And like I said, add a absurd amount of value you know, and joy to the people and the clients that we work with and like work at the company with, you know what I mean?
[00:36:05] Lindsey Dinneen: Yeah. Yeah, that's a absolutely wonderful legacy to aspire to. I love it. All right. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:36:19] Spencer Jones: Oh, I gotta be, I've got a 1-year-old kid. Banks. Banks Austin Jones. So it's gotta be him, and my wife of course. One thing that makes me smile though, every time I see it, oh... you know, I am, I'll cry at a good TikTok, so I'm so I guess that's like a form of smiling, you know? But I'm a pretty big softie, honestly. You know, this is gonna sound weird, but it's kind of those moments where you know, people usually strangers and usually people that don't look like each other, just show humanity to each other. And that could be like holding a door open for somebody. It could be small things, you know what I mean? But I really love seeing those moments and capturing them like candidly, you know? Just you know, oh, I was in a restaurant, I saw this thing happen. You know? I really love that these days.
[00:37:09] Lindsey Dinneen: Yeah. Yeah. We all need more of that these days too, so, yeah. Love it. Alright, well, Spencer, this has been a, a fantastic conversation. I really appreciate you and your time today. I love what you're building in the medtech industry and cultivating community and resources and providing value. So just thank you for everything you're doing to change lives for a better world.
[00:37:34] Spencer Jones: Thank you. Can I ask you a question? I feel like you were so good, like with the questions and kind coming on the back of like my responses, but I have a question for you like what? You know, what about the medtech space, like most excites you? It can be a specific technology, it can be a specific, you know, company doing something. It can be anything, but what's most exciting to you, kind of looking at 2026 and, you know, kind of in the realm of medtech broadly.
[00:38:00] Lindsey Dinneen: Yeah. Oh, I love that question. So I love this industry in general, but there, there's something really special about the energy of being around people who truly care about making a difference. Part of the reason I started The Leading Difference was because I, when I first joined, had sort of noticed this sort stigma from people from the outside who weren't very familiar with the innovation, what it takes to get from, you know, drawing to commercialization. Just didn't, just didn't know. And there was this stigma that people were here just for the money.
And then I started meeting all of these incredible change makers who they had personal stories of what they were seeing, or a family member was impacted. And I just loved the fact that there were so many cool people doing such cool things and getting to play a small role in that was the coolest thing in the world. So, you know, I, I say I happily stumbled into medtech five years ago and found my people and my happy place, haven't looked back. I love it. I love being around people who are genuinely trying to do good things in the world. And I hear about new and you know, new ideas every day, and I get excited probably almost equally about most of them because it's just cool to see. So I don't know. Does that answer your question?
[00:39:29] Spencer Jones: No, it, it does. I mean, it, it really the, it all comes back to the patient at the end of the day. And I definitely, I, I feel like when people think of like medical device stuff, like their minds immediately go to like Stryker sales reps or something, you know what I'm saying? And there's just so much more to it than that. And there's one of my favorite things about medtech is like the personalities, you know, like you got your wacky, you got your wacky inventors and you know, you got your straight laced regulatory people. But when you get to know 'em, they're, they're absolutely hilarious. You know, you got your attorneys, you got your like, and I, every industry, every industry has their personalities.
But I think medtech, you know, you got your beef head sales reps that are like posting " What's up guys? I'm here in the locker room in my scrubs" and like "Motivation Monday." You're like, "Oh my God." But it's just like all these personalities and you go to these conferences and you just see 50 of the same person, but they're each different, they have their own dreams and conflicts and ideas and whatever, but they're still like so in the same box in some ways. I think that's one of the funnier, like funnier things about medtech that just makes it quirky, you know?
[00:40:30] Lindsey Dinneen: I love it. And I also love the amount of respect that I see shared amongst people of very, very different backgrounds and areas of expertise. And that was one of the things that made me fall in love with the industry too. I was like, I, for instance, you know, I'm in, I'm in marketing and business development, so I play a very small role in, in sharing about these devices. But people, the engineers that I work with and the consultants that I work with, and everybody in the ecosystem is always just " Wow, well, I can't do what you're doing. And so I think what you're doing is fantastic." And so there's just, there's this mutual respect that I think is super cool about being here too. So yeah, I'm a fan.
[00:41:08] Spencer Jones: Yeah, I agree. I agree. We could, we could keep going for, for days...
[00:41:12] Lindsey Dinneen: I know.
[00:41:13] Spencer Jones: ...On this. I really, I know, I know we have to wrap it, but but yeah. Well, Lindsey, thank you for having me. Seriously, this was a blast. And you know, I'll just maybe like quick sign off plug or something here. If anybody that's listening to this is like interested in, leveraging AI, leveraging AI in medtech or for you personally or whatever, follow me on LinkedIn and post a lot of content about it. You know, talk about it a lot on the podcast.
But then if you're, if you're on the founder side, if you're an innovator, like join XO Medtech. If you're on the CDMO side, if you're, you know, on a sales and marketing team, contract manufacturer, CDMO, even like signed development groups, that kind of stuff like, you are like, "We know we need to be using AI to better leverage X, Y, Z, or do this thing. We have all these, we have HubSpot and this thing and that thing, and none of it works together well and we've got too many tools." Whatever. Just hit me up. Let's have a conversation. We're doing some absolutely incredible things leveraging AI, giving these sales and marketing teams like crazy leverage. So yeah, just drop a dm. I'd love to talk to you.
[00:42:08] Lindsey Dinneen: Awesome. Sounds good. And we are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support, and we wish you continued success as you work to change lives for a better world. Looking forward to seeing the future of all the good things that you're doing. All right. Bye.
[00:42:41] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Kat Hurd, executive coach and founder/CEO of Med Tech Collective, shares how nearly two decades in medical device sales and leadership, including at Boston Scientific and Saluda Medical, shaped her mission to help reps and leaders build influence, ownership, and long-term career momentum in complex, high-stakes environments. Kat explains why strong clinical partnership can elevate sales conversations into trusted-advisor relationships that impact outcomes, and outlines how she coaches individuals, trains teams, and supports go-to-market strategy. She also dives into the distinct challenges women face when navigating rooms where they’re “the only,” the career accelerant of mentorship versus sponsorship, and practical ways to break into medtech by identifying gaps and learning the industry’s language. 
 
Guest links: https://kathurd.com/  
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPTEpisode 079 - Kat Hurd
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I am delighted to welcome today Kat Hurd. Kat is an executive coach and the founder of MedTech Collective, where she helps medical device sales reps and leaders build influence, ownership, and long-term career momentum in complex, high stakes environments. With nearly two decades of real world experience in medical device sales and leadership, including senior roles at Boston Scientific and Saluda Medical, Kat brings a rare blend of commercial rigor, strategic insight, and credibility earned in the field based in Arizona. Kat is a speaker, advisor and coach who believes that when sales reps and leaders learn to own their voice, their business and their influence, the ripple effects extend far beyond individual success, shaping teams, cultures, and the future of the industry itself.
Kat, welcome. Thank you so much for being here today. I'm super excited to speak with you.
[00:01:45] Kat Hurd: Thank you so much for having me, Lindsey. It is an honor. I always love these conversations.
[00:01:49] Lindsey Dinneen: Excellent. Well, if you don't mind just starting off by sharing a little bit about who you are, your background, and what led you to medtech.
[00:01:58] Kat Hurd: Yeah, absolutely. Well, medtech, I like to say it's always, I was kind of born into it. So my mom is a nurse and she ran a medical clinic when I was in middle school and high school. So truly I would go to the clinic after school and, if, if actually we didn't have school, I remember one of the days sitting in a pharmaceutical rep lunch presentation, so I really got exposed before I even knew what it was.
Even in that moment, I wish I'd understood more of what that rep was doing and really dug deep. You know, I thought I was gonna go to school and be a doctor, and then I quickly realized I didn't like freshman bio. And I wanted something where I could have an impact but still have some flexibility. So I actually, my to, to take you back to like how this all started, my background, sports medicine and so my undergrad and graduate degrees are in exercise science. I used to be taping ankles and rehabbing knee injuries and doing all of those things.
And then I got exposure through that of being in the operating room when our athletes would have, you know, the injuries that were being surgically repaired, and that was really where I got that secondary introduction into medical device and started having conversations with other people who'd made the transition from athletic training where you have a ton of, you know, in insight into the human body and understanding of the medical world.
And moving that into the sales arena. And so I met with someone in Iowa City. I'm a University of Iowa grad, and he was running the western half of the US for Boston Scientific at the time. And one thing led to another, led to me flying to Arizona and interviewing and then moving their site unseen really. I was there for, you know, max of 24 hours total in my interview process. And I just packed two suitcases and said "I wanna break into medical device." And that was in 2010. And I just fell in love with the industry and the therapy.
So I was in neuromodulation working directly with spinal cord stimulator patients and started as a clinical specialist, and then I really quickly realized the way to have very clear impact on patients and providers was really actually to be in that sales role and be the one directing the support, directing the resources. And in neuromodulation, because you're in the OR and actually programming the stimulator, you're also kind of supporting the patient's care, which for me was right in my wheelhouse.
And then I moved into leadership. And you know what you really wanna know is probably how did I land where I am now? And so I spent 10 years or 11 actually at Boston Scientific. And then moved to Saluda Medical, so to commercialize a small Australian based startup here in the US, which was such a fun and unique opportunity. And I always knew that was gonna be more of a three to five year play, and I just had it on my heart that I wanted to build a business to help reps be better reps, because I believe that the quality of care and the quality of outcomes is also directly tied to the partnerships and the caliber of the industry that supports the therapies.
[00:05:00] Lindsey Dinneen: Okay. I love that. And I have so many questions as a result, but okay, let's start a little bit with what you're doing now and then maybe, we'll, we'll get to some of the other stuff as well, but, so you're supporting reps, and I think you said something really impactful about a lot of the patient outcomes kind of goes back to how, how the reps can be the best they can be. So I'm curious what all goes into that for you and what kind of training or coaching do you provide?
[00:05:31] Kat Hurd: Absolutely. You know, I really, I saw that squarely and believed it when I was a sales rep myself. So I spent the first six years of my career on the sales side of things, and then moved into being a sales leader. And as a sales leader and then an area Vice President Saluda, it was the thing that I saw of like our teams and our people that excelled the most, weren't just the best salespeople, but they were the people that understood how to, for lack of a better word, leverage that clinical and patient experience into the entirety of the sales process and sales cycle. So good clinical care and driving good sales conversations, levels up the partnership and really creating this layer of, not just being a partner, but being a trusted advisor with the providers that you work with.
So how that translates into my business now, 'cause oftentimes, you know, I get the question of like, why did you leave a burgeoning career? I had one physician who was like, "You were gonna be a CEO. Like, why'd you leave medtech?" I'm like, "I didn't leave. I'm just doing it differently," because I saw so strongly and so clearly that having the right resources as a sales rep and at the right time as a sales rep changes your career. I was lucky to have great mentors, but there's things that if I had had the right support and resources at the right time, I could have been even, you know, faster or more impactful in my results.
And so that's what I do now. What my business looks like now is really, you know, threefold. So I work directly with sales reps who, not through their companies, but they'll come to me directly and we do sales and leadership coaching. So working on the strategies in their business, how they're, you know, clinically supporting. But, you know, I, I leave the clinical nuts and bolts to the organization because I'm not an expert, and that, unless it's spinal cord stimulation, then we can talk that for days. But you know, really how they're leveraging their clinical prowess into their sales process and building systems for success. And then I work directly with companies helping train and elevate their talent, both on the sales and leadership level.
Then I also have an arm of my business where I do, and that's kind of more of the consulting arm of my business. I also help with sales strategy and go to market strategy. And then I also do more of like corporate speaking. So keynotes and workshops and seminars really focused on both how do you build and grow your career in medtech, particularly as a woman, because we know there's just not a lot of us. And you know, part of what I'm so passionate about is helping everyone and raising the caliber of talent everywhere, but also making sure that women have the structure, the resources, and the idea of the systems that they need to create so they can go as far as they want to. Doesn't mean they have to go all the way to the C-suite level if that's not what they want, but to ensure that they have the representation and the pathway in front of them to understand how to get there.
[00:08:27] Lindsey Dinneen: Excellent. Okay, so let's dive into that a little bit because I know, I know you're super passionate about helping, you know, in general the industry succeed and, and move forward. But yeah, you have a particular passion for helping women. And I'm curious what's, what are some of the challenges or differences you see in a woman as she's trying to build her career in this versus say, a man who might just have a, a different experience?
[00:08:52] Kat Hurd: Yeah, very different lived experiences and a lot of the tools and tactics and strategies that I work with my clients on are pretty universal. But what isn't universal and what we really work on for my female sales leaders and sales executives is that mindset and approach. Because you both have to you, well, you have to understand one thing, how to navigate rooms where you're the only or the lonely. Because most often in medtech, you will find yourself, at some point in your career, and if you haven't, please call me. I wanna know who you are and talk to 'cause that would be amazing if you've never been in a room where you haven't been the only woman. But it, it requires nuance. It requires an understanding of how to position yourself and your insights in a way that they land. And land effectively with the decision makers that you build the right connections. So you have access and visibility, and that's really the internal corporate side of things.
And then you have the customer facing where there's of course nuance of, I mean, I had, when I was a sales rep, I had three female physicians as customers over the duration of my career. So I needed to understand how to work closely and collaborate with male physicians and do it in a way that there was a clear and fast line of what that relationship and rapport was. And I was able to do that so successfully that not only did I win a bunch of awards, but many of those individuals have become friends and mentors and sponsors of mine as well.
[00:10:22] Lindsey Dinneen: Wow, that's incredible. Yeah. I actually wonder if you could speak a little bit to what you just said, because this is something-- so recently I had an opportunity to host a leadership summit, and one of the things that came up in the keynote was about how there different types of mentorship available. So, so you need, you need people who are kind of in your corner coaching you, but then you also need that kind of next tier, which is that sponsor like you were saying. So I wonder if you could speak a little bit to that.
[00:10:54] Kat Hurd: Absolutely. Mentorship and sponsorship is, is some of the best lighter fluid that you can add to your career growth, truly. And I'm so passionate about it, I, some of what I do from a consulting work standpoint is actually help organizations build mentorship programs. That was my very first consulting contract when I started my business. So I, I'm actually very proud of that and I, I don't ever share that, so thank you for asking that question. 'cause I don't think I would've even called that out.
But it's so inherently valuable and I, I'll just take us on a quick sidebar of why it's so important especially for women, because women, when it comes to career growth, will wait until they have 100% of the qualifications to apply for a role. When left to our own devices, we oftentimes will look at it and say, "I either don't wanna be rejected, I don't wanna waste anyone else's time or my time, or, well, I don't have all of those qualifications, so I'm not going to apply. I'll wait."
Now, our male counterparts are far more brazen and they need three out of five of those qualifications, and they are convinced they are the top candidate, and there's something to be said for that, right? You know, I, I aspire to that level of, of confidence and conviction and I, I, you know, really both, you know, encourage and in some ways push and, and motivate my clients to do, to take that mindset and approach and not just the unbridled confidence. We do need that. But to understand that you don't have to have every single checkbox because when you're looking at career growth, if you're fully qualified and can do everything of the entire job scope on day one, you've actually already entered a role that you're already overqualified for.
[00:12:37] Lindsey Dinneen: Ooh.
[00:12:39] Kat Hurd: Because where do you grow?
[00:12:41] Lindsey Dinneen: Mm-hmm.
[00:12:42] Kat Hurd: So, so that's, that's the importance of mentorship and sponsorship is to have others see maybe what you don't, and help you identify where your talents and where your strengths are. Because really career growth, the best thing you can do is lean into those talents and then explore the edges that you need to grow into, and mentorship can help you do that. Now, the difference between mentorship and sponsorship: a mentor is someone who's likely walked the same path or similar, has done much of what you've done or has insight into it, and can provide insight, guidance, resources, and be a sounding board.
What you don't want is a mentor that just commiserates or tells you that everything you're doing is right, yeah, because we all have areas to grow. So that's, mentorship is so important to have those people that it's kind of your lifeline, right? Can you, what's your phone a friends? You gotta have some of those phone a friends. And then sponsorship, those are people that can help you open doors. And sometimes a mentor will also be a sponsor. They're not mutually exclusive, but those sponsors are individuals who have influence and access to rooms that you aren't in, as do your mentors oftentimes, but can help open doors create introductions and open pathways that you didn't even know existed. The mentors and sponsors alike will be those people to encourage you to apply for roles when you think, "Oh, I don't know, I'm, I'm not sure if I'm ready."
I mean, that actually, as I said, that took me right back to, I was in Atlanta, Georgia when there was an area vice president role that opened up. I was a regional director at Boston Scientific at the time. And I went to my area vice president, who I worked for, and he's like, I was like, I don't know if I'm qualified. He's like, absolutely, you're applying.
[00:14:28] Lindsey Dinneen: I love that and "I'm gonna follow up with you."
[00:14:32] Kat Hurd: Yeah, yeah, exactly. And I didn't get the role, but that isn't the point. It's the conversations and the growth that even comes from it too. So, so sponsorship is so important because it really is what can create some of the access and avenues and opportunities that you didn't know were possible. I'll share kind of a quick illustration of that 'cause it's very relevant. Dr. Mike Dorsey, he has a, a society called Sierra Spine Society. Not sure if you're familiar it.
[00:14:59] Lindsey Dinneen: Little bit. Yeah.
[00:15:00] Kat Hurd: It's one of the best conferences out there. I'll just say that. Like you get to ski while you're there and it is wonderful. But when you talk about sponsorships, so I've known Mike through my career, especially as I moved to Saluda Medical, you know, expanded my sales leadership influence and the geographies that I supported. But when I went out and started my own business, he was the first one to come to me and say, Hey, I wanna partner with you. I want you to come to Sierra Spine and run an industry panel.
[00:15:30] Lindsey Dinneen: Yeah. Yeah.
[00:15:31] Kat Hurd: And there's no conversation like that that exists now. And we were texting about it this morning. It's why it's such a timely example, because now these conversations are, are popping up at other society meetings about the partnership, the collaboration, what is the role of industry and outcomes, all of those important things. And so his sponsorship has led to me now having other opportunities and conversations with different societies and different physician partners about the importance of those collaborations, about the accelerant that they can be in care and in, in outcomes. And so without someone like Mike, like Dr. Dorsey, I wouldn't have had that opportunity. I wouldn't have even had necessarily the proof of concept to go have these conversations. So that's where sponsorship can be so inherently valuable in your growth and creating movements and motions that you just truly didn't know were gonna be possible.
[00:16:26] Lindsey Dinneen: Yeah, and I think you said something that I wanted to touch base about. So, you know, you were talking about how oftentimes women don't apply for positions because they don't meet all the qualifications. And I, I know that's a very common thing and something that I've heard from people that I've helped mentor are sometimes when they're young in their career or they're wanting to break into, say, medical device sales, sometimes they have all of these incredible skill sets, but because they're not already part of the industry, they feel that they're not always sure how to connect the dots and get seen. And I'm curious, what are some of the things that you recommend for young professionals who are in this spot trying to break in or trying to keep growing?
[00:17:10] Kat Hurd: Yeah. Yeah. It's getting, gaining a clear understanding of your talents, your experiences, and how they translate to the person that's hiring is one of the most challenging and also most transformative things that you can do when you're searching to break into the industry. And so it's really, you know, having conversations with hiring managers before you're in an interview process. The job interview starts, the job application, the job opening, and you know, recruiting starts far before the opening is posted.
So, step one, and I know that folks out there know this, but it's really, it's getting clearer on what facet of industry you wanna get into, understanding what those pieces are that you, that are, are critical in that role. Like what does that hiring manager really need? What are the problems they're looking to solve with that hire? And then translating your experience into the solutions that they're ultimately looking for. So what that like in said and simpler language, you have to be able to speak their language and understand their needs so you can position yourself as the solution to those needs.
[00:18:31] Lindsey Dinneen: Do you think also there are some good resources out there that you would recommend in terms of, part of what I know the barrier can feel like, and, and it, it can be really daunting when you first get in the medtech industry because, for many reasons, but somebody might say an entire sentence where you're like, I have no clue what you're talking about, based on all of the industry jargon um, and acronyms and things like that. And so I'm wondering, are there resources available that, you know, people that are looking to break into the industry could access?
[00:19:04] Kat Hurd: There are a ton of resources out there. The challenge is knowing the right resources. There's also a ton of programs that will support you in your breaking in. This is gonna be an unpopular opinion. I don't think you need big, expensive programs to create results. What you need is a strong belief in your candidacy and an understanding of what your gaps are.
[00:19:29] Lindsey Dinneen: Mm-hmm.
[00:19:31] Kat Hurd: And then the solutions and strategies of how to fill them. Now you can get there faster with the resources and framework. I mean, I don't have a formal program, but I still help people on a, you know, one-off basis break into the industry. But at a broader level, I think what you're really asking is how does someone, it's kinda like eating an elephant. Like where do you, where do you take the first bite? You have to get started in knowing what you don't know.
And so truly, I would encourage people if you're looking to break into the industry, to sit down and make a list of all the things that you don't know about the medical device industry. And that might be what are the different, you know, verticals of the industry? What are even the, you know, the specialties or the therapies and then, okay, so "I don't know even what space I would want to get into." That's, you know, bullet number one to identify. Then, "I don't know the language or terminology." That's an easy one to fix.
I used to always tell candidates that go take an online medical terminology class. Learn to speak the language. I feel like they're out there for like 20 bucks or something. You can find really easy ones. I'm sure you could do free ones. You could probably ask chatGBT to create you, you know, a laundry list of acronyms and medical terminology and an understanding. Because when you understand the environment, that's when you can translate your experience into something that's relevant. But when you don't understand the environment the customers work in, what the needs are of the hiring manager and what the positioning is of the company, it becomes really hard to position yourself as the right candidate.
So to go back to like, what are those resources? Absolutely. There's, there are folks that do some free programs. I mean, honestly, TikTok, there's a ton of people dropping knowledge on TikTok. There's some YouTube channels out there. I'm actually recording kind of a mini podcast series this week with Jay Pendleton, who's another. You know, big name in the medical device space, but adjacent to medical device from an industry standpoint, where we're gonna be talking about a lot of this because there is such a need, and the most important thing is first you identify the gaps and then you go find those resources. Of course, AI is a great place to go, but also have those human connections, make that outreach because that actually will help you then in your job search as well.
[00:21:47] Lindsey Dinneen: Right, exactly. And then making those connections. I always say you never know where that'll lead. You just, you don't, you might think it's just a quick intro and, and that's fine, but then your, your name will come to mind from if somebody's hiring or needs something. It's just, yeah, that, that's great advice. So, one of the things I wanted to ask about is you do a lot outside of, you know, your full-time job, which I'm sure feels more, even more full-time now, uh, running your own business. But tell us a little bit about some of the things that you're passionate about outside of full-time work that you volunteer for.
[00:22:25] Kat Hurd: Yeah. It, it's funny you say that, you know, the, the, the full-time job now is definitely like an all-time job, not just a full-time job, but I love it. So I hate to be that person that's like, it doesn't feel like work when you love what you do, but I loved what I did before, you know, this is a new way of me doing it. But I also firmly believe that the, and I've seen it in my business, the best years I had as a sales rep and as a sales leader were the years where I wasn't just giving to my team and to my organization but was also connected and giving to my community as well.
So right now, that looks like me spending a ton of time at Ballet Arizona. I'm the Vice Chair of the board of directors, so I have, I committed to a four year leadership, yeah, leadership journey with them. So I have two years as vice chair and then I'll be Board Chair for two years. And it's just really, you know, I've been dancing since I was itty bitty. I had a short stint on the Phoenix Suns for a hot minute, and you know, it's been something that has been creatively my kind of happy place since I was little. And it's been really fun to take my business acumen and my strategic mind and get to apply it to the art form that I love.
So that's where, you know, these days where I'm spending a lot of my time, but I also do rescue work and work at our local animal shelter, walking dogs, giving them treats, you know. There's something to be said for walking in after a long day or a long week to, and yes, people often are like, it's so sad. How can you do that? Those dogs are so happy to see you, there is no way, truly no way that you can leave pissed off. Like, it just, it takes the, the weight of the week or whatever the situation is, and shifts your mind and shifts your perspective because truly I think when we, you know, come from a head space of gratitude, because we are all so lucky to be in the medtech world, the opportunities that we have, the, you know, just uncharted territory really that our career can take.
That's the best part. I'm sure you didn't imagine that you would have a podcast and you would have, you know, the influence that you do with MD&M and all these other opportunities that are afforded to you. And so, it's good to be reminded of how much we do have, and it never hurts to get some puppy kisses too.
[00:24:42] Lindsey Dinneen: Exactly. Well, you're speaking my language on both of them.
[00:24:46] Kat Hurd: Love that.
[00:24:46] Lindsey Dinneen: When we were, when my husband and I were paused for a little while in Oregon, we would go and do and go walk dogs and, and yeah, it is, it is hard because you kind of fall in love instantly all the time, but it is such a, it's so, it's such a gift. It's a gift for you.
[00:25:02] Kat Hurd: Yeah. It, it really is. And we foster failed twice, so, yeah. You know, so we probably just should admit that we aren't good fosters we're good, you know, pet parents, but it is, and even you can't take all of them home with you. So just, you know, having those moments with them is really fun.
[00:25:21] Lindsey Dinneen: So you mentioned your business acumen being wonderfully applied to the arts world, which is a, which is so great. I'm also wondering how it's worked on the opposite side of things. Like what do you think dance taught you growing up that you apply?
[00:25:37] Kat Hurd: I love this question, and I was just saying this last week. I sat down at dinner with a mentor and sponsor of mine, and I was telling him that I am convinced --you cannot convince me otherwise-- that my dance background-- 'cause I actually, I went as far as to get a degree in dance. So like I live and breathe it for for a long time. And that is what made me such a successful sales rep especially in the OR environment because what do you do as a dancer? You observe patterns of movement and you, you are, you can predict what's going to happen physically before it happens because you can read those cues and so that is exceptionally valuable in the OR when as a sales rep, your job is to be like bright and present when they need you, and blend into the background when they don't. And it is like a dance in the OR, it's absolutely choreographed.
And then when that goes into sales conversations, it's reading the nonverbals and understanding what someone's body positioning and posture is telling you without their words. And you really do, especially I, I did a lot of modern dance in college, you learn that improvisation, you have to be able to read someone's movement before it happens. So yes, it's a great question and I, I, you know, strongly believe, I know that athletes often get hired as medical device reps, but I think dancers are just an untapped and really under leveraged subset of talent because their skills can translate so strongly.
[00:27:09] Lindsey Dinneen: I love that. Well, shout out to dance is I think many of the listeners know I'm also a dancer, so I of course, feel very strongly about the connection and the power that the arts can provide for any career really.
[00:27:23] Kat Hurd: Truly. I'm curious for you, what do you feel like your, if of your background, right, of your maybe it's dance or some of the volunteer work or the travel that you do, how has that positioned you in your current career for success?
[00:27:36] Lindsey Dinneen: Oh, that's, that's a fun one. I think so I think all of the skills that I learned as a dancer have been instrumental. Things like learning how to take correction with grace and apply, apply it quickly, apply the feedback quickly, permanently to make a big difference. I think learning teamwork and how you fit into the broader picture as a whole, you're not always gonna be the soloist or kind of the leader in charge necessarily. So sometimes you have to know when you're gonna be to put in dance terms, the corps de ballet. You have to know when to be the main group of dances. But again, not feeling like any role is insignificant. We all work together to success.
I also think that resilience is a huge component of it. The grit that is required for dancing translates so well into anything else because this industry can be difficult and like you said, depending on where you're navigating, and what you wanna do, sometimes it takes a lot of sort of persistence and, and resilience and grit. Yeah, I could go on and on, but those are things that come immediately to mind.
[00:28:48] Kat Hurd: Yeah, absolutely. It's that resilience. I mean, when you take it back to the conversation about breaking into the industry, you have to be willing to-- and same as in arts or in athletics-- like be willing to let yourself fail, to push yourself to your edges, to understand your limitations, and then blow past them. Because if you just stay at what your limitations are, you're never really gonna get where you wanna go. And as a dancer, you have to live that life all the time. And it is, it's absolutely, those are the hallmarks to breaking in. You have to be agile. You have to be very comfortable with rejection. You have to be very gritty in trying and trying and trying again, and it doesn't matter how many times you don't get a response, you're still gonna send out those messages. You're still gonna ask people for coffee chats. You're still gonna send one question to one person and ask for three minutes of their time.
[00:29:39] Lindsey Dinneen: Yep. Yep. I love it. All right, so I'm curious, as you've had a really cool career in this industry, what are, what is a moment maybe that stands out as really solidifying that, "Hey, I'm, I'm in the right place at the right time."
[00:29:54] Kat Hurd: Oh man, that's a hard question. I love that because I feel like I've had so many of those moments, and interestingly, it's not the moment that have been, you know, me standing on stage accepting an award. I think it's been in the little moments, like those quiet whispers of like, " Yes, this is it." You know, the, the times where my customers, you know, as a sales rep would come to me and say, "Here's the challenge I'm having. What are your thoughts?" Not about spinal cord stimulation, but because we built this trusted partnership and, you know, and I became an advisor in their world and not just another rep, right? So like those moments as a sales rep really were the moments that were were those kind of inflection points for me.
And then I look as a sales leader of seeing my team win as a coach. You know, I, I get the question of like, well, you know, how did you prepare for what you're doing now? I'm like, "Guys, I'm coaching. I was coaching people for the last 10 years as a sales leader. Now I just do it for my own company instead of others."
You know, but, and I will say this. The moment I knew that I was on the right path in my, my current role in starting my own company was starting to see the impact that it would have on the reps that I was working with. The sales leader who came to me as she first got promoted and then now is currently ranked first in her company, you know, like the, the reps-- even just this last weekend I got a text message from a rep I hired a few years back and who's at a different company doing big things and they just won a massive onstage award as Rookie of the Year. You know, really cool moments that getting to be a part of their success and their journey because not only is it incredibly fulfilling do you get to make a, a massive impact, but it also financially sets you and your family up for massive opportunity ahead. You know, I just had a client where we negotiated an additional 25K on her offer. Like that's a big deal, right?
[00:31:58] Lindsey Dinneen: Wow. Yeah. Yeah. That's huge.
[00:31:59] Kat Hurd: So, so I apologize because I didn't give you just one moment because, for me, it's, it's the invisible thread that runs through and that, because that thread has always been present in a different form or fashion, it's given me this in some ways insane courage to do things that people think are, are delusional and know that it's the right thing because of the impact that it's gonna have.
[00:32:24] Lindsey Dinneen: Love it. Absolutely love it. Okay, so pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be within the industry or what you're doing now, but it doesn't have to be. What would you choose to teach?
[00:32:42] Kat Hurd: Anything I want? Oh my gosh. Can I give two answers? Good. Because the first thing I would absolutely just want to teach one on this industry, and that's the power of influence in building your net, your web, I call it your, your web of, of influence. That changes your career. It's who you, who knows you, what they know of you, and that is what opens doors. So I feel like I would, I would do that. Right. And I, I have to do that because that's really what I'm so passionate about. But if it was like any off the wall topic, it would be traveling to Europe on a budget. I have it on lock. And particularly how to do the long haul flights without jet lag.
[00:33:35] Lindsey Dinneen: Oh, excellent.
[00:33:37] Kat Hurd: Yeah.
[00:33:38] Lindsey Dinneen: Might need to talk more about this offline.
[00:33:41] Kat Hurd: I feel like I have such a system and one of my my last boss used to always say, he's like, "You can go," 'cause I international travel is my, like, my passion outside of dance. And he's always like, "You can go, you just have to promise me that you'll come back." He used to joke. He's like, "I'm afraid that one day you just won't come back." So I made good on my word. I always came back, but I did learn a lot of tips and tricks along the way.
[00:34:07] Lindsey Dinneen: Awesome. Excellent. Great masterclass topics. How do you wish to be remembered after you leave this world?
[00:34:15] Kat Hurd: Oh, I love that. And what it unique question to ask in a podcast about medtech. I, I think we get so stuck in talking about who we are as professionals, that we don't always talk about the bigger pieces. So I wanna be remembered as someone who cared deeply and made an impact on others. Yeah.
[00:34:35] Lindsey Dinneen: Yeah. Yeah. I love that. And you're well on your way, so there you go.
[00:34:41] Kat Hurd: I like to think so. It's all a work in progress and it's truly a testament to, you know, to take it back to some of the start of our conversation to the mentors and sponsors I've had along the way who have given me-- you know, I, I talk about borrowed belief a lot because there's gonna be times in your career where you don't think you have what it takes. And that's where mentors and sponsors come in. And having people that will loan you their belief in you, so you can believe in yourself, even just for a moment to go do the thing that feels really scary. And because I've had those people, you know, I've I've felt brave enough to take those risks and moments.
[00:35:17] Lindsey Dinneen: Love it. Yeah. Excellent. All right. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:35:26] Kat Hurd: Oh my gosh. Well, at the risk of sounding like that dog lady, it's a hundred percent our pups. We have, we have two now, and our current foster slash foster fail has this unbridled energy that I always look at her and think, "Gosh, if I could bottle that." Yes. So yeah, it's my family, right? My partner, Matt. I think that those, it's those moments. At the end of the day, I couldn't do what I do without my family, without Matt and yeah, so I'm very lucky to have them.
[00:35:55] Lindsey Dinneen: Love that. Excellent. Well, this has been an amazing conversation, Kat, and we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. We're grateful, and I wish you the most amazing continued success.
[00:36:30] Kat Hurd: Well, Lindsey, thank you for all that you're doing as well. Even hosting these conversations, it's such an important, you know, distinction to talk about how do you make a difference in this space and change things for the better. So thank you for your kind words and the opportunity to have this conversation, get to hang out with you for a little bit. And yeah, I look forward to our next conversation.
[00:36:50] Lindsey Dinneen: Awesome. All right. Thank you.
[00:36:53] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Emily Muir, Director of Sales & Marketing at Ontogen Medtech, shares how a non-linear path from retail merchandising to dental implants, optical, and a medtech startup became her superpower for building relationships and driving growth. Emily explains what it takes to break into medical device sales, from self-directed learning and curiosity to finding mentors and giving yourself grace through the learning curve. She also discusses what she’s building at Ontogen: a Chicago-area CDMO that supports medtech innovators from early design and brainstorming through quality, regulatory, and contract manufacturing, with an emphasis on trust and long-term partnership. 
Guest links: www.linkedin.com/in/esmuir 
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPTEpisode 078 - Emily Muir
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Emily Muir. Emily serves as the Director of Sales and marketing at Ontogen Medtech. Her work focuses on enhancing business performance through strategic new business sales and channel partner collaborations. Throughout her career, she has developed expertise in business reviews, retail strategies, and employee training. Her goal is to contribute to organizational success by leveraging her skills in building partnerships, and driving growth across competitive markets.
All right, well, welcome to the show. It's so great to have you here today, Emily. Thanks for being here.
[00:01:31] Emily Muir: Thank you so much for having me, Lindsey. I'm so excited to be here.
[00:01:36] Lindsey Dinneen: Yeah. Yes. Well, absolutely thrilled to have you on and I was just wondering if you'd start off by telling us a little bit about yourself, your background and what led you to medtech.
[00:01:48] Emily Muir: Oh yeah, this is gonna be a good one. I would love to. So, full name. My name is Emily Muir. I am the Director of Sales and Marketing at Ontogen Medtech. We're located in the suburbs of Chicago and Ontogen Medtech is a contract development and manufacturing company that helps medtech innovators really bring their visions and their devices to life.
My path to this position is not linear, however, not even close, which I've really come to view as my superpower. Really started out in retail merchandising, my degree in retail merchandising, and I started merchandising women's shoes and handbags in probably every department store in the Midwest that you can think of. So I know where all the good deals are, essentially. Yes, which is great to have if you're a girlfriend of mine.
But about 10 years into that, I pivoted into medical device sales. I'm starting to cut my teeth on dental implant sales. And then I moved into the optical space and now seeing how really the sauce is made with product development. And really, I fell in love with the industry being able to have an impact on a patient's life, see it in real time, educating their physicians and staff. And really the complexity that comes with that is really what stole my heart. So along the way, I worked at a startup called Avulux. They're a migraine lens company, and that's really where I caught that startup bug like a lot of people do. This really gave me wonderful insight into what makes startup companies successful, really from a commercial standpoint.
And then in late 2025, I left and joined Ontogen MedTech, and now I'm here building our entire sales and marketing function from the ground up, which is a daunting challenge and task. And that's kind of what I thrive on. So they really nailed it, in my opinion, the right candidate for the position here.
But, you know, outside of work, I really love to foster dogs. I'm very passionate about rescuing dogs. I have two rescues of my own, and there's something about giving a second chance to something that's really been overlooked that really resonates with me. And personally I really love watching the rescue dogs decompress and really melt into incredible companions. Truly, I just think that they need the right partner and the right environment in order to thrive and be successful.
[00:04:38] Lindsey Dinneen: Yeah. I love that. And so I'm curious-- I have so many questions of course, but okay, so we're gonna start with the, well, I guess we'll go back first. So you started with retail merchandising and you worked for a lot of different corporations. What were some of the lessons that you learned for that, and during all those experiences that translated really well into medtech sales and now marketing and whatnot?
[00:05:07] Emily Muir: One word, relationships. Those are crucial. Working in the back rooms of department stores, as a retail merchandising rep, you had to figure out who to talk to quickly. Who was the right person, you know, was it a sales rep to promote your product on the floor? How did I get frontline exposure? And do I need to get out there and get dirty to sell my product?
Fostering those relationships really helped me understand how to be successful in sales, and that is something through and through no matter what industry you are in, and especially in the medtech product development, you, you have to have strong relationships in order to get your point of view across, in order to effectively communicate your value proposition and to know who to talk to help founders find you. There are so many, there are so many people building in this space and you always hear the noise out there of people saying, "You need to find the right partners. You need to find the right support."
And who's gonna help you determine that, who's truly gonna help lead you through all of this? It's finding the people that have the direct access to the founders to help them get into your pipeline so that you can really have that direct experience with them and help them bring their products to life. So if I don't know who those players are and they can't find me, I can't be successful in my role at all. So that's, that is something I always think about coming into this every single day. What can I give to someone else? Who can I talk to? What part of my network can I reach out to so that I can give the right resources, I can give the right message, and we can all grow collectively.
[00:07:13] Lindsey Dinneen: I love that. And I think to your point, it is so important to nurture those relationships, as in general, I would say that's just good life advice. But at the same time, yeah, but at the same time, I would say what I appreciate about this industry is that yes, there's so many players in this space and it's huge, but at the same time it feels small. So your relationships really do matter in terms of like how you're coming across, how you're perceived, but just in general building that know, like, and trust factor, which again, is really important for your sales and marketing strategy too. So yeah, I love the fact that's a key thing that you took away. And, you know, sometimes I feel like things in our past that aren't directly related to what we're doing now might feel, I don't know, like, "Oh, I don't, what did I get from that? Or how does this help me?" But to your point, so many skills learned along the way that help you now, yeah.
[00:08:09] Emily Muir: Absolutely. I, you know, when I made the decision to go from the retail merchandising world in a hard pivot into medical device sales, I really had to step back and say, "Oh, okay. What are those transferable skills that I can use to, to get me there? You know, what do I already know in terms of a process that I can parlay into this, and how can I create that story so that, you know, that my future boss, the recruiter is going to understand where I've been and where I want to go." So that, that was crucial. The story of that is crucial in order to help someone else understand how to leverage you within their company too.
[00:08:59] Lindsey Dinneen: Yeah, absolutely. So, okay, so let's talk about maybe that transition too between having worked in maybe larger corporations or for larger companies and then going from that to startup life, which is often an adjustment. So I'd just be curious to know how has that been and what lessons have you learned from that journey?
[00:09:23] Emily Muir: Oh yeah. That there really is, 'cause I did go from a very large company. I worked for Esler Luxottica for six years as a sales rep for them. One of the, you know, arguably the largest player in the optical world to, to a startup. And what I really took away is that, well, some of the lessons of working in a big company really do work while coming into a startup life. And that is really how do you self-direct yourself and learn because in a big company, you know, sometimes there isn't always someone there to hold your hand and navigate that. And, you know, I did the same thing from not only changing industries, going from retail merchandising into implants, implant sales. And then I went into another industry of the optical world, which is very different. So I had to learn a whole new vernacular. I had to get certified in order to be a speaker there in order to understand what I was talking about.
And having the self-direction of, "Okay, I need to get this done. Who do I need to talk to within my own company? What resources do I already have and what do I need to figure out in order to get my job done or create myself?" were lessons I had already experienced within that big company. And maybe many don't think that's something you're gonna learn there, but it actually sets you up really nicely to be in a startup because those are all things you have to navigate on your own and show how you succeeded in that.
So kind of with those lessons and having that under my belt already coming and leading within a startup space, I was really able to sit back and say, "Okay, so if I, everything I do, I imagine that I have, you know, multiple staff already, right? That, you know, if I have a new employee, what resources do I need to have in order to help them out?" And that really helps direct my every day.
So, having that startup experience I loved it again, you know, got that bug and I just wanted more of it. And I did have my founder, one of my founders say the other day, he was like, "You know, you are just made for that. You're made for taking on this." Like, I go, "Yeah. What else do we need to have done? What do we need to create, you know, what do we, yeah, let's get in there. Let's get dirty." I think it's really about getting in there and getting your hands dirty and just saying, "What else? How do I?" And then being as resourceful as you can to get it done, because there's always somebody who knows something. There's always someone who's kind of done something before. You know, that's really where we can, your startup experience puts all of those pieces together for you.
[00:12:22] Lindsey Dinneen: Yeah, that's great. Oh, I love that. And yeah, so, okay, so that reminded me too of like, you know, your point of, you know, really getting in there, being self-directed, all of that good stuff. When you first joined the medical device industry I'm curious what your experience was. How was that learning curve for you? Because I remember coming into it and like. I would start listening in on conversations and learning and try, you know, absorbing. And there was a lot of that right at the beginning. And I remember sometimes people would say a full sentence that was just acronyms or ISO something and I was like, "I have no idea what you're saying right now." So anyway, it was, it's lots of learning and curiosity helped to bridge that gap. But for you, what was that like?
[00:13:10] Emily Muir: I do pride myself on being pretty good at social cues. So, you know, you go, "Yeah, absolutely. Yeah, we can. Yeah!" And you just really take note of every word that's being said and and really look it up later. Or, "Tell me more about that." You know, getting, it's the curiosity aspect of it, but you do have to do your homework. You do have to, you know, you're in your every day and you have to acknowledge that there is additional homework when you get home or have a friend. I always like to say I would have a friend to ask for dumb questions. We all know the saying, like, "There is no such thing as a dumb question." There are I think sometimes, or at least you feel that, you know that the feeling of the dumb question is real.
So really having someone either who's in it with you starting out, or who you can really use to, to help you understand, who can guide you if you can have a mentor. Otherwise, somebody who you can just call who's been in there maybe one more day than you have and say, "Hey, can you help me understand what they said here?" You know, I think this is the context. I'm a big believer in doing your own research first, trying to figure it out yourself, and then going to someone and asking for greater context, asking for a layman's term of it.
But it's, it is important that you understand that you're gonna be doing extra research on your own, and that's a really important part of getting into a new industry is being able-- whether you're a founder or you know, you're. You know, a leader in something new or I you just have to dive in and understand there's gonna be extra work, but it's gonna be worth it. And honestly, in my opinion, I think you learn faster that way because you can digest it on your own.
[00:15:11] Lindsey Dinneen: Yeah. Okay. So I love the idea of having a buddy and I was very, I think, lucky that when I first joined the industry, there were the, I was really surrounded by, I would say, buddies. You know, colleagues who were just super, open and happy to answer anything or explain anything more. And I remember just having this notebook of just like so many notes about all the things, but you're right, you have to be self-directed in that too and recognize that there is a learning curve, but also give yourself grace for that learning curve because, I think, unfair perhaps to-- and I'm very guilty of this. I expect a lot of myself, so, so, you know, I'm like, "Here we go." And, you know, gungho and like wanting to be as accurate as possible, as quickly as possible, which is a good thing. But at the same time, giving yourself grace to know that, yeah, you're probably gonna slip up every once in a while. You're gonna call something the wrong name. Okay. That's okay too. Just being o- okay with that. Yeah.
[00:16:09] Emily Muir: Oh yeah, absolutely. It's wonderful and that I had one person in particular that really took me under her wing and helped direct me. She was a former manager at another company and really was like, "Emily, you need to go here, Emily, you need to look this up, Emily. This is how this is." You know? And saying, "Okay yeah. Just tell me where to go. You know who to talk to, you know, and I'll do it." And we've created a really nice working relationship in that way. But not everybody has that. So it is wonderful to give yourself grace and know that there will be a point where it all clicks.
And that's what I think about every single day is that, you know, maybe it's six months, maybe it's a year in where all of a sudden, you explain something flawlessly or you get that, you know, customer, you explain everything. You know, like the pro, like it's every, the world aligns, you get that sale. Or you know, and like somebody looks at you like normal again, like, you know, those are the wonderful moments. And they will all happen.
So as a leader, I think it's also good to understand that if you bring someone on that's new to really try to set them up for success and that most people don't want, you know, they're so hard on themselves coming into something new and to just make sure you guide them appropriately. You know, let them know, maybe sometimes people cry. It's tough, you know, like it's, and you're laughing and I hope everyone else who's listening is laughing too 'cause there's always that one moment where you're like, "I swear I'm gonna, I hit my breaking point today" when you're trying something new, like the world is not working out, maybe you slipped up and said something, you sent the wrong email to someone.
You know, there, there is always something and you know, understand that these things happen. You know, we don't need to beat ourselves up about it and to gently correct. We can correct or, you know, say, "Hey, I, you know, maybe we could say it like this or, you know, I understand how you might have used that in this context, but this is what, you know," just generally redirect.
[00:18:35] Lindsey Dinneen: I love that and I, that's beautiful leadership advice in general and something that I think isn't talked about enough. I think there's a lot of talk about, you know, mentorship and sort of, empowering people. There's a lot of great leadership advice out there, of course, but I really like the way that you put it and really like you said, just helping your team be set up for success.
And so I'm actually curious. That's a good segue. So now you, as a leader, are building out a sales and marketing department, so to speak, it's at least at some point. So as you're growing and continuing to go down that pathway, that's really exciting. So tell me a little bit about how your process is going in terms of setting not only the yourself up for success, but the department and you have hires coming in for success and like, how are you thinking about all of that? Because that's a lot. That's no small undertaking.
[00:19:34] Emily Muir: It is no small undertaking. And honestly I'm really excited for those days to come. I believe me when I get the "A, okay," I've got plans for what I need and in all of it, asap. I really, first of all, I want to embrace my non-linear path. And I, when you're looking to build a team, it's always important to come first with a realization about what you bring to the table, and I think embracing that. I'm very fortunate with my founders and principal that they really trust me and understand that I bring something very different than they do, and that was very strategic for them.
I work with so many engineers and know that I can have the best minds available, but we really need to have different personalities, a different set of reps over on this side so that we can really drive and communicate the mission and vision effectively. So, you know, knowing I don't come from a very linear path, I think it's important to not only look for those people also, but also look for personalities sometimes that do. And you know, because I do, I need a complimentary team to what I bring to the table here.
So, but also there are foundations of that I'm always looking for in, in people like curiosity, someone who is adaptable, someone who has a passion for solving these problems, who can really understand what the engineers are bringing to the table and communicating that to potential clients and even having passion for those client projects because it's not our vision, but at the end of the day, we're really telling the story of so many founders and saying, "This is how we help them. This is what they're doing. Look at their success." And that's so important.
And to be able to connect the dots across so many disciplines for people as well. Like my tactical advice for somebody who wants to approach my team is kind of approach it with that curiosity, but at the same time, or show me that you are gonna be a student of the business. We just shared about how, you know, we, you have to learn so much that you have to do that extra research on top of your every day, do your homework. That's what I'm looking for. I'm looking for someone who's going to dive in no matter where they're from, in order to be the best version of them themselves and support this team.
I'm looking for somebody who is really gonna be investing in their brand because I'm doing that as well. I think that's important. I think that's important for my engineers and my founders as well. People buy from people and not logos. Right? You're a great example of that, Lindsey. I need people to show up consistently as well, consistency sells as well, and also authenticity. I'm a big fan of that. I think that's probably coming across very evidently right now. You know, I'm not a fan of the perfect resume but I'm a fan of when you show up authentically, consistently, and show the effort, that's when you win the sale. And when you connect with someone authentically. So in terms of like leadership with that non-linear path, the foundation of that no matter where you are is crucial, is non-negotiable.
[00:23:26] Lindsey Dinneen: Yeah. I love that. That's great. And it's really exciting to get to know you at this particular period of time too, because it's fun to watch, you know, and get to see the growth and expansion of your whole business and company and whatnot. And so speaking of that, can you tell us a little bit more about the company, who it serves, how it helps the medtech world?
[00:23:51] Emily Muir: Ontogen? Oh yes. Love to. So we are really soup to nuts everything for your startup medtech team. Truly I have a wonderful team of engineers who can take a napkin design that you have a dream, a vision, and take you through that design development process. We can help you with quality management system, regulatory strategy and execution. We can even help you with contract manufacturing. So truly like, and I think people don't believe that, and it's so much to digest, but when you're really looking for a partner out there who can be a part of your team, an integrated part of your team that has wonderful communication, we are truly those people.
And my founders have an incredible passion for what they do, which is why they started this, which is why they keep adding things, capabilities that we can do and give to the world, and especially in the Chicago land area. This is not a hub yet for medtech, yet. We are gonna be growing that. And you know, there are other partners out in our space around here that are growing, that are really diving in, and that's our goal for this year. That's our strategy, not only to get our name out there, but also to really have those wonderful relationships with our ecosystem in the Chicago land area.
Well, beginning here and then you know, the world but, that, that's our goal. So, you know, if you wanna have, if you wanna look for someone to help you with design and start us out there, try us out there, you're absolutely open to do that. But we do have this habit of getting people early and then helping them into that growth stage. So that's our goal for you, for the early founder out there is to grow with us so that we can get you there and then they can take over the world.
[00:25:57] Lindsey Dinneen: Yeah. There you go. I love that. I love that. And I think it's so cool that you're able to come alongside companies like that and literally help them from that, you know, sketch all the way to development, like the whole process. That's very cool. Yeah.
[00:26:13] Emily Muir: The whole process 'cause so many people out there-- and I understand, you know, it's so hard to. I think really know where to look to and where to go, and so many pitfalls from founders are experienced in those in between times. They come to a company that can do X, Y, Z for them, but they can't do then the A, B, C of it, you know? And some people think they're ready for certain stages and we're able to say, "Hey, you know, we know you might think you're there, but wow, we see this opportunity a few steps back. If you'd start here, then we can actually get you here a little bit quicker without having to look for a new partner. We can help you do all of that."
And it does require a little trust on the front end in order to do that. We understand that which is why I always say start out with that design or even start out with a brainstorm. If you have an idea for something and you just need to see, is this feasible? We can just do a quick one hour brainstorm with ya. We're actually gonna be doing that with a company soon for diagnostics, which is really exciting, because that was the pitch. They said, "Well, we're really interested, but I don't know." I said, "Hey, let's go in. Let's work this out. Let's see what ideas we come up with. Let's see if this is feasible with my team first, and then we can go from there. No need to commit to everything right up front."
[00:27:48] Lindsey Dinneen: That's awesome. Yeah. Yes. That is a, that's a great approach too. I think it's helpful. Also in the idea of, like you kind of mentioned, is the building trust component of not saying, "Oh, you're locked in with us forever and ever. Amen. But no, we really, we are coming alongside you. We wanna be partners with you. We care. I mean, my, I don't think it's the stretch to say we care just as much, you know, about the success of you and bringing this life-saving device to the world." So yeah, I love that approach.
[00:28:20] Emily Muir: Ab, absolutely. And honestly sometimes I'm in there with my R&D managers and they're like, "If they would just let us do this one thing, you know, we really think that this would be great. You know, like how can we get them to really see that like this can be better." Like they care so much, and you know, really I just need more angel investor friends for them so that we can, you know, do all of the things that we, you know, we really wanna do for all of our clients. That's my PSA, I need more angel investor and VC friends, so, so that we can truly make their dreams come true with their devices.
[00:28:59] Lindsey Dinneen: I love that. Okay, good call to action there for our listeners here. So, you know, you've had a really amazing career and you've done lots and lots of different things within the medtech industry. Have there been any moments that really stood out to you, is just affirming, "Wow, man, I am in the right place at the right time."
[00:29:22] Emily Muir: Oh my goodness. Well, I definitely remember the first time I knew I could do it. You know, there are a few moments along the way that I affirm where you're, I'm on the right path, right? Truly, anytime you get a job, a new job, you're like, "Okay, well, somebody's still gonna hire me. We're still here. This is great. We're still going here." But the first time I really figured out that this was the right place for me was meeting a medical device sales rep. I met a new friend I was in the retail merchandising space, kind of, you know, figuring out what my next step was. Do I keep going here? Do I try to do leadership within the retail space or do I go into something else?
And I met this wonderful friend, she's, well, she was an orthopedic sales rep and we were talking about our jobs and I was like, "What we do sounds so similar, but like you help people's lives. You know, like you have a direct impact on the surgeon. Like, you know, you set them up for success so that they can execute their surgery, right?" Like that's so amazing and impactful and really they made a lot more money than I did, frankly speaking which doesn't hurt.
But, it was truly that moment when I was going over it with her and then starting to throw ideas about my next step. And she goes, "Oh yeah, you can do that. Oh yeah. What you do, like you just add my terms in there, my vernacular, and put you in front of a surgeon and that's it." And I said, "Okay, you know what? You get help people. I wanna help people. I wanna have an impact. Let's, that's what I'm gonna do." And I just keep finding ways that parts of the industry that keep me excited, and there's no shortage of that here. There's literally something new every day. There's a new product that we're helping bring to market. There's a new part of the industry that is emerging, evolving that you need to learn. That was probably the most impactful moment for me to really know that I was on the right path here.
[00:31:42] Lindsey Dinneen: I love it. Yeah. Okay, so. All right. Yes. And I think it's so cool that you have many moments to draw from 'cause it sounds like the inspiration keeps coming, which is always super helpful, 'cause of course you're gonna have good and bad days. So being able to draw on, oh my goodness, this series of, "How exciting is this to be able to play a part." That's great. Well, all right, pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want, could be in your industry. It doesn't have to be. What would you choose to teach?
[00:32:21] Emily Muir: This is gonna be really left field. This is gonna, yeah. Yeah. I this is for-- and Lindsey, I don't know if you enjoy the franchise "The Real Housewives" or...
[00:32:32] Lindsey Dinneen: I've never watched an episode.
[00:32:33] Emily Muir: Or if any, listen-- oh my goodness. Okay. Let's. I will, there's too much. I'll have a brain dump after this. There will be homework to it. You think the medtech industry is hard? Let's go. It would truly be about "The Real Housewives" and their impact on the reality lands and also the personal branding evolution of the reality stars. It's really a case study in marketing and as a marketer, you, I really would look into that heavily because a lot of those women either create products outta that or, I mean, some of them do go to prison unfortunately as well, but I wouldn't look into those as much. There's a strong pipeline there, but a lot of the businesses that are created from women from this platform is truly astonishing. And there really needs to be a course about it, like an MBA level course about it and the successful women who have come from it.
[00:33:39] Lindsey Dinneen: I love it. Oh my goodness. That is out of left field. That is probably the most interesting answer I have ever heard. Not expecting it. Love it. Oh my goodness.
[00:33:51] Emily Muir: Thank you. Thank you so much. You can start with Bethany Frankel. She's a great one. I'm sure you've heard of her before, maybe Skinny Girl Margarita. Not a paid plug for her. Yes. That she's a great one. But there aren't many. There are many out there. Yes, start with her.
[00:34:07] Lindsey Dinneen: All right. Homework. Excellent. And then how do you wish to be remembered after you leave this world?
[00:34:13] Emily Muir: How do I wish to be remembered? I hope to be remembered as a very supportive person to my friends, my family, my support system. When you are part of my, when you're in, and truly, no matter what you need-- if you give a call in the middle of the night, I, you know, will jump outta my bed to go and help, you know, whatever it is that you need. I try to be truly that ride or die for my friends, my family, and I really hope that's what I'm remembered for, because everyone needs a wonderful support system and someone to, you know, stand behind, stand alongside you, hold your hands sometimes and be that cheerleader.
So I try to be that. I have people who are so wonderful in my life who are that for me. And, like, if you imagine, you know, heaven forbid it's like, you know, your funeral. But I do imagine that they are there truly like pom poms in their hand, you know, being my cheerleader because I've been a cheerleader to so many people. That is my dream with some sort of like Whitney Houston or Mariah Carey on probably going at the same time or something that would be...
[00:35:30] Lindsey Dinneen: Naturally.
[00:35:32] Emily Muir: With "The Real Housewives," you know, just playing in the background, just my masterclass, you know, playing for everyone, the marathon of it, that would really just in probably like a puppy yoga fostering situation happening at the same time because everyone needs to rescue and foster a puppy at some point, so that would be the pinnacle of my life. Something like that.
[00:35:58] Lindsey Dinneen: Very specific requests. I love it. We're gonna have, it's gonna be...
[00:36:02] Emily Muir: Yes. Absolutely.
[00:36:04] Lindsey Dinneen: ...A sad event and like, weird, you know, like, 'cause you're supposed to, you know, you're sad but also puppies, so.
[00:36:10] Emily Muir: Puppies for sure. Absolutely. There would be, you know, I'd be like, "Everyone has to leave with a rescue puppy. Like these are my final wishes."
[00:36:21] Lindsey Dinneen: Yeah.
[00:36:22] Emily Muir: Mandatory. Mandatory, absolutely.
[00:36:26] Lindsey Dinneen: Amazing. Alright. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:36:37] Emily Muir: Puppies. Re, re, rescue puppies. My, my dog specifically. They make me smile every time. Heaven forbid you are following me on Instagram or something and seeing my dogs just all the time. I am unfortunately that person. But also if you need a rescue puppy at any time, I probably know like three people off the top of my head who I can get you a puppy like now. So that always, there are always on, on some sort of social media so that always makes me smile.
[00:37:07] Lindsey Dinneen: I love it. Nope. I had a really strong suspicion that was gonna be your answer, so, so I am delighted that you you chose puppies 'cause that, that works for me too. I love animals in general and it's like, they just make me smile randomly. I'm just like, "They're just happy," you know? It's so cute. I just love them
[00:37:28] Emily Muir: They are so happy. I did foster three puppies at one time, and that was a lot, but there was a lot of happiness. You're just like, you know, they're a little crazy. They're just, you know, all over each other, but they're, you know, playing and you're just like, oh my gosh, this is, there's nothing better right now than the happiness of these puppies.
[00:37:48] Lindsey Dinneen: Yes. That's amazing. I just love that so much. My goodness. Well, this has been an amazing conversation, Emily, and took several twists and turns I didn't expect, and absolutely love. And we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. We're grateful, and I wish you the most amazing continued success.
[00:38:32] Emily Muir: Oh my gosh. Thank you so much for having me. I, this was truly a pleasure. Well, thank you so much. Really, I appreciate it.
[00:38:38] Lindsey Dinneen: Of course.
[00:38:40] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Omar Ford, Editor in Chief of MD+DI, shares his journey from small-town print journalism to covering medtech, and the steep learning curve that taught him how to find the real story behind press releases, FDA pathways, and industry trends. Omar explains how thinking like a “contemporary medtech historian” helps connect past events to present innovations, and why curiosity—and an unusually open, helpful industry—accelerated his growth. He reflects on defining leadership moments, imposter syndrome, and the mentors who shaped his style, plus memorable conversations from his Let’s Talk Medtech podcast.
 
Guest links: omar.ford@informa.com | https://www.mddionline.com/ 
Charity supported: March of Dimes
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPTEpisode 078 - Omar Ford
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest Omar Ford. Omar is an experienced Editor in Chief, currently at MD+DI, with a demonstrated history of working in the medical device industry. Skilled in medical devices, technical writing, marketing, strategic planning, and marketing strategy, he also has a strong media and communication professional background with a bachelor's degree focused in journalism from the University of South Carolina, Columbia.
Well, hello, welcome. I'm so excited to have you here today. Thank you for being here, Omar.
[00:01:28] Omar Ford: Lindsey, I'm excited to be here as well. You know, I have been prepping for this all week, and then all the little notes and all the things I took down, I said, "You know what? I wanna give her the original experience," so I'm gonna chuck 'em to the side and we're just gonna do this off the top of my head. How's that?
[00:01:43] Lindsey Dinneen: That's perfect. My favorite.
[00:01:46] Omar Ford: Awesome. Awesome.
[00:01:48] Lindsey Dinneen: That's how conversations work in real life. I feel like this shouldn't be any different, so, great.
[00:01:53] Omar Ford: Agree. Agreed.
[00:01:54] Lindsey Dinneen: Love it. All right, so would you mind starting off by telling us just a little bit about yourself, your background, and what led you to medtech specifically?
[00:02:02] Omar Ford: Oh wow. So that is an interesting story what led me to medtech. But a little bit about myself first. So, I graduated from the University of South Carolina in 2001 as a print journalism major. And, my goal was to go into newspapers, you know, I wanted to go into-- I wanted to be that next print journalist 'cause I had a face for radio, right? I had a face for print, you know, wasn't the, the, the broadcast type. And so I, I did small newspapers for a few years and then this magical thing called marriage happened. And, I was looking at the salary that I made as a print journalist, and it just, it, it just wasn't enough to sustain a family. So, was looking at branching into something else.
And back then, we had the, the, the classified ads in the newspaper where they would actually advertise jobs, and I and my wife pointed this one out to me and it was a, a job about it was a job for a company called AHC Media and they had a publication called Medical Device Daily, and that was around, I wanna say 2007.
And she said, "Why don't you try it? You know it the pay--" 'cause they advertised the pay there too back, back then-- she said, "The pay is much more than, you know, being, you know, a newspaper reporter. You can, you can leave that, that's something that you could do to, to support the family." And I said, "Yeah, yeah, why don't I try it?" And a lot, there were a lot of adjacencies, so I jumped on it and, you know, got hired and left the newspaper behind. And that was in 2007 and I've been with medtech ever since, so it's been an incredible journey. It's been one that you kinda, you know, once you jump in, there's like a, a steep learning curve, but if you manage to stay in for a few years, you can, you can really learn a lot about the industry.
[00:03:53] Lindsey Dinneen: Yeah. Okay. Excellent. Lots of questions. I'll start with that learning curve because I was just thinking about this.
[00:04:00] Omar Ford: Yes. Yes. Go ahead.
[00:04:01] Lindsey Dinneen: So, okay. So you go from, I might imagine a more generalist approach to all sorts of different topics, to...
[00:04:09] Omar Ford: mm-hmm.
[00:04:10] Lindsey Dinneen: ...a really crazy niche industry where somebody can say a full sentence and. If you're not from the industry, you're like, "Mm-hmm."
[00:04:18] Omar Ford: Yes.
[00:04:19] Lindsey Dinneen: So what was that like for you and how did you, how did you navigate that, that steep learning curve and your own personal growth so that you could, you know, really speak to the industry?
[00:04:32] Omar Ford: So going back to the head nod, "Um, mm-hmm," a lot of my interviews were like that at the very beginning. But I remember the Editor in Chief of, of Medical Device Daily. He's now deceased-- Don Long-- he pulled me to the side one day and he said, "Omar, each of these companies has a story. You want to be able to tell that story." You know, you look at it from a business sense, and then you drill down into the innovations. You know, when you get a press release from a company such as a Boston Scientific or an Abbott Laboratories, or a Medtronic, you wanna drill down in the press release and look at what the news is. But you also wanna look at the story that they've been telling up until now about that product or about that sector that they're in.
You know, if they're looking to get approval for a device, you know, was it easy for them to go through clinical trials? Was this something that bombed a couple times or that was rejected by FDA? Each company has a story about their innovation, right? And you look at the company as your sources, like your, like they're your county commissioners or they're your --I'm going back to my newspaper days-- or they're your board of education members. You know, each company has a personality like that. And you try to hone in on that and you look for those adjacencies and then you kinda fill things in as you go along.
The other thing that helps is traveling to some of the trade shows and talking to the people and meeting them face to face, because back when I started, we had this wonderful thing called a landline, a telephone, and we could call people and get messages, right? There were no teams calls or no Skype or anything like that, or, or Zoom. And in fact, I don't think they're Skype anymore. But you know, you didn't have that, so you just heard a person's voice, but when you met them face to face, when you talked about some of these innovations, when you saw how passionate they were or when you could read some of their body language or when you could say, "Hey, can you kind of take the time and talk to me about this," and make that personal connection, it helps you understand the science a little bit more. It helps you understand what they're trying to communicate a whole lot more.
And that kind of rounded out that steep learning curve. But I like to tell people all the time, when I first started, I didn't know a 510K from a PMA. You know, I struggled to explain that one time to our, our sales manager back when I was with AHC Media and Medical Device Daily. But if you can stay in this industry long enough and if you can you know, just focus long enough on the content material and have an understanding of the companies that you're, you're talking to and see them each having an individual story, you know, and, and also finding the conflict that the companies might have too, that helps round that, that, that steep learning curve down out a a whole lot. A whole lot.
[00:07:44] Lindsey Dinneen: I love that. That's, that's great advice. And also something I was thinking about is the more that you get into the industry too, you know, curiosity solves so much, right?
[00:07:59] Omar Ford: Yes.
[00:07:59] Lindsey Dinneen: The more that you can just be curious and ask questions. And I've found-- and I'd be curious about your own experience with this-- but I found that this industry is extremely helpful. Like if you go with a genuine desire to learn and grow, people are like, "Great, how can I help you?"
[00:08:17] Omar Ford: Now, that is one thing that I will testify to and I will say was different from reporting, doing beat reporting because when I was working with the small newspapers, it was all about holding back information. It was all about, "I don't wanna talk to you about this." But this industry, when you talk to people, when you show a level of interest and the ability to understand, they will talk to you for days and they are very, very helpful. So that is ano--, I'm, I'm glad you brought that up because that is a, a another level that really, really helps to understand this industry a lot. Yeah.
[00:08:55] Lindsey Dinneen: Yeah. I love what you were talking about in regards to storytelling. You were talking about you know, sometimes I feel like press releases can, they're getting out information. There's obviously a really important point to them, but it sometimes can feel very dry and slightly just inhuman, I suppose.
[00:09:15] Omar Ford: Mm-hmm.
[00:09:15] Lindsey Dinneen: I love the fact that you were able to take what you saw, read a little bit between the lines and go, "Okay, I know there's a story here." Like you said, "What did you overcome? What are the challenges you're still facing?" Yeah. I'd just love if you speak a little bit more to that, that fine art of digging through and finding the gems.
[00:09:35] Omar Ford: A lot of that is being a contemporary MedTech historian and realizing that everything builds on something else, right? That there are different layers. I'll give you an example of this. Back in 2018, Boston Scientific was acquiring a lot of companies. I think they acquired like 10. That was the trend. And they bought a lot of different companies in a lot of different areas and the easy story was, "Boston Scientific is on a spending spree. Look at what they're doing, look at what they're doing." And that was the easy part of it.
But what happened to Boston Scientific before? What happened to them when they acquired Guided back in 2006 and that was heralded as one of the worst acquisitions ever. You, as a writer, as a reporter, as a journalist, when all of this is happening in 2018, I'm able to go back and say, "Wait a minute, this is a far cry from where the company was a few years ago," because there wasn't as much information. You know, they weren't as talkative as they used to be, as they are now.
You know, a lot wasn't communicated, but when you go back and, and, and you, you look at where they were and then you look at where they are now. That is a great story and that's how you can read between the lines. And you can see those connections. Okay. They're really, they're really building up their electrophysiology space, right? You know, they're building up their cardiovascular offerings. This is something that was perhaps heard or tainted during the acquisition in the fallout from it.
So let me draw back from those past stories, make some connections, see the adjacencies, see the parallels, create a new piece of content from that, that really communicates the story of what's really going on with Boston Scientific. So it's being able to look to the past, realizing that things don't happen in a vacuum, and also to, to work on the trends, to look ahead at how the trends will develop and are developing.
[00:11:51] Lindsey Dinneen: I love that, and especially love the term contemporary historian. I was just giggling to myself about how wonderful that is. Okay, so I'm all right. So going back to when you were growing up, could you have imagined yourself where you are now? Would, were you always interested in writing and journalism?
[00:12:11] Omar Ford: Oh gosh, you, you're gonna ask me about growing up? Oh God. Oh. So I, I, I, to answer your question, no. No. I am very blessed to be in this position. I never imagined myself here. I was a poor kid growing up in rural South Carolina. My mom was a teacher. My dad was a Vietnam veteran who became an educator. I'm saying that for a reason. Read between the lines. He was, he was tough. And, but my mom always wanted something better for me, right? And my dad, he was just sports and the news. He didn't watch any movie, I don't think, for as long as he lived. I think the only movie we saw together was "Lean On Me" with Morgan Freeman is is Joe Clark. That's the only movie that my whole family watched. He was just. That's all he, he did.
And I wanted to impress him, and I wanted to be able to you know, he, he wanted an athlete and that's clearly not what I was back then. But he I, I just wanted to impress him. And I remember he would sit down, he would watch "Crossfire." It was, that came on, I believe, 7:30 on CNN. Pat Buchanan, he was a host, I can't remember the other host, and he would watch "60 Minutes" and then he'd watch the local news with Dan Rather on CBS, that that's all he watched. And he would read the newspaper. It'd come out Mondays and Thursdays.
And so I, I wanted to be a journalist to impress him. So I got on the school newspaper, you know, I found out that I had a gift of not necessarily talking, but I had a gift of listening to people and being able to, to kind of relate to, to relate their stories of what they were telling me in writing. So I was able to, to write down what people told me in a sense.
And, so if you would've asked me, would I be editor in chief of MD+DI or, or anything like that growing up, no. That wasn't my intention. I just wanted to be, I just wanted to impress my dad. I just wanted to be a a, you know, a good reporter and thankfully he, while he didn't live to see me be Editor in Chief, he did see me become Managing Editor of MD+DI, and my mom actually lived to see me become Editor in Chief and, you know, she was I remember when I told her and she was like, super, super proud. So, yeah, yeah. But no, I couldn't have imagined that me a kid growing up in a, in a, in rural South Carolina in a trailer? No, no, no.
[00:14:56] Lindsey Dinneen: Wow. Thank you for sharing that story. That's really powerful. And I actually love how inspirational it is too. You know, you, of course you have to start somewhere and you're working your way up and look where you are now. It's incredible. And now you, you have been there now eight years, is that correct?
[00:15:13] Omar Ford: Yes, I've been with in, with MD+DI for eight years now. Yeah, yeah, yeah. I'm going back. Well, yes, I'm thinking back. Yeah. Yeah. I have to think about that. And I've been Editor, Editor in Chief, I think I took over in of 2022. Yeah. April of 2022. Yeah. So yeah. Wow. My hair was a whole lot darker; it didn't have gray streaks when I started.
[00:15:40] Lindsey Dinneen: What a journey. Oh, that's so cool. Congrats. Yeah, so as you've been a journalist, but maybe specifically within medical device, what are some interviews that kind of really stand out that you just for their impact or how they touched you or how they touched others?
[00:16:00] Omar Ford: I would say some of my best interviews I did on the podcast, Let's Talk Medtech, because I could finally kinda let-- I could let my hair down and my guests could let their hair down as well, and we could just, we could just talk and just, it, it would it, we could just be open and transparent. And sometimes that doesn't always happen when you're doing an interview. Sometimes some people are reading from the script. Sometimes people are guarded. Sometimes people like to use the old, "Okay, I know I said that, but. That was off the record. Please don't use it."
You know, sometimes that happens, but to answer your question, some of my best interviews have been with Marissa Fayer. She is CEO of DeepLook Medical and HERhealthEQ. In fact, we just did a podcast with her. It, it's not even fair to call that an interview because it's just like two old friends talking and our banter is going back and forth and I'm like, "Yeah, I saw some pictures of you, you know, on Facebook. You were on this trip. You were on this trip." You said, "Oh, Facebook is still a thing. I just put everything in Instagram so it funnels out. What you trying to call me old? Marissa, are you trying to say that that old, old people use Facebook?" "No, no, no. I'm not saying that."
And, and just that. And then we leap into AI and how AI is really helping the cause of women's health right now and how it's helping with imaging and how it won't replace the radiologist or the physician, but it will give them an extra tool. But you see how comfortable that transition is. We're able to have those talks. We're able to have those conversations. And it's not stiff, you know, it's, it's just like. It's not like we're reading from a paper or we are just trying to be super, super guarded. So Marissa's a good person that I that I talked to.
Chris Toth-- he's the CEO of Vantive-- and he had the most energy and enthusiasm about, about his job and his position, and it was just smooth and we, we interviewed him for an episode of Let's Talk Medtech, and it was just incredible. He, he, he really opened up about the company. He talked about some of the goals and it was refreshing to see a CEO, you know, have that type of discussion you know, have those discussion points. So those were some of the most memorable interviews that I've had in, in recent, in recent months.
[00:18:29] Lindsey Dinneen: Awesome. Thank you for sharing those. That's, that's fun. Now I'm gonna have to go and listen to them. Marissa was one of my first guests, and I couldn't agree more that the conversation was so just easy and natural and she's got such cool things to talk about.
[00:18:43] Omar Ford: Yes, yes.
[00:18:45] Lindsey Dinneen: Yeah. So one thing I noticed about your LinkedIn was it seems like you are very fond of learning because you are continually taking courses, maybe on and off LinkedIn, but I was looking through the laundry list of, of amazing courses you've taken, and I was like, "That is impressive." So I'm curious if you could talk about that.
[00:19:06] Omar Ford: Oh gosh. Well, I look at some of the, the most interesting courses that I can find. And one of the things that I've been looking at is just artificial intelligence and generative AI. How to best use that, how to best write prompts, what are some of the pitfalls? Just how to, for lack of a better term, master it or understand it a little bit more because I understand that content is changing and generative AI is a huge driver of that. I don't fear change. I want to change. It's just, I don't know where change is going to, to, I, I don't know what that looks like now because we're in the middle of it, you know?
Something similarly happened to me back in 2006, I wanna say, when Google kind of came on the scene and was taking newspapers and, and publishing the entire newspaper online, and you could look at it for free. And I was like, "This isn't a sustainable model. I need to get out of this and I'm barely making, I'm barely making enough to get by. I need to leave, but what do I need to to go to?" And that was the B2B experience that was in medtech.
And that was where it was more focused. It was more targeted. There was a paywall. The, the sales metrics were a whole lot different. It wasn't necessarily about buying an ad because someone is looking at the at the site or looking at your story or the ad impressions, but it was more, "Who's going to buy in for this gated content or this content behind a paywall that specifically talks to them, not everybody." I think that's an issue that newspapers had back then. They tried to be something for, for everyone and I don't think that turned out to, to work too well for them. But I just totally went off the cuff and went off line and just talked about everything except answering your question, so.
[00:21:03] Lindsey Dinneen: That is, it's not, you're awesome. I absolutely love it. Okay, so, oh, this is what I wanted to ask. So as you have-- especially with the medical device side of things-- as you have grown in your journalist career, are there any moments that really stand out to you as just affirming to you that, "Wow, I am in the right place at the right time?"
[00:21:32] Omar Ford: Yeah. Yeah. And one happened fairly recently and it happened at West. I was coming out of, from the, the showroom floor at, in the Anaheim Conference Center and I had my Informa name tag on and I had my suit and one of the, the guys at the door-- he was a, a, a young person of color-- and he came up to me and he said, "Man, I want to be just like you when I grow up." And I, I brought him in and I gave him a hug and I couldn't say anything and. I walked up those winding stairs. I didn't take the escalator. You, you know what I'm talking about. I didn't take the, I walked up those winding stairs and by the time I got upstairs, I was in tears. And that was validation that, "Hey, you're supposed to be here." If you know, if not, for just that one moment where that young man was able to see me and make a connection. And that was really, that was really emotional for me.
And, again, I grew up with a dad that was a Vietnam veteran. Emotions weren't allowed, so you had to hold it in, but that was a point I just, I, that was just an emotional moment for me, and it said, "Yeah, you're, you're supposed to be here. You're all right, Omar. You're supposed to be here." Because I think when you're in leadership, I think you struggle with that, especially coming into it, right? You, you have, well, for me, I had imposter syndrome. I, I just, I, "Why does anybody wanna follow me? Am I doing this right? Am I doing this wrong?" Oh my gosh. And, and also I, I wanted to be the person that always got all the accolades or that, because I thought that that was doing a good job.
And that's not what leadership is. You, you will get some of those accolades, but your accolades are to build someone else up so that they can get, so that they can get the spotlight and so that they can become leaders in their own right. So you wanna grow your professionals that are under you. That was the challenge for me at first because I was a great soldier and I was a great person who could roll up their sleeves and I would jump headfirst into it and I would, I would work and knock out and tackle the problem, but asking someone else to do it-- you know, coming up with a strategy to do it was easy too, but just enforcing it, having someone else to do it, that was the tough part for me. That's what I struggled with.
And so bringing back to when you, when you were talking about that defining moment, that moment when that young man, you know, when I embraced that young man, when I hugged him, that was saying, "Omar, you're supposed to be here." And that meant a lot to me, so, yeah.
[00:24:29] Lindsey Dinneen: That's a beautiful story. Thank you for sharing that. Oh, I, yes, I understand the imposter syndrome for sure. And, you know, and, and you know, I recently, as you know, had the opportunity to host the Leadership Summit at MD&M West, which was really an amazing experience. And there were moments-- I remember I was, I was checking out the space ahead of time, you know, looking to see what it's all gonna be set up as. And I had this moment of like, "You don't, you don't deserve to be here." And like that just very intrusive thought, just came into my head and I just said, "No, that's not true. That's, it's, it's not true. I've worked hard to be where I am apparently some people care what I have to say."
Not everyone, I'm sure, that's a thousand percent fine, but it was just such an interesting, it, it, it's just you keep having to have these moments, I feel like, of sometimes, sometimes outside validation from somebody who looks up to you like that, that young man, and just to say, "Yeah, I'm, I'm okay to be here. In fact, I'm, I deserve to be here. I'm supposed to be here. I make a difference. I, at least I try."
[00:25:40] Omar Ford: Yes, it, it's hard because you're, you know, you're trying to be humble, but you're also coming against all of these different, these different things in your role. You know, you have people above you, you have people below you. You're kinda like the sandwich generation when it comes to, to, to leadership in your professional career. And you're not necessarily-- I don't wanna say fighting against them. I don't want to say that-- but you're, you're giving up. You're giving down at the same time, you know, you, you're, you know, you're talking to, to your management team, to your managers, and you're giving them information and you're serving their needs, but you're also serving the needs of, of the people that work under you. You're giving them support
And so, if you don't have anything to constantly fill you up, it can be it, I don't wanna say draining, that's not the word, but it can take a lot out of you. So you, you, you sometimes don't see the role that you play because you're, you're giving both ways and, you know, I was I, I'll, I'll tell you, I had an amazing leader. She was a great leader, because when I look at bosses, I look at people who tell you, "Okay, I want you to do this. I want you to do this, I want you to do that." All they wanna do is get the task done and go home. That's what I see as a boss.
But a leader will actually sow into you, will actually nurture you, will actually tell you right from wrong and will feel like they have a personal responsibility or stake, or stake, I'd say in your growth, right. And that person for me was Daphne Allen. She was my predecessor. She's now Editor in Chief of Design News. It's a sister publication to MD+DI. And I can always remember she was firm and assertive and, but in a almost nurturing way. And if you came up with an idea that didn't quite jive right, she would talk to you, she would say, "Well, maybe we could look at it this way."
It would validate the idea, but tell you you're not quite on the right path, but show that she's willing to help you get on the right path all in one blow. And that was so incredible. And I can remember at West, I, I, I pulled her aside, 'cause every time I see her, I talk to her and I tell her, "You've been such a great inspiration for me, you've, I, I'm. I'm forever thankful for you. I'd say the only bad thing is that you're, you're no longer my manager. That's the only bad thing that I have to say."
But she just taught me a leadership style. You don't have to yell and scream to get your point across. You don't have to be nasty. You can be assertive and you can give support while being assertive. I think that's something that is missed in in a lot of roles. Just, "Hey, Omar, you, you might've done this a way that we didn't need to do it. But here's how we get back on track to do it, and I want you to think about what you did over here and how we can improve, improve upon it."
So it, it was just, it, it, it's just those conversations that I had with her that were, you know, I mean, she really stands out to me as, as one of the best leaders that I've had. And there, there are quite a few more that I could mention. But definitely Daphne Allen. I owe her so much and I'm so thankful to have met her. She's just an amazing person.
[00:29:25] Lindsey Dinneen: Well, shout out to Daphne.
[00:29:27] Omar Ford: Yes, yes, yes.
[00:29:30] Lindsey Dinneen: Excellent. Oh, that's, that's wonderful. I love hearing stories of really great leaders who make an impact because it does matter so much in your experience at work just as a whole, but just also your personal and professional growth. So yeah, thank you for sharing that. So, all right, pivoting the conversation a little bit just for fun.
[00:29:51] Omar Ford: Sure. Sure.
[00:29:52] Lindsey Dinneen: Imagine you are to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, but it doesn't have to be. What would you teach?
[00:30:03] Omar Ford: Hmm. A million dollars to teach anything. Oh gosh. I, you know what? I would teach really common sense, old school journalism. I would do that. I think that there are a lot of things that have been lost in journalism over the years and that is one thing that I would teach, not necessarily the writing aspect of it but just how to relate to people, how to talk to people you know, how to just be in a position where you can have discussions with, with a person.
We have so many people nowadays that don't even know how to talk on a telephone. They don't know how to have a phone conversation. And I think that that is one of the basics for journalism, right? You gotta be able to pick up that phone or hop on that Teams call and have a conversation with someone. I, I remember a few years ago we had a, a journalist and this person was, this person struggled with talking to people on the phone or doing those cold calls. And I said, "You know, you gotta be able to breach that and you gotta be able to, to, to try and at least make that connection."
And there are tips that you can do to, to really get that information out there to, to really make connections with people, you know, you can-- subtle things that you can do, but if you gave me a million dollars, I would yeah, that's what I would do. I would teach just common core principles of journalism.
[00:31:39] Lindsey Dinneen: I love it. Sounds like a great course. All right. How do you wish to be remembered after you leave this world?
[00:31:48] Omar Ford: Oh gosh. I would say as a good husband and a good father. Those are two things that are really important to me, but I would love to be just a go out as a good husband and a good father. That's, that's ultimately what I wanna be.
[00:32:04] Lindsey Dinneen: Yeah. Wonderful. All right, and then final question. What is one thing that makes you smile every time you see or think about it?
[00:32:14] Omar Ford: Oh goodness. What's one thing that makes me smile or, oh gosh. I will say this. My youngest daughter, my youngest daughter, Emily, and she, we named her after my mom. She was a total surprise to us. We're in, well, I will tell my age. I am 47 years old and she is now two. So do the math. My other children are like in their teens. And Emily makes me smile because, you know, we didn't know that my wife was pregnant at the time. We just, and then when we found out she was pregnant at 21 weeks-- yeah. Yeah. Yes, yes. When we found out she was pregnant, we didn't even want to we didn't know if Emily would survive. We, we didn't. She spent like 10 weeks in the NICU and now she is a big, healthy toddler who has caused a lot of this to turn a lot grayer, but she makes me smile each time I see her. You know, she reminds me of her grandmother, my mom, and she reminds me that miracles can happen. So, yes.
[00:33:29] Lindsey Dinneen: Oh, I love that. What a beautiful answer. Well, Omar, this has been an absolutely amazing interview and I am so very thankful for your time. Thanks for just sharing a little bit of your afternoon with me, and thank you so much for everything you're doing to change lives for a better world. Really appreciate it.
[00:33:48] Omar Ford: Thank you. Thank you, and thanks for having me on and we've gotta have you on Let's Talk Medtech.
[00:33:52] Lindsey Dinneen: Yeah, let's do it. I would love that.
[00:33:55] Omar Ford: Awesome.
[00:33:56] Lindsey Dinneen: Well, thanks again.
[00:33:59] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Lisa Jacobs is the President of US eCential Robotics and the Founder of STRIPES Women in MedTech. Lisa shares how her path evolved from registered dietitian, ballerina, gymnast, and NFL cheerleader into a two-decade MedTech commercialization career focused on bringing surgical technology—robotics and navigation—from concept to clinical adoption. She explains her consulting-based approach to sales centered on solving surgeons’ real problems, and her leadership philosophy of creating clarity, trust, accountability, and momentum without being a “know-it-all.” Lisa also unpacks why she founded STRIPES, a global nonprofit with 3,000 members offering mentorship, networking, and education to support women navigating growth, career transitions, and negotiation. 
Guest links: https://www.stripes.network/ 
Charity supported: Safe Horizon
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPTEpisode 076 - Lisa Jacobs
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome my guest, Lisa Jacobs. Lisa is the president of US eCential Robotics, as well as the CEO of STRIPES, which is a networking organization for women in MedTech. With expertise in medical device sales, she's a high performing executive sales leader, known for formulating and executing scalable strategies to accelerate business expansion, revenue generation, and team development in startup turnaround and rapid growth environments across domestic and global markets.
All right, Lisa, welcome to the podcast. Thank you so much for being here today.
[00:01:30] Lisa Jacobs: Thank you so much for having me.
[00:01:32] Lindsey Dinneen: Of course. I'd love if you would start off by sharing a little bit about yourself, your background, and what led you to medtech.
[00:01:40] Lisa Jacobs: Of course. Yeah. So I've been a medtech executive and commercialization leader for more than two decades. My experience has been in bringing surgical technology from concept to widespread clinical adoption. Also, my career is really focused on startups with high growth and complex environments. Everything from early stage robotics to scaling global platforms across the US market. Today I serve as president of North America for eCential Robotics, where I oversee commercialization, surgeon adoptions, partnerships with implant partners, market strategy, and open platform surgical navigation ecosystem.
In parallel, I'm the founder of STRIPES Women in Medtech, which is a global non-profit, created a support, connect and elevate women across the industry. I spent my career sitting at the intersection of innovation, people, and execution, and I care deeply about building businesses that are both high performing and human centered.
[00:02:47] Lindsey Dinneen: Very nice. Okay, so going back to, let's say growing up, did you always think that you might an interest in or a future career in healthcare, health techs, things like that? Or did this sort of evolve over time?
[00:03:03] Lisa Jacobs: It evolved over time, actually. My degree, I'm a registered dietician by trade. And I was a ballerina, so I always thought I was gonna open a dance studio. So it's been, it was a complete pivot from what I went to college for and what I thought I was gonna do growing up.
[00:03:21] Lindsey Dinneen: Okay. Yeah. All right. Well, we have to dive into the ballerina aspect, obviously, since I am too. So, so did you dance all the way through high school, college, beyond?
[00:03:32] Lisa Jacobs: Yes, I danced through high school and college. I was also a gymnast. And then I became an NFL cheerleader in my, when I was 18 years old for the Patriots. So that's kind of where it took me. So then, you know, when I, after college, I decided I was gonna be a starving ballerina, but it's always been my passion and love. So I'm still very into fitness and wellness and definitely do Pilates and yoga and try to keep that part of my life alive. But I always miss dancing and wonder what would've happened if I went down that path, yeah.
[00:04:08] Lindsey Dinneen: Yeah, of course. Well, the good thing is you can always still do some kind of dancing or support it or however you, so it's it's not gone.
[00:04:19] Lisa Jacobs: Yep. It's around my house. Yeah. Yeah,
[00:04:22] Lindsey Dinneen: Exactly. Okay. And so nutrition. Okay, so did that evolve because you were a dancer and interested in that kind of wellness aspect or?
[00:04:32] Lisa Jacobs: It was, you know, I'm Portuguese, so there is obesity in my family and I had to work really hard to stay thin for dance, gymnastics and, you know, cheerleading. So, you know, at cheerleading I used to get weighed in, so I was always exercising and trying to find what was right to eat and I didn't wanna hop on the diet fat. So I studied nutrition because of that. And throughout my dance career, I found a lot of girls who were either anorexic or bulimic or a combination of both. And it really, and one of my friends did die from anorexia, so I dove in deep into the study of that and how to help people.
[00:05:22] Lindsey Dinneen: Yeah. And you're still helping people all the time. You're in medtech and you're doing amazing work. So do you mind sharing a little bit about, yeah, your current role and maybe sort of the leadership journey that took you there?
[00:05:36] Lisa Jacobs: Sure. My current role is with an open platform, which was based out of France. And I'm bringing, I just opened an office in Franklin, Tennessee. It's just been a year to this month. So, our technology is differentiating in robotics and navigation. And I remember earlier in my career when I stood in the operating room watching a surgeon place a complex implant using a navigation system I helped bring to market, I realized my work was directly impacting patient outcomes, but also easing the mental load of the surgeon with navigation.
And still today you hear that surgeons want navigation to decrease their mental load and robotics to decrease their physical load. So that moment crystallized something for me. I didn't wanna just sell products. I wanted to build platforms that changed possibility in medtech to give a rare opportunity to blend science, engineering, technology, and give experience to surgeons that would help them directly to help patients. So it's hard to imagine doing anything else now that has such an impact.
[00:06:54] Lindsey Dinneen: Yeah, I I can, I understand how-- it's really cool to be a part of mission-driven organizations, which is something that I actually wanted to talk with you about because I know that you are very mission-centric and you care a lot about making a difference and and being helpful and and so I was just wondering where did that come from, was this a core belief of yours sort of throughout your whole life, or how did that evolve too?
[00:07:22] Lisa Jacobs: I think it was embedded with me, with my parents. Both of my parents were incredibly helpful to neighbors, community, family. I come from a big family and my father would always go out and help anyone who needed it. And my mother was the same, you know, all of my friends wanted to come to my house to hang out with my mother 'cause she would take care of everyone, drive them to any games or anything they had. So, it was just, I think a core belief with the way I was raised.
[00:07:54] Lindsey Dinneen: Yeah. Okay. That makes a lot of sense. And then it's something that, I think, is so helpful 'cause it continues to drive and motivate as you go along throughout your career and you've had such a wide variety of experiences. So tell us a little bit more about your approach to selling. I was, I was reading a little bit on your LinkedIn profile and it mentioned that you prefer to have kind of a consulting approach, I think to, to selling. And I was curious if you could expound on that a bit?
[00:08:24] Lisa Jacobs: Yeah, absolutely. So a lot of salespeople are taught to sell on features and benefits, right? You go in, you have a widget. You're talking about your widget. You're trying to get them to use whatever you're trying to sell, but they don't listen to the surgeon's need and ask doctor, surgeon-- whoever you're selling to-- your client's needs about what are their problems they currently have? How do you solve for their problems? What are you bringing to the table to help them either in the operating room or in their clinic. And I think it has to be more natural and more conversational instead of selling on features and benefits.
You need to know who you're talking to and do your homework before you enter the room or even try to sell to that person. But what problem are you trying to solve for? And I think too many times people go to sales training and you learn your surgical technique. You learn your features and benefits and you learn your pitch, but it's not conversational and it's not natural. And I think whoever you're selling to gets very turned off by that type of selling.
[00:09:38] Lindsey Dinneen: Yeah, I, I have found that it's actually being-- I I don't like being sold to, I suppose most people don't in some way, and it, and, you know, especially that tactic of sort of, yeah, just kind of coming in uh, maybe assume it-- well, the way that it comes across is assuming that they know exactly what I'm dealing with or that all the problems are the same regardless. And you know, that might be true, but I think you're right. Having that very human moment of curiosity and connection can make all the difference in terms of how I feel about, well, the salesperson and the product or the service. So yeah, that's, that makes a lot of sense.
So, okay. When you became a leader, this is of course a, a journey and a pathway, but what are some of the things that you knew, you know, "Yes, I want to be like this" and "No, I don't want to be like this." Like what, did your your own leadership style develop?
[00:10:39] Lisa Jacobs: Yeah, I think leadership is about the ability to create clarity for an organization, alignment as a team, and momentum, you know, especially in uncertainty. And it's not about having all the answers. I know I don't wanna be a know-it-all, right? And only my way, and the way I sell and I approach is the only way. I think it's about building trust, setting direction and empowering people to do their best work. I think that great leaders definitely create environments where people feel safe to think, challenge, and grow, while also being held accountable to share a mission. Right? So, I don't like working for leaders that are know-it-all and if you don't follow exactly their, their rules, then you know you're not gonna win. And then it's always about your, who are you in your next sale? And don't listen to the people who are forward facing, their feedback, and able to pivot.
[00:11:42] Lindsey Dinneen: Yeah. That's, that's great. That, and I, I definitely know what you mean-- know-it-all and it's my way or the highway, and not usually, not very pleasant to work with.
[00:11:53] Lisa Jacobs: Yeah.
[00:11:54] Lindsey Dinneen: Okay, so let's talk about STRIPES. What made you realize there was a gap, a need for this organization, and how did all of that come about?
[00:12:07] Lisa Jacobs: So I was getting, I was teaching some courses at Medical Sales College and speaking there, and I was getting an outpouring of women on LinkedIn asking for advice and asking for help, not only from med device school, but from other women who are trying to become the Area Director or VP of Sales and were hitting some roadblocks. So, I really felt compelled to help, but I didn't have the bandwidth to help. So, at the time I brought a bunch of girls, I worked together in a room and said, "Guys, I have this idea." And I think half of them thought I was crazy. And, you know, "Lisa, you don't have time to do this." But it was really important to me to give back to a career that gave so much to me.
And I know there's a unique set of problems and situations that women have in medtech that. It's not always comfortable to speak to either a coworker or a male counterpart about, so I wanted to create a safe place where we could learn, grow, and network together. And I got very tired of hearing women say, "You know, I didn't get that job because it's a good old boys network at a good old boys club." So change it. Let's do something about it and let's do it. Let's do it better. So that was the reason for STRIPES.
[00:13:25] Lindsey Dinneen: Nice. Okay. That's excellent. And like you said, very needed. So I'm so thankful, you know, you've, you've put love into the organization. Alright, so you host monthly networking events, virtual and sometimes in person, right?
[00:13:41] Lisa Jacobs: Right. Live networking events across the country. Yep.
[00:13:44] Lindsey Dinneen: Okay. Uh, So I definitely wanna hear a little bit about those and maybe some of the impact that has that you have already seen happen, 'cause the organization is how old now?
[00:13:55] Lisa Jacobs: About two years.
[00:13:56] Lindsey Dinneen: Oh, nice.
[00:13:58] Lisa Jacobs: We have 3000 members. So, grew really fast, which was great. But what, so we offer mentorship programs. So you can be a mentor or mentee. We have what we call WIne Down Wednesdays, which is really a networking event where we talk about anything that anyone is in the group, whether they're interviewing or looking for a job or negotiating a contract or just need a safe place to talk through a issue that they're having at work.
Then we also have Women in Career Transition. This kind of happened organically. We had office hours and there was a group of women who were always joining who were looking for jobs and wanted help by recruiters, by resume writers. So we evolved that group. And we have live networking events around the country.
And then we have a monthly webinar for education. So that's what we currently offer. And we just opened a Slack channel where people can network together and we're having a bunch of different books and different clubs join as well. So we are, we're growing rapidly and the goal for '27 is to have one big national meeting together.
[00:15:08] Lindsey Dinneen: Ooh. Oh, I'm so excited about that. That's great. Excellent. Well, yeah, it, that is no small feat to grow it so quickly and clearly there's, there's a need for it and a hunger for it. So that's excellent. And I am wondering, with your webinars, what kinds of topics have you covered that you've realized, you know, "Oh goodness, we we really needed to tackle this."
[00:15:30] Lisa Jacobs: Yeah. One was about communication style. So speaking with confidence is one actually that we're having this Thursday. We're bringing it back. One was about contract negotiation that women you know, really need to understand how to negotiate shares, how to negotiate time off, and we don't get a lot of understanding of once you get to a certain level how to negotiate those type of scenarios, right, with different shares and equity and what it means. Something I wish I knew younger.
So, and then we also are having some webinars. Omar talked about building your brand and who you are. So those are some of the big ones. But I realize I didn't answer your previous question of what has it brought to some women, and we've seen women, a lot of women get hired, change careers drastically, and open their own consulting. Seeing people who were in sales go into product management and understand, you know, what classes and what education they needed to have. And people who were always scared to post on social media about building their brand and who they are.
So it's been really beautiful to see the evolution of some of our, and the testimonials from some of our women. We also have people who are breaking into med device and finding jobs through others. So, it's been a beautiful evolution.
[00:16:54] Lindsey Dinneen: Oh, that's exciting. Yeah. Oh, I love those stories And and it sounds to me like, or one of the things that I've kind of observed is, is even to your point of showing up on LinkedIn, I think that there's some of the women that I know are part of the network, uh, I follow, they are continuously, I feel like becoming more and more confident in how they speak. And it's really fun to see even that evolution too. And, I, I am, and those are things that you talk about too, in the, the Wine Down Wednesdays, right, where we, you know, you can kind of tackle some of those if you're feeling a little anxious about it, maybe get some advice from someone who's confident in that.
[00:17:34] Lisa Jacobs: Yeah. Absolutely. Yeah.
[00:17:37] Lindsey Dinneen: Okay, um, I, so it was I, I really enjoyed reading some, um, recommendations that are on your LinkedIn profile, and there were a couple of things that's kind of stood out to me. So, one person said that he particularly appreciated your "resiliency, character, and performance in leadership" and I'd love to hear a little bit about that. The other, another one that I, that stood out was that you were the "definition of integrity," and those are beautiful endorsements. And so I'm wondering where did your, you know, character development, integrity, focus, resiliency, where did that all come from and develop?
[00:18:18] Lisa Jacobs: Yeah, I think that I changed becoming a mother, and I was a single mom for many years when I started my career in med device, and I wanted to be a huge role model to my sons. So I think that my integrity and trying to always be honest and be the best person I can, especially in such a competitive environment in spine and orthopedics, really I wanted to stand out in a different way and it truly is the root core of who I am. So I do believe in building things that matter, doing things the right way, even if it takes longer, and building that trust and relationships. And I think that's why I've had such a wonderful career and have so many friendships, you know, with that.
And when, and the resilient-- I don't think I've even read these recommendations, so thank you for bringing 'em to me-- and being resilient. You know, when I was a VP of Sales, I went through Hurricane Ian lost everything I had, and we were going through a really hard financial time at the time, and I think that you just have to get up and keep on moving and keep on going. And I think a true character is showed in tough times and a true leader keeps on leading in those tough times. So, again, being a mom, I think, you know, my boys are my everything. They're the my reason. So I always wanted to be a good person for them.
[00:19:50] Lindsey Dinneen: I love that. Yeah, and I think you're absolutely right. Character is developed and tested during some of the toughest seasons.
[00:20:00] Lisa Jacobs: Yeah.
[00:20:00] Lindsey Dinneen: But, but when you can come out of them on the other side, and also, I don't know if you agree with this or not, but one thing that I've personally found when you're looking back, and it can be tempting to kind of have the "why me," you know, sort of feeling and if, yeah, can, if you can look at a situation or a season and go, "Yes, but I also learned X, Y, and Z," or "I built my resilience up," or "I, you know, learned that I actually can handle," and I think one thing for me too is that, without getting too far off the subject here, is that it builds empathy for others. Yeah. Then you're, you're more able to say, "I understand what this is like." And think that that makes a huge difference as a leader specifically?
[00:20:55] Lisa Jacobs: Mm-hmm. Mm-hmm. And then always, yeah, staying humble.
[00:20:59] Lindsey Dinneen: Yeah. Yeah.
[00:21:00] Lisa Jacobs: You know, because you can have a really successful career and things that of your control can happen and you could, you know, next year we may not be the same. So I think you always have to be humble, as well.
[00:21:14] Lindsey Dinneen: Yeah. Uh, Yes. Humble, resilient, character led.
[00:21:20] Lisa Jacobs: Yeah.
[00:21:21] Lindsey Dinneen: Makes for a good leader. Excellent. Okay, pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be within your industry, but it doesn't have to be. What would you choose to teach?
[00:21:37] Lisa Jacobs: I think I would teach a masterclass on building confidence through competence. I think so many people, especially women, are taught to seek confidence first, and in reality, confidence comes by mastering hard things, making decisions, and surviving failure. I would teach how to build technical, financial, and strategic competence so that confidence becomes natural byproduct, and you don't have to fake it. I don't like the term "you fake it until you make it." I think it's quite the opposite. You have to go through the trenches to gain that confidence. So, there's no easy path. You have to go through it.
[00:22:19] Lindsey Dinneen: Yeah. And-- well, first of all, that would be a great masterclass. And secondly, I think when you go through it too, again, you are also, how do I put this, building up the sort of credibility within not just your own mind, which I think does help build confidence, but with others as well. So love that. Okay. And then how do you wish to be remembered after you leave this world?
[00:22:46] Lisa Jacobs: I wanna be remembered for being compassion and opening doors for other people who didn't see in themselves characters that, and qualities that they had. You know, whether it's through my work in med device by creating change and creating better platforms, but helping people step into their potential because I was willing to stand in their corner is what I wanna be remembered for.
[00:23:13] Lindsey Dinneen: That is beautiful. That's a wonderful legacy. Love that. Yes. And you're already doing it all the time, through STRIPES and through your other mentorship and love that so much. Oh, excellent. All right. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:23:32] Lisa Jacobs: My sons, Kent and Ryan, you know, especially now that they're in college, one just graduated. I don't get to see them as often, so they were here for the holidays and just hearing their voice or seeing them just makes me smile.
[00:23:46] Lindsey Dinneen: I love that. I, I wondered if that was gonna be your answer when you were talking about them earlier. Excellent. Excellent. Well, this has been a fantastic conversation, Lisa. Thank you so much for joining, and thank you for just everything you're doing to leave the world a little bit better than you found it. I think a lot better. I just wish you the most continued success as you work to change lives for a better world.
And we are so honored to be making a donation in your honor and as a thank you for your time today to Safe Horizon, which is the largest victim service organization in the country. Every year, over 250,000 people seek safety through their services. So thank you for choosing that organization to support.
[00:24:32] Lisa Jacobs: Thank you so much. It's been a pleasure.
[00:24:34] Lindsey Dinneen: Absolutely. Thank you.
[00:24:37] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.