The Leading Difference

Rick Sherak | CEO, Exokinetics | Mobility Innovation, Destigmatizing Sales, and Life-Changing Impact

Rick Sherak, CEO of Exokinetics, shares his incredible journey from serving as an Air Force officer to leading a company that develops transformative mobility devices. He discusses the importance of leadership, sales psychology, and creating compassionate company culture. Rick's passion shines through as he recounts heartwarming stories of how Exokinetics' Zeen device has profoundly improved the lives of people with mobility challenges, including children with cerebral palsy.
 
Guest links: https://gozeen.com/ | https://vimeo.com/1011399920 | https://vimeo.com/856975581/9994ad1cb8?share=copy
Charity supported: Project ELEVATE Mobility
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 053 - Rick Sherak
[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, Rick Sherak. After serving as an Air Force officer, Rick spent over 25 years in the medical diagnostic industry as a commercial and product development executive. Leveraging his broad leadership and medical domain experience, he became CEO of Exokinetics in March 2024 to lead the company into its next expansion phase of market awareness and revenue growth.
 Alrighty. Well, welcome, Rick, to the show. Thank you so much for joining me today. I'm so excited to speak with you.
[00:01:30] Rick Sherak: Well, it's nice to meet you, Lindsey, and I'm glad to speak with you today as well. Should be fun.
[00:01:36] Lindsey Dinneen: Yeah. Excellent. Well, I would love if you would start by sharing a little bit about yourself and your background and what led you to MedTech.
[00:01:45] Rick Sherak: Sure. Well, so I currently live just outside of Philadelphia with my wife and our four dogs. We just recently moved here from Boston, so we've had to quickly become Philadelphia Eagles fans. Go birds. We love it here. And my background is kind of interesting, a little bit diverse. I started off my career as an Air Force officer. I tried to follow my dad in his fighter pilot footsteps. Got almost there, but I had a medical disqualification, so I had to do a land based job, but really enjoyed the Air Force. It was a great way to pay for my college and to serve my country and also to learn leadership. It was like a masterclass in leadership. Talking about getting thrown into the leadership fire, and as a young 22 year old, lead a group of people on a mission, motivate everyone, and get everyone producing at their highest capacity. So that was a great way to start.
But after I got out of the Air Force, I really wanted to go back to my roots, and that's in the sciences. I've always loved the sciences, especially the biological sciences. I have a degree in biological science from Baylor University. So out of the military, I was looking for an opportunity to use my interest in something that would support my family.
So I started with Abbott Laboratories. And Abbott Laboratories, back in the day, was a Fortune 100 company, one of the up and coming medtech companies, had a pharmaceutical arm, but I belonged to the medical diagnostics side of it. And it was great. They, at the time, were hiring a bunch of ex military officers to be their field sales people and none of us knew how to sell. We were all out of either the Air Force, Army, Navy or Marines, but we learned quick.
We understood, you know, there's the hill we have to take, but I really respected Abbott because they trained us not only how to sell, but how to sell with integrity, right? And they also, you know, they had 200 products that we had to learn and become masters at because we were selling to hospitals and medical laboratory clinicians, etcetera. But it was a great way to start my career, and I truly found that I loved it. One, I enjoyed the sales aspect. It was fun helping people solve problems with our products, and ultimately, help the patients get the best care right from their diagnostics.
But two, it also taught me that I was pretty good at it. I did very well at Abbott. I promoted several times and won some national awards. And as a result, I was recruited away by another medtech company, which was a early stage organization called Ventana Medical Systems. I intended to be there for three years and learn everything I could and then expand my career. I was there for 15 years. And we had a ball. We took this little medical diagnostic company that came up with a transformative device that would automate very complicated processes in the pathology laboratory environment. So it was disruptive technology. We were going out there with something no one had ever seen before.
And I joined them pre IPO. So we went public and then we started churning and burning and impressing Wall Street every quarter so that we can up our value. 15 short years later we sold the company to Roche Diagnostics. So what a great exit and just a wonderful experience and developing my leadership cause I was management as I quickly was filling levels as we were growing. But what a wonderful ride, that's something to see, somebody with an early vision to take it step by step to a wonderful exit. But we helped a lot of people, we became a market leader in immunohistochemistry automation, and it just truly was a great experience.
But after Ventana, I wanted to do something a little different. So I stepped into the world of startups. I spent about 12 years in the startup world, worked for four startups, two of which died, which happens a lot in that environment. And then the other couple did pretty well. I really enjoyed it because now I was helping people on the oncology diagnostic side of medtech. So each startup had a unique laboratory technology that would better predict the patient outcome to a particular chemotherapy or targeted immunotherapy for their cancer. So, the whole purpose was to see how can we get better predictive value so that these patients don't have to suffer unnecessarily with the wrong drug.
So that, again, was just a wonderful opportunity for me because more than not, I would come into these startups and have to create the commercial organization from scratch. That means I had to hire my own national sales team, my own marketing team, my own customer service team and logistics team to handle very delicate samples. But I loved it. It, it enabled me to take everything I learned from the air force, from Abbott, from Ventana and apply it to a small company environment. And I found that it was addictive, and that's why I stayed in it for many years.
But then I did another turn and I took a sidestep because I loved also, has always been kind of a frustrated engineer. I joined an engineering company that just focused on design development of medical devices, and they hired me because of my diagnostic domain experience. And I went out and found early stage companies and brought them to this engineering firm so we could take the novel technologies from these companies and make them into a product that could be commercialized. So I did that for several years.
Long story short today, I'm in a completely different type of medical device environment. I'm the CEO of Exokinetics, and Exokinetics is a very unique organization in that we decided to look at the mobility device market and fill the gap, because unfortunately people with mobility challenges are basically regulated to either wheelchairs or walkers or electronic scooters, all of which have significant problems to their health because they're not using their body in many cases. And fall prevalence-- people with walkers-- oh, it's just such a shame. There's over 50, 000 emergency room visits a year of people falling with their walkers. So anyways, Exokinetics has developed a very unique mobility device that gives people a lot more freedom. and safety in their daily challenges with mobility. So, sorry, it's kind of long.
[00:08:44] Lindsey Dinneen: Oh, I loved it. No, I so appreciate it. Thank you for talking us through all of that. That was great. And so many questions, but I'll try to start at the end a little bit and then probably work my way back. But yeah, so, okay. So I'd love to hear more about the company that you are now involved in and this device. But I'd love to take it back a little bit further and say, what made you aware of this challenge existing that there isn't a great solution in the marketplace, or not maybe more updated options. So what made you aware of that challenge and then decide, "Okay, I think I have the tools, resources, ideas to fix it, to address it"?
[00:09:25] Rick Sherak: It's a great question. I, one, I was not aware, right? I was not aware of the challenges. However, a buddy of mine, we go to the same church, you know, we're in a men's group, we're a bunch of old guys hanging out talking about stuff. And he was doing some investment investing into early stage or startup medical diagnostic companies. A very generous individual, and he knew of my background and he goes, "Rick," he goes, "I'm looking at this company. I'm not sure I want to invest, but maybe you can look at it with me." So I did some free consulting for him, he's my friend. And then he kept dragging me to this company to their board meetings. Right. And I'm going, "Hey, this is great," and I give him my advice because, because it was new for me.
And that's how I found out, Lindsey, about the challenges that people with mobility issues have, is that the status quo now is, oh, you have Parkinson's, or you have cerebral palsy, or you've had a stroke. Put those people in a wheelchair and just let them live their life at that level. And I didn't realize how horrible that is for many of these people because they still have utility of their legs, right? But when you're confined to a wheelchair for long term, your legs will naturally atrophy, right? And become so weak that they won't be able to use them anymore.
So what struck me, as mission driven, was that this company invented with their own engineers, this device that not only promotes people with mobility issues to use their body, but to use their body effectively moving around horizontally around the world, but also vertically. It enables them to go from a seated position to a standing position. And for us, for you and I, we're thinking, "Well, yeah that's pretty good." For them, that is a game changer being able to go from seated position to standing and then walk from that position all without the fear of falling.
So, it really touched my heart as I learned more and more about the company and I kept giving more and more time to them. So eventually I was pulled aside and they said, "Rick, what's your appetite for running this company because we need to grow it and we need to get out there and help more people." So lo and behold, I've been here for almost a year.
February 1st is my anniversary and it's been a great ride. I just love it. I have a passionate team, mostly of young people. I love it. I couldn't script better people, more compassionate, more caring. All of our customers are suffering in some way or another. Even our elderly customers that are just bad knees, bad hips, bad endurance, our device is perfect for them. So, yeah, you know, we're having fun.
[00:12:27] Lindsey Dinneen: That's great. Well, yeah. Thanks for sharing a little bit about that too. And so, as you've stepped into this leadership role that you weren't necessarily anticipating was your next right thing, what were some of the challenges? Because you've had an amazing career, and like you've said at the beginning, you were learning leadership skills all throughout and you've had many iterations of different ways of approaching medtech, with the industry. But now as CEO, that's another thing. And so I'm curious, how was that transition to step into this leadership role and take it on?
[00:13:03] Rick Sherak: No. And it has been different in many ways, but it's also very similar in others, right? Because in my opinion, leadership, really the definition from my perspective is that a good leader motivates effectively a group of people, talented people, and usually very diverse group of people, pulls them all together to accomplish an overall mission or goal, right? And it's it.
That's the part I wouldn't say that's easy about my job now as a CEO, but it's natural and I love motivating my people. I'm a big fan of management by walking around and I try to talk to all my employees at least every day or every other day just to see what's going on, not only in the business side of things, but also in their personal side of things. I, I assume that nobody's going to respect me unless I earn it. And, I just wanna make sure that I'm leading by example and I'm the guy that either gets to the office first or leaves the office last, just trying to make sure that I'm there for my people when they need me.
What is different, Lindsey, is that I am struggling with delegation because I want to do it all myself, right? And I know better. It takes me a long time to dye this hair white because I'm not that old, but just know better. But it's a struggle because you have to allow others to get things done and especially in a small company like this. We were still very early stage. People are wearing a lot of hats and I just have to allow them to go and give them the best guidance I can and then press on to the next thing, right?
[00:14:49] Lindsey Dinneen: Absolutely. So, it sounds like you've been very intentional building a company culture that reflects the values that you care about, of course, and also reflects compassion, because you mentioned, your customers, for instance, are all folks that are in a difficult, challenging place. So how do you feel the importance blends from really intentionally cultivating a culture that is this empathic, creative problem solving, just really good culture, it sounds like, to how that affects how you basically present to the world who you are.
[00:15:28] Rick Sherak: Yeah, well, no, that's a great question. So where our challenge is that our customer base is so broad, right? And like you said, all of our customers in our DTC business-- that's about 40 percent of our business is direct to consumer, right? But we have other customers, distributors. We have hospitals that use our device, physical therapy, occupational therapy, neurological research, you know, things like that.
But the key, I think, from our perspective, is we want people to realize that, hey, we don't have 20 products, right, that we've gotten from other folks. We have designed and developed a very new and transformative device that only came about because we had our own internal engineers, and we've listened to what is needed out there to help people live a better, more free, more independent and active lifestyle.
So, you know, interestingly, when we broadcast ourselves out there, I hope that people realize that, "Wow, this is not just a company selling something new, they design and develop this with their own people," right? There's a lot of love in our products, and people can tell because each one of our products is handmade, and it's customized to the individual ordering it by their weight, how much they weigh, and how tall they are, so we can adjust everything for them.
And I tell you it's a lot of fun because some people literally take the time when they get their Zeen-- that's the name of our product, Zeen-- but they'll write us these wonderful notes on how this device has just transformed the way that they engage with their world. And, when you sit back and you go, "Hey, what difference are we making today?" Wow. That's why I think I have such a motivated group of people because every day we're talking to these wonderful, courageous individuals that have lost a big part of their ability to live effectively in the world and they're looking for something new, something meaningful and something that's going to help them. And when we can provide that it's just wonderful, very rewarding.
[00:17:52] Lindsey Dinneen: Yeah. Yeah. Of course. Just to know the impact that you're making and able to make. And so the days that get really tough or frustrating or whatever, you can still hold onto this anchor of, "But we're making a difference. We know that."
[00:18:07] Rick Sherak: And we see it. We have visitors come to the factory just about every week. Maybe two or three visitors will come and they'll try it out. Try out the Zeen to say, "Hey, I saw it on social media, just want to try it. You guys are local." And that's when we really get that, that visceral customer experience, right?
It's just crazy, Lindsey. I've seen people come in, bent over sitting on this little electric scooter with a joystick. And they come in and they just look broken, right? And then we get them into a Zeen, and then they're all of a sudden their spine starting to straighten, right? They start sitting up, and then we slowly and compassionately show them how the device works and everything, but we make sure that they feel safe and that they trust.
And as soon as we get that go ahead, which often you just see it in their eyes, then we'll engage the levers and the Zeen will lift that person with-- it's kind of like a big bicycle seat under them. It lifts up with this non motorized lift mechanism, that we invented, up to 75 percent of a person's body weight. So now they go from the seating position to standing. Now, many of these people can't do that on their own. They can't extend their legs from seating to standing. They need other people to grab them and lift them, right?
But now Zeen lifts them. Now they're standing. And again, it's just phenomenal because this person that came in on this scooter bent over is now standing. They're putting weight on their legs. They're stimulating their brain because there's weight on their legs. Right now, neural connections are starting to flow again, and their spine straightens, and they stand tall, and when they take those first steps, often it's very slow, just tiny little steps.
But then we just leave them be, and we talk to their family that came with them, and we go get something to drink, get some snacks, start chatting, and just let them be. And it's amazing, you can just see their brains working, and their legs moving faster and faster. I've seen people barely moving at the beginning, and at the end, they're cruising, we call it the lap, they go around the office, around all the desks and everything, and everybody's clapping, you know. It's amazing.
[00:20:28] Lindsey Dinneen: Wow.
[00:20:28] Rick Sherak: It's so cool! I'm not trying to overstate it, but this is our daily life. So I'm just very happy and pleased that my background has led me here. It's a great way to finish my career. I want to stay here for as long as I can. Hopefully it'll be many years because I enjoy every day of it.
[00:20:52] Lindsey Dinneen: Wow. That's incredible. Yeah, and thank you for sharing those stories. I was just imagining that, that laugh and how amazing.
[00:21:00] Rick Sherak: It is so cool.
[00:21:03] Lindsey Dinneen: Can't possibly get old. Just witnessing joy and hope, honestly, even hope alone is...
[00:21:10] Rick Sherak: One of the best is this father comes in with his twin boys. And the boys have cerebral palsy. It's a disease that you get from birth, right? And their legs are just not good. They have no balance at all. And the father brings them in. He carries them because they don't even have a mobility device that really works for them, except for walkers, like an old person walker, right?
But he carries them in, he puts them on the, in the lobby, and we bring over the Zeens, and these little boys are the cutest things you've ever seen. They're just, they're twins, they're chatty, they're so excited. We get them into the device, and their first few steps, it's like I said before, we're just tiny, tiny. But then they built their trust. And at the end of the visit, these boys were running. I mean, they were digging in with their little legs, fully supported, fully trusting the device and their hands were in the air waving.
And their dad is just like tears. He's just like gushing. He's going, "One, I've never seen my sons run before. Two, they've never moved without their hands either holding a walker or crawling on the floor." He goes, "These boys are running around with their hands in there in the air." And they're saying, "Hey, look, Daddy, my hands are in the air. I don't need to use my hands." Of course, we have Kleenex boxes all over the office.
[00:22:36] Lindsey Dinneen: Yeah. I'm pretty sure you'd have to, it's just part of the the office supplies.
[00:22:42] Rick Sherak: Exactly. Yeah. We have a Costco membership for regular shipment of Kleenex. Yeah.
[00:22:49] Lindsey Dinneen: That's amazing. Oh, thank you so much for sharing that story. That's incredible...
[00:22:53] Rick Sherak: Oh, yeah.
[00:22:54] Lindsey Dinneen: ...just for a father's heart.
[00:22:56] Rick Sherak: Oh, it's just so amazing. Yeah, it's so amazing.
[00:23:00] Lindsey Dinneen: So this is all incredibly exciting just the way it is right now, but I imagine there are future plans. Can you share a little bit about what's next? What are you excited about as you move forward?
[00:23:12] Rick Sherak: Well, what's really exciting is our growth potential, right? So again, the Zeen is a very unique device, but it fits so many different segments of populations. Like we've been talking about people with chronic illness. That is our core group, right? We work with people with Parkinson's, MS, muscular dystrophy, cerebral palsy, ataxia, you know, just about anything like that where people have strength, balance, or endurance issues.
The other part that we're really excited about this year is that we didn't realize until those boys, how much our Zeen would help in the pediatric environment. So now we're making a very concerted effort going after the children's hospital physical therapy groups, showing them the amazing utility of a Zeen. And also because it's so adjustable, a person, a child can get into a Zeen early, let's say at the age of seven, and it could actually stay and grow with them until they're 14 or 15 years old. The whole thing adjusts up. So we're very excited about that market space.
And we're also introducing the Zeen to luxury senior centers, because so many of our Zeen customers are just elderly people that don't want to give up, that have this incredible determination to either maintain or regain their mobility. Their knees hurt, their hips hurt, their endurance is down. So that's another avenue that we're introducing ourselves to, primarily through social media and publications through PR. But we're hoping this new awareness will get more Zeens out there.
Our goal is really awareness. And that's one of the reasons that you and I are talking. I want to get out there as much as possible and let people know that there's other alternatives out there for their loved ones or for themselves if they have mobility challenges. And please check us out. We have a really cool website, a lot of videos, a lot of testimonials, and we just love helping people.
And we're very fair in business. Our product is not cheap, but we give most customers a 14 day minimum home trial, and we say, "Use it a lot, as much as you can to make sure it's a good fit." If you don't like it, money back. So we try to be as fair as possible to make sure it's a good fit.
[00:25:39] Lindsey Dinneen: Yeah, that sounds good. Yeah. And so for any of our listeners that are, you know, going to go and check out the website, just make sure you have your own stash of Kleenex. Oh man.
[00:25:54] Rick Sherak: And every time we sell a Zeen, it comes with a virtual training session. So it's a one on one with one of my specialists. And I tell you, these folks are the best. So the best trainers and they're just the most delightful people, right? And they're like you. They're virtual, but you feel like they're right there with you. So we do virtual training for every one of our customers. And, it gives us that opportunity to see people eye to eye and to ensure that they understand their new tool and how to use it and how to, like I mentioned before, how to trust it, and realize that they're not going to fall, that they can move again, and they can do it safely.
[00:26:34] Lindsey Dinneen: Amazing. Well, gosh, thank you so much for sharing about the company and...
[00:26:38] Rick Sherak: Yeah.
[00:26:39] Lindsey Dinneen: ...the device and the lives that it's impacting. And I just, I love learning about this. I'm so excited about the work that you're doing. So thank you for putting in the work. It's not easy. Startup world is difficult and especially medtech, but you've done it. So good job.
[00:26:56] Rick Sherak: Well, and this is also interesting for me because it's manufacturing. Before, I didn't have to manage manufacturing. So manufacturing is a whole different beast with getting your parts, getting them ordered in time 'cause everything has to be built just right. This is like a high end super bike, you know, has the latest in technology for aluminum framing and engineering leverage. So that's a challenge for sure.
But the other thing I wanted to plug real quick, Lindsey, if you don't mind, is again, we're a premium priced product, but we're not covered under insurance plans right now. That means Medicare or Medicaid. So, part of our outreach is we've created a foundation. It's a nonprofit foundation so that if we can find donors that want to support, the money goes into our foundation, and we take applicants and we provide grants for up to half the cost of a Zeen through the foundation. The other half is on the people that are trying to buy it.
And, it's so interesting. Talking about putting skin in the game, right? People call and say, "Geez, I just can't swing that amount of money." Well, let's talk about the foundation, but you have to come up with half. And that creates such a-- it's such a partnership, and they're so excited. They'll be emailing my folks going, "Hey, I was able to raise 500 through a crowdfund! I just got to keep going!" And we're going, "Yeah, keep going!" And as soon as we hit that halfway mark, the foundation kicks in and covers it. So again, I just want to put a plug out there so that we can help very deserving people that just financially need a little support. Yeah.
[00:28:37] Lindsey Dinneen: I love that. So that's a great way for even listeners to get involved, even if they don't necessarily personally need the device, but donating to this incredible cause, that would be awesome too.
[00:28:48] Rick Sherak: Anything would be so appreciated.
[00:28:50] Lindsey Dinneen: Great. Yes, absolutely. Well, okay. So pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. It can be within your industry currently, it could be about anything. What would you choose to teach?
[00:29:13] Rick Sherak: You know, that's funny that you said that. I live right next to Villanova University, and a lot of my neighbors are professors there. And one of our best friends that lives a few houses down she's in the business ethics department. And she even said, she goes, "Rick, have you ever thought about teaching?" And I said, "You know, I've never really been a teacher."
But if I were to teach, the thing I would love to do would be to capture over all these years of me being in this industry, the nuances of the psychology of sales. Because people think of sales as, "Oh, you're trying to trick people into buying, right?" Turn that completely upside down to, you're trying to assist people to buy. Because people really, when they're looking at your product, they want it. But they need help. They're counting on you to help them in that process.
And it's a psychological bond when you're talking to somebody and you have a product and they have a need and you're trying to find that, that perfect combination, right? So that they feel, "Hey, this is great for me. It's worth every penny because I see the value." Versus having them feel, "Oh man, I'm going to get ripped off." So I would love to go down that path.
I think that's so interesting because people are people, and salespeople, the best ones I've ever seen, like I mentioned before, are compassionate and caring, but they're also pleasantly persistent, right? And they just, they go, they listen and they say, "All right, but let's keep moving down the path." And people that are on the buying side truly want that. They want that partnership, that walking side by side down that path to purchase, because sometimes they're not courageous enough to buy just by themselves. So, to destigmatize sales would be kind of fun.
[00:31:13] Lindsey Dinneen: I love that. That would be great. That'd be a great masterclass too, just to really dive into some of that, and yeah, to put a different perspective on your role and you're helping somebody to achieve what their goals are, to be honest.
[00:31:26] Rick Sherak: Absolutely.
[00:31:27] Lindsey Dinneen: I love that.
[00:31:28] Rick Sherak: Absolutely. And we've all had those good experiences, and we've all had those bad experiences.
[00:31:32] Lindsey Dinneen: Definitely. Definitely. So how do you wish to be remembered after you leave this world?
[00:31:40] Rick Sherak: You know, that, that's interesting because I love to read. My morning time is my reading time. That's my time. It's me and my two collies. They're also early risers. The pugs, the two pugs, no, they'll sleep in with their mother. But in my reading and in my studies, essentially, I think it all boils down to at the end of the day, when the curtain starts coming down, wouldn't it be nice, when you're out, you're no longer here and people look back and they just say, "You know what? That guy or that lady really genuinely cared about other people." I think authenticity and being genuine is something I would love to be remembered for. And it's not easy, because sometimes you're not authentic to yourself, yet to others.
[00:32:29] Lindsey Dinneen: Yeah.
[00:32:32] Rick Sherak: But especially at this stage in my life, I just see caring for people is just amazing. Talking about, if everybody cared a little bit more for each other, it might be a different place.
[00:32:43] Lindsey Dinneen: Yeah. And having the courage to be authentic and honest can sometimes also be, it does come with a little bit of vulnerability. So I love that.
[00:32:55] Rick Sherak: Oh yeah. Oh my gosh. You know, it's all about, if you're just so lucky to have a little bit of grace, a little bit of wisdom, but like you said, a lot of courage. That's when it all means something, right? Cool. Oh.
[00:33:10] Lindsey Dinneen: I know. What is one thing that makes you smile every time you see or think about it?
[00:33:22] Rick Sherak: Well, you know, funny because we've been talking about leadership and sales. I just got to tell you a quick story because it always makes me smile. As I mentioned before, I was an Air Force officer and all of a sudden I jump out of the Air Force into a sales role with a medical diagnostic company. And, I just went through training. I got assigned to my territory. Baton Rouge, Louisiana. I'm a Colorado boy. So Baton Rouge, Louisiana was a little bit different for me, but the company moved me down there, and I started my sales career. And my, my customers were all hospitals and clinical laboratories in Baton Rouge, Lafayette, and the Bayou South, all those little towns in there. And I didn't realize it until after I started, but my territory was made out of the accounts the other sales people didn't want.
[00:34:16] Lindsey Dinneen: Oh.
[00:34:17] Rick Sherak: So the guys that were there, they cherry pick the good accounts, and the ones they didn't want, they made into my territory, right? The new guy. But I went in, I was dialed in. I had my brochures. I knew all my product knowledge. And I'd make appointments and I'd sit in front of these lab managers and these clinical influencers. And these lovely people, they would sit there. They would be so kind. They'd have their arms crossed. I go through my spiel and then they just look at me and they say, "Thank you, Rick, for coming. I'm not interested at this time." I go, "Okay."
So this went on, Lindsey, for six months at every single hospital or clinical laboratory. I was like on the bottom of the sales list. I couldn't get anybody to buy anything. And it was like, it was so funny. And this is what makes me laugh. I'll never forget. I was down in south of Lafayette, and I was sitting in front of this lab manager and I've seen him every three weeks like clock work, right? And I'd always bring in new information, recap what we discussed before, and asked for the business. And he'd always say, "No, I'm not interested."
But about six months in, he just looked at me and I got through my spiel. And he goes, "Rick," he goes, "Are you just going to keep showing up every three weeks?" And I said, "Yes, sir." And he says, "Look," and I mean, he's going, "Well, I'm not buying anything from you." And I said, "Yes, sir. But I, I truly feel that my products are the best products that you could use in your laboratory to make you more successful and to give your patients the best diagnostic information to help them fight their disease." Because it was mostly oncology focused.
And he just looked at me and he goes, "You truly believe that?" I said, "Yes sir, I truly believe and I'm going to keep coming back until you believe." And he just sits back and he, I'll never forget this, he unfolded his arms, put his hands on the table and he goes, "Well, okay, then let me see what you got." And it was awesome.
Lindsey, I swear there was like some underground communication channel because every hospital or clinical laboratory started listening to me after about six months. It was weird. And then another six months, I was on top of the sales rolls, and I had turned my territory around and we were just having a ball.
But it was that persistence, it was just in the caring. I just cared. I was convinced my products were better, and he appreciated that. And, it, it was a fun, it makes me smile today because there's nothing like seeing somebody say, "Well, you know what, I trust you enough to listen to you now."
[00:37:06] Lindsey Dinneen: Yeah. Wow, that's awesome. They really had to go through that know, like, and trust you cycle or a journey.
[00:37:15] Rick Sherak: These are long term Louisianians. I'm coming in as an outsider, too. So that was, I had to prove myself. But they are the one most wonderful people. Before I got promoted out of that territory, I used to show up at least once every, maybe two months, per hospital with all these crawfish and a big old pot and a boiler and I would be out in the parking lot. I'd be boiling crawfish and I called the lab and I'd say, "Hey guys, I got crawfish!" And they go, "Oh, Rick has crawfish!" And they all come out and we'd all eat crawfish. That's how you do it in Louisiana. It was a good time.
[00:37:54] Lindsey Dinneen: Very cool. Thank you. Thank you so much for sharing about that. And just in general, being so willing to share so much of your story. I really appreciate it. I loved getting an opportunity to learn about you and your background and your heart for MedTech, your heart for the people that you're serving. So thank you. I know days aren't always a walk in the park as much fun as I know you're having, but I know you have good days and bad days. So thank you again so much for joining me.
[00:38:19] Rick Sherak: Thank you, Lindsey.
[00:38:20] Lindsey Dinneen: And I just wish you the most continued success as you continue to work to change lives for a better world. And just also thanks 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.
[00:38:40] 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.

Mike Knox | Medtech Advocate & Comedian | A Father's Perspective on Epilepsy & the Power of Medical Devices

Mike Knox is a standup comedian and the author of "Vivien's Rain." In this unique episode that reveals the perspective of a device end-user, Mike shares his personal journey into the MedTech field through the lens of his daughter's epilepsy and the life-saving (and life-giving!) impact of a vagus nerve stimulator. He discusses the challenges faced before discovering the device, the transformation in his daughter's life post-surgery, and his advocacy work. Mike also touches on the stigma surrounding epilepsy, the importance of compassion, and his career shift from law enforcement to comedy, using humor to inform and inspire others. 
 
Guest links: www.MikeKnox.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: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 052 - Mike Knox
[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, Mike Knox. Mike is a standup comedian and author of the book, "Vivien's Rain," about his daughter's epilepsy and the medical device that saved her life. He is a retired parole agent, and I am so excited that he is joining us today because he has a very unique take on the medical device field from a personal encounter.
All right. Well, welcome, Mike. Thank you so much for being here. I'm so excited to speak with you.
[00:01:27] Mike Knox: Thank you for having me.
[00:01:29] Lindsey Dinneen: Yeah, of course. Well, you come to the medtech field and to medical devices in a very kind of unique pathway, and I'm very excited to dive into that. But before we do, would you mind just sharing a little bit about yourself, your background, and what you're doing today, what led you to today?
[00:01:48] Mike Knox: Sure. I'm retired law enforcement and now I'm full time stand up comedian and an actor, much better than law enforcement. And I have a daughter who has epilepsy. She's 17 now. She started having seizures at the age of two. And by the age of eight, she got a vagus nerve stimulator, which basically saved her life. So it's a small implant that's like a -- I'm not supposed to say this-- but it's basically like a pacemaker, but for your brain. So it's a small generator that attaches onto your vagus nerve and sends impulses to interrupt your seizure. So she's now been seizure free for eight years.
And I go basically go and I'm an ambassador for the company that makes this product. And I go and talk about this product, which is basically, I mean, it has saved my daughter's life. And not only that, but beyond that, it's allowed her to be get her life back basically because she was pretty much just a little zombie cause she was on so much medication at the time. So really for the past 15 years, it was just my wife and I living day to day as parents just trying, you know, in and out of the hospital with my daughter. So now she's in a great place and that affords me the time to go out and talk.
[00:02:54] Lindsey Dinneen: Wow. That's incredible. Okay. So can we go back a little bit and talk about what life was like before this device, before you discovered this device, before all of the changes started happening for the better, but can you just paint a picture of what did daily life look like and how did that go?
[00:03:13] Mike Knox: It was waiting for the seizure to happen. And most of them were at night, so it would usually be my wife and I taking turns watching my daughter all night long. And she'd be be on medication, but she'd have break breakthrough seizures. She would have partial seizures, but they would go into grand malls and we'd have to go always to the hospital because that's where the rescue medication was.
And then it would be at the hospital, always confusion because they were the hospital that was local, wasn't really trained. And we kind of found out not a lot of hospitals, emergency rooms, were trained for seizures, which seizures have been around 2000 years. So there's a lot of misinformation, a lot of not really good education. And that's where I, as a parent thought, this stuff really needs to change. So that's what my wife and I did was, you know, started small talking to our hospital and just trying to get a policy in place where we could, you know, safely get my kid from here to the hospital.
Then as time went by kind of technology caught up and we were able to have a rescue medication at home. But there were times where my daughter flatlined twice. So it was very scary. And it was just like living day to day because we we're in crisis mode and waiting for that next seizure to happen. It really did for us, was that seizure was stalking us, always waiting, we never knew when it was going to happen, kind of narrowed it down to that might be at night or coming out of her sleep when waking up, like on the way to school.
But it really held you hostage. You weren't able to, we weren't able to go anywhere. You always had to think of where you were gonna go and plan things out. And your friends and family kind of abandoned you be just because they don't know what's going on. They don't understand what your family's going through. And I think a lot of parents see that also as, people just don't understand what it is you're going through when you have a medical problem.
And so, when she did get this device that changed everything. And the number one thing that it did was it finally allowed our family to sleep, which we hadn't been doing for years. I mean, it was really same with my daughter. She wasn't able to sleep. So then she's not able to really concentrate at school. The school didn't understand, and they thought she was just being lazy rather than she has epilepsy. And so it's always there trying to advocate for your child. It's still doing that, still dealing with school things where I'm having to advocate for her. And that's just what you're doing as a parent is trying to do the best for your child.
[00:05:24] Lindsey Dinneen: Yeah, absolutely. Oof. Yeah. Thank you for sharing more about that and painting a picture for us. And then, so in your research, in thinking, there's got to be something out there. I would imagine as a parent going, "There's got to be a solution. There's got to be something out there." Did that research eventually lead you to the company that you now help speak about and whatnot?
[00:05:45] Mike Knox: Yes. And that was, and I always tell people this too, is don't rely 100 percent on the medical system, meet them halfway and do your research. Cause a lot of it is, it's what I realized is, just a lot of it is failure. It's constantly failing and failing. And we went to different doctors in different hospitals and the insurance would say that it doesn't cover this, but we kind of bypassed the insurance to get to where the doctor that we wanted to. It took us about five years to get a diagnosis, to find out what was happening, to find the right doctor cause there were a lot of horrible doctors.
And then you have to understand that, because I never really was in and out of hospitals, and I never really understood what, what the policy, every hospital is different. Every doctor is different and different doctors don't know. We were going to doctors thinking that they knew what epilepsy was, and they didn't. They weren't going to say anything, but they were a primary doctor or they were a specialty doctor.
They didn't know what epilepsy was. And so researching and finding out, and then we had read about VNS, Vegas Nerve Simulator. And our doctor at the time had said, "No, it won't work." Well, that wasn't true because it's worked. And a lot of it is the drive is pharmaceuticals and you're kind of experimenting. That one doctor, she was doing fine on one medication and he wanted to change it and that caused her to have all these crazy other seizures.
And you got to let go of this kind of grudge that you have, and the kind of anger, which we did for a lot of medical, you kind of got to look positively at the ones who are helping you. I really found out that a lot of the nurses were a lot more helpful, where I always thought the doctor's the one that's going to have the knowledge. And a lot of it was the nurses that had the knowledge, not that the doctors don't, but there were more nurses that were more helpful. And I always, my number one thing was compassion. You as a parent coming in there wanting compassion for your kid. At least that's what I was looking for.
[00:07:25] Lindsey Dinneen: Yeah. Yeah, and so okay, so you found this device or you found this technology and you go, "Okay I think maybe this could help my child. The doctor is a little skeptical, but we don't really know the reasons behind that. Maybe they just don't have the experience to understand how it could help. And there's new technology coming out all the time." But so, so that happened. And then what got you to a yes, where you could actually try this and see the impact that it could have for your daughter?
[00:07:52] Mike Knox: A lot of it was desperation. We had left one doctor after just years there and kind of figuring out, he has no idea what he's doing, and we can never call him on that. Went to another doctor and what you're doing with epilepsy is you're trying to find out where the seizure is coming from. So they do an EEG, and so they're attaching all these leads to your head and we were in the hospital for eight days the first time. No seizure, you know, you're off the meds. They're trying to induce a seizure, nothing happened. So the new doctor said, "We've got to do the same thing again."
It's just exhausting because you're like, "I don't want to put my kid through that." But you have to, so we went through another EEG, caught a seizure, saw that they were coming from three different ways. Cause we were first looking at brain surgery and then her seizure was coming through three different areas of the brain. So now you can't do that. And then that doctor showed us the Vegas Nerve Stimulator, which at the time we had just come to my daughter having this horrible seizure in the hospital. Her recovery was really bad at the time.
So I was just overwhelmed with this doctor showing me this small device that looked like a silver dollar and it just was too unbelievable for me at the time, but I knew that we had to do something for my daughter because it was the last resort. We didn't really have we'd run out of all options. It had been years of hospitals and doctors and back and forth. And so really, to me, it was our only option. And It just seemed so unbelievable because it was such a small device and, I think a lot of it was, nobody else had ever talked about it before.
And so I had to go back and like look and go, oh, at the time, it'd been around 20 years. And then I also looked at-- I mean, I was a horrible student-- but I looked mathematically at, "Wow, this percentage of-- it's not a cure, but she could have a life that's 80 percent better. Well, I got through college with all C's. I'll take those numbers." And so it was pretty much at the time it was a no brainer just because everything was just so horrible that it was just, it was-- another chance was given to us. We had run out of options. We didn't have any.
[00:09:46] Lindsey Dinneen: Yeah, of course. So you take this risk and you go, "Well, you know, if it has the percentage potential of maybe it'll improve her life this drastically," it was worth the risk, I would imagine, from both your perspective and your daughter's perspective. And then, so you do this surgery, you've got this implant. Now what is life like these days? Can she travel? Can she do much more than she was able to do before?
[00:10:11] Mike Knox: Life is great. I just want to talk about the surgery itself, was that was another fear. I didn't want to put my daughter through the surgery, how horrible it was. It was so easy. It was, we went in and out. It's an outpatient surgery. It took maybe about an hour. It was so simple and a lot of it was just me as a parent being afraid. I was so afraid of everything watching my kid go through so much that that's what I tell everybody now. It was so simple because she's on her second battery because it needs to be replaced. So the first one lasted almost about eight years. So she's on her second one.
And the second time around was even simpler because now they've got, at the time we got ours, I think she was only the eighth, in Los Angeles that got it, so the protocol wasn't in place. Now the protocol is in place. So they'll kind of get you in and out real quick and they all kind of know what it is, where at the time when my daughter first had it they didn't know what it was, so a lot of strides have taken place and now the hospitals know exactly what to do. So it's very simple.
Whereas, and I run into a lot of parents that are afraid to give that the surgery and kind of all the things that go along with the surgery. And it's so simple and you never, you don't really. Nobody really knows. Now her life is absolutely wonderful. I mean, she went from not being able to keep up in school to now. Shockingly is cause I was such a horrible student. Gets straight A's and she, I mean, to me, that's the amazing part of, I really saw this device propel her and she was learning, which she couldn't do before because she was having seizures and her You know, she couldn't think, she had brain fog, she had all these kind of things that we all kind of, kind of take for granted that we don't really know, but that's what I mean by she, when she was a zombie at the age of eight was that she just couldn't think because she was having so much brain activity from her seizures, and a lot of times she's having seizures you couldn't even see them just as a parent you would instinctively know, oh, this isn't good, I've got to get her out of these, you know, I've got to take her home or I've got to give her medication.
You know, that was another fear of mine too, was that, you know, when she's at school or she's with, you know, I'd come to school a couple of times where she would, I'd had them at school, but the school wasn't aware I found her on the play yard. I found her in the classroom and the school just, none of the schools are equipped because they're by law, they don't have to be.
And so what I love about the Vegas nerve simulator is it's her bodyguard. It's with her 24 hours a day. It's somebody watching over her and it allows her just to do the things that we all take for granted. And. You know, like she's able to go to school and I feel comfortable now that she's a teenager, which was another thing was growing up.
I want her to have her independence. You know, and now I can feel comfortable where she doesn't text me through the day because she's just a teenager forgets that she has it. And that's the best part to me about it.
[00:12:47] Lindsey Dinneen: Yeah, that's incredible. Wow. That's an amazing story. Thank you so much for sharing that. And I'm curious now. So you got to a point where you saw the incredible difference it made in your daughter's life and then of course your family's life. And you're obviously very passionate about this device itself and the company. So now you are helping to spread the word. Can you share more about your advocacy and your work for that?
[00:13:11] Mike Knox: I just felt nobody was there to talk to me about it, and so if there's ever any parents or kids that are looking at it, and it's, again, it's just fear of the unknown. So I go and advocate and talk about this great device. I probably get four or five calls. Most people don't want to talk about it, but I probably get four or five calls a year from parents, then they just have all sorts of curious questions.
Number one, "Is it going to hurt? Am I going to be able to," one kid asked me the other day, "Am I still going to be able to ski?" And I said, "You're probably going to be able to ski a lot better because you're going to be able to focus on that." And I just tell him basically my story, which going back to, because it's not a cure, you have to wait.
And so in the beginning when she first got it, it was about six months of no seizures, which was great. But then she had about five, but the vagus nerve stimulator comes with a magnet. And you can swipe that over your chest and that'll stop the seizures most of the time. And so I saw that progressing. And so I was always kind of writing down stuff and seeing that progress.
And it was really at the six month mark where we all slept through the night. And I said, "Oh wow, she's sleeping." She never slept through the night before. She was always a lot of insomnia and stomach pain and I'm just getting up through the night. So she slept like a good 12 hours. And I was like, "Oh wow, that's huge." That, beyond the seizures, is huge.
And then there was a morning where she got up, dressed herself, which she could never do; made her lunch, which she never did; made her breakfast, ate breakfast. So while my wife and I were sleeping, she did all this stuff on her own, which she could never do. You always had to tell her, like you literally had to tell her, "Okay, it's time to get up out of the bed," and you'd have to tell her several times. It's not just being a kid. She just wasn't processing. Just like she couldn't process sarcasm or humor, which was very hard for me as a father 'cause I wanted to joke around with my kid.
And then she put together this Lego set, read the directions, which she could never do before. So you can really see like, wow, the Vagus Nerve Simulator has got her basically mind on track and she's being able to focus, which she could never do before, always distracted about everything. And then on the way to school, driving her, she was joking with me, and you could see like that spark in her eye that I had seen when she was younger, but hadn't seen in a long, probably six years.
And, so beyond the seizures I was like, "Oh wow, this is working." So it really doesn't matter if it's working 100 or not. Something is happening here, and it's for the betterment of my child. And that's what I run into also is, people want that quick fix. They want 100 percent. They just want a cure. That's not what this is, but it's a heck of a lot better than where she was eight years ago, almost 10 years now.
That's another thing. It really flies by because she got her first one at the age of eight and then she got her next one at 16. And, that is another positive about it, because life kind of stands still when you're in this crisis from anything medical, and now she's just able to live her life and be a kid. And that's the amazing part about it.
[00:15:54] Lindsey Dinneen: Yeah, absolutely. Thank you for sharing. You mentioned early on something that stood out to me is, it's often difficult, I think, when there's a medical diagnosis or some pressing medical issue. It makes it hard for people outside of the family to understand what's going on, and therefore they might feel uncomfortable, and they're not quite sure how to offer to help or to just be there for you. And I'm curious, since you experienced some of that loneliness and distance, going through this difficult time, as a parent and now as an advocate, is there just some general advice you might share with people who might be in a situation where they have a family member or friend struggling with something, but they're not quite sure how to be there for that person?
[00:16:40] Mike Knox: Yeah. I think the easiest thing is send them a card and just let them know. 'Cause I think a lot of people are thinking, "Oh, just text, but I don't know what to text them. And I don't want to say like, 'If there's anything I could do,' cause there isn't anything I could do." And that's a lot when you have like with epilepsy, there isn't anything anybody could do. And then people, they're giving you bad advice because they see it on TV. Like I would always get advice about, "Have you tried smoking weed with your kid?" And I'm like, "She's two. Yeah, I'm not going to smoke weed with my kid."
So that's why I say a card, because then you can think about what you're going to say, and what I think is nice is, send some food or something or send a gift card, because for my wife and I, we were at home all the time because we couldn't leave. And I think a lot of people didn't realize that. I could not go to the store because if I leave the house, she's going to then have a seizure and I'm not going to be there for the seizure. So it was debilitating because I'm having to watch her 24 hours a day and nobody else understood that.
I just say a card so that people at least know you're thinking about them or something like that. And most people just don't do that. I mean, I think people are thinking that people are going to, I think you see on TV shows, people rally behind you or whatever. They don't. I mean, most people are living their life. And for you as the person that's sick or with the family that's sick, just know that the people still love you and they care about you. They're just doing their own thing, but so you have to then understand that and not be upset with them.
I'm not upset with my family that just, my family and friends that just abandoned me, you know? And I think that's life also. It's like, you have to repeat yourself over and over again when you're sick or have a sick kid too, and you'll hear the same stuff like, "Oh, I didn't know your kid was sick," even though you told him a thousand times. You know, "I never knew she had epilepsy." And I just think that's human beings. I think you have to have the compassion for other people also.
And that's just, I think you go through all those phases in the beginning. You're going through all that grief and regret and all that stuff. And you just have to kind of let it go. Because people don't know how to deal with it, nor did I as a parent. I had no idea. So I had that crash course in dealing with it. But I think we as a family came out the other side of it. So I am very thankful at the outcome. And all I have is gratitude for where we are now, very thankful that she's in a great place.
[00:18:40] Lindsey Dinneen: Yeah. And now I'm a little curious. So coming back to you and your story and your career trajectory, which sounds like it's had some fun twists and turns in it over the years, but so how has this experience affected both your professional life when you were in law enforcement, and then now as a comedian, are you able to use some of that platform to help even sort of process and then maybe inspire or educate other people through that?
[00:19:09] Mike Knox: Yeah, and I look at it like it's all like with my comedy. I use the epilepsy. It's not making fun of epilepsy. It's informing. And I have people that come up to me and talk to me. "Hey, I have epilepsy. I'm so glad you talked about this because there's such a stigma." And I meet so many people and I'm gonna do it again next week where they didn't want to come because they're afraid, they're getting bullied. They don't know how to talk about it. They don't know how to approach it. A lot of families look down on it. There is a huge stigma for some reason. They're embarrassed that their family member has it or their child or whatever it is.
And I really think that starts with state laws. So there was a law that was just passed in California where the schools have to identify seizures and everybody needs to be trained and that passed. And that took about five years and I worked on that. And that's where it starts with trying to educate people and starting with that one on one, you going and talking about it. But I do believe that only laws are going to change things and change people's mind.
There's a lot of fake seizure videos that are on YouTube, a lot on TikTok, under the guise of comedy. And I don't agree with that. I don't think it's comedy at all. It's not something that I do. And that's something that I try to educate people on also is, it's not funny. There's people that are dying from epilepsy. And so just getting out there and talking to people. When I get that information, I just write that down and categorize it and see where the problems are. And it all goes back to just misinformation and people not talking about it.
And that goes back to the funding and how the world works. Can people make money out of this? That's the only way that they look at it. If I had tons of money, I think you could solve it a lot quicker. I just take it day by day, and who I can talk to, and who I can show compassion to, again, because I think that's what people are looking for. And people just want a voice. They want somebody to talk to and you, and listen to other people. You know, I, that's kind of how I approach it also is listening to other people's stories because they feel unheard. And I think that's important.
And through my older jobs and this job. And I think all you can kind of do is laugh at it 'cause it gets so overwhelming and so crazy. And you can't force people to see the way that you see things. So you kind of just got to laugh at it. And I think that's, I think that's healing in a way, a lot of people also, and especially with comedy. I mean, people come there, they know why they're coming there. They're coming there to laugh. A lot of it is they're coming from their horrible life, coming there for an hour or two to get away from it all. So I think it is beneficial to a lot of people.
[00:21:27] Lindsey Dinneen: Yeah, absolutely. So what is your hope for the future or your excitement for the future as things continue to progress and more awareness is in place, more legislation to help with responses to this kind of situation? What are you looking forward to or potentially excited about?
[00:21:46] Mike Knox: So I just look forward to a day where I don't have to do this anymore. Not going to happen, but I do see a lot of great technology and I see a lot of great strides within the last five to 10 years in the medical field with medical devices. And that's what I hope for. I hope for something, like with the vagus nerve stimulator, they're looking at having a rechargeable battery or not having to replace the battery. And that's what I hope for. And I hope for, that I never have to hear anything about seizures or epilepsy. I know that's not gonna happen, but for my daughter and everybody else I would love to find a cure for it.
And anybody that has to deal with any kind of medical device, hopefully, you know, we can put more funding into it and have more cures. And I think we are at a great time for so much success in, I mean, we're living longer, we're living better. These next couple of generations are, I mean, my mom's 88. People are living a lot longer and a lot healthier, and so I guess if I have to be positive, that's what I'm positive about.
[00:22:41] Lindsey Dinneen: Yeah. Well, that's good. That's taking the challenge with the opportunity and saying, "Okay, let's see what happens from it." So, you know, it's a step in the right direction for sure. All right. So, pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be something that you've been working on from your career so far, so a skill set you've developed over time, but it could be completely unrelated. What would you choose to teach and why?
[00:23:13] Mike Knox: It would have to be comedy because I've done so much comedy for free. I think that I can understand to teach that to other people and to tell them kind of all the traps of comedy. And it is just, comedy is consistency. It's getting your, you know, five minutes is really four minutes 'cause you're going to have about a minute of laughter if you're funny or not, but getting consistent and embracing the failure of it.
And to me, those are the components of comedy because you've got to stand up there. A lot of it is you got to stand up there and embrace the darkness of being up on stage, which a lot of people don't want to do. And then you've got your material and you've got to be able to care. You've got to get new material and carry that material. So if you can, what I've seen, if you can get past that first five minutes and get 10 minutes and 15 minutes and so on, you're going to be okay. And so if I were to get a million dollars, I think that's the masterclass that I could teach.
[00:24:00] Lindsey Dinneen: I love it. I love it. Okay. Awesome. And how do you wish to be remembered after you leave this world?
[00:24:07] Mike Knox: To me, it's just that I did good. I think that to me, that's important. Do good and be good. ' Cause we see so much negativity all the time and we see so many people that it's like, you know, "Oh, I scammed this person out of that, but they deserved it." And there's kind of like no moral compass.
So, when I was a, when I worked in law enforcement before, you know, people that you didn't even think that you touched their lives at all would say, "Hey, thank you. You made me recognize something different." And I think that's what life is all about. You've changed somebody's life or done some sort of kindness. It doesn't even matter.
I think that's what a lot of it is these little things in life where you didn't even know that you did something to somebody. And it's that spider web of life where you your life intertwined with somebody. You weren't even aware of what you did but that impacted that person's life so much. And I think that's what we're here for is you're always trying to help other people. I mean, that's the whole point.
[00:24:59] Lindsey Dinneen: Yeah, I agree. Yeah. Okay. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:25:08] Mike Knox: Definitely seeing the vagus nerve simulator working; anything with my daughter. I think being in crisis for so long, and just like yesterday, my daughter made cinnamon rolls. She likes to bake. So watching her make something from scratch and then having her happy and excited that she made something-- that, that to me is happy. Well, that always makes me smile. So it is those little things that always make me smile.
[00:25:35] Lindsey Dinneen: I love that. Excellent. Well, this has been an incredible conversation. Mike, thank you so much for being here. I really appreciate your time and I really appreciate your commitment to sharing the word and being a positive helper in this situation. So if folks would want to get in contact with you, maybe because they have some questions or whatnot, or they want to follow your work, how could they do that?
[00:25:59] Mike Knox: Sure. On all platforms, I'm Mike Knox, at Mike Knox comedy, or I have a website at mikeknox. com.
[00:26:05] Lindsey Dinneen: Perfect. Excellent. Well, thank you so much again for your time today. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world.
[00:26:35] Mike Knox: Thank you so much for having me.
[00:26:38] Lindsey Dinneen: Of course, absolutely. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I would love if you would share this episode with a colleague or two, and we will catch you next time.
[00:26:53] 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. And we just wish you the most continued success as you work to change lives for a better world.

Kelley Satoski | CEO, Pelva Health | From Personal Struggle to Innovative Solution & the Realities of MedTech Entrepreneurship

Kelley Satoski is the co-founder and CEO of Pelva Health, a pelvic health startup dedicated to making intimacy pain-free for women suffering from chronic vaginal and vulvar pain. Kelley shares her personal journey with vaginismus, which led her and her husband to seek innovative solutions where none existed. They discuss the staggering statistics of women affected by this pain, Pelva Health’s progress, and the significance of addressing women's health issues head-on. Listen as Kelley talks about the challenges and triumphs of starting a medtech company, the importance of curiosity and bravery in leadership, and the profound impact Pelva Health aims to make.
 
Guest links: https://www.pelvahealth.com | https://www.linkedin.com/in/kelleysatoski/; | https://www.linkedin.com/in/douglassatoski/
Charity supported: https://www.savethechildren.org/
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 051 - Kelley Satoski
[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, Kelley Satoski. Kelley is the co founder and CEO of Pelva Health, a pelvic health startup on a mission to make intimacy pain free for women with chronic vaginal and vulvar pain.
 All right. Well, welcome, Kelley, to the show. I'm so excited that you are here today.
[00:01:18] Kelley Satoski: Yeah, this is amazing. I'm excited to chat.
[00:01:21] Lindsey Dinneen: Yeah. Wonderful. Well, would you mind just starting by telling us a little bit about yourself and your background and what led you to MedTech?
[00:01:29] Kelley Satoski: Yeah. So, we were talking before the show about you being in dance and all your different ventures. I also have a similar background in the arts, so I didn't really anticipate starting a medtech company. That was probably the furthest thing from my mind. But I did grow up in a very entrepreneurial family. So I went to school for art and design, wanted to do my own thing, wanted to start my own startup. So I feel like that was always something in the back of my mind.
But we started this pelvic health company because me and my husband, Doug, had a condition called vaginismus, which basically is a problem that keeps people from being able to have sex due to chronic vaginal and vulvar pain. And so we struggled with that for about 10 years and then after seeking treatment for five years, not seeing any relief, we decided, "Okay. There has to be a better solution."
And so that was really the catalyst for starting Pelva Health and for getting into medtech. And we're the perfect duo for it. My husband's a biomedical engineer, has worked in many companies, has worked at biomaterials before, and then me with my background in art design, entrepreneurial spirit, and really fits us really well. So we're excited to be a part of the community.
[00:02:57] Lindsey Dinneen: Oh, that is exciting. Wonderful. Thank you for sharing a little bit about the background. So that just sparks so many questions and I love the fact that you two have both sort of, you've got the creative side, you've got the business sense, you've kind of married them together. So tell me a little bit about what was this journey like for you of going through this really painful, difficult, experience and frustrating. I can only imagine probably spending a lot of money on trying to find solutions, not finding the answers that you're seeking. So how did you go from, "Gosh, this can't just be us. Other people have to be dealing with this too," to "Let's figure out the solution," because that's, that's a huge leap.
[00:03:37] Kelley Satoski: Yeah, definitely. People are always surprised that 75 percent of women have pain with sex. 75 percent. And nearly 30 percent will struggle chronically over six months. In fact, most will suffer two to seven and a half years without relief. These are massive numbers. This is huge groups of people, and this is not just affecting women. This is affecting couples. This is affecting, like you mentioned, finances. I spent over ten thousand dollars in out of pocket treatment for these conditions. I saw over five providers.
And then the impact really for me, the worst impact, is the one that it can have on your mental health, on the mental health of your partner, and your guys' intimacy in your relationship. It gets you fired up because it's such a complex issue that doesn't have a lot of research around it, does not have a lot of innovation around it. So something that really catapults us into trying to innovate in this space was personally a lot of dissatisfaction with the options I had.
So, you know, for women with vaginismus specifically, one of the most common prescribed therapies is called dilator therapy. So it's basically a bunch of dilators that are of different sizes, and you basically do exposure therapy to stretch the vaginal canal, improve elasticity, and also to try to get over the psychological fear around the pain that you experience with sex. But it's got incredibly low compliance rates. We're talking like 75 percent of women won't comply because of the emotional turmoil, the amount of commitment that's required, the slow results that they see, and often a lack of translation to sexual intimacy.
[00:05:38] Lindsey Dinneen: Mm hmm.
[00:05:40] Kelley Satoski: And so part of me was frustrated with, you know, there's a lot of companies and it's good that we improve dilators, but to me, if women can't comply to something, or if a user can't comply, or if it's emotionally exhausting, and it's causing these problems, then we need to think of a different solution, like surely something better exists. And so it was important to that us that we didn't just create a better dilator.
[00:06:12] Lindsey Dinneen: Mm hmm.
[00:06:12] Kelley Satoski: We wanted to figure out, "Okay, how can we prevent pain immediately? What could we create to give people relief so that tomorrow they can go out and enjoy intimacy in the way that they want without pain. Tomorrow, not in six months after therapy, like tomorrow." So that's what we have set out to do. And just from that personal experience is really what catapults us into doing this startup.
[00:06:39] Lindsey Dinneen: Wow. Wow. Amazing. Oh my goodness. Thank you for sharing the statistics too. I mean, that is, yeah, I think what's, what's crazy is there are so many of these kinds of stories that are emerging more and more, especially for women, of oh, wow-- so many of us are affected by these things and there just hasn't been the research or the money or time, who knows, devoted to it.
So, you know, kudos to you and your husband for starting this company and trying to solve something, but also to your point of Not just, you know, six months, one year, whatever down the line. But hey, let's, let's actually solve this tomorrow. So as you've started in on this amazing adventure, which I'm sure has your, you know, shares of entrepreneurial ups and downs...
[00:07:24] Kelley Satoski: Oh, sure.
[00:07:25] Lindsey Dinneen: ...What are some of the exciting milestones that you've achieved so far and what are you looking forward to?
[00:07:30] Kelley Satoski: Oh, yes, so many good things. We're an early startup, right? So we've done some proof of concept studies with some really incredible results. We are heading into a pilot study at the Center for Vulvovaginal Disorders with 10 women with provoked vestibulodynia, which is another term for basically having some pain around the entrance of the vagina with any sort of penetration. So getting some of that real data and feedback and seeing that we are actually creating something that is helping is really exciting. So I'd say that's the biggest milestone that I'm most excited about.
[00:08:09] Lindsey Dinneen: Of course. Well, and proof of concept is such a great thing to, to really go, "Okay, yes, here we are. We can go ahead and get this going." So yeah. So, okay. So then you're going to do this pilot study with these 10 women. And then after you get the results of that, what happens next in this journey?
[00:08:27] Kelley Satoski: Yes. So hopefully that pilot data helps inform, "Do we need to make any more design changes? Is there anything else we need to be considering before we fully lock the design? You know, don't make any more changes. This is what's going to market" type of thing. And then start preparing for FDA approval 'cause we are going through the FDA. There's so many wellness... you can't see my, I'm doing quotation marks, "wellness," "vaginal wellness" products that exist on the market, that you would be shocked by the amount of products that are on the market but did not go through the FDA.
But we really do want to give women a product that's done the work, that's done the safety testing, that's done the clinical data, that's really has efficacy behind it so that we give women the best. That matters to me a lot. So we're going to go through FDA approval and then it'll be market launch. Once the FDA says "Yes," which hopefully they will.
[00:09:28] Lindsey Dinneen: Of course. Yes. Rooting for , . Absolutely. So, okay, that is so exciting. So, so backing up a little bit when you first started this, I know you've, you've had this entrepreneurial sort of background and mindset to begin with, but the actual reality of starting a business is definitely still a learning curve, no matter how prepared you feel like you might be.
[00:09:50] Kelley Satoski: Yep.
[00:09:51] Lindsey Dinneen: So I'd love to hear about your experience as an entrepreneur and leading a company. And in, you know, going from here's this, here's this idea and now let's make it happen. So how, how was that transition for you personally as a leader?
[00:10:06] Kelley Satoski: Oh, man. Yes, definitely starting one, an FDA regulated device company, and two, a startup that typically raises venture capital funds. So there's certain things that come with, that are a little bit different maybe than some other types of startups that exist, is definitely a learning curve.
And so when we first started Pelva, we were so fortunate to be connected to the Purdue University. That's where my husband went to school. And so they have a whole program for alumni to basically join their incubator and learn all the basics of startup. And they don't take equity. They don't do anything with your IP. It's like purely to help support alumni startups in the Purdue ecosystem.
So that was the most transformative experience for me, because it just thrusts you into the basics of doing a startup, of doing a medtech startup, of doing customer discovery, and all that's required of that, and then surrounding myself with so many incredible advisors, mentors. I'm a firm believer you can't do it by yourself. And so, you know, I'd rather be one of those people that just jumps in and then knows that I have people to support me rather than waiting till I have it all just perfect before I go. And I couldn't do it without that support system and those people that helped us in the beginning, so helpful.
[00:11:34] Lindsey Dinneen: Yeah, that's great. And getting to learn from people who've been there, done that, and have that perspective and just even the experience of, "Oh, here's a couple things to watch out for" or whatnot can, yeah, make such a difference. And then, you know, you have had such an interesting career, also. You know, you haven't just been-- not that it's 'just' at all, you are quite the entrepreneurial leader now as well-- but in the past you've also had a really interesting trajectory, so I'm just curious, can you tell us a little bit about even your, your career before this and maybe how it's helped influence what you're doing now?
[00:12:11] Kelley Satoski: Yeah. That's-- oh man, I've done quite a few things. So I went to art school and I worked with different nonprofits and businesses, did some freelance work for a while, and that was helpful. I'm really used to a blank canvas and making something out of nothing. And that's like quite literally what we do is like, "Okay, there's nothing here. What are we going to do? We just got to start." And so I'm used to that, that overwhelming feeling where it just feels like so much, but you just have to jump in. And I think that's something that I've carried with me from that time is just making something out of nothing, thinking about things outside the box. I think so often we get, you know, so in our little boxes and ways that things have to be done, and I feel like that's very limiting most of the time. Sometimes it's good, but most of the time I think we could all do a little dose of new perspective and seeing things from maybe a different view.
So that, that's a very applicable part of what I learned there. Then after I sought treatment for about three years, I started to feel the itch and this was, we were thinking about starting Pelva, but I, you know, we weren't fully in or anything like that, but I was like, I need to interface with more people that are struggling with this. I'm starting to get interested in women's health because of this problem.
So I actually quit the work I was doing and I became a postpartum doula and I started taking patient intakes at a pelvic pain clinic in Atlanta, Georgia for about a year. And so this is right before Pelva actually, I went to Pelva full time. So I probably interfaced and took intakes of over 400 women with chronic pelvic pain and different vulva vaginal disorders for about a year prior to pelvis, which I say too was like a super. Incredible way to get a foundation of customer discovery before, before you start a company is to go talk to 400 patients day in and day out. So I also say that was super impactful to really immerse myself around people that are struggling and need a better solution.
[00:14:28] Lindsey Dinneen: Yeah, absolutely. And I love how different things from our past can really translate eventually, and I'm curious for other people, actually, you have such a unique and great perspective. So, so maybe for other people who have the spark of an idea for something like a medical device, but just, you know, maybe they're not from the industry or they would feel like that's just such a huge next step. What are some pieces of advice you might have for somebody?
[00:14:57] Kelley Satoski: That's a great question. It takes a certain personality. I feel like I'm not super risk averse, I guess you should say it, in a good way, I think. I think the biggest thing I see people hold up on is "I don't have all the exact perfect experience. I need to go and be a manager of people for five more years before I'm comfortable being a CEO of a startup." And to me, that feels more limiting than expansive. And I think a better perspective is to, sometimes you just have to jump and just, what you can do is make sure you have people around you to carry you through and to help support in areas that you will need help. You will need help.
And so I feel like that's what we did is just the very beginning, "Okay, where can we get mentorship, what other femtech, what other medtech leaders exist in the place that we live, we should connect with them, we should tell them our idea and get their feedback. And then you create this support system that actually makes it easier to step into a space that is new for you because you have support. I'd say that's like the way to go.
[00:16:13] Lindsey Dinneen: I really like that. That's great advice. And I think there's actually kind of a correlation because I was curious, I was looking through your LinkedIn profile just for fun. I always like to kind of see what the guests are up to. And one thing that piqued my curiosity was actually your article that you wrote at one point that was replacing fear with curiosity.
And there was a beautiful short little article about some ideas for how to do that. And I'm actually curious if you could speak a little to that because I think this is the exact right scenario to apply it to, is maybe somebody who's nervous and feeling overwhelmed by the idea, maybe we replace that with curiosity and see where that leads us. So, but I'd, I'd love your take on it since this is your thing. Yeah.
[00:16:55] Kelley Satoski: I was so wise back then. I think I wrote that article like back in 2020 or something. But no, it is, I wrote that at a time where I had just graduated from college and I was in the arts, right? We talked about this, "Oh, getting a career in the arts. It's tough. It's full of unknowns. It's really competitive and competitive for very little pay. And so there's all of these strings attached." And I was just, yeah, feeling pretty insecure about like, I want to have impact. I want to feel like I have purpose. And I want to do all these things, but it's all very unclear and very scary.
And having to say yes to different opportunities that like we said, sometimes feel like they are outside of our realm of expertise or comfort. And I feel like when we can approach things more from a place of curiosity and less out of this quick, reactive state, we can better move through that fear a little bit more, you know? Instead of being like, "Oh, I don't have enough experience," or "I don't do that," or "That was never on my game plan," or " "That's too risky, that's gonna fail," or "Nobody has created a better solution for vaginismus, there's no other solution, so what you guys have put out there, that's not going to work." Or, "No one has made a hydrogel like that. So that's not going to work."
And so I'd be a little more curious about where do these limiting beliefs come from? And are they as set in stone as everyone makes them out to be? Or can we be curious about this? And actually, maybe they aren't so hard and fast as we thought at first.
[00:18:44] Lindsey Dinneen: I love that. Yeah. Thank you for sharing about that. What I love about the idea behind curiosity, too, is that it helps because if you're in a place where you're really concerned about trying something new and failing, 'cause that's such a common, shared experience for so many people-- so if, if you're in that boat, but you treat it as " I'm going to explore this next thing as an exploration," then failure is not even part of an exploration, right? You're just exploring. You're just curious. So you're going to learn. And hey, if you find out that this isn't for me, you go on, next thing.
[00:19:19] Kelley Satoski: I love that. Exactly. Yeah. And I always say to, you know, entrepreneurship and doing a startup and MedTech is not for everyone, absolutely not. But for those that I guess have the itch-- and I feel like you can usually tell who those people are-- I always, this is a quote actually from my husband, not me, but we always talk about "what's the greater risk?"
 The greater risk for us is never going after a greater dream, never doing the things that we want to do, never pushing and going after. The greater risk is comfort, the staying in what we feel is the comfort zone, but never going after. That's the greatest risk. And so if you can reframe what's risky for you-- is going after your dreams really the greatest risk? Or is the risk that you never go after your dreams? That's, that seems pretty scary to me.
[00:20:12] Lindsey Dinneen: Yes. Yes. Wow. That is really powerful. I love that. That's such a great question to ask yourself too, because to your point, sometimes it just feels like the risk is this one thing. Like, you know, it's just this one idea you have or the dream you have. It's not a comparison. I love the comparison. "What's the greater risk?" Oh my goodness. That's fantastic. I'm going to hold on to that one.
 Wonderful. So, you know, okay, well, as you've been going along this journey and you've been talking with these women and other folks that have a shared experience or similar experience to yours, and you're creating this innovative solution, are there any moments that stand out that just really confirmed to you, "Hey, I am, I am in the right industry at the right time, doing the right thing."
[00:20:58] Kelley Satoski: All the time. It's always a thing, you know, as a startup, like talk to your customers, talk to your customers, never stop talking to your customers. But for me, I love talking to customers because it continually, day in day out, reminds me why we're doing this. I had one person literally say to me, "This is the first time I felt hope in 10 years." I've had women that have gotten, been divorced over vaginismus, over an inability to experience intercourse, couples on the rocks, tears, you know, like the whole thing. The just feeling hopeless, I think is a really common theme from the women I talk to.
And in fact, we had feedback groups for our product. And, I was like, "Okay, guys we'll keep you in the loop. We might be doing some clinical trials, studies in the future." And it's not even been a month and I already have people messaging me, "When's the clinic? I want to be a part of it. So just making sure that you're still doing it."
So it's so confirmed, the prevalence. And I mentioned the statistics, but the other thing that always confirms to me that this is a real issue is almost every space that I pitch Pelva or talk about Pelva, I always have at least two people, men and women, that talk to me afterwards and talk about what they're experiencing with it, which really lines up with the, you know, the statistics on how many people are struggling. So, it's, yeah, it's a really big problem.
[00:22:34] Lindsey Dinneen: But knowing that you're making an impact and a difference and inspiring hope in folks who don't have that right now, that's amazing. Yeah. What a gift.
[00:22:43] Kelley Satoski: It is. Yep. And women's health is all the rage right now. So it is like you said, is this a good time? This is a fantastic time. This is, there is no better time, I think, to innovate in women's health right now.
[00:22:56] Lindsey Dinneen: Yeah, exactly. Absolutely. Yeah. So, okay, so pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industries, which you have several, or it could be something completely different. What would you choose to teach?
[00:23:16] Kelley Satoski: Oh, I feel like, if we were gonna keep this related to Pelva, I would hand that million dollars to my medical team and we'd put out this massive broadcast educating everyone about women's gynecologic health and educate on our anatomy and all of that stuff. I'd put a broadcast out there for everybody. That's very cheeky, but, and related Pelva, but, you know what? Hey, it's a million bucks. You gotta do something.
[00:23:53] Lindsey Dinneen: Very good. Yeah. And it would be helpful because gosh, like we've talked about earlier, I mean, I had no idea the staggering statistics and I'm sure many of us really don't. So just, just having that awareness and that education and, what do we do next, and how can we help? And that's awesome. Well, also, how do you wish to be remembered after you leave this world?
[00:24:18] Kelley Satoski: My goodness, going deep. But no, I love it. It's an interesting question. I, I want to be remembered for being someone that really went after things and was somebody that also really encouraged people to do what they want to and made that possible. I love big dreamers. So big dreams, always went after it, and was honest, a really honest person, really real, and kind. Those things, you know, good qualities. But yeah, I think a go getter was, is the first thing that popped into my head. So maybe that's the one I should go with.
[00:25:05] Lindsey Dinneen: Yeah. I love that. And you know, the way you answered that actually brought to mind, I, I had a question I meant to ask earlier, was it difficult for, for you and, and, or maybe your husband as you're forming this company and you're talking about a very personal, your own story, what was that experience like? Was that really hard to get comfortable and used to talking? I just...
[00:25:30] Kelley Satoski: Oh yeah! I lead every pitch that I do telling my story. I say it really quick, "I spent over 10 years unable to have intercourse with my husband due to a chronic vulvovaginal pain disorder. And as crazy as that sounds, here's the statistics." I've got it down to, I've got it down line by line. 'Cause it is tricky, it's tricky to talk about in such a way that others are comfortable. How do I share it in a way that doesn't objectify myself and lose people when I'm trying to really pitch a real company? So it definitely felt like a bit of an art on sharing.
[00:26:07] Lindsey Dinneen: Yeah.
[00:26:08] Kelley Satoski: I'm learning how to share my story, but I do remember at the very beginning, I hadn't told really anyone that I was struggling with this, not my family not, yeah, like no one. And I remember telling Doug when we decided to start Pelva, "Am I going to have to start telling people about this? If we're going to start this company, I'm going to have to tell my parents, I'm going to have to like, we're putting this out there." And he's like, "Yeah!" And I bet I just had to make the choice that it was worth it.
But the more I talk about it, the more other people talk about their experience. And it ends up actually feeling really good. You end up starting to get more experience as you feel more, more supported and less alone. In fact, sometimes I wish people would not tell me so much, but they do! Talking to you, to my mother in law, too much info.
[00:27:01] Lindsey Dinneen: Mm mm. Oh, man.
[00:27:03] Kelley Satoski: Yeah, you get to create these really safe spaces for people to also share what they're going through. We need to talk about it.
[00:27:11] Lindsey Dinneen: It's so true. I definitely commend you for that. Because yeah, that that would certainly be uncomfortable for a while, maybe, maybe forever. I don't know. But, you know, being able and willing to share and be vulnerable to your point, I think, is what creates that safe space for other people to say, "Oh my gosh, me too." And, "How, how can we change this? How can we band together or at least support each other?" So I love that. Thank you for creating those safe spaces.
[00:27:36] Kelley Satoski: Yeah, and I feel like, and the other thing that I would say is that, I always got a lot of like, "Ooh, be careful, you're going to run into a ton of pushback and people are going to be weird." And something I feel like I've decided really early on is to give people the benefit of the doubt. I think, yeah, sex is hard to talk about, like, it is, you know, and I'm not gonna blame anybody for feeling a little uncomfortable talking about it, and talking about me and hearing those really personal stories. So I think the more I've approached it from just a very accepting and less reactive and looking for people to be weird about it, or not accepting or not supportive, whatever that energy you project, you almost start to receive. So I've tried to be a little bit more open about it all.
[00:28:29] Lindsey Dinneen: I love that. Yeah, that's fantastic. Thank you. So, final question. What is one thing that makes you smile every time you see or think about it?
[00:28:40] Kelley Satoski: Oh. Oh, man, that is an interesting question, but I like it. I would say I was a part of this Herb Society in Minnesota here, the Minnesota Herb Society, and it's full of the most lovely old ladies, and I am the youngest person there, for sure, but they are the most wonderful ladies and the most joyful people to ever be around, so I think whenever I think about them, they make me smile. There's a bunch of old ladies digging in the dirt and planting herbs, what can't you smile about?
[00:29:16] Lindsey Dinneen: Yeah, what's not to love? That's phenomenal. I love it. So cool. Well, oh my goodness, this has been an amazing conversation. And Kelley, just thank you so much for for sharing and for being willing to take the risks, right? And and to, to compare risks and say, "The greater risk is doing nothing or or not chasing after this. And we don't know where it's going to leave, but we're going to try." So...
[00:29:40] Kelley Satoski: Yes.
[00:29:41] Lindsey Dinneen: ...Thank you for doing that work. I know it's not hard. There are probably days where you're just like, "What did I do?" But you're doing it. So thank you for bringing this to the world and being open and vulnerable and, and letting other people be too. I appreciate that.
[00:29:54] Kelley Satoski: Of course, I appreciate the opportunity.
[00:29:56] Lindsey Dinneen: Yeah! 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. We just wish you the most continued success as you work to change lives for a better world. And thanks again for being here today and sharing your expertise with us. And thank you to all of our listeners for tuning in. And if you're feeling 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.
[00:30:41] 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.

Aaron Burnett | CEO, Wheelhouse DMG | Achieving Success with MedTech Marketing, First-Party Data Strategies, & Generosity as Company Culture

Aaron Burnett, founder and CEO of Wheelhouse Digital Marketing Group, delves into the unique marketing challenges faced by the MedTech industry. He discusses the critical importance of continuous messaging and creative iteration in data-constrained environments, highlighting how accurate first-party and zero-party data strategies can drive performance in highly regulated markets like healthcare. He emphasizes the need for proprietary data solutions to stay compliant and effective amidst evolving privacy regulations. Reflecting on his personal and professional journey, Aaron shares practical insights on optimizing marketing strategies for better business outcomes while maintaining a culture of generosity and helpfulness.
Guest links: www.wheelhousedmg.com | www.linkedin.com/in/aaronburnett | Aaron@wheelhousedmg.com | https://youtube.com/@wheelhousedmg
Charity supported: https://www.feedingamerica.org/ 
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 050 - Aaron Burnett
[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 introduce to you my guest, Aaron Burnett. Aaron is CEO and founder of Wheelhouse Digital Marketing Group, a sought after digital marketing agency based in Seattle, Washington, that helps brands thrive by solving their toughest digital challenges.
Every point of Aaron's career has been marked by his ability to leverage technology and his own creativity to drive growth. He has propelled Wheelhouse into working with some of the world's most innovative healthcare and medical device brands for more than a decade, consistently delivering exceptional business value through a combination of deep healthcare marketing expertise, purpose built technology, and creative capabilities. Most notably, Aaron and his team have developed technology and services that guide digital strategy for clients such as Providence, Fred Hutch, Delta Dental, and NASA.
Well, welcome, Aaron. Thank you so much for being here today. I'm really excited to talk with you.
[00:01:47] Aaron Burnett: Yeah, I'm excited to talk with you as well. Thanks for having me.
[00:01:50] Lindsey Dinneen: Of course. Well, if you wouldn't mind starting off by sharing a little bit about yourself, your background, and what led you to MedTech.
[00:01:59] Aaron Burnett: So I'm CEO of an agency called Wheelhouse Digital Marketing Group. It's a 14 year old agency. We provide performance marketing for privacy first industries. We have a particular concentration in medtech and healthcare, and have had that concentration for the last dozen or so years. We work with very large health systems like Providence, we work with some of the largest health insurance systems in the U. S. as well as large to mid size medical device manufacturers, and interestingly, we've also worked with NASA for the last six years, which is in neither of those markets but is interesting and complex and is NASA, and we get to do things on a scale that you don't get to do anywhere else.
We're probably a little bit different from most other agencies, first in that everything that we do is attuned to privacy first industries. So we are, because of our long standing relationship with healthcare in particular, accustomed to working in environments that are highly regulated. So being attuned with HIPAA compliance and implications on third party tracking, working with much less data than you would work with in a typical e commerce or B2B lead generation sort of a situation.
And so we have folks who are deeply expert at working in those markets, know them well, have an orientation toward performance marketing, which is what all of our clients want. They are diverse, but they're unified in that they want us to achieve an outcome with business value. It's important. It's lead generation. It's a transaction. It's something that has tangible value that can satisfy a chief financial officer. So deep expertise.
We also have developed our own proprietary technologies and methodologies that help us to deliver performance marketing in these markets. So you know, in a highly regulated industry, you can't just use platform data for audience targeting. You don't get a lot of that data. You can't use platform data for optimization. You have to be very careful about what you collect and what you share and how you evaluate and commingle and analyze that data. So we've created our own HIPAA compliant data warehouse and a BI practice on top of that allows us to bring in not only platform and analytics data, but also CRM information so we can integrate it in an API level with CRM systems and first party data.
So we get a lot of insight. We can see the entire user journey, customer journey, prospect journey in the context of our analysis in this platform and not share data with anyone else. So we never fall afoul of any regulations. And then our analysts can identify insights and then activate those insights in advertising platforms in sort of an air gap situation. We never have to share data.
We also provide creative, but it's creative in the service of conversion rate optimization. So it's performance creative. We're not going to develop a new advertising campaign or a new branding strategy, but we are highly adept at figuring out how to get creative to perform, which is increasingly foundational to driving exceptional marketing outcomes.
Now, because so much advertising is algorithmically driven and because in the absence of audience targeting, it turns out that creative variation and a really broad set of creative variation is kind of the new way to target an audience. So if you have 15 variations on a particular creative and they're attuned to different audiences and different messages, you can in some contexts rely on the platform algorithms to find your audience for you through that creative. So we're attuned to delivering that way.
In terms of my own background, I started as a marketing exec. So I was a VP of Sales and Marketing with AT& T Wireless, worked for some other telecom and software companies, and started consulting and helping other folks with marketing, and found that I was good at and loved digital marketing, starting with SEO and then moving into the other disciplines.
And the thing that I loved about that and that I continue to love about it is that it combines creativity, the art of marketing, with a definitive outcome which you don't get in traditional marketing. So it's there in the data, whether you did it or you didn't. And that's quite satisfying and also create security when you're working with clients.
We can, at the end of a quarter say, "Listen, you're up 85%. And here's how we did it." And that creates certainty around the value of the relationship. It creates longevity in the relationship. We strive very hard to develop long term client relationships. I think our average tenure is about six and a half years now. And we find that just continuing to deliver and continuing to clearly explain what we've delivered puts us in good stead and makes for a nice, stable, and growing business.
[00:06:37] Lindsey Dinneen: Nice. Well, first of all, congratulations on that business that you've successfully launched and is going strong. That's awesome. I know that's no small feat. I know a lot of our listeners can relate to that too, of being that CEO and taking on that incredible new job opportunity, and how many things you learn and the day to day ups and downs of entrepreneur.
[00:06:57] Aaron Burnett: That's right. You get an opportunity to make a new mistake every day.
[00:07:02] Lindsey Dinneen: Indeed. Indeed. Indeed. But that's a good thing. So that's fantastic. Thank you for sharing a little bit about that. So going a little bit back into some of your personal background, and then I'm delighted to delve into the company as well and what you do. But in the growing up, did you have an inkling that marketing would be the thing for you, or did this sort of grow out of schoolwork, or what was that thing that said, "Oh, I think I know where I want to be?"
[00:07:30] Aaron Burnett: I figured out where I wanted to be by figuring out where I didn't want to be first.
[00:07:34] Lindsey Dinneen: Oh.
[00:07:35] Aaron Burnett: So no, the thing that I wanted to be, from the time I was seven until I was in the middle of college, was an attorney. Then the notion that I had of being an attorney was you would fight for truth and justice and fairness and all of those virtues, sort of a cinematic version of being an attorney. And what changed my mind was that I paid my way through college by working in restaurants, and in a particular restaurant in which I worked-- it was a fine dining restaurant-- there were a lot of attorneys who came in with clients or came in after work. There were also a considerable number of law school students during the summer who were taking a breather and recovering before they went back again.
And I got really consistent insight and advice, which was sort of distilled. The law school students said, "Yeah, we used to think that's what this was for too. And that was beaten out of us by the second year of law school. That's not what this is for." The attorneys who were successful, particularly financially successful, they were focused on transactions and they were very conventionally successful and very apparently miserable.
Then the other thing was that I came to believe that being an attorney would draw out the very worst in me. I'm a little bit competitive and I really enjoy arguing. I couldn't see how that was going to be good for me, a marriage, or being a good father, or any of those sorts of things. So, I figured out what I didn't want to do first.
And then when I graduated from college, I had studied communications and then I also had studied political science and eastern philosophy and religion. And after college, I was aware that I wasn't ready to get a job, because I had no idea what that job would be. So, I went backpacking in Southeast Asia. I bought a one way ticket to Bangkok. And the plan was that I would travel for three years, and I would see in person some of the things that I studied. I would learn more and think more and get more clarity as to who I was and who I wanted to be.
But that plan changed when five months into that trip, I met a woman on an island off the coast of Malaysia at a beach party during Ramadan when everything else shuts down at sundown and the only thing to do is to hang out with other backpackers. And we met and stayed up until three in the morning talking and both of us knew, like, right away, "Oh, you're the person." So we spent most of the next seven days together. Got engaged at the end of those seven days. Got married three months later in New Zealand. She's a New Zealander who was headed to Europe. And then came back to the U. S. so that she could be in the U. S. for the two years that required to establish permanent residency.
And I started working for a telecom company in a temporary role. I worked there for three weeks as a temp. I was hired as an employee into the marketing department and discovered that marketing was an aptitude and something that I really enjoyed. I was also in a really fast growing company. It was a cellular company, part of Macaw Cellular at the time. And kind of the ethos there was, "Doesn't matter if you have done it, because nobody's done this stuff before. If you can do it, and you show aptitude, we're going to give you a shot."
And so I got to do all sorts of things that I had no business doing, but that I succeeded at. I built a call center. I built a marketing organization of 75 employees and ran that for about three years. And I ended up becoming VP of Sales and Marketing, about seven years into that stint and just discovered that I love marketing and I particularly love marketing the intersection of marketing and technology.
I love the tech part. I love developing new technology. One of the things that I did there was to develop a call completion platform for the network that we worked on that had a significant impact on revenue and a decrease in cost. So I loved identifying technical solutions and then activating them from a marketing perspective.
What I also discovered, though, when that company was acquired by AT& T was that I didn't like really big companies, where you got to be VP of something very deep but very narrow, which is how that was going to turn out. And so I went from there to a series of smaller and smaller companies. And the closer I got to entrepreneurship, the happier I became, and the more at ease I became until in the year that my first daughter was born, in a job that was going super well-- I joined two years prior, the company had increased its customer base by about tenfold, things were going super well, it was five minutes from my house. It was easy, I wasn't stressed, but it was also super bored.
I quit and started a company, and from there went into, I made all of the first time entrepreneur mistakes in that company. I left that company. Actually, that company left. That company didn't succeed.
[00:12:32] Lindsey Dinneen: Oh, no. I'm sorry.
[00:12:34] Aaron Burnett: It was great. I learned a lot. I also learned that I loved that and then started to consult and learned that. No, I actually love technology and marketing, but I love more helping people. That feels really good to me. And so sort of fast forward a few years. I created Wheelhouse for a couple of important reasons.
One is I wanted to create the agency that I always wished I could hire when I worked for other companies. And what I wanted out of an agency partner was that it was partnership. It was somebody who really did have my best interests at heart that didn't deploy an account manager on me who is constantly looking for opportunities to monetize the relationship, who was playing this sort of kabuki theater where we pretend we're friends, but really it's about the change order, which felt bad on a soul level to me. And I also wanted to create this sort of place I always wanted to work.
[00:13:29] Lindsey Dinneen: Yeah.
[00:13:30] Aaron Burnett: I worked in larger and larger companies-- and actually this was true in venture backed companies as well-- in most instances, what I discovered is that people were asked to be someone different at work than they were at home. We have a set of values that we all agree to societally. We believe in being helpful and generous and kind. We would help anyone on the street if they asked us. If a friend called, and asked for help, you wouldn't figure out how you were going to get paid for that help. You wouldn't be playing the angles. If you were doing something with a friend, if you were coming to an agreement, if you were writing letters to an exchange of letters to agree on plans, you wouldn't be crafting the language, looking for the way that they might transgress, and you could take advantage of them.
And yet, I found lots of instances where that was true in business, and that didn't make any sense to me. So I wanted to create a place that I wanted to work where the same values that you uphold that you believe in that are healthy in your personal life are the values that you adhere to in your professional life as well. And so the core values that have informed and continue to inform the way that we behave here are in part traditional. Integrity and stewardship are there, but so too is helpfulness and generosity and joyfulness.
We say to every prospective client, every current client, everybody who works here, "We exist to be helpful." That helpfulness is not constrained by a piece of paper. If a client asks us for help, we will help first. We'll be generous with our time and our expertise and our resources. We'll almost certainly do work that we're not being paid for explicitly. We'll look out for our client's best interests, but we'll look out, we'll ask them to look out for our best interests as well. And we say that explicitly.
And my experience is that in almost every instance, if you remind people of who they are at the beginning and that, "Hey, this is a personal relationship here. I know there's a contract and it's a business contract but as a person with my business I'm helping you as a person to achieve your aims as well. And anything we do that's detrimental has a personal impact and anything we do that's additive has a personal impact. And I'm going to try to make this the best experience for you and I'll rely on you to do the same with me."
You know it creates a much healthier relationship, and that's part of the reason we have such a long client tenure. Our clients very quickly know, "Oh, you're on my side. You're going to help me. I don't have to walk around with one hand holding my wallet. I don't have to worry every time I call and ask for help. I don't have to review my SOW."
[00:16:06] Lindsey Dinneen: Yeah.
[00:16:06] Aaron Burnett: Pretty quickly get to a place where neither of us remember what's in an SOW. And we're only going to go back and look at it if something really gets to the size that, "Oh no, that definitely wasn't a part of this initially. We should talk about this being a separate thing." And quite often, it's the client doing that, saying, " Doing this thing, we should pay you more for that."
And I love that. I see that as an indication of health. We do other things that are unconventional as well. We do have an account team. They focus on hospitality, not monetization. And one of the metrics that we track internally is laughter. So if we're in all of our client meetings, we're listening for laughter. We're not scoring it. We're not trying to make it happen X number of times, but I see the presence of laughter as an indication of ease and trust and health, and we really care about that, and so we invest in it.
[00:17:02] Lindsey Dinneen: I love that. Oh my goodness. I love all of the culture that you have so meticulously crafted, and it's so interesting because as you were talking about it, I was thinking how you had mentioned early on career wise you were saying, "Well, I, I learned by discovering what I didn't appreciate." And I'm wondering then if part of the culture that you have so carefully developed and cultivated over time is also partly, "Oh, I see what hasn't worked very well in the past. So now I'm really focusing in on something that is aligned" to who you are, obviously because you're the CEO, this is your business, but also just, "this is what works well for our client relationships and everyone who works with us."
[00:17:45] Aaron Burnett: Yeah, that's true on a number of levels. It's true in that, at times we see the way that other agencies or even writ large, other service organizations behave. Sometimes we bump up-- actually frequently we bump up against other agencies, particularly in large client situations. And we're really explicit in saying we're never going to try to poach business from another agency because we just don't think that's very nice. You have to behave in a very mercenary way to make that happen. You have to undercut someone. And so instead, we talk about creating the conditions that make people want to work with us. So we'll work hard to create the conditions that show us to be expert and clearly demonstrate the value that we can deliver, but we're not going to say, in contrast to those people over there.
[00:18:32] Lindsey Dinneen: Yes.
[00:18:32] Aaron Burnett: And there's a difference. And so, we come back to our values on that. We also, you're right in that the impetus for the culture came from me, but I also have a strong belief that everyone who comes here should add something to the culture and they are free to express the culture in their own way. Some of those ways might not be comfortable to me the ways that I would think you might go about doing this, but they're great for other people, right? And there are things in the company rights that are kind of like that where I know a majority people love this thing. It's important culturally. It doesn't do anything for me, but that's okay.
And then we also have learned-- I joke that you get to make a new mistake every day and that's a joke. It's also pretty true. I make lots of mistakes. I have made cultural mistakes over the years that were very well intentioned and have been costly, either financially or culturally. I think that, you know, there are byproducts of a culture like ours that are behavioral. If you're going to be helpful and generous and pursue joy in your daily work, then the byproducts should be that you also are, you know, kind and gentle, and that you extend grace to people when they mess up.
And those are great things, but taken to extreme, they also can be damaging things. And there have been times when I've taken them to extreme, when I thought with a, let's say an employee who wasn't performing well, but I had a great deal of empathy for. I would want to give them many chances and think, "Well, surely, okay, if I explained it one more time but different, or if someone else gave them clearer direction, or we did something else, we're going to get there from here." thinking, "Well, this is very kind to them. I'm giving them more runway. And it's good culturally as well. This is the right, sort of the moral decision to make."
And in retrospect, that was totally wrong. It wasn't actually kind to them because we also communicate frequently. They knew where they stood. They knew they weren't performing. And this just extended the non performance in a lot of instances. It was also not kind to their team members because they had to fix the work or do the extra work. It was frustrating to them to see that their merit wasn't held in higher esteem, treated differently, that they were getting less attention than a person who was underperforming. And it took a long time for me to learn that. Other people told me I was doing that wrong for years.
And in fact, there's a great book that we have used, that you're probably familiar with, called "Radical Candor" that really speaks to the importance of being quite direct, but in a kind way. And there is, there are four quadrants described in that book for different sorts of styles. And there's one just for me, I think, called Ruinous Empathy. And that's where I lived for a while. Super nice, very empathetic. But sometimes a bad result.
[00:21:34] Lindsey Dinneen: Yeah. It's a great book. Highly recommend it for anyone eager to improve communication and how to give feedback and whatnot.
[00:21:42] Aaron Burnett: Right, yeah. We call it telling the kind truth. You can say a hard thing, but in a nice way.
[00:21:49] Lindsey Dinneen: Indeed. Indeed. And we all need that. We need that personally. We need to be able to give that. So that's incredible. So, now, specifically with medtech companies-- which I know you've chosen to really spotlight in addition to your healthcare organizations that you work with-- what major challenges or common challenges do you see medtech companies have when they're starting to think about-- well, maybe they haven't even gotten to a really good marketing plan yet because, you know, at first maybe they're just building, building and they haven't even thought, "Oh, I'm not quite sure how we're going to communicate about this." But just in general, what are some of the major challenges or common challenges that you see MedTech companies having with their marketing and how can you help? How can we help?
[00:22:30] Aaron Burnett: Yeah. Huh. There are a couple of key challenges. One is figuring out messaging that resonates and drives performance. And a mistake that we often see is that messaging is viewed as static rather than iterative. It has always been the case that constant testing has real value, outsized value, particularly in digital advertising. It is exponentially true today that constant iteration and tweaking and tuning in messaging and in creative is absolutely essential to driving performance. And what also is true is that messaging and creative increasingly help you find your audience.
So, if you're in a company that is highly regulated, that is governed by privacy regulations, that is perhaps governed by HIPAA regulations, you're significantly constrained in the data you have access to, the things that you can track. In the main, you can't really use third party tracking. It seems every week there is some sort of new announcement that further restricts the data to which you have access.
The latest announcement is Meta declaring that they are targeting sensitive industries and categories. And that in targeting those industries and categories, they're going to block certain types of data, and the data that they're blocking in the main is conversion data. And so, you're blind with regard to whether anybody actually did the thing you needed them to do. Did they sign up for a trial? Did they complete a lead form? Did they ask for follow up?
If you're using a conventional approach to those sorts of things, if you're using certainly their tracking, which I hope nobody is doing anymore, then that data just goes away on some date. But as you lose fidelity of the data and as you take into account sort of the more meta issue, not Meta the platform, but the global issue of cookie deprecation and privacy settings in browsers and the fact that already about 40 percent of the third party data that you would have gotten through browser signals is gone. You've lost fidelity.
So the way that you find an audience now, particularly in a data constrained environment, is through what you put into market. It's messaging variation, and it's through really significant creative variation, not one ad, two ads, three ads, like old school conversion rate optimization, but 15 ads. 15 different creative concepts with variation of messaging that look very different.
And as you do that systematically over time, you allow the algorithm to both optimize performance, and those algorithms work very well now, but increasingly-- and this is particularly true again on Meta which we find to be really powerful when done well for medical device clients-- you find that you don't just optimize the creative. In that optimization, the creative finds your audience for you. You're able to tune your creative to the audience that performs for you and continue to iterate in terms of both audience targeting and creative.
So first there's, there is a need to test into all of this. And there is intensive testing at the beginning of the process, but there's continuous testing, perhaps at a lower velocity or intensity, even as you go along. It doesn't stop. You don't get to a point where, "Oh good, we're on cruise control. We've got the ad that works. We've got the PPC that works. Everything is working well."
It's just constant iteration because it is algorithmically driven and because in the algorithms, you know you can think of this in terms of social media. In social media, I think people are familiar with algorithmic fatigue. If your algorithm in a personal feed on a social platform didn't change, didn't refresh fairly frequently, you get really bored with what you're seeing. The same is true in the platforms. And so we find creative fatigue, even with creative that performs super well, happens fast-- like a week, ten days, something like that. And the fall off isn't subtle. It's you're going along and you do that. It's a big drop. So it's constant iteration.
The second thing that we find is a lack of, I was going to say a lack of sophistication with regard to data strategy. It's actually more often the absence of data strategy. I think for a long time data strategy didn't need to be foundational to marketing, even to digital marketing. If you think of digital advertising or even organic forms of digital marketing, the platforms did the work for us. You targeted audiences in the various advertising and social platforms. You got all your data through analytics. You could see what was happening in search through search console. Perhaps you use some third party platforms as well.
But what is true now in a data constrained environment is that the most important signal, the signal that delivers greatest value, isn't the signal that's in the platform. It's the signal that's probably in your CRM. It's the one that tells you that a lead converted, someone actually went into trying a device, or they actually became revenue generating. So you need a strategy at a system, at a platform level, to bring all of that data together and to normalize it in a manner that enables it to be evaluated and analyzed as a corpus of data that enables you to see the entire user journey.
You need a strategy around naming conventions in advertising that allows you to bring that in a way that can be integrated with CRM data and other analytics data or other platform data. You need a first party data strategy, because in a data constrained environment, in a tracking constrained environment where you can't rely on third party data in the same way, audience targeting and even optimization now rely substantially on first party data. It's the data you own that you have permission to use, or on zero party data. Well, you can't put that in a public database. That has to go in a purpose built data warehouse that has been developed for privacy sensitive industries.
And so, in our case, we created a HIPAA compliant data warehouse and a BI practice on top of that that gives our analysts the ability to view the customer journey in entirety, to see people as they move through sort of the prospect funnel, and to optimize for the conversion step that isn't in the platform but delivers business value. And then to use the insights that they glean there to optimize in a platform without sharing data, which is the key.
You're able to know, and this is something for people to remember, despite all the increased privacy regulations and constraints, as a website owner, as long as you have the right data environment, meaning the data you collect is in a HIPAA compliant environment, if you're governed by HIPAA, certainly in a privacy sensitive environment, even if you're not, you can collect full fidelity data regarding what people are doing on your site. You can't share it with a third party platform, you can't send it to Meta, you can't send it to Google, but you're able to know everything that you knew before, so long as you collect it in the right way, and evaluate it in the right way.
And our experience is, the privacy regulations, despite being uncomfortable and alarming and forcing a lot of intense activity up front to create a new systemic approach, new infrastructure connections and new data strategies, actually yield a much better business outcome. We can drive better performance with first party data. We drive more business value with first party data than we did when we were doing it the easy way and using platforms for targeting and optimization.
[00:30:27] Lindsey Dinneen: Yeah. Okay. Yeah. So, so your company really helps to bridge the gap between what maybe, if you're not into the nitty gritty details, say we're speaking with somebody who's developed a device what they may have learned as, as far as like Marketing 101, but it is so different when you have, like you said, very specifically protected industries and they have a lot of regulation and we have to be really careful with how we talk about things. So your company is really helping bridge that gap between what we may have all been taught and kind of know in the back of our head versus here's the actual reality of the situation today. And you're keeping on top of all of those regulations.
[00:31:08] Aaron Burnett: True. And then, you know, because we concentrate on the medical device industry, we also are highly attuned to what language we can and cannot use. And we know, alright, we need creative variation, but we also understand that we can't just test anything. That we need to be very careful with language, we have to use language that's approved, it needs to come from certain sources and not from others. If it's new it has to go through a certain approval process. So, we end up creating a lot of efficiency by simply knowing how it all works and having a lot of experience with needing to create new ad variations that win easy approval and can very quickly be put into market.
[00:31:50] Lindsey Dinneen: Yeah, of course. Now, you know, in working with MedTech and you've chosen again, some very specific niches, which I love. Have you had any moments that really stand out as, "I'm working with this client and I am in this industry and I am realizing, 'Wow, I am really in my element.' I am here for a reason." It just sort of stands out at this moment that matters.
[00:32:15] Aaron Burnett: Yeah. One of the clients we've worked with for a very long time has an insulin monitoring and delivery device. We worked with them when they were sort of mid sized, but also kind of looking for market fit in their digital marketing was dormant. Almost dormant. I'd put it on the verge of dormant. It wasn't doing well. So, we started on a series of projects with them, and they started quite small, and very quickly were able to deliver a lot of performance for them.
So, the first year, we increased lead generation by just under 500 percent for them, which was super meaningful and exciting, and enabled us to start this very long term relationship that is broad and multifaceted now. What I've loved about working with them, and we were talking about this when we first got online, is that the people who work there really care about the people they serve. And as a matter of fact, there is almost a universality in that the people who work there either have close friends or family members who deal with diabetes. And so it's not a commercial endeavor. I mean, it is, but it's also a very personal endeavor and they're aware and convinced-- and I think they're right-- because I also have a close family member who uses their device, that their device makes such a difference to the quality of life for the people involved.
The difference that I've seen in this family member is that she went, I think, from being aware, moment to moment, "I'm diabetic and I need to keep track of this, and there are some things I need to do at certain points throughout the day," to "That's not really a main thing I have to think about. I mean, I have to be kind of aware of it, and, you know, I've got an app on my phone, and I do have this device, but this is not something that is at the forefront of my brain. I can think about other things, and this is very much in the background."
And that's a really big deal. And we feel the same. I know I have been to public events. I went to a high school play and one of the performers was very clearly wearing this device and not hiding it. It was super visible just a part of her life, not anything she felt embarrassed about. And I felt proud of that, even though I have, I play such a small part in that. But, just felt proud that she felt comfortable, and she was a lead in a school play, and it was a good play, and a big deal, and there were hundreds of people in the audience. And so, to see the impact of something like that, and to have confidence that the work that we do actually makes a positive difference in the world, is soul satisfying.
[00:35:00] Lindsey Dinneen: Yeah. Thank you for sharing that story. That's, that is really special and impactful. And I always think, you know, we don't always get those moments of realizing the impact of our work. I agree with you, even in the small, like, "Oh my gosh, I had a tiny little piece to play in it." But it just makes you think, "Oh my goodness, what I do really does matter. It does make a difference." And so to get that opportunity to have seen it in action and in such a positive light is incredible. So yeah, I appreciate you sharing that.
[00:35:29] Aaron Burnett: It's comfortable. It feels so good to market for clients when you're sure that what you're putting in the marketplace is really good for them. And what you're trying to do is just make sure they're aware of this good thing. That's so different than marketing for a client where you're sure they want to make more money and you're not sure that anybody who buys this thing-- does it matter? Does it not matter? Does anyone really need this thing? You know, that's a very different feeling than being confident that the thing you're promoting will make a positive difference in their lives. So, yeah.
[00:36:09] Lindsey Dinneen: Amen to that. And that's a really interesting thing about marketing that can be divisive a little bit among people who aren't as familiar with the industry or as comfortable. And so it's really nice to know, you know, marketing can, and is very often, used in a very positive way to highlight the important things 'cause you know, as I try to remind my lovely engineer friends is you can make the most wonderful thing in the world, but if nobody knows about it, that's that. You know, that you're just, you're stuck. So, so it is important to have marketing and to have that bridge that gap and make it known. But to just know, like you said, that it's going to make a positive impact is just wonderful. So yeah, I love that.
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 can be totally separate. What would you choose to teach?
[00:37:07] Aaron Burnett: Oh, the power of culture.
[00:37:09] Lindsey Dinneen: Ooh.
[00:37:10] Aaron Burnett: And if I had to focus more specifically on the power of generosity in business. My experience, our experience throughout the history of this company, is that helpfulness and generosity are our BD strategy. We're not trying to convince anybody of anything. We're trying to give as much away as we can be as generous as we can. And we find that if you help people, if you are generous and if you do it without expectation-- and I can't fully explain why this is true. I have some guesses.
If you help people without expectation, you just help them because you're helpful, and that's the right thing to do, and you do that for a person, that good things happen out of that. I think I can explain it. I can understand it more mechanically. I might bump into you. We may or may not know one another, but we get chatting, and you tell me you've got a problem, and I know the answer to that problem. It's also a service that I offer. And I could certainly play the angles and try to get an engagement to get you to pay me for that service. I could just help you. And you may or may not ever become a client, but I've helped you.
And my experience with that is that we've gotten referrals from people who have never been clients. And sometimes those referrals occur years later, like long enough that we only vaguely remember who that person was and what we did for them. But I think that being generous, you can't tell someone to trust you. But you can behave in a trustworthy way. You can't tell someone in a way that inspires confidence, "Look, I'm gonna look out for your best interests. I'm not gonna try and pick your pocket." But you can behave that way. And you can communicate it with your actions.
So, I think it's interesting to consider what business and society would be like if the orientation was toward generosity rather than the orientation being toward protection. When we write SOWs, for the longest time we wrote the most naive SOWs. And we did it intentionally. A, because, practically, we're a small agency working with big clients. And if somebody wants to take advantage of us, they probably can because I have a limited attorney budget, and I don't really want to spend my budget on that anyway.
But the other reason is that I that seems to have integrity with what we say. We're going to be helpful and generous. We're going to do work you're probably not going to pay us for. We'll look out for you. You look out for us. We're not going to get you with business terms. We're not going to squeeze you with scope of work, that sort of thing. So, let's not kid each other. Let's not now create this document that's super conventional and has five pages of terms and conditions and that sort of thing.
It's honestly only as we've worked with larger and larger organizations where their legal teams won't let them sign an SOW that's as goofy as ours were. You have to have certain terms and conditions, and if we don't provide them, they send us theirs. We don't like theirs as much as we like ours, so. Yeah. Yeah. So I think generosity is a tremendous engine for very healthy business growth and very healthy personal relationships.
[00:40:30] Lindsey Dinneen: Absolutely agreed. And how do you wish to be remembered after you leave this world?
[00:40:36] Aaron Burnett: As kind.
[00:40:37] Lindsey Dinneen: The world needs a lot more of that, so I'll take that answer any day. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:40:50] Aaron Burnett: Oh, I have two daughters. Yeah.
[00:40:54] Lindsey Dinneen: Yeah, excellent. Oh, that's wonderful. Family is important and special. That's wonderful. Well, thank you so much, first of all, for your incredible insights today, for your generosity, to your generosity of your time with us and diving into some really specific areas that, that med tech companies can think about, can be aware of as they're even seeking somebody to help them with their marketing. I really appreciate you being open and willing to talk about some of those those nuances. So thank you very much for that.
We are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger and also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support. And gosh, I just wish you the most continued success as you work to change lives for a better world.
[00:41:55] Aaron Burnett: Thank you. I really appreciate it. You too. It was a great conversation. I really enjoyed it.
[00:41:59] Lindsey Dinneen: Good. Absolutely. Well, and 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 episode with a colleague or two, and we will catch you next time.
[00:42:14] 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.

Scott Burwell, PhD | Founder & CEO, Neurotype, Inc. | From Psychology to MedTech & Transforming Substance Use Recovery

Scott Burwell, PhD, is the founder and CEO of Neurotype Inc. Scott shares his journey from a background in experimental psychology to establishing Neurotype, a company developing brain therapeutics to address cravings in substance use disorders. He discusses the innovative use of EEG technology to measure brain responses to stimuli, providing an objective biological assessment and treatment of cravings. Scott emphasizes the importance of integrating science-led approaches in creating medical devices and reflects on the challenges and rewards of leading a MedTech startup.
 
Guest links: https://www.neurotype.io | https://www.linkedin.com/in/scottjburwell/ | https://www.linkedin.com/company/neurotype
Charity supported: Equal Justice Initiative
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 049 - Scott Burwell, PhD
[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'm so excited to introduce you to my guest today, Scott Burwell. Scott is the founder and CEO of Neurotype Inc, developer of new brain therapeutics to make environmental triggers less problematic for people in recovery for substance use disorders and other addictions.
Well, hello, Scott. Thank you so much for joining us today. I'm so excited to speak with you.
[00:01:17] Scott Burwell: Great. Thanks so much for having me, Lindsey. Thanks.
[00:01:19] Lindsey Dinneen: Of course. Well, would you mind by starting off and tell us a little bit about yourself, your background, and maybe what led you to MedTech?
[00:01:28] Scott Burwell: Sure. Yeah. So, I have a background in experimental psychology, a PhD in psychology from the University of Minnesota. And kind of what led me to that was experience: my family had a liquor store growing up and I worked there for many years. And so I saw firsthand from behind the counter people with substance use disorders occasionally, and just knowing from extended family, substance use disorders, and it was an interesting observation to me to see different people, how they get to a substance use disorder. Some through genetic propensity and some through experiences in their life. And that led me to get a PhD in psychology where I really focused on the genetics and physiology underlying substance use disorders.
And during this time of getting my PhD, I was always trying to think of, where does my skill set and my interest align in the future? What kind of job am I going to have after this? So I looked around. I had some experience, thought, "Could I go the academic route? Could I apply for grants, be a professor at a university?" That approach, which is a very good approach for some people, where your main outcome are publications and grants and dissemination of science.
And then I also looked at industry, but a lot of the companies in industry weren't doing exactly what I wanted to do, which was take these biomarkers that we were studying in psychology and transforming that into medical device or medical innovations. And then the third path that I didn't quite see at the time was this sort of like rabbit hole, this unknown path of medical device innovations or startup innovations.
And it was an eye-opener to me through some programs at the National Institute of Health, National Institute on Drug Abuse, that led us to this opportunity that actually, I could start my own startup in this space. And and I'm happy to talk a little bit more about that, that later. But really, this opportunity to make something new, based on the science that we know today, and based on the opportunity and the gap in terms of what people are being treated for with these substance use disorders. So that's kind of what led me down the path, and happy to talk about it today.
[00:03:41] Lindsey Dinneen: Yeah, excellent. Well, thank you for that. And yeah, I'm so excited to delve into so many aspects of your story. So going back just a little bit, you had this childhood where you were observing and you were seeing what was happening to some folks and you thought, "Okay, maybe there's a better way, or at least I'd like to understand more about this." But now, were you always sort of science minded and kind of interested in going into psychology, or did that come about as a result? How did that interest develop?
[00:04:10] Scott Burwell: Yeah, really, I never saw myself getting a PhD, never saw myself going to an academia setting. People with graduate degrees, people with doctoral degrees-- all those people seem to be other people and not something that what we did. But my parents really instilled an appreciation of higher education in myself and my two older sisters. But again, it was never this plan for me to go out and get an higher education, PhD degree.
I think that what really led me to the path was just try to understand myself. I think that's what led me to psychology. It was a psychology class in behavior genetics that I took in undergraduate that, you know, behavior genetics is the field of understanding how your genes and your rearing environment lead to who you are and influence who you are. And it was one of these, this realization that actually it's not just your experiences, it's not all just the soft, mental processing and soft psychological experience. There's really a physical, biophysical basis, to a lot of who you are and who you turn out to be.
And I think that was really eye-opening to me and helpful for me understanding who I was and how I am in the world. And I think, you know, just that little bit of information of understanding, there's this objective information that is programmed in your genes or programmed in your physiology that influences who you are in everyday life, that I found super interesting and eventually led me to work at the Twin Study at the University of Minnesota. And then and then while I was there, I realized there's a lot of people getting PhDs that I'm not that much different from and we're all just curious people. And it's an opportunity for me to, you know, if I apply myself, it was an opportunity for me to pursue a field.
[00:06:06] Lindsey Dinneen: That's very cool. Yeah. Okay. So, so you're pursuing this field and you've already had this background and interest in helping folks who have these substance abuse disorders, and I'm wondering, what were you observing as you have now developed this company? And I'm so excited to dive into that as well, but a little bit before that, what were your observations when you started realizing, "Okay there's a gap in the way that we're treating this or handling this or responding to this." And then what was the outcome for you that you thought, "Okay, let's try something different."
[00:06:42] Scott Burwell: Yeah. So a couple of things. I think the first thing is that, the treatment of substance use disorders and all behavioral addictions and to some degree mental health is been sort of a parallel development. It's been a, it's been a parallel field that's been outside of the rest of the way that medicine is traditionally done. And so, even though we have for some substance use disorders medications for management of the substance use disorder. Or there are social support groups, AA, Narcotics Anonymous also, that help provide social support to people with substance use disorders. These are sort of groups and services that have been built outside of traditional medicine.
And with the exception of these services, there haven't been too many medical innovations, FDA regulated innovations that doctors can prescribe for people with substance use disorders. And this is despite decades of research that are showing there are biological underpinnings of substance use disorders. There are biological interventions that, that can potentially help people with these afflictions.
And so, that was one of the pieces that during my training, I was just constantly looking for companies that were doing this kind of work to treat disorders from a biological or psychobiological perspective. And I just wasn't finding anyone. And also at that same time, the DSM Five, the Diagnostic and Statistical Manual for substance use disorders, the criteria that sort of outline what it takes to get a diagnosis had just included the symptom of craving. It might be surprising to people, but it's only been since about 2013 or so, that craving has been an official symptom of a substance use disorder. And I mean, that's despite again, decades, many years of people reporting cravings being an issue that they deal with day in and day out.
And so I was aware of this addition of a new symptom, but also I'm aware of the fact that the way that substance use disorders are diagnosed, they're assessed, they're monitored, is entirely subjective, meaning that people are reporting these symptoms in an interview in a one on one kind of subjective interview that people can report what they believe, report what they experience, which is valid information. But sometimes what you're aware of, what the clinician is aware of, might not be what's going on an objective biophysical level.
And so I was aware of a certain biomarker that you can measure with brain waves using electroencephalogram or EEG and this biomarker is what leading science says is the biomarker underpinning of craving. And so I felt, well, you know, if there was a way that clinicians had this in their hands as either a diagnostic assistant or as a way to treat people with craving, this could be a valuable medical device that people can use. And so, I can talk more about the specific biomarker, but these were two realizations that I saw that there's a lacking and a need for innovation in this field.
[00:10:03] Lindsey Dinneen: Great. Yeah. Okay. So yeah, could you share a little bit more about the biomarker and then how you have found, how you have discovered to affect this and what this device is and how it works?
[00:10:14] Scott Burwell: Yeah, so Neurotype Inc., we were founded in 2019. We were founded after we were participating in this workshop at Yale University called Innovation to Impact. It's funded by the National Institute on Drug Abuse. And we really pitched this idea to them as kind of a off the cuff, last day of the workshop pitch event and won first prize in that thing. And that's really what gave us the steam to go ahead and apply for these federal grants to support further development of this biomarker.
What the biomarker is, basically we put a headset on you and that headset is kind of like a fitness tracker except other than being like a fitness tracker that's tracking your steps from, you know, a watch or, you know, being a glucose monitor that's on your arm, that senses how much blood sugar you have, this fitness tracker is on your head. It measures the electro physiology that's generated by your brain. And it's entirely passive in that regard. We're not putting any like, you know, electrical stimulations in, but it's just measuring how your brain is acting at all moments.
And what we do is that's different from other companies is we're actually recording how your brain responds on a millisecond scale in response to pictures. So we hand somebody an iPad while they're wearing one of these headsets, and we show them a flip book of pictures. Some of those pictures are like chocolate cake, puppy dogs, you know, cute, emotional pictures. Some of those things are boring things like kitchen supplies, office supplies, whatever they might be. And then some of those things are like opioid pill bottle, right?
And so, for opioid use disorder, if you are liable for craving, and if you're likely to start reusing after being discharged from treatment, your response to that opioid pill bottle, the brain response, the objective brain response, is going to be very similar to how it responds to, for instance, chocolate cake, than a person that's not at risk for returning to opioid use or other kinds of craving. And so this biomarker is really a biomarker of what's called 'motivated attention.'
How interesting you find that stimulus on the screen and how much it grabs your attention. And what we know from psychology is that if something grabs your attention, you're likely to behave in a way that is going to correspond with that. So if it grabs your attention, you're going to act a certain way around that stimulus. And so for people with opioid use disorder, it might be that it stimulates some thought process or some behavioral process in your body that leads you to seek that substance, affiliate yourself with people that have that substance, you know, all sorts of indirect ways that eventually lead you to start using that substance again.
And so, we have done a few different research projects funded by the National Institute on Drug Abuse, and these are different projects over time that have really established the core assessment capabilities of the device. And now we're working towards clinical trial validation through a small business innovation research project from National Institute on Drug Abuse that will be a pivotal clinical trial for us.
[00:13:30] Lindsey Dinneen: That's really exciting. When does that happen?
[00:13:32] Scott Burwell: So, that is part of what's called a fast track project, and we are finishing up our phase one portion of that. And the phase two portion will probably start sometime this coming summer. Yeah.
[00:13:45] Lindsey Dinneen: Great. Okay. That's great. And so what is your dream or ultimate ideal goal for the company and for this device? What are you hoping to affect or where are you hoping this device will be used?
[00:13:58] Scott Burwell: Yeah. So, our main goal or our first sort of beachhead market, if you will, is the intensive outpatient treatment clinics for substance use disorders or other mental health. It's a certain kind of clinic where people are seen on a pretty regular basis during early recovery when they're still in a kind of high risk period. And in this group of patients, they tend to be in a scenario where they are living at home or living in the wild, so to speak, it's no longer a residential treatment setting. But they are living and being challenged day to day with the triggers in their environment that, that can lead to risk for problems.
And the interesting thing about this space though, and this market is that in that space, there really are not many regulated, or any regulated devices, that are being used to manage specifically certain symptoms. And especially none that are applying to brain physiology like ours. And so, it's a pretty big step to bring our device to these spaces because they might be familiar with a blood pressure cuff or people might get blood work done from time to measure other health related risks. But for us, we are bringing an EEG system, and it's a portable EEG with a software device, into a clinic where they've never been before.
And so my grand vision for this is really to be, you know, we're not a fix all. We're not a cure-all solution, but we are solution to help one specific slice of somebody's condition, and be a fix for craving in these settings. But if we can get the device in these clinics settings, it opens the door for a whole lot of other biomarker solutions to take place. And so right now, we're just focused on craving, monitoring the craving, but also treating the craving through what's called closed loop biofeedback.
But the but the long term vision for this is to do-- we can additionally build out with the same brain kind of assessment, we can build out other kinds of biomarkers. So, those that are related to genetic risk. So we don't have to do like a full genetic test, but we could use that same brain data to to study what are called endo phenotypes, but basically a genetic marker of risk for a certain disease type or a certain disease progression.
We could also measure other aspects of distress or you know, other depressive symptomatology or things like this with our measures. So, I think if I were to, at minimum, if we were to be able to make a dent or just get our device into these intensive outpatient clinics, that would be a huge success for me and the company. But, I think much grander speaking, it would open the doors for a lot of more transformative addiction treatment care.
[00:16:56] Lindsey Dinneen: Yeah. Yes. Okay. Well, that's incredible and thank you for sharing your vision, 'cause I always love hearing, all right, what's the longterm heart for this company in this project. So that's great. Yeah. Are there any moments that stand out to you, maybe as you're developing this device or maybe even before as you're studying the biomarker and you're thinking through, you know, how can I make a difference in this particular indication? So are there any moments that stand out to you as really affirming to you, "Yes, I am in the right place at the right time. Doing what I'm supposed to be doing."
[00:17:32] Scott Burwell: Yeah, I think one piece was when we won first place at that at the Yale workshop that we did. I would say another was just getting each of these grants. We've applied for grants over and over again. And you don't get every one of those grants. But when you get certain projects, and when you're awarded these monies, it is incredibly validating because, you know it's gone through scientific review at the NIH. You know that also at the specific institute, so National Institute on Drug Abuse or Alcoholism or Mental Health-- they're different -- that this is an intense area that they see value. And so when you get these projects, and we've gotten over a million dollars now in these projects, that there's some validation behind it from federal and also a scientific level.
So that's one area, but then I would also say that, when talking to clinicians, we talked to clinicians and we talked to some patients about the device, and we demo the device and demo the technology with some clinicians and patients. And, people will come back and be like, "Wow, why is this not out there already? Why don't we have this kind of data?"
And to me that is incredibly rewarding to just see people and their immediate responses to the technology, because I don't think anyone really knows that this science or this technology is readily available. It just needs to be packaged in the correct way. And it also has to go through the correct regulatory and reimbursement pass. I mean, to just say "just," I think that's probably an understatement for sure. But, the science has decades of work behind it. And really it's up to us now to move that, to make it to that next milestone, that next goalpost. And that work isn't really science. It's just hard work.
[00:19:14] Lindsey Dinneen: Yeah. Yeah, indeed. Well, speaking of hard work, you know, forming a company on its own, working in the medtech field on its own, all of those things are difficult challenges to choose. And I'm curious, how has your personal path been in terms of growing into this leadership role where you are directing this company and directing people. How's that journey been for you too?
[00:19:43] Scott Burwell: You know, I think it's been a journey. And when people say that you can't do it on your own, that is 100 percent true. And even if you hear it and you believe it, sometimes I think it takes a lot for me to come to the realization to put that into practice. I tried to do a lot on my own. In the team, I am the CTO, the CEO, the COO, all these different roles that I've assigned myself. We participated and were awarded into the-- NIH has this program called Innovation Core, iCore. And we did this program and one of our mentors there was really harping on the idea of leaning into your what are called core competencies. So what are you actually really good at as a team and as a company? And what are you less good at?
And and I think that the more that I've learned to lean into my core competencies, which are really around the science, the translation of the neuroscience, the translation into a clinical tool that can be used, thinking about the vision of our technology. And tried to offload some of the other things, whether it be regulatory or whether it be some aspects of business strategy or other otherwise to, to other people that can help in a fractional sense or whatever to help us out. That's helped me both maintain my role as a leader and keep on doing the work that I think that I can actually contribute to and be useful contributing to, as well as keeping the company afloat in terms of funding and just hitting our milestones on all the different projects that we've been awarded and need to produce for.
So, so I would say that, you know, I'm no, I'm not a perfect leader. I'm not a perfect CEO by any means. But I, but as I go on, I kind of learned that you can't do it all yourself, and you can't accomplish everything to the same degree as another person possibly could. And so trying to build good teams, trying to lean on team members that can do certain things, finding the strengths in certain team members and asking them to do the right kind of work given their skill set. But I think that's been a crash course for me.
[00:22:00] Lindsey Dinneen: Yes, indeed. Well, that makes complete sense because, you know, like you said at the very beginning, it is a journey, and it is a constant learning and growing process. So yeah, that's, that's fantastic. Well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your field. It doesn't have to be. What would you choose to teach and why?
[00:22:29] Scott Burwell: Oh my gosh. Well, You know, I think that-- I'm not sure anyone would offer me a million dollars for this. But if I had the time, I think If I had the time, I would actually really love to teach a masterclass on how to do this sort of neuroscience innovations. There's a lot. This is a really hot area for startups and innovations, the idea of using neuroscience tools as products. There are companies out there like the Muse headband or there's Nurable, which makes these smart sort of headphones that also measure brainwaves. Neurocity is another company that's doing things for productivity. And I know people at these companies. They're all great companies. And these are some very successful examples.
But there's other companies out there too that, that are doing things that I feel are led by engineering first. So, just because you can do something, it doesn't mean that you should do something. And it doesn't mean that there's any validity to what it is that you're doing. So, you know, there's a lot of interest in that. Around developing brain computer interfaces or other kinds of neurological or brain diagnostic or treatment devices. They're doing brain stimulation or brain sensing or biofeedback or all these sorts of buzzwords.
I think we're kind of part of that group, honestly, but the difference between us and the others is that we are science led and a lot of these other companies are engineering or technology led. And when you lead through something, when you start by innovating by technology and innovating by engineering, that's great from a perspective of showing others that you have a tool. But without a use for that tool, and without evidence from science that tool actually does something useful, then it's kind of useless. And so a lot of those companies go broke because they don't have a user for that tool or the tool that they built doesn't actually do what they intended it to do.
So one thing that I think I would do in this course, if I were to do this course, is to really emphasize like, here's how you can approach certain kinds of biomarkers. Here's the types of biomarkers that people actually think is correlate with a disease, major depression, ADHD, substance use disorders, whatever it is, and actually have a scientific grounding versus building a headset that does XYZ first and not really having a scientific basis.
One, one tip I would just offer people is just get a PhD that has the background in that content space first on your team, because they will tell you what the field thinks of it. And a lot of times, the field thinks that a lot of the products that are being developed out there are just snake oil. And so, so really, you know, do your diligence on the science before diving into something.
[00:25:27] Lindsey Dinneen: Cool. Yes. I'm sure that would be a fantastic masterclass and very needed. So, all right. Sounds good. All right. And how do you wish to be remembered after you leave this world?
[00:25:40] Scott Burwell: Great question. You know, I would love, like I mentioned earlier, for Neurotype to play its part in establishing these kinds of brain biomarkers in the treatment for behavioral and mental health disorders. I would love for us to be a building block for what the future looks like. I think we're using the most current science available to build our innovation. And if we can be sort of that first step into the future, I think that would be so great. And the science will change in the future, but I think that if we can be that stepping stone, that would be ideal.
I think on a more personal level, I think I would love for anyone I know, anyone that I come into contact though with, I really want to be remembered as a person that's just been kind to you. If you can remember one moment that that you felt like, "Oh, Scott made me feel good in that scenario" or "Scott was helpful in that scenario." I think that would be a more realistic grab or a closer term grab. So, so, you know, both those things I think would be great. But in the day to day, I really work to at least hope that people remember me and felt that I was kind to them.
[00:26:48] Lindsey Dinneen: Yeah, absolutely. Kindness makes all the difference. Yeah! Okay, and then, final question. What is one thing that makes you smile every time you see or think about it?
[00:27:00] Scott Burwell: Oh, geez. I think, you know, Is it is it okay to say cute animal memes from Twitter or something? But so...
[00:27:08] Lindsey Dinneen: Sure!
[00:27:09] Scott Burwell: I love cute animals. I love any cute animal or cute baby thing on Instagram or wherever. But I will also just say, back to the impact aspect of our company, we do research with people. We do early demo testing with people with substance use disorders. And some people struggle, they're in and out of treatment programs five, six times before something really starts to click. And they put in so much hard work and so much effort to keep on their pathway, unique pathway to recovery.
And so, you know, I think that I'm really encouraged and really puts gas in my tank when I see people that are doing well and that they're happy. And because there's some degree of pride that person carries around and some, and and maybe that pride was not necessarily there beforehand. And so, you know, I think that I will, regardless if they are achieving their goals and living a happier life because of what Neurotype is doing, or something else, really doesn't matter to me.
When I see people that are doing better, it is warming to my heart to see somebody that has made some sort of sustained change in their life that is impacting them in a positive way, because it really does show that people can change. People can do what they want to do and live the life that they want to live in many cases when they. are given the opportunity. And so that's heartwarming to me.
[00:28:38] Lindsey Dinneen: Absolutely, yeah, absolutely. Ah, that's wonderful. Well, yes, and also, awesome little cute memes are the best, especially with animals, oh my gosh.
[00:28:48] Scott Burwell: I know. Yeah.
[00:28:49] Lindsey Dinneen: I spend way too much time looking at baby animals, but I always smile, so, you know, win.
[00:28:54] Scott Burwell: Yes, it is. It's the main, it's the main way I get my little like boosts of dopamine throughout the day for sure.
[00:29:00] Lindsey Dinneen: Yes, absolutely. Well, Scott, this has been a fantastic conversation. I so appreciate you joining me and sharing more about the work that your company is doing and all the innovation. I'm so excited to watch it continue to succeed. So thank you for spending some time with me today. I appreciate it.
[00:29:18] Scott Burwell: Absolutely. Thank you, Lindsey. Thank you.
[00:29:20] Lindsey Dinneen: Of course, and we're so honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongfully convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So thank you so much for choosing that charity to support. We just wish you continued success as you work to change lives for a better world. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I would love if you would share this episode with a colleague or two, and we will catch you next time.
[00:30:02] 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. ​

Isabella Schmitt | AI & Regulatory Affairs Leader | Strategic Communication, Navigating Pre-Subs, & the Power of Mentorship

Isabella Schmitt is a prominent life science, AI, and regulatory affairs leader, and was recently named one of the top 100 MedTech Leading Voices Worth Following on LinkedIn in 2025. Isabella shares her diverse career journey—from aspirations of neurosurgery to becoming a regulatory expert in MedTech and biotech. She emphasizes the importance of early regulatory involvement, strategic use of pre-submissions, and understanding the voice of the customer in product development. Isabella also discusses the critical role of communication skills in regulatory affairs and offers invaluable advice for aspiring professionals.
 
Guest links: https://www.linkedin.com/in/isabella-j-schmitt/
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: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 048 - Isabella Schmitt
[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, Isabella Schmitt. Isabella is a life science, artificial intelligence and regulatory affairs leader with expertise in navigating the intersection of science, technology, policy, and innovation.
With a robust background in medtech and biotech regulations, she has contributed to over 200 projects ranging from hardware and software medical devices to AIML products. Isabella holds an MBA from Texas A& M and is pursuing advanced studies in AI management and policy at Purdue University. Known for her engaging communication style, she is a sought after speaker, author, and consultant on AI regulation and innovation.
All right. Well, welcome to the show, Isabella. I'm so excited that you're here.
[00:01:41] Isabella Schmitt: I'm excited to be here. I feel like it's been a long time coming as we just talked about a second ago. We've been needing to connect for a while so I'm glad we're finally getting to do it.
[00:01:50] Lindsey Dinneen: Me too! Well yes. Thank you for taking some time today. And I wonder if you would be willing to start off by sharing a little bit about yourself, your background and actually what led you to medtech.
[00:02:00] Isabella Schmitt: Yeah. So it's an interesting story because I actually have a pretty varied background in general. Like if we start back, back in high school, even so we'll go that far back, I wanted to be a neurosurgeon originally in life, and... well, originally I wanted to be marine biologist, but that was when I was in elementary school. No, I wanted to be a neurosurgeon probably from the time I was like, 14 to like, 21. And then I did a surgical externship and I didn't love it. And so then I had a quarter life crisis where I was just like, "What do I do? This is what I've wanted to do for so long."
And then I found myself going into research, so I did a lot of lab work in primarily healthcare type things. So, with nanomaterials for oncology, you know, specific targeting of tumors and things like that. But then I found with that, I liked the design of the experiments and like the design of new inventions and all of that, but I didn't actually enjoy the lab work. So like the actual part of being a researcher was not fun for me.
And so, I shifted gears, had a little kind of a stray off of the, this normal trajectory, I guess. And I was like, "Oh, well, maybe I want to do veterinary medicine." I love animals, so I did that for a little bit. And then I felt like there was always this drive for me to do something that felt good, aligned with my values, right? But was also intellectually stimulating so that I felt like I was constantly challenged. There was something new. It was very diverse. A little bit of ADHD there, right? So like I need, I need lots of inputs and stimuli. And so I, with veterinary medicine, I felt like I really liked this. It was ticking the sort of values box, but it wasn't really ticking the other boxes for me.
And so then I kind of went back and was like, "Well, maybe I want to go to medical school. I'll revisit that." So I took a job at a pharma company, a midsize biopharma company. And I started off in the clinical research side. I didn't know anything about the industry at this point, 'cause they don't really teach you anything about biopharma or medtech in school. I don't even know what I thought about how products like drugs and devices got to market. I just kind of assumed someone was checking over that, I guess. And so I had no idea and I took the job thinking it was more truly clinical related. Like, I was going to be, I don't know what I thought I was going to be doing, but something clinical, and it was, it was a CRA position.
But what they noticed about me, was that I started trying to analyze the patient data and I unblinded myself in doing that. And so they were like, okay, well, maybe you need to do something that's a little bit, not that there's, you know, that being a CRA is not intellectually stimulating, but not in alignment with exactly where I was. And so they put me towards regulatory affairs. And so I started helping kind of just general regulatory affairs. Then the guy that was running the product side of things, all the manufacturers and getting the product ready, was retiring. And so they promoted me to that position.
And so what was happening at that time was I was getting intellectually stimulated. I was doing well. It had the diversity that I liked where it was ticking the altruistic box and helping people and it's, you know, scientific, it's medical, it's writing, it's reading, it's understanding. And so it was kind of scratching that itch for me, so I didn't go back to school. I well, actually I did, but that's later down the line. But I, I stayed there.
That company got bought by Allergan and I left at that point and I went to a medtech startup company and that was my first foray into medtech. So I moved from biotech to medtech. And, you know, some of those things can translate, right? The cultures between biotech and medtech are very different, but a lot of the foundational knowledge of how you think about things can translate. So at that company, I learned more about medtech, but I could apply the biotech lens to it, which I think ultimately helped me from a strategic standpoint in the medtech world.
And then I left that company and I started at Proxima, which was the company where I first met you. And I was like employee four there, and I ultimately built their regulatory consulting group and that whole kind of department from me to 15 people and over 200 projects. Loved working there. I did a lot of talking, BD, consulting, all kinds of things. I then started running their clinical department as well, and then I left Proxima and now I work at a AIML company as their VP of clinical and regulatory. So I manage all of their suite of products for global submissions and kind of all the clinical collaborations that are ongoing there.
There's a long background, but it's a trajectory and I feel like people feel like they need to know what they're going to do at some point, like early on. And when you go to college, you're like 18, you don't know, and you barely know about what's out there, right? But you feel like 'I should know the answers to all of these things,' and you don't. And sometimes you find yourself in places that you didn't really expect and I know that a lot of people also want to get into regulatory affairs, and it is difficult sometimes to get your foot in the door. It's a competitive type of role largely because it, it is so diverse and stimulating and you have to have a lot of different types of skills to actually be successful in it.
But, you know, what I would suggest people do is look for smaller companies to kind of go towards, because those are the types of companies that'll maybe take a chance on you with leadership that helps and guides you through that transition. So when I was running Proxima, I like to hire people kind of earlier in their career because one reason was selfish. You don't have to reteach or get them out of bad habits, right? And then the other part was I just liked kind of, I liked the, the helping and the molding and the growing of them. And it's really nice to see them be successful there or afterwards as they move on into other places. And we have lifelong relationships now. You know, I've left and I still talk to them and they still come and they ask me for advice about things. And so that's really nice.
[00:08:42] Lindsey Dinneen: Yeah, that's incredible.,Well, first of all, thank you for sharing a little bit about your background. That was really cool to hear about your career trajectory and so many things popped up for, for me right away. But one of the things that really stood out was this idea-- I love how you talked about the fact that you don't have to know at the very beginning of your career or really, I don't know, even in the middle of it, is this what I'm going to do for the rest of my life?
I mean, it's okay to kind of. stumble into a path you didn't expect and see where it leads you. And, I'm curious too, you know, you've had such an interesting, diverse background and you've had all of these different skill sets. So when you first started, I know throughout different places you've been, you've done a lot of business development, but can you share a little bit about the skillsets and the things that you've learned through business development that actually really do translate to... Yeah.
[00:09:35] Isabella Schmitt: So, so business development is... so weirdly I had this sort of side thing where I was doing marketing work kind of just as like a side hustle for a bit. And so at Proxima, I really helped with market. So, business development and marketing, particularly for the consulting side of things reported into me as well. So I did a lot of that work, and I think in those cases, business development and marketing, if you're good at it, is all about communication, right? Like, it is about communicating effectively with other human beings, whether that's through talking to them or through writing. And understanding the audience that you're talking to, whether it's talking to them or through writing.
So, you know, in a conversation, you get good at reading people, right? Like you can kind of hear what they're saying and you start to learn like, okay, this is their pain point. They're saying this one thing, but what I'm getting from it is this other thing that I know a little bit more about that they're not necessarily picking up on. And so you, you start to be able to take on more of an advisory role, I think? There's different approaches to sales and marketing, right? There's the hard sales approach where it's like sell, sell, sell, which is, there's nothing wrong with that. It's just not my approach to business development and marketing. Mine is much more advise, educate, relationship. What is it that you actually need? How can I meet your needs?
And I think that skill set translates really well into regulatory affairs. There's different types of ways you can be involved in regulatory affairs. If you're doing high level strategy type things, you need to have these communication skills. You need to be able to see the forest and the trees and be able to redesign a forest if you need to. But there's also the very by the book administrative side of regulatory affairs where I think these skills probably aren't as necessary and there's nothing wrong with that. Some people really like that sort of structure.
I'm not that way. So I really like the strategy communication talking aspects of it. And I think the business development and marketing, the crux of it all is the communication aspect. And that is incredibly important when you're pulling together regulatory submissions, and you're engaging with regulators, you need to understand your stakeholder there, who you're talking to, the audience, what they're interested in what they're not interested in and be able to read that in that instance as well because you want to give them enough information, but not too much information about what it is that they need to understand in order to clear or approve your product.
For the people that I would bring in, you know, when they were early in their career, I think them being in a more of a consultative environment was probably beneficial to them in the long term because they had to learn those skills in the context of engaging with clients, right? And so we would do different things, you know, as they were training, I would be on the calls with them, but sometimes we'd do sort of like the mic in the ear thing, but through Teams, I would send them messages like, 'say this, ask them that.'
And then I would explain, you know, or if I said something that seemed unexpected, you know, like that was a different direction from the conversation or they expected me to respond to something that I didn't respond to, I would explain it to them afterwards so that they could learn and kind of absorb those skill sets so that they could then take that forward and apply it whether it's with clients or with regulators, or just with teammates, whomever it is moving forward, they would understand the communication aspect is so incredibly important in the strategic side of regulatory affairs.
[00:13:38] Lindsey Dinneen: Yeah. Yeah. Yes. Thank you for, for sharing more about that. I can absolutely see the critical importance of the communication skills, being able to translate, but, but building those skills. And honestly, it's probably just great advice across the board. You know, anyone, especially young in their career. Those are the skills to build.
[00:13:57] Isabella Schmitt: Yeah.
[00:13:58] Lindsey Dinneen: Yeah.
[00:13:59] Isabella Schmitt: Yeah.
[00:14:00] Lindsey Dinneen: So.
[00:14:01] Isabella Schmitt: Nothing, nothing better than relationship building and communicate and clear communication in your personal life, in your professional life, everywhere. So, yeah. And I think, you know, it's interesting too because there are things about my childhood and growing up that also translated into having a skill set associated with communication and understanding people and dynamics that was like a long term training, you know, from being a little kid to now, which maybe not everybody gets and that's okay, but they can learn it. It's something that, it's learned. It's not innate. You can learn it at any point if you're willing.
[00:14:48] Lindsey Dinneen: Yeah, I, I love that. So, you know, okay, so now you've had all this incredible experience. You've helped a lot of companies and, you know, regulatory affairs is your jam. What kinds of things do you see that are kind of common, perhaps stumbling blocks for, especially smaller medtech companies that are trying this for the first time and this is their big hurrah and it's really exciting, but what are some things that you see that, that maybe we could help mitigate?
[00:15:16] Isabella Schmitt: Mm. Yeah, I think the first things that come to mind and it's kind of like two opposing flavors. One, is... and they're both around pre-subs, right? So pre-subs are the big talking point, I think, all the time, and you will often hear people say like 'just do a pre-sub 100 percent of the time.' I think generally, that's true. There are cases where you don't necessarily need to do a pre sub. But as you go into a pre sub, it's again about communication. You want to make sure that you're not saying something that you can't get yourself out of in the future.
So, like, you know, oversharing or oversharing erroneously too. You can share things that maybe are not particularly relevant to what you need to convey but then can cause a flag that sticks in the minds of the reviewers. So you want to go to a pre sub typically with someone who has done them before successfully, and you probably want to find, if you're an innovative company that's doing this for the first time, someone who works with innovative companies a good bit more on the strategy side, even if they're not the one that's writing the pre sub, but that it is overseeing the sort of process with it.
Like I said, there's, there's a very administrative side to regulatory affairs too, and there are people who can turn, turn, turn submissions out and that's great. But when you're dealing with an innovative type product, that sort of administrative part of it== it's still important, but it becomes less important-- because you're basically navigating a new landscape and you need someone who has done it before, who can kind of understand how the regulators, whether it's FDA or notified body might think about it so that you can convey the information adequately or answer their questions adequately too.
The flip side of it is... so do a pre sub, but do it smartly. The flip side of that is don't do too many pre subs. So one of my friends in the industry and I were just talking recently about ' death by pre sub,' where you do so many pre subs that you've kind of painted yourself into this corner and you maybe don't want to be in that corner and you have to figure out a way to kind of claw yourself out of it. It, it can become very restrictive. So if you go, you know, if you're on pre sub eight, you're probably too far, too far or too deep in at that point. So you want to be smart about the pre-subs and generally speaking, I think that was the first comment, death by pre-subs is usually if you're not being smart about the pre-subs.
And then I think people go in maybe without a pre-subs at all thinking that, "Oh, I have a 510 K. It's straightforward." Maybe they're using a predicate. If your predicate's really old, they may have changed their thinking on it, so you probably still want to do a pre-sub even if it seems straightforward. Those are the things that I think are are probably major pitfalls.
I'd also say companies not involving someone with regulatory expertise early enough on, so even if you're not engaging with FDA, companies can get kind of stuck in a perpetual loop of product changing and advancement to the point that is detrimental and that a lot of that doesn't actually help in the long run, from a regulatory standpoint, understand your minimal viable product. And then from there, once you understand what that is, right, then you should really start engaging someone who has regulatory expertise. Or maybe you need someone to help you figure out what the minimal viable product is through, you know, some sort of regulatory lens as well. But I wouldn't spend 10 years going through design iterations and all of that before you get someone in to level set with where you are from a regulatory standpoint,
[00:19:31] Lindsey Dinneen: Mm hmm.
[00:19:32] Isabella Schmitt: And then I think shifting a little bit from regulatory, also involving regulatory and clinical, is understanding the voice of the customer. You design a product, you kind of want to design a product that people want and will use, because you can get through regulatory right? But if nobody wants that product, you've wasted years developing it, and a lot of money, and so getting with whoever the, the end user is going to be and understanding what their actual needs are and having them kind of look and touch and feel the product is, I think, incredibly important, even in the earliest stages, because you don't want to spin your wheels, designing something that nobody ultimately wants or can use.
[00:20:19] Lindsey Dinneen: Yeah, absolutely. So design with the end user in mind, talk to the end user in mind, and then talk to an expert such as yourself to really help guide you through that regulatory process. And it sounds like the earlier the better just to start that process going so you have an idea of where you need to head.
[00:20:39] Isabella Schmitt: Exactly, yeah. That's exactly right. Yeah.
[00:20:41] Lindsey Dinneen: Yeah, excellent. So, you know, you have had such a very cool diverse background and, you know, you've been honored a lot. You're, you know, a Houston Woman to Watch. You have gotten a business award, multiple ones. You just recently got named to MedTech Leading Voices, you know, 100 MedTech Leading Voices. That was really cool. So congratulations.
[00:21:02] Isabella Schmitt: LinkedIn's been blowing up from that. I was like, yeah,
[00:21:06] Lindsey Dinneen: That's awesome. Yeah.
[00:21:07] Isabella Schmitt: I haven't looked at it on my own LinkedIn yet. And it's, I opened it today. I wasn't on it all weekend and I had like 50...
[00:21:14] Lindsey Dinneen: Oh!
[00:21:14] Isabella Schmitt: ...requests. I was like, what? So yeah.
[00:21:17] Lindsey Dinneen: Amazing. Well, congratulations! That's really exciting!
[00:21:21] Isabella Schmitt: Yeah.
[00:21:21] Lindsey Dinneen: You know, like, just looking back, could 10 year old Isabella have ever anticipated this is where you would be right now?
[00:21:29] Isabella Schmitt: No. Well, you know, not exactly, but I was Student of the Year when I was 10, so maybe that was an early hint, I guess.
[00:21:42] Lindsey Dinneen: I love it.
[00:21:43] Isabella Schmitt: Yeah.
[00:21:44] Lindsey Dinneen: Yeah.
[00:21:45] Isabella Schmitt: Yeah, 10 year old Isabella I don't know. 10 was a weird age.
[00:21:51] Lindsey Dinneen: Yeah. Fair enough. Fair enough.
[00:21:54] Isabella Schmitt: I definitely wouldn't have seen myself in this industry and even, you know, 18 year old Isabella wouldn't have seen myself, because I didn't know it existed,
[00:22:03] Lindsey Dinneen: Right.
[00:22:04] Isabella Schmitt: But, you know, being highly on the business side of things too, because regulatory is very deeply integrated with all should be with all aspects of a product, right? And so I have to understand the voice of customer and I have to understand if there's a market for this and I have to understand the engineering and be able to translate all that information and, you know, and then on the other side of it with Proxima, I built the actual business. So, you know, I had to design pricing strategy and marketing stuff.
And so I never really saw myself being so heavily involved in the business world and that may have like honestly come from, not to get all political or whatever, but like a lens of sort of my vision of business person was male, you know, and so I just didn't have a lot of exposure to women in, in business roles and I don't, I don't think I ever had imposter syndrome because I always felt pretty confident in my abilities. I felt more like the world of business was male dominated, which it largely probably still is. But, but I think that kind of maybe held me from having that vision. And I mean, surgeons are male dominated too, but I was thinking I was going to be a surgeon. So, so, but I also had a vision of the business world as being more like Wall Street kind of world.
And you grow up, you know, and you learn new things and get exposed to new people. I'm very thankful for the people that I have met who have given me opportunities to, to shine, I guess who have trusted me, like Kevin with Proxima trusted me to build the department. The company that I work for now basically trusts me to do all the regulatory stuff. Obviously, hundreds of clients have trusted me with their regulatory, with their babies.
So it's one of those things where it's a combination of your own aptitude, but also other people. And, and I think for me, and that's why I wanted to also bring in, you know, green people who are coming new into the industry, to give those people opportunities to live up to their potential too, because a lot of it is having the opportunity and having someone trust you in order to, to show what you can do or can't do, I guess, but you learn either way, right? Failures are learning opportunities too. So.
[00:24:40] Lindsey Dinneen: Yeah. Well, I love that because you, you saw people, you know, 'cause sometimes it feels, especially as a job seeker, if you're young, or you don't have the industry experience, it just feels so invisible. So I love the fact that you were willing to do that. And then mentorship sounds like a really strong pull for you. Like, you very much care about that and helping the next generation of folks...
[00:25:02] Isabella Schmitt: Yeah, yeah.
[00:25:02] Lindsey Dinneen: ...find their footing too. So I love that.
[00:25:05] Isabella Schmitt: I, I love doing that. And I was teaching at Rice. I would teach a lecture a semester at Rice when I was at Proxima, maybe I'm going to do it now, I don't know. And then A&M a little bit too, and so even just kind of meeting students, I just, I like to give people opportunities, so if people are listening to this and they want to understand how to get into regulatory affairs or really anything, I am happy to have a conversation. Lindsey will tell you that I might reschedule it, but I will have the conversation.
[00:25:40] Lindsey Dinneen: I can attest to this. She will, she will. Absolutely.
[00:25:43] Isabella Schmitt: I do want to do it. It's just, yeah.
[00:25:49] Lindsey Dinneen: MedTech has become sort of, at least it sounds like your calling, for lack of a better word. And so I'm curious, you know, you are obviously very passionate. You are one of the leading voices in the industry. You are a thought leader. Along the way have there been moments where you just thought, "Wow, this really cinches it for me. I am in the right place at the right time doing the right thing."
[00:26:11] Isabella Schmitt: I mean, I think, in general, I feel that way. I, I'm the type of person who, though, is kind of always looking to grow and advance and more and more and more. And so I think it's, it's always kind of a learning experience. I think I will stay in this industry till I die, but for for a long time and it kind of just like, it clicks in my brain. Like, it just, it sort of makes sense with how my brain works.
But, you know, I have also expanded a little bit into AI kind of generally speaking as well. So, I work at an AI company now and I've worked with many AI products before. But I also am in a master's for AI, and I've been doing some policy work with it. So I, I try to, I try to go deep and broad at the same time, which I think is hard and maybe tends towards workaholism, workaholicism? But, but it keeps me stimulated and feeling like I'm productive and moving forward. And so, you know, I, I guess, to answer your question succinctly, I do think I've found a place that I really love.
I think that I will continuously look to expand and grow, just how I am, whether that's in specific with regulatory affairs or whether it's spinning off another consulting company or whatever, you know, my own product company one day, whatever it might be. I think this space is what I like. And I, I like growth personally, and I like growing people and I like growing businesses.
So I think all of that, I guess if there was a moment, honestly, Proxima. My experience at Proxima with growing, growing there, myself, the company, clients, employees, marketing, whatever it was that, that probably sealed the deal for me staying and not kind of looking to do something else. There was a short stint where I was very confused again before I started at Proxima. I was like, "I don't know if this is right for me."
I was thinking about leaving the industry and going and doing psychology and all of that. And, I got the job at Proxima, it just kind of checked everything for me. And so I think that, that, you know, if you're a person that likes a lot of diversity, I think getting into a strategic regulatory affairs role, particularly if you're able to work with multiple companies is, is the sweet spot. But yeah, that was one of the best places I've ever worked, one of the best experiences I've ever had.
[00:29:02] Lindsey Dinneen: That's incredible. Well, great. I'm so glad and thank you for sharing about that experience. Yeah, that's wonderful. So, okay, pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. It can be in your industry, doesn't have to be at all. What would you teach?
[00:29:21] Isabella Schmitt: would I would probably teach AI policy with specific towards regulated industries. So meaning, obviously, medtech, biotech to o, aviation, aerospace defense. So I kind of want to take it, sort of a broad approach, of how we think about regulatory with regards to AI, and the differences in regulating that type of product versus more standard types of products. So, that would probably be what I would would like to do if I were teaching a master course.
[00:30:06] Lindsey Dinneen: That sounds incredible and very needed, very timely.
[00:30:10] Isabella Schmitt: Yeah,
[00:30:11] Lindsey Dinneen: Yeah. Excellent. How do you wish to be remembered after you leave this world?
[00:30:18] Isabella Schmitt: That's a big question. So, and it's a tough question. I want to have made an impact on the industry, on people's lives, on an industry because, you know, with AI, it could be multiple industries, I guess, too. Probably sticking closely with medtech. It's what I like, and it feels like the best again, like value kind of.
I think if I were to like make up this dream scenario of where I ended up, eventually I would have my own product company. I would sell that off. I would probably start another consulting company that I helped people with still. And then I would do like philanthropic things with money. And largely focused probably on pediatric type devices, rare diseases and conditions, and probably veterinary medicine, which those areas I don't think get enough attention.
I have a lot of experience with with pediatrics in particular and I think I would like to be able to work closely with getting more of those products to market. They're, you know, difficult funding opportunities there because such a small, still large burden, but such a small group of patients that the ROI is not typical of what you would see, you know, a lot of VCs investing in. So something like that, I think, and being remembered for those, those things, I think, would be great to me.
[00:31:50] Lindsey Dinneen: Yeah.
[00:31:51] Isabella Schmitt: Also, if I influenced policy in some kind of way that was fundamental, I think that would be pretty cool too.
[00:31:57] Lindsey Dinneen: Absolutely. Yeah. Very cool. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:32:06] Isabella Schmitt: Oh, that's a good question. Not work related or work related?
[00:32:10] Lindsey Dinneen: Oh, both, either.
[00:32:12] Isabella Schmitt: I, probably my dogs would be, that's an easy not work related answer, although sometimes they drive me nuts too. So there's a spectrum of emotion with them, but generally dogs. Dogs are just the best. I'm, I'm a dog person. They're just so loving and understanding.
Work wise, obviously, anytime I have a successful submission, or there's an exit, any success, it always makes me smile. So, and then, you know, I also really like-- I haven't been to many over the last year, just with the change and the dynamics of my world-- I love networking events. So, like, thinking about networking events, I just, I really enjoy those types of interactions. They've always been really fun. I've been thinking about going to them just for fun, just to see people again because it's been a while.
And I used to love, like, my favorite thing was Medtech Innovator. So I'm answering this question, and I'm thinking of the answers I'm talking about. So MedTech Innovator, I love MedTech Innovator. It was almost like when you're a kid, and you go, and you have the summer off, and you don't see anybody or any of your friends, and then you go back to school, and you're sort of excited to see them again. That's what that community felt like, really to know the people there so well. So MedTech Innovator, that's my answer.
[00:33:35] Lindsey Dinneen: I love it. Great answer. Great answer. Fantastic. Well, oh my word, this has been so much fun. Thank you so much for taking some time today just to share with me about your life and your experience and all the wonderful things that you're bringing to the world. I just really appreciate it. And, just thank you for your time.
[00:33:56] Isabella Schmitt: 'Course, thanks for having me.
[00:33:58] Lindsey Dinneen: Yeah, and we are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support, and I just wish you the most continued success as you continue to work to change lives for a better world. And just also thanks 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.
[00:34:36] 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.

Steven Collens | CEO, MATTER | Accelerating Medtech Innovation with Collaboration & Entrepreneur Ecosystems

Steven Collens, CEO of MATTER, an incubator & innovation hub, discusses his journey and the impactful work MATTER does in healthcare innovation. Steven shares his transition from Abbott Labs and Capitol Hill to leading MATTER, emphasizing the importance of collaboration in accelerating healthcare advancements. He provides insights on how MATTER supports both startups and large companies and also reflects on personal moments that confirm his career path and the strengths that help him lead in the industry.
Guest links: https://matter.health  
Charity supported: Innovation Development Institute
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 047 - Steven Collens
[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 introduce you to my guest, Steven Collens. Steven is the CEO of MATTER, the premier healthcare incubator and innovation hub. MATTER opened in February 2015 and nurtures entrepreneurs and innovators building next generation health IT, medical device, diagnostic, and biopharma technologies. MATTER has worked with more than a thousand healthcare technology ventures and the company partners with dozens of industry leading companies, health systems, and universities.
Steven holds an MBA from Northwestern University's Kellogg School of Management and a BA from Washington University in St. Louis. He chairs the board of Hubbard Street Dance Chicago and serves on the boards of 1871 and the Chicago High School for the Arts. He is a member of Chicago Next, the Chicago Mayor's Council of Technology and Innovation, a Leadership Greater Chicago Fellow, and a member of the Economic Club of Chicago and the Commercial Club of Chicago.
Well, thank you so much for joining us, Steven. I'm so excited to be here talking with you today.
[00:01:57] Steven Collens: It's a pleasure to be here. Thanks for having me.
[00:01:59] Lindsey Dinneen: Of course! Well, I would love if you would start off by sharing a little bit about yourself, your background, and maybe what led you to MedTech.
[00:02:09] Steven Collens: So myself, I guess it's all intertwined together, so after business school, I went to work at Abbott and I was at Abbott labs for about 10 years. That was my introduction into healthcare and medical technologies of any sort. And after that, I went to work at an investment firm. On behalf of them, started an incubator that was not focused on healthcare, and then had the opportunity to do what ultimately became MATTER, which was starting something that could really help accelerate the pace of change of healthcare and figuring out how to combine elements and do that.
And our basic thesis at MATTER is that collaboration is the way to accelerate the pace of change of health care. And so MATTER is structured as a not for profit entity. We functionally incubate startup companies. They are different types of technology. It's primarily software and devices. They're all over the world. It's a membership model and we've got a suite of resources to help them at different stages of growth.
And then on the other side of it, we work with big companies, so big life sciences companies, health systems, insurance companies, and we help them innovate more effectively. We help them collaborate with entrepreneurs. We help them harness innovation in ways that they're otherwise not necessarily wired to do. And by putting all of that together you know, almost 10 years in, we like to think and certainly hope that we're helping make a change in healthcare.
[00:03:40] Lindsey Dinneen: Yeah, I know you are and I know that by your mission and the way that you go about your organization, and it's very exciting to see how the companies that have come through the program have continued to thrive. And I was wondering if any of those, particularly companies that you've worked with, really stand out to you in terms of making a huge difference in the way that you could come alongside them and work with them to make that difference.
[00:04:09] Steven Collens: Yes, for sure. There are companies where people come in and they come from the healthcare industry and they know a lot, and the ways that we help them are different than companies where the entrepreneurs come in and they're not necessarily from the industry. And we love working with all of them. We will work with entrepreneurs, but we don't have anywhere near the level of screening that a venture capital firm would do, where it's a more of a democratized approach. We look for companies that are trying to solve something that's meaningful in healthcare. So if they are successful, they will help advance healthcare in a direction that's meaningful.
We look for entrepreneurs and teams that give us some reason to believe they can be successful. Could be prior success, it could be that we're just so impressed by how smart they are. It could be their passion. It could be some combination of a variety of things. It could be somebody else has invested in them already. And like, "Well, we know they did a lot of diligence." And then the only other criteria is like people we want to work with and be around and that are going to increase the general level of joy and happiness in our environment.
And so, there's one guy who met his co founder at MATTER. He's more of the business guy. The co founder was more of the inventor, scientist guy and, you know, it's an example of a company that's solving one of these problems that if you're not in healthcare, you just sort of scratch your head as to, which in healthcare, there's like an endless number of these problems where if you look at it with a more rational lens or from an outside perspective, you're like, "Huh, that's how healthcare works? I don't, that's so strange."
It's a device for when a surgeon is putting screws into a bone, the way that they need like a, some sort of a depth gauge to determine what size screw to use. And it's like a reusable thing that they all use. It's totally analog. It's not a sophisticated piece of technology. They learn how to use it when they're doing their training and they just keep using it. And obviously they wash it and sterilize it, but you know, it's not ideal for a lot of reasons.
And so this company developed a digital and disposable version that is more accurate, more sanitary, obviously, you know, we don't always want to advocate for things that are disposable versus reusable, but in this case, having this combination of accuracy and not dealing with any issues around sterilization and cleanliness, is a big improvement.
And, it's a medical device, took a couple of years to develop. Again, he met his co founder at MATTER. He met a lot of other people who provided different guidance and advice and support and financing through MATTER. And so now the products in market and doing great, and they're working on other other products. So that's one of the companies that, that pops to mind. I mean, I, we could use up the entire time talking about different companies, but I'll pause there.
[00:07:27] Lindsey Dinneen: Yeah, I'm sure that we could. So, at the beginning, you talked about collaboration and how that can be the key to success for these companies that you're working with. And I'm wondering, I feel very strongly that collaboration is the key in so many ways to amplify success, and even to get to a point of success, because we don't know everything ourselves, but how do you get past-- and or help up maybe some of the companies that you work with-- get past sometimes a more competitive mindset where it's hard because you're very protective of your IP, you're very protective of your process and your business. So how do you help companies understand the value of collaboration and what we can do together to rise together?
[00:08:11] Steven Collens: I think it's such an interesting question, and I'll take you all the way back to when we first were creating MATTER. And so I had just recently built this other incubator, not focused on healthcare, more like web mobile tech stuff at the time. And I was working with the same architecture firm and real estate people. And one of the things that we were trying to figure out, because we knew it needed to be different, for that because healthcare is different. It's a different set of people. It's different archetypes. In some cases, it's even different motivations. It's just, it's a different milieu.
And one of the things that we spent a lot of time trying to figure out was, IP is so much more important when you're dealing with medtech as compared to your average software company, which is more about speed of execution. And I mean, it's about a lot of things, but it's, in the early days of most software companies, IP isn't top of mind. Whereas in the early days of most medtech companies, IP is top of mind. And how is that going to work? Are people going to be collaborative?
And so we spent a lot of time, we talked to lots of people, tried to figure out how to deal, it turns out it like doesn't even matter. For 95 percent of the entrepreneurs out there, obviously they care about their IP, but there's collaboration in two veins. One is, other entrepreneurs are not doing the exact same thing. They're almost never directly competitive. Knock on wood, we've supported a thousand companies who've been around for 10 years, and we have not had one entrepreneur steal another entrepreneur's technology and try to run with it. God forbid that we land in that stage.
The more complicated question is in dealing with the large players in the industry. And so on that dimension, some of the entrepreneurs are reasonably a little bit careful. Our basic thesis is that if you are building a new technology that you're trying to put into the healthcare system, you need to know more than you probably think that you need to know about how that system works, how things get paid for workflow solutions, decision making processes. It's just, there's so many areas of healthcare. Even if you've been in healthcare, unless you're just exactly in the space that you know inside out and backwards and forwards, there are so many areas and aspects of healthcare that are not intuitive, that frankly, if you were coming up with a design system, you'd never design something that way, because this doesn't make a lot of sense. But that's how it works. And you need to understand all of that if you're an entrepreneur in order to be successful.
And so, one of the ways that we help with that, we've got lots of mentors and executives and residents and folks, but we also have lots of relationships across the industry with payers and with providers and with medtech companies and pharma companies and software companies, big ones. And they are immense sources of knowledge and resources and understanding. We have actually had one case where a large company met with one of our startups that was not really a medtech company. It was not a regulated device and they didn't have any IP. Just had an idea, they had a prototype of it, and the company basically went and did it on their own and it was really quite disappointing. And so we did not bring them back for anything. And, that was disappointing. So far, it's a one in 1000 events and that still more than we want to have, and hopefully we won't have that again.
And we spend a lot of time with these large companies, and for the most part, they understand what the dynamic is, and they come and work with us for multiple reasons. One of those reasons is that generally large companies cannot innovate as fast as technology is evolving. And so if they want to capitalize on new and emerging developments, new and emerging technologies, one of the best ways to do that is find entrepreneurs to work with, maybe eventually by the company, it depends on the dynamics could be, you make an investment, could be you just collaborate, could be you buy it. I mean, there's all sorts of different structures, but that is a tried and true way of accelerating innovation within a large company to advance goals.
The challenge is that large companies don't necessarily know how to find the right entrepreneurs. Once they find them, they don't necessarily know which ones to work with. It's not as straightforward as picking Deloitte or Accenture or something with a massive track record. And so it's more complicated than that. And then once they do decide to work with one, working with an early stage startup is a very different experience than working with a very large company. And a lot of large companies just aren't very good at that. And so that's, we help them. And again, 99. 9 percent of the time so far, it's been successful.
[00:13:39] Lindsey Dinneen: Yeah. Well, thank you for sharing about that and your philosophy behind it. And also, I appreciate you being willing to share that one story because it's, you know, even though of course we wish that would not happen and never did happen, but the idea that you can still be successful in collaboration and there's still so much opportunity for mutual growth and learning. And yeah, you might have the bad actor every once in a while, but for the most part, to your point, 99. 9 percent of people really have that spirit of collaboration, which is great. So now you come into MedTech from a different background than some other folks. And so I was wondering if you might share a little bit about your early career and how that actually helps you now, because those skills I'm sure translate a little bit, but I would just be curious to know a little bit more about how that has played into your career.
[00:14:35] Steven Collens: Yeah, well, my early career, so I in college, I studied political science and French literature, like the farthest thing from, I walk by the engineering building and be like, "I don't, I have no idea what's going on in there. I'm going to go back to my French literature class where I feel comfortable." And then I went to work on Capitol Hill. So I, I was an aide to a Senator for almost six years. Spent most of that time working on education policy and transportation policy, loved it, but sort of looked around at a certain point and there weren't a lot of people where I, I looked and I said, " In 20 years, I want to be like that."
And it wasn't obvious to me what my longer term trajectory is. I didn't have the faintest idea what I wanted my longer term trajectory to be. So, you know, I sort of, tried and true strategy went to grad school. So that's when I went to business school and I ended up at Abbott because, when I came out of business school Abbott at the time had a kidney business, a renal business, and they made a drug for dialysis patients. At the time it was a 300 million or so product and Medicare, and this was a long time ago, the structure of how dialysis treatments get paid, get are paid for as different now than it was then. But at the time, this drug had was in the process of replacing a generic version, which Abbott also sold and it had been engineered and tweaked in a way that ultimately some researchers at Harvard that we had nothing to do with showed that it had a survival benefit compared to the old one.
But before we, before they showed up on our doorstep with this New England Journal of Medicine study that they were, it hadn't been published yet, but they said, "Hey, just FYI. We're, we've done this massive analysis and the New England Journal of Medicine is going to be publishing it and your drug prolongs life and there's a survival benefit based on all these." And we're like, "We thought that, but thank you for proving it."
Before that, Medicare looked at these two drugs and they said, "These are basically the same thing. One of them is way more expensive than the generic one. And we want doctors to stop prescribing that because we don't see the evidence." And, you know, obviously we believed in our own data and we showed it, but they did whatever analysis they did and they came to a different conclusion. And so they were trying out these different tools that they've never used before, because Medicare doesn't have the right, the ability today, and certainly not back then even less, but not today, to dictate what doctors can use and what they can't use. And they were trying out these new tools to effectively get around that and force doctors to use the generic. And so the business unit within Abbott was looking for a couple of people who had a mix of business and an understanding of politics and policy and how Washington works, and so I joined that team and focused for the first year and a half or two years on trying to solve this problem that Medicare was trying to essentially put this business out of business.
And then after we've solved that, I had a more traditional marketing job and then I kind of moved around within the company. Some of those jobs I had within the company are directly tied back to the experience I had in Washington. So I wouldn't have gotten that job, first of all, had I not had that Washington experience. After my sort of stint as a normal product marketer I went and wrote speeches for the CEO, which I was only qualified to do because I'd written a thousand speeches when I was in Washington. And so that moved me then into sort of a role around messaging and communications for the company, which I was in for a while in different roles.
Fast forward, when I left Abbott, I went and I joined this investment firm. I was effectively the chief of staff to the to the guy who was running or one of the two guys who was running the firm. I certainly wouldn't have, without that foundation from what I learned in DC, which was partly about messaging and communications and policy and things like that, but also it was a really strong foundation in two other things. One of just understanding how the world works and how people and groups interact with each other to advance their goals and how that happens. And also how to mobilize other people and organizations to help accomplish one's goals.
And so that was part of what fed into me getting that job at the investment firm. Building MATTER, and even the incubator before, I approached as very much a listening exercise to the community. Now I would say it was very much following a design thinking or a lean startup or those sorts of things where it's, we'd come up with some ideas and then go bounce it off the market and see what entrepreneurs or other stakeholders wanted. And they don't call it that in politics, but I certainly learned how to do that on Capitol Hill, because in order to get anything done, you need a lot of different stakeholders to both be bought into what you're doing. In some cases, you need them to think it's their idea. And so, so certainly that was very helpful and continues to be really helpful in building and then operating and running MATTER.
[00:20:33] Lindsey Dinneen: Yeah. Yeah. Well, thank you for sharing a little bit more about your background and how it has actually aided you getting a few different of the roles that you've had. I think there's always, if you look back, maybe some purpose to the meandering that sometimes happens where you go, "Oh, okay, here I am in MedTech!" And maybe didn't expect it, but I love how it worked out. So are there any moments that stand out to you as confirming along your career, maybe especially with MATTER, but even beforehand, as confirming that "I am in the right place at the right time in the right industry?"
[00:21:13] Steven Collens: Yes. I mean, there's so many. When I left the firm to, and then was starting MATTER, I assumed I would do this for two or three years. I kind of get it up and running and everything. And then I go do something different. I'm still here, just about 10 years later, which sounds to me like a really long time. And I, so I think about, and I have for probably the last five or six years, regularly think about, "Is this really what I want to be doing?" I've been doing this for a long time and, is this really the direction I want to go? And so there's a lot of things that, that keep me engaged and enthusiastic about what I'm doing.
So one of those is, it's probably hyperbolic to say every day, but every week, the kinds of people I get to work with and the kinds of things that they are thinking about and trying to solve, I find very energizing. I love working with entrepreneurs. They, for the most part, are people where their passions are aligned very closely with what it is that they're doing and building. If you want to build a successful startup, you have to be all in. You have to just be passionate about it and committed to it and dedicated to it. And you're giving a part of your life to building this thing and this company. I find that archetype just really energizing to be around, and to be able to help folks like that, I find endlessly enjoyable and and satisfying.
And on the other side of what we do, the people within these large companies that we work with are, almost by definition, trying to push the company in ways that it's not already going. They're trying to push boundaries. They're trying to change things because they are driven by this mission. It's much easier if you're in a big company to just go with the flow. And a lot of people do that. And you need a lot of people to do that in a large company. The things that large companies do really well, they don't do really well because every single person in the company is trying to constantly push the boundaries and innovate and change things. The company couldn't work like that. But there's a subset of people who are trying to do that and they're trying to push harder. And they're trying to go in different directions and experiment and try things, and we get to help them. And I also find that endlessly engaging and interesting and rewarding.
A couple of years ago I did a-- I love personality tests and all these different kinds of things. And so I did one, it wasn't really a personality test, but it was a fairly detailed exercise of, "Are you in the right role in the right industry and are you doing the thing you should be doing?" And I went through this whole thing and what came back was a resounding "yes" that when you just, when you look at it in a whole bunch of different dimensions, this really fits. Is it the only thing that I could be doing that? Of course not. Would I be just as happy and in other roles? For sure. But I get a lot of satisfaction and joy from the work that we're able to do, from the team that I'm able to do it with, and the people that we're able to help.
[00:24:43] Lindsey Dinneen: Yeah. Yeah. That's incredible. Thank you for sharing about that. So pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach?
[00:25:03] Steven Collens: Wow. A million dollars to teach a class on anything I want. There's some interesting triangulation of of what I'm actually capable of doing, but I guess if I had a million dollars to do it, I could become a lot better at something. It's an interesting way of asking about passions and things like that. It would probably be something around hiking and outdoors and camping and functioning in nature, which is how I spend a lot of my free time.
But I'd also would love to teach a masterclass on healthcare innovation and healthcare technology. I think more people would probably benefit from that than a class on hiking. But I like to think that I've learned a lot over the last 10 years about what makes healthcare innovations go farther, go faster and be successful, even if they're coming from different lenses. They're coming from large companies, if they're coming from entrepreneurs, if they're coming... and our healthcare system just needs an endless amount of innovation and technological advancement and, you name it, it needs everything. And so if I could impart some of what I hope I've learned over the last 10 years doing this, plus 10 years at Abbott labs and other things, but I would love to do that. And it would probably be more useful than a class on the outdoors.
[00:26:36] Lindsey Dinneen: Okay, well I think both sound like good classes, so we can do both. It can be a yes and!
[00:26:42] Steven Collens: Excellent.
[00:26:43] Lindsey Dinneen: Alright, and how do you wish to be remembered after you leave this world?
[00:26:48] Steven Collens: You know, I'm not a religious person, but one of the 613 rules in the Old Testament is basically like a catch all for other things, but if you take aside from all of the prescriptive, very specific ones, there's one that is just, "be holy." And the point of it is that, in this case, God, writes all of these rules about how people are supposed to act in order to create a functioning society. But the people will always get around that if given the opportunity. It doesn't matter how many rules you have. It doesn't matter how prescriptive they are. People have the innate ability, and a lot of people will, figure out work arounds and ways to get around it.
And so this one is supposed to be the catch all for that. Again, I'm not a religious scholar. I'm not even religious, but this is my understanding, and I love this as a concept. And so by being holy, you're supposed to think about what is the intention of all of the different rules or the rules that are tangential or this, what am I trying to accomplish? And is my behavior and action going to contribute to the kind of world that I think that I want to live in. And so, I would love to be remembered for somebody who is acting that way. And that's hopefully people see that or look back, the kinds of decisions I've made, the kinds of things I've done, the kinds of actions I've taken, and see it as a form of being holy in that sense.
[00:28:44] Lindsey Dinneen: I love that. That's a very thoughtful answer. Thank you for expounding on that too. I really appreciate that. And final question, what is one thing that makes you smile every time you see or think about it?
[00:28:58] Steven Collens: I mean, every time is a challenge. Most of the time, our six year old kid. Probably dog, most of the time, maybe even... the dog's a lot less complicated than the six year old. And so the level of feelings are not as quite as depth, but also it's a more of a pure, she's just a sweet, lovable dog. So maybe it's the dog.
[00:29:25] Lindsey Dinneen: I love it. Dogs are wonderful.
[00:29:28] Steven Collens: I don't mean to say that I love the dog more than the kid. It's just very specifically your question about.
[00:29:35] Lindsey Dinneen: it is specific.
[00:29:37] Steven Collens: Yeah.
[00:29:38] Lindsey Dinneen: I love that. I love that. Great answer. Well, I just really appreciate your time today. Thank you so much for joining me. Thank you for sharing about your background, your career, MATTER and how you are encouraging people to do things that matter. I really appreciate the way that you have this collaborative spirit and are helping to propel these companies to success. So thank you for all of the work you're doing. Thank you for joining me. And we just wish you the most continued success as you work to change lives for a better world.
[00:30:10] Steven Collens: Well, and thank you so much for having me. It's been a pleasure.
[00:30:13] Lindsey Dinneen: Excellent. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I would love it if you would share this episode with a colleague or two, and we will catch you next time.
[00:30:28] 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.

Justin Bantuelle & Michael Roberts | COO & CMO, Health Connective | Improving Patient Outcomes & Streamlining Processes

Justin Bantuelle (COO) and Michael Roberts (CMO) of Health Connective discuss the company's role in supporting medtech firms by developing custom web applications for surgical planning, post-operative reviews, and other solutions. Justin and Michael share their personal journeys into medtech, highlighting the rewarding experience of contributing to life-saving technologies. The conversation touches on common challenges in medtech like security and user experience, emphasizing the importance of empathy, active listening, and adaptability in solving complex problems. 
 
Guest links: https://www.healthconnectivetech.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: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPTEpisode 046 - Justin Bantuelle & Michael Roberts
[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.
 Welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I'm so excited to introduce you to my guests today. Justin Bantuelle and Michael Roberts. Justin is the Chief Operations Officer and Michael is the Chief Marketing Officer for Health Connective. Both have been working with the company for more than 10 years. Health Connective supports web application development for medtech companies, including online interfaces for pre surgical planning and post operative review, streamlined systems for customer orders, and training portals. They understand that every company's needs are unique, and your solution should be too.
Well, welcome, Justin and Michael. I am so excited to have you guys today. Thanks for joining me.
[00:01:35] Justin Bantuelle: Yeah. Thank you for having us.
[00:01:36] Michael Roberts: Very excited to be here. Thank you.
[00:01:38] Lindsey Dinneen: Awesome. Awesome. Well, I would love if you wouldn't mind starting off by just sharing a little bit about your background, maybe what led you to medtech and your heart for it. So I'll start with you, Justin.
[00:01:51] Justin Bantuelle: Sure. It was, I kind of fell into it, I guess, initially, which I think on the tech side, probably a lot of people end up doing that. I had a computer science background. I got my bachelor's degree and I started at the company we're at now, Health Connective, out of college. And I've been there for 16, 17 years or something, but we were healthcare focused. And so they needed web development skills. I was a programmer, and that's how I started, but I've learned a tremendous amount since then. So I think coming from that technical angle, this is like where I fell into it. And I've moved up to the company. I manage a lot of people. I manage a lot of client interactions, help build systems that support medical devices, robots, things like that. So I've gathered a tremendous amount of information about this field as a result of that.
And I've stuck with it cause it has been very rewarding. It's something that matters so much to so many people. You see the real Impact that it makes when you help get these products to market. And you see all the research studies that show how much this is transforming these different fields of care. And then just, I think we all have personal experiences with these healthcare systems and the challenges people face, the uncertainties about it. Just talking to like my parents or to friends who know less about the sector and just that I have any kind of insight into it helps assuage fears. And yeah, it just, it matters. And that's very rewarding.
[00:03:18] Lindsey Dinneen: Yeah, absolutely. Thank you.
[00:03:20] Michael Roberts: Yeah. I did not set out necessarily to be in medtech as well. Like Justin, long story short, when I got into marketing, I was working more in the hospitality industry, hotels, restaurants, all that kind of stuff. Decided I didn't want to do that anymore and thought, "Where can I get as far away from the hospitality industry as possible?" And so, the funny thing there was some non compete things that I had to deal with from my previous employer. And so I was literally looking for a place that had no overlap with the previous company that I'd worked with as a marketer.
And so I found the company, found Health Connective, and jumped into it and try to bring in the same skill sets. I'll just do some of the SEO and I'll do some digital advertising and some of that kind of stuff. And some of that worked and some of it was just so drastically different, right? Like this is such a different experience for people.
So my first thing that I worked on here at the company was working with orthopedic physicians, helping them out with their marketing. And it was very similar in small business marketing in a lot of ways, but again, drastically different in so many ways. And then one of the first things that I ended up working on within the first few years was working with Olympus on a campaign that they were doing about raising awareness around gastroenterology around going to get your colon checked and all of that fun kind of stuff.
 I have a family member that has a Crohn's disease. And so this was something that very quickly became like, "Oh, this is a part of what we're all experiencing." I was able to go and ask people questions at Olympus. We went to Digestive Disease Week, which I had no idea was a thing, went there and I got to meet with the Crohn's and Colitis Foundation, just purely as a dad. Being there and just going like, "Can you just tell me how to help my daughter, how to help understand it?"
So that was kind of the thing that really clicked, "This is where I need to be. This is what I need to be doing." Because so many of us are experiencing something like this somewhere in our family, whether it's us as patients, family members, whomever. So that was kind of the big click moment for me.
[00:05:20] Lindsey Dinneen: Awesome. Wow. Yeah, that's powerful. Thank you for sharing that. So could you tell us a little bit about the company and maybe also a little bit about your goals as it continues to grow.?
[00:05:33] Michael Roberts: Yeah, so, you know, we, as a company, we're out there to help MedTech companies with a couple of different kinds of things. So we end up helping the product and sort of R&D side of things. And that may be with robotic devices, if there's different types of data coming off of the device that they want to be able to show back to the different physicians, the different people that are involved with the procedure, that's the type of work that we do.
And I'm super glossing that over and saying that very quickly, but there's a lot of different people that we share this information with that comes off the robot, everybody from physicians to engineers, to field service teams, all those different kinds of folks. And the goal there is just, "Hey, you're obtaining an immense amount of data out of every single procedure. What can you do with that data? How can we help you better utilize that information and improve outcomes and do all those kinds of things?" so that kind of product development and like I said, R&D side of things that's kind of where we fit.
And then on the marketing side I, I kind of refer to it as like the, "Wouldn't it be cool if?" kind of group. It's like, "Wouldn't it be cool if this process that we had didn't suck? That would be awesome. How could we get somebody to help us with that?" So anything from ordering online kinds of processes where, because it's not as simple as just setting up an e commerce solution and just letting it run, you have to have different pricing for every sector and you have to have different contracts with everybody and all of those kinds of things. We can marry a lot of that messy data and make it a seamless experience for people so it doesn't suck.
And so that's what we're hoping for. And then also like, "Wouldn't it be cool if these things could be that much better?" So a lot of efficiencies, a lot of things where again, these systems don't natively talk to one another. How can I get my CRM and all of these other unique data sources that I have to actually cooperate with one another. So, that's the kind of stuff that we set out to do. Again, I'm saying it super simply as opposed to how Justin would be able to define it. But, but those are the things that we're setting out to do for people is improve that customer experience and then get better data coming back from their procedures, that sort of thing.
[00:07:41] Lindsey Dinneen: Yeah. Well, I would love to dive a little bit more into what does it look like when somebody starts working with you? How do you go from, you know, taking them through lead all the way to your day to day? What does that look like?
[00:07:57] Michael Roberts: Yeah, I'll start the conversation. And then Justin, 'cause Justin takes over at a certain point and I just go, "Hey, let me know if you need anything." But a lot of it is, these kinds of things are very trust driven, right? So we have a lot of messaging out there. We have a podcast, we have advertising that we're doing, we're going to be at a few different trade shows through the rest of 2024, figuring out which ones to be at for next year, but a lot of it does come down to relationships. So somebody has introduced us.
We've started having those kinds of conversations because any of these kinds of things that you're talking about there, there's kind of big, messy problems that aren't easy to fix. They aren't something that you just sign off on quickly that's a 5, 000 a month subscription and off you go. It's a bigger, more thought out process. So a lot of it is that sort of process of, "Hey, let's get to know one another. And then really digging into what problem are you trying to solve?" Everything that we do is a custom solution. So it's not, you don't have to use XYZ systems in order for us to work with you. We can be very flexible on that, but then, so we really get into that kind of problem definition stage, and then Justin, I'll let you kind of take it from there once we get into the problem itself.
[00:09:05] Justin Bantuelle: Sure. Yeah. I mean, the initial touch point with it is really just listening and reassuring that, "I've heard your problem before something similar to it. Okay, you have these different technologies. These are the things that are unique about what you're trying to do in this space. And here's how I can craft a solution for you." So it's a lot of listening, helping them along the process of requirements gathering, usually this part of it, this front end data visualization after the fact for a lot of medical device, I find that's not their core competency. Their core competency is the device itself. They've built the device. The device works very well. It achieves something and it solves a problem in the medical space, but then there's all this stuff you have to do after the fact. And so it's like, "Great, this work, the procedure is amazing. And now there's all these things that we need to take action with," and that's where we kind of step in and provide that end of it.
And we augment their teams that they already have. They have several very technical people. They've got brilliant engineers, they probably got brilliant developers involved in a lot of the software written around the device itself. And that's where we understand what their needs are, solutions are, their implementations where there's gaps. And then we help shape that for them and make sure it matches what they need. Yeah, like Michael said, never any one size fits all. It's always very customized. And that's where we shine is helping just lead them through that. They don't need to micromanage it. They're not just hiring a handful of developers and needing to tell them what to do. It's like, we take it kind of from, "You articulated the problem. We'll fully craft and implement a solution for you and then work alongside you for assessing how that works, how much it's solving your problems, what emergent needs are there, what maybe needs iteration."
So we also view this as long term engagements typically, and we find that's what works well for our customers as well. Usually you're not just building something and then just abandoning it. Hopefully this goes for years and years as a successful product that you continue to iterate on, improve in the field, and then you necessarily need these other systems to work alongside it. So, I find that a lot of people have a bit of a fear that. We'll build something for you and then kick it over the wall, and then now your team has to manage it. Good luck. And I don't like operating that way. I enjoy continuing to see the success of something I build. I like standing by what we have built. And so that's kind of our outlook on it, I guess, and how we try to assist people a little bit on the side, I guess, maybe, but hopefully that made sense.
[00:11:37] Lindsey Dinneen: Yes. No, that's incredible. Thank you so much. So, you know, I know you said that one of the strengths that your company brings is having this flexibility, being able to, like you said, be very customized with your approach to different companies and really help them because no problem is exactly the same. But I am curious, have you come across some themes that are a little bit common, especially in the medtech industry, that perhaps folks who are in the process of developing something could be aware of. What are some of the things that you commonly see that your company could help or they should be thinking through.
[00:12:15] Justin Bantuelle: I think that security is a big one that tends to get overlooked until the project is finished. And then you're going through some final regulatory steps and the security team comes in and assesses it and goes, "You didn't think about any of this." And now you're re architecting like half of what you built. I think that's probably the biggest pain point I see. There's like a major gap in looking at that. And it's important everywhere, but a lot of fields aren't as highly regulated, so they get away with not sweating it as much until it bites them. Whereas you can't really do that here. You're not launching if you didn't put these considerations in place.
And that's something that I think it's more unique to a handful of sectors where, and medtech is one of them, where you're really hurting yourself if that's not at the forefront of your mind. And so somebody who's not used to those considerations is probably not going to build you the right thing up front. And you're maybe not knowing how to articulate for this part of what's being built as a client that "No, you really need to think about this. We're going to be doing this as part of the process afterwards." Usually it's a completely separate team and it's all part of the documentation, filing it, getting it all in right at the end. And that's a terrible time to find out that you should've thought about something. So that's the biggest one that comes to mind up front.
[00:13:37] Michael Roberts: Yeah, I can jump in as well. I think one of the big things that we don't see a lot of medtech companies do that, that we ended up helping, right? If they had this right, they probably wouldn't need our help as much with it. But one of the things is that I think that, because this is such a complicated industry, everybody kind of gets used to sort of a cruddy experience. You know, it's like, "Well, man, this system is really slow, but you know, it's okay. It's just an internal tool." Or, you know, "Just the physicians are using this one so it's not as bad. We can make it too complex, too messy to whatever." And everybody just seems to say like, "Ah, well, that's good enough."
And I think that, one of the things I've been surprised by that people aren't considering more, is just how much we are all acclimating to an Amazon experience, to all of these kinds of things where we just expect it to work. And then as more and more of these AI systems catch on and we get used to being able to just talk to the systems and they just do what we want them to do, I think that that frustration is going to get more and more apparent even on systems that have nothing to do with AI, even if they never touch it. We're just getting used to faster and faster systems that intuitively work. And there are so, so many in medtech that don't across the board. And it's not just the stuff that we work with, but I think that there's a lot of pain points in that area.
[00:15:00] Justin Bantuelle: That's a really good point as well. Yeah. Yeah. I think most people are familiar at this point with Amazon being able to measure exactly how much money they lose per a 10th of a second longer the page loads, right. And you're right, Michael, that this platform isn't the, like what we're building, these visualizations, these like post procedural dashboards, things like that. Those aren't the product. Those are supplementing it. Those are where you're getting augmented value after the product has done a very good job performing a procedure.
And, so yeah, it's much more-- pretty much every system that physicians use in hospitals, like when you're on a computer in there, if you're a physician, if you're working the desk, whatever you're doing in there, those systems are often ancient, very slow, bad interfaces. And so I think Michael's right that a lot of companies sort of overlook that because they sort of assume this is the norm in this space. It's like, "No, we can do a lot better than that." And that's sort of baseline for us. And that's easy for me to forget that a lot of people are trying to cut corners on that front or not prioritizing that aspect of it. And you do see fall off in usage as a result of it. And yeah it's not something to be neglected.
[00:16:19] Lindsey Dinneen: Yeah. So just in general user experience and being able to help companies navigate that. And you know, actually, that goes back to what you were saying earlier, Michael, the idea of "wouldn't it be cool if," you know, so "wouldn't it be cool if this worked really well"...
[00:16:37] Michael Roberts: Right.
[00:16:38] Justin Bantuelle: Right.
[00:16:38] Lindsey Dinneen: ...instead of settling for, like you said, a cruddy experience. Maybe there's something else we could do. And I love that sort of "what if" idea, because it just opens you up to all these possibilities.
[00:16:50] Michael Roberts: Absolutely.
[00:16:50] Justin Bantuelle: There's some things that are sort of corollaries to that, where a lot of groups don't consider. A lot of developers, I find as part of the user experience, so much of that is there's accessibility considerations and how severe a look it is if you're borderline non compliant with ADA, when you're in the medical field, like that's embarrassing, right? And potentially outright illegal.
[00:17:16] Lindsey Dinneen: Right.
[00:17:17] Justin Bantuelle: And these things often also can get overlooked if you don't have somebody who's used to doing this in the space with the interfaces that they're building.
[00:17:25] Lindsey Dinneen: Yeah. That makes a lot of sense. Yeah. So I'm curious as you've worked with all these different companies and you've had very cool experiences, are there any moments that stand out to you as really confirming to you? Yes, I'm in the right place in the right industry at the right time.
[00:17:45] Michael Roberts: This is a big question. You know, it's interesting. We've been involved in a variety of different types of projects. And as we've talked about stuff going into COVID, you know, when we were prepping for that there was work that we were doing with physicians directly, the stuff that I was, that I started off doing at the company, we still do work with physicians directly. And then we do work with some of the companies that were involved at various stages of vaccine creation process and all that kind of stuff. And so as we were sitting home during COVID and everything's going down and everything's happening all around the world, it's like, "Well, hey, we're at least helping some of these groups navigate this process." We're at least helping out some of these institutions continue running, or helping them get their messaging out or helping them in one way or another.
We actually had a podcast previous to the one that we have now, and it was called The Paradigm Shift of Healthcare. And we named it that before COVID hit. We had no idea that was coming. It was just like, hey, consumers are more of a part of the healthcare process. People are making decisions more on their own and then everything changed about healthcare. And so, definitely made for some interesting conversations about, "Yeah, we had no idea that this is what was coming."
But I do think that going through that process, seeing the provider side of it, what they were dealing with, we dealt with a lot of orthopedic surgeons who had to close their practice during the worst of it, right, when everybody had no clue what was happening. So there was that process. It was a lot of getting communication out on their websites, getting information out that way as they were trying to figure out any kind of remote appointments that they might be able to do. Figuring out that for short term, helping them just get some of that information on their sites and everything. And then, yeah, like with working with the companies as they were going through all this mess and trying to figure out how to allocate resources and all that. So that was probably one of the big times I think of like, "Okay, again, we're in the right space, beyond just this is how it's impacting my family, but it's impacting all of our families right now."
[00:19:43] Lindsey Dinneen: Yeah. Thank you for sharing. Yeah. How about you, Justin?
[00:19:47] Justin Bantuelle: Yeah, I think I touched on this a little bit in the intro, but something that really stands out to me is working on supporting this robot. I didn't work on the robot itself, but obviously we're working on these systems that are ancillary and critical to the overall business operation of it. And it wasn't at market yet when we were coming in and assisting, and so seeing that process where it went through to market and seeing all of the studies that are continually coming out as they're performing this to submit to the FDA, and the actual tangible data showing the massive improvement in patient outcome and realizing that like, "Yeah, we're working on things that really are transformative for care."
I had no idea how bad the space was in terms of outcomes before this robot was coming in and how much it was going to make things better for patients. Seeing the actual, tangible impact that it was going to have and that it has have since coming to market was really remarkable and something that it was like really proud to be involved in some capacity. And it just made me that much more excited about continuing to support these groups as they're doing this.
[00:20:55] Lindsey Dinneen: Yeah.
[00:20:56] Justin Bantuelle: It matters. And seeing the numbers on it really drive it home for me.
[00:21:00] Lindsey Dinneen: Yeah. Yeah, absolutely. Both of you have said at various points, things like "it matters," like "matters" has been like a big theme so far. And I think there is so much to that. But I am curious to dial a little bit more into it because, obviously, work in general matters. There's ways that you can make an impact in any field, but what drives you when it's a particularly difficult problem, or frankly, or a difficult client where it's a little bit challenging to maybe see eye to eye. So what continues to motivate and drive you to this work that you know matters so much?
[00:21:41] Justin Bantuelle: I think, for me, it's wild to see that some of this is actually life and death. I never worked on something where like, and even some of what I'd done within medical device was just quality of life, which matters a lot too. But then some of this is about like diagnostics where a delayed outcome, a delayed assessment of the diagnostic and a misdiagnosis due to challenges with diagnostics, these things could be the difference if somebody survives or not, or like how quickly it gets them into treatment. So that's a weightiness that I never dealt with before prior to this. And so that was different than any jobs I had before where, I mean, I cared about things in like retail, but it's still, hopefully nobody's dying as a result of anything if they don't get the right thing.
So there was a weightiness to that, that I guess carries a commensurate responsibility on the same side, is there anything to talk about what keeps me going with it. For me, I don't find myself necessarily pushing through. I don't find client engagement to be that challenging. I find that everybody does care, but miscommunication can happen, but I try not to center myself in any of that. And I find that giving others the benefit of the doubt as well on that usually leads to a pretty comfortable resolution. I'm there to help solve their problem. I'm not there to win an argument or be right on the direction we take, and I've definitely recommended pathways before from a technical standpoint and they just disagree or overrule and I don't think that's necessarily the best pathway, but I defer to their judgment on what they want in this field. And we're still working towards an end goal. If I ever feel like what we're doing is not helpful, then I don't want to take their money and build something that's they're going to be unhappy with.
So, yeah, that, that part of it, I don't really necessarily personally experienced or feel that much, but it does help me just for from a personal motivation standpoint to see the outcomes on this. I don't think you always necessarily get to see that information. Some of our prior retail jobs, I don't know how happy somebody is with something once they go home with it, like unless they're coming in to return it, right? But here, it's not so much about the customer satisfaction the same way. There's very measurable. Improvements to treatment, diagnostic outcome. These things are very measurable, so you can see the results of it. And it's nice to see that you're achieving something with this, that you can
[00:24:16] Lindsey Dinneen: Yeah.
[00:24:17] Justin Bantuelle: estimate and keep with you as opposed to just hoping that it it's impacting somebody positively.
[00:24:22] Lindsey Dinneen: Oh, yeah. Excellent. Do you have anything to add to that, Michael?
[00:24:26] Michael Roberts: Yeah, I'll just quickly touch on-- so I actually came from a ministry background, from a faith background. And so part of, I guess my heritage in that field is this idea of service and this idea of trying to better people's lives in some way. And the concept of, when I started working with the physicians directly and still kind of applies with medtech companies same way is like, in my mind, I frame it as helping the people who help people. You know, really helping equip them so that they don't have to worry about that. They can go do their job. They can focus on the serving that they're doing.
I don't enjoy being the frontline person. So, when I was working for churches and stuff like that, I did some stuff where, you know, I did a mission trip and we built a house in Mexico and you see that like, "Man, this makes such an impact." But it's exhausting and it's hot and it's really tough to do. And, "Wow, what if I could help equip people that are going to be in those kinds of areas?" I could never work in a hospital. I could never be that person. I don't have that mental fortitude. I don't have that emotional fortitude to do that every day. But if we can help make that process easier, I can deal with a lot of stuff in the meantime to help that part, you know, and let them do their job well. So that's the framework that I kind of bring to it.
[00:25:45] Lindsey Dinneen: Oh, I love that. Yeah. Thank you both. Well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want-- could be in your industry, doesn't have to be. What would you choose to teach and why?
[00:26:03] Justin Bantuelle: Yeah, okay. It's kind of similar to what or it's related to what we just talked about those frustrations of the customer. I'd really want probably to teach something along the lines of empathy and listening, like active listening. I feel like so many of the problems that I see in the workspaces and personal exchanges boils down to a form of miscommunication and boils down largely to making bad assumptions about what the other person is thinking or feeling. And I find that you can alleviate a lot of that. And I think it's just being able to really put yourself in their shoes, understand their motivations, understand what their pain points are, what they're trying to achieve. I've seen people butt heads just so many times and often felt it was unnecessary. They're not, neither of them's wrong about anything, but I think they kind of lose sight of the common goal that they share.
And I've often helped my own employees who maybe feel like they're getting antagonized and help them reframe like what's going on and why it's not about them. It's not a personal attack kind of thing. I've seen Issues with clients where two different departments are having an issue. And I have less control over helping ameliorate that, but maybe sometimes helping to talk through it and just bring an outside perspective on it. Just with friends, family that struggle, often I find that advice to try to take a step back and reframe what's going on and think about that. I think there's a lot of techniques that, and it makes your life better, right?
You're not getting the outcome you want if you're in conflict with somebody else and that's something that I think is one of the most unnecessary friction points often in a work environment or in a personal environment that I really try to put at the forefront of my mind when I see something kind of going wrong or when I'm experiencing something where I feel like I'm not getting my point across or somebody is not really understanding. And there's probably something going on their side where I'm not communicating well myself and taking that step back and understanding what's happening. Just, I feel it makes a big difference in the outcomes for everybody.
[00:28:25] Lindsey Dinneen: I, and I really appreciate that perspective. It goes back to something you said earlier too. It's kind of, you know, you're on your client's team. It is you all against the problem. It's not you against each other. And it should never be. So trying to always remember that, or even in a work situation where it's maybe colleague to colleague, again, you're on the same team. So how do we go us against the problem rather than us against each other? So I really appreciate that perspective.
[00:28:54] Justin Bantuelle: Yeah, I think, yeah, I find that it's not that frequent that somebody's actually acting in bad faith. It's not that it doesn't happen, but I think it happens a lot less than we may be assumed. I do think that how much of our communications now are via text instead of verbally where you can hear tone a little bit more, I think it becomes a little easier to misread something and that can help contribute to the miscommunication that can then boil over into something. So yeah, it's a challenge probably we all face. I certainly like for all that I care about this and I'm talking about it, it's a challenge I face as well, but I think that awareness kind of helps to check yourself and reevaluate and maybe change how you're communicating that.
[00:29:42] Lindsey Dinneen: Yeah. Amen to that. Michael, what would you teach?
[00:29:46] Michael Roberts: I should have gone first. That was, that's like sets the bar so high. I think that the thing that I would try to teach is focusing on learning different types of skillsets that you've had before. I think that the next 10 years, we're just going to consistently see that need for everybody to keep reshaping how we interact with our work world with just the world in general. There's just so much that's changing and happening right now. And so I see this some for just basic literacy of the world that we're going to need this.
But also, you know, I had to transition from one job to another. I started out in ministry and it was not for me and I needed to do something else. And it was hard. It was a good long while before I found the right fit and skilled up enough in that area for it to work. And so bought myself a book on HTML, code your first site in 30 days kind of thing. And did that and figured out how to put together a very crude website. It was just not great, but it worked. And but that kind of stuff, you know, what's possible today for people to keep on learning, to be able to shift from career path to career path.
And then knowing how much you actually do bring with you because you very much feel out of your depth in so many ways. And I felt out of my depth at Health Connected for a good long while. But finding these experiences, these things that I'm bringing to the table, helped shape me and helped me deserve to be here in a way. And I think that everybody has that. It's just unpacking all that stuff, you know, and so getting the skills we need and then being able to figure out how like to actually like match up with where we're trying to go.
[00:31:22] Lindsey Dinneen: Absolutely. Well, and you know, that's such a good point too, because sometimes I think it can feel, especially when you do transition jobs or even broader industries and you do feel a little bit out of your element. And I think the thing that you can also remember is, though, it is a strength to draw from all of these different sources of information and experiences that you've had over the years and maybe actually it is a really positive thing for you because you can go, " I don't know if MedTech has ever considered X, Y, and Z, but we did this in hospitality and let's just try it, you know?" And so I love that idea of bringing all the things together and allowing it to help shape you.
[00:32:04] Michael Roberts: Yeah. Watching customer experiences be bad in healthcare just kills me. It just, 'cause you'd automatically lose in hospitality. You're automatically out if you don't have your customer experiences solid. That's the benchmark you have to start there. So
[00:32:19] Lindsey Dinneen: Excellent. Yeah. Well, how do you wish to be remembered after you leave this world?
[00:32:25] Justin Bantuelle: I, I think more than anything, I would just want to be thought of as somebody who was kind. It really matters a lot to me. I care about how people feel. I care about helping people. I'd like people to think that I always did right by them and helped where I could. So, that's at the forefront a lot of what I try to make decisions on in my personal life. So hopefully I live up to that.
[00:32:56] Lindsey Dinneen: I love that.
[00:32:57] Michael Roberts: I would add something similar to that, I guess, would be willing to invest in the people that I cared about, that I was willing to disrupt my day, ' cause I can get so focused on a thing. When I was a kid, I wanted to be an artist of some sort, and that you think about the artists that have kind of stood through time and it's like, "Oh, well that's the pinnacle of what it means to be a person is you're remembered through time for some major achievement." And it's like, well, yes, there are a handful of people that do that, but I think being able to be remembered that you valued other people as being more valuable, as being more worthy than whatever project you had at the moment, 'cause so many projects come and go. It's something that we all need to do, is something we all need to work on, but yeah, investing in those relationships
[00:33:45] Lindsey Dinneen: Absolutely. And I think that's a good reminder. Both of your points are very good reminders, especially for entrepreneurs who, I'm sure that most of them feel that everything kind of weighs on them. And so it is easy to get deep into project mode and maybe forget sometimes that they are human. So being kind and investing and willing to disrupt your day. But yeah that's really powerful. Thank you both. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:34:16] Justin Bantuelle: Sure. I think for me it's, I like animals a lot. I have my pets that I'm very fond of. I spent a lot of time looking at animal photos and videos online as I'm sure everybody does. I'm particularly fond of ones where it's two completely different species of animal that seem to be best friends. That is what really helped shape a positive day for me in the morning, if I come across some of those and that is just the cutest thing in the world.
[00:34:40] Lindsey Dinneen: Absolutely. How about you, Michael?
[00:34:44] Michael Roberts: For me, it's just being out, out somewhere where I'm just surrounded by nature and just getting that moment. And it's not, it doesn't make me smile in the same way, I guess, Justin, but it does kind of bring that peace every time I'm there of, no matter what else is going on, it's like, "Okay." Grounded, in a way and it's like, "Okay I'm here. I'm ready. And I can go face the day."
[00:35:04] Lindsey Dinneen: Yeah. Yeah. Excellent. Well, thank you so much, both of you, for sharing your stories, your insights, your experiences, and even some advice. I really appreciate you taking the time today. This has been such a great conversation. 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 I just wish you both the most continued success as you work to change lives for a better world.
[00:35:46] Justin Bantuelle: Thank you so much.
[00:35:48] Lindsey Dinneen: All right. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time.
[00:36:01] 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.

Chad Bareither | Principal Consultant, Bareither Group Consulting | Process Improvement, Systems & People, & "Improve LESS"

Chad Bareither is the owner and principal consultant of Bareither Group Consulting. Chad shares his journey from working as a civilian engineer in the U.S. Army to becoming a Lean Six Sigma Master Black Belt and consultant for medtech and pharma companies. Chad discusses his process improvement framework, the importance of understanding both systems and people, and insights from his recently published book "Improve LESS." He also covers the transition from being an employee to an entrepreneur and the qualities essential for leadership in the industry. 
 
Guest links: https://www.linkedin.com/in/chadbareither/ | https://www.bareithergroup.com/ | https://www.youtube.com/channel/UCTjC2ZBL3mqnriCeAIkmSlQ
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: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 045 - Chad Bareither
[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 I am so excited to introduce you to my guest today, Chad Bareither. Chad is the owner and principal consultant of Bareither Group Consulting. He partners with med device and pharma company leaders to boost productivity. This is delivered through the Focus and Align Framework, the subject of his book, "Improve LESS.". Chad is a Certified Lean Six Sigma Master Black Belt and holds a Bachelor's degree in Mechanical Engineering from Michigan Technological University, as well as Master's degrees in both Industrial and Systems Engineering and Applied Statistics from Rutgers University. He has over 10 years of experience in the med device and pharma industries and almost 20 years of professional experience.
All right. Well, welcome to the show, Chad. I'm so excited to talk to you today.
[00:01:42] Chad Bareither: Yeah, thanks for having me on.
[00:01:45] Lindsey Dinneen: Of course! I'd love if you wouldn't mind by starting off telling us a little bit about yourself, your background, and maybe what led you to what you're doing now.
[00:01:54] Chad Bareither: Sure. So I started my career in the US Army as a civilian engineer. So my background's in engineering, mechanical, I have a degree in mechanical engineering and also industrial engineering. So I started out in the U. S. Army as a civilian doing acquisition projects. So we would design and then purchase componentry for our warfighters from various defense contractors.
And so my role in that was quality. So understanding are we designing all of the elements correctly. Then when they're being produced, are they meeting our specifications? And then once they're in stockpile, do they continue to work before we hand them to the brave men and women that are defending our freedom. And so I worked there for a while and pretty early found my niche that I was really into process improvement. So I would visit defense contractors, and if we had an issue, what I was really seem to have a knack for was helping to understand the process and make it better. So we could either expand capacity or have better quality.
And so that kind of bridged right into a unique program they were introducing at the time, which was called Lean Six Sigma, which is a corporate program for reducing variation and improving efficiency of processes and the corporation at large. So I was pretty lucky that these two things coincide at the same time is that I was finding my niche and they were rolling out a program that really focused in that. So I was able to get into one of those programs, get trained and certified.
And then I followed that path on to several other industries, including med device, pharma, and then was also a corporate employee in some utility, electric, natural gas. After my last corporate engagement, I went off on my own and I began consulting. So delivering the same services I had internally to those larger organizations. But now I have the ability to target smaller or growing organizations. In my consulting engagements, if you combine corporate experience and consulting engagement, it's somewhere around eight industries that I worked in.
But I really enjoy the work and the challenges in med device and pharma a lot more. There's the purpose behind it of serving patients, and there's also some really significant technical challenges that I just find are fascinating to learn about. So for the last-- oh, it's six years now-- I've been consulting delivering those services in various industries, but really trying to focus my space into the medtech arena.
[00:04:46] Lindsey Dinneen: Nice. Well, first of all, thank you for sharing a little bit about your background. I appreciate it. And it's fascinating to hear how you started off with one focus and then it just continued to evolve and twist and turn into this amazing consulting career that you have now. So many questions, but the first is could seven year old Chad have possibly anticipated what you're doing now, since it's different than what you started off with.
[00:05:15] Chad Bareither: Yeah, no, I think seven year old Chad probably wanted to be a professional baseball player. But if I zoom forward a little bit from that, once middle school and high school, I always. naturally gravitated to our math and science was thinking it was going to be engineering. And I did, I studied engineering and most of my day is not engineering. It's really understanding people.
But what's fascinating is if I look back, I think what all of my engineering education taught me was really a system for solving problems, right? So the problems that we solved happen to be mechanical design or industrial design. Got it. But taking that mindset of problem solving and now saying, well, the systems that I work with on a daily basis with my customers are a little bit more complex because you have mechanical systems, but you also have people systems that are intertwined with that, right?
So, whether I've worked across the spectrum and still do of research and development, clinical trials, manufacturing and post market surveillance and across that. You can have systems set up, but people still operate it. So, it's difficult to just analyze your way into the perfect solution. Even if I can show on paper that it works, like you still need to understand the people elements of it. So I think that's been the biggest evolution through my career is early on, it was like, "I don't understand why we're doing this. It makes sense on paper." And it's like the change management component of that has been really something I've been able to develop personally, I'd say, over the last 6 to 10 years.
[00:06:51] Lindsey Dinneen: Yeah. And I'm curious, so bridging that gap between systems and people and understanding that what looks good on paper might not translate as perfectly into real life as one would hope, because we're people and people are complex. So were there certain learning opportunities that you had that helped bridge that gap of gaining your expertise and knowledge in that way? Or what led you to be able to do that so efficiently now?
[00:07:23] Chad Bareither: Oof, well, you're assuming I do it efficiently now, so but I'd say I still believe we learn more from failures than we do from success, right? So, there are specific projects or engagements I can look back to. So I'll talk about one specifically. This was a medical device assembly plant. And the particular production line that we were working on, we were trying to increase capacity on, and we even had the team engaged, right? So we were doing everything right in terms of the engagement project, had the teams involved, understood their pain points. We were trying to make it easier for them. And then like on paper again, showed we could do the production line, with the main assembly line, with three operators instead of four.
And so we were really pushing for that because being just transparent, looking back now, it's like the productivity gain would have looked really sweet to management. But we had the operators telling us like, "I don't think it's going to work. I don't think it's going to work that way." And we're like, " No, it's going to work," right and pushing for it. And I don't know, you, you get a little focused on your own goals or whatever you, however you want to phrase that. And yeah it was a struggle to launch. And they ended up having to cover some of that with overtime. They made some adjustments long term, but that was a big learning for me of, I mean, if the people actually doing that work eight to 10 hours a day are telling you it's not going to work, like you should probably pull back and either, you've got more explaining to do, more improvements to do, or you should just maybe listen to them a little bit more. But you know, there's other scenarios I can look at that were.
You know, when I say failure, right? Not everything means it's a flaming dumpster fire, but sometimes you don't get exactly what you expect out of it. And a lot of it can, I can point back to and say, " Ooh, you know, I could have done a better job. It's not that the analysis was wrong. It's not that the tool we put in place or the management technique or the visualization, it's that we didn't have the right level of buy in or the right people buying in."
[00:09:35] Lindsey Dinneen: Okay. Well, I, thank you. I appreciate your honesty and transparency. But I do think to your point, failure or whatever we perceive to be as failure because it didn't work out quite the way we hoped for, is such a powerful learning tool if you can take it and go, "Okay, here's what worked. Here's what didn't. Here's what I can do better next time." And you don't have to go, "Okay, that was a waste." It's never a waste if you can learn from it.
[00:10:01] Chad Bareither: A hundred percent. And I think only in recent years, I'd say the last four to five years, that I've really gotten into that of more of a bias for action of, " What's the worst that's gonna happen?" And honestly, I'm not talking about changes that are gonna bankrupt a company, right? It's if you're changing the direction, but " Well, let's try it." So having a bias for action and thinking, just like you pointed out, that it's going to be a learning experience, right? So if you treat it more of an experiment, success isn't necessarily binary-- it was a success or it wasn't-- we learned something. Maybe we got better. Maybe we didn't.
But that means the next round, the engagement that we talked about before we started recording, I'm just coming back from-- we had two weeks of not going so well. And then the last week there was finally a breakthrough. And it was like, but I'm comfortable with it. The team was getting disengaged and I'm like, "We're going to get there! You guys stay positive, 'cause I know we're going to get there." And the failures we learned, we know so much more about that process now than we did three weeks ago.
[00:10:59] Lindsey Dinneen: Yeah. Yeah. And that brought up an interesting point. So persistence and the willingness or the bias to action, which I really liked the way you put that, the willingness to experiment is something that does take a level of comfort that maybe not everyone is so excited about. But I'm wondering what you have seen over the years as being some of the top qualities of a leader that contribute to that success and that willingness to experiment.
[00:11:33] Chad Bareither: Yeah. So, it helps me to think about specific leaders when I, that are like embodying that rather than just speak generically about it. And there was an R&D manager that I work with, his first name was John, but really took the stigma of failure, and I think not even using that word as much, out of it, and just saying, " Let's try and see what happens." And kind of building that learning mindset of, I'd rather move fast and learn something than move slow and get it perfect.
And in industries, especially like a bunch of the medtech fields, I know in some of the pharma clients I've worked with, they're looking at things like new technologies, new modality of disease and I'm not a scientist, but these are things that we've never done before. And so the mindset of trying to get it perfect-- like this leader I work with previously, John is like, "Why are we wanting to get it perfect? We won't get it perfect the first time. And if we try to, we're going to be moving too slowly." so that's kind of the first thing that I think of is taking the stigma out of failure and turning it more into trying, learning mindset, things like that.
I think the other thing is keeping open communication. And what I mean by that is there's another leader I'm thinking of and his first name was Mickey. And trying to have more open conversations. Information can be used for power, in some cases, or if you're harboring information or knowledge, like, " I'm the conduit, right? So then I become what puts it all together." And he was big on breaking down some of those and having more open conversations about what we're learning and what works and what doesn't work. And I mean, you see teams grow together faster.
And so then when you take those two qualities, if I take the stigma of failure off of the organization as a whole, and I work to build more open lines of communication and you build trust, right? So then I'm more, I don't want to say confident-- that's not maybe the right word to go after-- but there's less hesitancy, less fear, maybe. So not being confident doesn't mean I'm not fearful, but if I can take a little bit of that fear, a little bit of the stigma of failure out, I'm willing to try. I'm willing to go off on something new. And as we look at this industry of new advances in technology, new challenges of diseases, we're going to have to keep moving fast and do it in areas that are pretty uncertain. So those are some things that I think help, of saying that we're not going to get it right every time, opening up lines of communication to build trust in the team. And then we can really move faster to a shared goal.
[00:14:08] Lindsey Dinneen: Yeah. I really like that. Thank you for that advice and insight. That's really helpful. So now with your own company, consulting, well, a couple of questions, but the first is what stage of business do you usually typically come in on? Or is there not necessarily a stage that's your sweet spot?
[00:14:28] Chad Bareither: There's, I wouldn't say right now there's a stage where I could say I have a, a litany of business cases for one stage, so multiple stages. I work with some organizations that are still in-- I mean, so if you think about the business, the corporate stage, established businesses, so they're past what would that be? Series two funding. So commercialized product. So I'm either working with the R&D pipeline on next generation products, next innovation, or in the operation space of improving manufacturing operations are typically the two areas that I'm working in the most.
[00:15:09] Lindsey Dinneen: Yeah. Was there an interesting learning curve going from being an employee to being an entrepreneur?
[00:15:18] Chad Bareither: Yeah, so let me answer that two ways. The first is moving from being an internal employee to being a consultant, right? Because it's just a different, you're of a different role in the company, right? And then there's also to your point is great moving from being an employee to an entrepreneur. So if you don't mind, I'll kind of tackle both of those.
The first is moving from employee to consultant is interesting. Because I was on the employee side when you would have consultants come in. And so leaving the bad taste in my mouth from some consultants we had worked in, they're there to make an impact so that they can either upsell their services or whatever. And I can remember being on engagement. So it's like pushing so hard and just, " I have to work with these people when you leave. So you're kind of creating a mess for us." And just trying to meet people more where they're at.
But you know, there's an adage of "a prophet isn't recognized in their hometown." It's sometimes they just need someone from the outside to point out what everyone has showing. And I know that sounds simple, but sometimes you just need to come in and say, "Independent third party here. And yes, that is the problem." So it's nice that you have that sense of authority, but I am personally, I am very cautious about the fact of, look, these people need to live with the solution when I walk away. The worst thing in my mind could be helping a client solve a problem, and then it returned for them.
So even if they did want to call me back, that would be seen as not ideal in my mind. I want to help them get to a solution that then they can buy in and sustain. So that, that first change is going from internal employee to consultant where, you do have to make an impact, a splash, a return on investment, whatever you say. But, I'm cautious to also say, but they need to adopt the change. They need to own it. It can't just be my great idea.
The other side that you talked about is going from employee to entrepreneur, which is also an interesting transition. As an employee, there's some perceived safety and stability, and I say that just perceived, because depending upon the industry that you're in, as markets change and things like that, layoffs come, things of that nature. So job security is never a hundred percent, but there is some perceived job security and stability there.
But as you get past the startup stage, you start to specialize, which means your job responsibility narrows, right? So in a larger organization, typically you become a specialist, but not very broad in thinking, and, and so that can be comfortable as well. You develop some technical expertise. Moving into the entrepreneurial space, which you probably have dabbled in a little bit as an, as a business owner yourself is, you are simultaneously the chief marketing officer and IT support and delivery services, and fill in the blank.
So you're wearing a lot of hats. And it can be difficult to gravitate towards the stuff you're really good at. So, I am best at the delivery, the actual client engagements. But I recognize if I'm not doing sales and marketing, and building new connections like that, eventually that work goes away. So it's trying to manage yourself and not stay where you're comfortable, if that makes sense. And not just deep dive all the way down to specialty in one area and have to learn some of these things. Or, you know, find the right people to do it for you.
[00:18:49] Lindsey Dinneen: Yeah. Yeah. Yeah. That's very insightful. So you are also a published author and I was wondering if you could share a little bit about your book.
[00:18:57] Chad Bareither: Yeah. So the name of the book I wrote in the fall of 2023, it was released, is called "Improve LESS" and intentionally thought provoking title that I got to it in a very roundabout way. The whole concept of the book started behind that, when I launched my consulting firm, I was still working full time as a corporate employee. So a friend of a friend asked if I can help. And I said, "Sure!" And that was a side gig. And then had another one come up and another one come up and then one of those clients wanted something more. And eventually I didn't have time to do a full time corporate job anymore.
But then I had three clients that were all kind of different phases and asking for different things. And so I had one client that was really focused on strategy. And, " We need to align our strategy. We need a better way to cascade that in the organization." Another client that was really focused on process improvement. "We want to build our problem solving and process improvement skills for the organization." And I had a third client that really wanted to have better eyes on the business, so we would call it a daily management system, visualization of metrics and understanding the business so we can diagnose problems.
Well, once you get good at strategy, then you actually have to go improve the processes. Once I'm pretty good at process improvement, I should probably align those strategically. Once I can see the problems in my business, I need to-- so essentially all of those three clients needed the three parts that were together. So I sat back and I said, "Well, this is starting to become a little bit of a mess. What would I do if I had a new client? What, where would I start?"
So I started writing down the process really for my own benefit. And then working with a business coach, I was like, "I'm going to give this away as like a PDF or whatever." They're like, "No, you should turn this into a book." And I'm like, "Like a book?" And they're like, "Yeah." And I had no idea how to do that. So, you know, back to our conversation about entrepreneurs is, so I found someone who did. And I'm work with someone else, a publishing strategist helped me go through everything, which I thought it was pretty good, in terms of editing, that was not the case.
So, went through some content editing and professional editing, and then, hired a professional illustrator from my hand drawn drawings. So, yeah, it was a journey, but that's how it started was me saying, " Well, what's my process?" And so really the purpose of the book is it is a framework. Anyone can pick it up and follow it. And I also tried to keep it short. I don't like to be very verbose in the communications to my clients because they need to understand it. So it's literally something that you could read in a weekend and start on Monday.
[00:21:39] Lindsey Dinneen: I love that. Okay. So yeah. Yeah. So you've written this book, and you have your consulting firm, and what are you excited about coming up? Maybe both personally and professionally.
[00:21:53] Chad Bareither: Yeah. Oh, I think it's easier for me to answer personally. So I'll start there. So my wife and I have three children and they're all pretty active in different competitive endeavors, gymnastics. We talked before, my middle daughter is a dancer, the two girls, the gymnast and the dancer, also play volleyball. And then my youngest son is on a baseball and a soccer team. And so, I mean, I just love supporting them in those. Now I say all that academics are also important. They're doing well academically. That's kind of the condition for doing the sports and stuff like that, but really pouring into them right now.
It's It's going to sound so cliche, but our oldest is 13 right now. And some pictures came up, memories on my phone, and it's goes by quick. So personally, I'm just excited about in them right now. And they're turning-- I use this term and my coworker laughs at me-- but they're turning into real people, with their own personalities and their own likes, and it's frustrating at times because they have their own thoughts. Yeah. But it's fascinating right now. And just being able to spend more time investing in them is, is great.
Professionally is exciting to really I'm niching back down into this medtech area, right? So I'm carrying a pharma client. I came off a pharma engagement. That was just at the beginning of this year and I've worked in other industries, but I'm just really fired up about the work, the technical challenges in these areas. So getting back into some client engagements that are med device and pharmaceuticals, and then, pharmaceuticals has stuff going on that I don't, I can't begin to understand. Bio therapeutic proteins and cell therapy stuff, which is-- it's fascinating technology, but it's still process, right? And so I might not understand the science, but I do understand process. And I've been able to help in those areas. And it's just, it's humbling to be contributing to the field. So I'm really excited to niche back down in that area and do some more work in this medtech field.
[00:23:56] Lindsey Dinneen: Yeah. And when it comes to medtech, are there any moments working with clients that stand out to you as just confirmation that you are in the right place in the right industry at the right time?
[00:24:10] Chad Bareither: Yeah. So, I know very little about cell therapy, but basically, you grow stem cells and you make them into other type of cells that would be beneficial. If there's people in cell therapy listening to this, you can correct me if I'm wrong. But I mean, it's just, it's mind boggling the science, but I was working with that group and so they were building up their pilot capabilities. And I'm looking at for more like an industrial engineering, manufacturing point of view, developing standard work. And so they're like, "Oh, this is so helpful." And I'm just thinking, I'm like, "I don't even understand what you guys do. So the fact that I can be of any contribution here is..."
But I think, pulling back on that is, you need to invest in your strength. So here's, very skilled multi year experience, PhD scientists. And sometimes they just need someone to help them with structuring up the process flow and the capacities and the standard work that they need to do this consistently. And I'm good at that. And so this kind of harkens back to our conversations about entrepreneurship, right, of knowing what you're good at and knowing what you need help with. And I just, I know what I'm good at. And if I find clients that need help in that area, I'm thrilled to support it. But that was one engagement where it was like, "I understand about zero of what you just explained to me, but I think I can help you."
[00:25:36] Lindsey Dinneen: I love that. That's fantastic. One of the things I've noticed and really appreciated about the medtech industry is everybody is really good about celebrating and acknowledging how we all fit into the efforts to make it successful. So even if you are not the scientist, or you are also an engineer, but say in my case, I'm not a scientist, I'm not an engineer, but I do have a marketing ability. And the respect mutually that occurs for everybody's contributions, I think is really special in the medtech industry. I'm wondering if you experienced that too.
[00:26:17] Chad Bareither: Yeah. You know, I think there's definitely times it's kind of like a family, right? Families fight, the families get along together. There's definitely times where it's like people are like, "Ah, sales department doesn't know what they're doing," or and you're like, but at the end of the day, you recognize you do need all those parts. Unfortunately, these technologies and this research is expensive. So you do need to sell, right? I mean, that's a reality. So you're right. They do all need to get to, and if people slow down, I think you're right. Eventually everyone's, " Yes, we need all these parts to work."
I think there's definitely times where people are having a bad time and they get a little grumpy and they're like, "That department doesn't know what they're doing." But it's, but no, I think all the departments are actually really good at what they're doing. So, you just look at the growth that you're seeing in the industry and the valuation of some of these companies and it's, they know what they're doing and they're serving a need that, that we have supporting our health and wellness. And so it's cool. It's really cool to see that all come together.
I think you get a very interesting view of that at some of the smaller organizations 'cause there is a lot more of that trust and that team camaraderie, but even, you know, I worked for a fortune 500 company when I was in in med device, as a corporate employee. And you still have that, within the product teams, within the production teams, that they're there to support each other, they're there for the win. There's also a healthy dose of competition in the industry, I think, that makes it a really driven. So it's, it's fun to be a part of it's fast paced because of the personalities. It's fast paced because of the science. It's fast paced because of the competitiveness with other competitors in the industry. So yeah, it's a fun space to be in.
[00:28:00] Lindsey Dinneen: Yeah, absolutely. Yeah, so pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a master class on anything you want. It could be in your industry, but it doesn't have to be. What would you choose to teach?
[00:28:17] Chad Bareither: Yeah. So this is maybe, I'm hopefully not being risk averse here, because I would teach something that I'm already good at teaching. So some of my favorite things to teach are structured problem solving. So most people that are in any type of leadership position got there because they were probably good at solving problems. And I think where we have challenges in, as organizations grow, is that not everyone solves a problem the same way. So how do you develop the new talent coming up to be like those next leaders? And you can't, you shouldn't just rely on individual people to be like, "We'll just find the good problem solvers and they'll go up."
I've seen in organizations where you can really multiply, even exponentially grow, the pace of improvement by having structured problem solving in. So that's what I would do. Personally, that's DMAIC formatted problem solving. It's a five phase problem solving approach: Define, Measure, Analyze, Improve and Control. So that's something that I love teaching because I love the lightbulb moment that goes off in people's heads and we teach them that. There is a portion of that is statistics and I love teaching statistics because most people think this is going to be the worst thing ever and I tried to make it a little bit fun and they're like, "Oh, that was fun. And I learned something." And that's what fires me up. So yeah, it would be structured problem solving. That's what I would teach a masterclass on.
[00:29:43] Lindsey Dinneen: Okay, I like it. And how do you wish to be remembered after you leave this world?
[00:29:49] Chad Bareither: Oh, my. So my love language that I express as in service. Helpful, that's, I think that's the main thing. Whether it's in a client engagement or in the neighborhood or the family, I enjoy helping people. And so whether that's consulting on the launch of a new diagnostic device or helping someone repair their tractor, right? I enjoy engaging and learning with people and solving problems together. So I really like helping people. So I think I'd like to be remembered in that way. Helpful.
[00:30:27] Lindsey Dinneen: Yeah, I like it. Absolutely. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:30:38] Chad Bareither: One thing. Well, I don't know. I've smiled a lot this week, seeing pictures of my kids when they were younger, because I don't know, maybe my iPhone's just paying tricks on me. It keeps showing pictures of my kids when they were little. So that's it. I think right now, just the point of life that I'm at right now as kids, two of my brothers just had babies as well. So little kids and just me realizing like my kids are never going to be that age again. I've been on travel and seen a lot of little kids in different cities, and it's sweet because it's so simple. Their world is so simple at that age. So I think it makes me smile just because the innocence is there. Yeah. I'm gonna stick with that.
[00:31:17] Lindsey Dinneen: Yeah, great answer. It's, it's special to witness and it always brings a smile too. Especially little kids at airports that are dragging their tiny little backpacks or rollie bags behind them and they've got their best stuffed friend. Oh my gosh, it's so cute.
[00:31:35] Chad Bareither: So one thing that's been interesting to see is when people have younger kids, and maybe they're misbehaving or maybe they're just excited, right? And the parents are kind of flustered. It's just it's, it brings a smile to my face. Not because the parents are flustered. It's just because I can remember being a parent and you make a big deal out of it, and it's man, but I just appreciate the innocence and the genuine joy that this small human is trying to have right now. And it's, I think, that's the thing right now in my life. That's bringing a smile every time I see it or think about it.
[00:32:05] Lindsey Dinneen: I love it. I love it. Well, Chad, this has been an incredible conversation. I really appreciate your insights and advice and everything that you're doing. If anyone's listening and needs some outside support, please definitely get in touch with Chad. We are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support. And we just wish you the most continued success as you work to change lives for a better world.
[00:32:42] Chad Bareither: Thanks a lot. And you got a lot going on. So I wish you continued success in all your endeavors as well.
[00:32:49] Lindsey Dinneen: Awesome. Well, 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 will catch you next time.
[00:33:04] 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. Silvia Blemker | Co-Founder & CSO, Sprinkbok Analytics | Teaching & Advancing Biomedical Engineering & Muscle Analytics

Dr. Silvia Blemker is a distinguished professor of biomedical engineering at the University of Virginia and co-founder and Chief Scientific Officer of Springbok Analytics. Silvia discusses her fascinating journey from a curious child who loved learning about anatomy to now leading groundbreaking research at the Multi-scale Muscle Mechanophysiology Lab. Learn how her innovative AI-driven muscle analytics technology is reshaping fields ranging from sports medicine to neuromuscular diseases. Silvia shares her passion for mentorship, the rewards of pushing scientific boundaries, and the thrill of solving complex challenges. 
 
Guest links: https://www.springbokanalytics.com | http://www.uvam3lab.com
Charity supported: Sleep in Heavenly Peace
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 044 - Dr. Silvia Blemker
[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 very excited to introduce as my guest, Sylvia Blemker. Sylvia is the Robert Thompson Distinguished Professor of biomedical engineering at the University of Virginia. She leads the Multi-scale Muscle Mechanophysiology Lab, which develops multi-skill computational and experimental techniques to study skeletal muscle biomechanics and physiology. The lab explores a range of applications including speech disorders, vision impairments, aging, muscular dystrophies, and human performance. New projects include developing models that incorporate for sex differences in musculoskeletal structure and simulating the effects of estrogen levels on muscle regeneration. Dr. Blemker is also Co-Founder and Chief Scientific Officer of Springbok Analytics, a company commercializing image based muscle analytics AI technology for many applications from muscle diseases to sports medicine.
All right. Well, welcome. And thank you so much for being here. I'm so delighted to talk to you today, Sylvia.
[00:01:55] Dr. Silvia Blemker: Thank you. I'm excited to be here also.
[00:01:58] Lindsey Dinneen: Awesome. Well, would you mind starting off by telling us a little bit about yourself, your background, and maybe what led you to medtech?
[00:02:08] Dr. Silvia Blemker: Sure. So I am born and raised in Lawrence, Kansas, a child of two immigrants who are from Argentina. And they're both professors. So from a very early age, I was exposed to the world of academia. My dad was a mathematician. My mom was a math person also. So, math and STEM was always from the get go part of my life and I knew it would be in the future.
And when I was trying to decide what to study as an undergraduate student, I learned of this field called biomedical engineering that was somewhat of a new discipline at that point. I started college in 1993. And I just thought it sounded perfect because I was really interested in medicine. I loved anatomy. I was one of those geeks that had anatomy parts, like models. I had an ear and I had an eyeball and a heart, all these different things. I just thought anatomy was really interesting and cool.
And I always thought being a doctor of some kind would be really cool because it would mix my interest in biology and anatomy with wanting to help people, but I don't think that was the right path for me, and it also wouldn't really leverage my interest in math and physics and stuff like that. So once I learned about biomedical engineering, I thought, "Wow, that sounds really perfect for me." And so it turned out it was because I did my undergrad in biomedical engineering from Northwestern University. I did my master's degree there, and then I went on to Stanford University. I got my PhD in mechanical engineering. But honestly, I would have been bioengineering, but back then there was no bioengineering department. So I was in mechanical engineering, but focused on biomechanical engineering.
And now I'm a professor of biomedical engineering at the University of Virginia. Been that since 2006. And I also, it's been about 10 years now, co founded a company that's in the medtech industry. It's called Springbok Analytics, and it's commercializing software to go from a rapid MRI scan to a fast assessment of muscle health and fitness.
[00:04:22] Lindsey Dinneen: Amazing. Well, thank you for providing some background and whatnot. That was so fun to hear about, you know, your interest in biology from even a young age and having all these models and that's just, that makes me smile. I love that.
[00:04:35] Dr. Silvia Blemker: like collecting bugs, too. That's weird.
[00:04:39] Lindsey Dinneen: Hey, you were interested in it. I love that. So I have so many questions, but the first thing that comes to mind: I love the name of your company and I'm curious why you chose Springbok.
[00:04:50] Dr. Silvia Blemker: Yeah, that is a great question. So, it was inspired by the springbok, the animal. It's very fast moving antelope that runs fast. It's very agile, jumps high. And the reason why we went that direction is our first market at Springbok was in human performance and elite athletes. And so we were using this technology to help athletes recover from injury and get to their maximum performance. So that's where that went. And, you know, honestly, when we first started it, we just kind of like dreamt that up and didn't know if it would stick, but now it has. And so here we are.
[00:05:32] Lindsey Dinneen: Excellent. So, yeah. So, okay. With the origin of that company, you brought something to market that has previously not existed in the way that you're doing very uniquely. Could you share a little bit more about what makes what you do so unique and how it's helped solve or covered a gap in the market, basically?
[00:05:54] Dr. Silvia Blemker: Sure. So I guess maybe while I answer that question, I'll tell you a little bit about where it came from in terms of the initial ideas. So I think that really answers your question too. So, so we're actually, it started as a research project in a combination of my lab and a few other collaborators at UVA. So started pure research funded by an organization that pro wanted to promote translational research. So research that starts on the very academic basic setting, but is translated to the outside world. You know, we do a lot of research that's very impactful, but it stays in the lab. And the idea is that some of it is ready to go out there.
So, having said that, the basic idea for the company actually really came out of some conversations I had with a collaborator, an orthopedic surgeon, who treats children that have cerebral palsy, in particular helps in terms of improving specific movement disorders that kids with cerebral palsy have. And so I've had a longstanding interest in understanding what's happening with muscles in these children because though it's an injury to the brain kind of right around birth which leads to these abnormal movement patterns, that ends up influencing their muscles and bones because muscles and bones grow based on the way you use them. And so this happening as a child means their muscles have a fair number of issues. And so I've been interested in that question, obviously, is if we know that, then we can help better improve mobility and treatments for these children.
And so, in my research, I've been making use of MRI a lot to study muscle, because that's a great way to do that in humans. If you're studying a mouse, which we do somewhat in my lab also, you can do a lot with a mouse muscle. But if you want to study human muscles, there's only so much you can do unless you're studying a cadaver, which obviously is not relevant. So, we use MRI and develop these fancy imaging techniques or interesting ways to get a bunch of information about the muscle from the MRI machine, MRI pictures, and do lots of different modeling and things like that.
So I was pretty young professor and I was developing new research ideas and this clinician said, his name is Dr. Abel said, "You know, all these interesting ideas about what you can learn about muscle from MRI is cool, but you know this is not something we could ever use in the clinic because the way that you're doing these scans is very hard. It's very research oriented. You're only studying one muscle, and really in cerebral palsy and impacts all the muscles of the in the body, but in particular for movement of the leg. And we don't have a way to, to quantify that or understand that. And that's what I really need to have in order to figure out how to treat these kids." 'Cuz ultimately he's has to do surgeries on a bunch of muscles and he has to make the decisions about which muscles to do surgeries on just by looking at the outside of the child and not really having a sense for what's going on at the muscle level.
So I was like, "Okay, well, maybe we'll try to solve that problem." Cause it seems like the problem I wanted to solve maybe isn't all that useful to you right now. So, that, that really was the basis for Springbok the initial idea was to develop a way to collect MRI rapidly and then transform that into a assessment of all the muscles of the lower extremity in particular for these kids because there's really no other way to get information at the muscle level.
We have ways to kind of assess how strong people are. But that's what we say in biomechanics, we call it at the joint level, you know, but like, for example, if you wanted to see how strong your knee is, you extend your knee for example, to get your quadriceps, but there's four quadriceps muscles. So if there's a weakness, which muscle is the one that is, you would have no idea what that was if from the outside. Same thing for all other joints. So, that's the idea is like to get to that detailed information and in this particular application it's very obvious why you need that because they're going to go in and do surgery on individual muscles. So they want to do the ones that actually need it.
And then, you know, the premise of where we went from there is that, the need to have information at the muscle level has a lot of different applications outside of that. And so that's sort of one thing led to another. And again, because we were funded by this grant agency called The Culture Foundation that wanted to promote translational research, one of the early pieces of feedback they gave us was the market that we was associated with the application we were first exploring in cerebral palsy was too small to start with. And there's too many barriers of entry in terms of being able to actually implement in practice.
So that's what led us to shift to other areas in particular. And in particular, elite sports because some of those barriers don't exist. The financial aspects are not nearly as challenging to start. And so it's actually a path I've heard of a lot of other healthtech or medtech companies to go start in sports and then veer into once they've gotten a bunch of data and validation, veer into the medical tech, and then that's precisely our path as well.
[00:11:12] Lindsey Dinneen: Yeah. Excellent. Well, well, thank you for sharing more about that. That was such a great explanation specifically about the quadriceps. I really latched onto that because what an interesting problem, but then what a great solution that you all have developed. And, you know, I'm wondering, looking back before you started the company and really dove in, could you have anticipated that you were going to become this entrepreneur? And did you expect that this might be part of your path or was this kind of just a happy coincidence after the research developed?
[00:11:49] Dr. Silvia Blemker: Definitely did not expect it to be part of my path.
[00:11:52] Lindsey Dinneen: Okay.
[00:11:53] Dr. Silvia Blemker: Absolutely. By no means, my brother was the one that went, like he was an engineer too, and he worked for IBM and he became more of a business man. That's what I would call him. But, yeah, it was really, you know, a multitude of things, the encouragement. I had some really good, you know, co founders. Craig Meyer and Joe Hart were both colleagues and they were excited. It was sort of like at that point, it was like, "Well, I don't want to be the limiting factor here. We should all do this together, right?" Found some really fantastic people to help it get started because, of course, when you first start something, there is a lot of risk there.
And also, the three of us co founders had day jobs. We're still professors. And so we found a great actually grad of our program. To be our first CTO or first official employee. You really need to have that team around you. It's not just one person or two people, there's a lot that goes into this type of effort. And so I think without that, for sure, wouldn't have done it. And then one thing led to the other, I guess. It's definitely has pushed-- I can speak for myself-- out of my comfort zone a lot, you know, and it still does. But I think that's why I keep doing it also is I've learned a lot.
[00:13:10] Lindsey Dinneen: I love that. Yeah. Well, and I think that it brings different challenges than you're probably experiencing in the academic side of things, and that's its own challenge too. But I love the fact that, speaking with leaders such as yourself, you're always pushing yourself to the next thing. You're not really just happy being.
[00:13:29] Dr. Silvia Blemker: My husband might appreciate it more, but
[00:13:31] Lindsey Dinneen: Okay. Yes, this is fair. Yeah. Well, okay. So, so just briefly switching sides to the academic journey that you've taken. So can you speak a little bit more about the program that you are in and helping to continue to develop? And what are you excited about even just with the university as you continue to grow?
[00:13:56] Dr. Silvia Blemker: So I am a professor at heart. Right now I'm in a particularly interesting kind of stage of my career where I'm still a professor at UVA, but I'm actually part time professor and I'm also officially employed by Springbok. I'm a co founder, but I'm right now working as Chief Science Officer. So I do have two jobs.
[00:14:15] Lindsey Dinneen: Yeah. Nice.
[00:14:17] Dr. Silvia Blemker: Yeah.
[00:14:18] Lindsey Dinneen: Oh.
[00:14:20] Dr. Silvia Blemker: Sons to o, but it's all good. It's, you know, it's nice full life, but so anyways, I have a research lab called, we call ourselves the Multiscale Muscle Mechanophysiology Lab. It's a mouthful. So we just call her, we say M3 Lab or M cubed. And we have PhD students, be it biomedical engineering, PhD students who are doing research and with in my lab going towards their PhD. I have postdoc, so students that have finished their PhD and continuing training for research in my lab, and then a whole bunch of undergraduate students who are getting involved in research for the first time. And the mentorship there that I do is ultimately, I think, honestly, what I love the most. And I joke with them because I now encourage all of my students to do internships while they're in their graduate program. I think it's incredibly valuable for a lot of different reasons that I could chat through. But I tell them, "You know, I never did that. And I did my internship in my late 40s. Fortunately, I realized that I made the right career choice, but I did it a little late. You should do it earlier."
[00:15:25] Lindsey Dinneen: Right. Oh, nice.
[00:15:28] Dr. Silvia Blemker: So anyways, I love my students all the way from ultimately in the lab, like exploring, you know, I talk a lot about with them, "You know, what we're doing is exploring the boundaries of knowledge together, pushing it and understanding where the boundaries are and figuring out how to push them in ways that can advance the world, really." And doing that with the student together and essentially I find myself like right behind them. I'm like, "Okay, keep going, teach me while you do it." I just find that, I just love doing that. It's very rewarding. And it's a real impact to be able to train other people to do this work. And there's the relationship aspect of it that is very valuable to me. So I just love teaching and hopefully inspiring new students to get involved in the kind of work I do, or help them figure out what they want to do. I think in the industry in the startup setting that mentorship is also a big part of it, but you know, it's just it's different.
So one of the big projects we have that is actually the cool thing is, it's empowered by the startup company. So there is a synergy there which I think is really cool. So we are in the lab creating the next generation versions of computer models of the body that account for differences between men and women, between males and females. So in the world of movement biomechanics, in addition to using MRI as a common tool, another way that we study human movement and to try to figure out what's happening on the inside of bodies is to use computer modeling where we have models that sort of help try to describe the person in as much detail as possible from the inside, their bones, joints, muscles, everything, how their muscles move, and combine that with measurements of motion from the outside and physics and use all that to figure out how the person, how their muscles are working.
There's a lots of different questions that you can answer once you have a model like that. The problem is that the model that everybody uses is based on data from like a 5'10 man. And then we scale it to fit anybody. So it doesn't even actually probably represent the 5'10 man, honestly. It's kind of an average. We're doing a big study where we collect MRI data of a large number of males and females, and we're doing a whole bunch of other measurements to allow the field to put that model aside and do a much better job at representing the population in particular, and accounting for the differences between male and female, because a lot of clinical problems, conditions, questions, issues that are the answer to them are different between male and females. And as a field, we don't really have ways to handle that. And I think that we need to do better than that.
So it's an interesting project because It's a very, it's, there's a lot of interesting technical thing problems that we're solving to do that, to do these modelings, models at scale and stuff like that. But it's also a bit of like a public service model or a project where we're answering these questions, but ultimately going to give these models to the community so that they can do their research better too.
[00:18:37] Lindsey Dinneen: Wow. It, you know, it continues to boggle my brain when I hear things like this, where it's like, "Yeah, we forgot to consider half the population." And I, you know, shouldn't make me laugh very much, I'm just very thankful, is really what I'm going to get to, of people like you who are going, "Wait a second, maybe this one thing that we've used all this time could be done more effectively and represent, like you said, just a better understanding of humans." So I...
[00:19:07] Dr. Silvia Blemker: Yeah. It's interesting. You know, I've wondered about this myself a lot, how do we come to be? And I think it's this interesting difference between thinking about the impact of what your science is versus how to do the science well, because as scientists were trained, take out all other extra variables so that you can answer the question, you can control for everything that's your questions not to do with so that you can answer your question or test your hypothesis. And so, if you add sex as a variable, that confounds your question. And then, if anything, it just means that you have to double your sample size, you have to account for that. And so to do it well, but maybe with less resources, it would make sense scientifically to go to one sex. So that's why that happens, right?
But then, if you're thinking about, "Well, yeah, but then I only answered that question for one sex," then you would do it differently. So I think that's where it comes from. Honestly, I don't think my predecessors were necessarily sexist or anything. I think they were doing things in the way that made sense scientifically by keeping things constant and wanting to have clean results. So that is what it is, but I think in a world where we're thinking more about the impact of what we do, we can't do that anymore.
[00:20:30] Lindsey Dinneen: Yeah, well, and I thank you for sharing that. I think that's a really great perspective and realizing that sometimes It's easy to get annoyed by something that when we don't understand maybe where it came from or why somebody chose the route they did and maybe there was a very just practical reason for it. And so I love that you shared that. Thank you for doing that.
[00:20:53] Dr. Silvia Blemker: But I will say that I have gotten annoyed though when you ask the question, like, "Why did you just do men?" Sometimes the answer is just, "Well, that's just how it's done." Not reasonable. I don't think that's, I don't think that's an...
[00:21:07] Lindsey Dinneen: A lazy answer.
[00:21:08] Dr. Silvia Blemker: Absolutely. Yeah.
[00:21:10] Lindsey Dinneen: Yeah, that's fair. That's fair. So, you know, either in your academic journey or perhaps in your entrepreneurial journey, are there any moments that stand out that really kind of affirm to you, "I am in the right industry, doing the right thing with my life?"
[00:21:29] Dr. Silvia Blemker: Oh, huh. That's an interesting question. I'll tell you when I know that I'm doing the right thing, when I'm excited to get up and do it
[00:21:39] Lindsey Dinneen: Yeah.
[00:21:40] Dr. Silvia Blemker: Morning, I'm like, "Oh yeah, I'm going to work all this. This is exciting. I want to figure this out." That's usually what gets me up. Like my husband knows when I'm, we call it "locked in" because, you know, we have Gen Z kids, when I'm really trying to figure something out. And that, that really like gets me like figure something out that I know is important and impactful. I just love doing that. I think ultimately that's what I like and being creative and coming up with solutions and questions and stuff like that. That's not, I don't know if that's answering your question though.
[00:22:13] Lindsey Dinneen: It actually, well, it does though, because I mean, everyone answers that in different ways, but what I love is the fact that it's your daily life. That's a great answer to that question. It's, " I'm curious. I'm excited. I want to work with these students and solve these problems." And that's a dream.
[00:22:32] Dr. Silvia Blemker: That's what I, that's what gets me up in the morning. I mean, obviously not every day can be filled with these super intriguing things. There's a lot about a daily routine of any job that involves other things. And I try to learn to do those. Like one example of that for me was when I first started as a graduate student. As a scientist, a researcher, you have to present your results or give presentations a fair amount, whether it be to your lab group or to your thesis committee or in at a conference or a seminar. And then ultimately as a teacher, you have to do that all the time too.
And early on, I really did not like doing that. It was really painful for me. I was really anxious about it. I loved sitting there working stuff out on my computer. That I loved, I knew, but I did not think I could do any-- presenting was scary. The first time I had to go presented a conference, I literally memorized every single word of the presentation to the word, and even my friends, my graduate student friends who I shared a hotel room with, they could give my presentation. They literally could, but now I absolutely love presenting. It's something that I've come to really enjoy all aspects of it. So that's an example of maybe not everything initially seems like that's what I'm going to love doing, but sometimes you can surprise yourself.
[00:23:57] Lindsey Dinneen: Yeah. Well, and I actually, to expand on that, I think the idea of you never know what your next sort of joyful surprise is going to be. So try the things and we'll discover that not everything is for you, but that's such great advice also for students, I feel like in particular, or maybe those young in their career is, "Just experiment, try it." You know, use it as this exciting time to just see. And yeah, you might even hate it the first couple of times, but you never know.
[00:24:27] Dr. Silvia Blemker: Yeah. Yeah. You never know. You never know. Absolutely.
[00:24:30] Lindsey Dinneen: Yeah. Well, this is going to be an interesting one because I'm going to pivot the conversation and ask you something that I ask all my guests, but in your case, you are used to teaching and giving classes. So the question is, if you were to be offered a million dollars to teach a master class on anything you want, what would you choose to teach and why?
[00:24:52] Dr. Silvia Blemker: Oh, a million dollars. Oh, but I, like, I love teaching,
[00:25:03] Lindsey Dinneen: Yeah, I know. That's why I was like, oh man, this is gonna be interesting.
[00:25:07] Dr. Silvia Blemker: I think it was last year I was so proud of the undergraduate students. They give these awards to professors and I got the Lecturer of the Year award. So that was fun. And then I brought it home and my teenage son was like, "Oh yeah, yeah, that tracks. Mom's the lecturer of the year."
[00:25:26] Lindsey Dinneen: Oh!
[00:25:27] Dr. Silvia Blemker: Momly lectures. So anyways, it's hard to turn it off, but let's see, what would I give it about? I mean, it would probably be something about how muscles work 'cause I love talking about muscles. Honestly, like at the end of the day, that's now I'm kind of all in it. So I, I like talking about that stuff. Randomly about tennis too. I love tennis. I play tennis as a very low level tennis player, but I've become a tennis nerd. So if I had another job, I would love to be like a tennis announcer, but the science tennis announcer to talk about the physics and stuff like that, biomechanics. I would love that.
[00:26:05] Lindsey Dinneen: Oh, I would love that. That would make it so much even more interesting to me because I'd go, "Oh my word, I had no idea that this was what's happening here." And yeah, that's cool. Excellent. Okay. Well, I like it. Well, how do you wish to be remembered after you leave this world?
[00:26:23] Dr. Silvia Blemker: Ultimately for my children, like Mom to Jack and Daniel Blemker, number one, then wife to Wes and the rest of my family. I think, ultimately, that's the most important, right? And then as a mentor to my students.
[00:26:41] Lindsey Dinneen: Yeah.
[00:26:42] Dr. Silvia Blemker: And then for like, you know, doing things that help people. Products that we've put out there, I feel like we've had an impact and we continue to see the potential impact. But honestly, that isn't really about me. It's about the impact. So I don't know that I-- I guess it's good to get credit for stuff like that, but ultimately it's just cool to know that it's had an impact and it's really connected to a lot of people not just me, so I think it's cool like sometimes I do reflect on, when I see cool stuff that the company's doing like "Wow, that was my idea. That's cool." But it's like not just that, right? An idea is just an idea. There's so much more. And the people that we have at Springbok doing, it's just a fantastic team of just ridiculously smart people who are also great, work well as a team and really value having a positive environment and they're fun. They're funny. So that's all cool.
[00:27:39] Lindsey Dinneen: That's awesome. That is so cool. Yeah. Yeah. I love that. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:27:50] Dr. Silvia Blemker: I have a few different things, maybe. Well, the first one that comes to mind, honestly, is every time, and this is one of my favorite things about doing Springbok, is every time we get like an interesting new scan in, and we look at a large range of individuals now from people with muscle disease, neuromuscular disease, and all the way to NBA players and everywhere in between. But whenever I see one that's different, I'm like, "Ooh, that's cool. That makes me smile." So I guess that's muscles. And then also, I guess the other one is just seeing like a mentee or student shine in some way. One of my former student just defended her PhD two weeks ago, and just sitting there watching her do her PhD defense, she's phenomenal. It was just amazing. I mean, who wouldn't smile at that? But
[00:28:43] Lindsey Dinneen: Yeah. Oh, that's amazing, and I love how it all ties together, just your answers are consistent, but I, what I love about hearing that is this just thread of appreciation for muscles and anatomy and impact and the students and the lives that you're touching. So I, you know, I definitely, I love that you're doing what you love and that it brings you joy. That's the best. Yeah.
[00:29:11] Dr. Silvia Blemker: That's so nice. That makes me smile.
[00:29:15] Lindsey Dinneen: Oh, I love that. Well, thank you so much for your time today. This has been such a joy for me actually, to get to talk to you and learn more about your background and what gives you energy, what gets you up in the morning. And so I just really appreciate you sharing about all the great work that you're doing. And I just wish you the most continued success as you work to change lives for a better world.
[00:29:38] Dr. Silvia Blemker: Well, thank you. Thank you very much. Thanks for producing such a cool podcast. So very much appreciated.
[00:29:45] Lindsey Dinneen: much. Thank you. Well, thanks for bringing a smile to my face. And thank you also to everyone who is tuning in today. And if you're 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.
[00:30:01] 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.