Transcript 0:00 [upbeat music] Make certain that your story is clear and concise and that the value proposition and the market are there. 0:14 Again, you can have a, a cool technology, but that may not mean anything. You can have a good market, but not a good technology. 0:22 You can even have a big market and a cool technology, but the value proposition when you pull into account economics is still not there. 0:29 So you've gotta really be able to explain the value proposition and make them confident that, you know, that how you're gonna execute on, on it with the use of proceeds and why you're going to be successful if they invest in you. 0:48 [upbeat music] Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey, everyone. 1:03 It's Scott, and in this episode of MedSider Radio, we caught up with Steve Anderson, CEO of Perceptys Medical and a fellow serial medical device entrepreneur. 1:12 While leading and serving as CEO of Acorn Cardiovascular, he and a neighbor came up with the idea of creating a device that could help doctors insert a tube in children's ears in the doctor's office instead of the operating room. 1:24 They ended up starting Perceptys Medical in 2011, and then in 2020, their Hummingbird device received clearance from FDA. 1:32 In this fun discussion, Steve explains why your value proposition needs to be front of mind from the start, why having someone who's been there and done it before can help you navigate the process of getting to market, and writing a study protocol that shows regulators exactly what they need to see. 1:49 [upbeat music] Okay, so before we jump into the discussion, I want to mention a few things. First, since you're listening to MedSider, you're probably aware of how expensive it is to run clinical trials. 2:00 Anyone who's spent time in the med tech space knows that you typically need to commit hundreds of thousands of dollars, oftentimes millions, towards clinical research. But it doesn't have to be that way, and here's why. 2:10 Proof Pilot is a new kind of hybrid clinical trial platform that enables you to run decentralized studies at costs that are 40 to 80% below traditional approaches. This is how they do it. 2:20 First, you can easily design a trial in the Proof Pilot visual protocol designer using their extensive library of templates. 2:27 Next, you can launch those trials to participants and virtual staff without any technical development. Skip the integration of disconnected providers because Proof Pilot pulls it all together seamlessly. 2:37 For example, you can recruit, consent, and retain participants, then schedule, remind, and collect data, often with minimal manual labor, manage site data in real time, query adverse events quickly, and review data and preliminary analysis within hours, all in one compliant platform. 2:55 Get up and running quickly with an annual license fee and launch as many trials as you like with an unlimited number of participants. To get started, visit medsideradio.com/proofpilot. 3:05 Again, that's medsideradio.com/proofpilot. For the MedSider audience, with an annual contract, Proof Pilot will provide IRB approval for your first study at no cost. 3:15 Some exclusions apply, so visit medsideradio.com/proofpilot to learn more. 3:22 Okay, second, if you're into learning from proven med tech leaders and want to know when the new content and interviews go live, head over to medsider.com and sign up for our free newsletter. 3:32 You'll get access to gated articles and lots of other interesting healthcare content. If you want even more inside info from med tech experts, think about a MedSider Premium Membership. 3:41 We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. 3:47 This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a med tech startup for an exit. 3:56 In addition to the entire back catalog of MedSider interviews over the past decade, premium members get exclusive Ask Me Anything interviews and master classes with some of the world's most successful med tech founders and executives. 4:08 Since making the premium memberships available, I've been pleasantly surprised at how many people have signed up. So if you're interested, go to medsider.com to learn more. 4:17 All right, without further ado, let's get to the interview. [upbeat music] Hey, Steve. Welcome to MedSider Radio. Appreciate you coming on. Thank you. Happy to be here, Scott. All right. 4:29 Well, I, I provided a, kind of a brief bio, um, at the outset of this, uh, of this episode. 4:35 But let's, uh, let's start, um, with you adding a little bit of, uh, a little bit of color, a little bit of context to your background. 4:41 And maybe, maybe take us to kind of your, like briefly touch on your early years in the, in the medical device space, maybe leading up to your, uh, your, uh, your time at, at Acorn Cardiovascular and your, your transition to, to Perceptys Medical now. 4:53 Well, sounds good. I'm a, I'm a true, uh, Medical Alley guy, and that's Medical Alley being the local trade association for, you know, devices in healthcare in, in Minnesota. 5:04 We're, we're pretty proud of what we've accomplished here. And, and in fact, my... 5:10 I went to the University of Minnesota, got an undergraduate degree in mechanical engineering, and then I, uh, did graduate work and got a master's degree in biomedical engineering. 5:20 While I was, while I was doing my undergrad, I was fortunate enough to get a job at, at Medtronic, and it, it, you know, it really opened my eyes as to the opportunity. 5:30 I think at that point, you know, a lot of people in our, in our class and in our business were looking at, at, at supercomputers, at thin films. 5:41 You know, a lot of the chem Es were looking at, at things in the petroleum industry. Uh, still a lot of, a lot of people going into automotive. I mean, this is back in, you know, 19... 5:52 I'm dating myself, but, you know, back in 1984, '85. And having the opportunity to see the medical device industry really in some ways- A, a nascent industry at that time. It was a great opportunity for me. I... 6:07 When I started at Medtronic, I think that they were under 300 million in revenue- Wow... if you can imagine that. 6:15 And the first project I worked on was a pacemaker that was not rate responsive, it was Brady only, and was the size of a, of bigger than a hockey puck. So we've, we've come a long way from there. 6:30 But so I, you know, from Medtronic, I went and worked at St. Jude Medical, which at, in the early stages of when St. Jude was evolving into, you know, the, the preeminent mechanical valve company in the world. 6:44 Uh, I then worked for a while at, uh, TÜV, T-U-V, uh, Süd Deutschland, which is the largest notified body in the world. And so I was actually a regulator for a while, and then I went back into the startup space. 6:58 This is my third startup. I was at, uh, a company called St. Croix Medical, which was doing fully implantable hearing systems, and then I was at Acorn Cardiovascular, which was focused on heart failure. 7:11 And now I've, now I've been at, uh, Perceptys Medical, uh, which is developing innovative solutions, instruments that enable ear tube surgery for children to be done in an office a- without general anesthetic and, uh, without the risk of general anesthetic, without the cost of an operating room, and far more convenience. 7:34 Got it. And, and I... and I'm anxious to learn a little bit more about, uh, that technology and kind of what you guys are doing at, at, at Perceptive or Perceptys. But before we go there, Steve, I know... 7:44 I mean, y- you mentioned this, you know, that, that you've got a, a lot of... uh, a deep, deep level of experience, um, kind of on, on the regulatory side. What... 7:51 Out, out of curiosity, what, what sort of, um, what caused you to kind of pursue that path, you know, with, with, with more rigor, um, you know, dating back to your days at, at St. 7:59 Jude and then kind of moving on to, uh, to TÜV? Is there something, there something that intrigued you about that, uh, that field? Is it, is it the c- the complexity, the nuance? Um, what was it? Yeah. 8:10 That, that's a good question. Something I haven't thought about in a long time. When I was at Medtronic, and again, I was working... You know, I was really a tech, right? 8:19 I mean, I, I was not a degreed engineer yet, and I was working full-time whenever I could and part-time during the school year. 8:26 But one of the things that I was interested in in mechanical engineering, I did a lot of materials work and kind of combining materials and mechanical engineering, which, which meant I was interested in, in fracture mechanics and failure analysis, and a lot of the emphasis was on, was on cyclic fatigue. 8:45 And so that was a big emphasis of what I was studying in school. And you think back on this, in 1983, '84, the medical device, the MDR regs only came out in 1984. 8:59 And so I got pulled into some projects at Medtronic. Or projects is the wrong word. 9:05 I got pulled into some departments who were responsible for issuing reports based on the medical device, uh, reporting regulation because I had this background in failure analysis and was used to, you know, analyzing and writing up reports on, on honestly things that had failed. 9:24 And so that's how I got the kind of the exposure to regulatory. And when I started at St. 9:33 Jude, I was working on a project that was very unique, and I'd had a little bit of background in this project at, at Medtronic, and really nobody else in the world had kind of worked on what we were working on. 9:45 So I was kind of fortunate that I was kind of flagged for having a unique expertise. But then the more we worked on it, the more we realized that the biggest challenge that we had in the project was with the FDA. 9:58 And so I kind of evolved in that project from the development side to having to be the person to handle it from a regulatory perspective and, you know, wrote up the reports and, and did the submissions. 10:12 So it just kind of evolved into that. Then I ended up, you know, between Medtronic and, and St. 10:18 Jude is, you know, where you, you kind of develop a lot of your really core competencies, and mine were in, you know, development, clinical, regulatory, quality systems, some operations work and, and some, some of the early work in reimbursement. 10:34 Hm. And if you think about that, uh, those things are all the early v- the value creators for startup companies. Right. The things you need to get through. I wasn't... 10:44 I was not quite as interested in that time in, in kind of pure, in the pure line function of sales. Um, I, I kind of enjoyed the other work. 10:54 I did some marketing, but, you know, in terms of line function, it was really the operations side. I didn't do any sales work. 11:00 But all of that combination of work, you know, kind of led me down the path into startups because, again, that's what you're doing as a startup device company. Right. Right. Yeah. That's, that, that's super interesting. 11:11 Not, not bad core competencies to kind of fall into, so to speak, and really hone, you know, in your early, uh, early on in your, in your career. With that, with that- No, and it, it is interesting, Scott. 11:20 You know- Yeah... a lot of the people that are going into startups, a lot of them come out of finance. Yeah. A lot of them are out of, out of sales. I, I kind of came in from the other path, right? Mm-hmm. 11:30 I came in from the, from the path of the other functions in the company that you literally use to build the foundation, you know, of that, of that startup. 11:41 And so I, I, I had a little bit different path into the, into the startup space and the C-level positions in the startup space, but I, in a lot of ways, I think it was, uh, it was an ideal background Yeah. 11:55 Th- there, there's no doubt. 11:56 I often, you know, when I'm talking to, to, to friends that aren't, aren't as, uh, familiar with the medical device or the med tech space, I kind of always use the analogy that, that folks that are experienced with clin, reg and, and, uh, and, you know, engineering, R&D, et cetera, that's like the equivalent of, of developers, right, in the world of software. 12:13 You know, it, it's, it's, uh, it's, it's folks with those, those types of skillsets, you know, that can get, uh, that are crucial, you know, in the, in the early days of a, of a med tech company. 12:20 Yeah, you have to know the details- Mm-hmm... in the early days. Yeah. Yeah, no. It, it can't be something that's handed off. 12:26 You have to kn- you have to understand them enough to know which questions to ask at a minimum. Right. Right. And I, I am, you know, some of the, um, I spent... I, I'm, I consider myself largely a commercial guy. 12:36 Um, some- that's where I spent most of my career in med tech. 12:39 Um, but it's, it's probably one of the things that I would do differently if I had a chance to rewind the clock, right, is I would actually probably get more involved in that side of the business earlier on in my c- my, my career. 12:49 'Cause when I, when I did have that opportunity with, uh, with Covidien, it was, it was so, I mean, it was instrumental, you know, uh, in terms of, uh, getting my, getting my hands, you know, dirty, so to speak, with, uh, with a lot of the, um, especially the regulatory, um, side of the business, which I didn't really have a, a great level of familiarity with at the time. 13:07 So with that said, Steve, let, let's, let's move forward to kinda your, your time at, at Acorn. 13:11 I think, um, maybe I'm not sure entirely if you were in the process of kinda shutting that company down or pivoting, but what, what it... I mean, this was kind of back in the 2010, '11 timeframe. 13:20 What attracted you to, to Perceptis? 13:23 Kind of wa- walk us through that story and then we'll, we'll kinda jump into to some of the things that you've, you've learned, you know, over the past, uh, you know, 20 plus year career in, in med tech. 13:31 Well, I'll, I'll, I'll say this too. 13:32 When I, you know, when I was at Acorn, and we ended up selling the assets of Acorn c- to another company in the space, we didn't get as far as we wanted, but, you know, I was very proud of the work that we did there. 13:44 And, you know, I reminded the people there that, you know, in the startup space, you know, you don't always win, but every bit of work, every bit of science that we produced 13:56 expanded the field of heart failure and our understanding of it. 14:00 And we did some seminal work there in understanding, you know, reverse remodeling and what it meant and, you know, it became the gold standard, uh, in the space for understanding reverse remodeling of, of the heart at, you know, from, uh, dilated cardiomyopathy. 14:17 And so, you know, it, it, that's kind of a, a message going forward to everybody is that, you know, you're gonna have successes and you're gonna have failures. 14:26 In all likelihood, more failures in the startup space than successes. These are hard jobs and hard projects you're taking on. Uh, this is why you have to go to alternative investment capital. 14:37 Banks aren't gonna give you a loan. It's too risky. But everything that you're doing, you know, you're doing with your passion. 14:44 You're putting your, your heart and soul into it, and that's why people can succeed with it, and it also means that the work you're creating is important work. 14:53 It doesn't always end up that, that there's a monetization of that company, but you're almost always advancing what we know in healthcare. 15:01 And so that, so that's something that I'm, I'm proud of and kind of advice, uh, in my career for people as they're thinking about these jobs. 15:09 But as often is the case, you know, when you're working on one area, you're always thinking about other things. And I have a son with special needs. Uh, he was born with spina bifida. 15:22 He's a wonderful, wonderful kid, but, you know, his name is Noah, and, uh, non-ambulatory, had, you know, hydrocephalus, so he had a shunt, uh, had s- had rods in his back. He's probably had 25 surgeries. 15:36 And so I spent a lot of time around these types of kids, these children's hospitals, uh, these parents, and I recognized what a dearth there was of technology, medical device technology for these kids. 15:53 And, and the problem with pediatric medi- you know, pediatric devices is that there, there's never as much incentive to do this because oftentimes the markets are very small, and the regulatory and clinical obstacles, and even the commercial obstacles are higher, uh, because they're children. 16:12 And so in the back of my mind, I wanted to do something with pediatric devices, and that was kinda my goal after, after Acorn. And one of my neighbors, 16:22 I didn't even know what he did for a living, and I don't think he knew what I did for a living, and we'd got to know each other, and our kids were, you know, swimming in the pool, and we're watching them and having a beer on a summer night. 16:34 And it, you know, it turns out we figured out what each other did, and so we started talking and comparing notes and ideas, and he was very, very smart, very creative guy. His name is Dr. Mike Luschien. 16:45 And it also turned out we were from the same part of Northern Minnesota as a, as a coincidence. 16:51 So we got to know each other, sharing ideas, and, and we were both interested in this space, and that's where the idea for Perceptis came out of the idea that there had to be a better way to do ear tube surgery for children. 17:07 Uh, so, you know, adults are mostly done in the office. Children are done in the operating room because they can't tolerate the trauma of an office procedure that adults can sit through. 17:20 So, you know, we wanted to think about how we could, how we could do this and what we could do in terms of technology to enable these procedures to be done in the office in young children. 17:32 And so that- that's how we got started. It was literally, you know, two guys sitting around, you know, a pool, having a beer with our kids, watching our kids swim, and that's where the idea came from. 17:44 [laughs] That's, that's great. So like, a, a classic startup story then. And so was... You were... I mean, it, it sounds like you were like, you know, at, at the ground floor of, of, of Perceptis. 17:55 I mean, you're o- you're at, as I mentioned, uh, kind of at the, at the outset of this interview, you know, you're, you're s- president and CEO now, but you were, you know, a found, you know, you helped found the company in its, in its infancy Is that right? 18:05 Yeah. It's- Yeah... you know, what happened was is while I was still work... So this was back in 2008, 2009, and Mike Luschien and Keith Leland, who was a, a mechanical engineer designer, a great designer that Mike knew. 18:20 I had never met him before. And so he brought in, he had brought in Keith to help him on some other ideas that he was working on, and then the three of us, you know, collaborated on what became Perceptys Medical. 18:35 And the more we looked at it, the more we were interested in the idea of what we could do here. 18:40 But, you know, the big advantage for me is I, you know, those guys did a lot of the work, you know, kind of as a skunk work project. 18:47 At night, you know, Keith was, you know, cutting parts and developing prototypes in his garage. I... You know, we'd meet maybe once a month. 18:56 I'd, you know, I'd look over what they were doing, we'd kick around the strategies of how to do things, but I, I really didn't have too much time to, to do much out- outside of my Acorn job and, and with my young family and a child with special needs. 19:10 So those guys carried, I would say, carried the water with me being there more sporadically. 19:16 But a- as Acorn was, was being, uh, the sale of Acorn was being consummated, you know, we started talking about if I should take over once that was done, and we made the decision that we were gonna try it. 19:31 And, you know, real- literally for me, what it was was we were, we still were not certain if this was a technology, a licensing agreement, or a real company, and because we hadn't done enough work on the reimbursement side. 19:47 And so in 19:49 at the end of 2010, early 2011, you know, I jumped in as the CEO with the idea that we'd, we'd work really hard on this for four months on the reimbursement and then make a decision if this was kind of a no go, go, no go as a company. 20:04 And the more I looked at the reimbursement side, the more I became convinced that we had a great opportunity here. There was obviously coverage error, and there was coding in place. 20:14 And while the payment wasn't what we needed it to be, there was tremendous opportunity here in working with the payers because of the fact that there would be so much cost savings by moving, transitioning procedures from the operating room to the office. 20:32 And so about midway through 2011, we started, you know, really getting serious about raising capital, and we closed our early seed capital at the end of that year and converted from an LLC to a C corp and then, and then got busy starting in early 2012. 20:50 I, I lo- I love it. 20:51 Since we're on the topic of, of reimbursement, um, as you well know, Steve, that's like somet- you know, I, I consider it, you know, just as important, if not more important than, you know, a, a, a regulatory clearance or approval, right? 21:04 Because if your, if your device is approved by a, a regulatory body but, you know, no one gets paid to, to use it, you know, it's, it's like a, a, a tree falling in the forest, you know? Yeah. 21:14 And if no, no one's around to hear it, you know, it's like it, it, it never, it never fell. 21:17 So with that said, can you talk to us a little bit more about, um, your thoughts around, uh, coverage and reimbursement and really more specifically, like as a, you know, as a serial kind of med tech entrepreneur, would you take on a project with a device that didn't have, uh, you know, a CPT code in place or, you know, existing, you know, coverage at the payer level? 21:38 It's a really good question. Uh, let me, let me start first on the reimbursement side. It's the most important thing that we do. 21:46 You can't succeed without a successful development, manufacturing, reg clean strategy, and execution. 21:55 You know, you can't succeed without that, but even with those, if you do not have a successful strategy and ability to execute on reimbursement, you will not succeed. 22:06 It's where the rubber hits the road, uh, in our space. It's where, you know, it, it's where investors, you know, spend a lot of their time looking. They have to understand, you know, is there going to be adequate... 22:21 Is there gonna be coverage? If not, how long it's gonna take. If there's not codes, what can you have in the meantime, and then what kind of payment are you looking for? Because if the economics don't work, 22:33 you, you just, you're not gonna be successful commercially. Yeah. It's good to hear you say that, especially considering your, you know, your deep, you know, uh, reg and, and clinical expertise. 22:43 You know, for you to say that's, uh, that is the most important thing, it's not, it's not, uh, maybe, it's, it is the most important [laughs] important part. It is. Yeah. It's where the rubber hits the road. Yep. 22:53 You know, and it goes to the heart of our business. I mean- Mm-hmm... it, it's a... You know, we always think of, you know, the hospitals and the physicians as our customers, right? 23:03 But I mean, really deep down, I mean, is it the payers? Yeah. [laughs] For me, it certainly is. And, you know, it's, it's not easy to blaze new ground in reimbursement with payers. 23:18 I mean, they have economic priorities that they have to adhere to also, and it's, it's not always economic. I mean, it, you know, depend... 23:28 I, I think when you've got life-saving technologies that can save lives, I think that you can, you can take more chances. You know, large markets- Mm-hmm... 23:39 enabling, you know, high ASPs, you're, you're more willing to enter startup areas without having all of your reimbursement pinned down. 23:50 A lot of times some of that is because if they are life-saving technologies, they're often inpatient, and the DRG system is the, is the most fleshed out aspect of reimbursement in a lot of ways. Mm-hmm. Right? 24:04 But I think it gets more difficult when it's non-life-saving technologies and, you know, maybe things that are, are outpatient, right? Or, or home use or things like that. 24:15 I mean, it gets harder and harder because oftentimes the, you know, uh, the, the payments are smaller and smaller, and you have to make certain that the, that the incentives are there for everybody involved. 24:29 You have to understand the incentives, uh, of your stakeholders, and really what it gets down to is having a very clear idea what your value proposition is. 24:41 What are you providing that is gonna, is gonna provide value to the stakeholders? 24:47 Right, and I, I love what you just said because it re- it resonates with me, um, probably, uh, um, probably 'cause I, I, I literally just had a conversation, and by the time our interview is, is published that, uh, the interview with Nick Anderson will, will go live. 25:00 He's one of my, my favorite, uh, you know, healthcare economists, and we, we did a, you know, a whole, a whole podcast on, on this topic. And he, he said the same thing that you just, you just mentioned, Steve. 25:09 He said, "You know, the one thing I, I really try to stress with, you know, med tech startups that I'm consulting with is that, you, your, your customer is not, is not the hospital. It's not the physician. 25:19 Your customer is the payer." Which is true in a, in a, in a lot of ways, right? Um, I, I would, I would argue, you know, there's, there's multiple customers, right? You can't ignore either. 25:27 But so many, you know, startup entrepreneurs, um, you know, forget about, about, uh, you know, that, that crucial aspect, you know, that's, it's, it's- And there's very, and there's, and there's two very different camps of payers, right? 25:37 Mm-hmm. Yeah. The 506 and then Medicare, Medicaid. Right. So it's, it's, it's extremely challenging in that it, you know, it's... 25:47 You know, one of the jokes in our industry is that when you become an expert on reimbursement in one technology, you're an expert on one technology. 25:56 [laughs] It, it doesn't, it do- it means that you've figured out one small piece of the pie and, you know, that doesn't always translate to other technologies or spaces. You've, you, you have to keep learning. 26:09 You have to talk to a lot of people. You know, it's, it's a very challenging area that at times I think overwhelms people. Yeah, there's no doubt. 26:19 And, you know, it, before we kind of transition to some of these other, uh, other questions I, I, I've got down for you, if you had to sum up your thoughts, right, um, on, on insurance, you know, coverage and, and reimbursement in general, you know, is there one piece of advice that you'd give to other, other, uh, you know, med tech or health tech startup, you know, founders, entrepreneurs, leaders of those companies? 26:39 Is, is there something that you... You know, what, what's the one thing that you'd like to tell them, uh, about, on this topic? 26:44 Well, I, I think the one thing I'd say is when I look at the serial entrepreneurs that are really successful, you know, they have an ability to recognize value and, and a successful value proposition. 26:58 But before they get to that point, you know, they understand, they understand these different areas. 27:04 They understand what the regulatory path is likely to be, what the clinical path is likely to be, what the reimbursement path is likely to be, how much capital it's gonna take to get through these different phases. 27:19 And really, you know, trying to figure out, making certain that you understand within that value proposition, look at all of the stakeholders associated with the technology, and look and see how that technology is, is go- uh, how it's going to affect them. 27:36 You know, I mean, to, a- another way to look at it is, you know, you're gonna be making changes to flow and logistics and payments, and you have to look at all of the players and, and understand there may be... 27:50 Typically, whenever there's, there's change in the healthcare system, there's winners and losers. 27:56 It's like tax code, and you have to understand who the winners are, who the losers are, and understand what your story is for both. 28:04 So it really goes back to making certain you do the homework, and you have to divine your value proposition. Ah, that's good, uh, good stuff. 28:13 Um, let's transition to something that's, that's, uh, that's definitely in your wheelhouse, which we, we've, we already kind of, uh, chatted about, um, earlier on in this conversation, which is, which is regulatory, right? 28:23 Clin- clin- reg. You know, when you think about this, this topic, you know, and within the, with, you know, within the framework of, you know, of, of, of med tech startups, you know, is it, is... 28:32 in, in navigating some of those, those, those nuances with, with various regulatory pathways, whether it's a, you know, a non-clinical 510[k] or a clinical 510[k] or a De Novo, et cetera, you know, what, uh, you know, what one to two pieces of advice maybe would you give to other startup leaders? 28:48 I guess the advice I would have is from a regulatory standpoint, start early, you know, with the FDA, or look for every bit of information you can. 28:59 Look for i- if, if you're in, you know, the, the, the individuals who are, who are currently regulating that thing at the, your, your technology at the FDA, they're the obvious ones. But there's other people, too. 29:12 Look for other people in that space. Sometimes you can come across, you know, uh, people in the industry who have worked in that space before and navigated those regulatory waters and can give you advice on 29:25 not just the technology and, and how it's treated, but even the individuals, right, within the agency. 29:32 Sometimes you can be, uh, lucky enough to find former FDA-ers who worked in that space who are now working as consultants. 29:39 So you really have to put together an understanding of the background, how, how devices have been regulated, you know, who is doing the regulation and what are, you know, maybe their strengths and weaknesses. 29:55 So you have to start early, and, and don't just think it's, you know, we're gonna have one pre-sub meeting with the FDA, and that's all I need to worry about. 30:03 Look for every bit of information and understanding of that regulatory puzzle that you can find. Ah, that's, that, that's good stuff. 30:11 Um, and on your, uh, your, your kind of point about, you know, looking for those people that may, may, may have some experience at FDA in a p- in a particular division and may be consulting That's really interesting that you bring that up. 30:23 Has that, has that been, uh, I, I presume that you've, you've been successful in, in, in doing that with previous projects, that's wh- which is why you, you brought it up? Yeah. I, I, I have been. 30:33 I, you know, it's, uh, you know, sometimes those individuals, you know, don't yield much. Sometimes it's a few kernels, sometimes it's a lightning bolt. Uh, you never know. 30:43 You have to, you have to really understand all of the factors involved and, you know, it's not as simple as, "Oh, we did this meeting, we agreed to this, we submitted that, and everything was fine." 30:55 It, it rarely works out linearly. Hmm. That's, that's good stuff. Um, on, uh, in a, in a similar type of vein, let's talk a little bit about, you know, the clinical evidence, right? 31:06 That's, that's often going to be needed, uh, to, uh, you know, uh, uh, th- that you're gonna need to push forward, right? Down a certain regulatory pathway. 31:14 Um, when you're thinking about, you know, that, that roadmap, right? 31:18 That, that clinical roadmap, especially with, you know, with, with in- more innovative technology like, like you have at, at, you know, with the Hummingbird device. 31:25 You know, is there some, some best practices that, uh, that you can maybe speak to for other, other, uh, other startup, um, leaders that are trying to do the same thing? Yeah. 31:35 It's, you know, o- obviously clinical overlaps a lot with regulatory, right? Because your, your regulatory strategy's defining the amount of clinical data that you need and why. 31:45 But the other thing with clinical data is don't just think about it from a, a regulatory perspective, you know, think about it from a market perspective. 31:53 Even if you can, even if you can do, for example, a 510[k] and get substantial equivalence to a, a technology that's 18 years old, right? And only, and they only did 40 patients. 32:07 That may not be near enough for the market, and especially as, as things have become more mature and evolved. 32:15 And then you also need to think about when and how, are there any reimbursement economic parameters that need to be captured? So, you know, clinical has become very challenging. You need to... One of the... 32:29 I, I would say that the amount of detail and thought that goes into protocols today is orders of magnitude greater than, than 20 or 25 years ago. 32:39 You know, back then you'd collect the data, you know, I think the regulatory audiences, the advisory committees would always think, "Oh, it's pretty good data, you know, let's go ahead." 32:48 And n- that doesn't work that well today, you know? They're gonna look for holes and, you know, they're gonna look for risks that may have not been covered. So you need to really carefully think about your protocol. 33:02 Have you gotten everything into it? These are, these things you need to, you need to draft them, you need to talk to a lot of people, you need to percolate on it. You need to go back to it. Uh, almost no protocol... 33:14 I can't even think of a protocol that I've been involved with where you read it 6 or 12 months later and you're like, "Why did we write it this way? Why didn't we include this?" 33:23 You know, we should have done it a different way, you know? So that, those are some of the things you need to be, you need to be aware of. You know, y- you may not get a second chance at a clinical protocol. 33:35 Technologies fail oftentimes because they were evaluated incorrectly by the protocol. The design of the clinical study didn't get it done. The endpoint wasn't adequate. 33:48 And so, you know, in large companies, they may have the wherewithal to take another crack at it with a new study. As a startup, you're probably done. You're not gonna get another chance. Got it. 33:59 And when, when you think about some of these crucial functions inside a, a med tech startup, right? 34:03 Whether it's regulatory or clinical, et cetera, have you found it most effective to build out those functions internally? 34:10 Or at what, what inflection point of the company do you typically bring those resources internally versus relying on, you know, f- agencies or, or, or freelance consultants? I don't know if I have a perfect story. 34:21 It really depends on the, the complexity of the technology and what you're trying to accomplish with your data. 34:28 But, you know, I think you, you know, my thought is you're bringing those people in, uh, uh, if I'm gonna compare earlier versus later, always earlier, and then you augment it with outside resources. 34:40 You know, it's, i- if your, if your clinical studies are unsuccessful, your company's a failure. So I mean, you can't miss on this. Mm-hmm. You have to be su- sure that you're doing it correctly. 34:52 You've gotta make sure that your data analysis makes sense. You've gotta... 34:56 There's just so many factors involved in it you have to be careful with and you've gotta have somebody involved with it who, you know, you're gonna be, you're gonna be... 35:05 Oftentimes the endpoints are, are things that are, are proposed by societies or physicians or the FDA, you've gotta understand them. Sometimes they don't work. Sometimes you will be challenged. 35:18 You'll, you'll be asked by the FDA to come up with endpoints and metrics that have not been used before in clinical studies, right? Because, you know, they're trying to find more. 35:29 They're trying to learn more, and yet you have to know when to hold your ground. And because it is not the job of companies to develop new clinical endpoints or to g- come up with new evaluation methodology. 35:42 That is the job of the societies, and even if a company does it, n- you know, it's not gonna be regarded, uh, it's gonna be regarded as conflicted. 35:51 So you also have to know when to compromise and when to hold the line on what you can and can't do within your studies. Hmm. Reminds me of a, reminds me of a, um, a newsletter that I recently read. 36:05 I think that, uh, I think it was Mark Duvall's newsletter that, uh, what does he call it? The Duvall Client Report or something like that. Yes, yes. I'm, I'm sure you're familiar with Mark's writings. 36:13 And I know Mark very well, by the way. Yeah. Yeah, he's great. I mean, I, I, I've, I've, uh, enjoyed getting to know him over the past, gosh, five to 10 years. It's probably closer to 10 years now. 36:23 But he, he, he mentioned something very similar, right? When it comes to, you know, working with FDA. He sees, uh, you know, they see so many startups not, not able to hold the line, right? 36:32 And at, on, on the flip side, not being able n- or not willing to compromise where they, where they, where they should [laughs] to your point. So that's- That's the wisdom of experience, right? Yeah. 36:41 You have to know when to compromise and when you can't compromise. And you know, I mean, 36:47 y- you know, and, and I, and when you can't compromise, al- you know, make sure that FD understands and you're offering alternatives. So but, you know, as an example, I mean, we used two clinical research organizations. 37:01 We used, you know, multiple regulatory consultants, and the one that we used the most was DeVollum Associates. Hmm. Yeah. So we did a lot of work with Mark. Yeah. 37:12 And, you know, with all of these consultants, it's complete- it's a completely collaborative process. You're not going to them, handing them a blank sheet and saying, "Tell me how to do this." 37:21 You're figuring it out together. You know, you're using their experience and expertise along with your knowledge of that technology and what you're working on, you know? Yeah. 37:31 So that, it's a collaborative process that yields the best results. You have to work together and rely on, on the expertise of both, of both parties. Yep. Good stuff. 37:42 Um, I wanna be cognizant of, uh, o- of our, of our time and, and your, your schedule, Steve. 37:47 Before we transition to learning a little bit more about what's ahead for Perceptys in, in the, in the rapid fire questions, uh, let's briefly touch on raising capital, which is obviously a crucial, uh, kind of, uh, kind of area for any, any med tech startup. 38:00 So when you think about all of your experiences, you know, at, uh, you know, even, even dating back to pre-Acorn, right, and then to, to Acorn, and then the last, you know, 10 or so years at, at, at Perceptys, you know, can you, can you filter some, some advice down to, uh, to maybe one or two things when it comes to, uh, uh, you know, raising, successfully raising capital for a, a, you know, a health tech or med tech, uh, startup? 38:22 Okay. I'm, I'm thinking on that one because it is... Raising capital is very, very difficult. And with... You know, capital is gasoline for the engine. If you don't have capital, you can't go anywhere. It has to... 38:36 You know, it's, raising capital is not a milestone, but it sure feels like one. 38:40 So, you know, I've been fortunate that I've been, you know, working around a lot of experienced people in the space and working with different investment groups and, you know, learning a lot from all of these people, so that when, when I had to go out and raise the money on my own and lead that charge, I had a pretty good understanding of how to do it, but that still doesn't make it any easier. 39:04 Um, you need to have a really, really good... Me- remember before we were talking about all of the homework, uh, for entrepreneurs? If you're gonna convince people to put money into this, 39:16 uh, especially, you know, venture capitalists, I mean, these are very skilled, very competent groups and people that have a lot of deals to pick from. 39:26 And they understand, you know, where strengths and weaknesses are in each space. You have to understand your subject matter. So, you know, you're gonna have a lot of nos. Uh, you're gonna have to leave no stone unturned. 39:40 You have to look at every option. You're gonna look at non-dilutive financing, whether it's grants, other things. 39:47 I mean, oftentimes, you know, people turn down grants because they're like, "Well, you know, in two years we won't need that." Well, guess what? In two years, [laughs] 39:56 you didn't have the capital you need, and you're like, "Oh, man, I wish we'd have started that- [laughs]... that, you know, that grant two years ago when we said we didn't need it. 40:04 But you have to look at, you know, leave no stone unturned. Look at international markets, you know, uh, uh, international capital opportunities. Look at US. Look at non-dilutive opportunities. Talk to a lot of people. 40:19 Make certain that your story is clear and concise, and that the value proposition and the market are there. Again, you can have a, a cool technology, but that may not mean anything. 40:36 You can have a good market but not a good technology. You can even have a big market and a cool technology, but the value proposition when you pull into account economics is still not there. 40:46 So you've gotta really be able to explain the value proposition and make them confident that, you know, that how you're gonna execute or not on it with the use of proceeds, and why you're going to be successful if they invest in you. 41:02 Right. Uh, I, I'm thinking the, the, the title to this interview is gonna bo- is gonna be, you know, why, why you need to, uh, you know, master your, your... or hone your value proposition, right? 41:12 'Cause I, I hear that coming through, um, in a lot of the a- advice you're giving here, Steve. On that note, um, I think it's super... You know, your... 41:19 You know, hearing you explain kind of your, your thoughts on raising capital reminds me of a conversation I had with, uh, with Derek Herrera, uh, a few months ago. 41:26 He was, uh, the founder, um, ex-Marine, uh, Raider, former Marine Raider, founded S- uh, Spinal Singularity, or, uh, which is now Eurodev. 41:34 Uh, they moved, um, recently moved their headquarters from, uh, from here in, in Southern California to, to Minneapolis. 41:40 Um, but, uh, he mentioned the same thing when thinking about, uh, capital, uh, in that you have to, you have to think about these, this in stages, right? 41:47 Knowing that a grant, you know, you know, taking shots on goal for grant funding may, may, that may be a two or three-year process, right? 41:53 But in the interim, you know, raising, you know, a pre- a pre-seed round, raising a seed round. 41:58 And then, you know, maybe when, uh, maybe when you are successful with grant funding, that's at a, at a, at a crucial time where it'll, it'll provide a little bit of brid- you know, non-dilutive brid- uh, non-dilutive bridge, you know, between, uh, between the next round. 42:08 So, uh, you mentioned something very similar, you know, in thinking about, uh, not, uh... Mo- moving forward and giving, giving yourself plenty of opportunity, you know, in the event that, uh- Right. Look for every-... 42:18 you need some more gas... look for every resource you can, you know, to help you to get a success- to find successful terms, right? Mm-hmm. That work for both parties. 42:28 Look for, you know, uh, experienced people in the finance space who have been through this before and have raised capital before and, you know, have negotiated multiple term sheets. 42:41 From your counsel standpoint, be sure to look at, try to find, uh, a general counsel that also has some background in understanding term sheets and fundraising. 42:52 So you're looking for every bit of information that you could get, especially if you haven't been through it before. Right. That's good stuff. 43:01 So I think that, that's, uh, that, that provides kind of a nice transition to talk a little bit more about Perceptys and then, uh, and then, uh, uh, close things up with the, the rapid fire questions. 43:10 Um, so before we get to the latter, tell us a little bit more about where you're at with Perceptys and, and what you're kind of looking forward to over the next, uh, one to two years. 43:18 Well, you know, as I, as I explained before, what we've developed is a, is an instrument technology that enables ear tube procedures in children to be done in the office instead of in the operating room. 43:32 So let's think about, yeah, I keep, I keep pounding on value proposition, right? So what's the value proposition with this? Well, first of all, for parents, 43:42 they get to eliminate the risk of general anesthesia for their children for a minor procedure. 43:50 You know, virtually everybody in the space knows that there's increased risk, uh, with young children getting general anesthetic similar to older people getting general anesthetic. 44:00 And FDA even has a, a safety alert out on the use of general anesthetic in children under three for long durations or for multiple exposures. 44:10 So, you know, you can't eliminate general for surgeries in children that need it, but if you can come up with alternatives or ways to do it without general anesthetic where it can be done, that's a big win. 44:23 So for the parents, they get to, they get to save money. It's done in the office instead of the operating room, so they save money. 44:31 Even with insurance, almost everybody has a pretty significant out-of-pocket component that they have to take care of, and that can be, can be substantial. Um, they have the convenience of doing it in the office. 44:44 And then again, as we talked about, they eliminate the risk of the general for the children. Uh, for the otolaryngologist, the ENT, 44:52 the ability to provide something that their, that their customers or parents want to do a procedure in, in a less risky fashion, to be able to do it with their staff in their office, it, it can be a huge advantage over having to compete in a hospital for OR time. 45:12 And then for the payers, you have the enormous opportunity of being able to reduce the cost by transitioning procedures from the expensive operating room to the far less expensive point of service in the office. 45:26 So that's how we would think about value proposition for Perceptys Medical. Uh, we've done two very significant clinical studies. We have completely defined and understood the coverage, coding, and payment perspective. 45:40 And really what we're doing right now is we... And we've got our clearances for the FDA. Our studies have both been published, uh, in prestigious peer review journals. 45:51 And, you know, fortunately for us, the American Academy of Otolaryngology has issued a formal position statement in favor, endorsing in-office tubes for children as part of the shared decision-making process between parents and physicians. 46:09 So we're right here, and now what we've done is we've started a pilot, and what we're doing on the pilot is we're doing this without reps. 46:18 I don't wanna spend, you know, 10, 20, $30 million on reps until we fully understand the market and what we're trying to do, sir. So we're in the pilot. You know, we're, we're affirming ENT demand. 46:31 We're affirming parent demand. We're building out our playbook, right? And the playbook is, you know, how do you train? How do you, you know, everything associated with what is the collateral marketing material? 46:44 Uh, all of those things. And then finally, we need to define the payment mechanisms that are going to be adequate for the otolaryngologist to wanna do this. So that's the goal of our pilot. 46:56 We're involved with it right now. And, you know, we are, you know... Once we complete that pilot, we'll make a decision on the next step. 47:04 We can, you know, one of the obvious things would be that we would collaborate with a larger strategic partner. There's any different number of ways you can define that. 47:15 Uh, but, you know, collaboration with a, with a larger, with a lar- with a larger entity, uh, and a larger infrastructure. 47:22 Um, we're also looking at, you know, doing a Series C, uh, financing round and doing an ex- a significant expansion of the pilot and hiring reps and going out and doing an, a commercial expansion, uh, nationwide. 47:37 So that, that's kind of what we see coming up here over, you know, the next six months to two years. Got it. I, I, I love the fact that you're not only... 47:45 I mean, you've got obviously an in- an innovative technology, but you're in- you're kind of innovating on the commercial model too. 47:50 You know, and that's coming from a commercial guy, like I said before, kind of at the, uh, I, I think either it was the, the pre-call or maybe earlier on in this conversation that I'm, I'm a commercial guy. 47:59 But I love to see, I love to see, you know, med tech companies at your stage, you know, innovating when it comes to, you know, downstream commercialization, um, especially with a, a, you know, something like this, right? 48:08 Where you can, you can more easily kind of garner, um, demand, right? Patient demand. Yeah, we, we absolutely agree. 48:15 Unique demand And we do think it's an innovative, not only commercial model, but think of it as a capital model, right? 48:20 Because by doing this, we're able to reduce the amount of capital that we need, and of course, at some point we've got to be able to justify an acceptable IRR and ROI for our investors. 48:33 And, you know, the less dilution you have, the better those equations look. So, you know, we've, we've felt this way for a long time. We're very happy with our progress in the pilot. 48:45 And in fact, even prior to COVID- Uh, we had a competitor, uh, who in many ways they, they didn't follow the capital practice, but they did get acquired pre-revenue, which, you know, to us further affirmed the validity of our capital/commercial model that you don't always have to get the 10, 12, 15 million in revenue before you're considered an adequate collaboration partner by the strategics. 49:14 Right. Yeah, no, I, I, I'm right there with you. 49:16 And if you can validate, you know, validate that your, your model makes sense in a more kind of decentralized remote fashion like this, it makes all the sense in the world. 49:25 'Cause, you know, that, that, that strategic, you know, acquirer, you know, likely has the footprint, right? Likely has the commercial footprint, right? 49:32 And alls they need to see is some s- some strong signals and they can, they can potentially t- tuck- That's right... into their technology. Slowly and surely, strategics are coming in earlier. Mm-hmm. 49:40 Now, it's, you know, you can't, you can always find cases where it didn't occur and it's not fully across the board, but as a generality, 49:49 you know, I think everybody can see this, and it's something we've all been talking about in our ecosystem back since 2008 when the markets crashed, right? Where's the capital gonna come from? 49:59 We're in a fortunate position now in our space where there is a lot of capital available. You know, there is capital out there. 50:06 You know, the medical device space is, is a very good space to be invested in, but at the same time, the strategics are looking at opportunities to come in earlier too, because it can be beneficial for them in terms of pricing. 50:20 Right. Yep. Ab- absolutely. Makes a, makes a lot of sense. And is it... 50:23 You know, for, for those that wanna learn, uh, a little bit more about, you know, Perceptis and, and the Hummingbird technology, I'll link to it in the, in the show notes for this interview. 50:31 But, you know, for those that- Yeah... are just going to, to listen to this, uh, this conversation, is it, is the best, the best place just the website, Steve? Humming- Yeah... 50:38 hummingbird or you're telling- Go right to our website. Okay. Yep. That's right. Hummingbird eartubes dot com. That's correct. Yep. Got it. Again, I'll- That's correct. 50:45 There's a lot of information out there on our website. There's, there's a lot of information on LinkedIn that, you know, we've been posting. 50:52 And, and from a social media standpoint, there's, we're, we're doing a lot of postings on Instagram and Facebook also. Got it. Very good. Cool. Well, that's good stuff. 51:03 So with the, with the little time we have left, um, we'll, we'll transition and we'll, we'll close out this conversation with the, with the rapid fire questions. 51:09 [upbeat music] Hey everyone, it's Scott, and I wanted to briefly interrupt this interview to tell you a little bit more about Big Sky Biomedical, a med tech incubator that I co-founded earlier this year with a team of serial entrepreneurs and proven operators that all have a stellar track record of success. 51:24 One of our first companies, Fast Wave Medical, closed on an investment plus milestone-based acquisition agreement within six months of forming the entity. 51:30 I've been told that breaks some type of record within the med tech space, which is pretty cool. 51:34 We're actively working on several other portfolio companies, one of which is Crossfire Medical, that's focused on endovenous interventional therapies and has attracted its own share of attention. 51:43 This accelerator incubator model is definitely not a new concept, but most don't work for a variety of reasons. So here's how we're doing it differently at Big Sky. 51:51 First, our entire team has deep domain expertise in the interventional arena. This is the only sandbox we play in, which allows for some pretty intense focus. 51:59 Second, through our partnership with Switchback Medical, we're able to scale up our development efforts incredibly fast, which often shaves six to 12 months off a traditional R&D PDP. 52:07 Third, our team can leverage capital to kickstart projects quickly and efficiently. Going from zero to one is definitely within our wheelhouse. 52:14 If you're interested in learning more or potentially partnering with us, check out medsideradio.com/bigsky. Again, that's medsideradio.com/bigsky. Okay, let's get back to the rest of the conversation. 52:27 The first one, what's the single best piece of advice for other med tech or healthcare, uh, entrepreneurs? [laughs] I hate to be so redundant, but it's understanding value proposition. 52:38 [laughs] I kne- I knew that might coming. That, that is, that is, that's it in a nutshell. [laughs] I knew that might be coming. 52:43 Um, alternatively, I guess on the, on the, on the opposite side of that coin, you know, what's the biggest mistake, uh, that med tech or healthcare entrepreneurs should avoid? They didn't do their homework. 52:53 They didn't fully understand the market, the stakeholders, a- and didn't have an adequate Reg Glenn reimbursement plan to help them understand what they were, uh, likely to encounter as they're trying to develop and, and monetize a company. 53:09 Got it. All right, next question. What, uh, what book or educational resource, uh, have you recommended the most over the past, uh, year or so? You know, I'm, I'm, I'm a little embarrassed to say this. I, I don't... 53:21 I tend to skim business books more than I, I read every word. [laughs] I always get the feeling that a lot of them could have been done in, like, 20 pages and- [laughs] Yep... filler, right? 53:34 So I, I, I'll skim business books, but the things that I read, you know, tend to be more, you know, it, it's about leadership. Mm-hmm. I read a lot of biographies. I lead a lot of, uh, read a lot of history. 53:47 And I, and it's about trying to understand human nature and leadership and understand, uh, you know, what it takes to be a good leader, both in times that are difficult and in times that are, that are good, right? 54:00 You know, what are the differences? How do you separate yourself? So that's... It's not a very good answer for what you're looking for. 54:07 I don't have a single resource out there that I can point to, but really understanding leaders and the differences. 54:14 And the one thing that, you know, that it, to me, it always comes back to is you look at all the different styles and you look at the different challenges, but at the same time, you have to remember, you have to be true to yourself and who you are. 54:27 Trying to be someone that you're not and something that you're not in leadership is not gonna work. Hmm. That's good. That's good stuff. 54:33 And I, I'm right there with you, Steve, in terms of [laughs] skimming, skimming business books. 54:37 Uh, I, uh- You know, the avera-- in my opinion, the average kinda 200-page business book could be summarized, you know, in, in, uh, you know, 20 to 30 pages. Um. Yeah, that's right. And so I, I apologize to- [laughs]... 54:47 all those business book authors out there who spent that extra year filling in the 200 pages, but. [laughs] You know, it's gotta- It-... it's gotta be worth the, you know, the 15, $20 price tag, right? 54:57 You know, no one's- That's right... gonna buy that. Exactly. No one's gonna buy, you know, uh, that for, uh, for 20 pages of, uh, of content. So, uh, joking aside, it is. 55:05 You know, re- reading any sort of book is, is, you know, decent, uh, a, a decent time commitment. So that's why I, I personally like, like apps like Blinkist and, and those where it's, uh... 55:13 I'll, I'll read a summary there, and then, uh, if it's, if it's intriguing or compelling, I might, I might dive in and read the whole thing. Um- Agreed. Yeah. 55:20 All right, so last question, um, and I'll, I'll, I'll let, let you get back to your, your time there in Northern Minnesota. 55:25 But, um, Steve, if you had a chance to, uh, step in the old MedSider time machine and re- uh, rewind the clock to, to, you know, your mid or late 20s, uh, what's the one thing that you'd do differently from a, uh, a professional standpoint? 55:39 You know, my advice is, is to get as many experiences as possible. You know, don't put yourself in a position where you're just learning one area maybe or one technology. I mean, I... 55:51 O- one advantage I had was that opportunity to jump around, and I probably should have, I probably should have worked in sales, too, as a line function. 55:57 I, I chose not to, and it probably was something that I would, that I should have done. 56:02 I, I guess I've been fortunate that I've been able to, I guess, do the ultimate sales function, which is raise capital, without it, but it would have been useful for me to do it. You know, and don't just think... 56:13 You know, I mean, if you're in devices, don't be afraid to look at biotech and pharma. You know, if you're in pharma, don't be afraid to look at devices. 56:20 Look at all of these experiences you can get because they're only gonna make you better, more productive, and, and frankly, more hirable. Ah, that's a good, that's a good way to, to wrap up the interview. 56:31 So I know we're, we're short on time. 56:32 So Steve, I can't thank you enough for, uh, for joining the, the, the program and, and lending kind of, uh, lending some, a lot of, a lot of advice but also, you know, telling your, telling your story as well as what you're, what you, what, uh, you and your team are doing at, uh, at Perceptys with, uh, with, with the Hummingbird, uh, device or procedure. 56:48 So appreciate- Yeah, thanks, Scott... you for your time. I appreciate it. And, you know, keep an eye on, uh, on Perceptys and the Hummingbird. We're, we're very pleased with our progress and the feedback. 56:58 You know, honestly, from the parents and, and, and the otolaryngologists and the referring pediatricians and GPs has been overwhelmingly positive. So we really love what we're doing and the value we're providing. 57:11 Uh, that's, that, that's great to hear. And I'll, I'll link to, uh, to Steve's LinkedIn profile as well in the show notes for this interview. 57:16 So if you're, uh, you know, if you're interested in the, in the technology, the company, et cetera, you can, uh, reach out to Steve as well. So I'll have you hold on the, on the, on the line here, um, Steve. 57:26 But for those listening that have listened this far, two things that I, that I, I leave you with. 57:31 One is, um, if you're not already subscribed to the, uh, email newsletter, go to medsider.com and enter your email address. You won't be spammed. We'll let you know when the, uh... 57:39 The only time we'll, we'll, uh, we'll, we'll send emails to you is when the next, uh, interview goes live. And then if you enjoy this podcast, um, leave us a review on, on iTunes. 57:47 Uh, that's super helpful and, uh, and greatly appreciated. So with that said, uh, until the next, uh, MedSider interview, uh, goes live, everyone, uh, take care. [upbeat music]