Medsider: Learn from Medtech and Healthtech Founders and CEOs - What It Takes to Win Physician Confidence: Interview with Secure Closure CEO Stephen Belcher

Episode Date: March 30, 2026

In this episode of Medsider Radio, we sat down with Stephen Belcher, co-founder and CEO of Secure Closure.Secure Closure is developing Quattro-Close, a device designed for large-bore femoral access sites.Trained as a veterinarian, Stephen has spent more than 25 years in the medical device industry, with deep experience in vascular access and closure technologies. He previously held commercial and marketing roles at Abbott Vascular, Edwards Lifesciences, and Teleflex, where he was involved in launching key closure devices, including ProGlide, StarClose, SAPIEN 3, and MANTA.In this interview, Stephen discusses what actually drives physician adoption in high-stakes procedural fields, how real-world clinical and patient challenges should shape device design decisions, and what early-stage fundraising looks like when traditional medtech VCs are increasingly committing capital at later stages.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you’re ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Stephen Belcher.KEY MOMENTS FROM THE INTERVIEW(02:52) - An overview of Stephen Belcher’s background and the journey that led him to founding Secure Closure (08:04) - How Quattro-Close works, using a purse-string suture and extravascular clip for reliable closure and artery preservation (13:53) - Stephen's lessons learned from large strategics and how he simplifies them for a startup (19:22) - How Stephen spent nearly a decade iterating on the device through failures, funding gaps, and small incremental progress (23:36) - Why physician adoption depends on consistent outcomes, not early excitement or new features (28:10) - How Quattro-Close is designed around the real unmet need, reducing complications while preserving the artery for future procedures (34:14) - His approach to first-in-human, site selection, and generating data that can stand up to FDA scrutiny (40:31) - How Stephen navigates early fundraising

Where we are with quadruclose and what we're doing is that we're actually using a method that physicians are still relatively familiar with from some of the products that they've used already. So the procedure, we don't dramatically change it. But what we do do is that we change the way on how the device works to increase the reliability of the device and the simplicity of it. 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, in this episode of MedSider, I sat down with Stephen Belcher, co-founder and CEO of Secure Closure. Secure Closure is developing Quatro Close, a device designed for large bore femoral access sites.

Trained as a veterinarian, Stephen has spent more than 25 years in the medical device industry with deep experience in vascular access and closure technologies. He previously held commercial and marketing roles at Abbott Vascular, Edwards Life Sciences, and Teleflex, where he was involved in launching key closure devices, including Proglide, Starclothes, Sapion 3, and Manta. Here are a few topics we explored in this conversation. First, how does the transition from a large strategic to a startup change execution? Second, what actually drives physician adoption in high-risk procedural categories? Third, how should establish clinical workflows influence device design decisions?

And last, what does building momentum look like in early stage fundraising? Before we dive into the full episode, if you're a MedTech founder or CEO preparing to raise capital, you should check out the MedSiter fundraising cohort. This four-week live workshop combines small group sessions with real-time feedback to help you sharpen your investor story, build a targeted investor pipeline, and run a focused fundraising sprint instead of a never-ending slog. Over the month, you'll walk away with an investor-ready narrative and deck, outreach scripts that actually get responses, a refreshed LinkedIn profile, a simple content plan that keeps you on investors' radar, and a repeatable system for running your raise.

You can join the waitlist at medsider.com forward slash fundraising cohort. Again, that's medsider.com forward slash fundraising cohort. All right, let's get to the interview. All right, Steve, welcome to Medsider Radio. Appreciate you coming on. Thanks very much, Scott. We're looking forward to the conversation today. Yeah, likewise. Likewise.

Likewise. I recorded a very short bio at the outset of this episode, but let's start there. Give us like a one minute, maybe two minute overview of your career leading up to co-founding and running a secure closure. Yeah, sure. I mean, it's actually probably a little bit more of an unusual one. I actually started my career as a veterinarian. I trained in New Zealand, graduated at Massey. One of the things there about my vet training was that it gave me a very practical way of thinking about biology, anatomy, and problem solving.

And I've taken that through my career, actually. After I graduated actually from Massia, I ended up in Singapore. I was in private practice there for a couple of years. And then I moved into human medical diagnostics working for a Singapore or a US company. And I spent a couple more years doing that. And then after that, I eventually then ended up with Abbott and primarily with Abbott Diagnostics. that's where I came to Europe. And then I transitioned into Abbott Vascular,

where I was involved in the Proglide and Starclose vascular device launches, then later on with Edwards, with Sapien3, and even Teleflex with Manta. What that really gave me was really interesting because I had the experience of launching products at these companies, but I was fortunate enough to have really a front row seat in all the cat labs and really seeing how the products work in real life and how physicians actually use them. One of the things that stood out to me over those years up to now of being in cardiovascular products has been just how much the minimal invasive and structural heart procedures have really taken off. And all of that innovation though has been mostly at the front end of the procedure,

you know, the valves, the implants, the delivery systems. But, closure, which is absolutely essential for the patient outcomes, has actually barely changed in that time. And I'd watch these physicians, excellent physicians out there having incredibly successful cases, but then often struggling at the end of the procedure, not because of their skills or anything, but simply because the tools they were using, weren't designed for the anatomy that they were dealing with. And that disconnect stayed with me.

And about 10 years ago, I started asking myself, well, why hasn't this been? fixed and I started asking well why couldn't I build something better and that question turned into years of development alongside my day job so at some point you know I realized that if I believe this strongly in the problem then I had to actually commit to it so stepping out and starting the company wasn't about timing necessarily so much or chasing an opportunity it was actually more about finally committing to solve a problem that actually seen physicians trying to deal with for years. And I'm looking at your LinkedIn profile, which we're linked to in the full write-up on an insider, but it looks like the company officially started in like mid-2020. Right. So we're,

you know, we're about roughly a year and a half into its official beginnings anyway, right? But it sounds like you know, you started tinkering quite some time ago. Well, yes. I started, like I said, almost 10 years ago started on it and started to develop. So where we are right now, we're not actually in our first generation. We're actually on our third generation product. And you mentioned there that the company was started in sort of mid-20204. I started it with Eric Goswell. He's been a great co-founder for me and really helped me as someone who has never done this before to sort of help me with the structure and everything and guide me through a lot of the processes

of actually starting a startup. If you're listening to this and you haven't checked out that interview with Eric, he was on the show maybe like a year ago or so, something like that, but that was a great conversation. I highly encourage anyone to go back and listen to that one. So I want to rewind the clock, right, and learn a little bit more about kind of the beginnings and we'll cover some other functional topics as well. But let's start with it, or let's, I should say, dig into the technology a little bit more, right? You mentioned closure and kind of the back, the back end of a lot of these structural heart cases. For those that aren't as familiar as you and I with the cardiovascular space, maybe are in

ortho or some other specialty, what's done now? Like, what's standard of care? and what's different about quatra, the device that you're working on? I think before I even dive into that, I probably need to even maybe explain what large bore closure is. Many people will know routine cardiac catheterization procedures, putting in cardiac stents, for example. Those are what's called small bore procedures. So a way to think about it is that those procedures are all done

through a arteriomy, a hole in the artery. It's about the size of the tip of your ballpoint pen. It's just a few millimeters across, that's all. Large bore, if you can imagine, is not the tip of the pen, but actually pushing that whole pen into the femoral artery. And some of those small bore procedures often now done in the radio archery, for example, can be closed just with manual compression. But large bore is on a totally different scale.

It's much, much bigger. And when you start doing things like structural heart, like Tava procedures, It's not just the size of the hole that you push into the archery. When you're actually delivering a taver valve through the delivery sheath. That sheep acts a little bit like a snake swallowing like a rabbit. And you get this bulge that goes through. And that actually even stretches the archery even more. And so you can end up with an arteriology hole in the artery that you have to close

being sort of like about nine millimeters often in diameter about 26 French, which is quite large. So that's what actually we're dealing with. And plus we're dealing with people who are quite old. Most of these people are in their 70s or 80s, and their arteries don't respond like a young person's archery where you would make a hole in the artery and it would spring back. You don't have that elasticity in it.

The other problem that you have with large bore in particular is that when you make such a hole in an artery, the femoral artery, for example, is under longotry. or tension. It's being pulled. So that hole isn't even round anymore. You're actually having to deal with an elliptical shape. So you have to do that as well. So there's quite a few challenges for that, you know, going forward. So that's a little bit of the background part of it. But like I said, earlier on, you know, the closure hadn't developed at the same pace. So that's why I wanted to look at sort of a solution for that. Where we are with quadruclose and what we're doing is that,

We're actually using a method that physicians are still relatively familiar with from some of the products that they've used already. So the procedure, we don't dramatically change it. But what we do do is that we change the way on how the device works to increase the reliability of the device and the simplicity of it. So one of the things we talked about, the elliptical shape, a lot of devices out there use like an X cross sort of of closure pattern. And if you do that, you can end up with, so you can get sort of puckering in the vessel on that. So we've developed a purse string type closure,

which gives us a much more gentle and circumferential closure around the arteriology itself. The other thing is that we've looked very carefully on a lot of these problems that physicians have had, particularly with calcified vessels, and tried to make the system much more reliable by the way that we deliver our, needles. So this is a suture system that we're developing because that is still considered the gold

standard in the field. So it's a suture system, but we've developed a way of doing it that when we deliver our needles, that a capture mechanism, even if those needles are deviated by calcification, we can still capture them. And the other part is that we want to make it much more easier. Some of the earlier devices and things like that, storyline on things like tying surgical knots. well, we don't want to do that. So we have an extravasculate clip that is used together, the sutures together, and that's how the closure is secured at the end. So it's sort of a simple thing like that,

but one of the things we are focused on is actually on the lifetime management of the femoral artery because these patients are not going to just be having one procedure. Tava, for example, is becoming to lower risk and even younger patients, which will mean that many of these patients will have multiple procedures through the same archery. So we want to try and really preserve the integrity of that archery. It's really important to think about what's going to happen in the next 10 or 20 years even. All of that sounds really intriguing. And we'll link to the company's website in the full write-up on

MedSider, which is secure-closure.com. So secure-hifen closure.com, just as it sounds. But we're recording this in early, early 26 year. Give us a sense for kind of where the company's at currently and what's ahead, you know, maybe the rest of the rest of this year. Yeah, sure. I mean, secure closure is still. in early development at this stage in our third gen. So as I mentioned, we've actually had a couple of generations before, and that's really helped us to de-risk the program. We've done some early bench and animal testing through that,

but we are still in our development stage. At this point, and particularly since we formed the company in mid-20204, it's allowed me to focus full-time on the development of that. And really now we're just trying to finalize everything in our design, lock it in, get our design free stunt. And then for our goal is then for the next period of time is to get to our OUS first and human. Got it. So that's our key milestone that we're targeting at this stage.

And we'll jump into this in a little bit more detail, but give us a sense for kind of that, that Clint-Rag pathway for a device like this. You mentioned the OUS feasibility study. So I would imagine that, you know, that then ladders up to some sort of pivotal trial at some point in the future. Correct. for large bore closure devices, it's a class three category. Okay. So for PMA approval, it means that you'll have to go through a clinical trial for that.

So that's how the regulatory path would go through. So at this stage, as I mentioned, we're doing our development work, do our OUS first and human, get our first human data together, finalize whatever that we may or not need to do to the design. and then go into a FDA trial at that point. Got it makes sense. And I think that might be surprising to most people that are hearing about this, you know, this device that in essence closes and ideally safely that preserves the artery, right,

for future access. You think it sounds like, sounds relatively simple, straightforward. It's a class three device, right? I mean, that's kind of surprising. But I think points to the kind of the critical nature of these devices, right? Kind of on the tail end of these structural heart cases. So with that said,

let's spend the next, you know, 20, 30 minutes kind of covering some key, key functional topics and really kind of diving into kind of like a lot of key lessons, right, that you picked up on throughout your career and now, now at secure closure. So with that said, though, again, for everyone's reference, secure closure is the website. Secure-hifen closure is the website willing to it in the full write-up on MedSiter. So first one on the doc I wanted to cover is let's talk about your experiences at some of these large strategics that you mentioned earlier, right? Abbott, Edwards, Teleflex, when you think about kind of all of the, you know, the, what, 20 plus years now, I think what it sounds like, you spent at large strategic and then decided to make the jump to the world of startups, anything particular that you either are carrying with you, right, as you begin to build secure closure or, or maybe flip that on its head and say,

you know, what are you specifically trying to avoid, right, as you begin to build a culture at your startup? Well, you know, I was fortunate enough to work at those. companies that you mentioned and being in those companies, you know, they're all large organizations and they taught me a tremendous amount. These companies are built around discipline and structure. You know, they have really strong processes and they have really deep expertise across multiple functions, you know, and they have the ability to, you know, to identify problems and they put large teams on them and they execute at scale. That's what all these companies have done. I learned a lot about commercialization in those environments.

so I was fortunate enough to launch quite a few products, particularly a large number of vascular closure devices. And in that environment, you know, I learned how to build sales teams and support physicians clinically. And that's a really important partnership to develop. I also had really good opportunities, particularly when I was at Abbott to work very closely with the R&D teams, quality regulatory manufacturing,

often very early in the development cycle. and that was really incredibly valuable for me. Now, if you take that experience in and you say, well, you're in a startup, you know, what does it give you? I think that part of it gives you perspective because if you look at each of those functions, those companies give the opportunity to see what good looks like in each of those functions, but you have to then take that and then simplify it. Because in a startup, you simply don't have that luxury of scale or funding to do things at that size.

you have to make those processes work for a much smaller team. And so for me, I think, you know, if I take from that, those large organizations, you know, they taught me discipline and cross-functional thinking and focusing on the execution. And that's been something to bring into a startup. But again, being aware of the scale that you can apply to a startup. One of the things that, you know, just hearing you kind of riff on that answer that reminds me of, of like my, when I, when I first sort of went in-house, this was back in, at Kavidion, I'm dating myself, but gosh, 13, 14 years ago now. But it was such an invaluable experience. But one of the

keys to making that invaluable experience was like proactively engaging with other functions of the business, right? So I was in a, in a marketing role at the time. And fortunately, as you, as you know, marketing touches a lot of different functions. But if you're early on in your career, you've got to be proactive about like reaching out to different, even with an R&D as an but right there's like there's all kinds of it especially at a strategic there's all kinds of different sort of um i would say departments within our r and d right that you can get more familiar with so you know if you're listening to this and you're at a strategic and maybe interested in in jumping to a startup at some point your career take advantage of those opportunities now you know

while you're in that while you're in that larger organization to to really learn not only from other people but also learn about you know how certain functions in a business at that scale really operate yeah i was very lucky yeah particularly at um Abbott Vascular, I moved from Abbott Diagnostics to Abbott vascular, primarily for the Starclose launch. And at that time, Abbott had a very limited amount of information on the product itself. It was a new acquisition. And my role there was to launch the product in the EMEA region. And to do that, I worked a lot with Global, but also with the R&D teams in Redwood City that were there at the time. The original per close team that was there, because then I did that.

the Proglide launch the following year after that. But you're right. I mean, it was a fantastic experience being able to go there. Reach out beyond your own area of expertise. To be able to do a launch like that required me to be able to fully understand the device, what works, what didn't work, how to work with the clinical teams, get all those set up, working with the physicians. We had to even figure out how to use the device correctly.

There was a lot of things at the beginning because we had very, very little data before the launch. So, you know, you correctly say this, Scott, you know, if you jump out of your own field and you talk to the other people, it's extremely rewarding. Yeah. And sometimes, like, if you're in, if you feel like you're in this sort of this point in your career inside a large strategic, sometimes it can feel kind of uncomfortable, right? Either reaching out to other other parts of the business or other people or even trying to like find a way into certain projects, right, that you maybe didn't get an invite to as well. But like some of that, I think just comes down to being a little bit ambitious, being a little bit proactive and kind of putting yourself out there. even if it feels a little bit awkward or a little bit uncomfortable, because those types of experiences are hard to come by. You may not feel the immediate sort of impact on your career,

but, you know, fast forward five, 10, 15 years down the road, and you'll probably look back and think, wow, that was, I'm glad I did that. So with that said, Steve, let's chat a little bit about sort of this, this tinkering phase, if you will, right? I mean, you mentioned, even though secure closure is only about a year and a half old, you know, officially, you've been tinkering, you know, you've been, you've been kind of kind of building,

and you're already on to your third. third generation of device. Give us a sense for kind of, you know, what you've learned sort of doing this on the side, if you will, right? Because I think there's a lot of folks that listen to this, whether they're, whether a physician or just more entrepreneurial minded, that have a, have an idea for a device. And, and the market seems to be big enough. The clinical needs seems to be there, et cetera. But they don't necessarily know how to get started. And so what, what have you kind learned in those earlier, earlier kind of development phases when you're, you know, not a lot of capital, not a lot of resources to be had, but you've still made some progress on your device.

And here we are on the third generation. So touch on that. What are some of the key things that kind of stand out as you look back over the past, you know, eight, nine, ten years? Yeah, I think one of the things is you've got to be persistent and be resilient and be able to take nose a lot of the time when you ask people for funding at, particularly in the early stage. But no, what's helped me tremendously was finding a really good engineer early on that like the business. work with and we then put our ideas together and then slowly took it forward and it's you know small increments at a time i mean you're not dealing in large amounts of funds you have to be very careful very strategic about your thinking about well what are you going to spend your money on and what would

those results be at the end of the day and you know learn from each each failure because when you start early on in a medical device program the bottom mind is you will fail multiple times you're in a field which is difficult. If it wasn't difficult, everyone would do it. So you've got to be prepared for the fact that you will have failures. And during that time period, too, you won't. There'll be periods if you're doing it on the side like I did, you know, alongside my day jobs sort of thing.

There will be times when you just can't do any more work because you won't have any more funding. And you just have to literally park it off the shelf, you know, maybe for a year, you know, until you are back into a position again to where you can take it forward. So it's about being resilient, being, you know, even through the funding process. We're now in the company now that we've established Secure Closure Incorporated, we're now, we're now actually raising funds through a convertible note in our C-Brown. But before I had that established, the only way to fund it was through my own pay packet, you know. So it's changed

a wee bit from there. But you do. You have to think very carefully and you just got to accept there will be failures and setbacks and probably times where you just simply even though you want to move forward you got all the ideas you financially can't do it and you just have to sit on your hands until you can get to the next stage yeah and sometimes you know you see stories of like like take ferra pulse as an example right you know everyone looks at at the success boston scientific has had with that franchise but i i had steve michelson on um gosh this was a couple years ago on the program And he was kind of riffing around, you know, what the early days of that technology looked like. And it was, it was very, very rough.

It was very, you know, there's a lot of ebbs and flows early early on, right? Because there wasn't a lot of capital to be had. And it was, in essence, him kind of building, building the very, very early stages of that. And you fast forward, whatever, like a decade now. I can't remember exactly the time frame. But fast forward like a decade. And all of a sudden, Boston Scientific does a billion dollars in the first year of the first year of commercialization.

And sometimes it's easy to gloss over like what those early, you. years, you know, really look like. And so they typically don't look pretty and they typically don't look like super clean. That's sort of like the nature of how a lot of these, a lot of these startups, you know, come to be. Yeah. I mean, we have to learn a lot of new skills to be able to do things in house. Even right now, I mean, Peter, for example, is an expert on being able to make the computer animations, for example. You know, he taught himself in house. And so we didn't have to go outside and spend a huge amount of money because that is often very expensive for a startup. If you want to show what your product could potentially do, you need that. But we were able to do

that in-house and save a lot of money. Let's chat about some of those devices that you previously launched that were in that are in the same space, right? Those closure devices, proglides, dark clothes, a couple that you, that you referenced previously. When you think about, I mean, I know this maybe sounds like, you know, you're pretty, pretty far down the road for secure closure. But when you think about trying to commercialize into a space, right, where there's a, you know, there's a pretty clear gold standard, right? It's a standard of care. You know, maybe it's a mixture.

It's a variety of devices per se. But there is a certain way, right, physicians are going to, you know, treat or, you know, or when it comes to utilization, there's a certain, like, you know, there's a pretty clear pattern of behavior. You've been around so many of these commercial launches. Like, what do you think is the, I guess, what are some of the key lessons, I guess, that you've learned in terms of trying to disrupt, right, that goal standard or really trying to kind of break through the noise with a new novel device.

It's really actually an interesting question, Scott, because when you talk about gold standard, you know, if we go back into the vascular closure, of course, gold standard originally was an open arteriomy. It was, you know, the physician, a vascular surgeon would close it with sutures. And the field then really evolved, you know, with the less invasive techniques, you know, and then became percutaneous, as you mentioned, with a number of those products out there. But all of those products that are out there, and they do work quite well in a number of situations,

there are always different trade-offs. And so I think if you even ask the physicians, is there a really gold standard, as we would define a gold standard? I don't think there really is a gold standard yet in large war closure for devices. And so I think from that point of view, that field is still open a bit.

I think though you're talking about commercialization and how do you launch a product into a field. I think, you know, the physicians, when we go out there, when I've done this with other devices, you know, the first thing that they need to see and you've got to deliver on these devices, it's got to be a consistible and repeatable outcome for them. You know, it's got to be reliable because you can launch a product that, and I've seen things before in the field over my last 20 years, you know, that can sometimes work, seem to work quite well at the beginning and have had a very big uptake in the first year or something. And then you find that market share changes dramatically after that.

It's about having those consistent long-term results. And that's what you have to show. And it's not something that's going to be quick. When you do a launch, you can normally, normally, when I've launched the closure devices, we all and we have pretty good pickup after about a year. that physicians really want to be able to have that level of time to build up confidence before they will really, you know, convert necessarily to a new technology. So I think that is sort of how that market looks like. And it's it's not something that you sort of go out with, you know, all the bells and whistles and you, you know, you shake around and people just come and run and buy the product. People are pretty conservative in this field. It's a pretty big hole that you're dealing with.

that they want to be sure because one of the biggest problems that you can have with particularly large ball closure is that sometimes things can look good in the cath lab. But if it hasn't closed properly, you get bleeding later on. And that can become quite serious. And in the fact, if you look out there and even in the published data at the moment, there's still quite a significant amount of bleeding issues and device failures out there. 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 or IVL systems to tackle complex calcific disease. Over the last few years, we've closed a series of oversubscribed funding rounds, bringing the total investment into FastWave to over $50 million. Corporate interest in the IVL space is growing to, the $900 million acquisition of Bolt Medical by Boston Scientific in 2025, and Johnson and Johnson's $13 billion acquisition of Shockwave Medical, signal a lot of attention on emerging IVL startups like Fastwave.

and we're making serious progress. In addition to recently receiving our ninth patent, we've successfully completed peripheral and coronary feasibility studies and are gearing up for pivotal trials. If you're interested in investing in the fast-growing IVL market, head over to fastwavemedical.com forward slash invest. Again, that's fastwavemedical.com forward slash invest. Now, let's get back to the conversation.

That's really that unmet need. And the device needs to be able to correct those unmet needs. that get that bleeding rate, that complication rate, and get the confidence back up because as we've gone into this minimal invasive field, dramatically over the last 10, 15 years, sites now are looking for people to have, for example, a tabar, some places that will even have that

maybe is the day procedure. You go in the morning and come out in the evening, even there are some. And if you start having complications, that whole model blows. Of course, it's not for the hospital cost, but it's dramatic for the patients as well. because if you have bleeding in such a large hole, it's not minor.

These patients can often end up having to have a blood transfusion, may even have to have the vascular surgeon called back in, and then extended hospitals stay afterwards. So that's the field we're going into where, as I say, I don't think there is a gold standard established at this point for devices. I think physicians are quite cautious, and you need to show persistent and repeatable outcomes for people to really make that,

that change. Yeah, it's sometimes it, this almost seems sort of counterintuitive to a certain extent, but, you know, you spend five, six, seven, you know, in some cases, 10 years, right, developing a device and you're in the weeds on, you know, how it works and why it's a difference and what it can do better, et cetera. And then you start to think about eventually, you know, whether it's commercializing or even just simply, you know, getting physicians excited to enroll patients in a trial as an example. And you've, you spent so much time in the weeds, but in reality, a lot of cases all they care about is, is it safe for my patients? And then two, is this repeatable, right? To your point, is it, is it durable? Is it repeatable? And as entrepreneurs,

right, sometimes we can gloss over some of those, just those, those basic sort of things that physicians are are expecting if you're, if you're wanting to, you know, sort of convert them over to either your device or just a different way to, you know, to close a hole, right? In, in this, in this particular example. It was interesting to see when I was doing a device. a number of years ago, it's also important on the feedback from the patients because when I launched a particular device a number of years ago, we had feedback from patients that they could feel in their leg, closure method, and that, and a lot of them felt very unhappy with that, and then that sort of translated back to the doctors as well, because then they didn't want to, even though that device

might work and could work quite well, you then had patients saying, well, you know, I can feel this thing in my leg and it's really bugging me. So you have to think about not just from a practical point of view, like you say, like you know, with the doctor and their comfort level and everything else, you really have to, when you're designing this and that's what we've tried to do with quadruplose

is really think very much about the patient and the comfort, their safety and the long term management of their artery and the access site, because these guys will have not just one of these devices, they're possibly going to have

multiple of these procedures and these devices implanted over, you know, the next 10 or 20 years. You touched on this earlier, but like this concept of preserving the vessel as well, especially important now, right, because not only are these patients often having repeat interventions from, you know, for structural heart, right? It's like valve and valve becomes much more common. But a lot of times these same patients are getting, you know, PCIs and coronary interventions as well, right? and access is typically done, if not through the wrist, right,

through the same sort of anatomical locations, right? So becoming that much more important to be using devices that do preserve, you know, the artery as much as possible. Correct. Yeah, I think that's a really important thing. I was talking to someone a little while ago, that's the same sort of topic. And, you know, when I was with Edwards, even,

let's just say, you know, 10 years ago with the S3 launch, you know, most of the patients that we're getting Tava at that time, in the studies and in the catholics, you know, are like mid-80s sort of thing, 80s, 90-year-old people. So they were probably only going to have one valve implanted at their lifetime. And so the closure of the vessel itself is important to close it, but whether or not you did any, you know, deformity to the vessel or left things that made it more difficult to reaccess later on wasn't so critical at that point. when you start to look at it now and we see like asymptomatic patients now being approved for Tava in the US.

And I've seen some of the studies coming out, I think it was California and I think it was New England, where they had a number of patients even being down to as young as 60 in their late 50s for Tava. Well, if you look at the average durability time of these valves, let's just say if they're 12 or 15 years, you can sort of work out they're going to have to at least two or three of these. to do that site. And as the patients get younger, the other thing we have to think about not just the structural and the integrity

and how it works, but we want to make sure that the vessel, the actual lumen itself is kept as open as possible because these younger patients getting Tava, for example, they'll want to be much more active than patients 10 or 15 years ago who were 20 years older than them. So they expect when they have a Tava valve

that they can go cycling, they can play with them. the grandkids say can go walking or maybe jogging or whatever. If you start closing up the femoral archery each time you deploy something in there to close the arteriotomy hole, you keep deforming it significantly each time, it will degrade their ability to be able to be so active because you just simply won't have the blood flow into the leg. And you've got to remember these vessels we're dealing with at the beginning are not pristine

anyway. They're calcide, torturous and plaque material. So the last thing we want to do is even try and close them up even more. Yeah, all really good points. I'm looking at the clock and I want to save enough time for the last few questions in the rapid fire portion of the interview. But let's talk a little bit more about the Klin-Rag pathway, the class three device, right, which we we chatted about a few minutes ago.

And you're kind of like the next major sort of Klin-Reg milestone, you know, and for you in the company is this OUS first in human study. So when you think about whether it's building kind of the Klin-Reg program for secure closure or even just specific to kind of your thoughts on how you're going about this first in human study or how you're approaching it in terms of you know site location geography etc you know what would be most helpful for you think for other other founders CEOs that are kind of going through this the first time i think as we we work towards our ous i mean i probably need to refer more to our regulatory guys but we're you know we're obviously selecting sites that

have done and been involved in OUS studies before have a good track record, have a good clinical reputation. These sort of things are just the basic things, but they're important to do because whatever data that we generate in our OUS study, we want to be able to take that forward, you know, eventually for to be able to show FDA, for example, and then to be able to see how we then structure our pathway within the US itself. So, you know, the exact sites, You know, where we would do it and that, we're still open to where we would do it. There are several good sites that are out there around the world, multiple countries. A lot of people are very familiar with sites in Paraguay, for example,

but there are also the ability to use excellent facilities in places like Georgia and Tbilisi and even Croatia and other places around the world, Australia and New Zealand, for example, as well. So there is actually quite a wide spectrum of places that you can actually go to to do these studies. You just need to pick the right one that logistically works for you and meets all the criteria that you want or want or need for that study. I'm looking at your website again, which is secure hyphen closure. And you've got what appears to be a pretty strong team around you, right? You mentioned Eric, you know, I know, I see Zach and Thomas, you know, in terms of, you know,

kind of Clint Reg advisors, great, great guys, very experienced. and then obviously a really impressive physician advisory team. How important, you know, whether it's the physicians or even, you know, industry folks, right, like Zach and Thomas, how helpful is that, right, in terms of being able to kind of narrow in on certain sites, right? And design a first inhuman feasibility study like this. And they're absolutely critical. This isn't my area of expertise, Scott.

So I rely very heavily on their opinions for this. So, you know, when Zach and Thomas tell me that a study should be done in a certain way or we should do a certain number of patients, etc. You know, that's the area of expertise. And I think it's a startup too. And when you're at the CEO of the company, you also have to trust your team. If they tell me that, that's the way we'll go. With the Medical Advisory Board, of course, they're critical to give us from the clinical point of view as well. We would probably, as you can see, from the locations of where our team,

is a medical advisory board, we probably wouldn't be using their sites for an OUS trial, but their opinions on how that trial should be done, et cetera, of course, are extremely valuable to guide us on the correct route. I'm glad you mentioned sort of this reliability on trusted advisors, right? Because I think sometimes in the CEO role, sometimes you can end up in this spot where you feel like you need to know it all, right? You need to sort of own all of these different, all of these different decisions and the reality is like if you can't get comfortable, right, bringing the right people around you and sort of dedicating that sort of accountability, right, to a certain function, whether it's, you know, a reg, a reg pathway, or whether it's

designing a clinical study, et cetera. Like, that's really, really key. You don't have to, in essence, I guess the easier way to say is you don't have to know it all, right? That doesn't, that doesn't mean that you get into the weeds, of course, right? But that doesn't, you know, it also doesn't mean that you're expected or should, you know, every, no, every certain aspect of how a, how a startup should operate. No, I, I think it's a good point there. I mean, as I mentioned, even earlier on, you know, having Eric as my co-founder, you know, has been fundamental to me. My side of the business, shall we say, you know, from the beginning was the ideas and the development

and the, and identifying the need, etc. For a device in this field, I didn't have any experience in how to set up a, a US company. For example, I mean, I had zero experience now. I worked for large strategics and things, but you don't do that. when you're working for an habit or, you know, or an Edwards or whatever else, that's way outside your scope. You're not going to set a company up there. So to do that, you know, I rely, you know, heavily on Eric's expertise there.

And then, again, you know, one of the things that you learn is, I think, in the startup, is, you know, number one, it's important to have a great product, a great idea, but equally important is having the right people. You've got to have the right people who can exercise. execute who you can trust and that can also have as for a startup a sense of urgency as well. The money that you do raise, you need to get to a particular milestone over a certain period of time. So it's important to have people on board that have that sense of urgency to get things done, but know how to do it the right way. And you've got to trust the people. And if you get the

right people, that makes it a lot easier. I couldn't agree with you more in terms of that being a characteristic to look for, right, as you're, whether it's bringing advisors by your side or even if you're at a point where you're, you know, you're starting to hire, right, full-time employees is looking for that sense of urgency because it's so, so crucial, especially at your C, series A, even in series B, right? In those, kind of those, that early trajectory of a startup, like pace and momentum and knowing that you need to do a lot with, you know, with a fairly lean, a lean amount of capital, like so, so, so important. So with that said, speaking of capital, It looks like you're, you know, you were able to get some grant, grant funds, you know, back in

2024. But talk to us a little bit about your, your fundraising journey so far. And, you know, one of the, you know, maybe a couple of the key things that you know now, right, pitching, pitching other investors that you maybe wished you knew five, 10 years ago. I mean, the OED process that you were talking about there, you know, it was valuable for us because it, first of all, it helped validate both the technology and, market because you're talking to people who, you know, understood, you know, the medical device area. So, so that was really great to have that, from that point of view. Right now, from our fundraising, we're raising a seed round through a convertible node. And, and that's very

milestone driven. As I mentioned earlier on, you know, that, that seed round is to get us to do our OUS person, human, finish our development and get our OUS person's human. So that milestone is super important for us. And then, of course, what we want to do from that to do is be able to, you know, we're also looking for a lead investor. That's an important thing for us as well, because we need to get from the seed into an A as well. So that's an important step for us. But I think if you're talking about for other people, what I learned about it? I think the first thing is, number one, you've got to pitch a lot. You've got to talk to a lot of people. Be prepared for people to take a long time sometimes to make a decision on investment. Fundraising is not.

easy it takes time it takes contacts as well if you're someone like me who hasn't ever done this before you know you're someone's got to get outside your comfort zone you've got to really sort of get out there and in front of people i'm more of a conservative person i'd say if you want to sort of put it that way so for me it's sort of a big step to do that but you know fundraising you know it's it's going to take you longer than what you think and both to find the people and to raise and even when you get people are interested, like I said, they often take quite a bit of time before then the final decision is made. A lot of a lot of good good points. And the thing that never sees to amaze me is like the sheer number of pitches, right, or people that you need to talk with in order to get sort of that

capital raise. And if you're new to that, you're new to this or new to fundraising, it very much is a full-time role in and of itself. And don't underestimate the number of pitches that you'll you'll have to do, especially at this stage, right? Because as VC, as traditional kind of MedTech VC, moves later and later, right, and deploys capital into more, I would say, de-rest startups, right, that are in maybe a pivotal trial, right, or on the precipice of commercialization, there is this funding gap, right? And C, kind of Series A, even, I would argue, even into kind of series B stage as well. And so you just kind of talk to a lot of people. I mean, there's money to be had, but it requires a lot of, a lot of pitches, a lot of, a lot of conversations.

Yeah, I mean, for our fundraising at the moment, primarily we were raised funds at this point have been through the, shall we say, friends and family. It's not quite that, but sort of like that, but people that were that I, myself or Eric have known or through contacts and things like that. So it's having that contact base, particularly at the very beginning, because it's like a snowball funding. You know, you start off with next to nothing. You get a little bit more, you get a little bit more. And as you get more, then you often find the, my experience, being that once you have some people on board, then other people will come on board. So, you know, some people will wait to see who else is joined or who else is investing. So it's like that. And like you say, you know, VCs are looking at later stages. So the way that we're moving ahead now, like I mentioned before, you know, through a convertible note, you know, we're raising funds through those contacts. But of course, we're looking for larger investment groups. And I think that for us, I think that VCs and strategics at this point,

tend to be much later than maybe they worked 10 years ago or something like that. Now you have to look through alternative ways of funding, you know, both through private investors and perhaps like family office groups, things like that. Yeah, yeah. And we don't have time to get into the sort of the mechanics of this in great detail, but you made a point to mention, you know, finding a lead investor, right? It sounds like you're raising on convertible limits right now. But eventually any startup that kind of moves on, right, you know,

from a round of a round perspective, will eventually, you know, need to find a lead investor. And that can be really, really challenging, right, especially if you don't have an existing investor that wants to take that lead. So I guess my message to anyone listening to this that's kind of going through this or about to go through a, you know, startup fundraisers, don't underestimate the amount of time, right, that it takes to get someone to kind of step out a firm or an individual or maybe it's an SPV, people that are coming together in SPV that will eventually, you know, kind of step up and become that lead investor. So it takes a lot of work a lot of time for sure. So Steve, let's get to the rapid fire portion of the interview.

But again, for everyone listening, secure hyphen closure.com is the website. We'll link to it in the full write-up on MedSider. If you knew to MedSider, if you haven't listened to many of these interviews, we do these longer form write-ups that accompany the podcast episodes on the site. And you can find a link to Secure Closure there. We'll also link to Stephen's LinkedIn profile as well. So Steve, first rapid-fire question, feel free to expand a little bit if you want to or you can answer in rapid-fire fashion. But since founding the company, officially, maybe, you know, in kind of mid-20204. What's the most surprising or unexpected thing that you've learned over the past,

you know, year and a half or so? Well, it's sort of surprising a way, I guess, as we touched on it just a moment ago, you know, funding takes longer than what you think, development takes longer than what you think, and engineering refinement takes longer than what you think. So it's not necessarily because anything's going badly. It's just because we're involved in a complex medical technology, and it takes time to get it right.

Such a... I'm laughing because I have this conversation quite a bit with my business partners. It's like it's this balance where, yes, everything is usually twice as long and twice as expensive, but at the same time as a CEO, you've got to set like some ambitious goals. You can't just say, oh, well, it's going to take longer than expected, right? I mean, and no one wants to hear that, right? So you've got to set some target dates, right, but know full well that you know, you may, you may have to flex on those dates, right, as the technology evolves.

So let's say we're, we just wrapped up. maybe dinner and we're having a glass of wine with some other med tech, you know, entrepreneurs. What do you think is like the single most important thing they need to understand if they're going to, you know, experience any success in their, in their venture? I would say that you really want to try and anchor your decisions on patient outcomes. You know, when you're developing both the product and the company is really thinking about the patient because when you do that, a lot of the things actually become simpler, particularly if you're talking about your development work,

what you may have to trade off later on in the development, for example. And also, if you're focused on getting those patient outcomes, that's really what you're out to try and achieve. Then even those fundraising conversations will be easier as well. Very good lesson to always keep front and center, no doubt. So, all right, last question I've got for you, Steve. Let's rewind the clock, go back to maybe your late 20s, early 30s. you're at kind of a maybe a point in your professional career where it's starting to kind of take off

anything you'd whisper in the ears of the younger version of yourself well i think early on you know everyone's focused or at least you know at least i was you know you're focused on you know different milestones you focus on job titles you know things like that but i i think you know what's super important and you pick this up just as you go is it's really developing a good judgment on things you know you get that feel of what works and what doesn't and you only really get that, you know, through experience. And a lot of times those experiences aren't necessarily the positive big wins. They can be sometimes the failures as well. Because eventually, you know, that experience really just compounds itself quietly over time. So it's not something that you're

just going to wake up one morning and that's it. So, you know, it's not like you have to, if you're someone at that age now and saying, well, gee, I don't have this experience or I don't have that. You touched a lot earlier on, Scott, you know, when you're in a strategic net, you know, reach out to different departments, get experience, find out how things work. And I think, I think that would sit sit up well. And that's what I keep saying to myself if I was 20 or 30 years old. Yeah. Good way to wrap up the conversation. Again, everyone listening, Secure-Closure or Secure hyphenclosure.com is the website. We'll link to it on MedSider.com as well, where you can find the full write-up summary that kind of highlight a lot of the key lessons that Steve shared

throughout the course of this discussion. So I definitely encourage you to check that out. Steve, I'll have you hold on online, but thanks again for coming on the program. Really appreciate it. Thanks again, Scott. Really appreciate it too. Thanks. Yeah, and thanks, Eric, if you made it this far, thanks for the recommendation, right?

Steve was a great guest. It'll be fun to kind of watch what you guys do together. You build a company getting into your first and human study here in the not too distant future. But everyone listening, appreciate your attention. As always, thanks for being a loyal MedSiter listener. Until the next episode goes live. everyone, take care. Hey, it's Scott again.

One quick thing before you go. You see, I love bringing you insightful conversations with the best founders and CEOs of medical device and health technology startups. But here's the thing. I'd be super grateful if you could help me reach even more ambitious doers who share our passion. So if you found value in this podcast,

if you found yourself nodding your head while listening, or if you simply enjoy what we're doing with MedSider, please take a moment to leave us a review. It's super easy. Just open your Apple podcast app or the podcast app of your choice, search for our show and scroll down to the ratings and review section.

honest thoughts and hit that five-star rating if you think we're worthy. Your feedback is incredibly important and it's the best way to ensure we keep bringing you awesome discussions with leading founders and CEOs. So take a moment to be a good friend and leave that review today. As always, thanks for being a part of our journey and for helping MedSider continue to grow and evolve. Your support is greatly appreciated. All right, enough talk about reviews. Stay tuned for another informative episode coming at you soon.