Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Succeed Without Venture Capital: Interview with Front Line Medical Co-Founders Drs. Asha Parekh and Adam Power

Episode Date: March 12, 2025

In this episode of Medsider Radio, we had an insightful discussion with Drs. Asha Parekh and Adam Power, co-founders of Front Line Medical Technologies. The company's COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System) is a compact, minimally invasive device, designed for temporary aortic occlusion in trauma situations. Asha has a PhD in Biomedical Engineering from Western University, and combines technical expertise with entrepreneurial leadership. Adam is an academic and practicing vascular surgeon at Western University, with extensive training from institutions including Dalhousie, McMaster, and Mayo Clinic.In this interview, they discuss how their clinical-engineer partnership accelerated development, their approach to clinical studies for regulatory clearance across multiple geographies, and their strategic decision to avoid VC funding during early development—and how that decision paid off.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 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and 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 VII. 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 Asha Parekh and Adam Power.

When you're pitching, like pitch well with a good story and you have that impact, it is not hard to try to get people interested in that, you know? Like, you know, we have life-saving stories and all of this. Like, I mean, it really garners interest pretty quickly. So that, you know, that was a big thing for us. 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 Dr. Asha Parikh and Adam Power, co-founders of Frontline Medical.

Asha serves as the CEO and with a PhD in biomedical engineering from Western University. She combines technical expertise with entrepreneurial leadership. Adam serves as the chief medical officer and is an academic and practicing vascular surgeon at Western University. Here for the key things that we discussed in this conversation. First, being a startup CEO takes balancing speed, adaptability, and informed decision-making. To maintain momentum, aim to act decisively with 40 to 70% of the information rather than waiting for complete certainty. Clinical feedback early on is vital. If you lack it, bring in the right expertise through co-founders, partnerships, or advisors.

and above all, keep listening to feedback even after commercialization. This can uncover applications for your tech that you never imagined. Second, when choosing your clinical regulatory roadmap, start where you can leverage local resources, which is typically where you live. But if you aim to be a global company, it's important to understand the tradeoffs between pursuing regulatory pathways in different regions. Even if you meet the regulatory bare minimum, keep investing in clinical data that demonstrates market value.

Third, VC funding can be alluring, but it often undermines your control over the company's direction. Be strategic when choosing investors. Physicians can be excellent candidates as they bring considerable credibility to your venture. The most important factors are having a compelling story that clearly outlines how your solution solves a clear need and consistently executing against your milestones. All right, before we dive into this episode, I'm pumped to share that volume seven of Medsider Mentors is now live. This latest edition highlights key takeaways from recent Medsider interviews with incredible entrepreneurs like Bill Hunter, CEO of Canary Medical, Brian Lord, CEO of Christine Surgical, Don Crawford, co-founder of Safion and current CEO of Corvista Health,

and other proven medtech founders and CEOs. Look, we get it. Keeping up with every MedSider interview isn't easy. That's why we created Medsider Mentors. These ebook volumes distill the best practices and insider secrets from top founders and CEOs, all in a downloadable, easy-to-digest format. To check the latest volume out, head over to medsiderradio.com forward slash mentors. Premium members get free access to all past and future volumes, plus a treasured trove of other resources. If you're not a premium member yet, you should definitely consider signing up. We recently revamped Medsider with swanky new features, especially for our premium members. In addition to every volume of Medsider mentors, you'll get full access to our entire

interview library dating back to 2010. You'll also get Medsider playbooks, curated guides packed with actionable insights and topics like fundraising, regulatory challenges, reimbursement strategies, and more. And if you're fundraising, don't miss our exclusive investor database, featuring over 750 life science BCs, family offices, and angels. We've even created three custom packages to help you with your next fundraise. Learn more about Medsider Mentors and our premium memberships by visiting MedsiderRadio. com forward slash mentors. All right, without further ado, let's dive in an interview.

All right, Asha and Adam, welcome to Medsider Radio. I should say Asha, welcome back to Medsider Radio. You've been on the program before. So interested to really kind of learn about the past few years, right, with all of the activity, you know, happening with Frontline. And Adam, a pleasure to have you on the program kind of as a joint fellow co-founder style interview. So thanks for, thanks for coming on a little bit of time. Thank you for having it stuff. We're very excited to be here. Yeah. I wouldn't have to meet you again when he'll meet John. That's right. That's right. That's good. So I recorded, you know,

very short bios for both of you at the outside of this episode. So, but let's start there. I mean, If you can like in just a couple minutes give us like some really high level highlights of maybe not only your professional backgrounds leading up to co-founding the company, but also maybe touch on like how you even, you know, came together to start. And then we'll and then we'll kind of dive into a little bit about the device and like the major problem that you're trying to solve. Yeah, sounds good. The nutshell version is I found Adam and chose him to work with and then not just joking. I'm a PhD biomedical engineer by trade. And I did. my training here at Western University. And then I went on to do a couple of fellowships. So one of those fellowships is actually that program kind of introduced us to each other. I will let Adam introduce himself, but he's a vascular surgeon.

So like they introduce you to relevant people in the field. And that's how we kind of met. But from there, we were working on a few projects. And it was actually the year after that that we started working on the cobra. and that kind of took off from there. That's the very, very nutshell version, but I'll let Adam fill it in a bit if you want. Yeah, before I met Asha, I was practicing a masculine surgeon.

I still am a practicing vascular surgeon. To become a vascular surgeon in the old days, I can say that now that I'm out of eight stories. You became a general surgeon first. I was a general surgeon, which is also trauma, And then I did special to it. I trained at Mayo with a sebastew surgery. And then in my

first few years of practice, most of my academic work was around in Asia and not a full advice development. I consulted for some companies. And ultimately, and I felt like if I was ever going to see in my hands something that ever came out

of my brain, I needed to actually do it myself. And thank good to Sasha was around and me to start down the path, right? Yeah. And we're recording this in late 24, but you both have been at it, I think at Frontline anyway, since, what, almost eight years-ish? Is that about right? Something like that? I mean, we founded the company in 2017, but we really didn't hit the green button until at least a year or so later. Okay. It's been a good, like, six years. Got it, got six years kind of heads down,

right, getting into this point. And I can tell, like, this is a full-on professional company now with your branded mug, right? We're recording this on Zoom. I can see the Cobra OS mug. It's like, I love to see that stuff. That's great. Yes. That's awesome.

So we mentioned a cobra a couple times already. Tell us, like, what, give us a, you know, for those that aren't familiar with Frontline or the device specifically, like what is, what's the major problem you're solving and tell us a little bit more about the device itself? Yeah. Yeah, I might take that one. A lot to match. So, I mean, if we, I'm thinking I'm a patient that I treated way back when, who was stabbed in the heart, basically, came into the emergency department. And we did an emergency room for our economy.

So we opened up their chest. And we clamped the aorta, trying to keep them alive. And ultimately, the patient didn't make. So what were we trying to accomplish there? Well, essentially, if you have major bleeding in your arm or your leg, you can put a turnic in off. And that usually stops the bleeding and allows you to get somewhere to, you know, fix whatever. When it's always a bleeding. If you actually if you have bleeding in the chest or the aptum, that's non- compressible.

We can't put a finger on it to stop the bleeding. And you can easily dump your entire blood volume either into your chest or your aptum. So it's non-compressible torso hemorrhage, which is the leading cause of death pre-hospital for any sort of trauma. So that was, and so when you see these patients, actually, if they ever do arrive to hospital, before we had minimally invasive techniques, you needed a very skilled surgeon to open up the chest, clamp the aorta above where the bleeding is, concentrate the blood to the brain and the heart. and stop with bleeding in the liver, the spleen, or whatever else, fix the problem, and then release the clamp. Advance forward, minimal invasive techniques at ovascular surgery.

Our device now can be introduced through the femoral artery and the grind, through an access sheet, they call it. It's like an IV that's in the artery from the point. And you feed that up into the aorta. Where you would have planned externally, we actually imploidable. internally and that blocks off the aorta, keeps the blood to the brain and the heart, stops the bleeding into the spleen or the liver, whatever else. It's a bridge to definitive, sir. Got it.

So almost like intravascular tourniquet, kind of, right, so to speak. Yeah, got it. Okay, perfect. And if you're following along and you don't get a chance to get to the full write-up on MedSider, Frontline MedTech is the website, just as it sounds, frontline medtech, all one word.com. is the website. We'll link to it in the full write-up, as I mentioned, but you can certainly learn a little bit more about the company, Asha and Amos backgrounds, the device itself, et cetera. So I encourage everyone to check it out. So it's actually a really cool, really good, really well-done

website. So with that said, where's the company at right now? I mentioned we're recording this is late 24 for those listening kind of after the fact. Gives the sense kind of for the stage of front line. Yeah, we are in a growth phase right now. You know, you kind of go through that startup phase and people tell us now you can't call yourselves a startup anymore so maybe scale up or it's still early stage so you know i think we're still considered an early stage med tech company but uh we're definitely on uh on a growth trajectory now um you know i'm sure we'll get into this but we started on the north american market but now we're literally growing we just launched in europe we got a couple of more approvals that are coming out uh an announcement shortly so uh

truly hitting the international markets and then growing in that way and then also into different applications as well and kind of getting, trying to get our device to help as many patients as possible. Yeah, that's really cool. One of the few startups slash scaleups, right, that's, that said, we don't care about NDR. You know, we're going full, we're going full steam ahead, right, in Europe. So I'm sure we'll talk about that in a little bit more detail. But yeah, certainly not for the faint of heart. So we're curious to learn a little bit more about kind of what that's been like, but that's awesome. That's awesome to see. So a lot of progress. And because I can't remember exactly when we last recorded. It was probably at least a couple

years ago, but really, really fun and really, really quite honestly, like really cool to see the accomplishments that your team has made. I mean, there's not a lot of startups that get to this point, right, with a novel device. So it's really cool to see the team, your team's ability to execute. So with that said, let's jump to kind of some cross-functional sort of, I guess, buckets, if you will, really with the goal of trying to understand, you know, key, key learnings, you right, that you've picked up on over the years, you know, since building frontline and maybe just other, you know, other companies in general that you've been you've been exposed to. But I want to start with kind of more early stage development, right?

Because, Asha, you said your PhD in bio-mechanical engineering, I believe, or, you know, that field. Adam, you've got a ton of experience with like, you know, early-stage sort of device iteration and consulting. So with that said, the corporate device now, I'm sure, at commercializing, it looks different than, you know, your alpha and beta versions. And so with that said, when you think about kind of that journey of iterating quickly, oftentimes probably with, you know, in most cases, in most cases, pretty limited capital and resources, you know, what was what was that like? Were there a few things that, in retrospect, like, really either helped you overcome some hurdles or, you know, just key, key learnings in general,

kind of working through that, that early stage, you know, development. Yeah, I can start. I think, you know, a lot of this comes. in retrospect, as you know, you know, and also talking to other fellow med tech entrepreneurs. But one thing that I heard a lot and I hear from a lot of people, and as we were going through it, it's like, you know, we need to, early on, that clinical feedback is so important because you're, especially through iterations, right? So I think one of our key benefits, I mean, you have to move the business along, as you know, like you're trying to get to a point always, always, like to path to market.

But to do that, like a lot of people we spoke to were having trouble getting a lot of that feedback quickly. So when we talk about moving quickly, I think that was one of our key benefits. We had an internal clinical person. I know not everybody has that benefit, but it was super, super helpful to us. That was one of our key things that I think enabled us to move a little quicker. So that was really, you know, important. And then I don't know that we've ever talked about this, but this is actually something from the surgeon kind of population, let's say.

But it's the work within the 40 to 70 percent. Have you heard that, Scott? No, no. Don't move. It's like, because we're talking about moving quickly. And really, it's like move quickly. But you can't make a decision at like knowing zero percent of the information. And I think because surgeons have to make those quick, that's why it comes up a lot, right?

like but you also can't wait until you have a hundred percent of the information so it's like work within that 40 if you have somewhere between the 40 to 70 percent like make moves like you know and I think they have to do that a lot which is why it comes up but I would still say I'm a little bit more to that I want more information I want to make like very informed decisions but probably Adam's more on the 40 side and I'm on the 70 side but we work within that you know pretty well but that's definitely something because if you get caught up on every single detail, you know, but that's definitely something we've had to balance even within the 40 to 70. So I thought that was spoken like a true engineer, right? I want to see, I want to see us closer to the 70%, right?

That's good. That framework is, I'll add him on that, but that framework's really helpful. I think that I'm really glad you brought it up. But go ahead and it looks like you're going to add a little bit the context there. Yeah, well, I probably go a little bit deeper on the partnership of having the engineering side and the clinical front line thing. I mean, we could or actually could make a suggestion or we could be talking to a partner, manufacturing partner, and they say, we can't really hit this spec. And I say, listen, that spec was a little bit more than arbitrary. What can you hit? Oh, my God, that's completely fine. If you had to actually wait or try, Why didn't expect that were not clinically relevant just because that was, you know, the alpha version or bigger version of your, it really slows things down.

So for us to be able to communicate and be so close in that process, and that's why not too many people have the time or want to do this, but we and me, but we're involved in every single step of the way. there was not a single part of our company, quality, regulatory, clinical studies that we weren't intimately involved with. It's not like we pretended like there are experts in everything, but we definitely understood it. We did our own homework and didn't, don't trust anyone. That's what I said. We didn't trust anyone. We did our own research, and we brought things to the table that a lot of people. And that really sped up. So I bet one of the other things just to go on with those, a fewer number of factors that you have as much easier.

And so if you can do as much as possible, it's also cheap, as much as possible get it as far along as you can. It speeds it up and it makes it a lot cheap. That's those are all such such really good points. And I think like just kind of double clicking on this idea of engineer, clinician kind of teaming up to get other, like one of my business partners, Brady Hatcher, who runs Switchback medically as a co-founder FastWa. Like a lot of the most nimble sort of fast-moving kind of set-ups, I guess,

for lack of a description that he often sees, is this very same thing, right? Its position maybe has an idea, is a co-founder, teams up with an engineer, and they just move like at a much faster pace. Because everyone like in the space talks about the need to move quickly, right? But how do you actually do that? Like this, what we're talking about is really, really crucial because there's all of these various decisions, right, that come up. And if you're waiting on, if you're finding it really difficult to, like, get feedback from clinicians, right? Or there's a week or two, you know, a week or two that goes by, you know, just to answer some question around a spec, as you mentioned. It just slows things down considerably.

So, yeah, I can see how that would be extremely, extremely valuable to frontline in the early days. And I might just talk to all the potential physician entrepreneurs. And I had to laugh about some of the experiences that we had in the innovation fellowship. Physicians, I think it's part of our nature and surgeons in particular. We think we're a heck of a lot more valuable than we are sometimes. And so when you talk about equity early on, if physicians just don't understand what it takes to get to this, I certainly didn't.

And I was more educated than most. And so the amount of equity, the amount that I expected or the amount of owner of things was, you know, me and a lot of other people is so much more. It's like, no, no, you work on it 100%, but I had the idea. So I'm going to take, you know, and you can take one. I just want to say this never, he's saying this, but that never actually happened between us. He's using it as an example, but we never do that issue. But for people who are listening, it's definitely something that might come up and has a point, like, some of the other projects I've worked on definitely had those issues and definitely had those

things to be concerned with. You know, I think part of that is making sure you are aligned with the right partners. And this co-founder partnership, as you know, is so important. Like, we always talk about, we talked last time to you about how key relationships are. And I mean, what is more important than your founding relationship, right? And so to be aligned, even. even from those early conversations about that is so, so important. Yeah, and maybe a couple take-home messages if you're listening to this and, you know, kind of, you know, leaning into some of this advice is one, to your point, Asha, that if you're, if you're sensing kind of these early relationships don't aren't kind of founded on strong footing,

it's a good signal, right? And that's not, it might be a, unless you can overcome those in the early stages, it's going to be a tough, tough road to haul. And then secondarily, if you're listen to this and you're like, look, I've got this thing that seems to be working, but I, I don't have a clinician co-founder. There's sort of ways to try to attempt to solve for that, right? Maybe the take-home is like, try find solutions, right, to get clinicians as close to the company as possible so you can move faster. And like as an example, with FastWave specifically, we didn't, we didn't have, we don't have clinician founders per se. We've got a lot of clinician investors, right, either individual or or through physician-led firms. That, that,

that it allows us to that with that kind of skin in the game, right? We get feedback that much faster. It's so, so crucial, right? So I'm really glad you kind of started off on that, on this point, because there's, even if you don't have this inherent kind of ideal structure, like you have a front line, there are different kind of ways to sort of tackle this, this issue. Yeah. Yeah.

Yeah. Good stuff. Let's move on to, let's move on to, um, to kind of, and you touched on this briefly early on, like kind of you've got this device that's working for this, this specific kind of application indication, right? And the last time, you know, we touched on this a little bit. Your frontline was, you know, a little bit earlier on in kind of its, it's stage, so to speak.

But now you're beginning to kind of, you know, think about other use cases, right? Other applications. And so as you, as you've kind of thought through that, oftentimes it's hard to make those decisions about how do we, where do we focus next, right? We've got this one thing that's working really well. Do we want to, do we want to even explore? or other applications or indications for the device.

So walk us through kind of that thinking and how you sort of approach to that frontline. And really what that experience has been like because clearly you're doing something right here. And so I think there's probably value and kind of learning from your experiences on this topic. Thanks for that, Scott. I will say, you know, we are still learning.

So it's always a learning process in this journey, as you know. And, you know, I would say a lot of that is coming from starting in trauma. But, you know, even when you get on the market, like it's not like you get on and you know exactly what's going to happen or how it's going to transform, right? Like, you're still kind of test marketing for a little bit to see how things actually shake out with your product on the market. And so really, it was after we got on the market and started getting some traction that you really I mean, you can hear some things.

There were some, like, signals, let's say that other applications for aortic occlusion might be useful. But, like, where better to get your information from than the market, right? Like, when you're on the market and you get real firsthand, like, insights back, I think that is what really helped us kind of decide where to put more focused efforts into what applications and again like I said we're still kind of going through some of that and and and that changes in international markets as well right there might be a a different focus there or more you know they might be weighted differently I guess um and yeah like listening to the market I think is really

important you have to you know not maybe be so set in like we have to do this this this and this and you know there might be some changes I don't know I mean you can almost follow how it basically I've taken me to talk about lines. Is these aortic inclusion cavitors for being used by trauma surgeons? They were the trauma surgeons that were in the

military. So worked at civilian hospital. In military trauma, junctional injuries that happen at the junctions to have body or can the mirror. Well, that's non-compressable bleeding. Well, there's a good. Let's try and save those soldiers. Well, is aortic inclusion device is going to use for that? Well, actually,

pretty good for civilians. And then you're in the trauma hospitals and the trauma surgeons, we know how to control bleeding. They get called to the postpartum hemorrhage suite because somebody is unfortunately bleeding in front of postpartum hemorrhage. Wow, like, why are we going to do a big laparotomy, open them off and let's try and use one of these. And that was, you know, one of the big second applications that we really spread into. And the features of our device made it really ideal for that particular application. And so it's, sort of, oh, well, we're going to use all. But now, now that this is available.

And so that's how it's sort of gross. And then you think about the pre-hospital environment. What's being helped in military, but we don't really in North America have a lot of pre-mospital physician and so in Europe, they certainly do. And so when we're going to touch in Europe, we have to keep pre-hospital. And now they're deploying a virus in place is pre-motsprop from various reasons. What's the number one reason? people are actually being called for at pre-hospital when this is cardiac arrest. And hey, it's for cardiac arrest.

You know, there's lots of data. Oh my gosh. Now non-tribun not bleeding cardiac arrest. Let's try and use. So you can see how you can tell a kind of a story. But I would like to just mention about appellations and in particular is that when you NFA, especially way back before it's the mark. you often have an idea, meaning not so much regard it, so you have an idea of what your technology might be able to treat.

But what you often don't do is realize the different avenues that your technology might do with take. Because you only have a view on, oh, cardiovascular medicine. But wait a second, did you know that in cancer and, you know, or somewhere else? this is like technology oiled down is perfect for this. But you didn't even know it was there. The eyes do not seem what the lives do not know. And so trying to figure out different applications for your technology sometimes save your company. And if you're failing and have a product branch or whatever else,

there are ways to stay within the confines or the regulatory and anything else to be able to find different ways to dig your product success. I'll just quickly ask on that front, I mean, as you know, like, we didn't have to do that, but it is a great point where you do have to pivot. So like in that situation, it's very different from us just adding on different kind of places to go. But you never know. You never know. Again, we don't know.

You never know what's going to happen in the market. in the future as well. And maybe if we did need to pivot, there's something else there to go to. So, yeah, especially if you've got like a functional device that does, in fact, work. It does what it's intended to do, right? Like, that's a really good point. But, but this, this concept of like, um, of, of looking for signals, right? There's this notion in, in, you know, Silicon Valley, you know, SaaS that, you know, you know, you want to ship fast, right? With some sort of minimally, you know, MVP or minimally commercially viable product. I like, I think it's a better, a little bit better way to think about this. And, and then the notion

in Metac is often like that, that's not applicable, right? We can't do that in the device world because if it's heavily regulated, you can't ship an MVP. But in reality, there's all these stages, right, that lead up to ventral commercialization, whether it's, you know, Cadar Labs, whether it's Canada Labs, etc., that effectively kind of allow you to start shipping, right, and getting like real feedback. And I think that's so crucial that you mentioned that, because, yes, ideally you can get to a point where you can start to commercialize, right? But there's all of those, you know, there's a lot of signals that can be gleaned earlier on that are really, really valuable, and that won't come unless you get, like, really,

hands-on feedback from end users, right, from clinicians in most cases. Yeah. So good stuff. So let's talk a little bit about your, you're a Glenn Reg roadmap, right? Because I mentioned this earlier and I sort of did it jokingly, but it's not really a joke, right? You guys have tackled multiple geographies, which is not for the faint of heart and seemingly done it pretty successfully, right? And so, you know, when you think about launching whether it's in Canada first or North America, even in Europe, what But like if you're trying to coach up other founders or CEOs that are kind of trying to determine, like, where do I start? Right? Does it make sense for us to approach multiple geography? Should I just stick with, you know, the U.S.? Or should I just stick with, you know, Europe?

You know, what are you, I mean, is there a few pieces of advice that you can kind of offer up based on kind of your learnings, you know, launching in multiple countries now with Frontline? Yeah. You know, I think people have different priorities sometimes when they decide, one, where to launch, you know, for us, North America, a lot of the times you, what is it, like you go where you are, right? You start where you are, where you live and all of that. But in Canada, for example, a lot of people go to the U.S. first because it is the bigger market, it goes faster, all of these other things. We wanted to do both because we are very proud. Canadian, obviously we have like, you know, a Canadian clinician on board. Like there are multiple reasons like that we wanted to do that. But our strategy in general, just as a high level overview, it's, you know, this is where we started and we want to be global, period. Like we want to help patients all over the world. But we're going to start where aortic occlusion is more practiced. you know, this is, this aortic inclusion, even these techniques, it's still very much a growing market. So it's not like, okay, you can pick and choose and everywhere is just, every region is just as heavily into it.

So that is our strategy. And so that's why we went to Europe, you know, and that's how we're tackling the other international markets that we're going to. MDR, like, it was no, it was definitely no joke and it was a lot more than FDA and Health Canada for sure. But that is why we did it. And, you know, it did take, it did take a bit longer in all honesty. Like, it took a lot more time, effort, energy, money than it did for us to get FDA and Health Canada approval. But we knew we wanted to do it. So we just had to go through the motions and keep on going and, you know, kind of get it done. I might just add to that strategy. I mean, if you can truly have a medical device that it could and is being used ever.

Okay, great. Well, where do we, where do we? I mean, we did pick in the Hallmark, Canada, not just because they're not proud Canadians, but also because of the resources available. I mean, I'm an academic, cardiovascular surgeon. They works at the hospital. Well, we took a sound first clinical study. I mean, it's very inexpensively because I worked free, essentially.

I performed the, and we did this because we were a class two medical device, so we did not even include data. But we wanted to get that to check the market. To show people at the market, they guess it's been useful. Yes, it books to late. And that's been very useful. But, you know, so that one thing helped like Canada itself. That was something that restored health and get better pool.

FDA, like if you think about FECD mark these days, everybody that's listening to some sure said, oh, in the past it was CE PARP that you start. These days, it's actually FD. And in fact, if you even look at something as simple as how your device is class, right? we're a class two medical advice through the FDA we're a class three medical device in Europe

only because of MDR I'll say under MDD we still would have been a class too yeah they matter early on and you know and so if we haven't we definitely would stay we would have done the same

to the actual trajectory like we would have stayed away from New I don't know. But if we, you know, but NDR would have started in her and read, they probably would have got through it picture. Right now there's a big backlog to a lot of the notified bodies. And that's why they keep pushing the dates or when everybody will steadily optimating with the Rangoratory.

Yeah. And then and then I shouldn't say also my intervention is that FDA often opens up many other avenues for other countries where they say, and you have MTA, that's great. But we've noticed, though, that CEMR and MDR, they prefer there. So they say, like Zern West.

And, oh, no, GMC, Martin makes it so much easier for us to get it. I know it's more than football in certain times. I think, you know, it's kind of like widespread across any, all of our METEC fields is like, if you have Health Canada, FDA, or CE mark, it's a little, like, you're, you're probably going to have a little bit of work to do, but those are like the major approvals worldwide that kind of help you catapult into those markets. But Adam touched on something I wanted to just talk about because, like, in terms of like the clinical stuff, because, you know, I think regulatory,

you have, you have to get that to sell and make money. Like, that is your ultimate, right? like your path to market, you have to do what you have to do from a regulatory standpoint in order to make that dollar. But sometimes you may need more than that from a clinical perspective to actually get the buy-in, which is, again, and I don't like we may have needed that. We may not have this was, I think it was more for us that we wanted some human data because we, as Adam mentioned, we didn't need it for the North American market. But it may, what you do for a regulatory may be enough for clinical as well, but it may not be, right? Like, you might see, like, what type of evidence

will the market want to see? Do your customers want to see before they actually start to adopt or something like that? That's just an example from us. Like, we didn't need it, but we did it anyways. It ended up helping us because now with that MDR change, we needed clinical data to do that. So it was kind of good like that.

Yeah, that's a really good point, that even though your reg pathway, may not require clinical data, thinking about how is this going to be adopted, right? What does that, what does that friction look like? Is there going to be like a more significant need that we don't really appreciate that that is going to drive the, a lot of this, this clinical work, right? Even though, again, technically it's not required. Hey there, it's Scott. 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,

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