The Leading Difference

Dr. Shalabh Gupta | CEO, Unicycive | Transforming Kidney Disease Treatment, Frameworks for Prioritization, & Leadership in MedTech

Dr. Shalabh Gupta, founder and CEO of Unicycive Therapeutics, shares his inspiring journey from practicing medicine to leading groundbreaking innovations in kidney disease treatment. Dr. Gupta discusses his comprehensive framework for identifying and developing medical solutions, his vision for Unicycive's future, and the importance of focus and execution in medical startups. He reveals the challenges and triumphs of bringing life-changing products to market and offers profound advice for new entrepreneurs in the industry.
 
Guest links: https://unicycive.com/ 
Charity supported: Feeding America
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 056 - Dr. Shalabh Gupta
[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, Dr. Shalabh Gupta. Dr. Gupta is the founder and CEO of Unicycive Therapeutics. He is a visionary in healthcare, leading groundbreaking efforts to design innovative therapies and reimagine how we approach unmet medical needs. His work goes beyond the lab as he's driving a healthcare revolution by developing innovative therapies addressing critical gaps in treatment. His perspective combines decades of experience and expertise in drug design with a deep commitment to equity in health care.
Well, welcome to the show, Shalabh. I'm so excited that you're here with me today.
[00:01:35] Dr. Shalabh Gupta: Thank you. Thank you for hosting me.
[00:01:36] Lindsey Dinneen: Of course. I'd love if you wouldn't mind just telling us a little bit about yourself, your background, and what led you to MedTech.
[00:01:45] Dr. Shalabh Gupta: By way of background, I'm a physician, trained, practiced, did my medical training in internal medicine, residency in physical medicine and rehab, research fellowship in cardiac and pulmonary rehabilitation, board certified physician, practice in New York at NYU hospital, NYU Medical Center. This is where I did my medical training for roughly decade after finishing medical school.
I also have a graduate degree in finance management from NYU. While I was doing my residency training, I realized that I wanted to find a way to have a broader impact on society as well as what we were working on in learning medicine. So, I started my career working initially with a biotechnology company at the time to help them get their drug with FDA through a regulatory approval process. The beginning of the process is called IND following a investigation new drug application, IND application. I actually visited FDA on their behalf, met with FDA back in the time when everything used to be in person.
Built from there onward, joined Wall Street from working as a stock analyst. So I covered biotech companies as a stock analyst, and the weekend and holidays that were available, I worked to continue to practice the medicine at NYU as an attending physician, and then joined another bank and covered pharmaceutical stocks and worked covering six of the largest pharma companies that include Pfizer, Merck, Viacom, Selling Power, Eli Lilly, Bristol Myers Squibb.
From there, I moved to California. I worked for Genentech in corporate strategy. Genentech, at the time, and continues to be, one of the largest biotechnology companies. And from working at Genentech, I got my inspiration to start my own companies. So I founded two companies prior to finding starting Unicycive.
All my companies are focused on aesthetic therapeutic area. Unicycive is focused on nephrology, treatment of kidney diseases, and we have two drugs in development. We have a lead drug that is pending approval from the US FDA in June of 2025 this year. And the second, I guess, finish phase 1 clinical trial in the UK. And we are in discussion with the agency to proceed with the next stage of clinical trial in the US. So that's a quick background.
[00:04:14] Lindsey Dinneen: Wow. That's incredible. Thank you for sharing your story. Yeah. So let's talk about your company now. You've become CEO of this company. You're developing these products that are going to change lives. What first made you realize that there was a gap that needed to be filled in the market for this? And then, what prompted you to go, "You know what? Hey, I think I can have the solution for this or I can have the answer to this."
[00:04:38] Dr. Shalabh Gupta: The first question that you ask, understanding the unmet need in medicine, there are a lot of problems that you can address. So, to give you a framework, if I am thinking about a problem, I want to understand if a couple of things, and in order of priorities, these are: can I find a solution that with my resources-- resources is time, energy, and money-- can I create a product that will truly make it to the market?
Number two is that I also feel that one can get very blindsided that "I have a solution," but not understand what other solutions exist in the market. So understanding the competitive landscape. If I create this drug, this device, this product, and it is going to take three to four years in the market to come to the market-- which, by the way, in medical word is a still very fast track because it takes much longer-- what will the competitive landscape look like for 5 years down the road? So that's the second part.
And third is that what is the solution that I'm developing? Is it unique in terms of having a novel, either as a drug device or drug device combination, or as a patented drug, patented device, because in our industry, it's not really possible to scale up something until unless you have an IP or intellectual property protection.
And then from there onward, the last thing is also, who's going to fund me, how I think about funding, not for next six months a year, but also a continuum of the product development. If I think about all these 4-5 problems, then you start to narrow it down.
There are some problems that are very much worthy of exploration. For example, treatment of Alzheimer's, we all know it's a big unmet need, we all know there's a big market opportunity. But I realized that was something we couldn't do it with the products or the development candidates that I had seen.
So, being able to define where is the end point and goal. Being able to understand, can I make an impact? And when I say I, I speak for myself, but each one of us, I always remind entrepreneurs, we each one of us have our own deck of cards. We have to play with our cards, we can't compare ourselves with somebody else, or we can compare some other cases study.
So understanding more about what is so unique that I can bring to table that can I make a difference and then making a business around this where the thesis lies. Once you identify that, then there's a question about continuing to execute and keep changing your plan as you go along.
[00:07:11] Lindsey Dinneen: Yeah, absolutely. Well, I love your framework for thinking through all of those things. And so of course you use that when you thought, "Hey, here's this issue. I could potentially have a solution," and you went through this process. And then can you tell us about your innovation now and how that is helping and how you expect it to help change all these wonderful lives?
[00:07:33] Dr. Shalabh Gupta: So, so for treatment of kidney diseases, first of all, it has been one area of development that has not had that much of innovation. And, and I think that is where the initial part of the thesis was that focusing on nephrology of kidney diseases is not same as developing a drug for cancer treatment.
Cancer treatment changes every six months a year. The standard of care continues to evolve. Is there an unmet need in cancer treatment? A hundred percent, but the part is that the pace of innovation is very rapid. Is it same in nephrology? It's getting there, but it's still the development of a new products in nephrology still is not at the same pace.
So I thought there was something we could make a difference by a small company. The drug that I acquired from another company was a drug that had finished a clinical trial. So it had shown that the drug is safe. It had also shown some signal of it working in healthy volunteers. That's a phase one trial.
And the innovation came from a car battery company that had figured out how to make a big, large size pill to make it smaller. And sometimes greatest innovation, greatest insight come from the fact that when I talk to the kidney doctors, the physicians who take care of these patients there with the treatment of kidney diseases, they said the problem for these patients are the patients have to take 12 to 15 pills per day.
And this innovation allowed us to be able to make that number of pills go down from 13 to 12 or 15 to three pills per day, one pill with each meal. And then the regulatory pathway became a bit more clear that if I can show that our drug is similar to the drug that was in the market, maybe there was an opportunity to go through expedited pathway, which is what we did.
And I acquired the drug in 2018, went to FDA right after acquiring the drug to expedite the pathway again, thinking about de risking the development pathway. And as I mentioned in 2025, we are expecting the approval. So that is the process about it. And that's the story behind the lead drug.
[00:09:51] Lindsey Dinneen: Great. Excellent. So that is really exciting. And as you continue to go forward with this company and the innovations that you're creating, what is your ultimate goal or dream that you're really striving for?
[00:10:06] Dr. Shalabh Gupta: So, the focus for Unicycive is building new novel treatment for kidney diseases. Our lead drug is expecting approval in June 2025. But we have a second drug in development, and we continue to think about what will be something that we as a small company can bring to market. There are other areas of unmet need in kidney treatment.
But instead of doing too many things at the same time, we continue to think, "How do we grow our company? What will be the vision for the company three years down the road, five years down the road?" And what we want to continue doing is to develop the drug candidates, advance them. Right now, after the first drug we get through approval, it will be the second drug.
There is a thought process behind it. One of the biggest challenges that I've seen for smaller companies and startups is that they end up in doing too many things at the same time, which is difficult to do, even for big companies. You know, big companies, they have a one product that is a marquee product, they launch that and then they develop other things. So, being able to stay focused is also key because you can have a lot of energy, you can have a lot of ideas, but you have to focus on which one you can do first.
[00:11:22] Lindsey Dinneen: Yeah, that is so true. It's such great advice, a good reminder. Yes, focus is so important. You know, honestly, that's probably one of the tricky things that startups in this particular field might struggle with is that focus. So I'm wondering what kind of advice do you have for say a brand new entrepreneur in the industry who has these great ideas, but you know, maybe has so many that they're a little too scattered.
[00:11:52] Dr. Shalabh Gupta: Right. So, I think you may start with 10 ideas but the framework I gave you that: can this idea in this given timeframe with my resources and the funds that I can raise, can it make a difference? So you start to narrow it down. You start with a big funnel, narrow it down. And then maybe you have two or three ideas. Instead of thinking to yourself that "No, I'm not going to tell my idea to anyone because somebody else can take it away," find people who will be willing to pressure test those ideas. Then you will have identified something, maybe one Idea that is worth the pursuit. So then you focus on that.
So that's one part of how to triage it because we all have ideas, but those ideas may not be worth developing once you go and talk to the marketplace. And marketplace is your investors, the physicians, and the patients. I keep saying about these three stakeholders, because if physicians cannot prescribe what you are developing, then it's of no use. If patients don't necessarily benefit, then it's of no use. And if you cannot get insurance companies a reimbursement for that means the product will never get here.
So it's a process, but nobody can come up with an idea. And there is no great idea. There are ideas that you have to, and then once you find that one idea that resonates with all the stakeholders, physicians are excited about it. If you talk to patients, and you want to do that early on, you don't want to develop an idea and then go, you know, that is the greatest idea but nobody really perceives it that way that except you and a couple of your friends and people who work with you.
I don't mean in a bad way. I mean, that you want to be able to test this idea very quickly. So once you get that idea, once you identify what is that the company should be focused on, then the question about is actually building an execution plan. And the only advice I can give is that at any given day for a company, startup, especially whether you're a founder or you're a founding team member, the list of priorities is 50, 5, 0, or maybe 100. It takes time to figure out of those 50, which are the top three that are most important and then being able to focus on those three.
You know, the reason I say that no one can work on 50 priorities at the same time. But we all can take two or three priorities and say, "These are the three things that I'm going to work on today. That is this week. Those are the things I'm going to do this month." And therefore you start to develop identifying priorities. The right ones takes time. Sometimes it is a fundraising. Sometimes it's a building a team. Sometimes it's a product development. Sometimes it's all three of them, but being able to allocate your time and energy and focus is a key.
People say it's the question of money. I don't think it's a question of money. Money is one of the resources, but the biggest resource we all have is a time and energy and focus. In a company of our size, we are a publicly listed company, and we now have grown from where we used to be, and it's still small. Even today, there are a lot of things we choose not to do. We choose not to go to conferences. We choose not to publish papers.
If something is a priority to us, we say, "This is the only thing we're going to focus on. This is the next three months, this is our main goal." And every team meeting I have, I always remind people, three priorities. More than three, way too many. One may not be enough. But because if you can't remind people, what is the priority for the company, then you will not succeed. It is a very challenging environment to think about a startup company or companies in general. And when you have too many priorities, you tend to lose focus on.
By building priorities, having priorities, executing them. You create momentum, you create confidence. They create success and you keep climbing the ladder. But truly the biggest challenge for us in the beginning of the career is that identifying which are those three priorities that matter. And once you have had some experience, then the challenge is to keep those priorities and change them as you go along, right?
As you go along, you have to continue to grow. For example, in the beginning, it may be the five people you have and that may be enough. But as where we are in the company, it's a question about growth of the organization, right size, not too many people, not too little, hiring enough people so we can continue to execute on our vision and the promises that we made to ourself and to our investors.
[00:16:27] Lindsey Dinneen: Thank you for that advice. That was fantastic. And such a great way to narrow it down and help people understand how to narrow down so that they can actually focus and succeed before moving on. I love that. Thank you. So, you know, looking back over your life, and of course, you've had such an incredible career that has really taken you in a lot of different directions. Could 10 year old you have ever anticipated where you'd be today?
[00:16:54] Dr. Shalabh Gupta: I don't think so. I think I think we all have a what I call a true north compass. What I did think at the 10 years of age, if I can go back, maybe 10 is too early but maybe 15 or 16 or 17, that hasn't changed. Let me tell you 2 things that I always felt most inspired and excited about.
Number one was that I wanted to be in healthcare because, intellectually, I like biological sciences. I felt, "My gosh, what could I do with that if I could make a difference?" And number two was that I, from very early on, I wanted to be something which could help people directly. As you know, there are many ways you can help people, but being in medicine or healthcare, I felt there was a direct impact.
Now, looking back after several decades, I feel that part of the influence was my dad. My dad is a physician, continues to see patients and do pro bono work. So that had a very lasting influence on me. That helped me to think about, okay, this is what I want to do. Then being trained as a physician, then going to work on Wall Street, then there was a question about understanding how the impact can be broadened, if you will.
The way to think about what I do today versus what I did, say, as a physician, physicians see, say, 10 patients, maybe 12 patients if you're seeing an outpatient basis per day. And if you're in an ICU or ICU doctor, an ER doctor, you could see more number of patients, but then smaller time. And you multiply that impact that many patients, let's just say 10 patients per day, and you work at 300, 350 days, 360 days, 365 days, don't take any break, but that is that many patients a year.
What we do today has a potential to impact hundreds and thousands and millions of patients and not just in the U S, globally. So from one vantage point is just magnifying the impact. And the other vantage point is doing what I would have done before. I still love sciences every day. My job is to not just talk about business, but also think about, "How do we fundamentally solve the problem?" And having had those experiences you know, it helps you to keep yourself grounded.
One part, I know this wasn't your question, but one advice I can give people who are thinking about developing their careers as an entrepreneur, if you are a founder and CEO, especially think about your career or skill set as I spoke, a wheel, a circle. Every skill that you have, some of us start with more technical background, like me and MD. Then you have to develop their finance and business skills and the business development skills.
So sometimes people say, "Well, you know, ABC went to grad school and they dropped out of grad school and they started a company." That's wonderful, but think about much longer beyond a two-year, three-year, five-year time horizon. And that's what helped me to think about my career.
So I worked on the Wall Street, but that gave me a finance and understanding about how public companies are valued, not just by the company, but how stock analysts value the company, how investors value the company, what moves the stock, what did Genentech to understood. That gave me the chance to understand how a big biopharma company thinks about their product development. And at Genentech, in some interactions we have had, we were looking at the products from other smaller companies, either to collaborate with them or to acquire those products. So that's a different skill set.
I went very early on, as I said, in my career, I went to FDA. So even though I'm not regulatory expert, but I understand how agencies think about the product approval so that helps you to make a more of a holistic viewpoint because the business has become more complex, and you cannot just have a only business degree and you say, "Well, I'm going to succeed." Some people have rounded that up by years and years of experiences.
And then there is also innate desire to learn. I learned from not just doing the work I do every day, but my, my, you know, talked a lot about it. I read anytime I get I read books that are not related to medicine, that are not necessarily related to health care, because you have to understand how to grow a revolution. You have to understand leadership skills that are not necessarily taught in schools. So, you have to find a way to continue to refine yourself, because the only way you can create a great company is to become a better version of yourself.
[00:21:31] Lindsey Dinneen: Thank you so much for talking about that and for sharing your advice. And I love that image of the wheel. It's a good reminder that sometimes life takes you on very interesting tangents, but sometimes they all do merge at some point. You've got this little sliver of this knowledge that you're working on, and then this experience, and then they start building and I really love that, that, that way of thinking about it and also remembering that It's very useful.
So, so like even earlier, I was struck, you talked about how there was inspiration from car batteries, right? And so how interesting is that to go from, what you might expect within your industry, here's how to solve a problem. But then you guys went outside and said, how do other people solve problems? Like maybe we can borrow from that. And I think that's really cool.
[00:22:21] Dr. Shalabh Gupta: And I also think that if you stop focusing on only in your industry, learn from anywhere. Some of the best learnings that I have personally, that felt inspirational to me, did not come from biotech companies. They come from tech companies, truly. When you think about the worst, most successful tech companies like Amazon, Apple. I can go on and on, but there are things that you can learn from them. There are things you can learn from the founder of Amazon, Jeff Bezos. He talks about building Amazon and he talks about doing many experiments at a smaller scale that fail at Amazon in order for them to succeed at a few that really work.
And this is where I was saying that culling the ideas, you may start with 10 ideas, but no one can develop 10 ideas, no one. And it's not because of money. People say, "Well, that if I had money." There have been numerous examples where companies have been funded with lots of money and the companies fail. Part of the problem is that when you get too much money, I think you may not realize that you still have to deliver. Because focus and execution takes really knowing what the target is, and then hitting the target and not one time and time again. Targets may change, but the companies cannot focus in 20 different things. In the beginning, you have to start with a very key thesis.
[00:23:39] Lindsey Dinneen: Yeah. Absolutely. Absolutely. And yeah, so learning from other industries, and that actually kind of also brings up a thought. So as you've gone along in your career and you've had many different iterations of who you are and what you bring to the world, now, are there any moments that really stand out to you as affirming, "Yes, I am in the right place at the right time?"
[00:24:04] Dr. Shalabh Gupta: Yeah, that's a very good question. And I have had a chance to think about it every now and then. So there are there, there are certain observations I'll make. You know, people always say, " What will be your dream job?" And I think the dream job for someone is the job that which you will do any given day, and you will feel a joy that you're doing it and you're not doing for remuneration. You're not doing because you're going to get paid.
And we all have those different moments in time. People talk about "flow" where the time stops because you're doing something so deeply engaging that you lost track of time. You forgot where you are. You're not feeling tired. For me building of this company and the team that we have assembled at Unicycive is that flow. Any day that I'm not traveling, I am in my office. I don't work from home. I am every single day in my office.
And sure we have a small team, but when we work with the team, these are motivated, driven people with decades of experiences. We feel that we are in a common mission, like we are solving the world's greatest problem. And I know that may be exaggeration, but that's how it feels. And being with them in a room and thinking about a complex problem-- and not just thinking of a problem like how big companies think about it-- but thinking of the problem in a scientific way, but delivering it a solution that only a small company can do that to me is a joy.
Number two part is that as I've gone further on my career, I, I am a mentor to a number of startups from Stanford and UCSF, and many Stanford companies, many of them come with a very different problem than purely a biotech company. Since the pro bono work, I do this because I find by telling other people from their problem, I get to reflect on my own problem, and I do that on every quarter.
There's one or two companies and I've been really privileged. I feel one of the greatest joys to meet with these great CEOs and Stanford has been a great collaborator. They have a program called Start X in which they have these companies that are participating in a accelerator program. And Stanford's accelerator is different and unique that they don't take any equity. They provide you the opportunity for mentorship. I was part of that program many years ago.
So I meet with the CEOs and many of these CEOs will come very different problem. As an example, there is a company that's focused on artificial intelligence using interaction between a physician or healthcare provider and patient, and being able to use AI to streamline that interaction. That is a point that I saw of 10 years of clinical practice, how that communication is broken, literally is broken.
Patients go to doctors, not because doctors are the world's greatest knowledge source, but patients at the end of day, they need someone to help them feel better, help them understand the problem that the physician can solve it. What ended up in being in today's healthcare system in the U. S. is that doctors have become mechanical and not because doctors are bad, because we are given these many things to document these many things to chart.
If you talk to a physician, a primary care physician, many times the physician is sitting behind the computer screen. Those bedside manners are gone, like literally they are not there until you go into concierge medicine because the physician has to fill up this chart. I practice medicine.
So understanding how this company and this CEO, this entrepreneur is trying to solve that problem, I lean back to the years of clinical practice. Then I lean back to the building the company. They're prioritizing it, having three priorities, having five priorities, and then being able to understand. And every company has some things which are similar, growth of your product development, continuing to advance the company, continuing to tell the story, attracting the right team members.
It just gets magnified at a broader level. But the problems start similar, very similar. You know, think about when we talk about tech companies, Apple, the first thing they had to do, develop a product, then build a team, then sell the product, tell the, sell the vision, you know, and then continue to raise money.
And that part is seems sometime very lonely. It also seems that I am uniquely burdened with these problems. And I always remind people, "You know, as much as you would like to think that you are unique. I assure you, it is not a problem that we are gifted with. We all have to face the same set of problems, sometimes more, sometimes less."
So then you start to take them less personally. You start to say, "Okay, I'm not the first one to face this problem. These problems have happened to people like me before and they will overcome. How can I do it?" Then you'd become safe, a solution based thinking versus a place where you get overwhelmed with the problem because problems exist.
And if anyone is listening to this podcast and if they've developed a started a company, I can assure you the problems come with a flood. They are not going to end ever. So it is disappointing. Sometime it feels that, "Oh my gosh, it is me versus the world," but it is not so. If you have good set of mentors, people who are not directly involved in day to day in your business, there are people who can help you think through it.
And that is something that I find a great joy in talking to these CEOs, being able to help them understand the problem. And I say, you know, a couple of hours a month, but then when I go back to my own work, one that I realized this was the same problem I faced a few years ago. Two, it's a similar version of the problem I face at a slightly larger scale today. And three, being able to step out of from your own narrow zone, it gives you perspective. Then what I said to you about that problems are not, these are not personal problems. These are the problems we all face developing a product. It doesn't matter whether you healthcare.
People tell me health care or product development is really hard. You talk to my colleagues, our CEOs who are running tech companies. Products in development and tech companies may seem easier, but to create a great product that truly solves customers problem, it's not easy.
[00:30:30] Lindsey Dinneen: Yeah, and well, I love that mentorship and sort of teaching and guiding, giving advice to the next generation is something is of a core value of yours and something you really care about. And it actually is a great segue into my next question, which is just pivoting the conversation 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, what you're doing right now, but it doesn't have to be. What would you choose to teach?
[00:31:02] Dr. Shalabh Gupta: I think as much as we all feel that entrepreneurship is an external game, I think it's a lot of internal mindset, being able to understand yourself better. Being able to understand who you are, what are your true core values, what really drives you. It takes time and it requires a continuous interrogation, asking yourself, "Is this really what I enjoy?"
Some of us feel it's a glamour that we feel like we want to be CEO. Some of us would be better off as a CTO, Chief Technology Officer. Some of us would not want to do startups. It's not for everybody. And it's okay because you can work in a bigger company and can be, you know, people talk about entrepreneurial pursued within a large organization. Maybe that's what for you.
But being able to understand yourself, it's a very important part. And I think unfortunately, formal education does not help us no matter what degrees and which schools. And it really doesn't matter whether you a science degree, MD, PhD, or your business school degree like MBA, we're all very uniquely different, and we have different values. What one person sees inspired by, for somebody else, it may be a nightmare, you know.
It's a thing that people think that startups are so much fun. I read a joke. It says, "People leave 9 to 5 job to work from 5 to 9, which is 5 a. m. to 9 p. m." So I think that's because this is some truth to it. And I've said to people again and again that if making money is your objective, please don't go as to run a startup. It is probably the worst way to think about pursuing the financial part.
You do something because you have a faith and belief in something. And it doesn't have to be the faith about changing humanity. It's about something that you have a unique skill set or unique product idea that you believe you can bring to the marketplace. The biggest focus we all can have is making an impact. If I can serve a large number of patients, I can serve a large physician, I will have a product that will make money, therefore, that will make money for enterprise that will make money for investors. And therefore, as a company, we will make money.
It's a very simple truth, but we like to make it complicated. I really mean it. The more I got to understand this part of the process better, which goes back to the basic thing that I said to you, if you said that you have a master class, the one thing I will say to you, it's spend time to understand yourself. And it's okay to realize that what I thought I like, I don't like it. The part that I talked to you about flow, it takes efforts.
I've had many careers, but when I work in my company, the time can stop for four or five hours, literally we can be working on something. And I have a team and it's not just me alone. I have a team that when we think about a problem, these are people who have spent three decades in working in different companies, large, small, many size companies, we could work cohesively, collectively, think about a problem.
And that to me, it's a joy. For me, that is a creation, right? You know, we're thinking about the problem, which may be a design of a clinical trial, because we have to think we have to use brains. And I always say, "God gave us a gift, which is a neuron. So use it, let's use them." And challenge yourself, right? And the challenge in a good way, not be a condescending ending jerk and say "No, how could you do it?"
I try to say to people, "Look, I understand this is how it is done, but I want to do two things. Number one, please believe me that we can do better, faster, cheaper. And number two, I promise you that whatever I'm telling you, I'm not going to tell you and walk out of the conference room. I will work hand to hand." We call it a hand to hand combat is essentially that I'm not just telling you I'm going to work with you. I want to find the solution, but we can't do that thing that are you used to.
Every trial, people tell me it's going to take 18 months, 12 months, it's going to cost as much. We shrink that thing timeline cost by not 10, 20%. We talking 50%. And these are people have done this before. So, so I need the courage to be honest and say, "No, we can't do it. We have to do it faster, better, cheaper, but how?" And then asking them. So, I say, "It's okay that we walk away and we don't have a clue. It's okay. Today's Thursday. Let's come back. Take three days to think about it."
But the reason is that because when you ask yourself from a place that I can't do it, the mind is start to find solution versus when you say, no, I can't do it. Because in that case, it's a subconscious mind that keeps on giving you 15 reasons why you can't do it. People talk about growth mindset. I've always said to people, "We may not be able to do this thing today, but the understanding that with a little bit of help, a little bit of patience, a little bit of it, making ourself better, we can become that company, we can become that organization."
And that really requires challenging ourself. And that's where I went back to. I want to go back to this question you asked earlier. People talk a lot about entrepreneurship as if it is some very specific skill set. I think because if you know yourself, you know what is your true zone is, then you want to surround yourself places that you are either not good at, or you don't enjoy doing it, right?
In the beginning, it is just you and a vast amount of problems to face. Then you start to build your team. Then you start to see yourself, "You know, maybe Bob can do this work. I really, I'm not that good at it. I don't like doing it." Then you start to rely and surround yourself with not same skill set, but the people who are complementary skill set. And that's how you build a team. That's the foundation of team. Then you build trust and you say to Bob, "Whatever you do, it's not your fault. I'm here to protect you." You don't point fingers at each other.
We always remind the example of Navy SEAL. You know, I've never worked in the US Army. I was not an Army veteran, but the ethos that Navy SEAL uses where the team wins, I always tell people we are a winning team. We are not looking for MVPs, you know, because the teams win. Teams create products, teams create value. Individual glories is not useful and this is something you have to keep reminding us that we keep drilling it down and say " No, it's not Bob. It's not John. It's not James. It's us. It's as a team."
Again, as you grow through the company stages, your skill set has to continue to evolve and people always say, "Well, how do you lead a team?" The first thing that I always said, "Every single person in my team, you are a leader. Why? You wake up in the morning, brush your teeth. You're leading yourself." Really! Like, what do you do with your day? If you happen to be a parent or partner, a spouse or somebody, you have people you influence around yourself, right? So instead of worrying about, "Oh, you know, I want to lead a company."
First, you have to lead yourself and you have to lead with courage. It's starting a company, building a company, right? Yeah. No matter what the media tells you, it is hard. It's hard to develop a product. It's hard because the challenges are not one or two. There are many. Being able to drill down, saying "These are the three things I'll focus on. These are the only things that matter." And then if something new comes up, you have to face that challenge and put the third in your list. It comes in a different page.
You know, I use this basic exercise. I have a notebook, a physical notebook and not electronic one, and a piece of paper. What are the top three priorities? And then the other part is that I've asked people to do this exercise when startup companies, CEOs come and tell me all their problems, all the things they want to do. I said, "Humor me if you will. This is the end of the year. And let's say today is we are in 2025. What would you like to tell yourself a year from now? If everything happened the best you could imagine, how many customers, how many products, what will be the stage of product, who would have funded you? Who are the people behind you?"
And I asked him to write in a whiteboard. And I say, imagine, no, this is the five thing. If they write 25 things, I say, "No, this is down to five things. What are those five things you would like?" And again, everything has just gone and you can't believe you're sitting there. What will it take? Is it this? And then you start to have a goalpost, right? It's a target. Then you work backward.
[00:39:37] Lindsey Dinneen: Yeah. Yeah. Well, that's great. That is such great advice. So thank you, first of all, for sharing, but I think in general, your masterclass would be so much-- you'd have to have a full day or more. That's great though. I love that. How would you wish to be remembered after you leave this world?
[00:39:57] Dr. Shalabh Gupta: That's a very good question. That's one that I ask myself every day. The most important thing for me is to be who I am to make a difference for people who are around me. For me, my family is very important. I have kids and I always think about it. What will my children remember?
Then it comes down to people who work with me. We want to give an experience to people. I've had people who have worked for I keep saying it two or three decades. My true wish is that I always say for whatever time they work at Unicycive, I want them to be remembering this is the best time they work for a company and that is the best hope we can do it. Because as a entrepreneur, if I can make our company the best experience, best environment, then that creates the best products.
And a company like us, we realize that we are going to face challenges and it's not a question of this, the question is how many challenges. The question is not going to be, "Will the challenge defeat us?" The question is, "How do we overcome the challenges?" So it's about growth mindset, having a very distinct, clear vision and empowering people.
And last thing is that what we do in healthcare affects millions of people people. Our drug is not going to be just in the U. S. We have partnerships outside U. S. We think about patients in China, South Korea, Southeast Asia. We are talking to companies in Europe. It's an opportunity to make a difference globally. And that is what keeps us going. That's what, you know, when that's when I talk with flow, that is what makes you want to work, whether it's a weekend or whether it's a late evening.
And I think that is something which we all need to do to find something that is meaningful. And meaning means different things to different people in different phases of life. So it doesn't have to be, you know, I tell even my own team member, " Unicycive does not have to be the purpose of your life, but let me help you to manifest your best version so you can work well, because you are working here, you are spending your time, might as well make it meaningful for you and for the company."
So finding that balance is key and it's a constant challenge. I never take anything for granted. It's a constant to my own team members. How can we make it better? You know, people always say the company grows and we started with the company. We went to IPO with one person. That was just me as an employee, which is not a common thing. I frankly don't know any other company that I've ever seen that went to a straight IPO with one employee.
But that wasn't about me. It was about building the company, building the team. Today, we have 25 or so more, but it's still a small team. And people always ask me, "How do we go from 25 to 50 and it still remain the same." I said "Exactly how we became 5 to 10 to 15, 15 to 20." Because if you keep the culture same, focus same, and you remind people that it's not about who we are individually, but it's what we could be collectively.
And you have it going and you know, something you're passionate about, you will give all that you got and then some more or else there is not worth fighting for because life is hard and building a product developing a technology or running a company is hard. So, either you are a full believer or else you can't do it. I mean, if you can do it, it's going to be miserable on both front. You want to do a good job and you will find it very difficult. So.
[00:43:24] Lindsey Dinneen: Yeah. Indeed. Yeah. Excellent. Well, and then final question. What is one thing that makes you smile every time you see or think about it?
[00:43:36] Dr. Shalabh Gupta: I think when you look back on the challenges that you once thought were unsurmountable, and then you say to yourself, "Huh, that was just a curve in the road, not a roadblock." Then you start to smile because of not because how smart you are, but how much together a team can accomplish. And you start to find, if you're working in a company setting, you start to feel that people start to feel empowered. My team says that you did it. I said, "No, we did it. I just showed you a judicious path, but you did it. I didn't do it. All I said to you is to change your framework."
Because it's a framework. It's a mindset. And I keep saying about mindset because if you come with the idea that " No, I only, I need this much money, this much time, these many resources," you'll find you the subconscious mind keeps on validating those challenges. But if you say, "No, people like us have done it before I can do it, we can do it." And give them the time and space and say, "Look, you don't have to have an answer right now, but please go back and just think about it."
Then they come back with the answer and they themselves surprised. But it truly requires a authenticity, a vulnerability, and being absolutely willing to fall on your face and get up and just fight again. And that's part people don't realize. People think about that every company is a smooth road up, but the companies go through the cycle. It's not when you're going up, it's what happens when you fall down. Can you pick yourself up?
And it's not just with your team, but with your investors too. You know, we thought that we're going to file an NDA in 2020. You know, 2024, we had planned for everything and the whole thing was there, but we ended up in having to run an additional trial and then you have to communicate with integrity through transparency. This is what happened. This is what is there, but we can accomplish that.
So then that all of all that helps you to look back a smile, laugh and say, "Okay, I accomplished that. We can do the next one." And that keeps the growth happening. And at the end of the day, we are not happy because we accomplished small things by doing small effort. Most of us as human beings want to be challenged in the right way and we feel joy in doing hard things that take a lot of efforts and once seemed just impossible to do it.
And the question is, can you do it with your entire team, not just personally? And that's what inspires people. We want to be that company that people want to work for not because they need a job, not because we can take care of their 401k. I mean, those are a wonderful thing and I'm blessed that we can do all of that, because once upon a time, we didn't have any of that. So I don't take it for granted, it is something. But the fact is that what was the mission hasn't changed ever.
And you know, that that is something which is worth pursuing it. And I think if people start to see that they can accomplish that, these challenges are not personal, that they are bound to come. And then they have a support group, you know, we all need somebody other than ourselves and people whom we are surrounded with somebody to hold our hand and say no, you fell down, but it's okay.
You can get up. I think it's that support system, right? The more you can have it, the more different types of people you can relate to and call them friends, mentors, that helps. And I have tons and tons of them because my gosh, I mean, there are days seems like, how would I ever get out of this? As much as you may think that I have all the source of inspiration, but then if somebody else holds your hand, they say, no, you can do it. That is what gets you going to the next step.
[00:47:25] Lindsey Dinneen: Absolutely. Well, goodness, this has been an amazing conversation, just packed full of incredible, helpful advice, and just very practical down to earth sharing. So thank you so much for your time today. I really appreciate everything you're doing to, to make an impact. So thanks again for your time.
[00:47:44] Dr. Shalabh Gupta: Thank you very much. Thank you for hosting me and thank you for your time and interest. Really appreciate it.
[00:47:49] Lindsey Dinneen: Of course. 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 we just wish you the most 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 right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.
[00:48:31] 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.

Zed Williamson | Founder & CEO, TrackableMed | Neuroscience & Mindset, Aligning Goals, & System Optimization

Zed Williamson is the founder and CEO of TrackableMed. He explores his transition from the advertising world to the medtech industry, where he applies neuroscience and behavior change principles to optimize medical systems. Zed discusses the importance of bridging the gap between clinical information and human connections in healthcare, and shares insights from his two podcasts aimed at medical sales and private practice growth. This discussion is packed full of practical advice for leaders in all industries. 
 
Guest links: https://www.trackablemed.com/ | https://www.linkedin.com/in/zedwilliamson/
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 055 - Zed Williamson
[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. My name is Lindsey, and I am so excited to introduce you to my guest today, Zed Williamson. Zed is the founder and CEO of TrackableMed, a medical growth platform established in 2011 focused on delivering tangible results for healthcare professionals.
He emphasizes that every system is perfectly designed to achieve its current results, and believes that by identifying and addressing system constraints, meaningful change can be achieved. Through TrackableMed, Zed applies neuroscience and behavior change principles to help private medical practices and medtech companies optimize their systems.
He also shares actionable insights as the host of two podcasts, The Medical Sales Accelerator podcast, providing tips and secrets from the industry's top performers, and The Physician Growth Accelerator podcast, aiming to assist private practice physicians in balancing excellent patient care with successful practice management.
All right. Well, welcome, Zed. It's so nice to speak with you today.
[00:01:50] Zed Williamson: Thanks for having me. Appreciate it.
[00:01:52] Lindsey Dinneen: Absolutely. Well, would you mind sharing a little bit about yourself and your background and what led you to MedTech?
[00:01:59] Zed Williamson: Sure. So actually I come from the advertising world, which maybe seems strange. I thought it my life plan was climbing the corporate ladder, and I thought it was a really good idea, and then I realized I despised the industry. I just thought it was totally riddled with a complete lack of accountability to actual results. And it wasn't feeding my soul to, to be working in that space. And so I started a company called TrackableMed back in 2011 with the idea that we all are, we're working with humans have brains and brains are pretty predictable because of the understanding of neuroscience and cognitive behavior, bias and heuristics, and that we could create a company that would help medical practices grow by bringing in very specific patients.
And that's when I was introduced to the medical device industry because the people and the organizations that witnessed the work we did for private medical practices first was that medical device space. And that really opened my eyes to this amazing industry where, unfortunately, patients don't know how much amazing technology there is out there. There's patients making uninformed decisions about treatment plans, and there's something better. In most every case, there's something better. So that really does feed my soul. And this idea that we kind of take ownership of it is our job to help people realize that they don't have to live the way they're living and that's really what fuels the organization.
[00:03:28] Lindsey Dinneen: Yeah, well, that's incredible and very important, obviously. So I want to go a little bit further back in your personal story first, and then I definitely want to hear all about what you're doing now. But back at the beginning, could you have anticipated that you would end up in this field and doing the work that you're doing now? Or was this just a happy evolution over time?
[00:03:48] Zed Williamson: I had major knee surgery when I was 16 years old and I thought physical therapy was really cool. Like I, that's where I thought I wanted to go. And too much math and science. So, so it was not the direction for me. And I really wrapped my head around human behavior, this idea that everything is so predictable. Our brains were built a long time ago to exist in a world that doesn't exist anymore, and when you understand the bias and heuristics of the brain, you can literally create and predict behavior. So that's why I went into that advertising space, because that felt like a better fit for that.
The way I came back to medical was, I actually heard a commercial for a procedure that sounded really interesting, and it was a horrible commercial. And I just, I did some research and realized that no one who had what this procedure would fix would ever think that procedure would help them. But once I realized what that procedure was doing, it was almost like I had to carry the flag and run this up the hill, because there's people who don't know that this exists, and that's how I kind of dipped my toe in and learned, and then I just got honestly addicted to the curiosity around what else is there out there from a technology standpoint.
[00:05:13] Lindsey Dinneen: Absolutely. So you started exploring what else was out there and then you formed your own company, which is a consulting firm and more. Could you speak a little bit about that and how the company has evolved over time too?
[00:05:25] Zed Williamson: Yeah, so started TrackableMed in 2011 really to help those practices. And what we learned is that medical practices generally just kind of-- this may sound strange-- but they generally sit around and wait to see what patients show up. And there are some amazing technology opportunities out there. And even medical device reps will, like when I say this, they'll go, "Yeah, I hear that all the time." And that is that a lot of times physicians are looking for perfect patients to use technology. And it's because maybe they're new to it and they just, they want that perfect patient.
So what we were good at is getting the perfect patient. And what we realized is the services we were providing direct to private practices also worked for medical device companies because if medical device companies took ownership of educating patients about the life they could be living, you really drove massive adoption of these devices.
So if you think about a physician, the training they go through, generally they're not really big to change, right? That's kind of built into them. They spent a long time learning abnormal anatomy, normal anatomy. They see abnormal and they go, "Ooh, we've got to fix that." And that's their mindset.
So when you're a medical device company and you have something that is better, and you know what I find is 99 percent of the people I meet in medical device are really passionate about getting the word out because it's better, right? It's like, we don't have to do it in the old way. You're doing a surgery that was done in 1942. There's something different now that's actually got better outcomes.
So anyway, but physicians are biased against that change. We see a lot of biases that pop up in that behavior. But one of the quickest routes to changing that behavior is have patients ask for it. Because it removes the, kind of that bias that they're not doing something they were trained and they're actually now serving the patient. And so what we started doing with the Medical Sales Accelerator is working with medical device companies on creating programs to make it so patients were saying, "Hey, doc, do you do the blank procedure?" And that would help drive adoption.
[00:07:39] Lindsey Dinneen: Yeah. Okay. That's incredible. So you have this consulting portion, which is huge. And then you also have podcasts. And I was wondering if you could share a little bit about your inspiration for introducing these podcasts to the world and what you hope to accomplish through these as well.
[00:07:54] Zed Williamson: Sure. And the two podcasts are very different. The Medical Sales Accelerator podcast is about putting the spotlight on the best of the best in the medical device industry. We talk to authors that have written books that have really impacted the industry. Jeffrey Moore was one of my favorite episodes. That was awesome. And the challenger sale, like there's a lot of really cool stuff there. And what we really built it for is we wanted people, who had some windshield time, to be able to listen to something that was going to make their next interaction with their customer better.
And so it's an interview style podcast. It's leadership in medical device. Sometimes it's sales leadership, sometimes it's authors, but it's all around this incredible industry and really just a conversation about these little tips and tricks that people are using that help them be more successful. And that's been great. That podcast is four, four and a half years old. So we've been doing it a long time and I've got some really good feedback.
The other podcast is the Physician Growth Accelerator. And this podcast is not interview style. It is designed to give actionable tips to private practice business owning physicians. The episodes tend to be eight to 12 minutes and it's, you can walk away, implement something that you heard. We do share it with the medical device community as well, because a lot of times if you're a medical device rep and you have a piece of technology that's very similar to competitive to competitors, you're always looking to how can I bring more value? You know, what can I do on top of the technology? And so we found a lot of medical device reps will share episodes from The Physician Growth Accelerator to their customers because they witness firsthand what is going on in the practice that can be very frustrating.
[00:09:54] Lindsey Dinneen: Yeah, well, both of them sound incredible, and I appreciate that you have two separate podcasts that are really impacting the industry. And I'm wondering, getting to speak with all these incredible people and hearing their advice and inspiration and things like that, what are some of the common themes you've picked out from these in terms of challenges within the industry that may be, you know, through these conversations, or even your own consulting work, that you can help solve?
[00:10:17] Zed Williamson: Yeah, so I would say the biggest-- is such a good question-- the biggest challenge is something called curse of knowledge. And curse of knowledge is this idea that when you foundationally understand something, it almost automatically makes you worse at communicating it to someone who doesn't, right? And you see this in sales a lot, where a salesperson goes, "Oh, you know, this one's great because it's got the X942 va ba da ba." and the person buying has no idea what that means and you're not helping.
And the thing that medical device very commonly miss, is they have this passionate route for the existence of their technology, the years, the effort, the expense, and they are thinking big picture, like it's really important that we achieve these things because we are changing lives. And then, they go to their customers, and they show them the X948, you know, vibidabidabada, right? And they're just trying to live in this world of, "Well look, this one has a number on it," or, and that's where we see the biggest challenge, is: physicians, surgeons, they're humans too, they connect with stories. They are actually in it to help patients. And that big disconnect is a challenge that you see almost every company face. Part of it is cause they're so excited about all the work they did that they're not using the foundation that got them through those speed bumps to actually help someone else wrap their head around the concept.
You know, it's just like if you cook an amazing meal, the person who watched you do that appreciates it much more than if they just tasted the exact same meal just served to them. If they see the effort you went through and why you did slice the onion this way or whatever it is-- maybe that's a weird example-- but, it's the biggest myths that we see across medical devices. They get trained to clinical information and they go try to have clinical conversations because they think doctors are going to make a logical clinical decision. But humans are not logical. We don't do that. So that would, that would be number one.
[00:12:24] Lindsey Dinneen: Yeah, that's absolutely core. And then how do you bridge that gap? Or how do you encourage people to think through bridging that gap between, yes, we love that you have all these shiny features that are very important, but they don't necessarily mean a whole lot to your end user just yet. So how can you help bridge that gap between all the shiny features that the engineering team wants to talk about versus how does this benefit that end user or the physician or whoever needs it?
[00:12:52] Zed Williamson: So a lot of it is understanding truly what the bias that this person may have against changing. It could be that they're uncomfortable with change. It could be that they don't want to make a decision that potentially is worse than the current thing that they're offering. And if you understand what is holding this person back, it's going to put you in a better position to understand that perspective.
But your conversation needs to be about aligning goals, asking questions. The medical device so often talks too much. They tell, as opposed to what's important, what's frustrating, what do you wish. "Tell me about a patient that it crushed you because you couldn't help them." So it's about connecting on the human side to see, is there actually a reason why this person should do something different?
If you go to a neurosurgeon and they don't do disc replacements, and you just try to bulldoze in and say, "Hey, a lumbar disc replacement is better for a patient than putting in a cage," you're not getting anywhere with that person. But if you can talk stories of patients and help them understand from a life impact, because physicians only get to experience a blip in time in the health care journey of a patient, and it has to be that way. And if you can help them understand kind of the parentheses around the rest of that person's life, like what led that person to need this, and after they leave, what is their life going to be? And now, if your device influences what that impact is, that's where you have the most leverage.
[00:14:37] Lindsey Dinneen: Yeah, absolutely. And so, you know, one thing that struck me as I was reading through what your company does and all the value it brings to the world, something that really stood out to me was you said something along the lines of you are passionate about balancing patient care with the business side. So what do you find in that particular realm are the gaps? Because obviously, like you said, these are very caring individuals, super smart, very capable people, and they're experts in their field. So how do you help them to marry that expertise with the business side?
[00:15:07] Zed Williamson: Yeah. So, this goes back to bias and sometimes people will have a belief about something. Here's what's interesting about our brain. So someone may tell you that we can't control emotions, that emotions happen. And I would slightly agree with that. The reason I say "slightly" is because an emotion happens based on a belief and we can control our beliefs.
And so what can happen is if someone believes that financial success is not good, then they are going to have an emotional response related to anything that goes down that path. But that is a belief that you can change. And, the biggest issue with business and healthcare is, there are organizations, unfortunately, that they're not seeing the patient in, from a standpoint of what we do. They're looking at a bottom line only, and that's why their organization exists, and I'm a believer that when you only focus on that, at some point, it's not going to go well.
If you focus on the patient, but be smart around the structure you have to the organization, you can build something that's very financially successful that's helping more patients. You're building a moat around your business so that you can continue to help those patients and we're helping more lives.
But it gets to belief first. If someone believes it's bad or wants to pretend they believe it's bad, because that's the thing too, then that creates that emotional response that really puts them in a position where they are going to have a hard time succeeding. And if you don't succeed on the business side, you haven't helped any patients.
There are medical device companies who've gone out of business and it's not because their technology was bad, but they didn't go to market in the right way. And how many people did we hurt by allowing that to happen? You know, if we actually felt like there was value, then we need to take ownership of creating something that can really sustain and help as many humans as possible
[00:17:23] Lindsey Dinneen: Yeah, and that's really great advice and insight, and you have this reoccurring theme, which is you have this psychology background and interest. Where did that element come from in terms of how did you continue to even elevate your own beliefs so that your emotions could also follow suit? But where did this whole thing come from that has allowed you to be so successful personally and then for your clients from that neuroscience and psychology perspective and background?
[00:17:51] Zed Williamson: You know, the origin story of that stuff comes from a long time ago, me wanting to help clients and realizing that the advertising world was broken because they were awarding creativity, and creativity does not equal success. The advertising world actually really hurt themselves back in the late 50s, 60s, where they started giving awards for creativity and it changed the reason people did something.
"So, hey, let me create something so I win an award." "Well, did it help the company that paid you?" "I don't know." That's not good. And so I've always been a believer that we really do exist in a state where we are always witnessing perfect outcomes of our current system. Someone might go, "Well, there's no such thing as perfection."
And I don't mean it's perfect from my perspective, but the system was perfect at creating that outcome. If I go and walk into a room and stub my toe, me stubbing my toe was the perfect outcome of the system I operated: the light not being on, shoes not on, not paying attention. And so the same thing with behavior.
And if we look at, you know, humans are pretty interesting from an organism. We have this fancy brain. We survived in a world we probably shouldn't have. We're not as strong. We don't have claws. We don't have big teeth. Most of us are not as furry. But you know, we still survived and it's because of the brain and the brain has this one thing to do: stay alive.
It does not know a grocery store is around the corner. It does not know that when someone cuts you off, that it wasn't a saber toothed tiger trying to eat your family. So if we just allow this brain that did a really good job of keeping us alive, if we allow it to continue running, then we're limiting the evolution of ourselves from what we can really be aware of and understand.
The idea that someone can make me angry is a really silly idea. It's not true. Anything you do, you can't make me angry. I have to believe something. Now you could do some things where you could maybe get a sense of what I likely believe and you might take some action and I would be angry, but I'm never going to give that power to you from the standpoint of you can actually make it so. You can't make it so.
And, there's an example I like to use to just help people realize how much perspective is in our control. You're driving down a road. It's 45 miles an hour, and you see this stop sign up on the right hand side coming up. And this car pulls up to that stop sign and there's something about the car or the driver, and in your mind you go," They're going to roll this stop sign and I'm going to have to slam on the brakes." It just, it pops into your head. Everyone listening right now, I know it's happened to you.
Sure enough, car pulls in front of you, you slam on the brake so hard everything in your chair or your seat hits the dashboard, your shoulders tense up, you get angry, maybe you say some things about this driver or the car, like, "I knew it." Blah, blah, blah, blah, blah. And so people are feeling that right now. You weren't harmed. Okay, there was no accident. You hit the brakes. You might get to your destination three seconds later than you originally were.
But here's the rest of the story. It was a mom driving and her child was in the back seat bleeding to death and she was going to the ER. Everybody's shoulders just went, oh. Wait, so now you're not angry, but nothing changed, right? You still hit the brakes. The stuff still hit the dashboard. You're still gonna be three seconds later than you were.
But our brain is designed to treat things with this fight or flight. And when you can understand that everything you say to people can be more helpful. Every witnessing of other people's behavior can be more helpful. In a work environment, if someone acts defensive, it's probably not because of you, it's they're in a state where their brain is trying to tell them they're in danger even though they're not, and they don't know that the mom was rushing her kid to the ER.
And so it was kind of like squeezing toothpaste out of a tube for me. Once I really wrapped my head around that understanding, I can't get it back in the tube, like it's now it's got to drive everything, right? Because there's so much value in it. There's so, I get really passionate because everybody on the planet can be experiencing more joy than they currently are without anything different in their life because it's purely perspective and understanding and knowing your own beliefs and then choosing, do I want that belief or does that belief actually serve me? Why do I believe that? Maybe I shouldn't believe that. So anyway, long answer. I don't know if I actually answered your question, but I kind of go off on a soapbox in those scenarios.
[00:22:39] Lindsey Dinneen: Love it. And I really appreciate that particular illustration because I think that was the perfect way to capture how much responsibility we are able to take for ourselves and our reactions to things. And it's such a good reminder too, that in the daily we get to choose. We get to choose what affects us, what doesn't, what brings us joy, where we can give grace and patience in a circumstance that we maybe know nothing about. Yeah. I love that.
So, you've gotten to speak with so many incredible people through your podcasts, through your consulting, and of course, you've worked with some pretty spectacular companies. What are a couple moments, or maybe a moment, that really stands out to you as just driving home the idea that, yes, I am in the right industry at the right time?
[00:23:21] Zed Williamson: So I love learning. I am really curious. And I don't think that there is a way for me to learn more faster than being in this space. There's things that we know about just human behavior today that it wasn't known 15 years ago. The technology is incredible. I had the CEO of a company that's building a remote control pill that you swallow and they swim it around your stomach to be able to scan your stomach lining for cancer without an endoscopy. They could ship it to somebody and control it from the other side of the world. That is fricking cool.
So there's so much unending opportunity. I think the exact, like I've always enjoyed history. I like learning, but I couldn't be in a role where that was my job. Like, "Hey, let's learn what already happened." I do like the context. I like thinking about humans, ancient humans doing things and how it affects us today. But I just think this space is, it's infinite from the standpoint of what's possible, what technology there is, the impact of that technology with the people that work in the industry, that work in health care and the patients. So it's just to me. It's just a vast place to play.
[00:24:44] Lindsey Dinneen: It's so true, and you can't get bored. Or if you get bored, that's entirely your fault, I would say, because there's so much innovation. And you know, like we were talking about even before pressing play, there's so much care and dedication and passion in this industry to really make a difference, and that alone is inspiring to even simply bear witness to.
[00:25:06] Zed Williamson: Yeah, absolutely. It's a big part of our entire organization. If anybody calls it up and says, "Hey, why do you guys actually do what you do?" Anybody would tell you it's to help people realize that they don't have to live the way they're living.
And if you know that someone is about to have a procedure that is from 1942 and they have one that's better, we call it, and this might be strange to share publicly, but we call it "pulling kids out of traffic." Like you wouldn't walk down a street and go, Oh, look, there's that kid in traffic. "I should just let him." You would do whatever you could to pull the kid out of traffic. And that's what I think medical device is really positioned, that's what they should be doing. They should be seeing these patients that they're helping and really attacking it from that level of passion.
[00:25:53] Lindsey Dinneen: Yeah, I love that. Yeah. And so, completely pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be within your industry, but it doesn't have to be. What would you choose to teach?
[00:26:10] Zed Williamson: Self awareness, 100%. The power your mind has and understanding that you are likely not under attack, that joy is not a destination. It's not a finish line. It's a decision. Man, if I could wave a magic wand and just make that where people really got it, it would be, that would be so cool. So I would definitely do that. And for a million dollars, man, I'd make it a pretty serious class. Lots of follow up, maybe even some role play for a couple of years. But the, yeah, that would be amazing.
[00:26:43] Lindsey Dinneen: It would be amazing, yes. And I particularly like your magic wand idea. I think it would change the entire landscape of the world, so I'm all about that. Excellent. And how would you wish to be remembered after you leave this world?
[00:26:58] Zed Williamson: "That he put aside his own discomfort and helping me realize what was possible." We have so many interactions with people and we can say like, "Oh man, you know, this person doesn't realize this." But then a lot of times the brain is saying, "Well, it's going to be uncomfortable if you bring it up." And so I think that cause I know I irritate some people and it's all, it's always out of love. But...
[00:27:24] Lindsey Dinneen: Right.
[00:27:25] Zed Williamson: ...but yeah, I would say that, "whatever he could to help me realize that there was more for me."
[00:27:32] Lindsey Dinneen: That's powerful. I love that answer. Yeah. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:27:42] Zed Williamson: Mmm. My family. Two boys and my wife, Nico, Elijah, and Chantel. We just have so much fun. Late teenage boys, well, actually my oldest one is 20 now, but it's all about laughter. What's cool is the sense of humor is so powerful because there's literally-- this would really could annoy some people-- there's nothing that can't be funny, right? It's always belief, right? And if you can have that mindset, and my family does, so anytime we spend together laughter is going to be happening soon.
[00:28:16] Lindsey Dinneen: Yeah. Well, it goes back to your whole thing about joy, too. If you choose joy, then there's also a lot more opportunity for laughter, too. Or it just comes a little easier, perhaps.
[00:28:27] Zed Williamson: Yep.
[00:28:28] Lindsey Dinneen: Excellent. Well, this has been an incredible conversation. I personally was not even expecting this deep dive into psychology, but I love it. It's fantastic. And I just really appreciate you sharing your passion and heart for the industry and for helping bridge the gap between the expertise and then reaching the people that they're intending to reach and having sustainable businesses so that people can continue to make a big impact with their work. So thank you for the work you're doing with the world. And thank you for your time today. I really appreciate it.
[00:28:54] Zed Williamson: I know the work it takes to put into a podcast. So I appreciate what you're doing and appreciate you having me on.
[00:29:00] Lindsey Dinneen: Of course. And we are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support, and we wish you continued success as you work to change lives for a better world. And thank you so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love if you'd share this episode with a colleague or two and we will catch you next time.
[00:29:36] 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.

Mildred Zayas | Global Supply Chain Executive | Operational Excellence, Worldwide Impact, & Mentoring Emerging Leaders

Mildred Zayas, a global supply chain executive with over 25 years of experience in the medical technology industry, shares her transformative journey from her early career in Puerto Rico to leading strategic initiatives at Johnson & Johnson. She emphasizes operational excellence, supply chain optimization, and mentoring emerging leaders. She discusses the importance of continuous learning, servant leadership, and the exciting future of MedTech with advancements in robotics and AI. Mildred also highlights her passion for empowering underserved communities and her involvement in nonprofit organizations like America Needs You. 
 
Guest links: www.linkedin.com/in/mildred-zayas/
Charity supported: Feeding America
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 054 - Mildred Zayas
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome Mildred Zayas. Mildred is an accomplished leader with extensive and global expertise in strategic planning, operational excellence, and supply chain optimization within medical technology and life sciences.
Well, thank you so much for being here today, Mildred. I'm so excited to talk with you.
[00:01:15] Mildred Zayas: Thank you for the invitation, Lindsey.
[00:01:17] Lindsey Dinneen: Of course. Well, I would love it if you would start off by sharing a little bit about yourself and your background and what led you to MedTech.
[00:01:25] Mildred Zayas: Of course. I'm a global supply chain executive with over 25 years of experience in the medical technology industry. I have had the privilege of leading transformative initiatives at Johnson and Johnson, where I optimize manufacturing network, particularly in Asia Pacific, resulting in cost savings, inventory improvements, improved customer service levels as well.
We also have introduced what I call the manufacturing ecosystems, which is instead of focusing on the product design on the customer only, which is important-- I'm not saying that it isn't-- but we also want to introduce a product that, of course, is high quality and dependable, but we also enhancing the efficiency and manufacturability is what is called designing for manufacturability.
Product design and manufacturing don't have to be mutually exclusive, and that is something that I definitely learned through my career. I was born and raised in Puerto Rico. I'm particularly dedicated to empowering underserved communities to achieve greater economic and career advancement. My career is driven by a commitment to operational excellence, strategic innovation, and mentoring emerging leaders to achieve their full potential.
[00:02:43] Lindsey Dinneen: That's amazing. Thank you so much for sharing a little bit about that. So I would love to go back a little bit further and start. When you were young, did you have any idea that something like this was something you wanted to do? What was your dream? What were you thinking about?
[00:02:56] Mildred Zayas: So I have to say yes. And I always, I'm an engineer by training and I always wanted to be an engineer. My uncle was an engineer. Even though he actually opened a university and did something different, he was pretty much, you know, I guess the big person in our family, everybody looked at him. We all wanted to be like my uncle, right? Unfortunately, he passed away. But with that, I always knew that I wanted to be an engineer. That's why I went to engineering school. Eventually, being an industrial engineer led me to the manufacturing industry.
I started my career in Puerto Rico and manufacturing was big in the nineties. Do we still have manufacturing? Not as much anymore. But that's how I started in the industry and in the manufacturing industry. And then I progressed through roles of increasing responsibility and continuing supply chain in leadership roles. But yeah, everything started by my family, my uncle and seeing what he was doing as an industrial engineer. And I wanted to be like that. Yeah.
[00:03:58] Lindsey Dinneen: Oh, I love that.
[00:04:00] Mildred Zayas: I'm also good in math.
[00:04:01] Lindsey Dinneen: That helps. Excellent. Well, you know, you mentioned during your opening how the values and the core beliefs that you hold to still came from your upbringing in Puerto Rico, and I was wondering if you mind sharing a little bit about that.
[00:04:18] Mildred Zayas: Sure. I grew up in a family, my parents, they love to serve. So when I grew up, actually, my mother was always with a cause. She was always helping people. She's still serves. She's 81 years old and she still has a number of ministries and serves. So that's what I saw with my parents since I was growing up. My father used to cook for homeless people when I was a teenager. So at that time, frankly, it bothered me a little bit, but now I can appreciate because really it's about serving and giving others. It's not just about yourself. And I have to thank my parents because they actually taught me that, and not only taught me that, they model it throughout their actions.
[00:05:01] Lindsey Dinneen: Yeah, absolutely. And how has that value of service and giving back impacted your own role as a leader and how you relate to other people?
[00:05:11] Mildred Zayas: Absolutely. So and that's interesting that you say that because when you talked about leadership, I always say, "be present, be transparent." You need to let people know what you stand for. But I also embrace what I what is called servant leadership. Of course, leadership is about direction and to have a vision and have followers and all that. I'm not saying that it isn't. But when you look about servant leadership, when you are really helping others, collaborating, and so people can move into where they want to go. So that's pretty much the way is looking into others and empowering them to reach their full potential and fostering collaboration and where trust and growth at the core of every decision.
[00:05:57] Lindsey Dinneen: Yeah, absolutely. So you've had a really long career with Johnson and Johnson specifically, and it sounds like you have had a lot of different opportunity there. And I was wondering if you could speak a little bit towards your experience and how starting where you did and then now where you are, what was the progression like? What did you learn along the way that was really beneficial in helping you achieve the next milestones?
[00:06:22] Mildred Zayas: First of all, let me just say Johnson and Johnson is a big company now, of course, 90 billion dollar and all that. But nowhere I started in the mid nineties, right in the early nineties, I should say. So, so it was a different type of company, number one. Number two, J and J has always been very decentralized, meaning each company-- we call it franchises now business unit-- each business unit is kind of run independently.
So I started my career with Ethicon, which is the suture manufacturing company, and that's where I grew up and I worked most of my career on and off. But I was also able to move to other sectors on other franchises as well. So I started in Puerto Rico as a second shift manufacturing supervisor shortly after I had a previous job after college in the pharmaceutical industry, also in manufacturing. But I definitely wanted to be a manufacturing supervisor. And in pharmaceutical industry, you need to have a pharmaceutical background, and it was going to be more difficult for me to be in manufacturing.
So Johnson and Johnson offered me an opportunity and I took it and I started in the second shift. From there, I progressed to what now is called process excellence, but it used to be called industrial engineer. Once again, C. I. P. process improvements and all that. Then I move into the planning organization materials management, we call it at the time, all in Puerto Rico.
I've worked for five years when Ethicon in Somerville, which we had the headquarters, they called me and they offered me an opportunity to move to New Jersey. And this was in, my goodness, in 1999. So, so I moved to, to, to New Jersey and started working, of course, in the planning organization, supply planning, planning inventory management and all that.
But then there was a big opportunity for me, and it was a transformative initiative in Edinburgh, Scotland. It was about manufacturing consolidation and optimization. So there were difficult parts because we closed a manufacturing plant of 800 people, yet we move operations to different places. So in the end, I mean, we definitely grew. It was tremendous for me to work in that initiative. It was my first global experience. I was in a commuter assignment in Scotland. And I had a global team with different functions, different areas, people in Belgium, people in Germany, people in China, because we transfer process to a fair places, people in Puerto Rico, of course, in New Jersey and in Scotland. And I can tell you that I made good friends that still they remember my birthday and we continue connecting via Facebook and all that.
So, so that experience was fantastic on gave me a good perspective. I came and talked to my boss at the time and say, "Listen, I already implemented a project. It was fantastic. It was great. But I want to work on strategies." And something that I've always done, and maybe you ask me later about an advice, just ask. You know, people can say no, but I mean, just ask for what you want. So I did! I asked and I got it. I was promoted to a senior manager at the time of my strategy development and deployment. So we were developing the five to seven year initiatives on where you want to have a manufacturing presence, whether make versus buy and those type of things. It did great. It was fantastic.
And then I'm like, okay, I have work in the U. S. I have work in Europe. You know, what about Latin America? Because Puerto Rico is kind of in the middle. It's not 100 percent Latin America, especially from a work environment standpoint. We're reporting to the U. S. So I actually moved and worked for Johnson and Johnson Latin America. I was based in Miami and I supported our cardiovascular business. And I was there four years, and then the other two years, our diabetes care business.
So I did that for several years and then I moved back to New Jersey where I actually continue developing strategies, was promoted into other directorship level, and work closely with Asia Pacific. That's where I created strategies in the region and help develop the network based on centers of excellence, reduce, of course, the footprint using a lot of suppliers and contract manufacturers as well. We try to optimize the model. So, it was exciting. I actually got to live in Singapore for a year and a half. So it was fantastic. I was there in an international development assignment.
Then I came back and I actually went back to Puerto Rico to work in global supply planning. I mean, that's what I started. As I mentioned to you, I did a lot of planning early on, and there was an opportunity there. Even though it was based in Puerto Rico, it was a global opportunity. So I have responsibility for for team in Brussels. I have people in Juarez Mexico, of course, in New Jersey and I was based in Puerto Rico. Did that for a couple of years, and then actually I moved to consumer, to Johnson & Johnson consumer, and I was there for four years. And it was interesting because it's a very different pace, the pace of consumer goods versus medical devices. But it was a great experience.
And once again, J and J is big. So I always wanted to take advantage and do different things. After that I came back, late in 2021, back to medtech. It used to be called medical devices by the way, but now it's medtech. And I came back in a strategy and project management role. I have responsibility to develop the overall strategies. But it was not for say, Ethicon, like before one of the franchises, right? It was for all of them. So I was working with orthopedics, of course, surgery, vision care, and then our interventional cardiology.
So that's been my career in J and J. I always say three areas or four for me: manufacturing, obviously planning, project management, and strategy. So there's four. Well, I sometimes I put project management and strategy together, but you can call it three or you can call it four.
[00:12:33] Lindsey Dinneen: Yeah. Excellent. Well, thank you for sharing more about that. It's an incredible career path you've had and taken you literally all around the world. And something that stood out to me as you were talking is, I'm so intrigued by your story, and courage seems to be a resonating theme. And so, between your willingness to step out of your comfort zone and go try and go learn and keep elevating your own knowledge and career and expertise, but then also to have the courage to ask for the things you want. I loved that advice so much. So I was wondering if you could maybe talk a little bit more about how did you have this courage to ask for what you want and how did this courage serve you as you continue to take advantage of opportunities in very new avenues for you?
[00:13:22] Mildred Zayas: Sure. Once again, I have to go to my mother. I come from a pretty, pretty matriarchal family. My grandmother, my mother, they were very strong women. But she always said, "Ask, and you shall receive."
[00:13:35] Lindsey Dinneen: Yeah.
[00:13:36] Mildred Zayas: Quoting the Bible as well. But also you have to deliver and you have to execute. I mean, you don't have credibility if you don't do the job. So you have to do your homework. And then once you establish that credibility, once the organization knows that you add value, then you can start asking. And once again, the worst thing that can happen is that they say "no." In my experience it's never been no. The worst has been "not now," but it happened two years after. So you know what? You have to tell people what you're looking for and what you would like to do. But again, don't forget you have to deliver too, critically important.
[00:14:17] Lindsey Dinneen: Yeah. Yeah. I love that. Well, and to your point, even if the answer is initially no, it's not usually "no, not ever for the rest of your life. It...
[00:14:26] Mildred Zayas: Yet. Not now.
[00:14:27] Lindsey Dinneen: ...Yeah, it's not yet. Exactly. So I love that, and your willingness to embrace that courage and do those things. So it looks like also, I know service is a big theme in your life, and one thing that I noticed when I was just glancing at your LinkedIn profile is that you have had opportunities to work with a lot of different interesting nonprofit organizations. America Needs You popped up and I was curious if you would speak a little bit about your experience with that.
[00:14:53] Mildred Zayas: Oh, absolutely. And thank you for asking that question. America Needs You is an nonprofit organization that works with first generation college students and how they transition from college to the work environment. I'm passionate about it because I truly believe in education and upward mobility, especially in underserved communities.
So what they do is definitely fantastic. And the program is a, it's an intense programs. When you commit to be a volunteer, you work two years with your student there, since they're sophomores until graduation, and we help them prepare for interviews, resumes, what to wear, and those type of things, but it is a tremendous and fulfilling program.
And you need to have in mind that, for some of us, it makes sense. I always mentioned my mom, she instilled in me, she worked very hard, etcetera. But not everybody has the model, right? I mean, when you're a first generation college student, you don't know how to navigate. And I love the program because helping others navigate I, I mean, I really enjoy it and sometimes I think that I get more than what I give, for sure. When I see people succeeding and doing well in their careers.
[00:16:08] Lindsey Dinneen: Yeah. That's really special. Mentorship is such a wonderful key component. I'm sure all of us have stories of these people who have come into our lives and helped lead us to the next thing or given us the crucial piece of advice at the right time. So thank you for being that person for others too. That's really special.
[00:16:23] Mildred Zayas: Of course, love to do it.
[00:16:25] Lindsey Dinneen: So I. Yeah. So I know one thing that's probably on everybody's mind is supply chain management, and since this is one of your areas of expertise, I was wondering if you could speak a little bit towards what should we look forward to in the future, especially, AI is such a big buzzword, but it is reality now. So I'm curious what are some of your takeaways? What are things that you're looking to as time goes on and technology changes?
[00:16:54] Mildred Zayas: So, definitely robotics and digital are going to change the game. And you mentioned AI, which is part of that. But if you think about, before it was called medical devices, because really, it was developing devices, but those devices are going to become smarter now, right? And what's important, I think, understanding the robotics, we're going to transform the way we do surgery. Maybe a doctor is in Germany and is operating in a patient in the U. S., right? So those are the type of things that we need to be open and understand and definitely stay current on the new trends. I believe, again, digital and robotics is the future of medical devices or medical technology, for sure.
[00:17:38] Lindsey Dinneen: Okay. Yeah. Excellent. So you've had so much incredible experience literally around the world. Were there any moments or a moment that stood out to you as just really reinforcing that you were in the right industry at the right time? "Yes, I am here for a reason."
[00:17:56] Mildred Zayas: You know, I mentioned the strategy in Scotland, but that was definitely a defining moment in my career. Because I had the opportunity. I was quite young, but I led the transformation of a big team. I mentioned 22 people. It was a complex initiative, a lot of alignment from cross functional teams, aligning different regions, managing diverse stakeholders in optimizing overall operations. And there was a challenge to balance operational efficiency with the business goals. But while I was doing that, it really confirmed my passion for supply chain leadership. It was incredibly rewarding to see how our collaboration improved performance, reduced the cost, strengthened really our global manufacturing network. And that experience reinforced my belief in the power of strategic planning and teamwork to drive meaningful transformation.
[00:18:53] Lindsey Dinneen: Yeah, of course. As you look towards the future for your own career and even for the future of medical devices, I know we touched on sort of your thoughts with that, but as far as your own career goes, what are you looking forward to coming up? What's your next challenge or adventure?
[00:19:07] Mildred Zayas: So I'm glad you asked that question because I'm thinking more and more-- I've been 30 years with J& J again-- but I'm looking more and more into a portfolio career. So where I can definitely continue doing some supply chain strategy, et cetera, perhaps in, in, in a consulting way, but I would also like to serve on boards, participate in podcasts, for example. So I want to do a little bit more of that. I have done for many years, the kind of nine to five one thing in different scales and in different positions, et cetera. But my next step definitely is more into a portfolio career. So I'm not going to do one thing. I'm going to do more than one thing. And of course, I'm going to be using my background and my expertise for that. But I can also combine my passion for helping others
[00:20:00] Lindsey Dinneen: Yeah, absolutely. Well, that's exciting. I am looking forward to seeing how that develops. I'll be cheering for you, rooting for you that whole time. Speaking of, you had a great piece of advice, and that was to just ask the question. And I'm wondering if anything else that pops into your mind, just pieces of leadership advice that you might give, especially to someone who's earlier on in their career, and might just need a little confidence boost.
[00:20:26] Mildred Zayas: Yeah, obviously, ask the questions is good. But my best advice is really to focus on continuous learning and adaptability while building relationships. Relationships are critically important. The medtech industry is fast paced and constantly evolving, so it's crucial to deepen both our technical expertise and our business acumen. Sometimes you need to seek cross functional projects, mentorship opportunities to broaden your perspective. So it might be above and beyond your day to day job, but it doesn't matter. Ask for those opportunities. Also building this network is critically important, and it's going to help you, demonstrating resiliency and it's going to set you apart as a future leader. I believe Theodore Roosevelt say something that I like: "Whenever you're ask ed if you can do a job, tell them, 'Certainly I can!' Then get busy finding how to do it." So that's the way to do it. Don't stress yourself. Don't be afraid. Be excited. Fear paralyzes us while excitement allows us to move forward.
[00:21:34] Lindsey Dinneen: That is such great advice. Thank you for that. I love that. And that's so great because you're absolutely right. You can use that strong emotional pull that often feels like fear, but what if you reframe it and think, "Hey, actually this means I care a lot and I'm very excited about this." So let's use that as energizing, not debilitating.
[00:21:52] Mildred Zayas: Correct. Absolutely.
[00:21:55] Lindsey Dinneen: Absolutely, absolutely.
[00:21:57] Mildred Zayas: By the way, one of my mentors told me that.
[00:22:00] Lindsey Dinneen: Ah, back to that. I love it. Full circle.
[00:22:05] Mildred Zayas: Absolutely.
[00:22:07] Lindsey Dinneen: Well, 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, based on your experience, but it doesn't have to be at all. What would you choose to teach?
[00:22:24] Mildred Zayas: That's a very intriguing question. And it's something I don't believe they give in college these days, but something along the line of advancing through corporate structures. I would love to teach young professionals how to navigate workplace politics, negotiate promotions and manage career transitions, something along those lines. We were educated very tactically, typically. Like in my case, I was an engineer, so I could do a lot of math and I could do a lot of models. It was wonderful. But I didn't know how to navigate in the corporate environment, and it took some headaches, and it took some time. So, I would love to be able ,to do something like that for young professionals specifically.
[00:23:12] Lindsey Dinneen: I love that. Well, I can sense a theme. Your heart is such a lovely heart of service and mentorship. So that is lovely.
[00:23:18] Mildred Zayas: That is true. Yes, indeed.
[00:23:20] Lindsey Dinneen: Yeah. Well, and sort of along those lines, how would you wish to be remembered after you leave this world?
[00:23:27] Mildred Zayas: It's gonna be also very similar. I definitely wish to be remembered for guiding others toward reaching their full potential, especially those who face systemic challenges and for helping them create their own path to success.
[00:23:43] Lindsey Dinneen: I love that so much, yeah. And then, final question, what is one thing that makes you smile every time you see or think about it?
[00:23:52] Mildred Zayas: Well, you can probably guess this, but I'm telling you, seeing someone I've mentored or supported achieve their goals always make me smile. It reminds me of the difference we can make in each other's lives.
[00:24:05] Lindsey Dinneen: Absolutely. That's just absolutely beautiful. Thank you for sharing that. So I am very excited to continue to watch your, how did you put it, portfolio career?
[00:24:16] Mildred Zayas: That's what I'm trying to build.
[00:24:18] Lindsey Dinneen: Okay. Unfold. So how can people maybe connect with you if they're interested in working with you as a supply chain executive or whatever else you plan to offer in this portfolio career of yours?
[00:24:29] Mildred Zayas: They can follow me via LinkedIn. It's the best way. I'm there, Mildred Zayas. So, yeah, they can reach out. I'm happy to collaborate. I believe in teamwork, collaboration, and really helping each other succeed.
[00:24:44] Lindsey Dinneen: Excellent. Excellent. Well, goodness gracious, this has been very wonderful. Thank you so much for spending some of your morning with us today, Mildred. Thank you for just sharing your advice and your heart for service and mentorship. And I'm so excited to see where this next step in your career takes you, so like I said, I will be rooting for you every step of the way.
[00:25:04] Mildred Zayas: Thank you, Lindsey. I appreciate that.
[00:25:07] Lindsey Dinneen: Of course. 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 we just wish you the most continued success as you work to change lives for a better world.
[00:25:37] Mildred Zayas: Thank you. Very nice.
[00:25:40] Lindsey Dinneen: Yeah. And thank you also to all of our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time.
[00:25:53] 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.

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.