Medsider: Learn from Medtech and Healthtech Founders and CEOs - Getting Past Rejection as a First-Time Medical Device Entrepreneur: Interview with Derek Herrera, Founder of UroDev and Habit Camera

Episode Date: May 13, 2021

In this episode of Medsider Radio, we're catching up with Derek Herrera, who has an incredible story to share. He’s a decorated Marine veteran who’s turned a major combat injury into a mission to help other patients with spinal injuries. Derek is the founder of UroDev, originally Spinal Singularity, as well as Habit Camera, the first low-cost, wireless camera purpose-built for skin inspection and telehealth.UroDev is on the cusp of bringing its Intelliflow device to market, a product uniquely designed for spinal injury patients who have urology conditions like a neurogenic bladder that require extensive catheter use. Today, Derek and I are going to chat about his journey from the military to the medical device space and get into what he’s learned about becoming a first-time entrepreneur with a big idea but not a lot of funding or experience.  First, here’s a bit more on Derek’s background: He graduated from the United States Naval Academy and served as a Marine Infantry and Special Operations Officer for over eight years. In 2014, he was medically retired due to combat injuries and left paralyzed from the waist down. Since this injury, Derek has earned an MBA from the UCLA Anderson School of Management and founded both UroDev and Habit Camera. He also serves as President of the Board for the Marine Raider Foundation.  Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content. Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, Premium members get exclusive Ask Me Anything interviews and masterclasses with some of the world’s most successful medtech founders and executives. Since making the premium memberships available, I’ve been pleasantly surprised at how many people have signed up. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Derek if you'd rather read it instead.

If I had to narrow it down to one thing, it would be to do what's right for users. And when I say users, I mean patience, but if you do that, I think there should not be a sacrifice when you're doing something that you think will be transformative for people. And so a lot of people I see, you know, they hear enough investors say no and they start to change things. You start to question things and everything else. And I can't stress enough to early stage entrepreneurs that, you know, you're going to hear no no matter what. But if you just stay true to what you know is going to be most impactful and effective for users, that's what you need to do. And people will get on board and they'll figure it out.

And someone will believe in you and write that check. Right. But I see a lot of people that after you get beat up and you get 20 knows or 30 knows or 50 knows, you start to question yourself and sacrifice. And then when you sacrifice, you still hear a nose. Right. And so I can't stress enough to like when you're, you truly have the message and the product market fit. like don't sacrifice it just because investors are saying no, like stay true to what you're

doing and passionate about. Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey, everyone, in this episode of Medsider Radio, I'm excited to talk with Derek Herrera, who has an absolute incredible story to share. He's a decorated Marine veteran who turned a major combat injury into a mission to help other patients with spinal injuries.

Derek is the founder of EuroDev, originally spinal singularity, as well as habit camera, the first low-cost wireless camera purpose built for skin inspection and telehealth. Eurodev is on the cusp of bringing its Intelliflow device to market, a product uniquely designed for spinal injury patients who have urology conditions like neurogenic bladder that require extensive cathar use. Today Derek and I are going to chat about his journey from the military to the medical device space and get into what he's learned about becoming a first-time entrepreneur with a big idea, but not a lot of funding or experience.

But first, here's a bit more on Derek's background. He graduated from the United States Naval Academy and served as a Marine Infantry and Special Operations Officer for eight years. In 2014, he was medically retired due to combat injuries and left paralyzed from the waist down. Since this injury, Derek has earned an MBA from the UCLA Anderson School of Management and founded both Eurodeb and Habit Camera. He also serves as president of the board for the Marine Raider Foundation. Okay, so before we jump into the conversation, I want to mention a few things. First, if you spend any time in the med tech or health tech space, you probably understand how difficult it may be to hire the right physician partners.

Whether you need help with voice of customer research, advice around clinical study design, or something more straightforward like content review. Whatever the task, instead of spending weeks searching for physicians or paying thousands just to meet one, I highly recommend you check out FlipMD. It's a physician hiring marketplace where you can seek the expertise of thousands of physicians in one simple platform. FlipMD features 2,000 plus physicians in every specialty and their marketplace is growing every day.

When you post your project and set a rate, physicians then compete for the job with bids and then you make the choice on who you want to hire. To get started, it's really simple. Just register your account, post your project, check out the bids that come in, and then hire a physician. No finder's fees, no obligation, and no risk. It's super easy.

Even better for the Medsider community, FlipMD is offering to waive their normal transaction fee, for the first 60 days. So just head over to MedsiderRadio.com forward slash flipmd for all the details. Again, that's Medsiderradio.com forward slash flipmd. Okay, second, if you're into learning from proven medtech leaders and want to know when the new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You'll get access to gated articles and lots of other interesting healthcare content. If you want even more inside info from MedTech experts, think about a

Medsider Premium Membership. We talked to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a MedTech startup for an exit. In addition to the entire back catalog of MedSider interviews over the past decade, premium members get exclusive Ask Me Anything interviews and masterclasses with some of the world's most successful MedTech founders and executives. Since making the premium members, I've been pleasantly surprised at how many people have signed up. So if you're interested, go to medsider.com to learn more.

All right, without further ado, let's get to the interview. All right, Derek, welcome to Medsider Radio. Appreciate you coming on. Pleasure to be here, Scott. Thanks for having me. Yeah, I'm looking forward to this conversation. We live so close, you know, now that I'm here in Southern California, but maybe at some point we'll do a round two, you know, and do this in person.

But I recorded a little bit your bio, at least at a high level, you know, in advance of you're at the outset of this interview. But let's start with getting your kind of elevator pitch on your background, your bio, and then we'll kind of jump into how you ended up starting spinal singularity, which is now EuroDev. Sure thing. So my name is Derek Herrera. I am a medical device entrepreneur based in Orange County, California, and the founder of Eurodev Medical, which was formerly spinal singularity.

Prior to entering the medical device industry, I served for eight and a half years as a Marine infantry and special operations officer, a Marine Raider, and then transitioned and left the military after I sustained an injury and became a medical device entrepreneur. Tell us a little bit more about how you ended up kind of in the MedTech space, because I think that actually serves as a nice transition to talk a little bit about how the idea for the Inteliflow device with EuroDev came about. Absolutely. So I always grew up with kind of an engineering mindset. I was always tinkering with things, trying to fix and solve problems. And my family, my family business essentially was the military. And so my father was

Air Force officer, both my grandfather served in the Air Force for careers and was always around a military environment and wanted to pursue that line of work and following their footsteps. And so I went to the Naval Academy and studied engineering there. And when I graduated, became a Marine officer. And so I served in the infantry for about four years and had such a great experience there, leading Marines and sailors that decided I wanted to, you know, continue to pursue this as a career. And if I wanted to do that, that I wanted to do it with the best Marines and sailors in the organization. And so we had special operations unit, which you're able to apply to be selected for and go through the assessment and selection process, which I did and was selected and then went through training to become what we call a Marine Raider, which is similar to Navy SEALs or Army Green Berets and just the Marine version of that.

And so I found myself as a Marine Raider team commander there as a captain and deployed again. to Afghanistan in 2012 and unfortunately sustained an injury. So I was shot during a patrol, during an enemy firefight, and instantly paralyzed from the chest down in 2012. And so fortunately, due to the heroism and selflessness displayed by my team members and our Afghan partners in that engagement, myself and the other Marine that were injured in that engagement were able to safely make it out of that situation. and recover and rehabilitate. And so I had a long recovery process, but I'm still paralyzed from the chest down today and still used a wheelchair. And so when I came back, realized that, you know, that I was never going to be able to be

a Marine Special Operator again and started to try to figure out what was next in my life. So I went back to graduate school at UCLA, doing a part-time MBA there. And while I was there, also was trying to become an expert in medical technology. and everything to do with spinal cord injury recovery and rehabilitation. And during that process, suffered from a lot of issues and a lot of challenges, everything from mobility to bladder management, to bowel management, to spasticity and pain, so many different things. And as I learned about them, understood that, you know, there were opportunities to solve these

problems and to do so in a for-profit environment as an entrepreneur. That was kind of the genesis up to that point for when I started the company Spinal Singularity, which is now EuroDev Medical, and really started that company because what I wanted to do was to develop products and solutions for people like me. And that I thought that I would have a competitive advantage in doing that because I had a spinal cord injury. And I knew firsthand exactly the challenges and what needed to happen to address these issues, that that would be our competitive advantage in designing products to improve quality of life. people with spinal injury. And that was the starting point for at that time, what the company was called was spinal singularity. Got it. No, that background is super helpful. And we could probably

have an entire conversation just on kind of, you know, all the lessons you've learned after kind of the tragic accident, you know, serving as a Marine Raider for a country. And for those listening that want to probably learn a little bit more about that kind of aspect of Derek's story, I mean, highly encourage you to check. Just Google Derek Herrera. He's been on some big shows, Jocko's podcast being one of them. So definitely we won't spend a ton of time talking about that aspect of your story, not to underappreciate it at all. But thanks for giving us kind of a high level,

kind of at least a high level overview of that because it's, you've got an amazing, amazing journey. But kind of fast forwarding to like when you, you know, when you're kind of, you're at UCLA, did the idea for like this, like a couple follow-up questions, right, as you're kind of thinking about, like, you know, jumping into the medical device game. One is, did you know, like, right away or how did you pick like the idea?

Because I'm sure you were, you were probably considering several different, you know, product concepts. And then the other one is like why, you know, most, the average person would probably just want to maybe join an existing, you know, a device company. But you were like, you know, I'm going to take this on myself and, you know, and start my own company. So kind of walk us through kind of where your, where your head was at at the time and like how you, you know, how you ended up choosing, you know, Inteliflow as the product that you

wanted to pursue. Yeah. So I've been on an amazing journey and been very fortunate to have learned so much along the way. But the initial experiences that I had that led me to the founding of this company and trying to pursue this as an entrepreneur were pretty impactful for me. And one was that after I was injured, I was able to utilize an experimental technology that was transformative and really transformative for me physically, but also emotionally and psychologically. And this device was a robotic exoskeleton, which is designed by a company called Rewalk Robotics. And this device was the first exoskeleton device to gain FDA clearance in 2014 that enables paraplegics to stand and walk. And so it has electronic motors and some circuits and software that I can strap on this device and stand and walk and move around.

And so it's the only way that someone who's completely paralyzed can do this. And so for me, being able to set a goal of walking again, and despite the physical limitations and, you know, physiological impact that my injury had, being able to do that again through technology was really impactful for me. And then as I got more involved with this organization, in particular with the Technion University, the high tech university in Israel, where the inventor of this device graduated from, I had the opportunity to go and meet him in Israel. Israel, and he's a quadriplegic, and he was the driving force behind this innovation. And that made it very accessible and very relatable to me in so much that here was this other guy who had a similar situation. And through hard work and ingenuity and resilience was able to design something that is now on the market and impacting people like me.

And sitting down to someone like next to someone like that, understanding, hey, this is a guy It was just like, this is something that's accomplishable and attainable as long as you follow the right steps and do the right things. That was a huge turning port for me mentally and psychologically. And, you know, when I looked at the landscape of all the things I faced on the challenges I faced on a day to day basis, walking wasn't the biggest one. And there's already people that were solving that issue. But when I looked at all the other challenges I faced, the biggest challenge I faced on a day to day basis was bladder management after my injury. and specifically urinary retention or neurogenic bladder.

And so basically the condition is such that, you know, after you're paralyzed or even people that just have other, you know, etiologies and conditions which cause urinary retention, if you're unable to empty your bladder, the current standard of care, the best method that modern medicine has to offer is for use these disposable plastic catheters every time you go to the bathroom. And so you can imagine as someone who's 28 years old faced with the prospect of, of doing this five, six, ten times a day for the rest of my life, it was a terrible prospect and a terrible situation. It also has so many other problems associated with like, urethal trauma, urinary tract infections,

high costs for insurers, you know, just so many issues associated with this. And as I was going through this process, going to business school, I actually had this moment where I had complications and found myself, you know, in a clinic with the urologist and asked him, and it was like, hey, doc, there's got to be a better way, right? And he's like, no, no, this is, this is it. Like, this is actually pretty good. You know, this is the best modern medicineist officer. And I'm like, it's 2013.

Like, you're telling me that technology hasn't cut. There's no better technology, right? And he's like, no, no, this is it. And, you know, kind of looked at me quizzically. And then, like, from that moment, I became obsessed with trying to solve this problem. And so I did as much research as I could while I was in business school, got as much as advice as I could from the business advisors that I had and the mentors that I had. and took another job part-time at another medical device startup to try to learn something

because I had like zero industry experience obviously and knew that I wanted to address this issue and solve this problem. And I'd also confirm that through my research, secondary research, that there were no other competitors really in the space working to address this issue or try to solve this issue for this patient population at the time. And so understanding that and finding the alignment and the product market fit essentially with just the drawing or the idea that we had at the time set off on that endeavor to try to fund and resource a company to build this product and address this issue for people like me.

Got it. That's awesome. It sounds like your experience kind of at Rewalk Robotics really cemented kind of the reality that this could be like this is doable. Like you can absolutely do this. And then obviously with your own personal experiences, you didn't have to really do a whole lot of, you know, voice of customer research. You were the, you know, you were the customer. patient, you know, so to speak, for this particular product. So that, that's great. And then the time that you spent at that, you know, I think this was during your, during your, during your, while you were pursuing your MBA, right? Was it Nova Signal? Was that the company that you were at or formerly neural analytics? Correct. Yeah. So with Rewalk, I was just a user. I was just a unpaid brand

ambassador and the first person in America to own the extracellleton technology. And I was fortunate to do that through the support of a nonprofit, the Marine Raider Foundation, who helped to raise money. because at that time, the insurance was not covering the cost of these devices, the exoskeleton devices. And so I was very fortunate to be able to have that opportunity, but that opportunity cemented the potential and the reality that, you know, people are doing this, right? And, you know, why not me? Right. Like what's different about these people or why are they successful and why can't I be? Right.

It's once things, you know, initially, things seem so daunting and so unachievable or impossible until you meet some of these people, right? and they become accessible to you and you're like, you know what? Like, this is achievable. Like, I can do this. Like, I have the faith and, you know, the ability to believe in myself that like, you know, why not me? Why can't I figure this out or help address this issue? Right.

And even if I fail, there's no harm in trying, right? What better or more noble pursuit could there be, you know? And so understanding the risk and the risk of failure and all of these risks associated with trying to be an entrepreneur, you know, because most startups fail. That's the reality. but like, you know, what do you have to lose by trying, right? Like ego, you know, money, you know, like all these other sorts of things. Like at that point in my life, I didn't care about any of that, you know, all I cared about was

I was obsessed with solving this problem. And, you know, an understanding that, you know, hey, if I don't solve it, no one else will, probably. And so that was the starting point of the motivation and the passion that I had for trying to address this issue. I love it. I love kind of the mental framework around, you know, why not? me, you know, some if this is a clear problem and if you're not going to do it, likely,

you know, no one else will or it's going to be years before something like this has developed. So I love it. And I definitely, I know, I'm glad you brought up MVP or med tech vets as it's kind of know now. Well, we definitely want to, you know, I definitely want to, you know, car out some time to talk a little bit more about that towards the end of our discussion here. But let's, you know, this is, let's kind of go back to the early kind of the formative years of of spinal singularity in Eurode. So you've got this, you've got this idea, you're passionate about it, you want to work on it. We both know that getting, you know, a medical device concept kind of, you know, from the idea on the back of a napkin to something that's tangible, right, can be

extremely expensive, not can be. It often is extremely expensive. So how did you like, you know, especially being, you know, relatively new to the med tech space back then, did that scare you at all? Like, how did you go about like kind of, you know, getting the, you know, building out these first, you know, alpha and beta versions of this concept in those, in those early years? yeah very inefficiently and not the way that you should do it probably so one of the good things about going to business school is they teach you some basic tips and tricks and tools for the way things are done and another good thing about it is is they often tell you how hard it's going to be but really you don't quite understand it until you've tried it or done it and so that's a good thing because

you know if you knew how hard it would be or all of the challenges and trials and tribulations you would go through ahead of time. Maybe you may be less likely or inclined to do it. And so I'm kind of glad that I didn't really have a good understanding for how challenging it would be because it was hard, right? It was incredibly hard. I had zero experience in industry, zero credibility other than I was like a guy who was really passionate about solving a problem with a pretty good idea, but no prototype,

no data, no nothing, just a plan. Right. And so we just went for it and really fortunate and lucky to, have gotten this far, but when we started, you know, we were doing everything. We did a crowdfunding campaign for donations. We did grants. We did business plan competitions. We talked to investors and they said no, but, you know, it's too early or, you know, you need this and all these sorts of things. And just through reps and effort, you know, we continue to make progress and de-risk the venture every day, every month, every year since then. And, you know, it took us a long time, took us forever,

right? Like, we're still, you know, still not on the market today, but we're optimistic we will be soon, you know, in hopefully by the end of this year, early next year. But, you know, the product is real and it works, right? And that's what we're seeing in clinic, you know, and so it's taken a long time. But in the formative stages, you know, we just went for it, right, and just try to figure it out. And I don't recommend that for everybody, but it helps if you have industry experience. It also helps if you have a network, right? So the two things that I lacked that took time to develop were knowledge and a network. And so knowledge of the industry, of the processes of all the things that were required to be successful in developing a medical device and a network of

employees, consultants, service providers and other people who can help you accomplish that. I didn't have those, but fortunately, we're able to find those and to build those and made a lot of mistakes along the way, but got to the point where now I have a group of people, a network of people that I can rely on for all aspects of medical device development and and have, you know, built that out. And, you know, it just took time. It just took a lot of time and effort and putting yourself out there and going and meeting people and building relationships and, you know, failing, frankly, you know, like there's a

a lot of mess and waste and associated with that. And it's unfortunate and it's ugly. But, you know, hopefully when we're on the market soon, you know, that's not the story that we'll be worried about or be focused on. All of that stuff will be memories of mine. but, you know, what will be important and impactful is, hey, this product is on the market. It's changing the lives of people every day, you know, and that'll be worth it. Yeah, totally.

Yeah, I think, you know, I just, I recorded a conversation with Bob Paulson, who's, you know, kind of a serial med tech entrepreneur based in Minneapolis last week. And by the time, you know, this conversation goes live, I'm sure that one will have been published. But even someone like that has, I don't know, like, gosh, five, six startups under his belt, you know, that have either, you know, has a history if like, you know, these exits, you know, these liquidity events with his startups. I mean, he mentioned the same thing. It's still, like still raising capital is tough, you know, even for someone, you know, with the experience and track record that he has. So it sounds like, you know, that's, that was definitely the case for you. And you were, you were sort of up against it, you know, not having an existing network

and kind of being new to the medical device arena. But if you, like, in retrospect, you know, if you had to raise money now for a new, a new device startup, you know, is, Are there like one or two things that you would do differently after trying so many, you know, different initiatives to get this company off the starting block? Yes. Yeah, definitely. There's an expectation and a good and healthy ecosystem for non-dilutive funding, mainly through government grants, right?

And so there's billions of dollars every year that are allocated for different government grants that are accessible. And a lot of investors expect you to use that money. And, you know, it's challenging. It takes time. and everything else to acquire, but it's not investment, right? It's just money that's used for development of products and ideas and different things. And even so much that, you know, some of the SBIR program taglines say we're America's seed fund,

you know, because that's what they do. They see ideas and high impact, high risk technologies and try to de-risk them so that investors will come along and support them. And then also understanding the timing, right? So like some of these things take time to develop and de-risk and to get to a stage where they are. So either you can do those and queue them up in parallel where you're working on multiple things at once, where they just take time to resource appropriately or you just have to massage the story in a way or find people that are willing to back the vision.

And so a lot of the earliest investors often will back you not just for financial return, but also because of the impact of what you're doing and their own personal experience in that. And then lastly, ultimately it's, you know, it's, you know, It's shots on goal, right? So how do you know if someone will back something? You have to ask. You have to try. You have to pitch them, right?

Knowing that there's a chance that 100% of the people you talk to will will not give you money to fund this venture or not believe in what you're doing. But you don't know until you try. And that's one of the most important things is just taking shots on goal and being willing to take and assume risk and continue to push forward in the face of adversity. Right. And so because at the end of the day, you know, maybe it's not 100% investors. Maybe it's only 99.

But if that one person writes you the check you need, then it was worth it. Right. And you don't know if that's 100 investors or 200 or 500 or how many you need to talk to and pitch until you find the person that will support your effort and believe in your vision. And so, you know, there's only one way to find out for any of that stuff and you have to assume some risk and take some risk, which is just there's no, there's really no way around. Yeah. Yeah.

I love this. Such great insight. You know, it's Sean Sain who sold companion medical to Medtronic. I think that deal closed in, gosh, mid-2020, late 2020, something like that. He mentioned the same thing, the very same thing. Like, you just, you have to talk to everyone, right? And, you know, 100% of the people that you don't talk to are not going to fund your project. So, you know, you just have having the right expectations around that.

And I think is crucial. But I love the second point. I know we have got some other topics to move on to, but I think I'm super curious. about this, you know, how someone like yourself, you know, went about this and what you do differently, you know, in terms of, you know, raising capital for an early stage project. But the second point you mentioned, like, setting the right expectations are on timing for all of this. I think that's so, that's so crucial because like government grants are a great non-dilative source, as you mentioned, but they take time. You know what I mean? You, I mean, I mean, talk about shots on goal. Typically you need, you know, three, four or five shots on goal to get it to get an SDI grant, you know, and that just takes time. You know what I mean? So you got to be moving, you know, other projects, you know, along and in parallel, you know, So I think that's great advice around just having the right expectations and understanding the timing of how all this kind of how the puzzle pieces sort of fit together. So great stuff. Yeah. And I think the one thing I would add to that too is you should be getting more efficient and better every time you're doing this.

Right. So like when we started, our grant, you know, success rate was very low, right? It took us three times. And then our phase two took us two times. And then when we submitted a DOD grant, it took us one time. which was a lot of luck but it was also you know adapting and learning and innovating right and so like a lot of people will say like hey you have to innovate and adapt to these environments in order to thrive and so like one of the many things I learned but one of the most impactful things and skills that

is absolutely essential is humility and the ability to be a quick learner right and that's something I learned in special operations community and in the military right is like we're not experts at any one thing were generalists, but were quick learners, right? And so I didn't know how to write grants five years ago, but now I do, right, because I've sat on the panels. I've invested the time I've done thousands of hours of grant writing and scientific writing and, you know, and literally like sat as a consumer reviewer on a DOD CDMRP grants panel in 2014 and saw behind the scenes and I was like, this is what I need to be able to do. And then, you know, four years later, we were awarded a $3.6 million grant from that same panel that I sat on, right? And

it took years of effort to have that come to fruition. And so much of the foundation had to be laid, but like, you know, we figured it out. And so like some of the other techniques you're talking about, right, like with investment and everything else, you know, you learn tips and tricks and you adapt. And there's other ways to reduce your cycle time. Right. And that's ultimately what it comes down to is like, how quickly can I learn? How quickly can I adapt, you know? And so like some of the stuff, Some of the things I've learned now, too, are like in the earliest stages of how to and talk to and engage strategic investors or potential acquirers, right? And what to discuss, what not to discuss. And some of the mentors I have have been, you know, incredibly successful.

Even in situations where they'll pre-sell, you know, a company before it's even formed, right? They're like, hey, I know you have this gap. Like, if you confirm the validity and the opportunity of this market gap, like, I can go raise the money, secure this. you know, bring this thing to market and then, you know, I already know that you're going to acquire it, right? Like that kind of stuff. And so a lot of those more nuances and adapting those environments are pretty impactful and really interesting to do. But again, like the one thing that I think every entrepreneur will need to be able to do to succeed is to adapt, right? No one can continue to reinforce failure because you will fail and you just have to learn from it and move forward. Yep. No, I, I, I, I, your last point about like, you know, even, even learning, um, learning how to approach strategic reminds me of a conversation I had with Duke Rowling, gosh, probably six, seven years ago now. He's pretty well known in the venture community, right,

the MedTech venture community way. And he mentioned like even that's how he, like even before going, and he was coming at me, he was speaking more in terms of like his operational experience, but he was like before I'll get involved in a startup project. Like I'm, I'm sort of serving the competitive landscape to see where this product might fit into a strategic portfolio. or the poorly of a strategic, you know what I mean? So I completely kind of echo your sentiments around being a, needing to be a quick learner, you know, and taking some of those learnings and adapting, you know, as fast as possible.

So. And that's one of the things I've learned from Duke as well, right? His story and his experience, like, is amazing. Like, he has an uncanny ability to assess that and to do that, right? Like, from your podcast for our podcast and from personal interaction. I've been really fortunate to have a few conversations with him and call him a mentor. And yeah, it's. That's right.

I forgot. I forgot. You know, you know, do pretty well personally. I forgot about that. Yeah. So, yeah, great guy. Yeah. And he continues to deliver.

I mean, he continues to deliver, right? Like, so it's not only his track record before, but the stuff I think he's working on now is, it'll be impressive to see. Oh, yeah. No doubt. He accomplished it in the next 10 years. So. Yeah, totally agree. There's some other, you know, topics I want to get into.

So let's kind of, let's move past the kind of the financing subject and move on to regulatory. You know, again, you had, you, you had sort of your appetite was wet, right, with your experience with as a brand ambassador, you know, kind of in that, you know, with, with the Rewalk robotics company, I spent a little bit of time at Nova Signal or neural analytics, but, you know, understanding, you know, the regulatory landscape can be pretty, you know, pretty complex, you know, and confusing almost to navigate. So take us back to like when you were, you know, when you were, you know, working on kind of your first concepts, how did you go about, like, you know, pick, you up on this, you know, on the regulatory path, you know, for the Inteliflow device.

Yeah, regulatory is very interesting. And it's incredibly nuanced and challenging. And so I don't have any like class three or surgical experience or anything in that regard. So I don't even begin to understand that. But the way that we approach this was so when we take a step back and look at the, as I think when you look at any regulatory strategy, you'll take a step back and look at the marketing intent, you know, the intended use and the marketing application for this, right? And so for us, before we even got to that, we looked at the clinical utility and the user experience. And

when we first started out, because we were technology agnostic and we were just focused on solving this problem, you know, I assessed, hey, is this something that should be a permanent or long-term implant, right? What does the market look like? How does this work? And it was like, well, maybe, but you know, there's some downsides of that, some serious downsides to that. In addition to the business and the overall profile of the, you know, the time to market, the regulatory challenges, all of the compliance and complexity of that, you know, we looked at that. But then we said, hey, well, right now these are disposable devices and they're 30 days or less and there's a precedent for that. How do we make a business case for that and how do we understand the user experience there? And it turns out that

actually provides the optimal user experience. We found this harmony between the business side, the financial motivations, the profit, the user experience and the user requirements, and also the clinical utility and the clinical benefits and optimizing that. And then once we had that, you know, we also assessed, hey, are there clear predicate devices? How do we look at, you know, the regulatory strategy, whether it's 510K or de novo and massaging those sorts of things. But at the end of the day, if we're doing the right things for our device.

and our patients and our users and clinicians and everybody in the ecosystem that's involved there, you know, we didn't necessarily let the regulatory strategy, you know, drive overall strategy. And I think that's really important to understand is a lot of people get kind of hooked on like, well, is it a 510K or is it a de novo or what's this? And there's nuances and challenges associated with all of that, right? And we're still figuring that out and going through that now, actually as we speak, engaging, you know, deeply and intensively with the FDA as we prepare for our regulatory submissions, you know, later this year. But all of those things can be solved and, I think,

addressed, you know, with good data and good clinical evidence and, and that sort of thing, as opposed to, you know, trying to make a product just to meet a regulatory strategy or regulatory need. That wasn't the path that we chose to follow. And so, you know, that might be experience or naivete on my part. But I think more importantly, we focus on the regulatory as one small aspect in a long line of business and entrepreneurship and commercialization. And so it's important to do. It's important to consider. But I don't necessarily always agree that like, you know, you should try to design around a regulatory strategy. You're designed to meet it. Obviously, there's extremes to that, right? Like, hey, you know, you don't want to do a PMA for something that you, you know,

you're going to sell for $10, right? And those sorts of things. But that was kind of the way we approached it. It was just figure out what the best possible thing is for users and then work from there and develop a good strategy to have the clinical evidence to justify what you need for any sort of regulatory submission. And then obviously we worked with a lot of experts and strategists and statisticians to try to lower the bar and lower the threshold.

Right. So we can achieve it. And it's financially achievable for the clinical study. that we're doing that we want to design or that we designed and want to utilize for for those submissions. But that was how we approached it. Got it. I think that that, the advice that you kind of, you mentioned around like, it's obviously incredibly important for MedTech. I mean, this is a, this is a regulated environment that we're operating in. But you're, you're common around, like not letting that be like the overarching kind of driving factor, right? Don't, don't pigeonhole

yourself just because it may be a smooth or regulatory ride. You've got to, you know, let the, Yeah, you know, keep the patient, you know, keep the customer in mind when you're designing devices and don't let, don't let Reg be the, you know, the sole driver there. Yeah. And I mean, everybody has different experiences. This is just my experience. So it's definitely not. There's nothing about this that's one size fits all.

But what I would say, and I was talking to somebody else about this morning, too, is like, in my limited experience, what I'm, what I know is I'm trying to do something that could be totally transformative for an industry and totally transformative for a patient population. And so in doing so, if it's actually as transformative as I believe as it will be, like, I should be able to find investors and people that will back us to get whatever we need to resource this to get it through regulatory, right? Like, it's not a situation where it's a Me Too or a knockoff or a commoditized industry or where it's a, we're cheaper than them and whatever else.

And so like in those situations, right, if you're going to, you know, have better margins than a competitor. Like, you know, maybe you won't be able to afford it. Maybe you won't find investors that will do it unless it's a 510K with like a pure 510K with no clinical data, right? Or a 510K exempt device, right? Like, I want to be very clear. That's not what I'm talking about.

This is like, and frankly, you know, that's just like a nature of the problems that I've chosen to try to solve is I want to solve things that have a transformative impact on people's lives and on the system. And in doing so, like, yeah, there's regulatory risk. Like it may be a de novo. But like, it's still, like, it's still something that there's plenty of experts we can hire to help us figure out and get through. Right. And frankly, like, you know, in some cases, there's more investors that are looking for PMAs because they have quicker times to exit and, you know, those types of more intense or more impactful things.

So I think it's just like anything. And coming from a government agency, the military right before, like, you know, I also understand a little bit of bureaucracy. right and like how many rockets and so like you know like you just it's a system right and so like it's important to know where you fall and what you're going to do with the strategies but like you know at the end of day it's a system and you can either you know complain about it or fight about it or or just understand it and work within it and be smart and be be able to utilize it to your advantage right and that's that's what it's all about right like you know certain things you can argue about and cry about and blame.

But like, and this also might be naive of me, but like, I'm not going to blame the FDA for us not getting to market fast, right? Like, because ultimately, like, we got to take ownership at some point, right? And it's like, if we provide the data and everything else, then or if we're not doing a good enough job to convince them of the data and the statistics, that's, that's our fault, not theirs, right? Like, they have a job to do and like a very pretty well established system to work within in most cases, obviously not talking about the extremes, but like we should be able to work within it,

you know, and be successful. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium Members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan, CEO of Cala Health, Nadine Mierrez, CEO of CVRX, and so many others. As a premium member, you'll get to join live interviews with these incredible medical device and health technology entrepreneurs.

In addition, you'll get a copy of every volume of MedSider mentors at no additional cost. To learn more, head over to MedsiderRadio.com forward slash premium. Again, that's Medsiderradio.com forward slash premium.