Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Innovate in Medtech with Limited Means: Interview with Field Medical CEO Dr. Steven Mickelsen

Episode Date: March 7, 2024

In this episode of Medsider Radio, we had an inspiring discussion with  Dr. Steven Mickelsen, CEO of Field Medical, which is developing the next generation of pulse field ablation (PFA) technology to address ventricular arrhythmias.Starting out his career as a professional musician, Steven made a pivotal shift in his late twenties and ventured into the world of medicine. As a practicing electrophysiology (EP) physician, he has combined his medical expertise with an entrepreneurial spirit to revolutionize cardiac care. Steven made significant strides in the development of pulse field ablation (PFA) treatment with one of his previous companies, Farapulse, which sold to Boston Scientific.In this episode, Dr. Mickelsen shares his hard-earned wisdom on how limited means can breed resourcefulness, how to build a modest yet effective prototype, why having real expertise in clinical and regulatory spheres is a necessity, and how to raise funds with a win-win mindset.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and a curated investor database to help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume V. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Dr. Mickelsen.

It's surprising how far you can get with nothing and it is surprising how little progress you can make with all the money in the world. Like, you know, both things are true. It does take some creativity. Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world. Now, here's your host, Scott Nelson. Hey, everyone, it's Scott. In this episode of Medsider, I sat down with Stephen Michelson, founder and CEO of Field Medical. Starting out his career as a professional musician,

Stephen made a pivotal shift in his late 20s and ventured into the world of medicine. As a practicing electrophysiology physician, he has combined his medical expertise with an entrepreneurial spirit to revolutionize cardiac care. Stephen made significant strides in the development of pulse field ablation or PFA with one of his previous companies, Ferris, which eventually sold to Boston Scientific. A serial entrepreneur, Stephen is working on his next startup field medical, which is developing the next generation of PFA technology to address ventricular arrhythmias. Here, a few of the key things that we discussed in this conversation. First, money will always be tight at the beginning of any startup. But scarcity can breed creativity, so use that to your advantage.

Build prototypes with readily available parts and focus on nailing your narrative to convince investors. Second, finding real expertise in the clinical and regulatory fields can be challenging due to the specific requirements unique to each startup. Find a good consultant early and keep them close. Their expertise will save time and boost your startup's chances for success. Third, when raising capital, be honest about costs and timelines, both to yourself and investors. Be clear and concise in your communication and tailor your pitch to the specific type of investor you are targeted. Don't stress over retaining a large equity position and aim to develop technology that meets the needs of physicians and patients. All right, before we jump into this episode, I wanted to let you know that the latest edition of MedSider Mentors is now live. We just published Volume 5, which summarizes the key learnings from the most popular Medsider interviews over the last several months with incredible entrepreneurs like Gabriel Jones, CEO of Proprio,

Kirsten-Carrel, CEO of Can Do Health, Dr. David Alpert, founder of AliveCorp, Greg Bullington, CEO of Magnolia, and other leaders of some of the hottest startups in our space. Look, it's tough to listen or read every interview that comes out, even the best ones. But there are so many valuable lessons you can pick up from the founders and CEOs that join our program. So that's why we decided to create Medsider Mentors. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. To check out the latest volume, head over to MedsiderRadio.com forward slash mentors. Premium members get free access to all past and future volumes.

If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. You'll also be able to see all of our playbooks, which are handpicked collections of the most insightful interviews with the brightest founders and CEOs that join our program. Whether you're looking to master capital fundraising, navigate early stage development, tackle regulatory challenges, understand reimbursement, or position your venture for a meaningful exit, Bidsider playbooks have you covered.

And last, considering that fundraising can be one of the most daunting tasks for any startup, we created a meticulous database of investors right at your fingertips. Explore a wealth of VC funds, private equity firms, angel groups, and more, all eager to invest in medical device and health technology startups. Access to this database is a premium member exclusive, so don't miss out. Learn more about Medsider mentors and our premium memberships by visiting medsiderradyo.com forward slash mentors. All right, without further ado, let's jump into the interview.

All right, Dr. Stephen Michelson, welcome to Medsider Radio. Appreciate you coming on. This should be a fun conversation, especially with our Iowa roots, you know, our Midwest roots. So, yeah, looking forward to the discussion. Hi, Scott. It was such a pleasure to be on your show. I'm quite honored. Thank you for inviting me.

Yeah, yeah. I've watched kind of your history and your experience in the world of startups from afar. So it's fun to finally have this conversation. So with that said, I referred to you as doctor, right, for a reason. You're a practicing EP physician for many years now and obviously have several successes under your belt. But let's kind of start with, you know, an elevator pitch of your background leading up to kind of where you're spending most of your time these days.

And, you know, if you can maybe summarize that in a few minutes, that would be great. Well, that's quite a challenge. You know, so for the last decade or so, I've been really focused on a specific area of technology. I think it would be reasonable to say that I'm an expert in this area, which is cardiac ablation using an energy source that's commonly called pulse field ablation or electrooperation. So in the cardiac application, it's kind of a, you know, there are some technical challenges that we overcome. by switching from a thermal ablation to an electric field mediated kind of technology. You know, that's stuff that you have to get deep into the weeds to really understand. And probably there's only four or five people listening to this that would even be truly interested in a deep dive into the technical part.

But decade ago, I started working on a number of things while training at the University of Iowa. and out of all those ideas emerged this kind of new direction. This led me into the world of entrepreneurial kind of activities because I realized at that time with the support of the university that if you want a good idea to make it into the market, you really have to kind of lead the charge. And so I went out of my way, started a company and became sort of a serial entrepreneur from that time,

surrounding myself with very talented people. And over the last 10 years really expanded my experience, working for a number of companies, working as a consultant, and starting several companies. Most recently, I started a company that I feel is ideally positioned, you know, both on the front of this new era of pulse field ablation, a company called Field Medical. That's about 18 months old.

And, you know, we've made enormous progress in this 18 months, largely because of, you know, years of suffering and failure leading to, you know, standing up and, you know, just pushing forward. That's what entrepreneurs do. And, you know, we learn all these lessons along the road. And so by the time you're starting your second, third company, you know, you can miss a few of those pitfalls. You can't miss them all. And so it's quite, it's been quite. It's been quite. quite a journey. So my elevator pitch is, you know, I'm a practicing electrophysiologist that's deeply involved in entrepreneurial activities in med tech development, all for the betterment of health and therapy for people who really need it. Yeah. You're, you're being humble. And I think most people that are listening are probably loosely familiar with variables, right, which is, you know, was a big kind of success story, a big win and really, really novel technology. But that's certainly not your only startup.

So looking forward to kind of diving in a little deeper. That's the one that people know. That's the one that people know. So Ferer Pulse came out of Iowa as it started as Iowa approach in 2014, kind of shifted the name, moved to Melo Park with Alan Zingler at the head. And I backed off at that point around 2015 and just was in the background back in my lab and working on other projects for a number of years. Yeah, yeah.

Well, excited to learn a little bit more. about kind of maybe some of those some of those pitfalls or lessons learned that you've picked up along your your journey but before we get before we get there let's talk about field medical just a little bit you know and I think you're widely considered like one of the as you mentioned earlier like one of the one of the experts if not the leading expert right in the in the world of kind of PFA or post field ablation but talk to us a little bit about what what's new at field medical and maybe how it differs from other other PFA technologies and again I wouldn't expect you to go too deep into the in the weeds I mean this is really

kind of scientific stuff. For anyone that's listening, that spent time in the world of EP, it can get really, really technical, really fast. But give us a sense for how this is different. Yeah, so the initial inspiration

back in 2010-11 was to move towards a non-thermal energy source that allowed us to be able to kind of ablate tissue. And ablation in the heart, you know, for people who aren't familiar with that is, you know, in the old days, you needed an open heart surgery to treat cardiac arrhythmia is where your heart went too fast.

And the heart's this electrical organ. You put, but sometimes there's some abnormal tissue that if you can get rid of it, you don't have these arrhythmias anymore. And so this whole field of catheter ablation was born in the 1980s and emerged and evolved over the years and now in 2023, now 2024. for the, you know, this technology mostly depends on a deflectable catheter that goes through a big IV in your veins and you get it into the heart and you're able to do all these amazing things without ever having an open heart surgery.

And so the tech, but the technology has limitations. The current technology back in 2011, 2012, you know, I really was focused on why we were using thermal energy radio frequency ablation, cryo ablation, these things, which had some safety problems and some technical drawbacks. And so I moved back to this old-fashioned energy technique, which was originally called DC ablation. And now pulse field ablation. So that history out of the way, I'll get to the question, which is what is different between something like Ferrapulse and, you know, this kind of first wave of pulse electric field, you know, anyone familiar with cardiac electrophysiology knows already that there's a, there's truly a paradigm shift happening

right now where the for treating atrial fibrillation. And this is where I started back in 2011. That's what I wanted to make the procedure go faster and be safer. And because this energy source does allow for a more predictable, faster, safer procedural workflow, it's really exploding in Europe right now. And currently there's two technologies poised to be in the market. One is, and very well, both may be in the market by the time you have this podcast. But one is a Medtronic platform. The other one is Fairpals, which I started back in 2011,

officially, really. And those two technologies are all full. focused on atrial fibrillation. And the vast majority of companies are focused on that segment of the market, that need that's out there because there's millions and millions of patients who suffer from arrhythmia. But AFIB is sort of a nuisance problem. And it only makes up, you know, it makes up the majority of procedures probably being done today. But there's a massive amount of patients who suffer from ventricular arrhythmias that are currently going sort of undertreated or untreated because the catheter ablation technology just isn't really refined

enough to work well in the ventricular chamber. And the difference is that in the ventricles, the tissue is a lot thicker and it moves a lot when every time your heart contracts, it moves centimeters, so it's moving all over the place. And so it's hard to get stability. It's hard to get the catheters there. And the result is that almost all the technology that's been developed for catheter ablation has focused on atrial arrhythmias, and very little has been spent on the deadly and life-changing problems of the ventricle.

And that's where field medical is coming in. You know, I feel like there's so much interest in doing a fib, you know, that, and, you know, after my own contribution to a fib, I feel like, you know, it's pretty good, there's a pretty good solution now. But there are no good solutions for ventricular dectricorcardia. So we started field medical with a big focus on open. the next big frontier of medical therapy for ventricular arrhythmias. Got it. That's super helpful overview. And if you're listening this and don't get a chance to get

to the full, the full summary write up on Medsiter, fieldmedicalink.com is the website. We'll link to it, of course, in that summary piece, but fieldmedical inc.com is the website. We can learn a little bit more about the technology. There's a nice little intro video from Stephen, kind of on the homepage. But with that said, give us a, I know you, you somewhat recently close a seed round for field medical. And we're reporting this kind of at the very tail end of 2023. But give it a sense kind of for where the company's at or maybe where you're headed over the next, you know, maybe six to 12 months.

Well, the lifeblood of any startup is finance. So, you know, it really requires having a combination of a lot of things, a great idea, a great team and the resources to be able to, to, meet the milestones and develop the technology. We had incredible luck, despite a very challenging year for raising capital for the startup environment. I'm truly grateful to everyone who saw the vision of this company and were willing to invest. And we closed a seed round of about $14 million, which we're putting to hard work,

right now. The funny thing is, you know, the cost of these types of med tech startups, when you have a Class 3 medical device that requires multiple technologies to enable it, so you don't just make a catheter that can handle certain electric fields. You make a, you know, there's a whole bunch of technology that goes into making, to enabling that vision. And for us, we're making a suite of tools that allow you to work in the ventricle much more easily than you've ever been able to as a doctor. And so, you know, our goal right now is, you know, we know the steps of this journey very well.

And our next step is over the next year is focused on early human clinical trial data. And we're poised to be able to hopefully present some preliminary results by May or June of this year. Very good, very good. So that's, you're, you're moving quickly. It sounds like, you know, based on kind of the close of that seed round and already into, you know, into, in the human, you know, first person human patients. So be fun to, fun to watch what you guys, you and your team do over the next, over the next year or so. But Stephen, let's use this as a nice transition point into kind of going, you know, stepping inside sort of the, the medsider time machine as I like, I like to describe and learn a little bit more about some of these various functions. areas and kind of what you've, you know, some of the experiences and lessons learned that you've gleaned over the years, you know, building not only just, just fairples, but several other, several other startups as well. And so first question I've got for you is, is really kind of rooted in your experience as an MD, right? And there's a lot of, you know, MDs, PhDs that listen to this podcast and, you know, are sort of, you know, have sort of a natural entrepreneurial

sort of bias or bent. And but they don't, they've never done it before, right? They don't know kind of where to start. And so when you think, you know, if, you're going back, maybe a decade or so, a little bit over a decade, you're at University of Iowa. You know, what, I guess what would you say to those same MDs and PhDs? They've got maybe a great, a great idea, but kind of don't know really how to get it out of the starting blocks. Well, it's actually pretty hard to do. And what I have all my friends and colleagues who are physicians who are practicing and PhDs that are out there, you know, they're exposed to the front lines of what is the true unmet need. What are the problems that we have to solve? And these are

creative people. So they often come up with great ideas on how to proceed. The problem is that, you know, the technical challenges of building something, getting it to the state where you can get to, you know, refined enough that you can prove the proposition that it's going to be a valuable improvement or a needed technology. And then to bring it through the regulatory cycle, you know, that's a big lift for anybody. And it's really a problem of whether or not you have, you know, because, you know, it takes multiple people who are super talented, full-time effort to take almost even a simple technology from concept to product. And so what I always, always tell, you know, like my friends and stuff is, you know, there's two ways to go. You can either

give your idea to somebody else and hope that they, you know, they develop it, which they may not have the same motivation and vision you have and it may get lost or it may get, you know, deprioritized. Or you can just pick up the gauntlet and run it yourself. And I've known a number of physicians who've done this. It's very hard to do. I consider my position at field medical to be my full-time job. And, you know, and that my practice, which is very limited, I only practice one day a week, basically. You know, I do procedures one day a week, see clinic patients, half a day a week. You know, the rest of the time is full-time, you know, working in at the company. And so it takes a lot of effort. And the, and it's,

very much, I think, I had this experience recently in Norway where I, for the first time, was in a sauna, and then I jumped into ice water. And I think that the reaction your body has when you do that is very much the lead that you have to take to jump from being a, you know, because it takes you used to be a doctor and a PhD, you know, you're focused in one area, you know, and then you got to just literally take the cold plunge and, you know, and pick up a whole new skill set. And so that's, Well, that's what I usually, you know, especially after a few drinks at the bar, that's what I don't tell my friends. I want to take an idea forward.

I love the analogy of, you know, the old sauna and cold plunge, right? The contrast therapy, because it's a bit, I think it's very accurate, right? It's a very, typically very stark contrast going from, you know, practicing medicine to trying to build a startup. But as sort of as straightforward as that advice seems, it's very, very practical because you mentioned several friends or like, you know, within your network that you've kind of coached up or given the same advice. And I too, you know, run into a lot of physicians that have really, really great ideas. But the hard reality is that it is, it does take, it's a full-time effort, right?

If you want to kind of have, you know, go at it. And so I think that's just really, really helpful and really helpful kind of framework to keep in mind. If you're listening to this and you've got a good idea, it's, if you want to go out, go out it alone and give it a real, real swing. It's going to, you know, you're likely going to have to make some. some other decisions in your kind of professional career to make that to make that happen. Let's talk about some of those earliest, earliest kind of stages, right? Kind of really where you're at or maybe where you've been over the past 12 months with field is probably a good kind of, I guess, analog, especially in comparison to kind of

your previous startup experiences, even at Faripolis. I imagine you're doing things differently or been able to move a lot faster based on some of those experiences. So when you think about, you know, building some of the alpha and beta, you know, prototypes of a technology, especially considering there's not endless, typically, there's not endless capital to work with, you know, what are, you know, what are, you know, what are, you know, one or two piece of advice that you would give to other founders and CEOs when it comes to kind of being able to move quickly in those early stages, but also, you know, being mindful of the burn. Oh, yeah, absolutely. You know, depending on what technology you're going

to develop. You know, it's surprising how far you can get with nothing and it's surprising how, how little progress you can make with all the money in the world. Like, you know, both things are true. And so, you know, it does take some creativity. So when I started Ferapulse, literally, I had a $40,000 budget to build a pulse generator in the capital. So I couldn't afford to outsource. it to anybody. So I literally learned how to build electronics, bought components, put them together, cross my fingers that I wasn't going to kill myself. And I asked for help from people and, you know, so at a university, I could find electrical engineers who just told me, look, don't touch that hard, you'll die. And, you know, that kind of stuff. You know, and so like to get through the alpha

stage, you know, when it was, you know, is tough. With Peripulse, you know, it was spectacularly challenging in the sense that, you know, like, there was, there was a lot to learn that was, and so there must have been a lot of luck involved. But the, with field medical, you know, this is the third human ready pulse generator that I've been involved with to some degree in the concept to designing. And so I kind of know the ropes. I know what it takes to get it done. I know the design inputs are ready.

So it makes it a lot easier this time around. And I know how to innovate it, which is something that I can't say, I mean, despite the fact that there was a lot of innovation in the early Ferrettockos days, you know, the reality is that, you know, the technical leaps that we can make, now are just so much bigger because we have a foundation to jump off of.

And we is a royal we there. So when I look at building the Alpha build, you know, a mock-up is so cheap to build. Build a mock-up. Show it to people. You know, if there are lots of tools out there, like the guts of the original Fairpulse generator were literally the guts out of a laser. and I literally had a laser pulsar that I repurposed

and you can learn all that stuff it's not that hard you can take an old ultrasound machine you can take you can take little pieces of stuff just to get it so that it is somewhat functional and you can get your proposition it's good enough to test the proposition once you have that and you have a good business

model because I mean nothing to moves forward without there being a model for making money at the end once you have those two things, raising money is a lot easier. And so being cash strapped makes you more creative. And, you know, because you can see that the big companies will often spend so much more to get to a milestone that a startup can get to at a quarter of the price. Yeah, that phrase that you use kind of at the beginning of your answer around the fact that two things can be true at one at one time, right? You can, you know, you can be, you can do a lot

with very little, but you can also do very little with a lot of money, right? And so, so true. But it's, to your point, you're kind of the, the way you phrased that answer in the sense that building something tangible, right? Building a tangible alpha goes so much further than just renders on a PowerPoint slide as an example. And, you know, there's been so many other, other founders and CEOs on the program that have mentioned something very similar, like Christian and Rambo Ramgo comes to mind. He's the, he's a physician founder and CEO of Tampa Health. But he mentioned something very similar. Like, you know, he was able to successfully raise capital in their earliest days, largely because he had something tangible to show. And he said that also helped, you know,

it was also very synergistic in terms of getting, you know, voice of customer feedback from his peers, too, because he had actually had something to show. He was like, this is, you know, it wasn't the prettiest thing in the world by any stretch of the imagination, but like it was that much more, like someone could connect the dots, right, that much easier, you know, with something, something that they could, you know, see and touch and feel. And so it sounds like that's, you know, that's, that's been, you know, maybe beneficial even in your earliest days at Fairpools. Yeah, I mean, it's, it's, you know, nowadays you can, you can model everything and, and have almost a photo realistic model even before. You, you know, it doesn't even have to be, uh,

handheld prototype. Yeah. You know, to get the concepts across, you know, the goal in my mind is that you have a narrative, you have a story to tell, and that the story is, you know, can be consumed by somebody without having, you know, to be a, oh, you know, to be a content expert. Yeah. You know, like you, you should be able to get the story across to some degree that, hey, there's a problem.

we think we've got a widget that can solve that problem. This is what it looks like. This is how we think it's going to be better than what's out there. And if we can get this over the finish line, it's likely to make a lot of money. Yeah. And a lot of, I mean,

to your point, even about using like off-the-shelf components, right? And kind of building your own alpha, not completely outsourcing that. Even if you're, maybe you don't have the technical prowess as someone like yourself, that effort in and of itself demonstrates kind of the grit, right? and the tenacity and the perseverance that's going to take to kind of build and get a startup off

the ground. And so even just that exercise in and of itself is sort of a forcing function, right, and does demonstrate kind of what kind of those inherent skill sets that are needed to kind of of push through a lot of hurdles that you'll likely eventually run into. Yeah, I was impressed early on by a guy I consulted for. He's a CEO of a company called Cardiomac Steed, Getter. he he started that company basically repurposing technology that was already out there that was a human uh was already available for human use kind of put it together put a clinical trial pilot study design and showed the physiology that he was going after if he could invent the perfect tool for

that physiology and it was just like shocking like how bold of a step that was you know to take a start up in the first step is a human study. That is just, you know, that, that is a rat, that's radical thinking. That's what you want when you're starting, starting out. You want to prove that there is, if there's a knob out there, if we could just turn it with a good tool, then we would be able to treat something. And, and he showed that. And I thought I was, you know, and that, that was something that, you know, I learned,

this is, it was eight years ago, you know, and that would impress me. Another Dr. You know, Dr. Colstad, he's an ER physician who invented this esophageal cooling probe to protect the esophagus from radiofrequency ablation and other heat and for cooling patients and temperature management. It's a very simple tool. But he's another one of these physicians who broke out, just, you know, started hitting the pavement, raising money and building the tool. And now, you know, they have a really meaningful business. and they just got FDA approval. And his first prototypes were nothing, you know.

These are great stories that they're out there. Yeah, yeah. I think maybe the kind of the theme that's surfacing is like, don't be afraid if your first prototype is ugly, right? It probably should be ugly, but it's at least, you know, starting with something that's, again, tangible, that you can sort of demonstrate some early progress and kind of directioning where you're headed,

I think is really, really important. On that, on that now, let's talk a little bit about kind of the race, Klin function. And I think, you know, this may, this may be a little bit easier for you. Well, maybe obviously the clinical side of this equation is probably maybe easier for you as a practicing EP. But, you know, it's a daunting kind of function. I think for most startup founders that, especially if they've never done that before and they're building, they're trying to build a novel, a novel technology, right? You know, something, even in your early days at Ferapultz, right,

very novel. What you're doing now with field medical, very novel. And so when you think about kind of navigating the Ray Klin landscape against the backdrop of, you know, of something new, right? A new technology, a new way to treat patients. You know, what, are there a few kind of lessons learned that you've looked, that you've kind of picked up along the way that maybe would be especially helpful for other, other, you know, first-time founders that are trying to, trying to, trying to try to do the same thing? Well, Clint and regulatory specialists, you know, are, you know, I shouldn't say that. That way, clinical regulatory expertise that's out there is difficult to find.

It's hard to Google search, what does it take to get a pilot study done? You know, what's it cost to get a pilot? What's the cost to run a large phase three clinical trial for a new drug? You know, it's actually hard to get the nuts and bolts on how do these things work. And the people who do it, it's actually a pretty small group of people worldwide. highly specialized talent. And so it is a huge black box to anybody working in the med tech space that doesn't, who hasn't had direct experience with clinical trials in the past.

I think the physicians out there that are doing this and a lot of the PhDs, but the people who have have some experience on why do we have prospective randomized clinical trials, why are they designed this way, what is a pilot study? Yeah, you get some exposure to that. And so there is a leg up. My advice, though, is that, you know, those people exist, they're out there, and once you find one that's really good, never let them go. It's not as daunting as you would think.

It's just that there's so many unknowns that you don't know what you're missing. And, you know, everyone blames the regulatory requirements for the cost and time that it takes to get new technologies to the finish. line, but the reality is, you know, that they serve a really good purpose. And most technology that's being developed, you know, you know, that has to go through these kind of review processes and hurdles, you know, is, it's there for a good reason. And it doesn't cost as much as you think. You can actually do, you can actually make a lot of progress in human trials, you know, as long as you can prove first and foremost that what you're testing is safe and likely to be effective.

And so if you focus on that and find one good regulatory person, and the reality is there's services out there that will pick up the gauntlet for you, but they charge a lot. There's CROs and things like that. And maybe that is very difficult. But there's almost no way around that as a startup. You're going to need one person who really understands how to submit stuff to the FDA, how many pieces of paper need to be produced?

What is the regulatory environment in Europe right now? What is MDR? Why is there a notified body? You know, all those components need to get put together. So I guess this is a very long-winded way of saying, boy, that is a tough thing to overcome for all early med tech startups, unless you have direct experience or know somebody. You definitely need to find an expert.

Yeah, yeah, it definitely is a. a black box and unfortunately chat GPT is probably not going to be a good resource, right, to find out how much your pilot studies are going to cost for, you know, to manage and run. But it's a really good point. I guess you brought up just as a follow-up question. And, you know, we're talking a little bit about pilot studies. As an example, you brought up Europe, you know, 10 years ago. I'm sure kind of you were in the mix when all startups would obviously, they'd go to Europe,

right? Get your C.E. Mark. Use the data. Yeah. Back to the U.S. Obviously, that's changed a lot with MDR. So are you thinking about kind of that process differently with field medical as an example? Are you even doing any work in Europe right now? Are you mostly focused on getting your pilot studies done in other geographies or just maybe entirely, you know, starting with an EFS here in the here in the U.S.? Well, EFS is a great program and we're excited about doing that. I'm still focused on going to Europe first. The difference between working in the United States and Europe is basically no difference anymore. You know, the regulatory hurdles that you have to overcome, the ability to engage in early pilot studies through our own, you know, FDA EFS program, for instance, the breakthrough device

program is also a big step forward. FDA is not the problem in the United States. FDA is actually pretty good, you know, as long as you can educate everybody who's review. you in your stuff well and what you're proposing makes sense. You shouldn't expect it to be any more difficult in the U.S. or in Europe. MDR is a little bit of a black box because the way that the notified bodies are going to be reviewing certain things. I think there will be a little bit of chaos for a little bit longer. But we no longer have a easy path to C.E. Mark in Europe.

That's what it means. It means basically the path in Europe looks like the U.S. path. but you can submit the same data to both. So that's a big benefit. The problem in the United States is the cost of doing the trial itself. The hospitals charge so much more. The enrollment speeds are so much slower. I mean, so you're a startup, you're burning money every day,

and you can go to Europe, you can fly everyone there, and you can enroll 10 patients in one week. And in the United States, it might take you three months or four months. And so, you know, because, you know, every site, you know, they have some people, it's just very hard to get a concentration of patients, depending, I mean, in my field. In some areas, no-brainer, absolutely go to the U.S. first. If I was doing a 510K or doing something like that, I would, definitely be super excited about just moving fast in the U.S.

But with Class 3 devices, you know, the cost of doing a study at any hospital in the United States is going to be substantially more than doing it in Europe. Yeah, it's really good feedback. And it's, I mean, it's, you know, something that you have to be extremely mindful of, right? When you engage or you commence a clinical trial, I mean, if there's, I mean, if you're looking, if you're staring down, you know, a three month or a six month kind of timeline, to get through, you know, your first, whatever, 10 to 15 patients versus maybe doing them in a week. That's such, such a significant difference in terms of, you know, the burn, which is, you know, ever ever so important in those earliest stages. Hey there, it's Scott.

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