Medsider: Learn from Medtech and Healthtech Founders and CEOs - Building Adoption Into the Design of Your Device: Interview with TRiCares CEO Ahmed Elmouelhi

Episode Date: September 23, 2025

In this episode of Medsider Radio, we sat down with Ahmed Elmouelhi, CEO of TRiCares.  TRiCares is developing Topaz, the first purpose-built transcatheter tricuspid valve replacement system — a technology designed specifically for the right side of the heart, where complex anatomy has made durable solutions elusive.Ahmed is a 20-year medtech veteran with leadership experience across electrophysiology, men’s health, neuromodulation, and structural heart. Before joining TRiCares, he helped build multiple businesses at AtriCure and held key roles at Medtronic during the early days of TAVR. He also serves as Chairman of the American Heart Association in Minnesota.In this interview, Ahmed shares why adoption — not added complexity — is the ultimate measure of medtech innovation, how a small group of physician champions can accelerate clinical studies faster than internal resources alone, and why treating your board like collaborators in the “sandbox” leads to stronger partnerships and better outcomes.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 Ahmed Elmouelhi.

Sometimes you try to do too much. Sometimes you want to create a whole system. And I remember sitting in front of several strategics and telling them, well, you know, we have a great valve, you've got a great delivery system, we're trying to improve on the delivery system, we're trying to create a stabilizer, we're trying to create a whole host of sizes,

we're trying to do 12 or 13 different things. And they said, listen, it's the valve stupid. They were a little nicer than that, but that's the message that I came away. with it's the valve stupid just focus on the valve get the best valve invest over invest your resources and make sure that valve the final implant that's going to stay with the patient for life is as perfect as it can be 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, Scott, in this episode of Medsider, I sat down with Ahmed, Unwilly, president and CEO of TriCare's. He joined the company in March of 2024 after serving his SVP of product marketing, strategy, and business development at Atricure, where he established left atrial appendage therapies, or LAA, and built two business franchises.

Earlier in his career, Ahmed held leadership roles at Medtronic Structural Heart Division and AGA Medical, which is now Abbott, helping launch multiple tab or systems, congenital heart defect treatments and percutaneous LAA devices. He also serves as chairman of the American Heart Association in Minnesota. Here are a few of the key things that we discussed in this conversation. First, adoption is the ultimate measure of innovation. The best device isn't the one with the most features. It's the one the whole care team can use with confidence.

TRICare's iterated its topaz system as dozen times, not to add. add complexity, but to make the procedure faster, smoother, and easier for everyone in the room. A focus on the core implant helped them prioritize what truly mattered for lasting adoption. Second, managing trials means managing people, not just protocols. Multicotinent trials can overwhelm even well-capitalized startups. For Ahmed, progress came from two things. Local teams close to the sites at a small core of physician champions who carry the study forward. These quote-unquote 10x physicians turned regulatory deadlines into momentum, showing that a critical mass of believers is more valuable than trying to win everyone at once.

Third, effective boards work in the sandbox, not the spotlight. The healthiest boards are about engagement rather than convincing members of a predetermined route. Ahmed's sandbox approach invites directors to build solutions alongside the company instead of judging finished plans. That requires transparency with both successes and problems and alignment across all investors. 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 Pristine 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 e-book 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 treasure 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

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All right. Without further ado, let's dive into the interview. Ah, man, welcome to Medsider Radio. Appreciate you covered out a little bit of time on this, on this two. Tuesday to have a nice little chat about TRICARE's. Oh, thanks for having me. I'm really looking forward to this. Yeah, yeah, I am too, as we were kind of chatting before I hit the record button.

We know a lot of the same people and are generally in the same space. So, yeah, definitely looking forward to this discussion. So first and foremost, I recorded a very short bio at the outset of this interview that probably didn't do your background justice, right? So let's start there. If you can kind of give us a, you know, two to three minute elevator style kind of overview of your journey before taking on the CEO role of TriCare's. Yeah, sure, absolutely.

And again, just awesome to be here. It's just a great podcast, a lot of energy, and I've learned a lot from it. So hopefully I can be at least partially informative like some of your past guests have been to me. I'm a tech veteran with over 20 years or so of experience. Started in R&D, a lot of experience in strategy, product pipeline planning, messaging, positioning, and then eventually sales marketing, multiple different organizations, but really focused in cardiovascular. And so I've been involved with electrophysiology, wonderful group of physicians.

I've been involved in structural heart, obviously, which I've come back to with tricare's in the tricuspid space. And I've been part of other industries and businesses and therapies as well, men's health, prostates and neuromodulation. So a lot of different experiences. Most recently, I was at Atricure, building several businesses. And I think my background has been marked by coming to opportunities that just could not be passed up. And so that was the case with Taver.

15 or so years ago, I was told you have to take a look at these transcatheter valves. This is just incredible technology. and it did not disappoint. And recently I was told again, listen, tricuspid is really, really exciting. It is very different than aortic and very different than mitral valve. And that has not been a disappointment as well. So that's a little bit of my background and what's led me to be part of the tricure story. That's a good overview.

And kind of speaking about Tavert, right, of structural heart in general. It's been one of those like hot spaces, if not the hottest space in cardiovascular for just like quite some time. Maybe touch on what drew you to Tricare specifically. And then for those that aren't as familiar with, you know, kind of this structural heart arena, give us a sense for kind of what, at least maybe at a high level, you know, what this solves for. And then maybe how topaz is maybe a bit different versus other devices that are in clinical studies right now. Yeah, happy to. So I was happily and gainfully building markets at the previous company.

And of course, over the years, as you get involved, with different therapies and you've gone through many battles to create different procedures with different key investigators. You really create a bond with people and that's kind of been the hallmark throughout is I have created a lot of strong bonds with people that I trust completely and who trust me completely. And so we have this wonderful ecosystem in medical devices, especially in cardiovascular. And we really support each other. We really look out for each other. and we're constantly trying to make sure everyone advances together. And so the reason I came to TRICARE is because of that network.

I was told by some physician partners who I trusted very, very closely that I really have to take a look at this company. The CEO is retiring. They're looking for someone with experience in the United States who can take it through a clinical stage. And I thought, okay, well, I trust these folks. And if they tell me this is the right thing for me to do, I need to take a look at it. Got to know the team fell in love with it. the team. The team is based out of Munich and Paris and Brazil. Brazil is where the valves are manufactured. A lot of people go to particular spots in Brazil to get certain types of tissue for their

valve that is very dependable. And I fell in love with the team. I thought the team was great. They had the right balance of innovation, but also respecting the process and understanding that you have to get to the market at the right time or else a great idea can die on the vine regardless. And then finally, it was just a high level of innovation. This is not a Me Too technology. It's not just another option. It is really intended to be the standard of care for tricuspid regurgitation patients. And then finally, the icing on the cake was, I met the board.

I don't even know how I can say this without people thinking that I'm making it up. But I love this board. It's a very supportive board, very experienced. They have multiple experiences in cardiovascular. VALVALS specifically and say they know all the ebbs and flows. They know the challenges and they're extremely supportive. They want to empower us. They want to fuel us and watch us just take off.

So what's different really about Topaz? A couple things, Scott, you asked about this. Two in particular, one, it's a technology that from day one was built to address the tricuspid valve specifically. None of these valves is the same. Aortic valves took off very quickly. and then for a decade after that, everyone has been trying to innovate in the mitral valve space. And we learned all of us very quickly that the two are not the same.

Now some mitral valves are coming to fruition and we're starting to see the fruit of that effort. But tricuspid is the same story. There's so many technologies out there that are mitral technologies being retrofit for tricuspid. It does not work. The two spaces are extremely different. Every tricuspid valve is like a fingerprint, different number of leaflets, different position of the leaflets, different amount of tethering, ventricles look very different on the right side of the heart. So it's a very unique space and the mitral technology doesn't always work well in that situation. And then finally, again, don't know how, but the founders of the company out of France had done a great job getting this technology to where it is because they started 10.000.

years ago. They've been through 12 to 15 iterations and now we have a technology that works. So what is this technology? It's a technology intended to treat patients with tricuspid regurgitation, which is blood flowing backwards through the valve and not getting out into the lungs like it's supposed to. This happens when you're typically in some form of heart failure or you've had a car accident or you've had a pacemaker placed across the valve itself, which kind of stents it open or keeps it open, and those patients have a tough time pumping normally. So the technology is wonderful because it replaces the native valve. It goes through a catheter system. So it's inserted through the femoral vein through a small puncture in the groin. It's snaked up into the position in the

right side of the heart, and then the valve is deployed. And really, what I love so much about this technology is it's extremely elegant. The whole procedure, from insertion of the sheath to remove of the sheath is no longer than 25 minutes. And so typically when we go to our cases, we show up. The physicians are bracing themselves for a whole day, trying to figure out how this technology works. And 30 minutes later, when we're sitting in the conference room going, okay, I think that patient is going to get a lot of relief. What do we do with the rest of the day? So it's a great technology. We're super happy with how it's performing. And it's very, very straightforward. That's great. So, so important, right? I mean, the technology obviously has to be safe, has to

work well, but sort of the efficiencies that it provides from a kind of procedural standpoint. I think sometimes that's often underappreciated, right, in MedTech and oftentimes leads to the to the most sticky sort of adoption commercially. But you mentioned something kind of describing kind of what sets, what sets, you know, topaz apart and the fact that it's purpose built, right, for tricuspid. And I'm sure you probably maybe even still kind of receive this sort of feedback or, you know, whether it's from investors or whether it's from other, you know, other, other, you know, physicians in the space, but it feels busy. There's so many technologies out there, right? And the reality is, is typically the technologies that are built for a specific purpose usually win in this

space, right, versus the alternative approach, which is we built this catheter, this device for aortic. Now we're going to repurpose it for mitral and then, aha, we're going to repurpose it for tricuspid now. And that often just is not, usually doesn't go well, right? There's always like nuances. And so I think you brought up a, you brought up a really good point. And some of these top because I hope that we'll get into in a little bit more detail, especially around kind of the comments you made about the board at Trichair's, right? You sit on yourself, you sit on some other boards yourself. So you have a fair amount of experience and probably seen a lot.

And so the fact that you mentioned the strength of that board and sort of what sounds like the sort of the healthy, you know, sort of function, I think is, I don't want to say rare, you know, is the ideal, right? That's the goal, I think, for most of us that are in startups. Certainly helpful. Healthy, healthy board function. So I think we're going to get into that in a little bit more detail. But TRICARE, so I'm looking at the website right now.

And if you don't get to the full write-up on MedSider, it's tricare's.com, just kind of as it sounds. So T-R-I-C-A-R-E-S dot com. We'll link to it in the full write-up. But give a sense for kind of where the company is at in terms of a, at least at a high level. Yeah, absolutely. And I want to come back to your comment about custom built, and I think you're exactly right. there's several technologies that talk about even being able to treat multiple vows with the same exact system. And I think that's really attractive and it can have some benefits.

But given just how unique the heart is and just how adaptive it is and just how the disease states are so different in each part of the heart, you know, one size fits all tends to be a little bit problematic when you're dealing with these types of really individualized disease. And so we have, like I said, gone through at least 12 iterations of the valve to get to where we are. And I think there's a lot of technologies that will succeed. Even the one commercial technology that exists today is a technology that started in the mitral position. And I mean, everybody in this field, everyone who's trying to treat tricuspid regurgitation patients owes a debt of gratitude to that technology. Because even though it may be suboptimal, maybe first generation, it is the one that has blood. lays the trail. And it is setting a fantastic precedent for people to be able to operate in.

And second generation technologies can supplement that and really make things a little easier to use. One of the biggest things is just not requiring a deep level of expertise from your imaging specialists. So I'll give you another quick story. As we were starting to do the procedures, we've treated over 65 patients now. We're very happy with the results. We've published our first in human. When we did the first procedures, I thought, oh, no, I'm going to go to this case, and I'm going to meet the echocardiographer, and they're going to be a little upset at me because I'm taking their job away. They typically spend three hours now at a case with very intensive imaging trying to decide if the leaflet is above or below one of the anchors. They have to spin their crystal

round and do this nine times for each one of the anchors of the current commercial device. And we went to the case, when we finished in 25 minutes, thought, okay, well, here it comes. I'm going to be hearing from this echocardiographer, and they did come up to me and they said, thank you, because we have been overworked in these cases, and now it's reasonable. People aren't looking to us to be the only decision maker in the room. We are now part of the team and we're being utilized at the right level. So that was a really, really pleasant surprise that we got along the way. Yeah, such a, Such a crucial point because the support staff, you know, everyone, I say support staff, but in a lot of instances, they're equally, you know, they're equally as sort of key decision

makers, right, in any cases, as even the operator. But that's so, so important to be mindful of, like, what is their perception? How does their workflow change with this, you know, with this device? And sometimes it's so easy to gravitate towards what does the physician think and the operator think or the interventionalist, regardless of kind of the space that you're operating in. But, you know, the nurses, the techs, the echo folks, right, that are in the, in the, in the case. as well, like, how does this, asking your question, how does this impact them, you know, positively or negatively? Such a good question to think about, even at the earliest stages of a devices of design. 100%. And if you want to build the standard of care, if this is going to be

something where the physician can line up five cases in a day and treat them successfully and not have snafews that totally overturned that schedule, then they can really build a practice in that fashion. everybody has to be able to participate in the case in a way that makes sense for him. So your comment is spot on. So getting to where TricCares is right now, we have finished our first in human in Europe. That was a 20 patient study. We presented it at one of the major conferences recently. We were very, very happy because we demonstrated that patients who received the TOPAS valve

had no tricuspid regurgitation remaining, either grade zero, which is none, or grade one, which is mild and both are well below the standard of grade two being a somewhat acceptable outcome. So we were very happy with that. We were happy to because the study showed that none of the patients necessitated a post-procedure pacemaker. This can happen a lot of times in the tricuspid space because the pacing complex protrudes really into the tricuspid annulus itself. So any device that puts pressure that is not soft like our technology is a super soft. outer stem valve. Anything that's rigid can put pressure on that conduction mechanism. And some studies, some experiences have reported up to 30 percent new pacemakers placed for these patients. So that's

something that needs to be avoided and managed very carefully. And we're very happy with those outcomes. And as a result, now we have a U.S. early feasibility investigation, a small study before we initiate our U.S. IDE pivotal study. And in Europe already, we've launched our European CE-MAR trial with 70 or 80 patients needed. Another benefit of being a company that's been around for a while, we are grandfathered into different study designs, and we're able to take advantage of that to demonstrate safety and efficacy without having to run a taxing trial. Your current U.S. IDEE EFS, is that another kind of 20 to 30 patient trials? Is that sort of the roughen? That's exactly right, Scott. Yep. It's a very straightforward trial. We're very fortunate.

because there's a lot of enthusiasm out there for tricuspid repair and replacement. And we've already enrolled the first half of that trial. And we have a great number of centers who have stepped forward and want to finish it for us in short order here. So we love the enthusiasm. We're really blessed to be working with the right investigators. And I'm looking forward to starting the big IDE pivotal trial shortly. Oh, yeah. These are huge inflection points.

And for those listening that aren't maybe as familiar with like a, I would say, clinically intense, right, you know, device like this. I mean, to get to this point, there's just not a lot of startups, right, that make it this far, you know. And so some of you listening might be thinking, well, this still feels like early. We're talking about, you know, early, early studies. It's like, well, to get to this point is a, is a monster lift. So congrats so far. And certainly it'll be fun to kind of see what, what you and the Tricare's team accomplished here of the next, next year plus. So with that said, again, triCares.com for everyone listening is the website. We'll link to it in the full write-up on Medsider. But let's maybe

spend the next 20 minutes or kind of running through, you know, some functional topics, right, that most startups have to kind of navigate or conquer, right, at some point, at some point in their journey. First one, I want to get your take on, especially considering your engineering background, is kind of early stage development. And maybe, I mean, you came into to Tricare's a little bit over a year ago, but even maybe think about other startups that you're around or that I've worked with or maybe sit on the board of iterating quickly, right, with not a lot of resources at that kind of seed series A stage is really, really difficult, right? Because you're trying to hit just the next kind of milestone or to demonstrate the next thing, right, so you can

raise more capital and kind of keep moving. It's just, it's really difficult and challenging. So when you talk to other, you know, other device entrepreneurs that are maybe taking on a startup for the first time, are there a couple key pieces of advice that you think, you know, are especially important at those early, early stages? This has been a learning process for all of us. And like you said, Different endeavors have different levels of difficulty. Some things have never been done before, and you're really going to run into a lot of obstacles along the way until you finally find a solution. And some things have been done, and you're iterating to improve on efficacy,

or you're iterating to improve on ease of use, and maybe the barriers are a little more benign in a situation like that. But I'd say the two things that really stood out all along, first and foremost, speed is never the goal. I know a lot of folks are squeezed and funding is tight and there's a lot of commitments and it has to happen now, but it's very difficult to trade off future success for success today. And so I always tell my team, speed is not the goal. The goal is to be smooth.

And I borrowed this from Formula One. I'm an avid Formula One fan. I love watching all the races. I love watching the difference between the different drivers versus the difference in technology and seeing what really is driving a win at the end of a race. But in Formula One, they always talk about slow is smooth and smooth is fast. So if you want to be fast, you have to be smooth. And to me, smooth really means that you know what the next step is.

You're prepared for the next step. Once you complete what you're working on, the next person is able to move forward. Think of it like a pit stop in Formula One. I mean, the best pit stops are 2.3 seconds. And in that time, they have replaced the tires. They may have replaced the front fender. They may have refueled. There's a lot that happens in those 2.3 seconds.

So it needs to be extremely smooth so that it can be fast at the end of the day. And sometimes to be smooth, you just need to take a breath, take a step back, and you need to slowly examine what are the sequence of things that we need to do so that slow can be smooth and smooth then makes you fast. So that's what I tell the team, focus on being smooth and we will be fast. And then finally, the second lesson that I've learned along the way is focus. I mean, focus is critical. Sometimes you try to do too much.

Sometimes you want to create a whole system. And I remember sitting in front of several strategics and telling him, well, you know, we have a great valve. We've got a great delivery system. We're trying to improve on the delivery system. We're trying to create a stabilizer. we're trying to create a whole host of sizes. We're trying to do 12 or 13 different things. And they said, listen, it's the valve stupid.

They were a little nicer than that, but that's the message that I came away with. It's the valve stupid. Just focus on the valve, get the best valve, invest, overinvest your resources and making sure that valve, the final implant that's going to stay with the patient for life is as perfect as it can be. And the rest we can manage. everything else will manage around, but it's the valve stupid. So I've always taken that lesson, which is focus on the most critical aspect.

Don't spend your time everywhere running around in circles. And that can help you be fast as well. Yeah, or smooth. Yeah, these are like Ahmedisms. I like these. Smooth is fast. Even if you stole it, I'm going to credit you with that one. That's actually really good.

And tell me you checked into like getting the Tricare's logo on, Brad Pitt's jersey and F1. Tell me maybe you checked into the price of that. I saw some numbers. Yeah, I saw some numbers that, you know, we're quite large for what it took to get your logo on. We're going to stick to some of the local races. I don't think we're going to get Formula One.

The board function that we mentioned earlier might have not made it. That would have impacted maybe the health of the board if you would have come to them and said, you know what? We decided to not pursue that thing that we were working on. Instead, sponsor F1. No, but joking aside, those are really, really good points, and especially the one around focus, right? And sometimes that means focus on one particular, you know, category, right?

Maybe you're a platform technology. You need to focus on one particular category. But you mentioned something that's kind of more specific to like device iterations, which is sort of the topic at hand. And it resonates for me because even thinking about, you know, some of our early learnings coming out of our first few patients for Fastwave with this coronary system, there's a number of different things that I think you always want to work on, right? And the reality is, like, if you do try to attempt to work on all of those, you're probably not going to improve upon

any of them, right? And so focusing and prioritizing on the valve, stupid, I guess, right, in your case or whatever that, you know, those major things, right, that are, if you don't fix this, or if you don't improve this, everything else really doesn't matter, you know. And so I think that's really, that's really, really healthy, healthy feedback. I think regardless of kind of the the device, the space, the domain that you're kind of operating in. So that's really good stuff. Let's transition a little bit to clinical work. And you obviously, even with just tricairs, have, you know, I've done a lot, you know, even now we're recording this and, you know, in mid-2020 here, but wrapped up your, you know, your 20 patient, you know, feasibility studying in Europe,

kicking off a pivotal trial there, obviously in the throes of an EFS as we, we discussed here in the U.S. with hopefully maybe a pivotal, you know, staring down a pivotal trial sooner rather than later. And so when you think about like this bucket of early state, let's call it all of an early stage clinical work, for those listening that have never operated or taken kind of a swing at doing this, it can it can feel overwhelming, right? Do I go to Australia, New Zealand? Do I go to Europe? Maybe maybe should I just start right away in the, in the U.S.? I've heard things about, you know, Paraguay and, you know, Ladam, you know, should I go there? What are, what are a few things that, that you think are, you know, wise to keep in mind for anyone that's kind of at this stage

and thinking about how to how to best kind of start the clinical snowball. Hey, everyone, let's take a quick break to talk about Fastwave Medical, the company I co-founded and lead as CEO. We're developing next generation intravascular lithotripsy systems, or IVL for short, to tackle complex calcific disease. The IVL market is valued at over $10 billion, but there's currently only one major player. In early 2023, we opened up an investment opportunity to our community and within a month we secured close to 10 million dollars that in early 24 we closed an over-subscribed 19 million dollar round in just a few weeks bringing the total investment into fast wave to over 40 million dollars corporate interest in the ivyl space is growing

to the 900 million dollar acquisition of bolt medical by boston scientific and then j and j's 13 billion dollar acquisition of shockwave medical signals a lot of attention towards emerging iBL startups like fastwave and we're making some serious progress fastwave recently we're received its seventh patent for our differentiated laser IVL platform for coronary applications. On the clinical side, last year we completed the first in human study of our advanced electric IVL system with some pretty compelling results. Next up in 2025, we have IDEE trials plan for both our peripheral and coronary IVL platforms. So if you're interested in investing in the fast-growing IVL market, sign up for our investor

waitlist at fastwavemedical.com forward slash invest. Again, that's fastwavemedical.com forward slash invest. Now let's get back to the conversation. You're exactly right, Scott. I mean, it is a snowball. Even small investigations become big undertakings and there can be audits. There can be a lot of back and forth with governmental bodies. There can be a lot of time that goes into these things and no shortage of effort. So that's a great way to describe it. All of these have to be mission focused. If it doesn't really advance you to get to the goal, then it's going to be too much to take on. But I think the thing, the thing is

that have helped us all along the way. And, you know, to borrow from Mike Carroll, who's a leader that I very, very deeply respect in the cardiovascular space that I've had the pleasure of working with, he says, look, we typically punch above our weight class. And that's been the story with the clinical studies at TRICARE's. Having a U.S. effort, having a European effort underway, going for both markets at the same time is not easy. But what has made it bearable and what has made it continue to move forward.

forward at the speed that we're seeing is two things. One, I can't say enough about how capable a team you have to have in place. A local team, someone who can be on the phone and is dedicated and can be out to visit centers and walk them through the process and leaders as well. So having a clinical leader or multiple clinical leaders who just really understand the space, have experience, have people on speed dial that they can go to for help, are connected. I mean, again, it's an ecosystem. We are so blessed, especially in cardiovascular, to have so many capable people who have done incredible things in this space and recently, too, that you can just call up and they are willing to help you.

They're willing to tell you, you know, you could try that, which is always code for, I'm not sure I would advise it, but you could also think of the following things. And it's just, it's just so helpful. So the ecosystem, having a capable team. And then finally, the thing that actually moves clinical studies forward are physician champions. I mean, if you have two or three champions, true champions of the technology and of the study, that study will be successful. It doesn't have to be everybody.

It's better if it is. But if you just have a small, critical mass of physician champions, that has worked incredibly well. And when you have it, you know it. And you're blessed. and you can rest assured that progress will happen. So it's more about focusing on the how, not the what, the what will take care of itself, but getting the right people involved,

that's what moves these forward. Yeah, and we're recording this on Zoom, obviously, so people listening can't see my face, but I'm nodding. I mean, I couldn't agree more, especially with those last two points you made around physician champions and trying to, I think, what would you say, you know it when you have it? So, so true.

And sometimes it takes a bit, right? to kind of figure that dynamic out, but like incredibly crucial. I mean, it's almost like hiring a, you know, a quote, quote, 10x engineer, right? To have a 10x kind of physician champion, really, really driving, driving your clinical work forward. I mean, it makes such a difference. And even, even thinking about the former points you made about, you know, even on site, kind of having, having folks on site. I mean, I can even, I'll give, I'll give Nick with clinical accelerator a shout out, you know, he specializes in Eastern Europe. But that's one of the things that I think, like he does really, really well is hat. He has really,

really solid relationships locally. And so, like, his team is local. And, you know, when it, when, you know, it obviously helps when you're actually doing the cases, but more importantly, all of the follow up and the dialogue kind of leading up to the cases and after the, I mean, it's just all, all of that is, is so, it's so much more helpful, right? When you've got, you know, feet on the, feed on the street there and relationships that have already, kind of already been built.

I love that term. You used a 10x person on your team. And that's, that's literally what it feels like. There are certain people that are such accelerating. and such connectors. And I mean, I'll give you an example from our recent experience. FDA really wanted to move forward in our case. They have been extremely supportive. We're very lucky to be working with them. And they said, look, we want to keep to our timelines. But to do that, we need to get on the phone within 24 hours. And within 24 hours, we had these physician champions

on the phone, had a wonderful conversation, came out with exactly what's going to work great for the physicians and for the patients and for the study. To be able to pull that together so quickly, those are 10x people, as you're describing. Yeah, no doubt. And I just, I keep coming back to what you said earlier. You know, you'll know it when you have it. And if you're, if you're listening to this and you don't think you have it, I would just encourage you to kind of keep going there, right? Keep, keep trying to figure that out because it is. It's so, so important. And, you know, I'm really fortunate to have a phenomenal group of, you know, physician advisors around Fastway, too. And it just, it does. It makes such a, such a monumental difference when you've got those,

those champion physicians kind of helping really drive, drive a lot of, a lot of that momentum. So that's really good stuff. I'm looking at the clock and I've got a few more topics. I want to get through, you know, I wish we had more time, but maybe we'll eventually we'll do a round two, you know, once you're in your pivotal trial maybe. But let's talk a little bit about fundraising, right? You, uh, Tricare's raised a series D, you know, I think it was right around 50 million based on our notes last year. And, you know, you've been around a fair amount of startups yourself and been around kind of the fundraising process. And so if you're going to, if you're going to coach another, another CEO up around, you know, capital raising, what are you telling them

that you know now versus maybe things that you didn't know, you know, five, 10 years ago? I wish I was the most qualified in this regard, but there are people who have done so much more than I have. And I would say in my small experience, investors love transparency. They want to be partners. They're already well informed about everything that you're going to tell them. If they're not, then they're probably not the right investor to be a partner with you, but they love transparency. And they probably can put their finger right on where the issues are going to be with your technology or with your company set up or with your future financing. So the transparency never hurts. It can only help. And I think that's very helpful for us. We've also looked for win-win situations everywhere.

I think that's basic for everyone. That's table stakes. It helps to have a strong technology, to have good, strong fundamentals when you go in. But really at the end of the day, just what I've seen is maybe a little atypical, but it's not a put your best foot forward, but put the truth forward,

and they're going to find it anyway. And so that just sets you up for maybe some of the other things that we can talk about with boards and how boards function. But that's just a great, way to go into things. And in reality, not every partnership is going to be a successful partnership. And so it's a two-way process. You're really looking for the right partner for your company. Like I said, I love our board. And our board is made up of our investors. And these are the right investors. They know what we need to do. They support the company. They're in it for the

long haul. And they're not shocked when we say, look, this is a very, very sick patient population. things happen. We wish they didn't. But overall, in the totality of the experience, it is wonderful, and we are making a huge difference for patients. So that's hard to get your mind around when you're very reactive or you're very jumpy. And so it takes people who have had a lot of battle scars, especially in cardiovascular. You know, it's different than some other spaces. So that's maybe the one thing that I can say. We're fortunate we had a great series D and we have other things in the work. but I think the transparency is key and it's a 2A. Remember, it's 2A interview. It's not a one way. Yeah, so true. And if you're not, if you're not trying to optimize for it being a win-win, right,

both on the company side and ensuring that your investors feel really good about, you know, whether it's the valuation or the terms. I mean, if it's one-sided, it's typically not going to be, it's not going to work. It's a relationship that's not going to work out. It may be okay in the first year-ish or six months or whatever. But, you know, when you hit a challenge, which is undoubtedly going to be the case, right, with any startup, especially with a, you know, pretty novel technology that's, you know, that does require a fair amount of like, clinically robust kind of data, you're going to run into hurdles, you know. And so if, if the, the most recent round was set up and it's totally one-sided, that's not usually going to result

in something that lasts, right? That's durable. And so, yeah, I completely agree. with that. That's that sentiment. The other part on fundraising, I mean, I know people are looking for the money and it's a matter of survival. So, you know, some of these are luxuries, let's say, that you can't always honor. But it's also important to make sure that there's going to be a synergy on the board, you know, just because someone is a great investor. Well, when they are paired with other investors, how is this dynamic going to look? You know, if you can achieve anonymous outcomes on your board, you are on a wonderful path. The minute it starts to get split and there are different motivations and there's different incentives and people have very, very vastly different

outlooks on what they'd like to do with the company, it gets really complicated, really fast. So it's not just the new investor or the person you're bringing on board, but also how they relate and how their outlook is relative to the people you already have on the board. So, you know, it's work and process, a lot of learning real time here. But if there's something I can share, maybe that's just the initial piece. That's it. And I like the fact that you, you, you, you mentioned that, yeah, this can feel like a luxury sometimes where, you know, someone, someone listening to this may feel like, well, look, I'm Ed, you've got like some, some pretty legit investors that are out in TriCare's. They're all kind of, you know, pretty well-known brands,

et cetera. If you just go to TriCare's website, you can see the list of, of investor logos there. It's pretty impressive. But I would make that, the, count my counter counter, I guess, to that would be all of this takes a lot of time. And it's, it is doable, right? You just have to like, bake that in the process. And so if you're looking at raising a series A or a series B, you know, you need to close that 18 months from now, start building those relationships now, right? That doesn't mean that you're hard pitching someone on your series B. That means you need to like just have a 30 minute, a 30 minute catch up. That means you're communicating with them on some sort of consistent basis, right? Building that relationship. So when it does

come time, right, to really, really think hard about that next fundraise, you're not starting from scratch, you know what I mean? And so, yeah, that's maybe the biggest, the biggest takeaway for those listening that are like, you know, hey, that's, you know, I'm sitting in a good seat here with a bunch of really good investors around the table. Well, you know, that, that didn't, that didn't just happen, you know. That's right. You're exactly right. And like I said, companies been around for 10 years. And that's where all those relationships came in from over a long period of time. So it always looks like there's a headline at the end of the day and oh that must have just materialized but yeah it's years and years of relationships like you've talked about and very open honest relationships where

the good the bad and the ugly and once people know you they trust you and things keep moving forward that way so yeah i think you make a very very good point it is worth the time the touch points it is worth the the relationship building with everybody and not in a planful way but more and they're on their top of mind for you. You know, these are people who are important to the company and I want them to be involved and I want them to know what we're doing. I want them to know what's going well and what's not. And they feel that and then they want to be more involved.

So it's a really great point. Yeah. And I'm smiling here, but these are all like lessons I've personally learned, right? And some of the more recent lessons, right? But it's just, it's going to feel sometimes like a lot of rinse and repeat. You're giving the same kind of like, you know, overview of your company over and and over again, but it's like, it's just like these are practice swings, you know what I mean? It's like no one gets better at something unless you're like, you're doing it and you're

practicing it and improving upon, you know, kind of how you tell your story. But all that's so so crucial kind of leading up to hopefully, you know, you know, successful syndicate of investors that are on the table. So I know we don't have a ton of time left, but I want to get to this this board related question, right? And you've kind of touched on some of these things already, but for someone that's first starting to put together their board, maybe, or maybe they're in in the position where there's, there's some board change up, you know, they're currently going through some board change up. You know, what one to two pieces of advice would you give to them that are going to hopefully lead, right, to this, this ideal kind of, you know, very functional board

versus the opposite, which is, you know, could be a, can be a nightmare, you know, where you've got, you know, board directors or board members that are, you know, just at odds with each other, right? And that's, you know, it can be a complete distraction. So, yeah, give us a sense for kind of like, what are the talk couple things that you think we really need to get right? You described a couple different situations here and some of those are pleasant, some are challenging and sometimes you flip-flop between the two. You know, it's not this person is attached to this outcome. It's really the group and what's happening at the time and what the environment looks like.

But the two things maybe I can contribute to this conversation because it is a conversation. It's not all in one person. But I would say you have to be on the same side of the table as your board. You can't be trying to sell them on something. I found at least in some limited experiences that I've had that if I go in with an assumption of what I want on the other end, that's never as successful as if I go in with a problem that I'm trying to solve. And we literally work through it together, you know, borrowing some other great mentoring that I have received over the years. I was always told, make sure that people can play in the sandbox with you.

Nobody wants to see the final product. You're not going to love it. They're going to say, well, it's not exactly the way that I want it. What everybody really wants to do is they want to be in the sandbox. I want to be there. Let's build it together. So let them, let them be in the sandbox. And that comes with the expectation that there's some maturity and there's some ability to delay judgment

and some ability to see the sausage being made. and not have an instant reaction. So I've always just tried to be on the same side of the table as the board and make sure that we come to them early enough to say, you know, we're trying to solve this problem, and I'm thinking of this is a path or this is a path. And I'm open to input. So I may not take it.

I may decide that it's not our best interest. I may come back to you and say, look, I'm sorry, we tried this, but it didn't work. But at least I want to hear from you. And I can take the collective wisdom. and then decide from there what's going to maybe be a best solution for us. So that's the type of atmosphere that we try to create on the board. And again, like I said, choose who you work with. I think we've all had different work experiences in the past.

And we all know what work style is going to work for us. We all know how people interact best and be productive. And try to fashion the group so that you can have an open relationship. And if this kind of relationship isn't the right thing, that works for everybody. Maybe there's a different method that works and make sure you have the right people who can work with that method.

So it's a work in progress. I would profess that I have not perfected this. My board will tell you, I have not perfected this. There's a few things you need to really work on here, but at least they know where my intentions are. I'm very transparent with them and they see where my shortcomings are.

So they give me a lot of grace because of that. That's such a good framework, right? like how can you let the team play in the sandbox with you? And that, I think it probably applies to almost every sort of decision, right, that you're, you know, talking about discussing, you know, is how to, and maybe, maybe you've already gotten to the point where you, you've sort of in your head, and maybe internally with your own team,

made the decision, or at least, you know, kind of, you know, you're up against the finish line to that decision. But presented, the way in which you presented the board is more like, hey, these are the three scenarios, right, that we consider it. And here's why. What do you guys think? and maybe don't even give your answer, right? But it's this idea of kind of building the sandcastle together.

So that's a really, really, really good framework. That's a great scenario. The way that you ask this question, what do you guys think, is all the magic right there. So if you present three scenarios and the one scenario you show will cost the company an infinite amount of money, the other scenario will bankrupt us. And there's only a third scenario that will work. What do you guys think? That's not a very genuine.

What do you think? versus look, we really see three paths that could work. Possibly there's a fourth path we haven't thought of. We need help. That's a very different question. So I think it always comes back to the same thing, which is self-reflection and self-examination and making sure that you really do believe what you're saying to people.

So for what it's worth, you brought that to mind. And I think it's worth emphasizing. Yeah, yeah, because you could frame this up in a very sort of disingenuous way, right? And you're bored, if they're a strong board, I'm going to see right through that. So I think even though you feel like you've already kind of gone down a certain path

and you feel really good about that, taking a step back, kind of representing it. And who knows, maybe they convince you otherwise, right? The alternative paths, you know, because that very well could happen if you've got the right people around the table. So it's really good stuff. I know we've only got a few minutes left here,

so I want to get to the rapid fire portion in the interview. But again, for everyone listening, tricares.com is the website. We'll link to it in the full write-up on MedSider, which these write-ups, if you're new to MedSiter, kind of capture a lot of the highlights and learnings that our guest share. So I highly encourage you to check that out. But again, trycares.com is the website.

And you can go learn a little bit more about the company, the board, the investors that we've discussed, the leadership team and the technology, obviously, as well. So with that said, rapid fire questions are exactly kind of as they sound. Feel free to expand a little bit on your answers, I met if you want to. But first question, fast forward, tickets fast forward to mid-2020. What are you most excited about at TriCare's? Oh, mid-20206 is going to be a great time. We're in the middle of execution, two clinical studies across two continents,

and having those for the most part wrapped up and starting in our big U.S. study and having a therapy that is very easy to perform and straightforward to the point where people are telling us we don't need a proctor. That's what I really look forward to. That's good. Good stuff. All right. Next question.

And let's say we just wrapped up a small intimate dinner, maybe at a maybe at manis there in Minneapolis, right, with a small group of med tech, med tech, you know, entrepreneurs. What's the one lesson that you think they really need to take home if they're going to try to see some semblance of success in their own ventures? It's so tough, one lesson. And I'm still learning these as we go. But you affect your team a lot more than you think you do. And the success of your team depends on you being balanced.

you're not too high on the highs, you're not too low on the lows, and you can weather the storm and keep moving forward one foot in front of the other until the path becomes clear. So being able to manage the fog yourself, your team will follow, and they will do the same. So it's really, really important to celebrate the small successes, keep moving forward, and demonstrate to the team what it means to be balanced and focused, and they will follow. that's the one lesson that I'm very fortunate to see here over and over at Tricare's. Yeah, that's good, good stuff. These interviews are always a little bit, you know, selfishly therapeutic for me, right? Because I get it. They're very good reminders for me.

All right, last question. Take us back to maybe late 20s, early 30s, your career is kind of really starting to take off. Anything you'd, you'd whisper in the ears of the younger Ahmed at that point in time. Like younger Ahmed was someone I would probably. walk on the other side of the street from. I'm not sure he's quite the role model, but I would say, look, I got lucky, and I got put in situations where I had to learn, and I was forced to work hard and grow, and it served me very well, and I always stayed focused on the physicians, but I got lucky.

That was not a path that I very intentionally chose, and I'm glad that it went that way, and I didn't choose a flashy experience or a little increment better in compensation. or reward of some kind and just went for the hard challenge and the big growth and the relationships. So what I would tell the younger me is this is a good path. It's going to work out. It's going to take a lot longer than you think. But that's okay because you're adding value in the end.

So that's what I would tell the younger me. You're probably not giving yourself enough credit. But I'm right there with you. Really good advice. I think for anyone in the younger part of the earlier part of their career. So I know we're up against the clock here, but I mean, thanks a, thanks a ton for carving out a little bit of time. This has been a really, really fun, really fun discussion. This has been super, Scott. Thank you so much. And I can't wait to keep following your podcast.

This is just a great contribution for everybody who's trying to do something really special in medical devices, and especially in Part of Vascular, too. So thank you for having me. No, absolutely. I have you hold on the line. And for everyone listening again, trycares.com, highly encourage you to check out the website and the technology itself. And you can get a sense for kind of how Ahmed is building and building the company. And I know, it's really, really cool to watch. So I highly encourage you to check that out. And again, for everyone listening, thanks for your attention as always. Until the next episode of MedSider goes live. Everyone, take care. Hey, it's Scott again. One quick thing before you go. You see, I love bringing you insightful

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