The Leading Difference

Charu Roy, Chief Product Officer at Enlil, shares her extensive journey in the software industry, which began in the late 1980s and evolved into her leadership role in medtech. Charu discusses her role at Enlil, where she oversees the development of an AI-powered platform to enhance medical device lifecycle management. She emphasizes the importance of understanding customer needs, fostering team potential, and ensuring cybersecurity in medtech software solutions. With profound insights on her career growth, leadership style, and the technological advancements propelling the industry forward, Charu's story is an inspiring tale of innovation and dedication to improving lives. 
Guest links: https://enlil.com/ |  https://www.linkedin.com/company/enlil-inc/
Charity supported: ASPCA
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 069 - Charu Roy
[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 absolutely delighted to introduce you to Charu Roy. Charu is the Chief Product Officer at Enlil, where she leads product strategy, vision, and execution for the company's AI powered medtech development platform. With over two decades of experience building and scaling enterprise software products, Charu brings deep industry expertise in product management, user-centered design, and go to market leadership. Before Enlil, she held senior product roles at industry leaders, including Epicor, Oracle, I-2 Technologies slash Aspect Development, HP and Agile Software, where she drove software innovation across enterprise cloud SaaS and data driven solutions. Known for her ability to align customer needs with business strategy, she is passionate about delivering products that transform complex industries and enable measurable impact.
Well, welcome, Charu, to the conversation today. I'm so excited to be speaking with you.
[00:01:54] Charu Roy: Thank you so much for having me. I'm very really excited about being here on this podcast.
[00:02:00] Lindsey Dinneen: Oh, awesome. Yeah. Well, I would love, if you wouldn't mind starting off by sharing a little bit about yourself, your background, and what led you to medtech.
[00:02:10] Charu Roy: Sure. As every other sort of person who gets into the software world, I came in a while back in 1987 to 89, where I did Master's in Computer Science at University of Louisiana. That was my first introduction to America, really. And computer science brought me to the Bay Area where I worked at HP, Hewlett Packard. In those days, it was called Scientific Instruments Division in Palo Alto. And there I programmed robotic hands to, to sort of move that, the vial from samples, drug samples from athletes so that they could get tested for drugs. So, I didn't know the importance of all this. It was my first job. I enjoyed myself seven years, you know, software programming, really, and understood how a large company works.
And then slowly I started getting a little bored. So I went on to my next startup and was involved in the same kind of principles that drive things today. So I just sort of built my way up. In terms of the software, I joined different groups, ran consulting services, ran engineering, and sort of worked myself up through the ranks and into sort of more decision making capabilities, and you know, continued to join companies and learn new things and leave them for some better opportunities.
So I moved from Hewlett Packard to a startup that was called Aspect Development, which got sold to I-2 Technologies for $9.3 billion in those days. So, you know, I went through that acquisition, trying to understand the market, what kind of software triggers buying, you know-- so sort of just the software aspects of how to sell software, how to develop software, how to deploy it. So in general, I was learning all of the ropes until I came to Agile PLM, which is a company which, very popular company which made it very sort of easy to deploy software, especially software called Product Lifecycle Management.
So I was -- here, I was in and out of companies, learning and understanding the world of software until I fell into med device companies being my customers. So med device being our customers meant, you know, a lot more strictness, a lot more process, with the software itself. So here I was trying to now go through those kind of features, trying to understand what med device needed when they were building products.
So, from Agile, I went to Conformia. Again, it was the same, it was regulatory product for wine, spirits and pharma --very adjacent to med device. But again, it was the same thing about how to be provide, how to provide a traceable platform where our customers can trace there, the make of the wine or make of the spirit, or make of a pharma drug or make off of med device. All the principles underlying it are the same because it's a regulated product at the end of the day, but so that's how I kind of fell into it, and I enjoyed every bit of that until I got acquired by Oracle.
And so I continued at Oracle doing the same thing over and over again; rebuilt the same products again at Oracle in the clouds, and I was managing the old Agile products. So it's an interesting journey where I was, you know, started off as a software programmer. And I didn't know anything about, you know, the use cases until the time I sort of joined Oracle and understood my customers better. And that's how I came in there. And of course I was at Epicor and finally I made my way to Enlil, which is a very small company, and I'm doing the same thing again. It's just with a different set of customers, very small to medium sized companies. So that's how my career sort of spanned 30 years.
[00:06:11] Lindsey Dinneen: Wow. Oh my goodness. Well, there is so much to dive into all of that. Thank you for sharing. It's so cool to hear about all of the winding paths that lead us to maybe, you know, where we're meant to be in, in any given season. And yeah, I just love learning about it. So, okay. So I'm curious, you know, way back when did you like growing up, did you always have an interest in computers and computer science? Is this something you knew you wanted to get into?
[00:06:40] Charu Roy: Not at all, actually it was a suggestion, and in those days, parents kind of suggested that you be a engineer or a doctor or a chartered accountant. The choices were very limited. And so my father said, "you will do computer science." And I said, "okay." And there I was and there was no, no sort of emotional attachment to any of those professions. And, I liked it well enough to continue, and I found it was easy enough to understand the principles and work at it. So yeah, there was no-- you know, in these days I think kids are training themselves like by seven or eight to program. And I'm seeing, you know, machine language I mean AI, ML, LLMs being taught to seven year olds and sort of trying to shape them, but in those days it was just some very simple choices, I guess. So, yeah, not a very romantic story. I was never programming younger in my younger days, but I think you know, compared to all the choices youngsters have these days, but just fell into it.
[00:07:44] Lindsey Dinneen: Sure. Oh, how fun. You know, even though, yes, it was somewhat prescribed for you, at least originally, and I'm so glad that you fell in love and it ended up being a happy place for you because...
[00:07:57] Charu Roy: Yeah, and I think I fell in love with the customer, how customers reacted to the software. I didn't fall in love with the software delivery process or anything else, but it was just the way customers said, "oh, I like that. It's gonna make it easier for me to do something. I'm having a tough time tracking it on paper. I just hate it what I'm doing right now, and your software will help." So I think that's a part that makes me feel really pleased that okay it's going into some good hands and it's going to be used.
[00:08:30] Lindsey Dinneen: Yes, by people who really appreciate and value what you can contribute, what maybe comes --at this point, I guess-- naturally to you. And so it's, you're able to translate somebody's ideas or dreams into a really tangible solution.
[00:08:48] Charu Roy: Yeah. And in fact, somebody's pain points, like they're really sort of, trying their best to use little resources they might have, wasting a lot of time on either tracking something on paper or in emails. And I think those are the kind of pain points that I really like to understand and say, "Hey, will the software help really help your day to day life? Will it make it easier to find things?" I think that's where I find my sort of biggest thrill of when a customer says, "Yes, you shaved off three hours of my time by giving me this efficient system."
[00:09:26] Lindsey Dinneen: Nice. Yeah. Oh my goodness. Yes , and the products that you're making are indeed life impacting and make a difference. And that is rewarding because you know that the work you --do all work is important, but it's really fun when you get to know personally the impact that you get to have.
[00:09:45] Charu Roy: Right, right.
[00:09:46] Lindsey Dinneen: Yeah. Yeah. So, okay, so I'm, I'd love to dive in a little bit more to your current company and role and learn about that, and how you're helping, you're still helping people you know, win through this.
[00:10:00] Charu Roy: So, yes, absolutely. Enlil is part of Shifamed, the portfolio. Shifamed invests in med device devices typically, so ophthalmology devices or cardio devices. Enlil came about as an enterprise software company within the portfolio because they realized that they needed some software to throw all their data into, right? So they had early designs, prototype data. They might have had some user requirements, what kind of standards they might have to follow. So all those were floating about, again, in emails and paper.
Enlil came in saying that we can store this data more successfully, more cleanly in a structured fashion so that our users can find that data. And this becomes really important as the med device company moves on and tries to apply for regulatory approval at that time, they need all that history and the data behind the device. And they wanna be able to find it easily and present it to auditors.
So, Enlil's a structured way of describing all the data that the customer has and being able to find it easily and then run their audits using the data. So it's a very crucial part of their lifecycle, their product lifecycle. And so it's really important for us to be secure, reliable, available, 24/7. All of that applies to us and basically defines how they go about driving their product lifecycle.
[00:11:34] Lindsey Dinneen: Yeah. Well, and you know, one thing that stood out to me when you were talking about that was of course the security aspect. And as we all know, we're, we're probably much more so than in the past, hyper aware of the critical need for cybersecurity and the role it plays specifically in medical device technology. And I'm curious if you could speak a little bit more to that particular element.
[00:11:55] Charu Roy: Yeah, we have a lot of layers of security, you know, right from the folks who are accessing the software. The software is hosted in a well-known, reputable cloud service environment. So apart from them providing us cybersecurity and access control and everything else, we have another set of layers on top of that. So our users are vetted and they all have a password. People can be invited and not just sort of show up. So, there's a lot of control of what they can see and can do. Every button sort of, you know, has a role behind it or a layer of control. So not everyone can do everything and press any and all buttons. So, security is at many levels. And we also have a lot of audit trails, e-signatures, and so on. So everything is done to protect the data, and audits are run regularly by them and by us to make sure that nobody who's supposed to be, you know, people who are not supposed to see the data, don't see the data.
[00:13:01] Lindsey Dinneen: Yeah. Excellent. Yeah, I know that's just something that is, should be at least, on the forefront, especially of startups' minds as they're thinking about this and working towards having a really secure device. So it sounds like you've built in all of that safeguarding really well and really intentionally. So, so, okay, so I know that -- well, there's a few things that really stood out to me on your LinkedIn profile, and I'm just curious if we could dive into a couple things. One was, I love how you said that you're "passionate about teams and people delivering to their full potential," and I was wondering if you could speak a little bit more to that.
[00:13:42] Charu Roy: Yeah, so, you know, along the years I've noticed that people in my team, the team members, they're there, they're working hard, but I do like to understand what's making them tick, what might they be wanting to do, which they haven't got gotten to do yet. Can we unlock some potential, some skill, some talent? And I think that comes about by sort of just talking about it , trying to give them openings about, "Hey, look, I've got this cool project or this cool feature. Any thoughts on that?" Just to understand, are they happy doing what they're doing, or is there something more they could do?
And so I think that human touch, you know, is -- it was given to me, or at least it was taught to me by some mentors along the way. And I think that's a part that I really like to explore and see how can teams do better, not just in a numbers, not just turnaround features and releases on time, but are they happy doing it? Did they contribute something meaningful along the way? Did they feel they grew in the process? Did they feel they were recognized for some new responsibilities that they may not have stepped up for in some other companies? So that's a feeling I'm trying to always give them and sort of hoping that we contribute to their growth, not just the company and the bottom line.
[00:15:02] Lindsey Dinneen: Yeah, that's critical and key,, and really speaks to who you are as a leader. And I'm actually very curious, you know, you mentioned earlier having kind of worked your way up at HP and then, you know, that may be opening some doors for you for of course, your future opportunities, and I'm curious, what has your own leadership journey looked like? Has, does leadership come naturally to you? Have you spent a lot of, you know, time and resources, whatever, developing those skill sets or how did that work for you?
[00:15:29] Charu Roy: I think I was thrown into the deep end of the pool several times, you know, like, so I kicked into the pool, so to learn to swim. So similarly I was made to take on responsibility pretty much the very beginning. So I kind of knew that there were certain things expected that I should be doing, can be doing and then this introspection saying that, did I give the right amount of energy to that particular responsibility and did I do well?
So just a lot of introspection and being able to understand, did I do well as a leader? But I've been honing it, honing skills. I mean, nothing out of an MBA school, nothing out of, you know, college that helped me. I think it was just about pure interest in psychology, pure interest in humans, you know, just being able to connect and how did I make them feel? How did they make me feel in those interactions? And is that, was that good? Was there something we could do to incorporate more people to get that feeling of ownership or anything?
So it wasn't a, you know, by rote or something that I learned in a school. It was more of just sort of. Being thrown into situations where I had to come out of it somewhat gracefully and some somewhat feeling like I had also learned along the way.
[00:16:46] Lindsey Dinneen: Yeah. Yeah, that, that's wonderful and incredible. And I think, you know, you mentioned learning along the way, and one thing also that stood out to me was, the recommendations on your profiles are so lovely for you. And two things stood out: they, one thing was somebody mentioned you're always learning, which is a gift in and of itself. And then the other thing was you're always letting others succeed. And that's such a beautiful gift and I'm wondering if you could talk more about both of those as well.
[00:17:16] Charu Roy: Yeah, I think it's not about just me being sort of the boss and being able to tell people what to do, though I think success comes from enabling or encouraging the teams to again contribute without any barriers, any levels, or politics. I love the fact that we are in a small company, and I can say safely that, you know, politics --in larger companies there are politics. People are always trying to sort of be showing that they are very valuable. But in a small startup, it's very quickly apparent that there are certain valuable players there and startups, everybody is valuable, right?
So I think being able to encourage the team members to do what they think is best for the problem to solve it. And of course, there are reasons why you can't sometimes accept the solution, but the fact that they're thinking about it and the fact they're able to openly express their opinions and say, "No, you're wrong, Charu." I think this is the way to do it. I love that. I think, somebody disagrees with me in a meeting, I just think that's the best thing that could have happened as a style of management.
Because I'm not, you know, insecure in that sense. I don't sulk afterwards. I have had bosses and so on who don't like that kind of, you know, disagreements in public. And I think that's a part where I beg to differ, and I want to have people say what they think, what are they feeling, what are the problems, really the truth, and fix it, really. So I think it's less waste of a time when people are honest, and get to the point, and we are able to solve it together rather than hide behind, you know, facades, I guess.
[00:19:01] Lindsey Dinneen: Yeah, that's beautiful. And yeah, I've often said for me personally, that, you know, more heads are better than one. I mean, I could have a, an opinion on whatever it is that we're talking about, but really, until we collaborate and start sharing those ideas and those thoughts and opinions , all of a sudden those kinds of sparks happen where, you know, you start with one thing and then it, and then somebody else catches that and they take it even to the next level and it just keeps going. And it's so cool to see the creativity and problem solving and innovation that comes from allowing those conversations.
[00:19:36] Charu Roy: Yes, exactly. Creativity and innovation. You've said it so well. That comes with smart people being in the same room, arguing, not agreeing, and then something comes out of that, right? I mean, either your thoughts get clearer because you've seen every side of the coin and you're able to say, "Okay, I know the pros and cons and we can go this way, knowing the full effect of what we are going to do." So I think surrounding myself with smart people who have varied opinions, I think that's a beauty and a blessing really.
[00:20:12] Lindsey Dinneen: Yes it is, and you've nailed it with varying opinions. You know, it's easy to get yourself into a situation-- and not necessarily intentionally-- but just it's easy to give into a situation where you've surrounded yourself with people who all kind of have the same opinions on things. And so inviting those conversations to take place that might be difficult, might be challenging, might be frustrating at times, but allowing for that and being open to other points of view and experience. I mean, that's the beauty of a really good collaborative environment is all of those varying opinions that don't necessarily match yours.
[00:20:50] Charu Roy: Yes, exactly. Exactly.
[00:20:52] Lindsey Dinneen: Yeah. Yeah. So, okay, so looking back, could 10-year-old you have ever imagined where you'd end up today?
[00:21:00] Charu Roy: No, absolutely not. I thought I wanted to be a doctor or something vague. 10-year-old me was climbing trees and eating guavas off the trees in Delhi. So it was really crazy childhood. And you know, it wasn't filled with studies and rules and stuff. So I think coming to this, a country when I was young, being able to absorb everything, the culture, the of course the education itself and being able to sort of grow within the companies that I joined, i, I think that was the journey that I was sort of a pointing more towards rather than the childhood me. The childhood me was horrible, I think.
[00:21:46] Lindsey Dinneen: Oh man. Honest reflection right there. That's awesome. Yeah, okay. Are there any moments that really stand out to you, perhaps with your current position or, you know, something in your past where you really thought, "Wow, what I'm doing makes a difference. I am in the right industry, at the right time, in the right place."
[00:22:07] Charu Roy: I think it's the technology now that, you know, speaking from a technical viewpoint of shipping software, meaning full software, more easily, the time is now. I feel that the culmination of everything I've learned about pain points and users and customers, all of that's culminating in in the product that I'm managing right now, using new technologies, having the right technologies to choose from and being able to propel that software forward to our users. I feel that, "Wow, what a time to be a product officer really, when we have so many choices and being able to be able to apply that to real world problems and real pain points."
I had the same pain points 20 years ago, even 30 years ago, but we couldn't do much. We had to, you know, write painful programs. We had to write database queries and, you know, things like that. It was quite painful, I would say. And then now to see all the tools where we can create things overnight and be able to ship it to customers, just hitting the nail on the head. We had to experiment a lot in the old days but I think the time now is is really special. We are on an sort of an industrial revolution or a computer science revolution here with the AI, MML, the LLMs, being able to do so much with probably less resources than before. So.
[00:23:39] Lindsey Dinneen: Yeah. So seeing the impact of the work and getting to not have it be so painful.
[00:23:45] Charu Roy: Yes. It used be very painful and now I'm thinking, I think we're at the right time, right place now with this product. And it's not just about the products. It's the kind of help we are getting as software professionals to help deliver software and support our users. I think that's really special and I, we are still learning, we're still trying to understand all the technologies that are available to us and how can we make our lives easier and our customers feel that we've solved some problems for them.
[00:24:14] Lindsey Dinneen: Yeah, absolutely. And I think that there's just, it is really wonderful again-- just to, to circle back to this kind of been a running theme of getting to be able to experience for the end user or with the end user, that moment of, "Oh wow, I needed this is so helpful and it's gonna make a difference."
[00:24:36] Charu Roy: Yeah. I remember in my past, same sort of software tracking wine being made. And that software was pretty cool. It, it used to track where the wine sat and which barrel for how long. And so the pleasure of talking to wine makers, and being able to show them how the software track the progress of the wine and being able to print out a label at the very end for them, saying that "this wine sat in these bottles or these barrels for a while," and that technology application for a simple, naive user, I thought that was it. That was the, you know, the culmination of all the learnings that I had over the years to be able to explain the software so easily to a end user who might be a distiller or a winemaker or somebody, a farmer. I thought that was pretty cool. And that since then, of course, technology has changed, but I think we're beginning to see the effect on a naive user, which we couldn't do, you know, 30 years ago.
[00:25:37] Lindsey Dinneen: Yeah, absolutely. Oh my goodness. That is, it is so cool. And I love the work you're doing and just learning all about your history so far and just exciting to see where it's gonna end up too, and as you continue along your career path, but 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 area of expertise, it doesn't have to be. What would you choose to teach?
[00:26:06] Charu Roy: I would probably think about teaching psychology of the individual. I don't have a PhD or a even basic courses in psychology, but I just love the fact that, you know, you can apply psychology, figure out how a user might or somebody might react to something that you say, do, think so I, if it was a master class and I'd be teaching you know, teaching more about life interactions, you know, ordinary interactions. How can they be made more meaningful, more fruitful, using psychological tricks or phrases?
I don't know all of those things, but I would really think that I could teach that based on, you know, facial expressions, body mannerisms, or body-- what do they call it, sort of, you know, criminal stories. They read your mind based on certain mannerisms of flutter viol. So yes, psychology is a masterclass I would teach, but more applied to daily interactions, maybe work situations and being able to use psychology better to improve your own work relationships with people and even just general interactions. Yeah, so that would be my attempt at being a psychologist and eventually be a criminal psychologist.
[00:27:28] Lindsey Dinneen: Yes. Oh my goodness. That would be so interesting. Yeah, I love that idea. And the masterclass sounds fabulous, so I'm signing up whenever you do it.
[00:27:37] Charu Roy: Okay, I'll go get my degrees for it then.
[00:27:40] Lindsey Dinneen: Right, right, right. Yeah. Ah, details. Awesome. How do you wish to be remembered after you leave this world?
[00:27:50] Charu Roy: This is something that I've always felt deeply about. It's not what you say or what you do, it's how you make people feel, that Maya Angelo said that this much nicer than what I'm saying, but and I've had a few people say this to me, saying that, "We worked together 30 years ago, but that day you made me feel good." And I don't even remember what I said, what I did, but the fact that they remember me for what I made them feel. The fact that somebody also told me that they "don't avoid me when I'm walking up to them because, because I make them feel like things are okay, things are good, however bad the problem is." So they say that with other people they would duck and, you know, go away in the opposite direction. But with me they're waiting for me to come up to them. I'd like to continue that, that feeling that somebody feels like, "Hey, you are coming up to them and you just make them feel good in some fashion." Nothing else. I think that feeling, if I could evoke in people, they say, "Oh yeah, she made me feel good that day. I don't know what she said, but she made me feel good." That's enough.
[00:29:01] Lindsey Dinneen: Yeah, that, yes, that is more than enough. What a beautiful legacy. Yeah, and then final question, what is one thing that makes you smile every time you see or think about it?
[00:29:15] Charu Roy: I think my dogs smile. I would say he's got missing teeth and so when he looks at me when I first come, you know, come back home and he is smiling almost, and he is sniffling and, you know, trying to sneeze and smile at the same time. Oh my God, what kind of a character dog this is? So that makes me smile and laugh the whole time, especially the missing teeth. Poor thing. He doesn't understand that his teeth are missing because of me, and yet he's smiling at me, so.
[00:29:50] Lindsey Dinneen: That is so sweet and cute. Oh my goodness. I love, I know somebody at one point said, "You know, dogs don't actually smile." I don't believe them. They smile.
[00:30:00] Charu Roy: They smile and they choke while they smile because my dog has a small nose, I guess. So he chokes when he smiles, and so he is choking, and he is smiling, and this missing teeth there. I was like, "Oh my God."
[00:30:16] Lindsey Dinneen: Oh my goodness. Yes. I mean, that would just I, yes, I can just sort of picture this. I love, love dogs and so I'm just picturing this and I, that would bring me joy every single day, definitely. Excellent. Well, this has been such a wonderful time spent with you today. Thank you for sharing your stories and your journey and your advice, and I really appreciate some of those in particular, your leadership advice, and the impact that you can have as a leader, inviting the collaboration, having conversations that encourage people to have varying opinions and maybe outright disagree with you. I love what you're wanting to, you know, wanting your legacy to be, and so that's how you're intentionally showing up in the world. And so I just wanna thank you so, so very much for being here. We're really grateful to have you.
[00:31:10] Charu Roy: Thank you, and thank you so much for your intelligent questions and insightful questions that go above and beyond just you know, a company and it's gold. It's there, there's something so human about your questions-- and I love when I'm like, "Oh my goodness, this is so, so interesting to see in this day and age, somebody taking the time to ask such questions" and I really appreciate you for that.
[00:31:36] Lindsey Dinneen: Oh, thank you. Well, I really appreciate that feedback too, because it's, you know, you come up with an idea-- speaking of sometimes echo chambers, you come up with an idea and you think, "Oh, this is how I'd like to go about this, but does it resonate with somebody else?" So that's delightful to hear.
[00:31:51] Charu Roy: Fantastic, thank you, thank you for having me.
[00:31:54] Lindsey Dinneen: And we're so honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thank you for choosing that organization to support Thank you so much, and gosh, I just wish you the most continued success as you work to change lives for a better world. And to all of our listeners for tuning in, I wanna thank you for being here as well. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time.
[00:32:31] Charu Roy: Thank you.
[00:32:32] 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.

Garrett Schumacher is Business Unit Director of Product Security at Velentium Medical and the co-founder and CTO of GeneInfoSec. Garrett discusses his journey from medical student to cybersecurity expert and educator, dedicating his career to securing medical devices. He shares insights on the intersection of cybersecurity and healthcare, highlighting the challenges of protecting genetic data. Garrett gives honest advice about navigating cybersecurity and data privacy concerns, how to be a good leader, and what medtech startups should consider as they design and develop their devices. 
 
Guest links: https://velentiummedical.com/ | https://www.geneinfosec.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 068 - Garrett Schumacher
[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 am excited to introduce you to my guest, Garrett Schumacher. Garrett is the Business Unit Director of Product Security at Velentium Medical, where he has led the cybersecurity efforts on 200 plus medical device products and systems.
He is the co-founder and CTO of GeneInfoSec, a startup focused on securing the world's most valuable and private data, our genetic information. In his work, Garrett has trained engineers, developers, manufacturers, healthcare delivery organizations, and laboratories across the globe in cybersecurity, and is an active member of several related industry working groups.
He also teaches secure product development and medical device cybersecurity at the graduate level for the University of Colorado Boulder's Department of Computer Science as an adjunct professor in the little bit of time left in his days, Garrett is either rock climbing or spending time with family.
Thank you so much for being here, Garrett. I'm so excited to speak with you today.
[00:01:48] Garrett Schumacher: Yeah. Thank you for having me.
[00:01:49] Lindsey Dinneen: Of course. Well, I'd love, if you wouldn't mind, by starting out and sharing a little bit about yourself and your background and what led you to medtech.
[00:01:59] Garrett Schumacher: Yeah. So I guess my background, I mean, it started as I always thought I was gonna be a doctor. I did my undergrad in physiology, thought I was gonna do med school, the whole nine yards. And towards the end of my, let's say junior year, just started being like, "I don't think this is what I want to do."
I always had a fascination with tech. I was really involved with a lot of the tech groups on campus at the University of Colorado Boulder, early days of Hack CU, one of the largest collegiate hackathons. And I really regretted not doing a computer science degree, but I was three quarters of the way done. So sometimes you just gotta finish it up, right? Get the degree, find out what's next.
After that I went and did a master's in genetics. I wasn't sure exactly what I wanted to do either yet, but hey, a master's degree is not a bad thing to do if you're unsure. And actually I was in a PhD program and dropped out early with a master's. Different story. But yeah. And then I started I helped the University of Colorado Boulder start their cybersecurity programs. So it was getting into the cyber world. I did a, I guess it was a bootcamp, at the University of Denver in cybersecurity. And so that all culminated in me always focusing on healthcare and cybersecurity together.
And then COVID happened and that made the world change for a lot of people. And basically I was looking for a new job and I found Velentium, and I think that's where it really spoke to me, where I could do my love of medical and human health with cybersecurity and technology development. And so yeah, I think that's really how I got into it. I had been doing projects related to that before, but Velentium's where it really culminated and I found a place that let me do all the things I love, not just one or the other.
[00:03:39] Lindsey Dinneen: That's awesome and such a wonderful gift. So can you share a little bit about what you do now and sort of your growth trajectory even throughout Velentium 'cause I know you've had quite an interesting and exciting career through the company as well.
[00:03:56] Garrett Schumacher: Yeah. Yeah. So I started out as a cybersecurity engineer, and just started helping internal projects, external projects with groups that were seeking FDA approval on a medical device and trying to navigate these kind of new cybersecurity requirements. That's where it started. And even since then I've been, so I teach a class at the University of Colorado Boulder on Medical Device Cybersecurity. We're going into our sixth year of that, seventh semester, starting here in the fall. And I also co-founded a startup in the genetic information security space.
So, and we can talk about that later. And so I, yeah, talk about what I do. It's all of those things and, it's not, doesn't happen in 40 hours, I promise you that. But after working as a cyber engineer for about a year, I think I got promoted to like Senior Staff Cybersecurity Engineer. Then probably three years ago, I took over more of an operational leadership role within the unit, the team, where I was doing project management and overseeing the other engineers and still doing engineering work. Definitely decided project management is not for the faint of heart and apparently my heart's very faint. It's not for me.
So anyways, and then fast forward to just here in like January, February, Velentium made some really awesome changes. They rebranded as Velentium Medical to make sure everyone knew we do medical. And then they created four business units so that they could really say, "Look, we have different core areas of our business. Each of them have their own different operational needs and what have you." So, I was promoted into Business Unit Director of Product Security.
And so now we're a business unit. We're a business within a business trying to better serve our clients and implement the processes we need for our small scope of work compared to a large contract development and manufacturing organization. So just that's been my growth goal so far is, come in as an engineer, work my way up to the leadership roles while also still loving to be an educator and and still having my own startup space in the biotech side of the house.
[00:05:58] Lindsey Dinneen: Yeah. Excellent. Well, first of all, congratulations on all of that. That is very exciting and it's really fun to see that growth and that development. And I'm also so curious now, can we talk a little bit about your startup? So first of all, let's talk about that and then I wanna talk about the crossover between the two, if that's okay. So.
[00:06:16] Garrett Schumacher: Absolutely. Yeah. So, well the name is GeneInfoSec, so it's just short for genetic information security. We're not trying to hide anything there. We focus on protecting the world's most sensitive data. At least that's our opinion is genetic information affects you. And the data you have today is not gonna be any different, for the most part, from the data that you have in, 10, 20, 40 years.
But then even beyond that it's partially your children's data, your grandchildren, great-grandchildren, and then even on the, in the inverse, all the way up to your great-great-grandparents, right? You share some, to an extent, some genetic makeup with them. And so it's this really interesting space where networked privacy is-- it's a very different form of networked privacy. It's not just that I upload a photo to LinkedIn and now I could be implicating someone else that's in the photo. It's, I share my info, and I'm also sharing info that belongs to my cousins in, in, in a sense.
And so if you think of the Golden State Killer case in California, that was a really interesting one where the federal authorities had genetic information or samples from a cold case in the eighties. And they sequenced that. They uploaded it to a third party, an open public genetic database, and said, "Hey, here's my data. Who am I related to?" And through that they were able to triangulate like, "Okay here it is. This is the guy that did it" many years later. So, there's a case where it's, there could be positives. We want to use it to find that kind of information and protect people.
But at the same time, that brings up a lot of privacy implications. And then you can go all the way to the extreme, the sci-fi of designer bio weapons, maybe tailored to certain persons or ethnicities or groups of people. So during grad school, a couple guys and I, we founded this startup, and that's what we focus on through a technology that really our founder, Dr. Sterling Sawaya, he invented, called molecular encryption. It's a way of encrypting molecules before we generate data from them so that the generated genetic data is already, quote unquote encrypted, or at least protected in some manner. So, so that's what we do. And yeah, I guess why we do it a bit.
[00:08:27] Lindsey Dinneen: Yeah. Wow. So, okay, so that brings up a really interesting question. I can guess the answer to this, but is there any safe way to-- this is a funny way to put it-- but recreationally to test your genetic data in the sense of the way that a lot of us would think about it in terms of, "Oh, I'd really love to learn more about my ancestors and things like that." But there are so many security concerns, like you've pointed out. So is there any quote unquote, safe way to do so at this time?
[00:08:58] Garrett Schumacher: You know that-- it's a great question. There's been a lot of things going on in the news recently, like with, I'm sure people have heard of 23 & Me, and how they went bankrupt and now a company called Regeneron is buying them and all their assets for a lot of money, but not that much compared to what 23 & Me was worth a few years ago. So that brings up a lot of issues, right? 23 & Me still owns a lot of samples, like maybe around 10 million samples. And the sequencing they've been doing is very small.
So if your genome's a whole book, they've been kind of flipping through the pages and picking specific letters, and that's the data they have. So that's not the most sensitive, it's not the full story. But if you have the samples, you can always generate the full book someday. And as that cost of full human genome sequencing decreases rapidly, someone's probably gonna want to do that someday.
So, okay, so back to your question though, is there a safe way? What I would say is that I, I don't tell people not to do it. I would say if you have health reasons, concerns, and your doctor suggests a genetic test, a lot of those tests are also that similar, picking a few letters, a few known letters and trying to just read that for a very specific purpose. If your doctor and you come to the agreement that you should do that, you should just do that.
However, I do not promote, and even to my family members, I highly don't recommend, using these services. I used to really love who's that group out of Utah? Ancestry.com. They used to be a great group. They were trying to sequence the world's DNA for understanding basically the family tree of everyone. Because anyways, they have interest in understanding who's related to who and how that relates to their religion. So they used to do it for internal purposes, keep it on pretty tight, secure. Well then, they sold to a venture capital group.
So, it's really tough to say that there's these groups that there's a good place out there to do it. There are some companies that have security or privacy focused DNA sequencing services. But it's really odd, like you have to set up a cryptocurrency account, pay with cryptocurrency, set up a PO box so that you're not like actually shipping to and from your home. And then ultimately the price of it and how they're getting it to be cost effective is China's doing the sequencing. So you do all those privacy measures and your sample gets sent off to another country. And the FBI has disclosed that they know that when certain countries like that are doing the sequencing, whether you want them to do a little tiny test, like a COVID test or whatever it is, they're sequencing the whole thing. They're keeping the data. This is known, disclosed, not conjecture.
So, yeah, so sorry-- long-winded answer of saying, I'm interested too, I wanna learn about this. I've got family members that have done it. But right now I recommend just thinking very carefully and critically about whether the immediate fun of it is worth the potential long-term impacts, and maybe if you're someone that's security or privacy conscious, maybe wait a few years because there are some things on the horizon that will make this a lot better.
[00:12:02] Lindsey Dinneen: All right! Thank you for the honest answer. I really appreciate it. So, okay, I wanna go back to your work with Velentium specifically and talk about-- you've gotten to work with so many different clients over the years and you've seen so many different variations on a theme. And I'm curious, what are some of the common mistakes or pitfalls you might see a younger startup make when they are perhaps first designing their device, and cybersecurity is maybe not quite top of mind. So what are some of the things that you see that are challenges we can overcome?
[00:12:41] Garrett Schumacher: Yeah I think one of the biggest challenges is that a lot of people aren't maybe aware yet of the scrutiny and the requirements that the FDA-- and not just FDA, but the European union's medical device regulations and the bodies over there that review submissions. And any, if you look across the board, pretty much almost every regulatory market has, very much in the last couple years, placed a lot of scrutiny on cybersecurity. So a lot of companies, especially smaller ones starting out in the space, may not be aware of this. And so then oftentimes they'll find out too late, they'll submit. They'll get feedback back, "Oh no, we have 90 days to respond and we didn't do cyber. We gotta do cyber now."
And they don't know how to spell it yet, which is a joke. But there's that. And then there's also, or they'll get in just late at the game, "Hey, we're submitting in a month or three" and "Oh, we gotta do this thing retroactively." And so then therefore, we haven't been able to support someone through the full process, at the proper time, doing the right design things to inform the design during the design, not after. So I think that's probably the biggest mistake is not seeking that external support early and often. And if you're getting that, it shouldn't just be someone that can help you navigate the regulatory space. It shouldn't be someone that can just do the pen testing for you at the end. Really I think in that context, you need a partner that can do everything end to end.
So that's what we've really tried to make our processes and our services geared towards is being that partner. And whether you have the bandwidth and you will do a lot of the documentation and work, but you just need someone to guide you, consult you, give you the materials to do so, or if you are truly looking for, no, we need to augment our own team and have you do a lot more of the work for us. That's great. We can do that. So, so that's, I think, the biggest challenge. And I think that the answer is just getting the right partner early and working with them often throughout that entire development, not at the end.
[00:14:37] Lindsey Dinneen: Yeah, absolutely. And I really appreciate that perspective. I think that there's a lot more awareness, it seems like even in the industry that, "Oh, cybersecurity is a thing now." But as you said, getting to partner with somebody who does know the ins and outs from the start and can really help guide you through is really critical. Now you do quite a bit of speaking and presenting. You're obviously still teaching a college class and all of those wonderful things. I'm curious how that has played into your career as well, and is that something that you will always want to do? You've got this educator side of you as well.
[00:15:13] Garrett Schumacher: Yeah, I mean, I love it. I actually taught at a high school for one year between my master's program and my undergraduate, decided that that's not for me, but that teaching at those higher levels where people are really wanting to be in the room. So now I teach at the graduate level, half of the students will be older than me. And now everybody wants to be there and we can have very mature conversations and they even can challenge me with some really great questions that I'm not ready for, right? And I think the best way to learn is to teach. Absolutely. That's, yeah. I think a lot of people have said that. I completely agree. So I plan to always do that.
I mean, I love, even with our internal engineers and external clients, like the idea of helping people understand something and humanizing it for 'em. That's really my big flag I'm waving right now is humanizing it. We don't have to use alphabet soups and crazy language. We can make it easy to understand and we can humanize it for the masses. So that's really what I'm trying to do, one of my big pushes. And so I don't foresee myself ever going away from that, I even do a lot of international training on the cyber biosecurity space where I go to all these countries and these biosafety laboratories and help biologists understand cybersecurity as a fundamental practice and how they can improve their personal security, their professional security. And to me that's the most rewarding thing.
[00:16:36] Lindsey Dinneen: Yeah. Oh my goodness. That's so cool. Thank you for sharing about that. So, as you are looking towards the future in the industry itself, but also I suppose your own career, what are some things that you're excited about? What are some trends that you see as being positive? I know that, recently, it's been a little bit challenging-- as a nice word-- for a lot of medical device companies and they're a little worried about funding and those kinds of things, and so, that's maybe a trend that's a little not as fun, but what are the things that are empowering and exciting to you as we move forward?
[00:17:13] Garrett Schumacher: So not to make it about artificial intelligence or machine learning, 'cause everybody does. It's definitely, its hype curve. But that is actually one of the things that I think I'm most excited about, but also most scared about. We've seen a lot of companies with layoffs because they believe this artificial intelligence enables them to be more efficient and therefore they can do more with fewer people. And that saves money. And I understand that. I think that one of my big pushes right now is trying to help people understand that AI, at least right now, it's not taking over human jobs-- that it can instead augment, improve how we do those jobs. But people have to be ready for it.
So even in, in my own space, like, making sure that our team and our people are ready for that. Because if you aren't getting into that space, if you aren't with the curve, then you're gonna fall behind. And yes, you could be replaced in that sense that someone has done it and so now they're doing it better than you. And so if you're not using these tools, these resources to, to improve your efficiency and to just maximize your capability-- like for example, my team, maybe I don't need to hire a person. Maybe we can build out things that enable us to, with the same amount of people, to better serve more clientele.
So that's what I'm really trying to navigate. But it is scary thinking about that future and am I even gonna be ready and technically savvy enough to navigate that new future in the next year, in the next five, 10 years. And especially as someone who I've always had this, this goal of maybe someday, and I'm getting talked out of it very quickly, but maybe like being a Chief Information Security Officer at a large company or a Chief Product Security Officer, something like that. And yeah, quickly, I'm-- "Eh, we'll see." But it's those kind of things that, if we can navigate them correctly, may maybe that is something in my future. So that's, I think, one of my big fears and also passion projects right now.
And then also, same on that funding vein-- with my startup, we're experiencing that as well. And we actually, we had a lot of funding potential pre COVID. And then even though our technology-- like in some ways COVID brought the need for our technology to the forefront of people's minds-- it also killed a lot of funding opportunity. And so yeah, I mean, navigating that space of how do you get funding and then does it come from venture capital backed or equity, private equity, and I've seen those worlds. I even advise startups. So I mean, that is also probably one of the biggest challenges I'm facing currently as well.
[00:19:41] Lindsey Dinneen: Yeah. Yeah. It's gonna be really interesting to see how things evolve, and it's been fascinating to read the news and see even the headlines where it's like, the FDA is using AI to review submissions and all sorts of things, and you really do wonder how we'll move forward and time will tell, I suppose.
[00:20:01] Garrett Schumacher: Yeah.
[00:20:02] Lindsey Dinneen: So you have stepped into quite a number of leadership roles fairly young in your career, if you don't mind me just saying so, and so I'm curious how you have navigated that growth for yourself. First of all, do you feel like you were a natural leader or were those skills things you developed along the way? And secondly, what advice might you have for younger leaders?
[00:20:27] Garrett Schumacher: Great questions. Yeah, definitely nothing is natural about it. I think for anyone, I mean, it's nothing that you just do and you're just like, "Yep, I'm a leader. That's easy." So it definitely something, just like all aspects of work and maturity, is you have to work on it. But I think how I got there was-- and someone told me a couple tips early in my career, I suppose-- and it was a couple are: find a mentor, and as the mentee you have to put in the effort. If you set up meetings and they're not there, whatever, like they're busy, and you are asking them to give their time for you. So, find mentors and then be a good mentee, meet up with them.
I had several people that were critical in my early career. One was Bunky Davis and she was amazing. She was no longer with us, but her and I grabbed coffee every single month. She had navigated biotech startups for like 50 years, was also just a phenomenal cyclist, Olympian, like just amazing. And we'd meet up every month for coffee without missing. And we did that for several years. And, and I had another mentor from the University of Colorado Boulder, Lloyd Thrall, who came from the Department of Defense, and just a spectacular, stellar guy, and we would go meet up all the time.
And so learning from these people I think I saw-- well, there's that. And then everybody has their bosses and their horror stories from work, whether that's a high school job or professional later on. And so you see the ways that people can be, you don't want to be. And so that, that makes it easy. But without having those mentors, yeah, I don't know if I would've exposed myself to the good ways, right, and the better ways, and be challenged. So that was really critical was finding a good mentor and then being a good mentee.
And then I think the other thing is interacting with people and just listening, active listening. So going to the professional shows and meeting people, listening to them, reading a lot of great books out there on how to be a leader, and you don't take all that exactly word for word, but there are golden little nuggets that you can just pick up out of all those things. So, no, definitely something that I have actively worked on and still am trying to work on. And then I'm constantly trying to listen and being that, have that open door policy for my people too. Because if I hire really smart people, I want them to do the thinking and therefore I need to listen.
[00:22:44] Lindsey Dinneen: There you go. I love it. All right, so. You've had a really interesting and exciting career so far, and you're obviously very passionate about medtech and cybersecurity and biotech and all those things, and I'm wondering if along the way there are any moments that really stand out to you as affirming, "Wow, I am in the right place at the right time."
[00:23:09] Garrett Schumacher: Yeah. Yeah. One was we had a really special project where and I won't give any names away, but basically my stepmother has an implant inside of her and it's it's not life sustaining, but it's one that you want working just so that your body's working normally, and so that you're not, not embarrassed. You can go into public spaces and be a normal person, right? And whether it's pain management, incontinence, those kind of things. So she had this implant and it was, she had one that came from the leading provider of that at the time. And it, the battery life, right, is supposed to last like 10 or 15 years, and it seemed like pretty much seven or eight was all she was getting out of it. And after decades of having far more surgeries than she needed, all the way up to the very last device she got in her-- it failed within the first year, I think-- so it was like, okay, time to pivot.
And we found this new company and they've become a huge leader in the space, recently acquired by another one of the big leaders in medtech in general. And we were hired to do the security work for that project. And the only reason that I actually found out-- because my stepmother was literally like in the process of getting this new device inside of her-- I was at that client's facility doing a pen testing and security testing engagement and some consulting and just visiting them. And I FaceTimed my family in the break room and there was a sign behind me and they're like, "Oh my gosh. We're literally, we just got that implanted in your stepmother like, a couple weeks ago. It's working great. She's so happy with it. It's smaller, it works better, all these things."
And it's like, "Wow." So I got to lead the security effort and what they're actually doing is adding remote programming capabilities so a doctor can, over the phone, be improving that therapy for you. But that leads to a lot of cybersecurity implications, right? That kind of connectivity. And so I gotta lead the security work on that for something that is in a near and dear, your family member. And it's those kind of things where it's not, you're not just helping patients. It's, I'm helping someone that I care very deeply about. And it hits home differently when it's not just, "Oh, I want this device to be secure. I want them to get FDA clearance. I want whatever." It's, "No, I need now, I need for my own family member for it to be the best." And it's not that project got special scrutiny from us-- we bring that to every project-- but it helps to have the actual experience of one of those projects.
[00:25:33] Lindsey Dinneen: Yeah. And to have that real-- well, you were mentioning it-- not just patients that I kept thinking, "Yeah. Not just patients, people," and the idea of it's sometimes probably necessary honestly, to have a little bit of separation from a clinical point of, "I'm helping all of these patients, and that's a really good thing." But then if you could take a step back and go, "And these patients are human beings that rely on what I'm doing for safety and for security and for this lifesaving, life enhancing device." That's-- what a gift to get to experience something like that.
[00:26:04] Garrett Schumacher: It is, it's especially like, if you work in the diabetes-- we've had several projects with insulin pumps-- and insulin's a drug that is, highly toxic if given in the wrong dosage. 99% of the world population would die if it's in the wrong dosage if it's too high. And the only reason the other 1% exist is 'cause they're insulin intolerant. They just, they don't respond to insulin and that's why they have their own type of diabetic issues. And I've got several cousins, a brother-in-law, that also use that stuff every day, rely on those kind of technologies. So, yeah, just it's a little bit more special when it's when you get to do that. But we try to do that for everyone. We try to think of everyone's that person that we're trying to help.
[00:26:42] Lindsey Dinneen: Yeah, absolutely. All right. Well, this has been so great, but 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. What would you choose to teach and why?
[00:26:59] Garrett Schumacher: Ooh. Well, yeah, first of all, a million dollars for-- I feel like I, I'd have to go with something like that I know deeply, very deeply on. But okay, if I wanna have some fun here, I would say rock climbing, because rock climbing is my other big passion. It's the one thing that takes me away from a computer screen typically. And so if you're paying me a million dollars to teach rock climbing, A, these people really wanna learn how to be good rock climbers, so they're gonna be very engaged. And B, that's going to mean that I can go now actually make money on something that has only ever been a passion for me. So, that would be fun. That would be awesome.
[00:27:33] Lindsey Dinneen: Awesome.
[00:27:33] Garrett Schumacher: If you're offering, Lindsey, I'll accept.
[00:27:35] Lindsey Dinneen: Okay, deal, right? Yeah. I'm gonna have to earn my first million first, and then I'll let you know.
[00:27:40] Garrett Schumacher: I'll wait.
[00:27:41] Lindsey Dinneen: Okay, fair? Fair enough. What got you into rock climbing?
[00:27:45] Garrett Schumacher: Oh man. Well, so my mother was, I grew up in like a small farming town in the northeast corner of Colorado. There's not a mountain for, until you get to Denver area, right? In the summers, she worked at the local college, and in the summers she ran the ropes course and they had a giant rock wall. So, I mean, as a 10-year-old, I'm just hanging out there. I didn't know that there was routes or certain ways or techniques. I just, who can get up the fastest, right? But that was always fun. That was my summers. I always, and I was, shoot, I was always told I was a monkey. I was always on stuff climbing something. I've had my share of injuries from it, trust me.
And then in college, it just was natural. I went to CU Boulder, as I've probably already said, and a lot of outdoor climbing opportunities. A lot of, they, they built a new gym there inside the school. And so that then it became this thing where, oh, I can actually-- as you move away from high school sports, basketball and American football and those things, you miss that. You can miss some competitiveness and some team-based things. So now I had another active thing that I could-- and I, again, I wasn't so formal in technique or things like that-- so now I could work with people, socialize and work on that technique in something that I was able to do at that level, instead of, I'm not gonna go beat myself up playing football again.
So, yeah, I think that's where it came from. And then it's just been my big hobby ever since. And I mean, now I have a bunch of friends down in Austin, Texas, and we go on a big climbing trip once a year, and I see them once a year. It's fun. So it's like expanded my friend group and it keeps me sane.
[00:29:14] Lindsey Dinneen: Huh. Excellent. Yes. That's wonderful. All right. How do you wish to be remembered after you leave this world?
[00:29:22] Garrett Schumacher: Oh, that's a good one. How do you humbly answer that? When part of the answer I would wanna say is humble, but that's something I always try to work on, is I just wanna be a good guy. I want people to remember that, he was kind, considerate-- would do something at the drop of a hat for you without expecting anything in return-- just kind, generous. And I think a family guy would be a big one. My, my friends and family first and foremost. And maybe second to that, hardworking. Yeah.
[00:29:46] Lindsey Dinneen: Yeah. I love that. All right. And final question. What is one thing that makes you smile every time you see or think about it?
[00:29:55] Garrett Schumacher: Oh, my wife. I wake up to her every day and that's she's the best part about everything. So yeah, she's my favorite person, and I'm lucky enough to, when I'm not traveling, wake up next to her and see her at night, and that's the best part.
[00:30:08] Lindsey Dinneen: Yeah, absolutely. What a wonderful thing. Well, this has been a fantastic conversation, Garrett. I'm so thankful for your time today. Thank you for sharing some of your stories, some of your advice. And I just honestly wish you the most continued success as you work to change lives for a better world.
[00:30:26] Garrett Schumacher: Thank you. Thank you, Lindsey, for having me. This was my first podcast ever. So it went great. Yeah, it was fine.
[00:30:32] Lindsey Dinneen: Awesome. You rocked it. Good job. That's wonderful. All right, well, celebrating that and celebrating all your future successes to come. 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 thank you so much for being here and thank you for doing what you do.
[00:31:05] Garrett Schumacher: Thank you.
[00:31:07] Lindsey Dinneen: Excellent, and thank you also to our listeners for tuning in, and if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time.
[00:31:19] 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.

Sarah Ptach, President and CEO of Canyon Labs, discusses her journey from professional sports and advertising to leading Canyon Labs, a company specializing in medical device and pharmaceutical testing. Inspired by her father's Parkinson's diagnosis, Sarah transitioned to healthcare to make a meaningful impact. She delves into her leadership philosophy, emphasizing the importance of trust, transparency, and collaboration in building a strong company culture. Sarah also highlights Canyon Labs' dedication to elevating industry standards and ensuring patient safety. 
 
Guest links: https://canyonlabs.com/ | https://www.linkedin.com/in/sarahptach/ 
Charity supported: The Michael J. Fox Foundation for Parkinson's Research
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 067: Sarah Ptach
[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 to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am super excited to introduce you to my guest, Sarah Ptach. Sarah is the President and CEO of Canyon Labs, a leading provider of medical device and pharmaceutical testing, consulting, and sterilization services. She joined the company during a critical ownership transition with a clear goal in mind: to raise the standard of service in the industry and build a true end-to-end solutions partner. Drawing on her background in packaging engineering and testing, Sarah focused on expanding beyond packaging alone to create a more integrated, accessible, and expert driven experience for clients.
Sarah began her career in professional sports and advertising, but a desire to create more meaningful impact led her to the healthcare space after her father was diagnosed with Parkinson's disease. She went on to help grow and successfully exit a packaging firm before bringing her vision and leadership to Canyon Labs. In addition to her role at Canyon, she co-leads Kilmer Innovations and serves on the board of the Medical Device Packaging Technical Committee of the Institute of Packaging Professionals. She remains deeply committed to advancing healthcare through innovation, expertise, and strong partnerships.
All right. Well, thank you so much for being here, Sarah. I'm so excited to welcome you to the show.
[00:02:05] Sarah Ptach: Likewise. Thank you, Lindsey. I appreciate you having me.
[00:02:08] Lindsey Dinneen: Of course. Well, I'd love if you would start off by telling us just a little bit about yourself, your background, and what led you to MedTech.
[00:02:16] Sarah Ptach: Yeah. Thank you. So I'm Sarah Ptach. I'm the president of Canyon Labs. I have kind of an interesting story of getting into to medtech. I originally started my career actually in professional baseball. I was a contract negotiation person mainly for closing pitchers. And I ran track in college. I thought like, "oh, I wanna be in sports." And I like to say that's the most fun I never wanna have again. It was, it was a great start of a career. It teaches you a lot about negotiation, teaches you a lot about high stakes opportunities. But, you know, in the end it, it felt very kind of un unfulfilling in that perspective.
And so I had kind of then taken that into to marketing for a pretty big ad agency in Chicago and hit the same thing. I felt like I was-- you know, now I was just selling people stuff that they didn't need instead of promoting people that, you know, that make a ton of money in the sports industry. And at the time my dad was diagnosed with Parkinson's disease and I wanted to feel like I was making a difference.
So I, I went back and got my MBA and my whole goal of that was really to, to use my skills to, to do something that makes a difference in people's lives. So, I had reached out to a really small medical device company and it's " I'm willing to make no money as long as we, we have a difference in a change we can make in the world." And at the time that company couldn't hire me but I ended up getting introduced to another company through that that was in medical device packaging validation. And that was the first dip of medical device that I had.
And that company's Packaging Compliance Labs. I was one of the first employees there and we grew that company until it sold a couple years ago. And through that, learned a ton about the medical device space. I kind of made it my personal mission beyond just my job to, to go try to participate in the industry as much as possible, push the status quo of things as much as possible, and really kind of learn where the testing realm or validation realm can make a difference in, in medical devices.
And so after that, I was given the opportunity to step in and run and grow Canyon Labs. And Canyon is a whole platform. So for me, it was taking the packaging knowledge that, that I love so much and making that a full service offering. You know, I had always dabbled in sterilization or heard about Biocom, but never really gotten my hands on it. And to be able to be that full service solution with Canyon has not only been a awesome offering to, to give to our clients to really be able to go A to Z, everything from your regulatory to your microbiology, chemistry, packaging, bio comp, and toxicology. But also a good learning challenge for me.
I thought that I was, you know, a pretty good packaging engineer and now learning chemistry and microbiology and toxicology, I'm like, "oh, wow. I'm definitely not as smart as I maybe thought I was originally," and I luckily have some amazingly intelligent individuals that, that work on our team, but it's, it's an awesome opportunity to, to not only get to help bring some life-changing medical solutions to market but also have a really good technical brain challenge every single day.
[00:05:26] Lindsey Dinneen: Wow. Oh my goodness. I love that. And yes, I mean, sometimes I feel like actually, you know, not being the smartest person in the room is such a gift because then you get to talk to all these really cool people with really amazing experiences and learn. And I'm just one of those people who's constantly-- well, I'm curious all the time, so if I don't understand something, I'm like, "can you tell me more?"
[00:05:48] Sarah Ptach: Yeah. No I love that. I completely agree. I think that the better that you can be at facilitating conversations, the, you know, the more successful your organization will be. And it, I really think as the leader of a company it's less about being the, you know, smartest person in the room and more about being the facilitator of that collaboration.
[00:06:10] Lindsey Dinneen: Yeah. Yeah, absolutely. I love that. So, okay, so going back in time a little bit-- so, so I know you started off with professional sports, which is really cool. Like what a, what an interesting, unique opportunity and experience and you know, you'll maybe never want that particular brand of fun again, but. I still love that you got to do it. And so I'm curious though, was that always the sort of planning goal for you? Or when you were trying to think about career paths and all of that, younger, what were you envisioning?
[00:06:39] Sarah Ptach: Yeah. I think I, I always envisioned myself as a leader. The packaging side of things became my kind of technical passion. But I mean, from a young age, I've always been the captain of the track team or the, you know, the head of any school organization I was a part of. So I always knew I, I wanted to be a leader. I think now, you know, being in that role, you, you learn so much about what different styles and brands of leadership is. I think, you know, to go back to your question about being the smartest in the room, I actually think that, you know, the CEO's job isn't to have all the answers. It's to create the culture where the answers emerge. And, you know, I've always wanted to be a leader. I've been passionate on that side, but I really think that the more, you know, more so than just having leadership pieces to you. It's about having that power to bring people together in that way.
[00:07:31] Lindsey Dinneen: Yeah. That's a beautiful way to put it. And I actually would love to dive into this more because I know creating a really positive, good company culture is really important to you, and it's frankly, easy to get wrong, unintentionally-- sometimes maybe it just is what it is, but like sometimes it's not a desire to create it, but it happens. So I'm curious, how have you really intentionally cultivated your current company culture, and where did those lessons come from?
[00:08:00] Sarah Ptach: Yeah. Deep question. You could answer that in a bunch of different ways and I could talk your ear off about lessons learned on that side. But I, I think the, you know, the most overlooked competitive advantage, both internally and externally is trust. Like the trust in your team to make decisions, the trust in your clients and even the FDA and your labs work. There's trust across it all. I think internally, from culture standpoint, it's have that trust in people and build, you know, people in a way that, that helps them feel most confident to, to make the decisions that they need to succeed.
You know, when we first started talking you, you asked if I have any kind of lesson learned stories and some, I dunno, harsh realities per se. I think one of the more difficult kind of lessons that, that I learned in the course of just being a leader, is knowing when you have a passion for someone and what passions they might have. And I stayed that in the standpoint that I'm a huge believer in people. I want them to be like the greatest version of themselves, and I want them to dream big and go big and, you know, sometimes that's not always what people want for themselves too. And it's, it's a tough reality somewhat to to come to at times.
But, you know, really finding what is the growth that people truly want. What is the environment that they want to live in, and how do you help foster something that, that meets the plethora of those ideals that you'll have across an organization is really important. But I think the, the culture I've worked really hard to foster at Canyon and frankly, my, my team fosters alongside me every day. This is by no means just a Sarah show on that piece. But it's a culture of trust, like I said, and it's a culture of transparency.
I always like to tell my team, "you know, when I ask questions or probe I'm not trying to get an answer or I'm not trying to, you know, question your way of thinking. I'm trying to understand so that I can be at the same table that you're at and we're not, you know, talking oranges and apples and not realizing it." And so I really try to make sure we foster an environment where there's collaboration, there's trust to have that collaboration. There's trust to have challenges made of each other without it being an inflection of, you know, disliking someone. And then creating that opportunity to ask questions and always stay inquisitive in a way that's meant to greater raise everyone up together.
[00:10:28] Lindsey Dinneen: Yeah, that's a wonderful culture that you're cultivating and I love that. But I think you hit on something really key amongst all of the really great points you made, but one of them that really stood out to me was, you talked about how it's not just the Sarah show in this way. It's a whole group effort. And I think that is a critical component that sometimes is forgotten. Like we sometimes think, you know, it's the leader's sort of job or role or just is. It is their leadership. That sort of filters down into the rest of the company and we think it's like a top down way of doing culture, but culture is about absolutely everybody involved in the company. So I'm curious, how do you empower your team members or, and, or when a new team member comes in, how do you communicate, "Hey, this is who we are, these are our values," and make sure that it is a good cultural fit too.
[00:11:23] Sarah Ptach: Yeah. You know, we really at Canyon do a lot of things that are just small to, to reinforce and drive culture. We have these bracelets that you can earn, and what they mean is they're all of our company values and you can honor a fellow coworker for, for going above and beyond, or embodying teamwork or really showing integrity. And they get that read out in front of their whole department, and then they get a bracelet to wear proudly. So we do little things to to enhance our culture.
And then there's the more macro level pieces, and I think having a baseline understanding of why we all show up to work every single day. You know, it really is to empower life changing medical innovation, and it's to ensure that all the products on the market are not gonna hurt somebody and they are going to, you know, do what they're meant to do in a positive way. You know, if we can all show up with the basis of "everything I do every day is for patient safety," then I think the getting on board with the culture is a lot easier if we all have that base, like regardless of how your day goes, regardless of your email inbox going crazy, we all agree that, you know, patient safety is what we're here to do. And you know, how we can have fun along the way, support each other, do teamwork is just gravy on top of that. So I'd say it's starting with culture that gets that base level item. And once you get that, everything else is just working better together.
[00:12:48] Lindsey Dinneen: Yeah. Yes. And honestly, that's a great segue to my next question, but I was really-- I think you, again, honed in on something really critical and having everybody around a shared mission is so cool because that passion and that excitement and that " we're all in this together" and when disagreements or issues come up, which --we're human, they do-- then you can always go back to that shared mission and values of the work we're doing matters. We are all on the same side to provide value to our clients to ensure safety for our patients. So, I think that's a really key thing that you touched on there. Yeah.
[00:13:33] Sarah Ptach: Don't get me wrong. I mean, it's a difficult thing to, you know, to keep going on teams. We, Canyon, we did two acquisitions this year. And with that comes a lot of combining cultures, changing culture together, all getting on the same page. And it's not easy, bumps along the road, you know, I think showing that we're all on the same page and working and rowing in the same direction is a conversation I have every single week. And so it's something you can keep reinforcing. And I think it's stacking bricks. You don't just have a house, you gotta continually stack bricks on it. And everyone needs to be involved in saying, "yeah, I wanna be a part of this team and I wanna be a part of this shared mission." And it doesn't build itself overnight.
[00:14:19] Lindsey Dinneen: Yeah, absolutely. So speaking and then mentioning back to that segue, 'cause I just didn't ask the question, but can you share more about Canyon Labs and the incredible work that your company is doing for this industry?
[00:14:34] Sarah Ptach: Yeah. Yeah. So like I said we're a full service contract testing and consulting firm within the medical device and pharmaceutical space. You know, a lot of the work we're doing is to help a lot of medical devices and drugs in their validation stage. So, you know, we're working through anything from, you know, designing your package to helping your sterilization strategy. You know, sterilization has been something I talked to, I've spoken on a lot this year. You know, it's a hot topic item in the industry. It's something that a lot of people are dealing with 'cause it has EPA implications as well as now tariffs affecting it as well as supply chain issues within it. So I'd say that's a division I talk to a lot and we help a lot of people navigate those.
But the underlying whole piece of Canyon is being that trusted lab partner and we're really trying to raise the standard of service in this industry. You know, I came into Canyon being on the other side of the table and sending samples off to get biocom tested or to go through their sterilization validation. And, you know, for me it was this baby I was sending off to be tested and I don't think I was always met with the best customer service or the best accessible expertise when I needed it. And so we, when we built Canyon, we really built it to, to change that. You know, I want our clients to feel like we're one phone call away for any question that they have. You know, we're not just gonna send them their samples back, say, "sorry, it failed. Let us know when you're ready to give us another PO." That, that transactional relationship is, it's a currency that I don't wanna participate in. And so we really saw it after changing that in the industry.
[00:16:16] Lindsey Dinneen: Yeah. Excellent. Well, yeah and I love the fact that you were on that flip side and it could bring such a valuable perspective to the company and go, "okay, here's some lessons learned." You know, and you're always gonna get a mix of it, right? You're gonna get like, "Ooh, I don't know if this is how it should be or needs to be," and you're gonna go, "oh, but here's something that they did excellently." So to bring that very valuable perspective is really cool.
[00:16:40] Sarah Ptach: Yeah it's been fun. It's you know, in Canyon's infancy a couple years ago, we had the opportunity to come together with a lot of people from different experiences on our leadership team, and so it's-- as long as we all have the baseline humility to say "the way I did it in the past is not necessarily correct," you know, we could all come together and say, "here's what I did, here's what I did, here's what I did. Okay, let's pick the best of all worlds." So it it was a cool opportunity to have a lot of people with a lot of past experience come to a table that was completely, even in that standpoint.
[00:17:18] Lindsey Dinneen: Yeah. Excellent. So I know that you are-- well, okay, so I took a look at your LinkedIn profile and had a wonderful time learning a little bit more about you, but I know you are involved so much. Like you are just, I don't know if you sleep because...
[00:17:35] Sarah Ptach: Sometimes.
[00:17:36] Lindsey Dinneen: Yeah. But the, I especially noticed, you know, you're a founding board member for thePACKout and you've done you're involved in a lot of different boards and groups and you're, it seems like you're just, you know, volunteering as kind of your heart and soul and serving in that way. And so I was wondering if you could speak a little bit about those opportunities that you're with too.
[00:17:55] Sarah Ptach: Yeah. I think, first and foremost, before any job or role or position I've ever held, I am baseline, a huge proponent of this industry. And, you know, going back to my original reason to be here, it was my dad having Parkinson's and Parkinson's doesn't have a lot of treatment at this point. And it was like, I hate that. So how do I participate in solving that? And I think being involved in the industry, the super cool part, especially about packaging, is there's so much room for improvement at this point. You know, a lot of the standards that we function off of, they are being improved on a yearly basis, but they weren't made that long ago.
So the, you know, the baseline ground zero is not that long ago. And I mean, there's people in the industry that are still in the industry that were there when they made ISO 11607. So it's, you know, it's, it's got a lot of room for improvement. I love how much the industry is trying to go back to patients now, and, you know, we're not just trying to design packages or devices that work well for, you know, me, the manufacturer, or me, the physician, but instead it, you know, really does consider patient comfort, patient safety.
So the, a lot of what you'll see of my involvement in the industry is related to patient facing parts of of standards. I'm part of the Kilmer Renovations and Packaging Group and specifically I lead the aseptic presentation group, which is meant to evaluate the way that healthcare technicians interact with packaging in a way to help reduce hospital acquired infections. You know, we used to only design packages as an engineer because it's the perfectly engineered package. And, you know, we didn't think about the nurse that's trying to open it and your perfectly engineered package is just way too hard for a nurse to open and the device goes flying across the room.
So it you know, we, we weren't considering those things. So our group is trying to correlate opening methods with types of packages and designs of packages. And we're trying to prove that with the different opening techniques that they teach in school for your surgical techs, your nurses, what is the best way for these different packages so that we can make that training and that design fit in the best way possible for positive patient outcomes.
So, it's, a lot of my industry involvement is passion based, but I'd also say that a lot of the industry problems they, they can't be solved by just one company and they can't be solved in a silo. So, you know, the only opportunity you get to get all these stakeholders at the same table are these industry groups. And it's unique, I think, to the medical device industry in general that a lot of us care beyond our day jobs. You know, it's like, "cool, this is my day job, but I genuinely, passionately care about the development of my industry. And so I'm willing to, you know, volunteer my personal time."
And I see that across the board every day. And it's really cool. I mean, you have people who have huge jobs at, you know, Johnson and Bausch & Lomb and Medtronic, and they're, you know, they're still willing to put their personal time on the table to advance the industry. So, yeah, all my industry involvement's pretty passion based, but it's the medical device industry and medtech industry is one that's super unique. A lot of people feel that personal passion.
[00:21:20] Lindsey Dinneen: Yeah, I couldn't agree more. And thank you for sharing a little bit more about your involvement and your passion for the industry. And I feel so similarly, I, you know, when I joined the industry now a few years ago, I remember having this just moment of getting to meet all these super cool, intelligent innovators that are just literally changing the world and thinking "how lucky am I to be here and play a small part in this big changing thing," and then getting to see exactly to your point, how passionate the people are in the industry and how it's not just a job, it's like a calling.
[00:21:59] Sarah Ptach: Well, I think the difference is, you know, in, in medtech, the origin or margin for error is not just financial, it's human. So where you have, you know, maybe your traditional job, you know, the margin of error is a financial impact. You know, the margin of error for people in our industry is human impacts, and that can be positive and negative. So it's hopefully the passion to make those more positively. So.
[00:22:24] Lindsey Dinneen: Yes, indeed. Yeah, so, you know, I love the impact your company is making and the industry itself, like you said, is just such a cool place to be, and I think it really does invite those kinds of passionate people who are willing to just kind of be evangelists in a way for the rest of the industry in some fashion and really moving things forward. But because of the impact that's made, I'm wondering are there any moments that really stand out to you as affirming that, "hey, I am in the right place at the right time, in the right industry."
[00:22:57] Sarah Ptach: Yeah. I mean, I definitely have some stories where you've-- without disclosing the details of a client-- but you know, you've been part of a launch that you watched that device go change the industry. I was a part of a company that was launching a, it's basically a, an organ transplant way of improving on how organs make it from, you know, the donor to the recipient. And it has improved patient outcomes tenfold to what they used to be. It's made it so that you could take, say, subpar lungs that used to not be able to be donated. And because of this technology, now it can, 'cause it, it has a way of it staying more intact while being transported.
And you know, you get involved in those projects and, you know, you might just be helping at a small portion of it, like the sterilization or the packaging or just the biocom testing. But, you know, you watch the outcomes of that and it's like, "wow. Like I, I did that." You know, I've talked to people that work in consumer product goods and, you know, their Super Bowl is seeing their package on the grocery store aisle. And, you know, my, my Super Bowl is seeing the product that you played a part in, reach the market and change the world. Like that's, it's so cool.
And to your point before you, you get to be in the room with such cool, innovative, smart people that came up with that product. I am, I'm honored to be the lab testing that is that silent backbone of medical innovation. But to be, you know, that trusted partner to, to get them to the finish line is a, it's a unique feeling, but it's really cool when you get to see a product that you played part of either touch a family member.
I've been in an operating room before where I was the one being operated on 'cause I tore my ACL or did something and all I'm doing is looking at all the packaging, like, "Ooh, I did that. I tested that." Such a cool experience. It's sometimes it can be concerning 'cause you're sitting there while your doctor's trying to tell you to just get ready for surgery and you're staring at all the packaging. But it's, it's an awesome round to be in.
[00:25:02] Lindsey Dinneen: Oh my goodness. I love that story so much. Yes. I mean, I could see that I, and I've talked to other folks who have similar experiences where they're, you know, they're kind of going along, something happens, they end up needing medical attention, or a family member does, and they go into the, to the hospital and they're like, "oh. I worked on that device" or "Oh, I did the cybersecurity for this one" or whatever, and just like how cool of a just full circle moment is that, and getting to watch in real time and in real life the impact that your work does. That is a huge honor and gift.
[00:25:34] Sarah Ptach: Yeah, I I really did tear my ACL and my, and I also broke my back at one point in time, but my back surgeon and I have a really cool relationship and I think it's half because I was probably the biggest pain in the butt patient, 'cause leading up to that surgery it was like, "what device is it? What's the sterilization modality? Tell me what testing they did on it." And I got very lucky. My, my surgeon, his name's Dr. Michael Glisi, he has played actually a big role in getting some better improved medical devices to market both with Globus and with Arthrex. And now he plays a role in training other surgeons on how to best use those medical devices and technology.
But it was such a unique relationship to get with him 'cause he's uniquely involved in the industry. So I think he, he maybe tolerates my 9 billion questions better than the average surgeon that just wants to operate on you and see you off. But it was a cool experience to get to, to have that relationship with him now after surgery and watch the impact that, that he's making on the industry as a surgeon too. So I think all stakeholders in this industry hold different areas of importance too.
[00:26:49] Lindsey Dinneen: Yeah, absolutely. Oh my goodness. Yes. And, yeah, I could talk about all of this for days and I'm loving this conversation, but I am gonna pivot it, 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 it doesn't have to be at all. What would you choose to teach?
[00:27:13] Sarah Ptach: Ooh, that's a good question. I do think I would teach it on people leadership. You know, I, i've been in a lot of different roles and scenarios of people, leadership, especially through acquisitions, seeing, you know, the good, bad and ugly of what other folks do. And I've been really fortunate to have a lot of different mentors in my career that took very different leadership strategies. And I'm by no means saying that I'm the perfect people leader, but I think-- I can tell you a lot of different options and why they do and don't work.
So if I was to teach a masterclass it'd probably be in that and I'd be heavy on the transparent leadership side. I'd be heavy on fostering a culture of people that are comfortable talking about issues. And it's not a easy thing to balance, I think with also driving, you know, the work product of the business and the financial success of the business. But being able to marry that, to marry, you know, having a great people culture and having, you know, people that, that love being a part of your company.
It, to me, it is the most important part of actually driving your financial success of your company too. And I don't think a lot of people correlate that. You know, they think "I'm the ultimate financial driven CEO. I am the gross margin king." And, you know, " I'm driving my shareholder value." But I really think that, while all that is important, it starts with the people and the more you can get people to care about what they're doing beyond just their job, the more that the natural effect is improved gross margin and better financials. So the masterclass I'd probably teach is how to combine positive people, environment, and culture with good company financial success.
[00:29:07] Lindsey Dinneen: Ooh, okay. That's a very powerful masterclass I wanna go take so, so sign me up for that, for sure. That's incredible. Yeah. And you have so much advice and insight and I could just tell, like, again, we could probably talk about this for hours and be very happy, so, yeah, I love that. Okay, and then how do you wish to be remembered after you leave this world?
[00:29:30] Sarah Ptach: Yeah. Someone that, that cared deeply about the industry and was willing to to give it my all. You know, you, you jokingly said, "when do you sleep?" I'd argue not a lot, but it's because I love it. Like it's 'cause I love what I'm doing and if that means I'm gonna sacrifice some sleep to make sure the thePACKout is an awesome conference or the, you know, KIPP aseptic presentation team has what we need to change a standard or Canyon, you know, do something better and greater, I'll do it all day long. So yeah, I'd like to be remembered as, at the end of the day, she just really cared. And she was in it 110% at all times.
[00:30:12] Lindsey Dinneen: I love that. That's a beautiful legacy. Yes, absolutely. Okay, and then final question, what is one thing that makes you smile every time you see or think about it?
[00:30:23] Sarah Ptach: Oh, I love that one. I think someone realizing that the solution to the problem that they came up with was truly right and the solution. And it's like you worked through it yourself. You made it through maybe the hard parts of that decision making, but then you executed and hot dang, it worked. Like that is such a cool experience, especially when it's someone's first time ever having like the leadership role of solving a problem or, you know, the project manager role of solving that problem. It's super cool 'cause you get to watch someone's thought process play out. You get to watch where they see the pros and cons of their decision or the faults that could occur. And then you get to watch 'em navigate that, and then it succeeds and it's like, "hot dang, you did it." It's great. I love that. So that's probably something that makes me smile the most is when someone sees, their true potential being achieved, and they get to see it in the form of something as tangible as solving a problem.
[00:31:22] Lindsey Dinneen: That is awesome. I love that so much. Oh my goodness. Well, this has been such an amazing conversation. I'm so thankful for you and for you being willing to share some of your time with me and with our listeners. So thank you so much for all the work you do, and thank you for being in the industry, being passionate about this industry and for being a change maker too, in the way that, you know, companies can operate and be successful. And we don't have to think about it just in terms of financial success, but we talk about it in terms of cultural success too. And so, I just really appreciate your perspective, so thank you for all the hard work you're doing to change lives for a better world.
[00:32:02] Sarah Ptach: Thank you. Yeah, thank you, Lindsey. And likewise what you do. It's awesome to see you highlighting some of the stories in the industry and bringing together really good conversations like this. So thank you.
[00:32:11] Lindsey Dinneen: Awesome. And we are so honored to be making a donation as a thank you for your time today to the Michael J. Fox Foundation, which is dedicated to finding a cure for Parkinson's disease through an aggressively funded research agenda and to ensuring the development of improved therapies for those living with Parkinson's today. So thank you for choosing that organization to support. Again, thank you so much and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two and we'll catch you next time.
[00:32:49] 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.
 

Tyler O'Malley is the Vice President of Clinical Affairs, Bioinformatics, and Market Access at Exagen, Inc. Tyler shares his journey in the MedTech industry and discusses Exagen's innovative approaches to autoimmune testing solutions, including cutting-edge diagnostics for lupus and other diseases. With over a decade of experience, Tyler provides insights into the challenges and breakthroughs in the field, highlighting the significance of early diagnosis and personalized treatment, while also discussing the challenges and opportunities in effective leadership during different stages of company growth.
 
Guest links: https://exagen.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 066 - Tyler O'Malley
[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 so excited to introduce you to my guest today, Tyler O'Malley. Tyler serves as Associate VP of Clinical Affairs and Market Access at Exagen, Inc., a leader in autoimmune testing solutions. In his role, he oversees clinical trials, bioinformatics, and medical policy development for Exagen's current diagnostic portfolio and pipeline of proprietary solutions. With more than a decade of experience, O'Malley has contributed to more than a dozen clinical trials focusing on clinical validity and utility evidence for autoimmune diagnostics.
His expertise is widely recognized with numerous publications in esteemed peer reviewed journals, and notably, he's the first author of one of the largest clinical utility studies in lupus diagnostics. O'Malley graduated from Georgia Gwinnett College with a Bachelor of Science in biology, concentrating in biochemistry. His 11 year career in research and development and medical affairs encompass medical science, education, assay development, and clinical research coordination.
Well, welcome to the show, Tyler. I'm so excited to have you here today.
[00:02:01] Tyler O'Malley: Thanks, glad to be here.
[00:02:02] Lindsey Dinneen: Yeah, absolutely. Well, I would love just starting off by telling us a little bit about yourself, your background, and what led you to MedTech.
[00:02:11] Tyler O'Malley: Sure. So, I'm the Vice President of Clinical Affairs, Bioinformatics, and Market Access at Exagen. We're a specialty diagnostics company focused on autoimmune rheumatic diseases. So we develop proprietary testing technology for conditions like lupus, rheumatoid arthritis, Sjogren's disease, as well as many others. And yeah, our focus is trying to find solutions for patients who are dealing with what are many times challenging chronic diseases that can present themselves in very mysterious ways oftentimes. And so, these are challenges that patients have that have, for the most part, gone unsolved for many decades, and so there's a lot of opportunity out there.
In terms of, myself, my background, I've been with Exagen for the past 11 and a half years. So I've been doing this for a while now, and I've worked in a couple of different areas within the organization, doing work within the lab assay development, as well as outside the lab doing clinical research, statistical analysis, which led to the bioinformatics role. And then as well as doing some work trying to align our clinical evidence with medical policy for our tests which is the market access role. So, a little bit of everything, but there are some through lines that I assure you do make some sense if you really think about it.
[00:03:33] Lindsey Dinneen: Excellent. Excellent. Well, thank you for sharing a little bit about that. There's so much to dive into, but going back a little bit in your story, when you were thinking about careers-- you're a eager high school student ready to embrace college, and you're ready for the next step --is this something that you could have imagined yourself doing or has this always been a passion of yours? Or is this something you kind of found yourself in?
[00:03:57] Tyler O'Malley: Not at all. So, no I, so I will say I've always been interested in autoimmunity. So that's always been something that has always piqued my interest, whether I was in high school or college. And so I guess in that sense, it's not a surprise. But the laboratory diagnostics component of it was not something that was on my radar when I was in high school or college.
And I guess the journey to Exagen was, after graduating from high school, went and got a bachelor's degree in biology with a biochemistry focus. So, that's sort of my background there. And while I was getting the degree and focusing on biochemistry, I had the opportunity through a resource scholarship at Georgia Tech to work in a graduate lab, which was a really interesting experience where, you know, for a little over a year I had the opportunity to work alongside PhD candidates, postdocs, on a research project that was partially funded and get the experience and understand what it's like to work towards a PhD and what it would look like to kind of go down that path of graduate level research.
And I think it had the opposite effect that it was intended to have in that it kind of showed me I didn't want to do that. So, I think in a lot of ways I was happy I had that experience 'cause it showed me before I went down that path that it was something I didn't wanna do. Nothing against it, I guess I wanted to do something that maybe had more of a translational impact, a little bit closer to the patient.
And so, finished my degree, and at the time I was living in Georgia, so I finished my degree in Georgia, left and moved out to California, and ended up at Exagen by pure chance through a recruiter. And that was back in 2014, and basically just joined Exagen at the time when it was a smaller company, and grew with the company, and was fortunate enough to have the ability to learn a lot of different functions within the company as it grew, and there were a lot of different things that needed to be done a as the company was growing. And so it, it's been kind of a, an interesting ride since then.
[00:06:08] Lindsey Dinneen: Yeah, absolutely. And of course all of those different experiences, I'm sure, have woven their way in, like you said. Sometimes you have to kind of look for that line, but there is one that's, apparent when you look back. So, can you talk a little bit more about the company, what it does, especially in regards to its testing technology, and I'd love to hear about some of the innovation that's just coming out of this incredible organization you're a part of.
[00:06:35] Tyler O'Malley: Sure. So our our testing, again, primarily focuses on addressing unmet needs in patients who have autoimmune connective tissue diseases. And specifically we have some proprietary technology around biomarkers that help diagnose systemic lupus. And lupus is kind of the prototypical autoimmune disease in that it can manifest in just about any different way. It can show up in your skin, your heart, your lungs, your kidneys, just about any way you can imagine, and sometimes in multiple different ways. And so in that way, it can be challenging to diagnose 'cause it can look like so many different things. And much of the testing that is used for lupus or has been used traditionally is very antiquated. Antibody tests that were developed many decades ago that have been refined to some extent over the years, but for the most part are not overly sophisticated.
So, what Exagen has done over the past 15 or so years is brought forward some technology, that was originally licensed from University of Pittsburgh, looking at measuring a form of the complement system, which is a part of our immune system. It's a very ancient form of our immune system. It's a collection of proteins that come together to help fight off pathogens and help clear debris to keep our our immune system healthy. And what we're able to do is measure essentially the buildup of a complement fragment that builds up on your red blood cells and on your B lymphocytes. And what this does is it gives us a unique ability to detect lupus that's much more sensitive than the conventional means. And what that means, when I say sensitivity, is that it's able to pick up more lupus patients than the conventional testing.
So, one way of thinking about this is like, if you have a hundred patients in a room that all have lupus, right? Because they've been assessed by a doctor, they've been clinically diagnosed, and you were to test them, and say your conventional test is 50% sensitive, meaning half of the room would test positive on this test and the other half would test negative. This test that we're talking about here, it would pick up two thirds of the room, right, as opposed to conventional testing, which would pick up fewer patients.
So, that's the kind of technology that we're trying to develop here, which is trying to be more inclusive, pick up more patients sooner, give better insights to physicians to combine with their clinical assessments such that patients can get earlier treatments and hopefully stave off some of the more kind of disastrous outcomes of the disease that come with not getting treated soon enough and not getting treated appropriately for their symptoms.
[00:09:31] Lindsey Dinneen: Yeah, of course. That's incredibly important and I'm so glad that the company is working to create those solutions, like you said, because previous methods while maybe somewhat useful, are more antiquated at this point. And so it's really important to have these new strides in innovation. So as you're dealing with all of this, I'm sure that there are stories that have come up about real people having impacted lives because of the technology that your company is bringing. Do you have any examples that you could share with us about that?
[00:10:05] Tyler O'Malley: Sure. Yeah, there's been a number of individuals that we've had the fortune of meeting over the years. And they come and share the story with our team. We like to bring folks in with, for example, when we bring on new sales team members, we try to bring on a patient just to be able to share their story. So, recently we had an individual, who is connected to someone who works in our organization-- again, just pure chance-- who happened to have a very unique story.
So first of all, lupus, for those who don't know, is a condition that primarily affects women. Lupus is a disease that affects women at a ratio of nine to one, nine to one female to male or so, in other words, around 90% of lupus patients are women. But that's not to say that it isn't an issue for that subset of of men that do develop lupus. And in fact, the disease tends to be more severe in that 10% of lupus patients that are men.
So this individual who we've had the chance to meet and hear his story, really interesting because he's-- you would never know if you met this guy-- because he's a CrossFit guy. He is probably the healthiest guy you can imagine looking at him. But he went a harrowing journey to get to his diagnosis. And it all started with, relatively -- well, I don't wanna downplay it-- but let's call it "less severe symptoms" like alopecia and rashes, things like this that sort of make you think, "Well, gee, that's strange," or "I wonder what that is all about." And then leading up to much, much more severe symptoms like severe edema and pericarditis that was ultimately life threatening.
And ultimately, he was able to get the right testing and get to the right doctors, but it was not a short journey from the time that these symptoms initially presented themselves to the time where he was able to get to the test and to get to the right diagnosis and onto the right treatment. The good news is, he's in a much better place now after finding out what's causing his symptoms and getting to a treatment management plan that works for him and he's even back to getting to an exercise routine that works for him.
It's maybe not exactly the same as what it was before, but I mean, that's the thing. Now, you can lead a relatively normal life with lupus. It wasn't that long ago, call it several decades ago, where the mortality rate for lupus was as high as 50% in the first year after diagnosis. Treatment advances have greatly improved that and have changed the lives of people who live with Lupus now, but it used to be a very severe diagnosis. It still is, but it's very manageable now.
[00:12:54] Lindsey Dinneen: Wow. Yeah. And so catching it and having that answer to, like you said, really difficult health journey where you're just not sure what's going on. And I really appreciate you talking a little bit about how Lupus looks different and manifests itself differently in different circumstances so it can be difficult to initially diagnose. So I love the fact that the company is focusing on things like that, when caught early can maybe make a huge difference in somebody's life like the gentleman you mentioned. Thank you for sharing about that.
So now your own career has been really interesting in that you have gotten to do a lot of different things within the company and learn so much. Now as you've continued to grow with the company, you've, I'm sure, developed a lot of different leadership skills along the way, and I'm curious what it's been like in that sense of your journey to embrace leadership and how do you go about it? What have you found works really well, and maybe what advice would you have for somebody who's a little bit earlier in their career?
[00:13:58] Tyler O'Malley: Yeah. Really interesting question. And I, I guess, my experience was, I came into an organization that was, I think at the time, maybe in the entire company was maybe 60, 70 people. So, as you can imagine, it was a very flat organization. I reported directly to the Chief Scientific Officer when I first joined the organization as a relatively low level R&D employee. So that afforded me, I think, a unique opportunity because I was often involved with project planning and discussions that I don't know that you get that opportunity in different types of corporate settings.
And I think what has proven very useful in terms of my development, and as I look back and reflect on kind of what's led me here is, I can just recall, so, so many times, especially early on in, in a startup-- which can sometimes be chaotic and there's a lot of moving parts and things are moving fast-- there would be times where I would be in meetings where I wasn't necessarily expected to do very much, I think, or contribute much. And I would just sort of observe, right? And I think there's so much you can learn through not just listening to the conversation, but the body language of the people around the table. The way that people present, the way that people take criticism, the way that they respond. It was almost like a, it was a lesson every day just watching that.
And I think where I thrived and maybe added value at times was realizing when people were talking past one another and just, at times, trying to find a way to come into that and say, "Well, right, but did you consider maybe what this person was trying to communicate here?" And, you can't always resolve those sorts of situations, but sometimes you can. And that's really valuable when you can help two individuals get past an impasse like that. So, and I think it helps you build credibility doing that too, being a bridge builder in that sense.
And, and I think, that was something I don't know-- whether intuitively or purely by accident, I don't know-- I figured out over time was that, maybe as a young person in your career, sometimes it can be easy to get caught up on sort of the X's and O's of your job, whatever it is that you're doing-- if you're a computer programmer, you're doing bioinformatics or whatever the case may be-- you can get really caught up in the technical skills that you're trying to hone and develop. But there's so many soft skills that you have to build as well at the same time. And there's the relationships that you build, as well, that you don't know when you're gonna need them or when they'll pay off. But things change at organizations and you're glad when you have those relationships when it comes time to need them.
[00:16:51] Lindsey Dinneen: Yeah. Absolutely. Yeah. I love your discussion on the idea of being a bridge builder, because I've been thinking a lot about that recently where there's so much unintentional missed communication, just literally just passing by where, one person is saying something, the other person's saying something, and as an outsider, you're able to have a little bit of a distance to go, "Oh, you're kind of saying the same thing, but I'm not sure that you guys realize that, and here's how." Yeah, that translating is a really important skillset and a fun one when you can nail it down. So as you look towards the future of your own career and the company's trajectory, what are some things that you're looking forward to?
[00:17:35] Tyler O'Malley: Well, we obviously have a number of exciting pipeline initiatives that bring a lot of energy to me as I think about what we're trying to do going forward. I'm excited about where the company is headed in terms of its trajectory. I've described my time at the company as, even though I've been at the same company for 11 and a half years or so, I really feel like I've worked for three different companies in that time, in that, there was a period of time that was a startup up until the point the company went public.
And then there was this time from when the company was public, where we raised a lot of money, there were a lot of expectations and didn't exactly kind of work out exactly as we had hoped. And then there was a leadership change. And now we're sort of in this third phase now where the arrow's pointing up and we have realigned our strategy here and we found a way to be sustainable and to be able to continue to build on something where hopefully we can continue to find interesting technology that's out there.
We have an ongoing partnership with, as an example, Johns Hopkins University to try to develop a test to help address lupus nephritis. So this is a particular form of organ manifestation of lupus. It's one of the more common manifestations of lupus, and one of the more devastating forms of lupus, in that almost 50% of lupus patients will have kidney involvement at some point in their disease. And as much as 10 to 20% of patients who do have lupus nephritis will go on to unfortunately develop end stage kidney disease and require dialysis or kidney transplant. So it's obviously life altering and can be, very impactful to individuals. So, to be able to work on something like that and be able to potentially alter the trajectory of someone's life in that way is pretty cool to think about.
And, not everyone gets to do that. I mean, it's not that other jobs aren't meaningful, it's just not everyone gets the opportunity to do that kind of thing. And if you can also find joy in what you're doing in your job. I think that's also great too. I mean, it's really cliche, the things people say, and so I won't do it. The whole, like, " If you like what you do, you never work." Believe me, it's work. I do feel like I'm working sometimes, for sure, but I can't complain. I do, for the most part, have fun with what I'm doing. I'm fortunate enough, I have a great team of people, well-- three teams of people-- that I really enjoy working with, and being able to work with people and see them grow and develop and be a part of that is also super rewarding as well too. So, yeah, I'm just, I'm having a lot of fun.
[00:20:26] Lindsey Dinneen: Yeah. Excellent. Wonderful. Well, gosh, I'm gonna pivot the conversation just for fun a little bit. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. Now, this could be within your industry, but it doesn't have to be. What would you choose to teach?
[00:20:45] Tyler O'Malley: I think that-- maybe this is kind of fun, probably not-- but I think that ,I don't know why, and it's funny because it's-- I don't even know if this qualifies because I don't even know how I would teach it-- but I think I'm fairly good at guesstimating numbers and it's really useful in that it helps in a lot of different situations to be able to shortcut math. And to be clear, it's not that I'm doing long division in my head or anything like that, but it's, if you can kind of shortcut and get the approximate number, it can be really useful. And it's a nice kind of party trick too kind of thing. Again, I don't know how I would teach it 'cause it's sort of like it's up here, and I don't know how I would externalize that, but yeah, that's something I feel like would be kind of cool to figure out how I could teach that.
[00:21:35] Lindsey Dinneen: Absolutely. Yeah. It's a superpower. So it would be very cool to try to then-- you've got this innate ability-- so then to try to break it down into how does somebody else develop the skill sets that you just sort of possess, and go from there. That would be really entertaining. I love it. Great answer. Okay. And then the next question is, how do you wish to be remembered after you leave this world?
[00:21:59] Tyler O'Malley: Yeah. Well, that's a deep question. I think that the most meaningful impact that you can have is the impression you leave on the people that you interacted with, right? And I think, for me, I would just hope that the people that I've had the chance to spend time with-- obviously family, friends, people I worked with, people who worked on my teams-- I would just hope that as they would reflect on the time that we had together, that it would be a memory that was time well spent and that hopefully there are some good shared experiences that we had and that hopefully I left something that was meaningful. But as it relates to the work that we're doing, I hope that the impact that we're having-- some of it has a longer reach than even what we can see today, 'cause I think, truly being selfless is trying to build things that you'll never realize the benefit of: planting trees that you'll never sit under yourself. It's for someone else down the line in the future.
[00:23:14] Lindsey Dinneen: Yeah. Yeah. I love thinking about it in those terms too: being willing to do your bits of good and let them go out into the world and not necessarily know the ripple effects and still use that as a worthwhile use of your time. I love that. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:23:39] Tyler O'Malley: Yeah, I think the easy answer is probably my kids. So I have two kids, and that's kind of the reprieve from the work life and kind of focusing on all this important stuff that we're trying to do here at work, but being able to kind of break away from that and focus on building them up and watching them grow and develop and become their own person is really cool. It's obviously a unique experience and it's a nice thing to be able to think about when you need something to kind of bring you back up.
[00:24:12] Lindsey Dinneen: Yeah, absolutely. Just a different way of looking at the world from such a fun perspective. I love that.
[00:24:19] Tyler O'Malley: Yeah.
[00:24:20] Lindsey Dinneen: Yeah. Well, Tyler, this has been such a great conversation. I so appreciate your time today telling us a little bit about your story, the company, and all the incredible work that you guys are doing to change lives for a better world. 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 thank you so much for being here and thank you for doing what you do.
[00:24:59] Tyler O'Malley: Thank you. It's it's been a pleasure.
[00:25:01] Lindsey Dinneen: Excellent, and thank you also to our listeners for tuning in, and if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time.
[00:25:14] 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. 

Sarah Aswegan, a seasoned biopharma leader and strategic advisor for global rare disease solutions, shares her journey from sales in pharma to her consulting work today. She discusses her experience in transitioning biopharma companies from clinical to commercial success, the evolution of medtech in diagnosing and managing rare diseases, and the collaborative efforts required to bring innovative treatments to market. She also shares insights on current trends in gene therapy, the dynamics of funding, and the importance of data in advancing care for rare disease patients.
Guest links: www.saraaswegan.com 
Charity supported: 
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 065 - Sara Aswegan
[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, Sarah Aswegan. Sarah is a seasoned biopharma leader helping organizations transition and grow from clinical to commercial success. She prides herself on the success of leading multiple global cross-functional teams and contributing to the success of the franchise areas she oversaw and served. Until recently, she's applied these experiences while serving in a consultancy capacity for many small to midsize biotechs entering or expanding in rare disease. She has also successfully helped organizations to start and scale adjacent spaces to biopharma, and most recently has been serving as a Global Head of Commercial Assets, Brands, and Care Solutions, and has led transformational change at UCP, having been part of the design and scale of the business unit for rare disease. She maintains a strong network among clinicians, access, bioethicists, and patient advocacy globally.
Well, thank you so much for joining us today. I'm so excited to speak with you.
[00:01:52] Sara Aswegan: Thanks, Lindsey. It's nice to be here.
[00:01:54] Lindsey Dinneen: Wonderful. Well, I'd love, if you wouldn't mind, sharing a little bit about yourself and your background and what led you to medtech.
[00:02:02] Sara Aswegan: Yeah, thanks Lindsey. You know, I, I started my career ages ago in the pharma side of things, and as my career has grown, so has the exposure across pharmaceuticals, into biotech and including aspects of medtech. As we look at some of the areas I've spent the last 18 years in rare disease, the medtech component is coming in largely around if we think about the diagnosis component and then the management of the different conditions over the lifespan of a child or adult affected by a rare condition. You can see things really evolving.
I started my career on the sales side of things. My education is in business and communication, so anyone can learn the science if you have good mentors and people to help you along the way. And I was really, really fortunate to work amongst a team of amazing individuals, both in the US and then now having lived away for about 15 years outside of the US that have helped open my eyes to what can be possible and the differences by markets.
And as I mentioned, I spent the last 18 years in the rare disease space really helping companies of all sizes build out and scale their teams, bringing in new assets and bringing solutions to the field of rare disease. And it's something I'm very passionate about.
[00:03:06] Lindsey Dinneen: Yeah. Well, thank you for sharing a little bit about that. So I'm curious, that's a very specific niche and I would love to understand how you arrived at that and how you realized, "Oh, this is what I'm meant to be doing."
[00:03:19] Sara Aswegan: Yeah. So I made a move geographically and company-wise to a small firm at the time. We were just a very small team. We called it the bootstrapping team at Shire Human Genetic Therapies, and I moved from the Chicago area to Boston, and that was my first really exposure to rare diseases. And, it's a completely different field and it continues to evolve even to this day. But the closeness and proximity you have to patients and their families and those with unmet need. And I have, you know, a couple of close friends as well as a family member that's been affected by a rare disease. So as you're seeking care and support for them, it's not always about the medications. It's about that total person and thinking really holistically about the individual and their care teams that are impacted by those conditions.
So the external community we were serving really drove me and introduced me to something that I've stayed with, and it brings great passion to try to find ways to support individuals in our western society, but also looking at low middle income countries and helping facilitate diagnosis to treatment to, again, that whole supportive care and largely from the internal teams within the organizations I've worked with has just is been tremendously rewarding and also equally challenging.
It's beautiful to see progress. I mentioned diagnosis and. One of the areas I worked in initially was in the lysosomal storage disease area. And it's the age-old question on diagnosis. Do you facilitate newborn screening, for example, so when your child is born, you have a heel prick done and you can do a series of tests depending on the state you live in, and in some countries in Europe it's also provided. But if there's not a therapy, is it okay to do that type of diagnosis support. And so that challenge, you know, in seeing the policy evolve on a state by state basis.
When I began in the rare disease space and MPS Type Two Hunter Syndrome, it's a condition that affects mostly boys and a very small part of our population. We knew we could do newborn screening and there was a therapy available, but it wasn't only realized until a few years ago to introduce newborn screening to help those families at the point of birth to know if their child was affected, and therefore start a different trajectory on how they planned for care for them and plan for if there was a medication or other supportive tools and resources available for them.
So it's been extremely dynamic to see how things have evolved. And then now as you see medical and pharma medical technology advance as well into gene therapies. You're seeing news about gene therapy and it's a one time treatment and then the individual hopefully will not have be re redos in their lifetime. Along with that come challenges on that diagnosis piece to make sure they're eligible for the gene therapy. So again, through the device and technology sector, it plays a key role. In addition to the supportive care that goes on for some of these really severe conditions, people have some pretty dynamic needs and it's great to see how things are progressing, but it's still as equally as frustrating, whether you're on the manufacturer side or the family side, to see things be kind of slow sometimes.
[00:06:15] Lindsey Dinneen: Yeah, of course. And you're dealing with a specific situation where many times-- please correct me if I'm wrong-- but it seems like many times there's these kinds of studies and conditions are not funded very well in terms of finding solutions to the problem. So how is that something that you, well, first of all, of course we're in a very interesting season of life right now. So how are you seeing funding evolve over the years for these different diseases that are a little bit more rare, and what can we all do in terms of even just awareness and understanding?
[00:06:51] Sara Aswegan: Yeah, so that's a huge question. We could probably have about five conversations on this just to scratch the surface, Lindsey. I think if I reflect on the question on what we've seen around funding, I mean there are some wonderful, supportive grants available for the brilliant scientists we have around the world that have a curiosity. So making sure we can facilitate that ongoing academic environment to explore and test the hypothesis. And one of the things that you see coming along, and it's not really around-- I won't think about funding as just pure financial-- but it's the funding of the smarts that go around the table. You see a lot more collaboration amongst academia, industry governments coming together to help build and scale so that there's an awareness and understanding of a condition.
I mean, a pediatrician could go through their entire career and never see a boy with Hunter Syndrome. It's just that rare. At the same time, and on the converse of that, if you're working in an industry where you do have access to more funds, the introduction of AI and looking at how we look at drug targeting, drug target selection, genetics and precision medicine have come along quite leaps and bounds in the last several years, but we're still not quite there. But you're seeing advancements with the different cell and gene therapies, having that precision medicine as an option. It's coming forward.
The challenge is the size of studies are normally very small because the population is small. So thinking about patient recruitment, how can we help facilitate better identification of individuals that may be out there and not have received diagnosis because of the rarity of the condition? So looking at technology and advancement of integrated electronic health records up to and including, how do we look at the trial designs? And how do manufacturers, academics, industry, and agencies work together to think a little differently around even designing clinical endpoints for the studies that really are meaningful, that will make a difference. And how do you balance that, right? Correct risk benefit conversation, in the spirit of doing no harm. But if there's one chance and there's something available, how do you do that?
And coming all the way downstream. If you think about where the organizations have advanced their thinking, their approach, and put funds behind, it's also that ongoing care of the individuals. If you look at the upstream, the types of tests that are available. It could be cancer, it could be the area I am so passionate about in genetic disorders, but it can also be thinking about the workflows that come into play in helping facilitate consistency of care across state borders, across country borders. It's a key piece that are really advancing in real time, but we're still trying to overcome the hurdles that are real.
And that's things around data privacy. How do we navigate that in a really meaningful way with the right ethics and integrity. If we think about the regulators, this isn't a huge anti-infective or cardiac study that's ongoing, that there are gonna be tens of thousands of people. So how can we think a little bit differently on advancing the care. In the area I'm working in, Lindsey, especially with some of these individuals that are kids, if they don't get access to care by a certain age point, their window of treatment has closed.
And so what could we do to help facilitate earlier diagnosis and then that advanced care. And so I think we can see a lot of really good intentions, and I think the most beautiful thing is even the collective gathering of different patient organizations that have a shared interest of a disease coming together and also helping raise research funds to help support the scientists that have a hypothesis on something that may really make a difference and may matter.
[00:10:21] Lindsey Dinneen: Yeah. Yeah. Okay, so, there has been so much innovation in the last few years-- of course, even before that, but it seems to be extremely exciting in the last few years-- especially things like CRISPR and all sorts of new technologies emerging. What are some of the exciting trends that you're seeing in this space specifically that give you hope as you continue to look forward and look for solutions?
[00:10:45] Sara Aswegan: I think for me, I mentioned, I touched on it lightly. I think it's that collective, that collaboration and the openness now. The FDA has advanced the way that they think and engage with agencies as well as industry partners. And so what I mean by that, Lindsey, is they're not just engaging with the scientists or with the manufacturers, the drug developers. They're also bringing patients in. And so that collaborative environment, they're even beginning conversations when there's discussion on clinical trial design to understand what really matters. Is it a six minute walk test or is it something around real behavioral or other abilities that can be learned and retained over time that help benefit the quality of life? If you're not gonna be able to cure something, what's really important at that patient front to help facilitate something meaningful.
So I think that type of conversation also with the agencies looking at, there was an amazing session held in Europe recently in the mucopolysaccharidosis or the lysosomal storage disease area, looking at advancements of science and saying, can we look at biomarkers alone and create that relationship and understanding there is a clinically meaningful impact if we can address this biomarker. And so, companies like Ultragenyx have really pushed to have that conversation and dialogue and have a drug filed now that's under review based on biomarker endpoints alone, where five years ago, you would never have imagined that being possible.
[00:12:12] Lindsey Dinneen: Yeah. Yeah. You touched on something that I would really love to explore a little bit deeper, and that is, when there's a situation that right now we don't have a cure for this disease-- and, you know, obviously we're still working towards it-- but if we don't have a cure, but we are trying to improve the quality of life, how do you balance that in your specific field in terms of: obviously you want the patients to live the best quality of life that they can while balancing so many other, and I don't mean this in a callous way at all, just from a practical perspective, balancing all of these other considerations and things that are also desiring funding and all those competing priorities. So how do you balance that? How, how does that come into play?
[00:12:57] Sara Aswegan: So that's a big one. It's a tough one. And I'll oversimplify it and just say data. And what I mean by that, Lindsey is really looking at, with the technology at our fingertips, regardless of the geography you're living in, there's a lot of meaningful information that can be captured. And it's not, again, around one aspect of a disease, but it's the totality of health. So really looking at what could be possible in capturing, is it around energy levels, activity levels. And you'll see that oftentimes in play with the gene therapy, for example, when it's administered, you may have up to 15 years of follow up that you're capturing specific data points.
But even in advance of a drug approval, and an area I am also equally passionate about, is access to unlicensed medicines for individuals that can't travel to a clinical trial site and could benefit from an investigational therapy, how do we do that with the right balance in place? And part of that is data and having the willingness of a participant or family member to be so consented in and participating in the study for their child to share that data and share that real world data or real world evidence so that you can measure back and show what impact that drug or treatment or intervention has been having on the individual.
So I think it's around that and figuring out how we can overcome some of the complexities and challenges that are real. Not everyone has electronic health records. There's still lots of paper-based offices out there. But in the meantime, there's a lot of advancements in technology. So how do you appropriately use that, that it's also not overburdensome for the individual, for the family as well, that you're doing what really matters and measuring back and having the right conversations with the individuals affected, the investigators, the clinicians, but then the regulators, and going back and sharing why this can be something to help substantiate. It's not your standard phase 1, 2, 3 clinical trial design. That's, yes, there's rigor, but it's a different way of looking at using data to help us advance our understanding of a disease and what's needed by the individual affected.
[00:14:53] Lindsey Dinneen: Yeah. So, so when you're speaking with these families and or-- well, first of all, let me actually back up. Do you have direct communication with some of these families and patients that you're working with?
[00:15:04] Sara Aswegan: Yes.
[00:15:05] Lindsey Dinneen: Yeah. And so when that happens, how. How is it for you? I mean, this is such a challenging area that you have devoted your life to and to, and I'm so impressed with that. And, you're doing the work that's helping save lives and make a difference. But that must be really challenging from a personal level to have these difficult conversations. So how do you balance that as a practitioner and somebody who's desiring to help, but you also have this real life compassion and human being that you're trying to help?
[00:15:38] Sara Aswegan: It's tough and it's tremendously rewarding. At the same time, I have so many patient stories I can share with you of meeting them and meeting 'em where they are. I made a trip to Sao Paulo, Brazil once, Lindsey, and met a family that were living in the favelas there, and their aim was to help raise awareness for Hunter's Syndrome because their son had been undiagnosed. They knew something was wrong. He was nonverbal. He had some physical presentation that you could understand. There was something going on, but the technology wasn't there for them. The access to the care center wasn't there for them to get a diagnosis. They were taking buses for hours to different clinics to figure out what's wrong with our son.
And he finally received a diagnosis of Hunter Syndrome and they wanted to share the photos because kids with Hunter Syndrome do have some different dysmorphism. So there's something that's strange. They have a bossy forehead, or their bridge of their nose is a little different. Their bellies might be a little bit bigger. So if you start looking at all of these different clues and putting it together, you might suspect and go-- there's other things going on, for sure. So I'm oversimplifying this. However, getting a diagnosis for him by just raising awareness to other families of the physical presentation and what their experience was extremely meaningful for them.
And on balance, a family in Florida that I met and their son was diagnosed at age 18 months because their grandmother had seen a program on Mystery Diagnosis and said, "That sounds like my grandson." And so creating the conversation and meeting people where they are is really important because you may have some individuals that are very aware of how drugs are developed and all of the rigor that goes through that to then others that just they don't understand that some drugs are intended for a specific indication, specific population, and helping explain why their child may not be eligible for a particular study. It's tough, and that's not my responsibility, but the clinical teams and the clinicians that are having those conversations. So it's listening and really coming with a open heart and mind and having empathy to help figure out how can you educate.
It's even moving into gene therapy. What does gene therapy actually mean? What are the risks? I'm afraid this sounds like it's something so futuristic. What will this mean for my son or daughter in 10 years from now? And, we may not have all of the answers, but you know, science has advanced and it's that risk benefit that you have to exercise. But really it's that coming with compassion and a listening ear and understanding and being honest. And if I can't help, maybe there's someone else that can help or there's a, did you know, there's a clinic here or a center there and helping that network stay connected and thrive is really important.
And also being their voice, Lindsey, I mean, we can, we have an opportunity on our pharma, biomedtech side of the world that we can share what we've observed and try to apply that as we come to work every day and think about that family we met in Brazil or in Boston or in Florida or in, you know, Frankfurt, and whatever they may be experiencing. So it's being their advocate in other areas as well.
[00:18:34] Lindsey Dinneen: Yeah, exactly. So with what you deal with, I am wondering what kinds of misconceptions or myths do you often encounter that are interesting and yet you would prefer to correct so that those of us in the general population are more informed?
[00:18:52] Sara Aswegan: That's a good one. So I think having worked in the rare disease space, one of the biggest scrutinies there, there's on two sides of the coin. One is around diagnosis and why we can't do more around diagnosis. And sometimes the science is just not there yet. So again, to some of these experiences, like the story of the family in Brazil, it may not be about a blood test. It may be about a physical appearance and helping people piece things together.
I think on the other end is at the point of delivery of the diagnosis and then if there is a treatment or intervention that can be taken, and not everyone has the same principle in their heart. There are companies that are motivated for different reasons, but certainly the big topic is are around drug prices, whether it's a gene therapy or a chronic lifetime medication, of how do we navigate that and how do we navigate that in a better way? And I think we have to start looking as an industry, as a community of people, of how do we address that?
The cost of doing a clinical trial is tremendous. It's hugely expensive. Does it warrant though huge price tags on drugs forever in perpetuity? What's that right balance? And I think having a level of social responsibility and looking at alternatives. And so imagine if we could reduce the time for clinical studies for requirements because we're able to look at other data. Things like the biomarker approach and the follow on real world data that could be captured, could that help us in the total overall offering and the cost to the overall health system? Maybe.
I think that as an industry, every company operates with different principles and wanting to do best for the patient community. Some are more profit driven than others, and so that's a reality, and it's one that I get so often at dinners with friends or in personal conversations, professional conversations, and it's a tough one. At the same time, a study of 60 individuals could be double digit millions of dollars. Just the cost of facilitating the study, the production costs of some of these highly technical compounds of different therapies also becomes a factor. So you have to put all these pieces together and really explore what's driving that.
[00:20:57] Lindsey Dinneen: Yeah, of course. And yes, I'm sure that's a really difficult conversation to have too, when you're especially working directly with patients and trying to explain all of that and that's a lot. That's a challenge.
[00:21:10] Sara Aswegan: Yeah. Yeah.
[00:21:11] Lindsey Dinneen: But on the flip side, you know, of course the work that you do makes a huge impact, and I'm wondering if there are any stories that come to mind that just really reinforced to you, "You know what? I am in the right place at the right time, in the right industry."
[00:21:25] Sara Aswegan: Absolutely. And I think it goes to, I touched on it very briefly, and there are people that aren't living in near major cities, near major medical centers, and that should not make them obsolete from receiving the best care. And there are two things that have happened and partly because of the pandemic, but also partly because of the willingness to educate and have that connected community amongst clinicians, is around that access to unlicensed medicine and finding pathways that it's not just because a doctor says your son or daughter needs this medication. I'm going to reach out to the manufacturer to see if I can get access because they're not near a clinical trial site or they don't wanna participate, or they're unable to participate in a study. But finding means to do that.
And there have been some really creative ways that clinicians have been able to do that, of setting up qualified treatment centers where the individual can go to receive the treatment and then that continuity of care is provided then over the life of their disease. It's something that's become real and meaningful, and you would be shocked at the number of individuals around the world that are receiving access to medicines that normally might have only 10 years ago been available if you were living in the Western Europe or the United States because studies weren't conducted in their country and so there's no pathway for access that is all changing.
Those dynamics are changing. It takes a team of people, though. It takes regulators, it takes lawmakers, it takes industry. It takes our logistics teams to be sure if something's stored at cold chain, that that product is delivered in the right context at the right time, just in time for that patient to receive it. So it's a complex challenge, but it's one that we've seen serve individuals in a really meaningful way. And without that, they wouldn't have, they wouldn't have another option.
[00:23:11] Lindsey Dinneen: Yeah. So having that impact and just being able to reinforce in those moments of maybe when it's especially difficult or you're especially frustrated like, "Oh my gosh, I wish I could help X, Y, and Z," at least you can look back and go, "Yes, but look at all this that we are doing."
[00:23:26] Sara Aswegan: You know, Lindsey, also it's that education piece and being curious and asking questions. The scientific community and one of the lead leaders in the NPS community is in North Carolina, Joe Munzer. Dr. Joe Munzer, he's brilliant. And one of the initiatives that we started was something called a masterclass. And so with Dr. Munzer and seven or eight other clinicians from around the world, we literally went on an educational program around the world. And some of the individuals that had just come out of their postgraduate work, pediatric geneticists or neurologists meeting the number one or two people that know this space so well, being mentored by them.
And now those individuals are facilitating their class, the same type of class in their local language to their local communities and creating that level of education and awareness. I mean, it's just to see that real impact over time. I actually get goosebumps just thinking back on the impact that has had. And you've got a community of clinicians that they're, I mean, there's a lot of needs still to study medical genetics. And so hopefully we have individuals that are scientifically interested and will continue that that journey so that they can be the next teachers across borders. That makes the difference.
[00:24:37] Lindsey Dinneen: Yeah. Absolutely. Wow. Yeah. Thank you for sharing that. I was also getting goosebumps just listening to it because that's incredible ripple effect that you had and continue to have. That's amazing.
[00:24:47] Sara Aswegan: Yeah. Yeah.
[00:24:47] Lindsey Dinneen: Yeah. Oh man. Okay. Well, I could talk about this for a long time, but pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach masterclass on anything you want. It can be within your industry, but doesn't have to be. What would you choose to teach?
[00:25:05] Sara Aswegan: Wow. That is a great question, Lindsey. A masterclass-- a million dollars-- a masterclass on anything I would want. I would be drawn to some of the advancements we're seeing in gene therapies, but I think that would be, I wanna try to serve a broader population. Do you know? I think it's, I think if I could look, I would do something around looking back on some of these, if you will use cases and best practices, to share those learnings, just because we know the impact that it will have and has had and continues to have.
And not just on the scientific community, but it ripples down into the patient communities of asking that question of "what can be possible, how can we together." Instead of " no," it's actually, "yes and" or "no and" we hear something else, another construct. And really breaking it down to really enforce what I've talked about on several moments during our conversation today is it can't just be the manufacturer, the, or the developer. It can't just be academia. It can't just be health authorities or regulators.
It's a collective community and it has to include that patient within that conversation to help for that learning and advancement and understanding. And so I think it's something around that, the best practices, use cases, and really things that made a difference. Meeting people where they are of a good understanding of the science, not good understanding of the science, that crosses all levels. Drug development overall. The total continuity of care for my individual affected. It's not just about a drug, but it's about assistive devices or other tools that they can have a better life. And so being really thoughtful about that I think would be something that would be really amazing. That it's actually captured and taught back.
[00:26:47] Lindsey Dinneen: Yeah, absolutely. That would be a fantastic masterclass. All right, and then how do you wish to be remembered after you leave this world?
[00:26:56] Sara Aswegan: Well, at some point I know my husband will admit I have the best sense of humor.
[00:27:01] Lindsey Dinneen: Yes.
[00:27:02] Sara Aswegan: I think for me, Lindsey, I really would hope that people would say an open heart, a generous heart, and just a connector of people, personally, professionally. It takes two seconds to be kind and open and nobody has all the answers. So help people connect with others and be willing to say, "How can I help?"
[00:27:20] Lindsey Dinneen: Yeah, absolutely. Yeah. And then final question, is one thing that makes you smile every time you see or think about it?
[00:27:31] Sara Aswegan: I just came in from my garden and I have to say, seeing my advancement of fostering my garden and I've got things blooming now. There is hope.
[00:27:40] Lindsey Dinneen: I love that. I feel that way every time I somehow succeed in keeping a plant alive.
[00:27:45] Sara Aswegan: There is hope. It's really around the simple things, right? That's it.
[00:27:49] Lindsey Dinneen: Yeah, absolutely. Now, for any of our listeners who are excited to get to know about you and your work a little bit more, can you just share briefly what is it that you do right now to help companies succeed and how can people get in touch with you?
[00:28:02] Sara Aswegan: Thanks, Lindsey. So I am currently doing some advisory board work for a couple of consultancies as well as helping some small and mid-sized biotechs figure out their pathway and how they go to market. How do they facilitate access to unlicensed medicines? I'm passionate about the rare space, so I'm serving also on a couple of special projects on getting drugs and diagnostics into low middle income countries. And it's something I'm very passionate about and I've got a great network of people. So if I can't help, I'm always happy to say, "Not me, however, I know someone you should talk to."
And to get in touch, it's not easy to spell, but it's www.saraaswegan.com. And again, if I can't help, I might know someone who can. And I think it's just, it's really good to share our knowledge and experience and really make a difference however we can.
[00:28:47] Lindsey Dinneen: Yeah. Absolutely. Well, thank you, Sara. This has been absolutely incredible to learn from you, to hear about your story. So thank you for sharing and being open. I really appreciate that. And my goodness, I just wish you the most continued success as you work change lives for a better world.
[00:29:03] Sara Aswegan: Thanks Lindsey, and thanks for everything you're doing. Really, hats off. Thanks a million.
[00:29:07] Lindsey Dinneen: Of course, and have the best rest of your day. And thanks also to our listeners for tuning in. If you're feeling as inspired as I am right now, I'd love it if you shared this episode with a colleague or two and we'll catch you next time.
[00:29:22] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Adam Power, co-founder and Chief Medical Officer at Front Line Medical Technologies, shares his fascinating journey from a background in vascular surgery to developing COBRA-OS, a groundbreaking device for hemorrhage control. He discusses the challenges and milestones in bringing this life-saving technology to market, the impact of the device in trauma and emergency care, and innovative future applications, including its unexpected use in non-traumatic cardiac arrest. 
 
Guest links: https://frontlinemedtech.com/
Charity supported: Canadian Cancer Society
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 064 - Dr. Adam Power
[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 excited to introduce you to my guest, Dr. Adam Power. Dr. Power is a leader in innovative medical devices for trauma and emergency care that is committed to lowering the barriers and bleeding control and resuscitation. Dr. Power was instrumental in the development of COBRA-OS, drawing on his unique clinical viewpoint and expertise to ensure utmost patient safety and assist with the company's global expansion. In addition to his current role as co-founder and Chief Medical Officer at Front Line Medical Technologies Incorporated, Dr. Adam Power is a vascular surgeon in the division of vascular surgery at Western University, which he joined in the fall of 2012, and he is involved in all aspects of academics and clinical care.
Also, Front Line was just named the 2025 Medical Device Technology Company of the Year, so I definitely wanted to highlight that too.
All right. Well, thank you so much for being here today, Adam. I'm so delighted to speak with you.
[00:01:55] Dr. Adam Power: Yes, it's a pleasure to be here. Thank you.
[00:01:57] Lindsey Dinneen: Of course. Well, I'd love if you would start by sharing a little bit about yourself, your background, and what led you to what you're doing today.
[00:02:05] Dr. Adam Power: Sure, I'd love to. So I'm a Canadian. I grew up on the east coast of Canada and was always interested in science and math and those types of things. I think, importantly, I grew up with an identical twin brother as well. So we really didn't know what we wanted to do with our lives, and ultimately we're good in science and math and ended up in medicine. And then both of us, when we got into medicine, we weren't sure exactly what we wanted to do in medicine, and ultimately both of us became surgeons. He became a urology surgeon, and I became a vascular surgeon, where we joke that we're both plumbers. I deal with the red stuff and he's the yellow stuff.
But I did my initial medical school out on the east coast of Canada and then I did my general surgery training, which also involved trauma training, and then did a Master's of Bioscience Enterprise, which was basically biotech business from the University of Cambridge in the UK. When I finished my general surgery training, I continued on and did vascular surgery training at Mayo Clinic down in the US, and since that time after graduating from there, I've been at Western University in London, Ontario, Canada, for the past 13 years practicing as a vascular surgeon and an academic vascular surgeon.
But when I was here at Western, I was always interested in innovation. I filed my first patent as a resident way back when, and have filed many over the years. But ultimately, if I was ever gonna see anything that came outta my head and was actually used in a patient or I could actually use in a patient, I figured I'd have to do it. I knew that I couldn't do it by myself. And so, I was very fortunate to meet my co-founder Dr. Asha Parekh. She's a PhD, biomedical engineer, extremely smart jack of all trades, and we teamed up now about eight years ago.
We met here at Western, teamed up and really took an idea right out of our heads and patented it and raised money for it, prototyped it, brought it all through the regulatory steps to approvals, built a quality system and ultimately got it out onto the market in Canada, US, Europe, now Australia, and more to come. So the commercialization piece is what we've been focusing on over the past three years. And it's been really fun, but very exhausting but very rewarding as well. I think I'll stop there because I've been blathering on, but...
[00:04:39] Lindsey Dinneen: No, it's fantastic. I really appreciate it. Plus, it's really fun to hear about your trajectory and so, okay, so you've teased us a little bit about this company of yours and this innovation of yours. Can you now share a little bit more about that and the development of it over time?
[00:04:55] Dr. Adam Power: Yes, of course. Well, I mean, thing that we recognized early on is, and I'll just explain how I normally explain it, is if you have bleeding, it's a hemorrhage control device. And so if you have bleeding in your extremities, then you can often either put pressure on it or you can put a tourniquet on it. The problem when you have internal bleeding in the torso is that you can't actually put direct pressure on it, and there's no tourniquet that necessarily works for intraabdominal, intrathoracic bleeding.
And when people bleed to death before coming to hospital, I mean, they're bleeding in these areas. You can empty almost your entire blood volume into your chest or into your abdomen. And this does account for a significant number of fatalities in all environments, basically in the trauma environment. That's military, that's pre-hospital, that's any time that that people are bleeding from internal organs.
And so, because this is such a problem, the old fashioned way to fix it is to open up someone's chest and put a clamp on the aorta. So what does that do? Is it basically above the clamp, keeps blood flowing. The remaining blood in the body keeps blood flowing to the brain and the heart, keep you alive. And then below the clamp, it stops sort of the hemorrhaging from the spleen or the liver or whatever. So there's two things going on. One above the clamp and two below the clamp.
But opening up somebody's chest in, you know, side of the road or in the emergency department really is impossible. You need highly skilled people like vascular surgeons like myself to be able to do this. And even if we were at the side of the road, we don't have the resources available to keep a patient alive.
So there is this idea that we could do this minimally invasively, sort of accomplish this through minimally invasive means. And this, the idea of doing REBOA, which is an acronym-- Resuscitative Endovascular Balloon Occlusion of the Aorta-- came into being. This was probably 15, 20 years ago now. It wasn't necessarily a new idea. It had been done since the Korean War. There was somebody actually put a balloon up into someone's aorta to stop bleeding, but it came back again and was starting to be used a little bit more because.
And so really the idea is to, through the femoral artery in your groin where you can feel a pulse, you introduce initially a sheath, which is your access point, and then you place the device up through the sheath, up into the aorta and inflate a balloon in the aorta. So instead of an external clamp, it's an internal balloon clamp that keeps blood flowing above the balloon and stops the blood flowing from below the balloon.
Initially these devices were as big as my baby finger, like they were massive. And so if you put them in and you took it out, there was a big hole in the artery, had to cut down on the artery and repair the artery. But as it got more and more advanced and technology advanced, they become smaller and smaller.
So that's really where we came in. The initial devices were 12 French, about the size of my baby finger. And then it advanced to Seven French and all of a sudden Seven French-- and these are diameter, French sizes are basically diameter-- and so when it went from 12 to seven French, now we could start doing it through the skin without actually cutting down on the artery. But that Seven French size was still very large and you're putting this in the hands of people that don't do this all the time. And so, we had the idea to bring it down even further now to Four French. And so this is essentially the size of an IV.
And so you put a tiny little IV in somebody's femoral artery. And lots of different people can do that. And then you advance the device up in, inflate the balloon and you can magically occlude the aorta. In our first study that we did, the first inhuman study, we averaged about just over a minute to occlude someone's aorta, which was really fast to be able to get that amount of control that quickly. So that, that was really been the advancement is to decrease the access size, make this whole procedure simpler so that so that we can essentially save more lives.
[00:09:08] Lindsey Dinneen: Okay, so thank you so much for sharing a little bit about that. Can you tell me about the beginnings of this innovation and how you brought it to market? Because it's really wonderful to hear all the success, and I'm so excited to hear that it's spreading, you have presence all over the place now. But you know, that's not an easy pathway. And I'm curious if you could walk us through a little bit about that decision to go, "You know what? We have a solution to a known problem, we can make this happen." And then how did you actually go about doing that?
[00:09:42] Dr. Adam Power: Yeah. I think, I mean, I make it sound fairly straightforward, like a nice story, but it certainly was not that. I mean, we were very lucky I would say, that we had a lot of great advisors and mentors that we figured that we try not to fail early, fail fast. We wanted to make this one as successful as possible. So before we made any decision, we often would consult our mentors. And I'm a surgeon. I like to shoot first, ask questions later. My partner is not. And so I think we, we strike an excellent balance between not just the engineering and clinical side of things, but also from driving a business forward, getting all the information, but helping to get decisions made and moving forward.
You know, starting out, we really had to choose the right sort of fit for what we wanted to pursue. We like to say it checked all the boxes. It checked all the boxes as far as even where we are. We're in Canada, we're not in a tech triangle where there's tons of funding opportunities. We knew we would be limited from a funding perspective, so we couldn't choose something that necessarily required a hundred million dollars to start up. So, you know, we had this device that we knew that we could fundraise for it. And then once it was fundraised, it was simple enough that we could get it manufactured.
We chose to go the OEM route for the original equipment manufacturer, so we didn't have to build a manufacturing facilities ourselves. And then really from there, and building a quality system in the regulatory, we did work with a lot of consultants, that was both positive and negative experience. We had great consultants. We had not so great consultants. But really what our our goal was, is to learn the process ourselves. And so there's always manuals for things, even from the FDA perspective. They give out great documentation about what is supposed to go into an FDA application. And we dug into that.
We really tried to understand. We did not trust anyone. That's one of my rules in surgery is, "don't trust anyone, not even myself." So we really didn't trust our consultants, and we tried to double check and triple check everything so that we didn't make mistakes. And of course, we did make mistakes and had to go back to the drawing board a few times. But as much as we wanted to get this out there, we really did wanna learn the process and know the process because ultimately we're the ones that are responsible to the patients in the end, and we needed to make sure that we had a handle on each and every step of the way. We, of course, because of that, were maybe not as quick as we could have been but in other places we became more efficient because, as we learned the process, getting feedback back and doing it right the first time, it really made a difference. So.
[00:12:39] Lindsey Dinneen: Yeah, absolutely. Of course. Yeah, and I appreciate you going into a little bit more of the nitty gritty details 'cause it is so fun to hear the success stories, but of course, as you go along, there's that pathway to success. And it's helpful to understand that yeah, it's gonna be potentially a long road, sometimes windy, sometimes weird, but at the same time that it is possible. So as you look to the future with your company, what are you thinking of in terms of the future? Are you going to continue down this pathway and continue with iterations of this device? Are you thinking of new devices to introduce as well? Or, what are your thoughts for the future?
[00:13:18] Dr. Adam Power: Yeah. And I have to be very careful what I say here, obviously. I can share generically what our thoughts are. We love this. Ultimately there was no better feeling than to use-- I mean, I've used my device to save a patient. And, you know, I would say that Asha, who's my co-founder, she cares. I'm a physician, but she cares about the patients just as much as I do, as does everyone in our company, which is really quite rewarding.
But the future, what does the future hold? We really want this to get to everywhere. Yes, we're in lots of different countries ,have commercialized really all around the globe, but we really wanna go deeper into a lot of these geographies and really help as many people as possible. We realize that we can't do it on our own and are gonna need help. And so that's, we're in a growth phase right now of our company and we're looking for strategic collaboration. We're looking for those opportunities to deepen our ties and in all the different geographies.
That being said, we are inventors and of course we have an idea every day about what we could improve on. But as far as the pipeline goes for our company, we are focusing on some very specific up and coming applications that we hope to have in the next couple of years. And I also wanna say that, I talked about trauma and bleeding, but the more exciting side of aortic occlusion has really been the applications. And you'd think, okay, it makes sense for trauma to be able to stop blood flow and stop bleeding.
But some of our recent successes have been through postpartum hemorrhage. And there is this really, terrible condition called placenta accreta, where the placenta grows into the uterus and when you deliver the baby either by C-section or by delivery, and then the placenta attempts to be delivered, it tears, and you can have torrential bleeding. And, and so our device is being used in these women who are pregnant when inflicted with this condition and helping to decrease blood transfusions, helping to save a mother's life. So that's been really amazing.
And then next on the horizon is strangely there's, it's not even a bleeding application. We've done some research and there's research going on globally about using aortic, minimally invasive aortic occlusion for non-traumatic cardiac arrest. And so if, which is really, again, it's like, "Oh my gosh, does this thing do everything? It might make your supper tonight if you're not careful." So it, so what happens there is that if somebody drops dead basically in front of you, and you start CPR, if you start pushing on their chest and pushing on their heart, you're pushing blood to the whole body. And the way you get someone back to life is if you can get the heart muscle oxygenated again.
So if you put an aortic occlusion balloon up close to the heart, every time you push, you're directing blood right into the coronary arteries and right into the brain as well. And so what we're seeing is that there's increased return of spontaneous circulation rates when you do this with CPR. And there are different trials around the world that if this shows that there's an increase in survival or in better neurological survival, this will be the first time that we've really changed the script on cardiac arrest since advanced cardiac life support came out many years ago.
So this, again, is very exciting for a simple device to be able to make that much impact in all these different areas. So, you know, we have a lot to focus on right now, even growing into the future because some of these, like cardiac arrest, are quite early on. So we don't wanna lose sight of this great original product, but we do think all the time about different pipeline ideas that could help other patients.
[00:17:18] Lindsey Dinneen: Yeah, but, and to your point, even the amazing other use cases for this incredible device, like you said-- maybe it's gonna make us dinner next-- but the idea being that, who knows? I mean, there's so much more to discover even now, which makes me excited just to think about how many more use cases you could have for it and how many more people you could save.
So, speaking of that, are there any stories that kind of stand out to you, moments that you've had where, you know, either through your day job, so to speak, being a vascular surgeon, but also being the co-founder of this company that really sort of affirmed to you that, "You know what? I am in the right place at the right time, in the right industry." Just those moments that really stick with you.
[00:18:05] Dr. Adam Power: Yeah, I mean, it obviously all stems back to the patient and what patients are impacted. And I remember, the first time that the device was used at our hospital, one of the radiologists called me in and said, " We need to use one of these balloon occlusion devices for a patient that's been in an accident." And so I went in and I said, "I actually have the device that my partner and I created. We can use this for the patient." And so we started using it for the lady that was involved in a very serious accident, had a pelvic fracture, and she was a Jane Doe at that particular time. She was anonymous. And anyway, we noticed that she had actually had some vascular surgery done based on her angiograms, and I leaned over and I-- so she was sedated, but she was awake-- I said, "Have you had vascular surgery? Who's your vascular surgeon?" And she said, "It's Dr. Power. He's such a nice man." And so I was actually helping one of my patients. That was pretty crazy.
[00:19:04] Lindsey Dinneen: Oh.
[00:19:05] Dr. Adam Power: Also from my hospital, when I heard one of my junior residents was able to save someone's life. So, you know, junior residents are often good, but they're not trained surgeons. And so to have a simplistic device that one of my residents could actually place and help someone, that's pretty amazing too. There's also been times where like even the postpartum hemorrhage, we hear the first cases in the States of saving mother and baby. That's pretty incredible. Or that we donated some devices to the Ukraine conflict as well, and we heard that it saved some soldiers' lives as well. And there's different military groups that, that use our device and save soldiers.
So it's all back to the patient. And hearing those success stories and hearing about somebody alive because of this particular device, because of all this effort that we've put in. I mean, it's really makes it worthwhile. It sounds kind of corny, but as a surgeon, I can help one person at a time, but as somebody involved in industry and medical device industry, I don't even have to be there. You know, this device can help long after I'm gone. The tricky part of it, being the Chief Medical Officer is, I usually only have to worry about my patients. Now I have to worry about everybody worldwide and the device being used. That was a little hard to wrap my head around initially, but yeah.
[00:20:28] Lindsey Dinneen: Yeah, of course. But the ripple, the ripples, the impact that you get to have because of this device and because of your diligence getting it to market, because it isn't an easy path, and that's incredible. So thank you for doing the work that you're doing. That's not easy and it's very appreciated. This is incredible. So, yeah. So, okay. When you were growing up, let's say 8-year-old, Adam-- you know, you're having a good time doing whatever you like to do-- could you possibly have pictured yourself where you are now?
[00:21:08] Dr. Adam Power: No, I don't think so. I mean, I, I. I came from a very small, like, small upbringing and, you know, in my family I had absolutely lovely family members, but they really, apart from my aunt, they weren't overly educated. And so I really didn't know what it took to be successful in life, really. I had work ethic from my parents, that's for sure. And so that's what they bred into me. And all I knew is that I was gonna work as hard as I could, and I figured that as long as I keep working-- and I was lucky to have some brains as well-- then I figured things would fall into place.
They honestly haven't fallen into place exactly how I pictured them as I grew older and what it would look like. But I'm certainly thankful for where I am right now, and what is the next five years or 10 years gonna look like? I have no idea. And I guess I just don't even picture it. I have goals, but I also know that those goals change depending on circumstances. And you need, as I'm growing into middle age-- I think I'm beyond middle age now-- I'm thinking about midlife crisis and things like that. I get into philosophy and there's like telic and atelic things and so, it's sounds, again, it's about the path and the journey.
It's not about the ultimate goal because, having reached a lot of these successes, that good feeling lasts for maybe a day or half a day. And you think you know, I spent all these years coming with the, with our device, getting our device to market and getting FDA approval and like, oh my gosh, like, you'd think, I'd feel so great about that. And it did. It felt great, but you wake up the next day and you gotta keep going. So you have to enjoy the journey and that's really what it's the wisdom that comes with age is trying to enjoy the journey as much as possible and not focus too much beyond that.
[00:23:09] Lindsey Dinneen: Yeah. Yeah, and I think that's really good advice too, in that it is because the daily life isn't usually all the celebration and successes. I mean, that does happen and those are good moments, but because the vast majority of our life is spent on the journey component of it, and going through those peaks and valleys, it is important to find something you love and feel that you can make an impact in. So I'm so thankful that this is what you've chosen to do.
So pivoting the conversation a little bit just for fun, imagine that you're 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?
[00:23:55] Dr. Adam Power: And would that mean that I was an expert in it?
[00:23:58] Lindsey Dinneen: Well, certainly if you're getting paid a million dollars, somebody has decided you aren't an expert at it. How about that?
[00:24:05] Dr. Adam Power: Okay. Well. Can I pretend like I'm an expert in it? There's something that I really love, but I'm not I'm probably not an expert in it. It would be, I would teach a masterclass in DJing. Isn't that strange? I know it's so random.
[00:24:21] Lindsey Dinneen: Oh my goodness! Tell me more!
[00:24:23] Dr. Adam Power: Well, I mean, I love music. I've, I grew up playing lots of sports and never was involved in music. And, and I've always appreciated music and art, but I was never able to do it. And, you know, growing up I did love sort of all types of music and then even electronic music and it just somehow talked to me. So I started DJing electronic music basically when I was around med school and have always loved it now, and when I was over in England, I DJ'ed on the campus radio and also DJ'd in a club.
It was really fun and it sounds pretty silly to be talking about this when I have these other things that are on the go. But honestly, being able to share space with other human beings these days, and actually having a good time and having it not be stressful and having it be only, you know, everybody's wishing others to have a good time. There's not many people that go out sort of dancing into electronic music that are thinking bad things about other people. Really they're just out for a good time. And so being able to steer that whole music and scene is pretty awesome. And I do love it. And I don't DJ as much as I used to, but I still do different events, usually Christmas parties for the operating room. I'll do the typically wedding sort of DJ, but then they always, 'cause they know me, they let me do an hour long electronic set, which is like hardcore electronic. But then I go back to the regular stuff. But I would want to teach a masterclass in DJing.
[00:25:56] Lindsey Dinneen: That is awesome. How exciting. Oh my gosh, I love that. And I think you're right. Music brings us together and it's a wonderful way to, to share a little bit of joy.
[00:26:07] Dr. Adam Power: Yeah.
[00:26:08] Lindsey Dinneen: Yeah. Okay. And then how do you wish to be remembered after you leave this world?
[00:26:15] Dr. Adam Power: I, so number one is I don't, again, with my midlife crisis, I've actually been trying to eliminate my ego as much as possible. And so when people talk about legacy, it actually gives me the hives these days to be quite honest, because I don't like that because I think you're focused a lot on yourself. In my opinion, a lot of legacy is all about you. The way that I would wanna be remembered, though, is truly that I was kind and compassionate to everyone that I met, and that I stood for something, and that I left the world a better place.
[00:26:57] Lindsey Dinneen: Yeah, those are wonderful things to want to be remembered for, absolutely. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:27:09] Dr. Adam Power: My kids. My son Kai and my daughter Saoirse. They are the light of my life. And I, you would think that with how busy I am ,you know, those things would deprioritize, but they truly are the one thing in my life that makes me smile when I get up in the morning.
[00:27:30] Lindsey Dinneen: Oh, that's wonderful. Well, that is absolutely incredible. I loved getting to meet you and speak with you a little bit today. Thank you so much for sharing about your journey. Thank you for sharing about your incredible device and your bits of wisdom along the way. The idea of we've gotta enjoy the experience, the path, the journey. And I just really appreciate you spending some time with us. So thank you for everything you're doing to change lives for a better world.
[00:27:59] Dr. Adam Power: Oh, well, thank you for giving me the opportunity to speak with you. It was absolutely lovely chatting with you today.
[00:28:05] Lindsey Dinneen: Wonderful. Well, thank you again so much. Thank you also to listeners who are tuning in, and if you're as inspired as I am, I would love it if you would share this episode with a colleague or two and we'll catch you next time.
[00:28:20] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Morgan Evans is a biomechanical engineer, serial medtech entrepreneur, and angel investor. She shares her journey from aspirations of becoming a doctor, to working in mergers and acquisitions at Medtronic, to co-founding/founding six companies, including Agitated Solutions and Avio Medtech Consulting. Morgan discusses the importance of supporting startups in accelerating market entry, the challenges and opportunities with innovative medtech development, and the value of servant leadership.
 
Guest links: www.aviomedtech.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
 
EPISODE TRANSCRIPT
Episode 063 - Morgan Evans
[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 excited to introduce you to my guest, Morgan Evans. Morgan is a serial medtech entrepreneur and investor, which means her passion is launching new businesses. She's a biomechanical engineer by training, went to business school and worked for Medtronic in corporate development before jumping fully into the world of startups. Over the past 10 years, she has founded or co-founded six companies: two medical device companies, two medtech accelerators, and two venture investing vehicles. She spends most of her time with Agitated Solutions, which is developing several innovations related to contrast and ultrasound, and Avio Medtech Consulting, which helps lower the barriers to entry for new ideas and new medtech companies.
All right. Well thank you so much for joining us today, Morgan. I'm so excited to speak with you.
[00:01:42] Morgan Evans: Thank you again for having me. Pleasure to be here.
[00:01:45] Lindsey Dinneen: Of course. Well, I'd love if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and maybe what led you to medtech.
[00:01:53] Morgan Evans: Sure, of course. Originally from Houston, I went to school in the Bay Area and studied to be a biomechanical engineer. I originally thought that I was gonna be a doctor, and wanted to start in heart lung transplant of all things. Did an internship between my freshman and sophomore year and quickly learned two things. One is that I love people a bit too much to distance myself emotionally, so it would've really been a hard career for me, I think being on the front lines with that.
But the second important thing I learned as well was there was a lot of technologies that existed in the medtech side of the world, just trying to buy people time and give options. And so I fell in love with medtech as a career relatively early. Started working for my first startup in the neuromodulation space before I even graduated undergrad, and loved that. Wore a ton of hats ranging from engineering, clinical commercial. I did some vertical line integrations in there and I started before we were even at 10 employees, left at 55. Thought it was massive 'cause we had middle management.
Then toward the tail end of that, started studying to go to business school 'cause I realized I was getting further and further away from my engineering degree. And then I went to Kellogg at Northwestern and when I was there, co-founded my first startup with a clinician that had a great idea, didn't really know how to navigate the regulatory side of the world, and we co-founded that company together. And toward the tail end of that, was recruiting for formal kind of post-business school. Where am I gonna land? What am I gonna do?
And decided to go to Medtronic and do mergers and acquisitions within the corporate development team. Did that for about two years. Loved it, learned a lot. The team was great. But big company was a huge change, especially as I just mentioned, you know, I thought 55 was large with middle management. And then you go to 90,000 at the time and deal teams of that. And kind of felt like my calling was going back to startups, so left in 2016 and have been innovating and building companies ever since.
[00:03:53] Lindsey Dinneen: Wow. Okay. Well, thank you for sharing a little bit about your background and everything that's led you to where you are today. I really appreciate it, and so I am so intrigued. Okay, so you were on track in, in theory, initially to be a doctor and to go that route and then decided, "Okay, well, maybe this isn't for me," which is so great that you learned earlier rather than later, of course. But so as you were processing through making this transition into medtech and going, "Oh my goodness, there's actually a whole lot here." Were there any particular things that really stood out as being the most intriguing? Were you just kind of interested in the industry as a whole, or were there specific things where you thought, "Oh gosh, I really wanna learn about X, Y, and Z."
[00:04:37] Morgan Evans: Yeah. Two things happened in relatively short order that I think landed me in my love, right? The first is, when I was doing this internship, they actually had some preclinical research going on in the basement of the hospital. And I, it's a long story, but I randomly ended up wandering into this place and figuring out it existed, and saw some of the early preclinical research happening live where they actually had a pig that they were trying to induce a heart attack in to then do a treatment for. And this pig actually coded in the middle of the procedure and they literally come out with paddles. And I'm just like, "This is the coolest thing in the world, this is actually how innovation is done and people learn." So that kind of, "Oh, cardiovascular sounds really interesting," was where I originally started.
And then, at the time when I was at Stanford, I was playing on the basketball team as well, and I went to a event with some supporters of the program. And the person at my table was Chairman of the Board of a neuromodulation startup, autonomic technologies. And the one thing I at least love that I'm not afraid to ask questions. And so I just was like peppering him with like, "What is this? How does that work?" And that actually led to my first job. And it's kind of fortuitous that you're in the right place at the right time, but then just get exposure, and that was in pain and pain's a hard space. The type of treatment we were doing was treating condition that was known as a suicide headache. And so I think that was helpful to see the impact of the work we can do so early on. And then I, like I said, I've been hooked ever since.
[00:06:05] Lindsey Dinneen: Yeah. Yeah, that's great. And those are great stories. I love the synchronicity and how those moments sometimes just play out perfectly and lead you to your next right step. So now you are in a position where you are advising startups, but you have lots of things going on. I feel like when I was looking at your LinkedIn, there were multiple different organizations you're a part of and participating in. So could you share just a little bit about all the wonderful things you're up to these days?
[00:06:31] Morgan Evans: Yeah, for sure. So my day job, as I call it, but where I spend by far majority of my time is I am co-founder and CEO of a company called Agitated Solutions. And we say that we're unlocking the potential of diagnostic ultrasound. So we have multiple products that include a contrast agent that's revolutionary and that it has a temporary micro bubble, looking for holes or flaps known as a patent foramen ovale in the heart that's highly associated with cryptogenic stroke. So we have contrast side, and then we also have some software as a way to have better prediction of what our high risk shunts and what could cause stroke. That had a company spin out of it called Moonshot Medical that is more of a traditional incubator where we put all of the IP and ideas that weren't quite ready to be full-blown companies, but we knew there were some things there that I also technically lead. So those are the two that I'm CEO of.
I founded a company called Avio, that I'm very passionate about, that is really focused on trying to help get these medical technologies to market faster. The work we do is on the backend of medtech, so quality systems, regulatory, R&D project management. But just in the theory that there's so much paperwork that is behind any innovation, like how do we get better at that paperwork so that we can keep innovators doing what they do best. And then we're just really that helping hand alongside.
I joke, all of the things I'm involved in, this was my happy accident. I felt like I was building what I needed for my own startups. Literally no intent of anyone else ever seeing this or offering that as a service. And I just remember distinctly, I woke up one day shortly before my son was born and I was like, "Oh, I think there's actually a business here. Maybe I should run it like one." So that's another one.
And then passionate about angel investing in early stage as well. When I fundraised for the first time, I was 29. I'm now 37. I get asked that a lot, although you're not supposed to ask a woman her age. When I fundraised for the first time, especially in these early stage rounds, no one looked like me, both in gender or age. And so I'm one of those believers, "Put your own money where your mouth is," even if they were baby checks to start, they were something. And that's been another area that I also spend some time.
[00:08:48] Lindsey Dinneen: Yeah. Wow. Okay. So you've got a lot going on to, put it mildly, which is fantastic. You mentioned something that really stood out to me. You're trying to help these startups bring their medical technology to market faster. And I'm curious, are there maybe one or two things that you see a lot of startup companies perhaps either accidentally overlook, or delay too long, or something like that, where, at the beginning, if they had done X, Y, and Z, they could have gotten their technology to market faster.
[00:09:21] Morgan Evans: Yeah, a couple thoughts. One is I think people underestimate the amount of time that it takes to formally document all of the things that go into getting your device compliant and on the market. For example, I've had a client before that came to us that had a product that was working. He had tested it, he'd done all these things and it was a software, and ready to go, and submit to the FDA. And then you're like, "Well, we need user needs and product requirements, and your design schema," which, you know, there is a reason that these processes exist and I think they can make you have a better product at the end of it.
But I think, you know, people assume, "Let's build the right product first and then worry how to document it." And then you forget sometimes why certain decisions were made or you know, is this actual requirement or was that done because it was an off the shelf thing? And so there is a lot of learning that I think can be lost by waiting.
Now all that said, the other part of it would be that if people kind of shore up too fast, so you overbuild the team, you have a quality person, a regulatory person day one that feel like they need to be doing all of the things and justify their full-time job, then you end up documenting and revising. So there is some healthy balance and tension between the two. So it's not easy to get it perfect. But I would say those are the two areas that come to mind.
[00:10:37] Lindsey Dinneen: Yeah, that makes a lot of sense. And I can see where the polar opposites could be challenging. So staying happily in the middle, working with an expert such as yourself, is a really wonderful way to go about that. You mentioned angel investing and being passionate about helping. It sounded like based on your own experience, you're very passionate about helping the next generation of leaders and entrepreneurs in this space create the products and bring what they envision to market. As you've gone about this, and even as you learned for yourself how to fundraise, maybe feeling like, "Hey, nobody else looks like me, is my age," or whatever, what are some learning lessons that you've experienced that you would suggest for somebody who's maybe in a similar situation that you were in?
[00:11:28] Morgan Evans: Yeah. Some of it is just to be a little bit fearless, I would say. There's a lot of people that have told me over the years, "Pick one. I don't understand how you do all these things." My least favorite question I've ever gotten is, "Do you ever see your kids?" Yeah. But people ask you that, you know? And I think it's easy to let other people tell you what you should be or what your product should look like or your path should be. And I think I have been fortunate to find some wonderful mentors that empowered me to be my own version. I didn't have an example of someone that had built the things in the way that I had built them or that had a couple of them at one time.
But I also knew very confidently that I wasn't dropping a ball and I was doing the right thing by the companies I was building and supporting. And it was helpful to have the army behind me that just loved me for me and supported me in that, in developing it. And I think that next generation of entrepreneur, if you can find the same, that's willing to lean in just for you and there's no ulterior motive other than just to see you be successful, hold on with both hands and then pay it forward to the next one.
[00:12:38] Lindsey Dinneen: Yeah. Yes. That's great advice and insight. So when you're thinking about your own career and the companies you're leading, what are some things that you're looking forward to in the future as you yourself continue to evolve and develop your own skill sets and whatnot, and also for your companies that you're leading? What are you excited about?
[00:12:59] Morgan Evans: Yeah, I think for me, I'm excited about building that next generation of entrepreneur, which we've talked about a little bit. And how do I influence and build and develop those things without me being the one actively leading them? That's been a new learning that I'm continuing to kind of dabble in and grow personally, which is leading through the art of board work or questions or advising, which is different than leading a company by physically being the head of that company. And thinking about how to train and develop and give people enough of a leash to go and run and be them, but yet have that support system that you're still within their appropriate guardrails that-- I'm kind of mixing metaphors, but I think you get it. You know, it's an art, not a science, and one that I'm enjoying learning and growing and developing in this next phase too.
[00:13:53] Lindsey Dinneen: Yeah. Well, and speaking to that in general, so I'm sure you've had a mixture as most of us have had, of good experiences with leadership and poor experiences with leadership, and I'm curious how that has shaped your own leadership style now, especially as you're in this new phase of further developing your leadership skills to look a little different than perhaps they have in the past. But what do you draw from and what's your inspiration when you've developed your own leadership style?
[00:14:23] Morgan Evans: Yeah. As I mentioned earlier, I've had a wonderful network of mentors that I think have really leaned in and and done it in the right way for the right reason. And I hope to emulate that myself, of being there to grow people and the technologies and the businesses that you're doing and giving them those chances to shine. As a leader, I believe very much in servant leadership. I never want someone to work a weekend that I'm not working as well. But then you kind of realize that isn't always feasible and can feel uncomfortable sometimes. And how I've evolved to give other people those opportunities, but recognize I'm not gonna be in the weeds enough to help them in the same way, it's a journey. I'd love to say I'm at the destination. I'm one of those, I love iterative improvement. I don't think I'm ever at a destination. But just really trying to lead through the art of question, for example, as opposed to coming with thoughts and opinions, has been a big one for me in the last couple months in particular.
[00:15:20] Lindsey Dinneen: Yeah. So approaching with curiosity, it sounds like in an effort to understand and or provoke even perhaps that person taking additional ownership or responsibility in their own creative solutions to perhaps what they're coming up with. Are there particular questions you've found that are really helpful as you're shaping these conversations, helping people understand their next right step?
[00:15:46] Morgan Evans: Yeah, I, it's funny because one of my mentors that's been coaching me on this is, she's kind of had that progression of learning to shift from, in the absence of leadership, lead, to leading someone else through that. I actually text her periodically and ask her for guidance of, "Hey, they came to me with... This is what I would normally say. How do I frame this in a question such that I'm giving them enough direction, but not leading the horse to water." So it the art of the question is in, in fact, itself an art. In general, I would think about asking something in the framework of, "Have you thought about the ramifications of?" or, " What is the key thing that we should focus on this week?" It's almost trying to pick out what I would focus as being the main thematic issue or next step, and giving them enough of a carrot that they can get there, but not quite telling them exactly how it should be done.
[00:16:44] Lindsey Dinneen: Okay. Yeah. So in general those sort of probing questions that might suggest, "Hey, have you thought about X, Y, and Z? Or, what are your thoughts about X, Y, and Z related to this?" And letting them continue to take ownership and responsibility for that. That's really great. One thing I noticed, and I don't know if this is something you currently still do or not, but I was noticing on your LinkedIn that at least at one point you had a Medtech Startup CEO Bootcamp, which just sounds awesome and I would love, if you don't mind, sharing a little bit more about that and what that looks like.
[00:17:17] Morgan Evans: Well, the good news is we are doing it, we're doing another one, I think in June. I'm happy to say I don't know the exact date 'cause that means I'm not in it enough to know exactly the dates. So in the spirit of me trying to take myself up a level -- success. But no, it's interesting because I had worked in medtech for five years before business school, went and got a traditional, you know, learning in all things business, right? Graduated, went to Medtronic, did M&A, and then came and did my first startup.
And I remember day one it was like, "Do I form an LLC or C corp?" No one had taught me that. And it's funny because, now you can understand the nuance of the question, but I can't imagine how much money I spent on the first attorney. And yes, there's pass through income, but you know, is that appropriate for investors for me to take a disproportionate loss or there's 1202 tax code and all these other nuance. So I started realizing that a lot of just taking the first step where things that you have to learn on your own or find a really awesome board member, advisor, et cetera, to lean in and help you too. Other examples would be, you know, "How much stock options do you normally give your board?" Or, " Should I do a convertible note or a safe? What is a quality system," right? I knew entrepreneurs that had no idea what those things were.
So the thought was, "How do I give enough detail to these other entrepreneurs, so where they at least feel that they can ask the right question?" Because to think that I can teach someone the nuance of verification, of validation strategy in an hour or four, versus someone that has done nothing but R&D for 15 years, right? That's not gonna happen. But if you could teach them enough to then say, "Hey, my CTO or contract design partner, should we dry run this test first? Or what test should we dry run?" Right? If we can give those people just enough there to phone a friend, that was the goal of the program. So just giving people that lay of the land and enough of a roadmap. And a lot of this too, like we literally have an acronym sheet because medtech is full of acronyms, and it's funny that like our acronyms can mean something completely different in other people's spaces. And so just even learning the lingo day one, like what's an SOP or CMO or CDO?
[00:19:40] Lindsey Dinneen: That's incredible. I love that. That's so great that you have a cheat sheet because I remember that being such a learning curve when I first got into the industry of, " You just said an entire paragraph worth of acronyms and I would love to understand what you're talking about, but I don't yet." so learning how to decipher all of that was great. I'm thankful for it, but yeah, that's wonderful. A cheat sheet sounds fantastic. You know, it's interesting 'cause you mentioned, with this bootcamp, first of all, I'd love that you offer that. What a fantastic offering for anyone in that position who's just needing that support and that extra guidance, and having something that's so specific to the industry is great. Do we just go to your website for details if anyone's interested in that?
[00:20:24] Morgan Evans: Yeah, it would be on the aviomedtech.com website. And then I believe there's a tab that is regard to the bootcamp. And yeah, like I said, it's all the stuff that I wish I would have learned or I learned. It took me way too much time and money, that I just want people to know where the landmines are that I had to step on. And if we can just accelerate that learning and that s-curve for the next entrepreneur, we can get these products to market a lot faster.
[00:20:50] Lindsey Dinneen: Yes. I love that you offer that. You've gotten to have an amazing career where you've been diving into the industry itself and working for other people, and then of course being a leader in your own companies now as well. I'm wondering if there are any stories that stand out to you as really just affirming, "You know, I really am in the right place at the right time in the right industry"?
[00:21:12] Morgan Evans: Yeah, it's funny. I don't get to reflect on this very often, but I co-founded Agitated Solutions and I founded Avio within one week of each other. I didn't know, again, that I was building what I was building on Avio's side. But what's been so much fun is that as I build and grow this awesome company, that's being an entrepreneur myself, being able to take learnings where I see them and try to pull them thematically into Avio so that you kind of have that flywheel effect. So I'm learning that I enjoy both operating within these technology companies, but also trying to figure out what of the system, or the process, doesn't make sense. Like I know other people might do it this way, but why? And, being able to innovate on the system and the output at the same time has been super fulfilling for me.
And like I said, it's kind of a little bit of coincidence that it was within one week of each other, but that's part of where I've learned for myself that I don't think I'm fulfilled by just being in one company or one thing fully, and in fact, me being in something else is part of what makes me better at the other thing. So I feel really fortunate to have found that and to know where my passion lies.
[00:22:41] Lindsey Dinneen: Yes. That's very cool. And definitely a gift. And you know how things sort of translate into each other-- I was thinking about this earlier because-- I noticed, and you also mentioned that basketball was, and is as my understanding, a core part of your life. And so you've been both a player, you've been a coach. How has basketball played a role in either life lessons, life skills that you've drawn from it, and or how does it just incorporate into your life?
[00:23:11] Morgan Evans: You know, it's actually a really fitting question. So first of all, as an athlete, it taught me I cannot stand to be the weakest link on a team. And when you think about that servant leadership, or that hustle or that grit, I was tall, but I was not the most naturally gifted athlete. And so a lot of where I excelled in basketball was on fundamentals, just solid, putting in the time and doing it. And then I got to the point in my career where I could not outwork other people. I could put all the time in the world in there and I was not going-- like I played behind All American Centers when I was at Stanford, and everybody was an All American coming in to play basketball. And it was a good evolution for me to learn a little bit of "How else can I then play a role if I'm not the most gifted athlete?" and to recognize that a team can function well with all those pieces regardless, right? So I don't need to be the leading score to still have an impact on the team was kind of a good mental awareness of how talent gets pulled together to make effective teams.
The other thing on the coaching side, so I actually had career ending surgeries between my junior and senior year. And basketball was, and still is, a big love of my life. And to then have my playing days over unexpectedly was a big transition, and I got to see basketball from the sidelines my senior year. And my job then was to make the other players more effective, to study scouting report, to teach, to try to do what I could to get the team ready, knowing I would never step foot on the court. And if you think about some of the parallels we've already just talked about, which is leading through the art of question or being able to lead and guide, but not being able to be out there, running around with everybody else in and of, in itself is a very similar transition to what I'm going through and continue to go through.
I coach young women. I did except for this last year. It's been hard with two kiddos, in particular on my husband, especially, you know, we would do travel tournaments and things like that. But coaching young women too, and realizing it's the end result, but it's also wanting them to be good people and life lessons and skills through it. And how do you have them help respond in adversity? All of that, I think, makes me a better leader, and there's a lot of parallels to the working place, for sure.
[00:25:35] Lindsey Dinneen: Yeah. Yeah, that's wonderful. And having a gift like that, even when it looks different and morphs over time, I love that you've been able to draw from it such inspiration and application to other areas of life. I think that's really special. Such a cool aspect of being an athlete. So yeah, thank you for sharing about that.
[00:25:51] Morgan Evans: Of course.
[00:25:53] Lindsey Dinneen: So, pivoting the conversation a little bit just for fun. Imagine that you are to be offered a million dollars to teach a masterclass on anything you want-- could be within your industry, doesn't have to be-- what would you choose to teach?
[00:26:07] Morgan Evans: I would teach something on scrappiness. From my experience, I think there's a lot of people that would know the industry really well, but the how to get things done atypically for less money faster. And that's some of the thematic elements that I hope I'm-- not for a million dollars-- but, you know, starting to teach in our bootcamp. Some of the belief that I think sometimes you get these companies in medtech in particular that are kind of overbuilt, too much too soon. And now they have a really high burn rate and everybody has to leave, essentially a unicorn exit or bust. And how can you burn down and mitigate risk with little dollars and making sure you're spending your dollars in the right places early on? I continue to learn from others in that too, I should mention, but I think it's an area with a lot of impact.
[00:26:59] Lindsey Dinneen: Yeah, absolutely. And so relevant and helpful for startups that have no choice but to be scrappy and learn how to be creative on a dime. I think that's fantastic. Great. And then how do you wish to be remembered after you leave this world?
[00:27:16] Morgan Evans: Yeah. I hope it's something to do with innovating on technologies that improve and help patients, but also innovating with people and process, that hopefully on all of this, that we're leaving the world a little better than we found it.
[00:27:33] Lindsey Dinneen: Yeah. Yeah, absolutely. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:27:42] Morgan Evans: Definitely my family. I have two kiddos, Marley and Mason. So my daughter's three months, my son is three. And then my husband Matt. It's hard to do all the things that I do without having an amazing support system. And, you know, you can have the hardest, most stressful day and you come home and my son's like, "Do you wanna play with me?" Or, "Let's play hide and seek" or something. And it's just funny how instantly all that stress kind of melts away. Very grateful for my family.
[00:28:10] Lindsey Dinneen: Yeah, family is such a gift. Wonderful. Well, this has been such a great conversation, Morgan. I really appreciate you spending some time with us today, and thank you for sharing about your life and your story and your advice. I am excited to see how you could just continue to grow and thrive. I love the fact that you are just a total boss with all the things that you're doing. So thank you for contributing your gifts to the world, and gosh, I just wish you the most continued success as you work to change lives for a better world.
[00:28:42] Morgan Evans: Thank you again for having me. I appreciate you.
[00:28:45] Lindsey Dinneen: Of course, 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. Thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you'd share this with a colleague or two, and we'll catch you next time.
[00:29:16] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Bethany Corbin, a nationally recognized healthcare innovation attorney and femtech entrepreneur, shares her inspiring journey into the medtech industry, driven by personal experiences and a passion for women's health. As the founder of Women's Health Innovation Consulting, Bethany discusses her new book, "The Femtech Revolution," which aims to educate and empower women in navigating the women’s healthcare space. She offers practical advice for self-advocacy in healthcare settings, emphasizes the importance of privacy and equity in digital health tools, and highlights her role in shaping the future of femtech through leadership, mentorship, and legal guidance for startups.
 
Guest links: http://linkedin.com/in/bethanycorbin/ | https://femtechlawyer.com | https://www.amazon.com/Femtech-Revolution-Harnessing-Technology-Supercharge/dp/139433091X
Charity supported: ASPCA
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editing: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPT
Episode 062 - Bethany Corbin
[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 am so excited to introduce you to my guest, Bethany Corbin. Bethany Corbin, JD is a nationally recognized healthcare innovation attorney, femtech entrepreneur, and influential thought leader at the intersection of women's health and law. She's the founder of Women's Health Innovation Consulting and Fem Innovation Organizations Design, organizations dedicated to advancing equitable cutting edge solutions in women's health. Her book, "The Femtech Revolution," empowers every woman to confidently navigate the femtech space, equipping them with essential tools to protect themselves and advocate for their health needs.
All right. Well, welcome to the show, Bethany. I'm so excited to be speaking with you today.
[00:01:35] Bethany Corbin: Thank you so much for having me, Lindsey. I'm honored to be here.
[00:01:39] Lindsey Dinneen: Awesome. Well, let me just start by asking you if you don't mind, to share a little bit about yourself, your background and what led you to MedTech.
[00:01:48] Bethany Corbin: Absolutely. So I'm an attorney by background, which is not the traditional path that one would think of when we think of medtech. I actually, when I went to college, I wanted to be a doctor and get kind of into the biology and the sciences, and I realized I was actually really terrible at them.
It was not where my skillset aligned at all and I had to do a bit of recalibrating ,realized that I loved kind of research, writing, learning about new things, and ended up going into law from there. When I first went into law, though, I was actually in financial services and litigation, so it was like the farthest thing ever from healthcare and medtech, and it was horrible. I actually hated it.
And, from there, I ended up getting a clerkship in DC and that gave me time to really consider what I wanted to do after that clerkship ended, and really where I wanted to focus my practice. I have been involved in healthcare since I was eight years old. My mom actually had an illness where doctors continually dismissed her. And so it took us seven to eight years to get a diagnosis. So, I had a lot of background with healthcare, then had a lot of background in healthcare with my grandparents getting sick. And so for me, healthcare was always something I was really interested in.
I started to look into health law. I actually, at the time that I was doing my clerkship and going into my next job was doing a healthcare LLM-- so essentially a master's degree for lawyers in healthcare law, and I ended up transitioning into healthcare law from there. I was doing big law in Washington, DC at the time, doing your traditional healthcare things right?
Like your managed care pharmacy, benefit management all of those kind of things--some healthcare privacy. And, it was great. I actually got the opportunity to teach law at my alma mater, and it was while I was there, it was in 2018 that I actually came across the term femtech for the first time, and I had never heard this term.
I got really interested in it, really excited about it, and I started focusing my research portfolio and scholarship on femtech. So I went and did my first conference on femtech, wrote my first paper on femtech in that time, and really started to see the impact that this could have on women's healthcare going forward.
So I actually left teaching went back into big law in order to focus on femtech and while I was there I realized that a lot of the companies that were creating these products were startups. And of course, big in big law, you're not really working with startups, you're working with those larger corporate institutions.
So I actually left big law, went to a smaller firm where I could start and focus on a femtech practice and work solely in digital healthcare. And I absolutely loved it. I got a lot of expertise and knowledge, and then from there branched out into having my own firm focused on femtech and working with early stage founders to help them bring their products to life, to revolutionize women's healthcare.
So I know that's a long roundabout way of getting there. I'm now running my own firm, and I have a book on femtech that's coming out this fall.
[00:04:41] Lindsey Dinneen: Oh my goodness. First of all, I love hearing the background and the winding path that led you to this incredible calling, and I would love, okay, so many things stand out, but let's start with your book. Can you share about that? Because I am personally very excited about this, and I would love to hear about your journey and writing it, and then what's it about and how can we even get a copy.
[00:05:02] Bethany Corbin: Yes, absolutely. It's so funny, right? 'because if you had talked to me three years ago and told me I would write a book, I would've said that you were crazy. And it's interesting. My book is called the Femtech Revolution, and it's really about harnessing digital health tools to improve and help to transform and revolutionize women's healthcare because for so long, women have been left out of the conversation about healthcare. Our bodies haven't been studied. There's a lot of disparities that we have and a gender data gap that we have when it comes to women's healthcare. And this has continued today.
When my mom, you know, when I was eight years old, she was continually dismissed by doctors and told it was in her head. Coming full circle, I had my own women's health issue very unexpectedly in 2021, and my pain was actually dismissed and mismanaged with my surgical team.
And so seeing that occur in today's environment and how little we've grown in women's healthcare and innovation over that time period was something that, for me, was really a driving factor, not only in my transition to femtech, but also in writing this book. Because there's been studies that have shown that about 89% of women have actually never heard the term femtech, and yet it's this entire multi-billion dollar industry that's being created for us, but we don't know about it, and we can't get access to it because of all of the censorship and stuff that happens online.
So we don't even know this exists. These tools are being built, and then we're not seeing a lot of investment or adoption into the tools because we don't even know they exist. So then, the companies can't get the consumers that they need. And of course we're also living in a time in which we're in this post Roe v. Wade environment where, I'm sure as people remember, there were a lot of calls to delete your period tracking app, and things like that when the Dobbs decision came out.
And so when I've been working with startups, I always do it from a very consumer-centric perspective, which is we want to maximize privacy for consumers, we want to give them accurate tools and devices that they can use. And we want to be promoting health equity so that these tools can be available for women regardless of their income and their status and their circumstances.
And as I was working with startups, it dawned on me that there's actually nothing out there for consumers and patients telling them, "Hey, this industry exists," but B: how do you navigate this industry with all of those considerations in mind, and avoid these products that are probably just going to be fake products, right? ...or inaccurate products, and they're actually going to do more harm than good.
There's nothing that tells consumers how to navigate that space. And so I thought, "I'm going to write the guide for how consumers can vet these products in under 15 minutes, and how they can navigate and understand this space.
So that's where The Femtech Revolution came from. It is a playbook for women to not only understand the background of women's health, how we got here, why we're being neglected, but also to then say, "I want to use these digital tools. Here's how they can help me in my health journey. But here's how I vet them."
I created a four step framework for vetting products. It's called My Safe Method. So it, that's based on security, accuracy, foundation and equity. And it's really focused on making sure that you as a person and a consumer are choosing products that align with your privacy goals and your security goals.
So your health data's not at risk, and you're choosing products that are accurate and how you actually tell that versus products that claim they're accurate but actually have no scientific backing. It focuses on foundation too, so looking at who is comprising the company, right?
What are their values, their goals, so that you can make sure you're supporting companies that are in women's health for the long term instead of just to profit off of us. And then of course, equity, right? Making sure that we're. Choosing and selecting solutions that are going to be usable by the majority of women regardless of racial, ethnic status, income status--any of that. We want to make sure that we are developing products that have the core of women's health in mind. So that's really what the femtech revolution is about, and it's just about empowering women and showing them how to navigate the space in a way that's never been done before.
[00:08:54] Lindsey Dinneen: Wow. Well, I am so excited for this book. I cannot wait to get my own copy. Are you doing pre-sells right now or how is this working?
[00:09:03] Bethany Corbin: Yes, the book is available at all major booksellers right now-- Amazon has it, Barnes & Noble, Books-A-Million. And then for companies or individuals who want to purchase bulk copies, there's actually a way to do that through Porchlight that gives you a discount. It comes out September 23rd. But if you pre-order, you'll get a signed book plate and you'll get all of these other resources that I'm creating kind of behind the scenes to actually compliment the book. You'll get all of those in digital form free because of the pre-order.
There's a link on my website. Site. If you go to femtech lawyer.com, there's a book section and there's a form there that you can complete after you'd make your pre-order and you'll be signed up to get all of those great things.
[00:09:42] Lindsey Dinneen: Excellent. Ooh, this is so exciting. Okay, awesome.
[00:09:44] Bethany Corbin: It is, you know, and I will say it was so far been a number one new release on Amazon for health law. And it was also listed in Publishers Weekly in its preview for fall books alongside books like Dr. Sanjay Gupta that's coming out. So, it is, it is getting some attention, which I'm very thankful for because we really need to drive awareness to this space.
[00:10:03] Lindsey Dinneen: That is amazing. Congratulations. I'm sure this is just the beginning of its success and I cannot wait to see, where it goes and how it changes lives and, improves so many women's experience with healthcare. So thank you for writing it and congratulations on its success already and just, it's just the beginning.
[00:10:20] Bethany Corbin: Thank you. I'm, I'm so hopeful. You know, the goal is really to get this in the hands of as many people as possible, just so that we as a collective group, have the power to change women's healthcare if we act together. And so this book is really kind of that rallying cry for saying, if we're not going to do it now, are we ever going to do it because we've, we have the resources, we have the momentum for women's health right now, but we have to band together to show our interest in this industry.
[00:10:44] Lindsey Dinneen: Yeah, absolutely. So on a very practical side, what are maybe just a few key things that women can do to advocate for themselves in a situation where they are being dismissed, their symptoms are being dismissed, people aren't taking them seriously, or they're like , " you don't know what you're talking about," kind of thing. So what are some of the just very practical things that women can do in order to advocate for themselves?
[00:11:09] Bethany Corbin: Oh, absolutely. You know, and we also have a chapter in the book that focuses on EmTech, specifically, how you can actually take your data and use it to advocate at the doctor's office. So I'll, I'll go into some of those tips as well. But, you know, kind of from a, from a high level perspective, the first thing that I always recommend is.
If you think that you're going to be dismissed at all, take a friend, a family member, or call the clinic and see if they have a patient advocate's counsel and take a patient advocate with you because you're much less likely to be dismissed if you have somebody there with you at the appointment whose job it is to advocate for your needs.
And I found, too, that women are a lot less likely to be timid and kind of shy and sit back in those scenarios when you have another person because you know, if you don't speak up, they're going to, and that adds, you know, just a little bit of empowerment to that office visit or the doctor's visit.
So that's kind of the first thing. If you ever feel like you're going to be in that situation, potentially, bring someone with you. It's another set of ears as well. If you are dismissed, you've got somebody there who's able to back you up and support you if you know you needed to make a claim out of it.
So that's kind of the first thing. The second thing I always say, too, is make sure that you're taking your own notes, whether it's at the visit or right after the visit. Be careful about using apps like notes or things like that from a privacy perspective, right? You want to have. Either an app write or a piece of paper that is going to be protective of your privacy and not upload all of your health data into some cloud system without encryption.
So just keep that in mind. But make a note if you felt like you were dismissed in the doctor's office about everything that happened, your concerns, how they were addressed, and make sure that you keep that paper or that application or note somewhere where you can access it if you need to, if you know you end up having an adverse health event down the line.
The next thing that I always say, too, is if you are dismissed in the doctor's office, don't just accept it. Ask why they're not proceeding with additional testing. And if you think that there's a particular test that you would like to have and your doctor continues to say no, or they can continue to refuse to do any type of follow-up, ask if they'll refer you to a specialist.
You can say something that's very simple like, " I understand that you're not willing to look into my condition any further, but I feel that further investigation is warranted. Can you please refer me to a specialist who may have more expertise in this area.
If they're unwilling to do that, the other thing that I also always say is make sure that they put a note about the dismissal in your medical record. And a lot of doctors are going to be very unwilling to do this, and it can cause them to reconsider. So I always tell patients, say, "Can you please note in my medical record that my concerns, desire for additional testing were declined by you." And, oftentimes that will be enough for doctors to take a step back and say, "Do I really want that to be in writing in a patient's medical record from a liability perspective?" And, it can cause them to give you that extra testing because they don't want that dismissal noted in the record. If they don't, then you've got that dismissal noted in the record, which can be very helpful for you going forward if you ever needed to pursue a claim. And then the last thing I will say is, as women, a lot of times we are very, you know, we want to be seen as getting along, right? We want to be friendly, right?
We want to believe that our doctors have more knowledge about healthcare and medicine than we do. But, only we know our bodies. Only we know how we are feeling. And so, if you're continually being dismissed and something in your body's telling you that, that's wrong, listen to it.
Push back and get a second opinion, go to another doctor. Don't be afraid of being seen as confrontational, or difficult, or things like that because in the end, it's your body, it's your health. And, if you have something that's seriously wrong and it's not caught, you're, unfortunately, the one who's going to pay the price.
So just remember that it's not about being difficult or confrontational, it's about saving your life.
[00:14:55] Lindsey Dinneen: Oof. That is powerful, and that is great advice. Thank you so much. Even just listening to just that snippet, I feel personally more empowered to have those kinds of conversations with my healthcare providers if and whenever needed, because I feel like I have better tools and even phrasing. So thank you for sharing that. I think that's really helpful. Yeah.
[00:15:16] Bethany Corbin: 'Course.
[00:15:18] Lindsey Dinneen: So to your legal side of things, can you share what do you do right now? How are you helping in the femtech space --these different companies that are really in need of support from a legal perspective. What is your role in that, and how do you support those folks?
[00:15:34] Bethany Corbin: Yeah, so it's interesting because, whenever I worked at large and smaller law firms before I branched out onto my own, one of the things I continued to see was early-stage companies really kind of... They had their idea, right? They're somewhere between ideation and their Series A fundraising round, and they would come to us for legal advice, but they wouldn't have a ton of money, and we would have to turn them away--we would say, "We get it. You're not ready for us yet. Come back when you have X amount of money and we'll help you." And, when they would inevitably come back at that higher price point, we would say, Great, here's 10 things you've done wrong in the interim and now it's going to cost you double the amount of money to fix that."
And that, to me, was heartbreaking. You know, because so many of those things could have been fixed early on and, nobody was really providing that support. So, I found a gap really, for these early stage companies who needed legal support, but really didn't have a lot of places to turn. So, whenever I branched out with my own law firm, what I did was I actually specifically chose to focus on those companies somewhere between ideation and Series A fundraising round, where I could guide them through those startup phases in a way that was not going to be cost prohibitive to them, and would allow them to get that early foundation set so that they could grow scale, build, get excess capital get investors, all of that type of thing.
So my role, it's interesting because it straddles two lines, right? It's of course legal advisor, but also there's a bit of, you know, kind of business planner in there as well with them and helping them conceive their ideas, right? Helping them kind of think about which features work or don't work from, not only practical perspectives, legal perspectives, but consumer perspectives as well. And so I get to wear a lot of those different hats.
So, on a typical day I might do anything from advising clients on corporate structures, you know, how they want to set up their business. Is it a corporation? Is it an LLC? Working through those equity issues--how you think about equity for co-founders, or for investors, or for your employees. I do a lot of that. I do a lot of setting up very specific corporate structure models. There's actually a lot of corporate practice of medicine laws out there that prohibit individuals who aren't doctors or medical professionals from owning companies that provide medical services.
And, it's very interesting because oftentimes the people who want to build these companies and make money are not the doctors who would be providing the services. Investors, for instance are not doctors. So there's a very interesting corporate structure that you can create that gets around that in most states.
I do a lot of that to help my company stay in compliance with the laws. I also do a lot of privacy work. So I have several privacy certifications, and privacy is one of the key areas that I'm very passionate about. But, I help companies with everything from their privacy policies, to disclaimers, to thinking through how their different features in the app could compromise privacy, and kind of everything in between there--security, cybersecurity, and really working with them to think about it from a consumer perspective.
I actually am selective about the clients that I do take on because there are so many companies out there that want to prioritize money over the patient experience. And so I'm very cautious to work with clients that want to make sure that they're doing things right and really wanting to make sure that they protect patient privacy.
I do a lot on the patient privacy front. I do a little bit on the fundraising side with my clients, as well. And then of course, everything from contract drafting and negotiations. I do a lot of that as well. And I've actually co-written a book on contract drafting before.
[00:19:02] Lindsey Dinneen: Oh my goodness. So, okay, first of all, that's awesome. I love all of this. And you know, I was thinking as you were talking, I was like, "Oh my goodness." I love how you're helping your clients and I love your your passion for especially helping clients succeed who they are about more than the money.
Everyone has to make a living, so that's important too. But, I love the fact that your heart is for those people who are so invested in actually changing lives, and that's their primary driver and motivation. I think that's really powerful. And then, listening to you talk about this, I'm like, "Okay, so you've got this amazing, probably more than full-time opportunity, you've written a book and then, you're also CEO of Fem Innovation and a mentor with Femtech Lab.
[00:19:48] Bethany Corbin: Yeah, I did a lot of mentorship through Femtech Lab. They were kind of an accelerator program for femtech companies, and I've worked with other accelerators over that time, as well. So it's the pro bono advice that you're able to give to some of the early stage startups across the world throughout their early stage journey through those programs, which has been really great and fascinating to work with.
And then through Fem Innovation, our focus is a little bit different there because we're focusing on both startups and medical professionals. We actually have a course that we've created that teaches clinicians and healthcare professionals about femtech, how to get involved in femtech, and how they could be using those tools to actually support patient care and help empower their own patients because there's such a lack of knowledge even among clinicians today femtech exists, and how you incorporate it, especially if we're thinking that there's so many tools out there, and the risks associated with them--how do you know which ones are appropriate as a clinician, that type of thing. We've also seen a lot of clinicians wanting to get involved with femtech companies as advisors, or even as part of their boards or, coming on as medical professionals in those companies.
And so some of the courses that we've done before have been focused on that as well, on helping them interact and get those roles with femtech companies. So we kind of see ourself at fem innovation as an ecosystem builder. We've obviously I have the legal side but now we're bringing in the clinicians, getting them integrated into this, getting them connected with the startups because it's their industry. This is what they're working on. But, there's oftentimes such a disconnect with the tech companies building the products and the healthcare professionals. And then we do offer some other additional non-legal resources to founders as well.
[00:21:27] Lindsey Dinneen: Wow, that is incredible. I-- good gravy. I love your heart for all of this. And I also am like, I don't know how you-- I think you must have a superpower of like squeezing more time into your day-- somehow you just add hours miraculously.
[00:21:42] Bethany Corbin: You know, it's so funny whenever I worked at, whenever I worked at a firm, a couple of my colleagues would come to me. They'd be like, "How do you get everything done? Like, there's gotta be 10 of you because how are you doing it?" And honestly, I honestly, it's just because at this point I don't have kids, and so I'm kind of able to really devote all of my time to working.
But no, it's, but I get such fulfillment out of it too because I really feel like we're pushing an industry forward in a way that hasn't happened before. And, getting to see all the new companies come into the space, the new organizations that are supporting the companies, it's been really heartwarming to see all of that. And, you know, on the horizon, we're also hoping to loop in the consumer side a bit more as well. Obviously, you know, the book that I've written is very consumer focused. It can also be used, you know, by clinicians or by startups who want to make sure that they're doing the right things. But, to date, as well, there also really isn't a single location for consumers to go to, to find all these companies.
And we have so much censorship that happens that unless you know exactly what you're looking for, you're probably not going to find the companies that are out there to serve you. And so we we have a partnership that's in the works right now to actually build a database of all those femtech companies and products and have them vetted to a certain extent, or information on there to a certain extent, about clinical accuracy, and privacy, and those things that I talk about in my book. So that's kind of the third component that we'll be weaving in later this fall.
[00:22:58] Lindsey Dinneen: Oh my goodness. How exciting. Oh, I am, I'm so thrilled about all the work that you're doing to push this industry forward and to really make a difference in women's health and, you know, you're such a thought leader in this space-- what was it like stepping into more and more leadership roles to the point of leading your own firm. What was that journey like for you?
[00:23:20] Bethany Corbin: Scary, I will say. You know, it's, interesting because I've always thought of myself, you know, kind of as somebody who could be the backbone of a firm, meaning that I do a lot of like the behind the scenes work, right? A lot of the legal research and writing, and that's kind of what I had made myself in at big law, and you know, also in the smaller firms that I worked with. Whenever I decided, I, was actually initially going to take a break before, you know, starting my firm, I was going to take two years off. I lasted five months. Oh no, I'm sorry--I lasted five weeks. Excuse me. And by that point in time, I had clients knocking down my door saying, "Where did you go? We need this kind of help. Nobody's out there providing it." And so that was kind of the impetus to say, "Okay, I'm going to start the firm earlier, you know, right now. And, I'm going to also look at kind of this ecosystem building, because of all the pain points that we were seeing."
And, so I will say. I, went into it probably unprepared. I, never, if you had told me three years ago that I would have my own firm, I would've said you were absolutely crazy--more crazy than me writing a book. And I'm, very glad I did it because there's something to be said about kind of plotting and planning your own trajectory and, you know, being able to pivot with your clients instead of having layers of bureaucracy that you have to go through.
So, I have loved it from that perspective. I'll also say it's definitely been the most challenging thing that I have done because as a leader, you're responsible for all the decisions. You're responsible for the trajectory, you're responsible if you're not making money. And you know, there's of course that fine line, right, between philanthropy and making money, and walking that whenever you are really, really wanting, you know, to help every single femtech company that's out there can be difficult.
So I would say, that can be a little difficult sometimes, and making sure that you have the right support system to actually allow you you know, to bounce ideas off of them or, get feedback, and being able to pivot when those initial ideas don't work. That's been something that's been really critical for me is pivoting. This really isn't like the first time, you know, this isn't like the first idea I had, for fem innovation and things like that. So, so being a leader is definitely challenging, and making sure that you kind of develop your own leadership style and leadership, you know, capabilities as well while you're through this journey has been something that I've been working on, too.
[00:25:27] Lindsey Dinneen: Mm. Yeah. Yeah, and, you know, it's a fun, thing because if you're, if you're passionate about helping people, which is clearly at the heart of who you are, and you desire to see improvement in the industry, but in individual people's lives, then as a leader, you're able to take that passion and allow it to help you in developing those leadership skills, and building onto them as time goes by, because you are already starting from a place of deep care and respect for others. And that's a great start.
[00:26:01] Bethany Corbin: No, that's exactly right. And, you know, I love what kind of comes with it too, is a certain level of creativity that we often don't think about whenever we hear the term leadership. But, for me, it comes with that level of creativity where I'm actually able to build something, almost from the ground up, and that is really exciting. I can kind of plan it, take it in different directions, I can pivot with it. And, that to me is just--it's really exciting because as a leader, right, you often think, you've got management, right? You've got delegation, right? You have all of those things that sound bureaucratic and boring, but there's this underlying current of creativity that I think gets missed a lot.
[00:26:37] Lindsey Dinneen: Yeah. I love that. I love that you highlighted creativity because I think that makes everyone's lives easier, right? If you have that flexibility to... this is such an overused word, but to pivot, I mean, it's, it's just, it's true. And so being willing to come at a problem or a situation with curiosity and go, "Hmm. I'm not sure that that's working the way I intended, or hoped it would. And then go, "Okay, what are some creative solutions to this?" And, maybe that means looking outside of your industry, too, for ideas. I think sometimes we can get kind of stuck like, "Oh, this is how the industry is, and that this is what they do," and then we forget that.... But that, you know, that's not necessarily bad or wrong, but we sometimes forget that we can learn from all sorts of different sources and, then bring it together, and creatively handle a situation that we might not have otherwise been capable of doing.
[00:27:27] Bethany Corbin: Oh, exactly. And, the other thing too that it's really done as well is make me a bit of a better lawyer, right? Because as a lawyer, it's interesting, there's always this tendency when you know something is going to either violate a law, or not be the best in practice, to say "No" to your client.
And, so for me, right, clients never want to hear the word "No." And, being a leader has, has allowed me to come up with some other creative solutions for my clients where I can say, "Okay, we can't do it the way you've proposed, but here's a different creative solution that I think could get around these key roadblocks.
And, so for me, with my clients, it's about trying to say, "Not that way, but this way." Right? Kind of like a "Yes, but" rather than a "No." And I kind of take that same approach in leadership, too, because I want to make sure that, you know, with the people who are working for you and things like that, that you're making sure that you're meeting their needs, as well. And so it's really caused me to adapt to kind of a "Yes, but" framework rather than like a flat out, "No, we're done."
[00:28:24] Lindsey Dinneen: I love that. That's really cool. And, that's a great example of how you can approach, again, a problem with that mindset of, "Okay, hmm. That will not work the way that you hope it will work. However, I've got an idea."
[00:28:40] Bethany Corbin: Exactly. It's so easy to say "no," but coming up with this creative solution--that's the fun part. That's really the rewarding part.
[00:28:47] Lindsey Dinneen: Yeah. Well, speaking of rewarding parts, I wonder if there are any moments that stand out to you along your journey so far of really affirming to you, "Wow, I am in the right industry at the right time, in the right role."
[00:29:01] Bethany Corbin: Yeah. You know, it's, it's interesting. I think kind of the first instance of that, that I had-- so I had a very unexpected women's health issue. I ended up with fibroids that were so large, I was the equivalent of six months pregnant. And, they were crushing some of my internal organs. And I'm that person, right, who... I go to my doctor every year, right?
I get my annual--I get all my checkups, and things like that. And somehow all of this was missed. And, so whenever I had to navigate that journey as a patient who-- and I have all of this, obviously, advocacy experience, right--legal experience. I'm navigating this at the height of COVID. I'm getting referrals and consultations with Mayo Clinic, right?
I'm getting the best care that I can. And then seeing how even when you can do everything right, you can still be dismissed... For me, that was a moment in which I said, "I'm not in the right industry at the right time," because at that point in time, I was still in big law, and I wasn't doing anything really related to femtech.
I had kind of resigned myself to not doing that--j ust given some of the internal politics of the firm where I was at at that time, and their desire to not expand into the health-tech industry. I had that experience, and all I could think of was, "This is not what I'm meant to be doing. I had this experience for a reason, and if I'm not going to make something out of that, what have I learned? Why did I go through this?"
That, for me, was the turning point to say, "I'm leaving big law, and I'm going to a smaller firm, and I'm going to work on femtech. And, I'm going to see where this pans out." It was so scary, right? Because you're leaving that high six-figure job, and something you're good at, the work you know, the people you're comfortable with, and you're going into something where you're making half as much money, learning a new industry. And I would be lying if I said I didn't cry my first week on the job, because even as a healthcare lawyer, digital health law and health-tech, medtech--all of that is so different than traditional healthcare, and there's so much to learn.
And honestly, I felt like I was back at school in a course that I didn't understand for a week. So, there's a lot of challenges with that. But, fast forward a few years, we had the, you know, unfortunately the Dobbs decision come out, and that for me was really an affirming moment where I said, "I'm definitely in the right industry, at the right time because I'm helping these companies build privacy practices and policies that are going to be protective of consumer data in this world. I'm helping to build an industry where women can get access to care in less traditional methods that won't compromise their privacy and their data."
And one of the moments that stands out to me --one of the highlights--is I actually got to testify before one of the congressional committees on reproductive health data privacy. And, you know, it was funny, I was actually on vacation at the time. I was in Greece, and we were supposed to be on a ferry going from one island to another. And like the night before I get this request to come and testify on reproductive health data privacy. And I was like, "Yes, I'd love to."
And, of course, the timing was exactly when we were going to be on the ferry with no internet. So, we actually had to charter a helicopter so that we could get over to the other island, get there, get me set up with the internet in order to testify. So that was kind of like my, my full circle moment where I really felt like I was having an impact, and being able to even influence some of the policies in the future of reproductive health privacy.
And then every day since then, I have just loved getting to work with these companies. And, as we continue to see the trajectory of women's health in America, it's just really reaffirmed that we need people doing this type of work for me.
[00:32:37] Lindsey Dinneen: Wow. Oh my goodness. Well, first of all. Wow, what powerful stories you were sharing. Oh my goodness, that is incredible. Thank you. Oh, I, wow. I just like, I was like so interesting how life works sometimes and the unexpected adventures that unfold, and I bet your, your creativity-oriented mindset helped you even in that circumstance, be like, "Okay, so we can't do the ferry. I have to do this. I know I need to do this. How do I make it happen? I don't know. Let's charter a helicopter." Cool.
[00:33:12] Bethany Corbin: It was definitely a moment. I tell you, it's one that has just remained in my head since then. It was just very funny when it happened.
[00:33:19] Lindsey Dinneen: That's amazing. "I'm going to do this." I love it. Oh my word. Okay. Awesome. Well, gosh, this conversation is so good. I know I could probably talk to you for hours and learn so much, but I do want to pivot the conversation a little bit just for fun.
[00:33:36] Bethany Corbin: Absolutely.
[00:33:36] Lindsey Dinneen: So, so, okay. If you were 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 choose to teach?
[00:33:49] Bethany Corbin: Ooh. I love that. I love that question. Ooh, a million dollars to teach any class that I wanted, you know, I would probably create a class that would be... I would say it would probably be at maybe like the high school level I'm thinking. You know, because whenever high school students go through those health classes, I would want to start early, there, for women to teach them all about the ways in which they can advocate for themselves and stand up for themselves at doctor's offices, right?
Things, for instance, period pain that they're probably having there, and thinking that's normal, right? Telling them about, you know, how that's not normal, how that you don't have to normalize your symptoms and your pain. Here's how you can protect and advocate for yourself at a doctor's office. Here's how you can use the tech that's out there to protect yourself, because even though, you know, a lot of tech is for 18 up, we know a lot of teenagers are using, I mean, the period tracking apps are like the number or three most used app for adolescents, so pretending it doesn't exist is not helping anyone.
But, we have to get to women sooner and empower them at an earlier age, so that those lessons and that knowledge carries with them as they navigate the healthcare system for the rest of their lives. So, for me, I think it would be a course that was really focused on the early high school student, teaching them all about how you navigate not only femtech, but health-tech in general, the healthcare system, how you advocate for yourself, how you have those conversations with your doctor without feeling embarrassed, and why that's so important.
[00:35:22] Lindsey Dinneen: Wow. Yeah, that would be a really powerful class and so needed, and I love the idea of starting that way, that that would be a part of just education in general, so that, you know, everyone benefits from that, it's a win-win when we, when we advocate for women, help them understand how to advocate for themselves, and how to protect their longevity, their health. You know, that's really cool. I love that.
[00:35:47] Bethany Corbin: I would love, I would love to do it. That would be a dream, really kind of creating a curriculum to incorporate into health classes for high school students.
[00:35:54] Lindsey Dinneen: Ooh, maybe your next writing project.
[00:35:56] Bethany Corbin: There we go.
[00:35:57] Lindsey Dinneen: More to do... when you find yourself bored at some point.
[00:36:01] Bethany Corbin: That's right. That's right. Next week.
[00:36:03] Lindsey Dinneen: Right, right. Amazing. Amazing. Okay. And how do you wish to be remembered after you leave this world?
[00:36:13] Bethany Corbin: Oh, interesting. You know, after I leave this world I would love to be remembered as somebody who participated in the women's health movement. We think back, you know, of course like to the suffragists, right? And you know, all of those amazing women who helped get us the right to vote...
I want to be considered part of the women who helped get women's healthcare on the map with men's healthcare, right? That helped really spur this movement forward for women. So I don't even need to be remembered by name, right, but just as somebody who was involved in that movement, and was very active in promoting women's healthcare and getting us to the place where women aren't being dismissed and we're being taken seriously.
[00:36:51] Lindsey Dinneen: I love it. Beautiful, beautiful legacy to aspire to. And you're already, you're already there. So that's, that's an encouraging thing. You're working on that right now.
[00:37:00] Bethany Corbin: Oh, thank you.
[00:37:01] Lindsey Dinneen: I love that. And then, final question, what is one thing that makes you smile every time you see or think about it?
[00:37:10] Bethany Corbin: Ooh, I love that. Ooh. Okay. So one thing that makes me smile, I have so many things. I'm usually not ever, like, not smiling. Okay. So I have, I have a couple obviously I'm a huge pet lover, so my dogs... we're getting to the point where they're a little old now. One of them's 15, one's 13.
But, any kind of animal, pet --especially little puppies, I love... so that's, that's something that makes me smile all the time. I will say, I also have a slight obsession with books that have sprayed edges. Which, you know, is, is becoming a major thing now. So it's, it's really cool. But there's actually artists who will paint the edges of books, and I'm a huge book lover, so I actually have a library of sprayed-edge books that I just love looking at, and they make me smile all the time to see the different, you know, artists and artwork on the bookshelves.
[00:37:58] Lindsey Dinneen: That's awesome. Oh my goodness. Yes. Well, I can relate to all of that and I. I, yeah. That's so fun. I love that too. Animals always make me smile. I mean, it's like a running joke around people that know me. It's like, okay, if you bring an animal around, I'm going to be like, "Can I hold it? Can I touch it?" Like, instantly.
[00:38:16] Bethany Corbin: You know, I've, already warned my family. I'm like, "If anybody... if you guys die, I'm sorry, but I'm going to have 10 pets. Like, it's just going to happen.
[00:38:22] Lindsey Dinneen: Yeah.
[00:38:22] Bethany Corbin: I'm not going to be able to control myself.
[00:38:25] Lindsey Dinneen: Right. It just... Yeah, that's what happens. I get it. Oh my word. Well, this has been such an amazing conversation. I'm so thankful for you and for your time today, and gosh, just sharing so much practical advice, and insight, and your journey. So first of all, thank you so much for doing the work that you're doing, for being in this industry, for pushing it forward for being somebody who is a pioneer and your own version of suffragette. And, I really love what you're building, and I'm so thankful you're doing this work. So, gosh... I just wish you the most continued success as you continue to work to change lives for a better world.
[00:39:00] Bethany Corbin: Oh, thank you so much, Lindsey. This has been so great talking with you, and sharing the knowledge, and I'm so hopeful that we can push this industry forward together because we do have the power to change it. We just have to act on it. So, thank you so much for helping to spread the word.
[00:39:15] Lindsey Dinneen: Absolutely. Amen to that. And, thank you so much to our listeners for tuning in, and if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two, and we'll catch you next time.
[00:39:29] 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.

Dhruv Agrawal is CEO and president of Aether Biomedical. Discover Dhruv's unique journey from studying medicine in New Delhi to creating life-changing bionic limbs. Under his leadership, Aether Biomedical has achieved significant milestones, including CE certification and FDA registration for its Zeus V1 bionic limb. Dhruv shares his personal story of transitioning from medical school to MedTech innovation, the obstacles faced and lessons learned as a young entrepreneur, and the hope and inspiration of seeing Aether's prosthetics transform lives, especially in war-torn regions.
 
Guest links: https://www.aetherbiomedical.com | https://www.linkedin.com/company/aether-biomedical | https://www.instagram.com/aether_biomedical/ 
Charity supported: ASPCA
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 TRANSCRIPT
Episode 061 - Dhruv Agrawal
Dhruv Agrawal
[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 excited to introduce you to my guest, Dhruv Agrawal. Dhruv is the CEO and president of the management board of Aither Biomedical. He studied medicine in New Delhi before dropping out to pursue a bachelor's in business management. He also has a postgraduate diploma in Medical Device Development Regulatory Affairs from University of California Irvine, and a Master's in Data Science from the University of London. Under his leadership, Aither Biomedical has achieved CE certification and FDA registration for the Zeus V1 bionic limb, and established distribution across nine European countries, the US, and India. Additionally, Aither has raised over 12.5 million US dollars in private capital from leading VCs and has been a part of multiple European grants and research programs for an additional 6.5 million US dollars in non-dilutive capital.
All right. Well, thank you so much for being here. Welcome to the show. I'm so excited to speak with you today.
[00:01:49] Dhruv Agrawal: it's a pleasure to be here, Lindsey. Thank you so much for inviting me.
[00:01:52] Lindsey Dinneen: Of course, of course. Well, I would love, if you wouldn't mind just starting by sharing a little bit about yourself and your background and what led you to Med Tech.
[00:02:02] Dhruv Agrawal: Yeah, absolutely. So I'm Dhruv Agrawal. I'm the CEO of Aither Biomedical. We are a company based out of Poznan in Poland, so on the western part of Poland. It's a little bit chilly here. As a company, we are a team of about 55 people right now, currently present in the US, Europe, Middle East, as well as India. And we focus on making bionic hands for upper limb amputees.
[00:02:25] Lindsey Dinneen: Amazing. Yes. So I wanna get into everything amazing that your company does, but going back for just a little bit, in your own personal history, can you share a little bit about maybe growing up and what experiences led you to think, "Hey, in the future, maybe I wanna do X, Y, and Z."
[00:02:43] Dhruv Agrawal: Mm-hmm. So first of all, entrepreneurship was never a plan for me. I didn't even knew that there was a thing called an entrepreneur until I was easily into high school. Both my parents are doctors. My dad's a pediatrician, mom's a gynecologist, and as it happens in India, if your parents are doctors, you kind of know that you have to become a doctor as well.
So I went to the coaching classes to pre, to prepare for medical entrance examinations. I actually met my co-founder there about 10 years ago. We both got into medical school. I was generally comfortable with medicine, you know, growing up in a hospital with doctor parents around. So I was generally comfortable in a clinical setting, but I realized that I was much more interested in the technological aspect of medicine rather than the clinical aspect of it. And that was when I was getting into the second year of my university.
And luckily my dad, for my 18th birthday, bought me a 3D printer, like a very simple 3D printer from China as my 18th birthday gift. 'cause I was really wanting to get into that world. And that's where the story begins. So even till today, my dad jokingly says that that's the worst gift he has ever bought for me, because that made me drop out of medical school.
[00:03:57] Lindsey Dinneen: Oh no. Okay, so you were given this gift and you started, I imagine, tinkering with it, learning how to use it. So tell me about that.
[00:04:06] Dhruv Agrawal: Yeah, the thing with my co-founder as well, even though we went to the same medical university, we were not really friends in the first year. We were just colleagues. But when I got this 3D printer, it was like one of those things that you assemble, you get a kit and you assemble. And I was asking around people in my university and they were like, "Come on, what are you doing? Like, I don't wanna come to your apartment to assemble a 3D printer." And my co-founder was the first one who said yes to coming down and assembling that printer with me.
So that's how our friendship essentially started in the university, even though we had known each other for three years by that point. And then we started, of course, by very basic things like printing mobile phone covers and key chains and we were just in awe with the fact that I have something in my room, in a studio apartment, where I can just build physical things, right? And this was back in 2018, so 3D printer was not such a consumer product where, you know, if it was of course used in industry, but it was not something that you would imagine having at your home, at least not in India.
And then we actually found out that there's a society called Enable, which is an NGO that makes very simple basic prosthetic designs for kids. So we started by printing those and started going to some amputee clinics around and trialing that out with patients, just purely out of technical curiosity. We didn't really had a draw towards amputation, so to speak. We were more driven by the technical curiosity of, you know, it sounds interesting to make a prostatic hand. So that was the beginning.
And then slowly, slowly things happened very organically that we went from wanting to 3D print basic things to starting a biomedical innovation club in our university, to incorporating a company in India, then to coming all the way over to Poland and now having 55 people.
[00:05:49] Lindsey Dinneen: Holy cow. That's an amazing story. Thank you for sharing about that. So, okay, so, so you started off with this curiosity, like, "Hey, let's see what we could do with this printer and, and how we can make it work for people." And I love that your initial pull with it was to actually provide something that does help people. So that's obviously a core value, something that you hold very dear. So can you speak a little bit more, did you have sort of any personal experience or within your family or what led you to say, "You know what, hey, I've got this really cool tool at my disposal. Let me start using it by actually doing something that helps others."
[00:06:27] Dhruv Agrawal: I mean, the honest answer, I would love to say I had some personal experience, but the honest answer is no, not, not really. I don't have one of those stories where I can tell you that, like I met an amputee 15 years ago, 20 years ago, and have had that motivation for that time. It was just pure technical curiosity to begin with. But of course, as we started building basic devices and giving it out to people and seeing the response of what a very simple, you know, $50 thing can do for a person who's missing a limb in an impoverished family in a village in India, that's a very powerful thing.
So at that point, we realized that we started getting more and more close to upper limb amputation as a field, as a clinical specialty within itself. Of course, both me and my co-founder coming from medical school growing up in family of medicals, we've always had it in our heart to work in the clinical side of things. We've always liked working around, helping people get healthier and better. But amputation specifically was an area that we were very lucky that we found as an area of interest that developed within the both of us.
[00:07:31] Lindsey Dinneen: Yeah, of course. Okay, so, so you started printing these limbs, and then you realized, "Oh my goodness, there's such a need for this. There's so much opportunity here to really help people." So, so tell me a little bit about the evolution over time of how you have made it better and better, more technologically advanced, more ergonomic, all the things that go into that. Can you speak a little bit to that learning curve and process?
[00:07:56] Dhruv Agrawal: Mm-hmm. Yeah, it was a very long learning curve because not only did, me and my co-founder had zero background in business. We were 18-year-old, 19-year-old kids, right? We were just teenagers and we really had no idea what we wanted to do. And not only that, we also were not engineers, so we didn't have any engineering experience or expertise either. So everything that we did in the very beginning, at least, was self-taught. I just knew I had an inclination towards electronics and programming. My co-founder was much more towards mechanical CAD design and things like that. So we started learning these courses for free on edX and Coursera and all these, you know, MOOC platforms. And that's how we built up the very first prototype of the product by getting some small grants here and there in India.
Of course, the situation is very different right now. We have R&D team of 30 people, very experienced, a few PhDs here and there. So I don't really design anymore in my day-to-day life, but that's how we started. And same was the side of the journey of coming from India to Poland. Again, that was not something that was planned at all. We had no experience in business. We had no experience in raising funding or raising money and things like that. We just learned on the go, applied to over a hundred different programs 'cause most of the investors said no to us back then in 2018 to funding 'cause why would they say yes?
And we looked at like, "Okay, can we get some grants and things like that?" Applied to over a hundred programs. Luckily got selected in this program in Poland, which was like a $50,000 program back in 2018 and decided, "Yeah, let's try that place out." And came to Poland. I literally came with a backpack with stuff for two months 'cause there was a plan, come for the grant, stay for two months, go back to my family in India, and it's been seven years since then.
[00:09:44] Lindsey Dinneen: Oh, there you go. Oh my goodness. That's great. So Poland, and you get along it sounds like just fine. Excellent. Excellent. Okay, so, I really appreciate you sharing about, especially, you were both so young and but so eager. It sounds like just, "Yes, let's learn, let's develop the skills that we need to along the way."
I would imagine though, coming into it, perhaps that young and not having as much business experience, or, or any really in, in the past, I-- something that I really admired when I was kind of looking through your LinkedIn profile was when you post, a lot of times you share stories about areas that, that may be considered I, I guess mistakes or stumbling blocks or things that, that you've overcome on your path.
And I would love if you would share maybe just a couple of things that come to mind, as an early founder, because your story is amazing and unique, but there are lots of other founders too who find themselves in similar situations where they're like, "Whoof, I've got this great idea. I know what I want, but here's maybe what I should look out for to avoid." could you share a little bit about that?
[00:10:49] Dhruv Agrawal: Yeah, absolutely. I mean, the first thing is mistakes are unavoidable, right? it doesn't matter whether you're coming from a background of a medical school dropout, or if you have 10, 15, 20 years of corporate experience and things like that. 'Cause I do find myself thinking a lot about, you know, wouldn't it have been better if I would've graduated and then did a MBA and then started a company? Yes, it might have been better, but the things that I deal with in my day-to-day life in the startup, I don't think this is taught anywhere. So the first and foremost thing, which is of importance, is that mistakes are unavoidable. It's okay to make mistakes.
The biggest learning that I have is mistakes are unavoidable, but it's up to you to be decisive enough to pivot as quickly as possible. So don't look back at the mistakes that we have made, because one of the worst things that we have done in this company, or where we have failed the most, or where we have seen that like, "Ah, this is where we could have done things better," are not about making a wrong decision. They were just about being indecisive and being in a dilemma for a long, long time. It would've been far better if we would've made certain decisions quickly, gotten feedback and quickly pivoted, instead of just being in a dilemma and trying to balance two sides for a long time period.
An example of that would be when we launched the first version of our product into the market, we realized that we had made some errors from the point of view of what should be the feature set in this product. And so, for example, the product was available only in a medium size hand in terms of the dimensions, but majority of the market is for a small size hand. So at that point we couldn't really just miniaturize things because there's a physical limitation.
So at that point we had to make a decision of do we scrap this thing completely and build a new hand from scratch that starts with a small hand and then has a medium sized option as a grow up? Or do we continue to work on the medium sized hand, and then launch a small sized hand separately? Finally, we decided to do the second option. But looking back again, I, I don't think it would've been better or worse either way. I think both of these options are fair. It's just the fact that we spent over nine months going back and forth between, "Okay, let's continue putting our efforts in energy into the medium sized that we have right now" versus, "Okay, this month we are now suddenly feeling, ah, that's not gonna work out. Let's start building the second version."
So that dilemma of indecision is probably the worst thing that you can do. Just make a decision, own up to it, move on. If it works out, great, if it not, if it doesn't work out, you're gonna have learnings and you'll be stronger at the end of the day. So that's, I would be an I would say would be an example of one of the key errors that we made.
[00:13:23] Lindsey Dinneen: Yeah. Well, thank you for being willing to share that, and that's such valuable advice and feedback. And so, as you recognize this and go, "Okay, so that didn't work as planned, or in the way that I would prefer," what did you end up deciding? How do you go now, moving forward, when you are in a position of "I have a major decision to make. I feel like both options have value and merit." How do you end up deciding, "Okay, I I'm not gonna leave this just in this hazy middle ground, I'm gonna make a decision." How do you go about that now differently?
[00:13:54] Dhruv Agrawal: I think the first and foremost thing that entrepreneurs, or anybody who wants to build a new product, or anybody who just wants to build something new, is be very, very, very honest with yourself about, "Am I solving a real problem?" As founders, as creators, as developers, it is so easy to go into that mindset of you find a problem that you can relate to or you somehow think that this is a real problem. It doesn't matter what feedback you're going to get. You're going to convert that feedback, or create a narrative or story from that feedback, that is going to align with the impression that you have built in your own head about what the real problem is.
So one thing that we really do right now is just focus on problem market fit at the very early stages of launching a new software, building a new product, building the next version of the hand, or whatever else we do is really try to question, "Are we solving a real problem?" And in a completely unbiased manner, "Do people agree with me that I am solving a real problem?"
So that's what I would say would be a primary thing that we do differently right now. Of course at this point, we start getting users involved much earlier into our development process. That is something that we did not do in the past, and hence the surprise that we got at that point. So we start involving users, different stakeholders, and things like that much earlier, but at the same time, I would say that it's not to say that I would penalize myself for the historical decisions that I took. We did the best that we could potentially with the resources that were available at that point. Now we have much more resources so we can do all these things. So don't feel pressured to do everything on day one. You know, start with something, move forward and build that maturity as you grow.
[00:15:38] Lindsey Dinneen: Oh, I love that. That's excellent advice. Thank you for sharing. Yeah, so you know that's a great segue and I love the fact that you were talking about the end user and the importance. And it's so funny because of course, ultimately your goal is to help these end users and improve their quality of life and whatnot. But to your point, it does get easy to get so bogged down in the details of what you're creating and innovating that perhaps you forget sort of the bigger picture at times. So, speaking of these end users, can you share any stories that might stand out to you as really reinforcing to you that, "Hey, gosh, I am in the right industry, doing the right thing at the right time."
[00:16:17] Dhruv Agrawal: Yeah, no, absolutely. So we have had many phenomenal end users that have reiterated our belief in the product that we are building, the problems that we are solving, the company, and the organization that we are building as a whole. I mean, generally speaking, patients change their devices every three to five years, and that's really our entry point of getting a device into the hands of the patients. But even with those, a patient is using another prosthetic device, they start using ours, they will see a step change in the functionality, and that's always empowering.
But the most interesting stories are where we have really seen patients who, for example, congenital amputees tried a prosthetic device 10 years ago, 15 years ago, and then made a decision to live their life without any prosthetic device. So got used to a life for 15, 20, 25 years of living a life without a prosthetic device, just with an amputated limb or a limb difference. And then, we come in with our product, they see it, they use it, and they are ready to adopt that again. And that's a much powerful validation for us because somebody who has used a device, looked at all the advancements over the last two decades, decided actively decided to not use any of those advancements, and looks at our product and says, "Ah, this really solves the problems that I was waiting for someone to solve for the last two decades."
Like we had this situation with a very famous Polish guy, Marek Kamiński, who is the youngest Polish person to go to both poles, North Pole and the South Pole, and he's a bilateral amputee on legs and he has a unilateral amputation to one arm. He has not used a prosthetic device in, I think 15 or 20 years, something like that. So for a very long timeframe. He met with an ambassador of ours and was finally convinced after 15 long years to give another try. And we fitted him over three months ago and he's been performing phenomenally with the device and he's so happy with that. So those are the moments that really give us more confidence or give us a boost of confidence in the product that we are building and the company that we are building.
[00:18:19] Lindsey Dinneen: That's incredible. Wow. What a story. Yeah, and I love hearing those kinds of stories and that just to reinforce, " Hey, you really are making a difference." And I'm sure that helps on the days that are a little bit harder, a little trickier, you know, it helps to have that to hold onto, so you know your impact goes so far beyond even the places that you've mentioned before. I was reading about how you've worked with the Open Dialogue Foundation and there's been some work in Ukraine, and I'm wondering if you could share a little bit about perhaps that collaboration, and or some of the other exciting collaborations you have going on with these amazing organizations all over the world.
[00:18:54] Dhruv Agrawal: Absolutely. I mean, the work that we do in Ukraine is something which is very close to our heart and what you just mentioned a moment ago, it's exactly that type of work that keeps us going on the hardest of days. I have so many amazing stories from the patients who have been fitted with our device 'cause at this point in the last year or so, we have already fitted over a hundred patients with our bionic hands in Ukraine. We primarily work with Superhumans, which is NGO based out of Kyiv, a great place, really the mecca for prosthetics at this point, I would say. They're doing a phenomenal job of getting these patients in, rehabilitating them, fitting them with our device and then training them on how to use the device. In fact, even supporting them in the post rehabilitation, acquainting them to back to the real world as well.
And we send teams of doctors from the US, from Poland, to Ukraine to actually fit these devices to patients. And we have had a lot of success stories come out of it. We have people who have amputations, even at the level of shoulder who are amputated all the way up to the shoulder or four quarter amputation, and they are successfully able to live a independent life with our device. I think the best story that I've had, or the part that really made me tear up, was when one of the soldiers got fitted with our device and his really, really big wish was to be able to do the first, to dance with his wife, with both hands. And I got to see that and it was, it was the most amazing feeling ever.
[00:20:20] Lindsey Dinneen: Oh my goodness. Yes. I don't know how you couldn't just have the waterfall start with that kind of story. That's incredible. Thank you for sharing about that. So, as you look toward the company's future and your own, what are you excited about moving forward?
[00:20:34] Dhruv Agrawal: I mean, we are currently in the process of getting a new version of our hand in the market, which has all the learnings of the last four years or so. So we are definitely really excited about that. You have to keep in mind when we launched the first product, we didn't even have enough money to-- because prosthetics are expensive-- so we didn't really have had enough money to buy our competitor devices, or the devices from the past to look around to see, touch, feel, how they are built. Everything that we built was purely out of our imagination and based on what we could find on the internet. And, you know, go visit a doctor who fits these devices, have that 10, 15 minutes to look around that device, and so on and so on.
I mean, four years later, now we have the experience of fitting close to seven, 800 patients with our device. All that feedback that has gone into the next version product that we are gonna be building. So very excited about that. We continue to develop the software platform, so we are not just a company that is focused on providing a device to the patient, but we provide an entire software platform that's like a digital twin for the patient. So it supports the patients throughout their end-to-end journey.
Because it's not just about giving a device to the patient, but it's all about can we improve their quality of life? Can the patient pick up a glass of water? Can he tie his shoelaces? Can he water a plant? Can he do the activities that he really wants to do? And from that perspective, the software platform that we continue to build focuses on things like adherence, occupational therapy, physical therapy, monitoring of the usage of the device. Because the thing in prosthetics industry is, the day you give the device to the patient is not the day you have won the battle. That's the day the battle actually begins, 'cause now it's all about making sure that you deliver on the promise of helping him get better quality of life.
[00:22:20] Lindsey Dinneen: Yeah. Yeah. I'm sure that's an exciting challenge, but it's a continually evolving challenge too. And there's probably variations, I would imagine, on people embracing the technology a little bit differently and how you handle all that. Yeah. Excellent. Well that is a very exciting future and it's so much fun to hear about, and you know, you've had a great career so far. I'm sure it's wildly different than what you may have imagined as a kid. But what a cool gift that you're bringing to the world. You've been recognized quite a bit. You're 30 under 30 for Europe, and you've been involved in lots of different cool organizations. You've been a TEDx speaker. What are some of those moments like, have they been surreal? Is it just like, "Oh, thank you." Just confirmation that, hey, you are on the right tracker. What are those kinds of moments like for you?
[00:23:08] Dhruv Agrawal: I mean, definitely the first round of funding that we raised in Poland was was a huge check mark for us, because it's that moment at which you realize, "Ah, somebody wants to give me money and somebody wants to give me a quarter of a million dollars." I've never seen that much money together on a single bank account or in any way, shape or form, right? I come from a normal middle class family. We don't have that. So, that was definitely the first micro checkpoint, let's say. I mean, both the things that you mentioned, the TEDx thing, the Forbes 30 Under 30 thing, coming from a background in India where these things are really important, although they're not so important for me as a person, but they're much more important for some reason to my parents and to society. It is a different place. We put a lot of emphasis on these types of things.
So from six, seven years ago, looking at these lists coming out or looking at, "Oh, this cool guy spoke on a TEDx talk, sending him an email about, 'Do you want to be an advisor in my company? I'll give you 5% shares,'" and so on and so on, to actually doing those things by yourself, that's definitely pretty well as well. But again, at the end of the day, there is nothing better than seeing a new patient get fitted with the hand, seeing the reaction of their family members. They have a daughter, they have a son who they hold their hand for the first time. They hug their wife. I mean, just, just being around amputees and patients who use your device, something that you built and that helps them get better at their daily life, that's, I would say, the most rewarding thing ever.
[00:24:39] Lindsey Dinneen: Yeah, of course. That's, that's wonderful. Yeah. So, oh my goodness, this is so great and very inspirational, but pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars-- speaking of those wonderful sums of money-- to teach a masterclass on anything you want. It can be something within your industry, but doesn't have to be, what would you choose to teach?
[00:25:03] Dhruv Agrawal: I have two topics in mind. One is I would probably teach a masterclass on pitching, especially for first time founders. I think that is something which I'm good at, and we have obviously raised a pretty decent amount of capital up 'till now. So that would be the one thing that I would say. So kind of a combination of pitching and starting a startup for the first time, especially in the field of hardware, medical devices, things like that.
And the second thing that I would really like to talk about is just probably trying to put my thoughts together and making a masterclass on how to never give up, because I think that that's a very underrated quality. But that's a very important quality. There have been complex times in the history of our company where we have felt that like, "Ah, this might be it." But it's all about what you do in those moments and how you go beyond those. I think it's all about that.
[00:25:47] Lindsey Dinneen: Yeah, absolutely. And how do you wish to be remembered after you leave this world?
[00:25:53] Dhruv Agrawal: Just as a positive change maker. I really would like all these patients that we are helping and giving these devices to. I, I just want to be a small part of their lives. Just as I was part of the life of the veteran who got married, I, I just wanna ha have those small moments club together amongst these different individuals that we are privileged to work with.
[00:26:13] Lindsey Dinneen: Hmm. Yes, of course. Wonderful. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:26:22] Dhruv Agrawal: Oh, that's very simple. Patients getting fitted with our device. Today we see a patient getting fitted with our device, and that smile on their face and things like that. And, you know, that's even much bigger, much more interesting in Ukraine because many times when you go to these hospitals, and when I go to these hospitals in Ukraine, you have to understand that these people have gone through a lot. These soldiers who are putting their body on the line for their country.
There, of course, there's a certain sort of low morale that they have when they're amputated and when they're in these hospitals and things like that where they don't really think that there is ever a possibility for them to regain something back. And you go in there and you show them a bionic hand, and they're not sure if this thing works, and you put the electrodes on them and they open the hand or close it for the first time, and then you suddenly see those expressions change from like, "Ah, what has happened to me?" to, "Oh, what can I achieve?" That is also an amazing feeling.
[00:27:16] Lindsey Dinneen: Yeah. Oh, I love that. What an amazing gift to be able to help somebody bridge that gap and witness it. How cool is that? Oh, well, I think this is incredible. I am so grateful for you and your co-founder for starting this company and just being able to give so many people hope and new life, really, just a new way of experiencing life. So thank you for all of the incredible work you're doing. I'm so excited to continue to follow your work, support your work, as I'm sure all of our listeners are as well. So, gosh, I just really appreciate you sharing all of your advice and stories and wisdom with us. So thanks again so much for being here.
[00:27:55] Dhruv Agrawal: Of course, Lindsey, thank so much for having me.
[00:27:56] Lindsey Dinneen: Of course, of course. And we are honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. We really appreciate you choosing that organization to support and thank you just again, so very much for your time here today. I just wish you continued success as you work to change lives for a better world. And thank you also so much to our listeners, and if you're feeling as inspired as I am right now, I'd love it if you share this episode with a colleague or two and we'll catch you next time.
[00:28:43] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Nidhi Oberoi is a dedicated medtech executive with over 17 years of experience and currently serves as Business Leader, Imaging Franchise at Terumo Medical Corporation. She discusses her journey from India to the heart of the medtech industry, her impactful work on innovative heart valve treatments while at Medtronic, and her advocacy for women's health. Nidhi shares her leadership philosophy centered on empowerment, the importance of mindfulness in business, and her vision for a future in cardiology and women's health.
 
Guest links: https://www.linkedin.com/in/nidhi-oberoi-278a111/
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 TRANSCRIPT
Episode 060 - Nidhi Oberoi
[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 excited to introduce you to my guest, Nidhi Oberoi. Nidhi is a seasoned MedTech executive dedicated to the mission of serving clinicians and patients. With over 17 years of experience working on commercialization of innovative technologies, She has led various strategic and operational initiatives that have transformed standard of care. Her bold, collaborative, and empathetic leadership style allows her to push boundaries and inspire teams to create durable value. She currently leads business initiatives for the structural heart business in Medtronic, which serves patients with heart valve disease. She's also an advocate for evidence based care for women's health. Nidhi has an undergraduate degree in economics from India and an MBA in marketing and entrepreneurship from Syracuse University.
Thank you so much for being here, Nidhi, I'm so excited to speak with you.
[00:01:44] Nidhi Oberoi: Yeah, thanks for having me.
[00:01:46] Lindsey Dinneen: Of course. Well, I would love, if you don't mind just starting off by sharing a little bit about yourself and your background and what led you to MedTech.
[00:01:56] Nidhi Oberoi: Yeah, absolutely. I was born and raised in India, and just like any typical Asian Indian household in those days, if you were a bright student, you were generally expected to pursue a track in sciences, medicine or engineering, or maybe a second option in accounting and finance. Predictably, after I completed my high school, I was on my path to pursue a career in sciences. But then I changed courses and ended up pursuing an undergraduate degree in economics, and eventually an MBA in marketing and entrepreneurship from upstate New York.
Now, as I reflect back and realize that what attracted me to business eventually, it was this realization that it's both in art and a science. The science aspect helps to ensure that the business can financially run smoothly with a strong P&L, while the art side of the business is the ability to set the vision, the direction, inspiring people, innovating, connecting with people.
So what I really was interested was in a career in marketing and general management. You asked me what led me to medtech, I'd say my entry into the healthcare industry was by chance. I got recruited into this industry through a summer internship when I was doing my MBA with a company called Conva Tech, which was part of Bristol Myers Squibb then. And by the time I had completed my internship, I already knew I wanted to be in the healthcare industry given the impact you have on the patient's lives. I did have opportunities to interview with other companies like Philip Morris and others, and I just decided that this is what I wanted to do.
And after I graduated, I started working for a company called Covidian, which was then a spinoff from TCO International. And Covidian was eventually acquired by Medtronic. It's been 16, 17 years since I've been working for this company and it has a really strong mission of elevating pain, restoring health, and extending life of patients around the world. So that's that's my story there.
[00:04:07] Lindsey Dinneen: Excellent. Thank you so much for sharing that. I'm curious. Of course your career trajectory has been really interesting and you've had a lot of different experiences along the way. So what are some of the key things that say maybe your schooling or your early career really set you up for success for what you're doing now?
[00:04:29] Nidhi Oberoi: Yeah, so there's just so many different experiences that either have shaped my interest, where I wanna go, or has shaped my leadership style. Now, as I mentioned, I decided to move away from sciences to a more kind of social sciences field, economics and then business, and that was due to the fact that I was not the person who could just crunch numbers sitting on the table. I liked connecting with people. So I think some of those personality traits helped me decide what I wanted to do.
And I would say one of my core value is impact, purpose. And so healthcare, it was just natural for me to gravitate towards healthcare because you are truly impacting people with different technologies. And I'd also say, as I grew further along in my career, early on when I joined Covidian, I had some great leaders who gave me a lot of ownership, and that shaped my leadership style as well. And that's how I operate. I empower my teams. I coach them along, but give them a lot of accountability. So there's so many different experiences, but these are some of the experiences that come to mind as. As as I reflect back now what that has shaped my career and also my leadership style.
[00:05:55] Lindsey Dinneen: Yeah, absolutely. And speaking maybe more into your leadership style, I'm really curious if you could tell us a little bit more about that philosophy of yours. I love that ownership mentality. It sounds very counter to what a lot of folks don't appreciate, and that's micromanagement. And so I'm curious, how do you bridge the gap yourself as a leader between making sure that, your team stays on track and the goals and really key, important performance indicators are met, while also giving them that ownership and that empowerment to make decisions and do things in a way that best aligns.
[00:06:35] Nidhi Oberoi: Yeah. So I think there's so many different facets of leadership, and let me highlight some of the others that feeds into the third aspect, which is the empowering team. So I think as a leader, first thing first, you need to provide clarity, direction, focus. I've been part of so many different teams where if people can relate to what they're doing, why they're doing, they can get lost, right? So I think that's the first thing. You need to have the ability to cut through the noise, provide direction to the team, organization you're leading.
And then the second part is inspiring and bringing people together to execute on that vision. So this is the culture piece. You are listening to others, you're hearing others' perspectives and being inclusive. And the last thing, which I mentioned early on, is empowering your teams and making them accountable. So to your question of how you bridge the gap, I think you have to give clear direction. And when you empower teams doesn't mean that you don't coach them, right? You are just telling them that you trust them to do the job and you are here to help them.
And one of the technique that I use is I ask questions, so I don't give answers. When you ask someone in your team to lead the project, they come to you. Then you ask questions. And I've seen, based on my experiences, that gives them a sense of ownership that this is something they're thought through. And oftentimes I've heard from people that they feel like they become a better version of themselves because I ask a lot of questions. I make them think. So that's my approach on how I kind of bridge the gap, but also make sure along the way that you're supporting them in the right direction.
[00:08:24] Lindsey Dinneen: Absolutely. Yeah, and you mentioned as you were speaking a little bit towards how your past experiences shape who you are and how you kind of relate to the world now, you mentioned core values, and I would love, if you don't mind, if you would share a little bit more about your core values. I noticed that on your LinkedIn profile, that was something that was very highlighted as being extremely important to you, which I love. I'd love if you would share a little bit about maybe how you developed your core values and how those play out for you.
[00:08:57] Nidhi Oberoi: Yeah, absolutely. I think core values is something that you always have, but you just sometimes need a little bit of handholding to unfold those, right? And so in my case, a few years back, I had an opportunity to work with a coach, and she really helped me understanding what I'm good at. These are things that you already have, but you may not realize or you may not know how to articulate.
So for me, the number one thing that came out was purpose. And I'm like, "No wonder I'm in the healthcare industry. I'm big on impact. I like building things." And so that's where it's coming from. The other core value of mine is excellence. I like to do things with excellence. I put my heart and soul into things. I'm a very passionate person. But also you gotta have an eye on quality versus decision making, right?
Over time, I've learned excellence is my core value, but it's a journey, it's a process. It's not a destination. So you don't have to dwell on things. Sometimes things go wrong and you just have to keep moving on and have a growth mindset. So there's a good aspect of the value, but there could be a blind spot, like in this case for excellence and I've learned to manage that as well.
And yeah, so I think these are some of the core values, which is, I think, also part of being a leader. You have to have self-reflection. You need to dig deeper and understand what you stand for. And, this has just guided me along the way. And yeah, so those are some of the things that I'd say has really helped me all along in my career.
[00:10:41] Lindsey Dinneen: Yeah, of course. So, tell me a little bit more about your current position and what are you looking forward to as you move forward in your own career as well?
[00:10:53] Nidhi Oberoi: Yeah, currently I'm in the structural heart space, and these are really old and sick patients. And it's just amazing to see these patients getting impacted by our technology, getting back to their day-to-day life. And as part of structural heart, also, most recently I've been able to work on therapies. I've been focusing on the congenital portfolio, which is, these are devices that are used to treat patients that have congenital disease, and it's very impact driven because you're dealing with children here who tend to get multiple surgeries throughout their lifetime. So my role right now is to focus on business initiatives. Some of it is expansion across geographies. Some of it is increasing supply for these products. I mean, there's not a big business case for these kind of products, but the impact is huge.
So that's my current focus. And, moving forward, in my career, I'm looking to grow into a general management track, and that's what attracted me to marketing because I consider marketing as running a business within the organization. So for me, running a business would be something that I would be looking forward to. And that's why I have spent time in so many different kind of roles, whether it's marketing, it's commercial transformation, whether it's global roles. So that's how I've been building my skillset so that I can one day lead a business.
[00:12:25] Lindsey Dinneen: Yeah, that's very exciting. Okay, so you're building all of these skill sets. You're working towards this incredible goal. Do you have an idea of what kind of business you would want to get into? Or is this, " We'll see," and I'll interview you again when that happens?
[00:12:38] Nidhi Oberoi: Yeah, I think cardiology, there's so much opportunity in cardiology. There are so many people getting impacted by cardiovascular disease around the world, and there's so much innovation too happening, not just on the treatment side, but also on the diagnostic side. So I would say either something in the cardiology space would be very attractive because it's innovative. There's such a huge population that gets impacted by it.
Or the other area of interest for me is women's health, and I think it just makes me smile how there's progress being made. I know there's so much work that needs to be done. We know there's not enough evidence, it's underfunded, but I think the work is starting there, and better evidence generation will lead to better decision making, which will lead to better outcomes. So I would say either in the cardiology space or the women's health space, these are the two areas of interest to me.
[00:13:38] Lindsey Dinneen: Yeah. And I noticed again, with LinkedIn, you are very passionate about women's health and I love that. And I am wondering if you could speak a little bit towards some of themes that I kind of picked up on, things like stigma with women's health, medical gaslighting and self-diagnosis. And I know there's a lot to that and it's probably too much for one conversation today, but can you highlight a couple of the areas that you particularly find concerning, that are things that we can all do better?
[00:14:11] Nidhi Oberoi: Yeah. Yeah. I think first of all there's such lack of education and awareness. As women transition through different stages of life, I feel like a lot of it is taken for granted. We don't question it. And as someone who's been following this for a little bit of a time, I almost feel like it's my duty and being in the healthcare industry, to raise awareness about this or encourage them to be more educated patients. When they go to a doctor, if they don't get answers, they should ask more questions. So I think, so that's that lack of education and awareness piece. There's a lot of work happening. There's so many advocacy groups. Women are coming together, supporting each other, so I think that's happening as well.
The other thing that really bothers me is on the diagnostic side. I wrote an article around women get mammograms. Just because there's not enough evidence out there, sometimes you just have to go through a number of tests to have a diagnosis, either a positive or a negative. So I also feel like maybe the advent of technologies like AI in the diagnostic field can help improve that, because it starts with the diagnostic side, and we just don't have enough right now. And like I said, it can either be a good thing or bad thing. I've also heard of women going through a number of tests to find out that they don't have anything, which is fine, but it's just a lot of money along the way getting to the diagnosis.
And then, the third thing I'd say is as we get more intelligent with evidence, it will lead to better awareness among the physician community too. And that's what gaslighting comes because there's not a lot of evidence, there's not a lot of awareness. Even physicians sometimes can't guide you in the right direction. But if you have more studies coming out, it will make them more aware and guide their patients in the right direction. So there's just so many different things, but I feel like you could start being a self-aware patient and not just assume as you go through different stages of your life that this is what it comes being with a woman. Be more proactive, ask questions, research, talk to other people and get help.
[00:16:32] Lindsey Dinneen: Yeah. Yeah, that's really great advice, and I appreciate your perspective in sharing with us a little bit about maybe even some of the things that we all can do as we're trying to hopefully push the quality of women's healthcare forward and make it more widely available and whatnot. So thank you for sharing. As you have been going throughout your career-- and you obviously care so much about purpose and you have a lot of passion for helping people and for the healthcare industry in general-- are there any moments that really stand out to you as affirming, "Hey, I am in the right industry at the right time?"
[00:17:11] Nidhi Oberoi: Yeah, there's been so many moments and I would say most of these moments are when I've interacted with patients. When I started with Covidian, I was leading an initiative which would help a lot of women who were having open hysterectomies-- this is like 10, 15 years back-- to have a minimally invasive hysterectomy through a new procedure technique. So it was called single incision surgery. And I happened to talk to some patients, and it was just amazing to hear those stories where they were telling me how they could get back on their feet, travel, within just a week after the procedure. So that's the defining moment.
And then, when I was working on one of the businesses where patients have very varicose veins, I met a patient who was a mom of four. So she had four kids within a span of six, seven years, and she had very visible varicose veins on her legs. And that impacted her quality of life. And when she got the procedure done with our technology, she was just so happy. It was not just cosmetic, but also less painful, and being more present with her kids because of that.
And then I'd say most recently in the cardiology space, these are really sick patients, older patients with multiple conditions, and just hearing their stories of getting a new heart valve, it's amazing to see how, again it's getting back to life. So it's always, when you meet these patients, those are the defining moments, and it just reaffirms why you're in healthcare and why you need to continue to work in the healthcare space.
[00:18:58] Lindsey Dinneen: Yes. I love that so much. Yeah, 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 can be within your industry. It could be related to anything your background, your experience, but it doesn't have to be. What would you choose to teach?
[00:19:19] Nidhi Oberoi: Yeah, that's a great question. I don't think I have an expertise right now, but maybe something on mindfulness and yoga. One of my goals is to do a yoga teacher training, but the importance of mindfulness in business. There's so many things you can do: power walks, taking a break, journaling. These are so underrated, but I think these things are necessary. It's more important than ever now, given the fast change. There's so much, so many changes happening at such a fast pace. So I would say that would be my topic, but I don't think I'm ready yet to have that masterclass.
[00:20:03] Lindsey Dinneen: Fair enough. Fair enough. So I'm curious, how long have you been incorporating these kinds of really important mindfulness practices into your own life and your own routine. Is this something that you've had for years and years or is it a more recent development?
[00:20:19] Nidhi Oberoi: Yeah, I think it's more recent. I would say three to four years, although I wonder why I did not do that. I think within the organization, as you are managing multiple things, it just forced me at that point of time when I was juggling a lot of things in my life and I wanted some pause and clarity. And I actually, years back, I had take a yoga class and then I started doing core barre yoga as well. So I realized that it really has a big impact on me.
And then I just try to be more disciplined and try to take out time, if not every day, maybe every two days, but I would say it's more of a recent phenomena. It does require a lot of discipline. Earlier you start, the better it is because you're not going to get it right away. It takes a lot of discipline and commitment to incorporate these. And you won't be able to do it all the time, but at least starting that and trying to incorporate day to day life is a good start.
[00:21:26] Lindsey Dinneen: Yeah, absolutely. I found personally that starting my day with a much more intentional routine that includes things like meditation and those kinds of mindfulness practices makes a huge difference in how I feel throughout the whole day and the week in general. So, and that's a more recent development for me too. So it's one of those interesting things about how that evolves over time. So I love that. Thank you for sharing about your own journey. All right, and then how do you wish to be remembered after you leave this world?
[00:21:59] Nidhi Oberoi: As I said purpose is my core value, big on impact. So I just want to leave the world a little bit better and do my bit. And whether it's working on things, like working on technologies and providing access to health care to patients, probably globally. So it's just continuing to make an impact in the healthcare space and leaving the world a little bit better than I inherited it.
[00:22:27] Lindsey Dinneen: Yes. Excellent. And final question, what is one thing that makes you smile every time you see or think about it?
[00:22:37] Nidhi Oberoi: Yeah. There are so many different things. As you start meditating or focusing on mindfulness, it's the small things in life that you start enjoying. Being in Minnesota, the good weather is difficult to come by. So sunshine really makes me happy. But yeah, I think being present makes you more joyful. You just start enjoying everything in life. The other thing I would say is just simple acts of kindness. People helping other people is also something that just moves me and touches me.
[00:23:11] Lindsey Dinneen: Yeah, of course. I'm really curious. Okay, so I said final question, but then I have a follow up. So when you said being present helps bring you joy, could you share a little bit more about what you mean by that?
[00:23:24] Nidhi Oberoi: Yeah. So I think being present means that you are not thinking about your past and you're not thinking about your future. And so what that means is all you're focusing is what's in the now, and I'm going to start speaking the language of someone who teaches yoga or meditation, but being present really is you're not in the past. You're not in the future. You're just enjoying your day, the moment, as it comes by, it's as simple as that. You're centered. You're aligned with yourself and you just focus on what's in your control. You don't dwell on things either of the past or in the future. So I think that's a very, that's a beautiful moment to be in.
[00:24:11] Lindsey Dinneen: Yes, I couldn't agree more. Well, thank you for sharing a little bit more about that. I really appreciate it. And thank you so much for your time today. This has been such a great conversation. I've loved learning about you, and I'm so excited about your career future, especially with your goal of starting your own company at some point. So I will be cheering you on for that whole process. I know that's no small undertaking. But in the meantime, I just want to say thanks again for your time, and thank you so much for working hard to change lives for a better world.
[00:24:45] Nidhi Oberoi: Well, thank you so much. Thank you for the opportunity. It's been so fun chatting with you. You're joyful.
[00:24:52] Lindsey Dinneen: Thank you. Well, excellent. 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. Thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two. And we'll catch you next time.
[00:25:30] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.