Why a Cleared Medical Device Can Still Run Out of Cash

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0:00 We were doing analysis on the hystopathology, the vessel integrity because that's part of the the FDA requirements and we were looking at the efficacy. How much are you bringing clot out of the body efficiently? Nobody was really beating the Fogarty. We're sitting here doing all the evaluations like that's so funny. The good oldfashioned 60-year-old Fogarty is still kind of pretty damn relevant to me. It's a question I ask all my guests. If you could go back and offer yourself one piece of advice that you wish you would have known then what you know now, what would that be? Let's try to bring something positive. Let's not just do a job just to do a job. I get it. You got to make money. You got to support a family. I get all that. But let's let's try to can we make a difference in the world. Let's make some contributions to the world and maybe we can make some money along the way. That that I think there's just a lot of gratification in that.

Hey there, I'm Terry Coutsolioutsos, founder of RevRx AI. We remove friction and architect revenue for medtec and consumer health practices. This is Terry Coutsolioutsos and the Zero Friction podcast. Great to have you here today and I have an exciting guest with me, Tim Blair. He is the founder and CEO of iCHOR Vascular. Tim has been in the medical device space for the better part of 30 years and he has deep deep history with his family in the industry as well. He loves this feel. He's very candid about and we both are in fact it's not what it is today what it used to be. And so our conversation is going to revolve around IICORVascular a little bit, Tim's history, and then we're going to get into some of the challenges that innovative new companies and technologies and what it's like to actually bring that to market and actually find a way into the hospital so those technologies can bring value and gain adoption in the marketplace. So

Tim, great to have you here. Really appreciate it. Why don't you give us a little background on your history because it's really extensive in the med device space and then you know we'll just carry the conversation forward. Awesome Terry. Thanks. I appreciate the opportunity and you and I have had a lot of private discussions so it's it's this is always a lot of fun. So I look forward to it. Yeah. By way of background, um Terry, thanks. Um 30 plus years in the medical device space. I I I often tell people I kind of grew up in this. I'm not I'm not sure I had a choice. I don't know. I I had a had an uncle who ran a major orthopedics company for for you know better part of 30 years. years. I had a father, American Hospital supply, backter, always in the med medtec, med surge business. And so our Thanksgivings were just lots of medical device chatter and networks. And so just kind of naturally through college kind of just found my

2:48 Way into the medical device world. And um you know, the rest is kind of history. And so I've grown up in this um as a career sales marketing managing GPOS um even did some M&A and some business development work. So a lot of uh really cool like yourself Terry a lot of commercialf facing activities in my life. Um and then I spent about 10 years at an organization called NAMSA where uh device development, testing, evaluation of products of medical devices, clinical um pre-clinical, regulatory quality. And so I found myself I I always liked it, Terry, because I went to more of the R&D engineering and development side and it was like a whole another language, right? we've got our unique language in commercial and medical devices, but then you go you go to the R&D side, you go, "What the hell is everybody talking about over here?" Right? Regulatory lingo and all this stuff. And so it was really a it was a good eye openener for me because I spent most of my life Terry

Sales marketing going what's the matter with these people? Bunch of idiots. They don't know how to get a product to market. We're just trying to make a simple change here to a tip design. What a I spent that 10 years at NAMSA and I went these salespeople don't get it. Don't they understand how hard regulatory is? Don't you understand every little change has such a huge and so I learned to appreciate the challenges that we live in in medical device world of it's highly regulated right safety efficacy these things are are are you know we're going inside of patients every day and so change and innovation is is really hard it's slow it's it it can be very frustrating and so it was good for me because I really cut my teeth there in that kind of regulatory world, clinical study world, and really helping, you know, from a NAMSA perspective, right? We were we were trying to shift who we were being more than a device company. We were really trying to build out how do we support

Innovation better? And this is where my passion for innovation really came from, Terry, was I I I my time at NAMSA, I was really watching big companies struggle with innovation, right? The big boys all became M&A machines because they just couldn't innovate in this big I mean you worked at Abbott. These are big bureaucratic mach things and they have to be right with really big quality systems to protect their brand. But that's the antithesis of innovation, right? It's you can't innovate in this thing. You can't move things across these silos very well. Hence why M&A became so, you know, important um to that. And and the the value proposition from NAMSA quickly became, you know, by by putting all of these R&D, regulatory, pre-clin, putting them all together, right, we found a value proposition that really supported innovation. like we we thought the value proposition would be huge for a J&J or an Abbott. It was important but it was more important to them about ohh we can do more with one vendor.

5:58 Okay. I mean that there's value in that right the real innovation for NAMSA was at the startup innovation level where we started seeing the learning from pre-clinical leveraging into your clinical leveraging regulatory things early on that supported downstream things. You know, we were finding, wow, we can move things that used to take five years into three years. Oh, that's a big deal. And we can do it shouldn't cost 24 million. Wow, we're we're we're demonstrating we can do this for five million, right? It was those types of things where we saw that NAMSA could bring value to the innovation pathway. And I only say that, Terry, because that's where my passion for innovation came from was was watching our ability to help companies move through this gauntlet, this nightmare regulatory gauntlet that's very unpredictable, lots of gray. Uh, it's hard, right? And and I I I learned through NAMSA the ability to to navigate that more efficiently, more effectively with the right partners. um and just

Essentially bringing product to the bedside more more predictably. I don't know if it was always less money, but it was doing it with more predictability and and less mistakes. So, that's a little bit of my background. Um today, I'm running IOR Vascular kind of full-time for the last we've been at this for better part of six years, but really full-time over the last four years. And then now we've got our devices on the market and we're kind of entering our commercial phases, right? This is a next big leap for us. So, we're excited about where we're at and uh um that's that's kind of my background a little bit.

Well, yeah, super exciting. And and before we pivot into to IOR, NAMSA's one of the probably the world's leading medtec contract research organizations. They're really designed to help innovation get to market whether it's design whether it's regulatory pathway whether it is um you know the clinical pathway as well right so all that kind of comes together and it's a it's more of a a consulting organization as well where you can kind of come in and offer one vague package correct yeah t it's it's all of it I mean they offer alocart services but to me the value and so what they're known for right is biocompatibility right in life you know animal testing they that's that's their bread and butter but I think their real value proposition for me was always integrating of some of these services right when you develop in the development side you're you're moving concepts and ideas in through a pre-clinical phase that's got some regulatory impact and nuance and you're you're trying to navigate all this

8:47 Engineering requirements and testing and regulatory and quality and you're so you're trying to satisfy all the safety and efficacy testing and evaluation that has to be done and it's all very alart right and it's all gray and so I think where NAMSA's value proposition is if we could leverage pre-clinical with our bench testing with our human clinical right we could come up with more better scientific proof methodologies for the FDA right we were able to show the FDA okay, better ways, more scientific proof that they wanted that that could support innovation, could move these things faster, right? And so we did a really good job of that. And I think that's, you know, kind of NAMSA's value proposition is integrating these things in such a way that it it it can just move things through the through that gauntlet much more efficiently.

Okay. So, let's go go to first base and we'll start with IICOR Vascular and you know we talked a lot about um you know just a couple things. So, let's talk about IICOR's mission. you know, let's talk about like who your customers are, what that what what the technology is designed to serve because I think it offers an incredible value across the board for an underserved market already that needs a trans catheterbased solution that is typically a surgical one. Correct. So, I'll tell you how it spawned, Terry, because I think this will help kind of support our vision.

It started at NAMSA, right? So Troy Long was a a fellow at Miami Baptist that I got to know in my sales and marketing career when we lived in Miami. And ironically, we our careers both ended up in Minnesota. So long story short, I'm working in NAMSA and and uh we're we're doing a lot of device testing on a variety of different throbectomy tools and lo and behold, the predicate device for most of these tools, aspiration, mechanical draggers, you name them, right? Archimedes screws like we were working on a lot of different things and here I was in the lab with my colleagues and the predicate device well before I go to the predicate we needed more physicians at the NAMSA preclinical labs right so that's where I started bringing Troy into labs hey Troy we we need hands we need real world physicians that know these devices and understand how to use them so that we can do good technical evaluations from a preclinical standpoint so I was bringing

11:23 Troy and others from my prior career, right, into our pre-clinical NAMSA world, right? And I could rattle off probably 15 guys that you would know. And they all got excited because it was an opportunity for them to get their hands on early stage devices and have a real direct impact. And the the one how I spawned out of this was exactly that was we were working with all these different cool technologies, cool ideas. Many of them are on the market today, by the way. Um, but we were always comparing to a Fogarty balloon, right? A predicate device, right, Terry? Nobody look at your market leaders. I'm not going to sit here and name names, but none of them beat the Fogarty balloon.

The the good oldfashioned so the good oldfashioned Fogarty balloon. We were doing analysis on the hystopathology, right? The vessel integrity, right? because that's part of the the FDA requirements and we were looking at the efficacy, right? How much you are you bringing clot out of the body efficiently, right? Um, nobody was really beating the Fogarty. We're sitting here doing all the evaluations like that's so funny. Like the the good oldfashioned 60-year-old Fogarty is still kind of pretty damn relevant. In fact, it it seems to be doing a better job from a vessel integrity standpoint than any of these metal dragging things.

And it's kind of beating aspiration on effective organized clot removal. So, right, that Terry became our aha moment because we joked, we laughed about it in the lab going, you know, it's almost like somebody should make an endovvascular version of one. You know, somebody just did that. That would be great. Yeah, certainly. Surely somebody's patented all that. Well, fast forward a couple years. We finally, Troy and I just sat down over a beer, literally a napkin idea, Terry, and just said, "You know, I don't see much in the way of patents out there, you know, Troy, what what if we just built some here in Minneapolis. What if we just started and and that was us in 2017, 2018 is we should just build a couple." We ponyed up, put our money together, talked to some local engineers, and and we that's where we started, right? We had some hiccups through COVID, right, through our regulatory process. But that's how it all began, Terry, was us just kind of monkeying around with different

Technologies. And to us, nobody could beat the good oldfashioned Fogarty balloon. And and here we are today using that same exact concept, just made it endovvascular, right? Made it non-surgical and dang thing works pretty well um relative to other therapies on the market. So that's a little bit of our I core background and how we came to be and and uh how we were founded. So let's talk a little bit about the market itself. Um there's a couple different markets that I think your strategic planning I'm planning to serve. So let's talk about those market segments and you know the value proposition that I core value is bringing to the table.

14:32 Yeah, it's a great question, right Terry? Because you say the word throbectomy, it's actually a pretty broad term, right? Because throbectomy, are you talking in the brain? Are you talking in the lungs? Are we talking lower extremity? Are we talking about diialysis fistulus cor? What are we talking about here? And I think you know where we've seen the unmet need, right? 2015 we had all the landmark studies of mechanical throctomy, right? And it forever changed the game. We got completely away from drug litic therapies and we've gone totally to mechanical and same kind of happened in you know coronary interventions right we've kind of shifted away from drug therapeutic options to perccutaneous endovvascular and and to me purple vascular is just following that pathway and and that's where we that's where at IICOR we felt like could we play in pulmonary embolism could we go after yeah we probably could, but they're pretty they're pretty well suited. The solutions are actually mechanically they're pretty darn good. Where we saw the unmet need and and where clot

Morphology and things were challenging was really in the lower extremities, right? We have two legs and we we looked at Venus disease um and we looked at arterial disease especially, you know, below the legs as real opportunities where current therapies just weren't translating real well. Right. aspiration can work but it has some challenges. Um some of the the tools that we use in in pulmonary embolism and stroke just didn't really work in peripheral vascular. And so that's where we were very intentional to say this is where the fogy sweep can work well. Acute clot emolic events you know on the Venus side right that adherent organized thrombus that can be very troublesome sometimes.

A good wallto-wall but not causing vessel damage, right? A tool in the toolbox that can help a lot of physicians. It's not to say, "Oh, aspiration is bad." No, aspiration is a great tool. I think everybody should have an aspiration tool in their toolbox. I I guess I would also say it sure feels like you need something mechanical because aspiration does have some shortcomings and does have some challenges that I think I core can satisfy. And so that's kind of how we've positioned ourselves in the market. Terry is kind of a lower extremity arterial and venus solution.

17:05 And now we've kind of pivoted as well now that we've gotten good with our cost of goods and and the mechanisms of action. We've recognized that we can we can pivot a lot of this into diialysis which we also see a huge unmet need right graphs and fistulas the access tools are just kind of they're gone basically there's a huge unmet need there and so uh a lowcost solution for people to treat those graphs and fistulas is is kind of our third you know leg of the stool here. So that's where we focused on from the throbectomy standpoint. Um simplified tools to address really some gaps in the throbectomy space.

What are the big gaps in the throbectomy space today? Just you know we talk about mechanical, we talk about litics, we talk about you know just retrieval of clot. How how does how does this really kind of serve that that notion? Yeah, I think as we assess the market, right, I think we're flooded with aspiration things, right? There's little variations of aspiration, right? But um generationally, right, you've got companies like Penumbra, now Boston Scientific. It's it's fairly advanced. I mean it it to me it's hard to it's hard to leapfrog to really far in aspiration and and I so I I feel like the market is really cluttered with a lot of aspiration things whether it's stroke owner I mean there's a lot of choices there right um where I where we see the gaps is on the mechanical right do we need another aspiration tool that was kind of our take was do I need another aspiration thing on the market or do we really need some good mechanical things

That just address some of the blood loss concerns and some of the the the adherent clot, right? There there are some limits on some of the aspiration tools. Aspiration sometimes fails, doesn't always work, and that's fair, right? Clot is not very predictable. And so to to us, this kind of sits next to aspiration tools as part of that, you know, toolbox, a good mechanical tool that can oftenimes work well with aspiration or addresses some of the the more organized, heavy stuff that sometimes aspiration tools can struggle with.

Okay, so Tim, that's a great point. And what I would like to do is just take a quick pivot maybe for a minute or two. I know you have some technology in a video that you could show us that would really give us a great idea of how the technology is working from, you know, a gold standard perspective, but what you're the new innovation that you're bringing to this photo technique. So, why don't you take us through that a little bit? Perfect. Thanks. It's really so simplification is our is our mantra, right? We have three components. We tried to stick to interventional 101. So we have a everything packaged in a single kit. So the concept was always this should be a kind of an openand-go system whether it's in an Obl or whether it's late at night treating acute limb eskemia in a lab. So we package the introducer access sheath the guide catheter and the working fog all in the kit so that everything is compatible and everything

20:33 Works really well together. And the way it works is basically the the sheath comes into the body, right? This happens to be the Venus video. Um the guide calf comes in and works like so. You've got a retrievable filter at the end of that that basically opens and closes much like a stent. And then you've got an overthe-wire system that comes in, crosses the lesion. You basically get wall-to-wall contact and you pull like so. close and then you'll remove the sheath the guide catherine the balloon from the body very easy to clean right so we kind of invert our baskets remove the clot flush it and we always stay on the wire and this is important Terry because we'll make multiple passes we'll sometimes in Venus disease we'll make four or five passes very quickly you and and to us sheath and wire access was so critical right it sounds so obvious But many devices give up the wire access, right? And that's where time time to reprofusion, those

Types of things starts to uh be become problematic. Yeah. Time to access too, you know, it's just more instruments, more wires, more more procedure time. So So Tim, that was excellent. Go ahead. Oh, yeah. You know, Terry, I was just going to wrap up and say that, you know, that sheath and wire access has been, I think, an area where PE our physicians have grown to appreciate it. They've recognized I think the initial reaction sometimes is, oh man, six passes to get reprofusion and it's like, well, no, doc, it's really about time. You know, if it takes you six or eight pads, it takes you sometimes you've got organized thrombus that goes from the poplil all the way up to the iliacs and it might take, you know, a handful of passes and and I think our physicians have learned to appreciate that that yeah, I'm still doing these in 25 to 30 minutes. It's not like it's taken me two hours. And it's that sheath and wire access to us that has always been fundamental, right?

To I mean that's fundamental interventional 101 right but many of the devices on the market today you keep giving up wire access and this is where the starting over and getting my wire back in 10 15 minutes starts adding up we just felt like that was had to be a must-have in the functional design you have to maintain sheath and wire access at all time right well thank you for sharing that I think it's a perspective and it really shows the value of how the technology kind of comes together and creating that therapeutic offering. But let's go take one more point of the conversation. You and I spent a little time kind of talking about history and we talked about innovation and you termed like this new valley of death in the innovation space and this is where I think the rest of the conversation is really going to branch off in a couple really interesting categories where you know whether you're another founder of a technology medical technology whether you're a commercial leader um or whether you're a veteran

23:52 Working for a big company um you know selling you know gold standard stuff but tell us about your perspective of the gold standard or excuse me the the valley of death today versus what it was before. Yeah. So when I and I'll go back to my NAMSA days a little bit on some of this, but if I go if I rewind about 10 years ago, right, and when we were in when we were working with different companies innovating, it was when I say valley of death, it it usually is a funding term, right? It's something we talk about with investors and different, you know, angel investors versus versus venture capitals versus private equity. There was always this funding gap in early stage innovation, right? Nobody wants to take that high risk of funding an early stage thing, right? So, you've got this cool concept.

The founders like Troy Long and I, right, we we rallied up quarter of a million dollars and we kind of got our prototypes and we built them and we got them into pre-clinical and we're like, "Hey, this thing works really cool. This is awesome, right? We need more money, right? We got to get through this the rest of this gauntlet which is going to cost three million or five million right in our case just to get close to an FDA submission right how do you fund that and that always became a valley of death Terry is there weren't a lot of people say it's a cool idea cool concept you know call us when you got FDA approval okay okay so there there was always this kind of challenge to figure out how do you bridge that and that always was kind of termed the valley of death and it's a challenge right and we all over these big risks too like not getting big that's where a lot of the risk it's

A it's a risk mitigation aspect of you got to get through FDA approval before you can even think about correct and and there was a time when the angel investor right so I break it down angels venture capital private equity right private equity is way out there so let's push them aside VCs aren't touching Right? So you you always kind of relied on your angel network, high net worth individuals to kind of fund that early valley of death. But I will tell you even angels, right? Sophisticated angel investors, it's a game of risk, right?

They've learned, they've been burnt, right? They said, "Well, so now they start kicking out further and further, right? They come in later and later." So that valley of death became very real. Now I move you you termed kind of the second valley of death. I think what we're seeing in in the innovation medical device sector is so you get a 510k you get your you get your device approved now what nobody bought me nobody acquired my asset there was a time when people used to do that right good IP strong you did 15 cases hey cool little asset somebody will pick you up doesn't happen anymore Terry unfortunately right so now you've got this new Valley of Death. So, you got the angels to help you. You figured out a way. You did a handful of cases with your Koss and your guys and you're like, "Hey, all right, cool. This works." Now, strategic buyers and venture capital has all that goalpost has moved, right? Everybody wants 5 million, 10 million in revenue,

27:15 Right? Hey, give us a call when you get out here. That that's a more scalable option for us. we just want to prove that you can check the reimbursement, sales validation, uh, all these other boxes. And you're like, h, how do I do that? How do I get to 5 million? I don't I can't sales people are expensive, right? So, now you've got this kind of new valley of death where VCs aren't quite there. They're they like you, but they'd like to see you over here. And strategic buyers just aren't buying assets right now at that st it's too much for them.

And it's it's actually a fair discussion, right? Cuz I've talked to the Bostons and the Metra. We've talked to all of them and they're like, "It's just hard for us, Tim. It's hard to take those gamles because we'll screw it up." That's us. We we we know we will muck this thing up if we buy it too early because we're just not good at innovation. We really need to buy things a little bit more refined and then we can move it into our sales and marketing machine and we can move it into our scalable manufacturing, right? We're good at that. We're not good at taking innovation and trying to figure out how to make it, you know, work more efficiently. So there's a there's a challenge there for innovation today to figure out how how to take it a little bit further to further you use the word risk, right?

It's all risk. How do you derisk this further and this is this is a tough bridge to gap again, right? You got the first valley of death. You got to cross it. Now, how do you get it into that commercial vehicle? How do you how do you get it to that $5 million revenue run rate or 5 million in IBIDA? It's a big leap, Terry, because the cost is is massive. This is not a $4 million investment round. This is a 20 plus million effort uh to to to move that needle. So, it's a challenge.

It is. And you know it's a different I can understand why a lot of the bigger more stable companies is they've turned into farmers versus hunters. And what new technology requires is a hunting mentality. It takes you know there's a lot of energy that goes through whether you're taking market share from existing technologies that's you know you're fighting inertia and friction there. If you're bringing brand new therapy or brand new innovation and brand new methods, there's another may not have five competitors against you, but you have 60 years of history that you're battling against, right? And so it takes special clinical and sales professionals to break through that I'm going to call it inertia that that that energy to get through to the other side because everybody's doing something different and transformation and change in the midst of all the other things that are happening in healthcare are really hard to do. And so that's why it's so challenging to have that specific sales mindset that I'm a hunter and not a

30:26 Farmer because they are two different motions, right? And I think Terry, we're you and I have talked about it in the past, but it's uh and we can segue that way, but it's it's compounded by the fact that postcoid is a new world, right? So here we are trying to commercialize, right? You say, "Okay, great. Terry, if I took our device today, the the the device that we have today, and I could rewind and I could go back to when you and I started in sales, we'd get 20 people to use it next week. No problem, Terry. You and I would walk into Naples, we'd walk into Miami, we'd walk into Mount Sinai, we'd walk, you and I would go like, "Ah, I got I got a bunch of people to use." No problem. And you'd be off to the races.

It doesn't exist anymore, man. So there are a whole host of new challenges not only to fund it, right? So now you got to fund this beast, but we're seeing a record number of companies fail even with substantial money at this commercial launch, right? Going out and hiring 15, 20 reps at whatever cost, right? They're expensive. The ROI is is not a one-year OI. It's not a two-year ROI, right? It's a it's a long drawn out thing that is really hard to to move the needle on. And so this is representing I think a real challenge for innovation. We're we're we're we're cautious going into this Terry as as I because we're watching a lot of our peers, vascular and interventional companies trying to figure out this commercial effort and many of them are failing. Good technologies, Terry. good stuff that is having a hard time finding its way through this commercial gauntlet and they're burning themselves out and they're going bankrupt for bad reasons.

Wasn't a bad plan. It's just I think people are underestimating this new world, this new sales world that we're living in is more daunting than people thought. And and I think this is a reality, Terry, that we're being very we're very aware of and and we're trying to figure out how to navigate this efficiently without, you know, going the wrong direction at some point. So some real challenges, you know, and you think about the landscape, right? So now you have these new value, they're not new anymore, but now you have the value analysis committee. And frankly that process has evolved over the last 10 or 15 years too. Mhm. You have COVID which you know proved that you know medical device sales reps don't need to have full access to hospitals and the world still moved on right worked fine didn't it?

33:16 Yeah. You know we still got to the other side of it. We have um in these new value analysis committees. It's what's really interesting is like you know it used to be and you and I talk about where the doctor would raise their hand and they would say I want this and I can remember the day when you know doctor would call you and say yeah I want come and bring it over for a case it' be a brand new hospital you'd walk in the door you might you might check in the procurement you may not you know you know but if you didn't you went down did your procedure and filled out your invoice and you walked it over to the purchasing department and you handed them your you said I need a PO for this and the O supervisor or the cathab supervisor had signed it and you know you got a PO number you know kind of a an interesting process and today you know you have multiple gates

To get in the hospital then you have to like present and it's it's a it's a long process and it just feels like a lot of the complexity of getting new technology and innovation into the system is intentional I don't think it's by accident. I think it's you know it's designed and this is where companies today need to build a strategy around how to manage the hospital complexity. Look at other markets that might be faster to turn and faster to get access to to at least get some activity and sales motion running.

Yep. um you know using maybe starting earlier or certain stages that you know before you're you might have an approval but you might have a launch that might be six to nine months out that you spend time actually using that time to ramp into where the top five or six hospitals that I need to get into and start that back process already. So, you know, there's other ways to do these things that can, but you have to take a strategic moment. If you're just waiting for an approval and then running out the door and then doing your work, then then you probably are not in a good place.

Yeah. And I I just think, Terry, there are some inherent challenges. Everything you said is accurate, right? Totally agree. I think um what we're seeing a lot of too and we've talked to a lot of our physician colleagues about this and that is you know the physicians are marginalized in this new process right there used to be a time right where physicians were on the value and there still is some of that I hear oh yeah one of our guys is on the value oh okay but I've also been in a lot of value analysis processes where there is no physician representation or if it is it's from a cardiologist uh from one of the groups who shows up every third meeting, right? So, is there good physician representation sometimes?

36:04 Not really. So, and and you said intentional, right? That's intentional, right? This is a new supply chain driven phenomenon that um has different motives sometimes. And I I don't want to point fingers because I I'll get I'll get slammed for this, but I'm not convinced those supply chains are always functioning around outcomes and economics, right? I think sometimes other motivations there uh that that drive supply chain decisionmaking. And so it so it is what it is, right? T I'm not poking holes in. I'm just saying this is a new challenge where your physician champion may not be enough, right? That used to be a thing. No, if you got a physician, he'll he'll kind of work it through and he'll he'll champion that through. And that isn't always the case anymore, right? We've had some really strong physician champions, big podium names who are just struggling to support innovation, not just us, lots of things, right? They're trying to be supportive.

They're trying to help and there's just not a lot of wiggle room to to help. So, they've got to pick a battle, right? You don't get to you don't get to pick a battle every month. It's like once a year, pick your battle, and that's the one. And so, it's a real challenge there, Terry, of of how how are you compelling enough to really move the needle across a value analysis process? Uh, we we've we've mapped it. It's hard and it and it's so it's hard for big companies, right? I would say it's 10x for smaller companies, right? At least Boston Scientific reps have access already. They've already got their credentiing. They've already got the Boston Scientific is in the system, blah blah blah. Right there. Good luck finding a a girl down in supply chain to get excited to get IICOR onto the vendor list. It's hard, right? So, so there's a lot of challenges for young companies to navigate that that weren't there 10 years ago and and nobody's look nobody's

Excited to add another vendor to their vendor list to manage. It's just another thing to do. So, just just things and I think Terry, you and I always talked about, you know, what are some pearls that hopefully somebody takes away from this? This is the kind of stuff, Terry, that I hope innovators and other CEOs and other people that are in the startup world can can gain from this is just it is what it is, guys. We're not changing it. We've got to though understand it so that we can build the right models or the or the or the right funding to make sure that we don't fail, right? And I think it's just sometimes we just don't know what we don't know. and and and failure is coming because we just didn't we didn't predict it right. we we thought we could get through quicker and you just can't. You just can't, you know, and think about the things that you know from your perspective, what would be the top three things that

39:14 Any new and I've got my perspective on this so I'll share after you, but like what are the top three things that when you're bringing something to market that if you don't have you are dead in the water period? You know, if you just think about that for a second, well, you you certainly have to have something that addresses the health economics. Yeah. I'll just say it in the spirit though, Terry, that it's um it it has to be able to check the box. I wouldn't build health economics, you know, in other words, if you're trying to develop technologies that don't have a reimbursement code, Yeah. you you've really given yourself in today's world another challenge that we used to be able to overcome some of that you know off label do this it's really hard now right to to get through that process now without that oh boy I I don't know how you would do it anymore um so I think you've got to make sure

That you've got a good sound story around the economic elements of it and and by the way that has to be embedded in the early design must haves right is I think about when you're designing technologies like have you guys talked about your cost of goods and reimbursement. Yeah, not really. They're just developing tools that engineers can build and go. Well, hold on. I think I think you've really got to have a good grip on your ASP cogs targeting into the design of the device very early on. So that's something that it sounds obvious, but I see it overlooked all the time in early stage development of tools that that element is kind of we'll figure it out later.

I don't know if that's true any better have that designed into your musthaves early. That's that's one that kind of comes to mind. Um, you know, Terry, I think you've got to really be I think it's hard to be a fast follower anymore. So, you've got to really think about your value proposition and where you fit in the market. Um, because that's going to segue into my third piece, but I I think we did a good job of really understanding the unmet need and throwing back to me. We kind of knew it because we lived in it and we grew up in it and we're like, "Yeah, but nobody's addressing this, this, and this. where we get a little lost from an I core perspective is yeah Tim there's a lot of things in throbectomy and that's not a false statement it's true but I think we're we're so immersed in the space that we understand the gaps and it's it's sometimes challenging for us to educate investor world or banking

42:05 World no you're talking about stroke pulmonary embolism I get that those are big markets But they're saturated. They're heavy. There's a lot there. You're right. There's a lot there. And I'm not I'm not a proponent that we need to compete there. I think we've got to address the gaps, right? And so I think we've done a good job of it. I'm not sure we've done a great job of educating the we're doing a better job. uh but we we we needed to do this earlier to the investment and banking world so that they really understood the thrombctomy sub segments and then the last part of it is Terry um if I could do anything differently right you got to move fast and it's easier said than done right um we've been incredibly disciplined with our capital we've done a very good job but I think sometimes it's at the expense of speed, right? And speed is important. So, I I I would just say that

You got to be disciplined with your capital. You can't spend frivolously because you can't predict what you can't predict the unknowns. You're going to get them despite how good you are. So, you've got to be able to overcome some things along the way. But, you you've got to find a way to just move swiftly. You do have to move fast. And and there's something to be said for for for moving quickly. So if I had to ever fund it again or do it differently, I would try to fund ourselves a little bit to have more working capital in the spirit of trying to move fast. That's just one thing I wish we could have done better.

Looking back, I said, man, I wish we could have moved quicker in some areas. And hindsight's easy, right? You can look back and say, oh, there were some areas. But we've also by being disciplined, you know, we've we've overcome some very significant things we never saw coming, right? So there's a balance there. But it's just something I if I could do it differently, I I I would strategize to figure out how do I fund this around speed? Even if I have to dilute the organization a little bit, speed is important, right? So speed connecting the value proposition and make sure that story is solid and economics and then tie to that with the economics where you know I would just say that you know without a reimbursement pathway you're probably dead in the water even if it goes into the hospital situation you get through that committee you know um getting doctors to adopt getting facilities and acute care centers to adopt things is pretty challenging there's no renumeration system in place

44:48 For it. Yep. And I think to echo that Terry before you before you say it, just to echo or build upon the economics because I've seen a lot of technology say, "Well, we bring it into the O in the hospital and by doing this X, Y, and Z with our technology, we're going to save time downstream into the acute center down there, over there, blah blah blah." And I go, "So, you're asking the hospital to be a cost center with no reimbursement, no way to really pay for it. I get it. It saves down there in the health system, and that's awesome.

That's that's flimsy today." Now, Terry, I I get it. The health economic story is there, but I think your health economic story has to be cost center thought through, right? that how does it affect this the person buying it? How does it how do the economics impact them? And I so I say that Terry because I've seen a lot of technologies where I go I get the deny I I got it. I connected the dots with you. I follow you but I don't think you're going to get cost center A to be paying for stuff that helps cost center E over there. Ah I don't know. That's a tough one because it you you got to make sure you've got the economics hitting the right P&L and that goes back to connecting your value proposition to the right stakeholder as well, right?

Yeah, that just that's where that part and I think that ties into your value proposition statement. It's one thing to have a value proposition, but as we discussed earlier, these VAC committees have eight, nine, ten people on them. They all have their own value proposition. And so that's kind of the thesis where you know you got to connect the value to the stakeholder. Um, well, good. I I love that conversation. And the last part where I really want to go into because I think this is something that you and I are both really passionate about and knowing that bringing new technology to market is very challenging um, economically. Um, it's it's tough to stand up an entire sales organization of five or 10 or 15 or 20 people and it gets expensive.

And so in this new world where access is limited number one and the cost of standing up a W2 sales organization is expensive that creating this sort of um I don't want to use the word repless environment but less rep right or rep light. So let's talk about a less rep environment and an Applelike experience with the product itself and what do you think that can do to the marketplace? Couple thoughts here, Terry. I mean, as as we've developed I core, we've always developed it with that mindset, right?

47:46 Current technologies in our immediate space are very very rep heavy, right? Clinical and rep heavy. And we've always looked at that and said, "Well, that doesn't feel right." I mean, I get it. You need reps. You need to sell. Selling is important, but if I need a rep for every single procedure, have I engineered this properly? I mean, it I get it. We're dumping more and more algorithm AI discussions. All this stuff keeps coming into these technologies and all we've been watching is, oh, I need a rep to trick the algorithm. Oop, this thing isn't working. Hey, how do we trick this thing again? They got to flush it with saline. Got to reconnect. Gotta got the algorithm's not working right. the blood detection did and we just keep rolling our eyes going shouldn't we just develop simple tools that can just work and it doesn't need all this AI and rep dependency. So I think we've always fundamentally said we we need to build our tools around simplicity that don't

Require rep dependency that that just seems like a not optimally designed technology. So that's always been at the forefront. And then we couple that with kind of just where we see the future going, right? We we see a a marketplace in front of us that's kind of anti-rep a little bit. And so can we develop technologies with that in mind? Right? That I can operate more as a strategic forces, right? You need sales presence. You need something sales light. You got to make people aware of what you do. your phone just doesn't ring just because so you've got to have a marketing and sales effort but can we make it such that it's highly adoptable can we democratize the way we do throbectomy in such a way that I don't need to build you know a 400 person salesforce to make it work right and and that's just kind of been how we've been thinking about technologies how we've been thinking about throbectomy can it fit into a bigger bag

That can be more efficient, better cost of sales. And that's just kind of been at our our forefront is is building around this concept of we we've got to find a way to be repike. It can't be rep dependent or we just haven't quite done it right. You know, it's so true, too. And it's, you know, it it's very challen I mean it's you I think you said a couple things that were really resonating with me is that the customers don't want reps running around. They've made that obviously clear in the last 10 or 15 years with rep tracks and putting red hats on sales reps heads and you know just you know the whole the whole incursion process of even getting in the doors number one and and I don't actually disagree. Yeah, I mean that's you and I talked about like if we were in a restaurant and every part of that restaurant had, you know, at the bar you had three liquor reps standing around the bar and in the

50:53 Kitchen you had five or six, you know, you had one for your vegetables, you had one for your steak, you had one for your chicken, you had one for your spices, you had vendors that were taking care of the equipment. I mean, the it'd be hard to get anything done with all these people running around. and and at the end of the day, that's what med de device and and health tech reps actually do all day. They're in the hospital. They're in a place of business. And so leaning towards this Appleike experience where you're still going to need human and human engagement. So I'm not I don't think either one of us ever advocating like a no rep model, but what we are advocating for is technology when you open the box is really intuitive to use.

Simple one like it cannot be putting together 18 pieces and you know this screws on this way and that screws on that way and so it's got to be really intuitive to use. Um and it serves everybody very well. It gives the hospital system a technology that is easy to use and adopt number one where and and not have people running around that don't need to be there. Number two is from a cost perspective, it helps the medical device company to lower their cost of delivery. Maybe not the cost of goods sold, but at the end of the day, if you can minimize some of the, you know, administrative cost and the sales costs, then maybe you can have a stronger economic offering.

Now, you're if you're not spending stuff on reps, trust me, you're still going to spend it on other technologies to make sure people are using those things. And then you know and then you get into the where I call it the real good thing is that you create customers and to me there's a lot of doctors and implanters in the world that use companies products but really to be classified as a customer in my opinion those are the physicians that use the products when the reps aren't there right so I think there's there's a great avenue where everybody can win in this equation if we just take a little balance to it all and you know but then it's you're going to put a lot of pressure on R&D you're going to put a lot of pressure on your manufacturing team in terms of you know making it costefficient you're going to have packaging challenges I mean you know making that Appleike experience impacts a lot of that front-end stuff that that

You know and frankly when you're first building the device you're just caring about getting something that can get you to market let alone own Apple experience. But maybe that's something that has to go into the R&D upfront and like you know maybe one of the top three things that when you design it for it has to be easy. It has to be adoptable. Um, and that might be a good lesson for others to Well, it's been our mindset, Terry, is the simplicity, right? I mean, even in our limited market release, even when you think you've nailed it, the limited market release taught us that, okay, there's some elements here that weren't, you know, weren't perfect, right? And sometimes in bench and preclinical and animal studies, we had 15 people touching the device.

54:10 Right. Right. You know what I you know what we didn't do? We didn't have 15 texts touching the device. Right. So then there's little things, right? So there's a lot of stuff you learn in innovation through real world utility that that you just couldn't replicate. So to us, the limited market release was important because it really honed in on some key elements of ease of use, right? You know, Terry, people do weird stuff with devices. I I've told you this before, like we had some people like twisting knobs, trying to break knobs off, and I'm like, why why are you trying to break that? Like, I don't know. And I'm like, wow. Okay, these are the things we had to go through and endure. and and so even the best wellthoughtout designs until we got 60 70 100 uses it was really hard to understand some of those nuances. So the limited market release was super important for us to really hone in on simple some are simple changes some are a little harder but really honing in on

Refining around the ease of use and simplification of things and just constantly but again I think our vision has always been the same of Simple drives adoption. Simplicity drives up. Not health economics. Got to check the box. But to me, and you're a marketing guy, simplicity really can drive adoption. If I can make his life easier and still have good outcomes, we're going to get uses at two in the morning, right? So, we just kind of keep dialing in on those things that drive simplicity and ease of use. And at the end of the day, right, we're I I use it with my team. I try to have the Disney experience, right? Disney to me is the ultimate in Disney experience, but I want people to have a good experience with our device. We're not going to replicate that experience. But that's my mindset is how do I get physicians to have that kind of oh my gosh, that was really good. That I didn't have any

Blood loss and I that worked really quick. Dang. Awesome. That's what we're striving for is to have physicians have that kind of experience. And we've got a few now, right? We've got some docs who have told us, Terry, like, Tim, I I've gotten so comfortable with this. I I barely need my tech. And that gives us hope, right? We hear that and we go, and by the way, that was always Troy Long, my co-founder's vision. He's like, Tim, I want to design this such that I I can do this by myself, right? And I so I've always loved Terry that mindset of that's the kind of simplicity we got to be striving. It's not just rep light.

56:51 It's almost like tech proof, tech light, right? Can I do this in such a way that can really make everybody's life so much easier? Then I think we're on to something. And and that to me ultimately will drive adoption in the long run. And so we've got some work to overcome some changes and some sales strategies, but I think those are the types of mindsets you have to have when designing technologies um especially in the medical device realm. So well put, you know, as we start putting um a pin on this one, there's a couple closing kind of questions I have for you. One is, you know, um, what would be the one piece of advice that you'd have for, you know, another founder of technology today if they were walking away from our conversation today? What would be the one piece of advice or what do you want them to take away from this conversation? Be a better way of putting it.

I don't know if it's one thing, but I'll try to be succinct here. Um, there's a belief system that just Terry, it has to be inherent. It's maybe some might call it a passion, whatever that is, right? You you just have to believe. If you don't believe in this and you don't have that kind of passion, this probably isn't for you because it's it's a long grinding, highly regulatory, you know, highly regulated pathway. Um, so and I think maybe coupled with that is because you've got such a passion and such a belief system, there is so much negativity in innovation. Like I've told people in in a 30-day given month, 29 of your days are just putting out fires, pain in the ass, nothing's going right, and you get one day of kind of like, ah, that was awesome. We had a we had a breakthrough, right? And so you've got to not listen to the naysayers because everybody's telling you things that are wrong. Well, you didn't think about that. You didn't do that right. You

Didn't you don't know what you're doing. Everybody's poking holes in everything you do. Everybody every But nobody does it right. Nobody's funded companies. I got everybody telling me how to fund a company. I'm like, "But have you ever funded a company?" Like, "No." I'm like, "Oh, okay. Well, but that's your life, Terry. That's your life in innovation and startup world." And so you've just got to have that passion, that belief system to ignore the noise, stay hyperfocused on what you do. Um, and then I you got to celebrate the wins, right? Troy Long and I still we have a little celebratory scotch. We we we spend a little money on our scotch, but when we have some breakthroughs, we take the time to step back and say, "Guys, we need to we need to celebrate this one, right? this was a good good day today or a good week, whatever the case is is. And celebrate those things because there's just a lot of negativity and a lot of heartbreak

59:51 That you're just you're constantly solving problems. You're constantly trying to overcome the negativity. And so celebrate those wins, man. Enjoy them and uh use that as your motivation to to get to the next stage. So that's just how we've operated. some things we've fallen into that kind of help us get through um you know kind of the day-to-day grind. Well, I got one more for you. Um it's it's a knuckle ball curveball, but I'm going to throw it at you anyhow. And um it's a question I ask all my guests and we're you know we're going to take you back to you know a period in your life when you're at one of these pivoting you're either graduating from college and moving on to somewhere but it's a a pivotal point in your in your younger professional career from today. So, if if current day Tim could go back and let's just say go back to 22-year-old Tim and offer one piece of advice. It can be

Professional, it can be personal, it can be financial, but if you could go back and offer yourself one piece of advice that you wish you would have known then what you know now, what would that be? I've got a son who's 20, right? So, you're kind of hitting that cord right now where we have these conversations with my kids, right? Right. And you're trying hard to let them find their way, find their path, but in the same breath, you know, there's a part of me that says, "But I wish somebody would have told me this back when, right?" So, I find myself trying to kind of hedge my bets with my kids kind of. So, I have my oldest daughter going into nursing.

She's got a passion for nursing. She She belongs there. But I'm so proud of her because she's gone into nursing. And I liked it, Terry, because I knew the world and I know there's a shortage of nurses and I feel like it's a profession that a I think she fits really well as a caregiver. It's just who she is. But I I think it really I was just trying to think about her future where AI and some of these other things are kind of creeping into some worlds and I'm like I don't know about that. But nursing to me felt like it was a good fit. And then I got another daughter who wants to go down the teaching path. So these aren't money-making worlds for them but they're passionate about it and they're following it and they love it. And I think there's some job security in their futures for that. my son uh going to be a sophomore. Fits your question, right? Because he's like,

1:02:35 "Hey, I want to get in medical device sales." That sounds cool, Dad. I'd love to. Could I help him, Terry? Absolutely. Right. And do I do I let him do some work for us on the Absolutely. Right. I'm always giving him work to do and and and he does a great job with spreadsheets and building trade show schedules and just little odd stuff throughout the summers. It's great. It's great exposure for him. I don't know if I want him going into sales to be honest with you. I'm Terry.

If I'd said that 25 years ago, I said, "Ah, absolutely, man. This is a great Oh my god, you could have so much fun." You and I touched on it on today's world. I I'm not sure it's what it used to be. I'm not trying to discourage anybody from going into sales. It's a great profession. You can make a lot of money. You can build an awesome career. I I I'm just trying to have him think about the realities of what that world is today. It's just different. I don't think it's as um rewarding as what you and I grew up in personally. That's just my opinion.

And so I'm just trying to encourage a young Tim to explore what you're passionate about, right? He's got a creative side. um things like engineering and architecture, things like drawing, right? We've been talking about Disney, right? Disney's a perfect exposure. So, I I guess my I grew up in medical devices, so I just kind of fell into it. I don't know that I necessarily followed my passion. It's fine. I I love what I do. I'm happy with what I do. Uh, but I think for for a young Tim, I'd like to really fall back on let's not talk about money so much. What are you really passionate about? And then let's go figure out how to make a career and a living out of it because and I know it's cliche, right? If you love what you do, you know, you or you won't you're not working, right? I I know there's some truth to that, but I just really that's my advice to to my kids is let let's

Talk about these things. Let's think about the future of AI and the impact that these things are going to have on that, right? Doesn't mean you don't do financial or you don't do certain areas, but you just have to think about where our future is going with some of these these redundant roles and jobs. But that's where I'm at, Terry, is I I want my younger self to really step back and say, "What are my what are my true passions?" And then how do I make that my reality?

1:05:15 And if it's medical devices, great. If that's what you're, you know, if that's what you're all in on, then let's go do that, right? But, um, you know, I that that's my advice. And I I didn't come out of college that way, Terry. I kind of came out and I got to find a job. I got to find a job, right? And and that's a reality too, right? And you and you make your own pathway. But, uh, that's my hope. Um, I'm not upset with anything I've done in my life. Do I I don't really have any regrets, right? You try to make the most of everything you're dealt with. And, uh, your path is your path. But, uh, that's what I want my younger self is to find those things that you're truly passionate about and let's just go go for it, man. Find a way to enjoy that and make it happen.

Love that. Find your passion. Find your purpose. By the way, you know, both those things are and everything kind of take care of itself. You know, it does, Terry. And I I do with with my kids, you know, I and I have it in my office. um you know make a difference you know I and I just so I say that and this is part of why I did I core is I was like you know what one of the things that's most gratifying to me this was a concept on a napkin right you know what Terry we've got some patience so we've done a and so there's something very gratifying to say all right this was this felt good like it's a this is a worthy device it actually we've got some great outcomes to show for it and so as I think about nursing as I think about teaching and I think about even whatever my son does like well whatever it is you do let let's try

To make an impact on people and life you know let let's try to bring something positive let's not just do a job just to do a job I get it you got to make money you got to support a family I get all that but let's let's try to can we make a difference in the world and and that's where I something we talk a lot about as a family is just let's make some contributions to the world and maybe we can make some money along the way that that I think there's just a lot of gratification in that. I love that. And and Tim, I just have to say thank you. Been so generous with your time today. Number one, um you are candid, you're witty, you're funny, you know, you're authentic, and all those things really help, you know, make, you know, Zero Friction a really impactful, you know, piece of content for those that um will benefit from this. So, thank you so much. Appreciate you being here.

1:07:46 Likewise, Terry. Thank you and hope this uh helps some others in the innovation world. Thank you. I'm sure it will. And thank you for paying it forward.