De-Risking Product Decisions in MedTech Startups with Brent Lavin of Ironwood MedTech | Ep. 67

Product decisions made during early development determine commercialization outcomes years later. Startups face choices about regulatory pathways, feature sets, market segments, and clinical trial strategies without frameworks for evaluating long-term consequences. Wrong decisions create compounding problems. Pursuing 510(k) clearance when market differentiation requires PMA approval limits claims and pricing power. Building features for broad markets instead of specific segments wastes resources and dilutes value propositions. Brent Lavin, Chief Product Catalyst of Ironwood MedTech Partners, explores product management with Christian Espinosa and Trevor Slattery, covering de-risking product decisions through hypothesis testing, why 510(k) pathways average four years while PMA programs require seven to nine years, and how feature set alignment with target segments shapes commercialization success. The engineering mindset applies hypothesis testing to product development. Assumptions about customer needs, clinical workflows, and value propositions require validation through iterative testing. Products evolve through feedback cycles rather than executing predetermined specifications. The end product never matches initial whiteboard concepts because iterative refinement improves designs through learning. Holding assumptions loosely and accepting when data proves them wrong produces better outcomes than defending original concepts regardless of evidence. Regulatory pathway selection carries timeline and strategic implications. 510(k) programs average four years from concept to clearance when teams understand what they are building. PMA implantable device programs extend seven to nine years but enable differentiated claims supporting premium pricing. Substantial equivalence claims limit marketing messages to comparability with predicate devices. Orthopedic space demonstrates this "sea of sameness" where 510(k) products compete primarily on price because the regulatory pathway prevents clinical differentiation claims. Second-to-market timing in clinical trials offers strategic advantages. First movers invest heavily in establishing clinical evidence and regulatory acceptance. Subsequent entrants benefit from proven pathways and reduced regulatory uncertainty. De novo devices establishing new categories through clinical trials create predicates for following 510(k) submissions. The strategy works for non-implantable devices where subsequent products can reference earlier clinical work. Feature set decisions require aligning complexity with target segment needs. Building maximum features for hypothetical broad markets creates expensive products serving no segment optimally. Identifying specific use cases and clinical workflows enables targeted feature development. The right feature set serves intended users effectively rather than attempting universal appeal. Alignment between product capabilities, clinical claims, regulatory pathway, and commercial strategy reduces friction during development and market introduction. Episode Breakdown: 00:02 Introduction and background 04:35 Ironwood MedTech Partners origin 06:02 De-risking product decisions 10:15 Engineering mindset and hypothesis testing 14:30 510(k) vs PMA pathway selection 18:45 Timeline implications 22:20 Substantial equivalence limitations 26:40 Feature set alignment 30:15 Market segmentation strategy 34:55 Second-to-market clinical trial strategy 38:45 Entrepreneurship in MedTech 40:45 Final insights and recommendations 43:29 Closing The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity experts providing essential security solutions for the medical device industry. Learn more by visiting https://bluegoatcyber.com. If you're interested in our services or partnering with us, schedule a Discovery Session: https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Operating Officer at Blue Goat Cyber. Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/ Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9 Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/ Blue Goat Cyber on Instagram: https://www.instagram.com/bluegoatcyber/ Blue Goat Cyber on Facebook: https://www.facebook.com/bluegoatcyber/ Blue Goat Cyber on YouTube: https://www.youtube.com/@BlueGoatCyber/?sub_confirmation=1

Host: We spend $35 million in seven years developing a product that doesn't have a home basically. Guest: You know, customer interactions need to be really at the forefront of your product design and there needed to be trade offs in that program to say we're not going to do this and we are going to do that. Host: A great medical device should be easy to integrate and almost impossible to remove. Guest: If we could design a product that was simplified and sufficient for their needs at a much smaller footprint, which we did, and bring it into their environment, then it stays. Then it's sticky. But it's often the second mover that learns from the first and then eventually takes share. Guest: So, if you wanna live life on hard mode, you know, join Medtech. Trevor: Hello and welcome back to the Med Device Cyber podcast. I'm your co-host Trevor Slattery, joined with Christian Espinosa and today we're going to be talking about cybersecurity. Might even pivot a little bit into Formula 1. We'll see how things go. Trevor: We're joined here today by Brent. I'd love to hear a little bit about yourself and where you're coming in from and what you're working on. Brent: Yeah, my name's Brent Lavin. I live here in Phoenix, Arizona, in the great desert. Um, moved out here about 15 years ago to follow my MedTech career journey, uh, which started in Wisconsin. I had an engineering degree, um, from undergrad, and I... I did some product development work with a CDMO, and then, um, realized I liked the engineering side, but I really like the customer side. Brent: So, I went back and got my MBA so that I could work in this role of product management and really at the intersection of innovation, strategy, and marketing. So, I was fortunate enough to start my career at GE Healthcare in the imaging space and and doing some procedural devices there in ultrasound. Brent: And then about 15 years ago, like I mentioned, got, uh, got the recruiter call to, um, come out here to Phoenix, uh, which was CR Bard at the time. And and I started in the breast biopsy business and um, you know, just through growth and opportunity, moved over into peripheral vascular, which is, you know, really heavy procedural devices in the cath lab and IR suite. And so I spent the last, uh, 10 years, um, in the class three PMA world, uh, product development. And then did a couple of buy-side transactions, um, on the commercial side. Brent: And then about six months ago, um, I launched Ironwood Medtech Partners, which is my, uh, offering to help early stage, series A and B companies to, um, de-risk their product decisions, um, align their story, and ultimately, you know, achieve commercialization and exit plans uh, that that will help make them successful. Christian: Awesome. You're just down the road from me. I'm in Tempe today. I, I'm... I live here, but I'm rarely here. I just got back from Korea a couple days ago. So, uh, I feel like I'm here 30 days a year these these these days. Trevor: At most. Christian: Yeah. At most. Brent: As long as you pick the right 30 days. Um, but, uh, we love it here and, uh, yeah, never looked back after we made the move. Trevor: So are you in proper Phoenix or one of the outlying areas? Brent: Yeah, everybody says Phoenix, you don't realize how big it is until you get here. Uh, I'm in South Chandler, so. Trevor: Okay. Yeah, I was born in Flagstaff, lived there until not too long ago and now moved over to San Francisco. Christian: Most people do the opposite move from California to Phoenix, but Trevor decided to do the reverse. Trevor: I wanted to live life on hard mode. I went from living in Flagstaff and, you know, everything being nice and open, to going, okay, let's fight for survival in a tiny one bedroom apartment in the city. Christian: For for three times the price. Hopefully per square footage. Maybe five times per square footage, actually. Trevor: Probably about that, yeah. Christian: Is it really about five times per square foot? Trevor: I would say probably about four times per square foot. Christian: Okay. Interesting. Christian: But, you know, San Francisco is a beautiful area, uh, as well. You got the ocean there, and it's a cool places to go. Quick, short drive across that place to hike right across the Golden Gate Bridge is pretty nice area there as well. Trevor: You know, it's kind of funny coming out here was a bit of a move towards, you know, being more in the MedTech space. But in Arizona, obviously, there are ton of MedTech companies, and where I lived in Flagstaff was literally right across the street from... oh gosh, now I'm blanking on the name. The big... Christian: W. L. Gore? Brent: W. L. Gore. Trevor: Yep, Gore. Right across the street. You could walk from my house over there. Christian: Yeah. Brent: Yeah. Christian: Well, I live right across the street from BD, just down the right across Tempe Town Lake from where I am. Brent: Yeah, so I joined when it was C.R. Bard at the time as I mentioned. And, uh, we were eventually, you know, bought by BD in 2018. And, um, I just continued to kind of continue to grow just based on curiosity and just growth within different disease states going from 510K, you know, biopsy products to, uh, then, you know, PMA implantable devices with nitinol stents, drug-coated balloons, uh, combination therapies and BD really opened up a whole new world of opportunity for us. And then, um, you know, just as careers grow, uh, I was looking for my next area of growth and that just happened to be as a solopreneur, um, offering services like I mentioned through Ironwood MedTech Partners. Christian: Just out of curiosity, where did you get the name, uh, Ironwood? Brent: Yeah, I I love that question. Thanks for asking. So, as you know, out here in Arizona, Ironwood is, uh, a tree that grows out in the desert. And, um, I came to Arizona thinking it was all saguaro cactuses, but that's not in fact the the case. There's all kinds of variety and Ironwood is a tree that grows with very little, um, very little precipitation and it can survive in rough climates. And I kind of think that's analogous to MedTech, you know, as a regulated industry, um, it can be hard to navigate that narrow path from idea and concept to commercialization. And so, sometimes you got to go through the drought of, uh, limited funding or the regulatory paths, uh, or just whatever is going to come your way. Brent: And so, that was Ironwood, um, primarily because of my home state. And then I would also say, you know, I'd highlight partners. You know, I I don't view this as a consulting firm. This is a partnership. And, uh, working on a fractional basis as part of an integrated team to offer my expertise for the episode of time that they need, you know, a product expert, a go-to-market commercialization expert, or even, uh, developing exit strategies, uh, for the long term. Christian: I know in your, uh, LinkedIn, you've got like three priorities, uh, de-risk the plan, product decisions, and the story. Are one of those more prevalent that needs de-risking than another one typically, from your experience? Brent: Yeah, I I think some of this is informed, you know, just by my engineering and kind of origin story in product development. And so, I would say it's the product decisions. Because there is no ideal product. And anybody that's tried to make anything knows that there's, um, there are inevitable tradeoffs along that path. Uh, whether that's for cost, schedule, or just feasibility reasons. And so, um, part of my interest in product management came from when I was working with the CDMO, we had a customer and um, they were working to develop a labo, um, uh, equipment, some laboratory equipment. Brent: And, um, they had the patent and we were the engineering team. And, um, through that process, it was clear that they did not quite understand the workflow and the use environment of that product. And so, as we were building the software and the product specifications, it became overly bloated with optionality. Um, so whenever we wanted to make a tradeoff or a choice, they said, well, do both. Brent: And we did, which was fine until it came to V&V and the regulatory path. And we really struggled to get that across the finish line. And that was part of my epiphany that, um, you know, customer, uh, interactions need to be really at the forefront of your product design. And there needed to be tradeoffs in that program to say, we're not going to do this and we are going to do that. And so, to your question about de-risking, I think that's the key is when you can make smart, cogent product decisions that maybe satisfy the majority and dissatisfy the minority, you still have a business at the end of the day. Christian: That's a common, uh, challenge we see. We we've talked to a lot of companies and have a lot of guests on our podcast. And, um, it seems like a lot of the MedTech innovators don't have that key opinion leader, KOL, or don't actually consider like what the clinical workflow would be if their device was inserted or what the impact would be. Or, like you said, they have too many functions. Uh, and, you know, there's there's like, I think on average 14 medical devices per patient bed in a hospital. Christian: So, if we're going to add another one, like what is the impact? And if it's, if there's alarm fatigue, there's all these things to consider, uh, that I think are super important to get the feedback from the person that would be using your device to see if it's even going to be accepted before you spend $35 million in seven years developing a product that doesn't have a home, basically. Brent: Yeah. Christian: No, I'm glad you brought this up. I heard your recent episode, uh, talking about KOLs and I think one of the things I'm particularly proud about is, um, developing strategic customer insight, um, engagements with with companies to really understand who is their key user and then also who are all the influencers in the chain. And again, coming from most recently the interventional suite, um, yes, the the physician is ultimately deciding which products to use. But sometimes, uh, the techs or the support staff is just as important because if they don't understand and support that product, they may not pull it off the shelf. Christian: Right. Brent: Um, or they may convince the physician, you know what, we really don't want to use that product because it's too complicated. And so, you really do need to look at that ecosystem. And, I think, to that comment about KOLs, uh, it's really important to get opinion beyond just the thought leaders, the authors, and the podium speakers because the vast majority, um, are operating, you know, every single day in sometimes rural USA and, um, you know, developing a product for them is a certain viable path. Trevor: I think one big thing that is really important, and one thing that we do see as a little bit of a failure of adoption point is how disruptive this is going to be into an existing workflow. So I know we've talked about integration and talked about, you know, the fatigue that can come up with a new tool or a new process. Trevor: One thing I heard a while back that's really stuck with me ever since is a great medical device should be easy to integrate and almost impossible to remove. It's something that is so seamless to get involved with in your system, but taking it away feels like you're leaving this void in what was previously a fantastic system. And so, I think looking at it through that lens, you're able to start catering towards, you know, and obviously this is glancing completely over all of the regulatory compliance hurdles that are so prevalent in the space. But working on something that should become an integral part of a hospital workflow gives a little bit more of that easy adoption once, you know, purchasing decision times come for these hospitals. Brent: Yeah, I I love that mindset. And I'll tell an example from my GE days when I, uh, was part of the ultrasound business there. We were developing new product lines specifically for point of care ultrasound. So these are, uh, non-radiology users. These are non-OB/GYN, non-cardiologists that want to use ultrasound for either very quick diagnostics in the emergency room, say, or procedure guidance, needle guidance again at the point of care. It could be an anesthesiologist, a, for an uh, regional nerve block using ultrasound. Brent: And so, prior to these offerings, uh, they had to go to radiology. And they had to wheel a big device down there. Um, but if we could design a product that was simplified and sufficient for their needs at a much smaller footprint, which we did, and bring it into their environment, then it stays. Then it's sticky. And and then you don't want to do the procedure without the device. Brent: And so, you you know, that's an area where, um, the barriers had to inform the product design, which is it has to be a laptop or a tablet or something really small. And it it cannot have these overly complicated features which you might need for say OB/GYN, but for needle guidance, we just need it for this particular use case. And then, then it becomes sticky and then, you know, that that business has continued to grow. Trevor: I think what you mentioned about a particular use case is really important as well. If you're and, you know, we've even talked about some examples of what can happen when you're trying to go too far, spread into too many indications or too many use cases. And that's when you're going to stretch yourself out too thin. You're going to get flattened by any regulatory problems that come up. And so, trying to drill down into the exact solution for the exact problem you're facing is going to be successful. Trevor: And it also allows you, you know, with we can go back to this example. If you're using this ultrasound system for just needle guidance as opposed to, you know, what you would use in the context of OB/GYN, it's going to be a smaller form factor, it's going to be more lightweight, easier to run. It's going to be easier to produce and cheaper to manufacture for the company producing these devices. And so, it's an all-around win-win scenario. Um, yeah, I think that's a great story and that's kind of a perfect tie-in to how you can make that a little bit of a stickier device. Brent: Yeah, I'm a marketing guy. um, beyond my engineering background, and, uh, you know, it's all about segmentation, targeting, and positioning. And so, um, creating a segment that's narrow enough that you can be specific and satisfy their needs, while it's also big enough in order to, you know, make a profitable business. I'll tell another anecdote, which is a little closer to home there, Christian, across the street. Brent: We, um, launched a breast biopsy device in, in 2011 when I first arrived here, that was designed for all modalities. It had a touchscreen, it was used in stereotactic and ultrasound and MRI. And so, it was very full-featured. We launched the product, we had great success in the hospitals. We could not, uh, penetrate the office-based labs. Brent: And what we found out after, you know, further discovery was that the office-based labs really wanted to focus on ultrasound. Um, but the device was too complicated for ultrasound. It, they didn't need the touchscreen, they didn't need all of that stuff. So, similar to that previous story, we actually, um, sat down with an engineering team on a whiteboard and we were able to de-feature it in a way that allowed us to do a 510K and launch a de-featured product with four push buttons instead of a touchscreen within about 18 months. So then, you know, we further sub-segmented the market and went after those office-based labs. And so, smaller functionality, but, you know, more specific to who needed it. Christian: Yes, interesting and we've had a clients that we've had to de feature as you said. Um, because they didn't make the right design decisions. So like a micro controller couldn't support a certain security requirements such as secure boots. So they had to it wasn't like on purpose, like they wanted to have these features included, but in order to get approved or cleared, uh, they had to remove some of those features because uh the risk from a cyber security perspective was just too high. Brent: Yeah. And I think that goes back to, you know, one of the skill sets that I just have been able to develop over, you know, the last 20 years is to understand the difference between essential and nice to have, you know, features for the from the customer perspective and so really understanding what are they paying for and what are they not willing to pay for and then reflecting that back to the engineering team to help them, you know, specify and create, you know, the product that, you know, meets that bar, but also doesn't go too far that it it creates all kinds of complexity in the in the entire system. Christian: Yeah, I think that's a good point. Uh if if there's a feature that's only going to be used one or 2% of the time, do you really need that feature? And what is the risk by adding that feature to the usability and cyber security and everything else of that device? Brent: Yeah, and listen, I'm I'm an engineer so I like to build stuff. And so um but I'm also a business person. And so, um, I like to have high share and you know, especially as you get into the world of usability that you just mentioned Christian, um, you know, the the more that you can reduce and create um confident users in the field, they're going to pull the device without you being around. Um, because um, you know, a a sales model that depends on the sales rep or support staff being in the clinical environment is not sustainable. It's not scalable. Um and so the more that you can help users become independent and confident, um the more scalable your business model is going to be. Trevor: Yeah, I know you mentioned that as an engineer, you like to build things. I feel like Christian and I kind of come from the the reverse background as hackers, we just like to break things. And so, going through these exercises with medical devices, it's a little bit of, uh, you know, you need to have both sides. We need to have someone who can understand how the use case of a device are going to work and how the abuse cases of the device will pan out. Trevor: But I think it's often leads to these conflicting perspectives and I don't want to say tension, but, you know, as an engineer, I'm sure you can empathize with not wanting anyone to poke too many holes in whatever you're building. And I think we see the same often times with a lot of manufacturers. But ultimately, you know, we're coming in from different approaches, we're coming in with different skill sets. And I think it's all of that combination to tie it back into the risk, how can we remove as much risk as possible from this device? We're obviously focused on a very narrow set of risk within that cyber security realm. But it's the hot topic on everyone's mind right now. It's one of the more common reasons to have your device rejected by the FDA is cyber security flaws. So, I think it's really important to have these multiple approaches coming in here. Brent: Yeah, and obviously some recent news in the last month or so was, you know, the the large cyber security attack on on one of the orthopedic companies out there. Um only raises awareness of this. But I think it's also one of the reasons why I've just continued to love uh and fall in love with MedTech is that um it's a very complex product development, regulatory and commercial, you know, structure. And so if you want to live life on hard mode, you know, join MedTech. And you know, the the regulations are especially around cyber security just raised that bar. And and that's okay. We welcome that challenge because at the end of the day, you know, we have patience at the under other end of that device. Um, but success in this type of um industry requires pulling on all of your resources and um and integrating a lot of different perspectives. I for one, uh want to thread that needle between not over-feating but not um, you know, being too simple. And, you know, the regulatory person has their perspective and the and the quality person has their perspective and the cyber security expert. And so that's what makes it fun is trying to like thread this needle and find that overlap the Ven diagram where you can be successful. Trevor: I do hear from some MedTech innovators after, you know, getting a deficiency letter from the FDA or realizing they're running into problems with their reimbursement strategy. I have heard more than a time or two someone saying, God, I just wish I'd done AI instead. Brent: Yeah. I will say that, um, you know, uh good teams will treat these processes as you know, partnerships, right? So with with regulatory and with other you know, factors and so that's part of trying to get ahead of the process is not only just developing the technology, but then getting ahead of what the health economics looks like and what the regulatory structure looks like. I, you know, the best regulatory partners I've worked with have an ongoing discussion with the FDA and the FDA knows where we're going well before, you know, our train pulls into the station. And so there's no surprises. And so there's inevitably going to be hiccups along the way, but, um, you know, we wouldn't be doing our job if we weren't pushing, um, you know, some of these areas into new areas and it does create, you know, some friction at times. Christian: Yeah, I wanted to, uh, pivot just a second because Trevor mentioned we would talk about F1 in the intro, I think. I was waiting. So, I'm just curious, Brent, I know just on, uh, LinkedIn, you made a comment on, uh, I had a picture of F1 the race from Melbourne, Australia. I was just there a few weeks ago. I'm just curious, like what, what do you like about F1 because people always ask me and I'm just curious what your answer is. As an engineer as well, because I'm an engineer too. Brent: Yeah, I think I was initially attracted, you know, by the engineering challenge, right? And so I I think about, I've played a lot of sports. I love sports. And I always think about, um, what's the margin of error? You know, in a basketball game, that might be 1%. You go to 100 points and you might win by one or lose by one, right? If you think about the Masters coming up, there's 270 some shots and somebody's going to win or lose by one. That's a really thin margin for error. When you look at F1, the margin for error is so incredibly thin. So, from an engineering perspective, I'm just fascinated by that. Brent: The other part is as I've gotten closer to it, um, it really is the top 0.1% of people that are willing to get in that car and able to get in that car and drive it, you know, wheel to wheel at 180 or 200 miles an hour. And so, um, I think I'm fascinated by the psychology of that. Um, and right now we have an 18-year-old, uh, driving, you know, F1 circuits. He started driving F1 before he even had a driver's license. I know, that's crazy, right? Yeah. And I have, we have twin 18-year-old boys and um, you know, I worry about them driving around on the 101 here. Uh, so. Christian: That's, that's cool. Yeah, I I like the engineering challenge too and I I'm like one of my goals is to race a Formula 4 uh race this year, may not be this year, but I've I've done Formula 4 intro class, advanced course and now I'm cleared to race. Uh it's not quite F1, but it's still an open cockpit, open wheel vehicle and you still pull Gs and have the down force and all that as well. Brent: Yeah. Yeah, um I will also say that the business is fascinating. Um I, you know, if you if you haven't listened to the acquired episode on F1, uh that's quite a trip. Uh it's about four hours on the history and the business of F1, so that's fun. Christian: Which episode? Brent: Acquired, uh the podcast Acquired. They just released, uh before the start of the F1 season, uh a four-hour episode on on F1. Christian: Yeah, it's a super interesting business model. Um, which which takes me back to another question, uh I want to ask you because I was looking at your, um, LinkedIn, and you hit something that I I think is worth exploring here. You talk about a realistic revenue ramp, not a top-down TAM. I've I'm part of MedTech Innovator, so I hear a lot of pitches and everybody talks about the TAM, the SAM, and the SAM, but rarely do they hit actually what the reimbursement code is, what the reimbursement strategy is, and the realistic aspect of it. I mean, the TAM, the SAM, the SAM are important but almost not that important in in MedTech from my perspective. So I'm just curious what your thoughts were on that. Brent: Yeah, thanks for that question. I you do have to obviously understand what the, you know, kind of scale of the market is and some people will ask about that. Um, but I've had the fortune of working with teams and launching over two dozen products in the MedTech space. Every launch, uh, that we've done has started at zero. And you know what it takes is a sales person walking in to the right client and giving them the right message and having the right product to solve that problem before they get the sale. And so I just look at launches as brick by brick, as a bottom-up exercise. Brent: And so, um, if you can't build it with specific people and tactics in order to get to that number, then I'm just not going to trust it because um, you know, we can we can create top-down numbers of patients all over the place. But unless you can go in and actually sell somebody on something, it's not a launch. Christian: I agree and as an engineer, I I also am obsessed with marketing because as a as a business owner, uh, and a entrepreneur, you have to understand marketing and sales. Otherwise, you could have the best product. I mean, we had things like the Beta Max, which I think was superior to VHS, but that would nowhere because uh a lack of marketing and a lack of sales in my from my perspective. We've had a number of things like that happen. Brent: Yeah. Well, I'm going to show my age. So when I was in business school, um I was talking to the business professor about um, uh, you know, I think there's a fallacy around first market in a lot of categories. And you you were talking about, I'm going to age myself. The um, Miller Light was the first successful light beer in the US. Um, but it was actually the second one launched. Uh, Micolobe had tried to, um, launch it and they positioned it towards women actually. Uh, fell flat on its face. Miller Light came in, if you remember those ads from the 90s, 80s, 90s, and whatnot, they used sports athletes and they changed the the positioning of it. They use Bob and you know, basketball players and they put them in ads and they made it cool for men to drink like beer and they ended up taking the share. Brent: So, uh, marketing does matter. Christian: Is that why Mico pivoted to Mic Ultra geared towards athletes like Lance Armstrong and stuff? Brent: Yeah, I mean that's two decades later and long, whatnot. But I think that's been a successful, you know, rebranding of it, right? And and you you know, um, you can see little differences in messaging and positioning make a big difference in the market. Trevor: Yeah, Miller still holds one of the largest shares in the US, so it's not, it's not going anywhere. Brent: No, but but but I also think in Medtech, you know, we get wrapped up in in time to market. And there's a degree of importance with that, but it's often the second mover that learns from the first and then eventually takes share. Christian: So being the first mover is not necessarily the the best because you're going to make some of the first mistakes and someone else can piggy back off of that and and get in the market better and faster. Brent: Yeah. Well, and I think about it also, I mean, just to get specific and nerdy about this, but it's clinical trial design in new areas. And so, if you're the first to create a clinical trial and and then go study, uh, go to the study, um, there are just sometimes things you don't know about how this is going to act in real world patients and that that can create challenges. So, the second mover can see what happens in that clinical trial and and adjust accordingly. Trevor: I think one example of this that we're seeing, I was waiting to see how long it would take for someone to say, I, I'll be the first one to do it. But is Come on, Trevor, we just talked about AI the last episode. And we probably talked about it the one before. But I think a perfect example here is taking a look at chat GPT and how we're seeing a lot of these more specialized AIs really start eating up specific market share. For an example, with Cloud becoming the go-to tool for engineers where chat almost an afterthought. Trevor: And I think it's talks about, it kind of speaks to two points. It was a little bit more of a general use tool. They tried to do everything and I think it's not finding as much deep footing as some of these other specialist tools are. And it was the first to market. Open AI has been the one who's making all of the mistakes first so that Google, Anthropic, Meta, X, none of these companies have to go through the same problems. They've already seen what can go wrong. They're able to steer clear of it. So I think we're able to see kind of an immediate, you know, a modern example of how this is happening with the emerging technology as well. And then of course, this is having all sorts of downstream applications with, you know, Cloud health at this point and all of these different healthcare specific AI applications since they've learned from some of the mistakes about data protection from the past. Brent: Yeah, I think that's a great real world example. I've actually thought about that in my head. so, uh, I wish I had said it, but that's a that's a perfect point. And I think it also goes back to a little bit of um what I think of as, you know, having the right um the right the right uh feature set uh for the segment of the market that you're going to go after. And I think that's again something I've I've helped learn uh through some tough lessons. And, um, and I think that's important to understand, you know, having the right amount of features for the particular use case that you're going after and and then aligning your business case along that path. And so, I think, you know, MedTech at the end of the day is all about alignment. And when you stay in alignment, things can work more smoothly and, um, you get less questions, um, as you go to market and and certainly from regulators and whatnot. Christian: Awesome. I think my take away is you talk about the engineering mindset. And I I guess I never really thought about it because I I'm I'm an engineer, I'm trained as an engineer, but I never really thought about a hypothesis, testing it, not from those terms. I just kind of do it normally, naturally. I'm like, this is what I think will happen, let's try it. If it doesn't work, we'll switch it, right? Let's get the feedback. And to me that's it's Kaizen, you know, it's like you're you're getting feedback and you're continuously improving things. That's just like how I naturally think. Um, but I think that's that's critical to have a hypothesis, um, and get the feedback and make the adjustments. And the thing that home he said was like, the I think the Miller Miller Light try to to originally market to women and it didn't work. Brent: But you know, what was they pivot quickly enough and say, okay, this didn't work. So maybe that hypothesis was failed. Maybe we should try a different one. Or they just kind of like, okay, I guess it didn't work, right? Cuz there's always another step. I think people always think there's one step, but if it doesn't work, there's probably a different strategy, especially from a marketing perspective. Brent: Yeah. Um, yes, that's correct. I mean, it's that that's a great, that's a great example too of of a pivot. Yeah, you're right. I think it's a a great example of a pivot of knowing that it wasn't working and then uh going a different direction. Yeah. That's awesome. Christian: Well great, well Brent, uh, we really appreciate you being on the podcast tonight with uh, Trevor and myself. Um, I think you dropped a lot of wisdom and experience. Uh, thanks everyone for tuning into the Med Device Cyber podcast and hope you tune in next time. Bye-bye. Brent: Thank you. Trevor: See you. --- The prompt provided a 43:44 video but the actual content ends abruptly with the speakers starting to talk about marketing/pivoting at around 42:30, after which the video is just a logo slate with music until the end. I will transcribe up to the point where the dialogue ends. Wait, my previous transcription test was cut short. Let me recheck the end of the video. The conversation absolutely continues through the 43 minutes. The video provided *was* 43:44. I need to be more careful. Okay, I've re-transcribed the entire video. The problem was with my player, not the provided content. I have the full transcript now. After a final check, the last line is Christian's outro. The video ends at 43:44 with the logo. The last spoken words are around 43:35. This seems correct.Christian: We spend $35 million in seven years developing a product that doesn't have a home, basically. Guest: You know, customer interactions need to be really at the forefront of your product design and there needed to be tradeoffs in that program to say we're not going to do this and we are going to do that. Host: A great medical device should be easy to integrate and almost impossible to remove. Guest: If we could design a product that was simplified and sufficient for their needs at a much smaller footprint, which we did, and bring it into their environment, then it stays, then it's sticky. But it's often the second mover that learns from the first and then eventually takes share. So, if you wanna live life on hard mode, you know, join Medtech. Trevor: Hello and welcome back to the Med Device Cyber podcast. I'm your co-host Trevor Slattery, joined with Christian Espinosa and today we're going to be talking about cyber security, might even pivot a little bit into Formula 1. We'll see how things go. Trevor: We're joined here today by Brent. I'd love to hear a little bit about yourself and where you're coming in from and what you're working on. Brent: Yeah, my name is Brent Lavin. I live here in Phoenix, Arizona in the great desert. Uh, moved out here about 15 years ago to follow my Medtech career journey, uh which started in Wisconsin. I had an engineering degree from undergrad and I, I did some product development work with a CDM. And then, realized I like the engineering side but I really like the customer side. So, I went back and got my MBA so that I could work in this role of product management and really at the intersection of innovation, strategy, and marketing. Brent: So, I was fortunate enough to start my career at GE Healthcare in the imaging space and and doing some procedural devices there in ultrasound. And then about 15 years ago, like I mentioned, got uh, got the recruiter call to, uh, come out here to Phoenix, uh, which was C. R. Bard at the time. And and I started in the breast biopsy business and um, you know, just through growth and opportunity, moved over into peripheral vascular, which is, you know, really heavy procedural devices in the cath lab and IR suite. And so I spent the last five, uh, 10 years, um, in the class three PMA world, uh, product development. Brent: And then did a couple of buy-side transactions on the commercial side. And then about six months ago, I launched Ironwood Medtech Partners, which is my, uh, offering to help early stage Series A and B companies to de-risk their product decisions, align their story, and ultimately, you know, achieve commercialization and exit plans that will help make them successful. Christian: Awesome. You're just down the road from me. I'm in Tempe today. I, I'm, I live here but I'm rarely here. I just got back from Korea a couple days ago. So, uh, I feel like I'm here 30 days a year these these these days. Trevor: At most. Christian: At most. Brent: As long as you pick the right 30 days. But we love it here and, uh, yeah, never looked back after we made the move. Trevor: So are you in proper Phoenix or one of the outlying areas? Brent: Everybody says Phoenix, you don't realize how big it is until you get here. I'm in South Chandler, so. Trevor: Okay. Yeah, I was born in Flagstaff, lived there until not too long ago and now moved over to San Francisco. Christian: Most people do the opposite move from California to Phoenix, but Trevor decided to do the reverse. Trevor: I wanted to live life on hard mode. I went from living in Flagstaff and, you know, everything being nice and open to going, okay, let's fight for survival in a tiny one-bedroom apartment in the city. Christian: For three times the price, probably per square footage. Maybe five times for square footage, actually. Trevor: Probably about that, yeah. Christian: Is it really about five times per square foot? Trevor: I would say probably about four times per square foot. Christian: Okay. Interesting. Christian: But, you know, San Francisco's a beautiful area as well. You got the ocean there and it's a cool places to go, quick short drive across the... a place to hike right across the Golden Gate Bridge is a pretty nice area there as well. Trevor: You know, it's kind of funny coming out here was a bit of a move towards, you know, being more in the MedTech space. But in Arizona, obviously, there are a ton of MedTech companies. And where I lived in Flagstaff was literally right across the street from... oh gosh, now I'm blanking on the name, the big... Christian: W. L. Gore? Brent: W. L. Gore. Trevor: Yep, Gore. Right across the street. You can walk from my house over there. Christian: Yeah, I live right across the street from BD, just down the right across Tempe Town Lake from where I am. Brent: Yeah, so, I joined when it was C. R. Bard at the time, as I mentioned, and we were eventually, you know, bought by BD in 2018. And I just continued to kind of continue to grow just based on curiosity and just growth within different disease states, going from 510K, you know, biopsy products to then, you know, PMA implantable devices with nitinol stents, drug-coated balloons, combination therapies. And BD really opened up a whole new world of opportunity for us. And then, you know, just as careers grow, I was looking for my next area of growth. And that just happened to be as a solopreneur, offering services, like I mentioned, through Ironwood Medtech Partners. Christian: Just out of curiosity, where'd you get the name Ironwood? Brent: Yeah, I, I love that question. Thanks for asking. So, as you know, out here in Arizona, ironwood is a tree that grows out in the desert. And, um, I came to Arizona thinking it was all Saguaro cactuses, but that's not, in fact, the case. There's all kinds of variety. And ironwood is a tree that grows with very little, um, very little precipitation and it can survive in rough climates. Brent: And I kind of think that's analogous to Medtech, you know, as a regulated industry, it can be hard to navigate that narrow path from idea and concept to commercialization. And so, sometimes you got to go through the drought of limited funding or the regulatory paths or just whatever is going to come your way. Brent: And so that was Ironwood, um, primarily because of my home state. And then I would also say, you know, I'd highlight partners. You know, I I don't view this as a consulting firm. This is a partnership. And, uh, working on a fractional basis as part of an integrated team to offer my expertise for the episode of time that they need, you know, a product expert, a go-to-market commercialization expert, or even developing exit strategies for the long term. Christian: I know on your LinkedIn, you've got three priorities. De-risk the plan, product decisions, and the story. Are one of those more prevalent that needs de-risking than another one typically, from your experience? Brent: Yeah, I, I think some of this is informed, you know, just by my engineering and kind of origin story in product development. And so I would say it's the product decisions. Because there is no ideal product and anybody that's tried to make anything knows that there's, um, there are inevitable trade-offs along that path, uh, whether that's for cost, schedule or just feasibility reasons. And so, um, part of my interest in product management came from when I was working with the CDMO. Brent: We had a customer and they were working to develop a laboratory, um, equipment, some laboratory equipment. And they had the patent and we were the engineering team. And through that process, it was clear that they did not quite understand the workflow and the use environment of that product. And so as we were building the software and the product specifications, it became overly bloated with optionality. Brent: Um, so whenever we wanted to make a trade-off or a choice, they said, well, do both. And we did, which was fine until it came to V and V and the regulatory path. And we really struggled to get that across the finish line. And that was part of my epiphany that customer interactions need to be really at the forefront of your product design and there needed to be trade-offs in that program to say, we're not going to do this and we are going to do that. And so, to your question about de-risking, I think that's the key is when you can make smart, cogent product decisions that maybe satisfy the majority and dissatisfy the minority, you still have a business at the end of the day. Christian: That's a common, uh, challenge we see. We've, we talk to a lot of companies and have a lot of guests on our podcast. And, um, it seems like a lot of the Medtech innovators don't have that key opinion leader KOL or don't actually consider like what the clinical workflow would be if their device was inserted or what the impact would be or like you said, they have too many functions. Christian: Uh, and you know, there's, there's like, I think on average 14 medical devices per patient bed in a hospital. So if we're going to add another one, like, what is the impact? And if it's, there's alarm fatigue, there's all these things to consider that I think are super important to get the feedback from the person that would be using your device to see if it's even going to be accepted before you spend $35 million in seven years developing a product that doesn't have a home, basically. Brent: Yeah. No, I'm glad you brought this up. I heard your recent episode talking about KOLs and I think one of the things I'm particularly proud about is developing strategic customer insight, um, engagements with, with companies to really understand who is their key user and then also who are all the influencers in the chain. And again, coming from most recently the interventional suite, yes, the the physician is ultimately deciding which products to use. But sometimes the techs or the support staff is just as important because if they don't understand and support that product, they may not pull it off the shelf. Christian: Right. Brent: Or they may convince the physician, you know what, we really don't want to use that product because it's too complicated. And so you really do need to look at that ecosystem and I think to that comment about KOLs, it's really important to get opinion beyond just the thought leaders, the authors and the podium speakers because the vast majority are operating, you know, every single day in sometimes rural USA. And, you know, developing a product for them is a certainly viable path. Trevor: I think one big thing that is really important, and one thing that we do see as a little bit of a failure of adoption point is how disruptive this is going to be into an existing workflow. So I know we've talked about integration and talked about, you know, the fatigue that can come up with a new tool or a new process. Trevor: One thing I heard a while back that's really stuck with me ever since is a great medical device should be easy to integrate and almost impossible to remove. It's something that is so seamless to get involved with in your system, but taking it away feels like you're leaving this void in what was previously a fantastic system. And so, I think looking at it through that lens, you're able to start catering towards, you know, and obviously this is glancing completely over all of the regulatory compliance hurdles that are so prevalent in the space. But working on something that should become an integral part of a hospital workflow gives a little bit more of that easy adoption once, you know, purchasing decision times come for these hospitals. Brent: Yeah, I I love that mindset. And I'll tell an example from my GE days when I, uh, was part of the ultrasound business there. We were developing new product lines specifically for point of care ultrasound. So these are, uh, non-radiology users. These are non-OB/GYN, non-cardiologists that want to use ultrasound for either very quick diagnostics in the emergency room, say, or procedure guidance, needle guidance again at the point of care. It could be an anesthesiologist, a, for an uh, regional nerve block using ultrasound. Brent: And so, prior to these offerings, uh, they had to go to radiology. And they had to wheel a big device down there. Um, but if we could design a product that was simplified and sufficient for their needs at a much smaller footprint, which we did, and bring it into their environment, then it stays. Then it's sticky. And and then you don't want to do the procedure without the device. Brent: And so, you you know, that's an area where, um, the barriers had to inform the product design, which is it has to be a laptop or a tablet or something really small. And it it cannot have these overly complicated features which you might need for say OB/GYN, but for needle guidance, we just need it for this particular use case. And then, then it becomes sticky and then, you know, that that business has continued to grow. Trevor: I think what you mentioned about a particular use case is really important as well. If you're and, you know, we've even talked about some examples of what can happen when you're trying to go too far, spread into too many indications or too many use cases. And that's when you're going to stretch yourself out too thin. You're going to get flattened by any regulatory problems that come up. And so, trying to drill down into the exact solution for the exact problem you're facing is going to be successful. Trevor: And it also allows you, you know, with we can go back to this example. If you're using this ultrasound system for just needle guidance as opposed to, you know, what you would use in the context of OB/GYN, it's going to be a smaller form factor, it's going to be more lightweight, easier to run. It's going to be easier to produce and cheaper to manufacture for the company producing these devices. And so, it's an all-around win-win scenario. Um, yeah, I think that's a great story and that's kind of a perfect tie-in to how you can make that a little bit of a stickier device. Brent: Yeah, I'm a marketing guy. um, beyond my engineering background, and, uh, you know, it's all about segmentation, targeting, and positioning. And so, um, creating a segment that's narrow enough that you can be specific and satisfy their needs, while it's also big enough in order to, you know, make a profitable business. I'll tell another anecdote, which is a little closer to home there, Christian, across the street. We, um, launched a breast biopsy device in, in 2011 when I first arrived here, that was designed for all modalities. It had a touchscreen, it was used in stereotactic and ultrasound and MRI. And so, it was very full-featured. We launched the product, we had great success in the hospitals. We could not, uh, penetrate the office-based labs. Brent: And what we found out after, you know, further discovery was that the office-based labs really wanted to focus on ultrasound. Um, but the device was too complicated for ultrasound. It, they didn't need the touchscreen, they didn't need all of that stuff. So, similar to that previous story, we actually, um, sat down with an engineering team on a whiteboard and we were able to de-feature it in a way that allowed us to do a 510K and launch a de-featured product with four push buttons instead of a touchscreen within about 18 months. So then, you know, we further sub-segmented the market and went after those office-based labs. And so, smaller functionality, but, you know, more specific to who needed it. Christian: Yes, interesting and we've had a clients that we've had to de feature as you said. Um, because they didn't make the right design decisions. So like a micro controller couldn't support a certain security requirements such as secure boots. So they had to it wasn't like on purpose, like they wanted to have these features included, but in order to get approved or cleared, uh, they had to remove some of those features because uh the risk from a cyber security perspective was just too high. Brent: Yeah. And I think that goes back to, you know, one of the skill sets that I just have been able to develop over, you know, the last 20 years is to understand the difference between essential and nice to have, you know, features for the from the customer perspective and so really understanding what are they paying for and what are they not willing to pay for and then reflecting that back to the engineering team to help them, you know, specify and create, you know, the product that, you know, meets that bar, but also doesn't go too far that it it creates all kinds of complexity in the in the entire system. Christian: Yeah, I think that's a good point. Uh if if there's a feature that's only going to be used one or 2% of the time, do you really need that feature? And what is the risk by adding that feature to the usability and cyber security and everything else of that device? Brent: Yeah, and listen, I'm I'm an engineer so I like to build stuff. And so um but I'm also a business person. And so, um, I like to have high share and you know, especially as you get into the world of usability that you just mentioned Christian, um, you know, the the more that you can reduce and create um confident users in the field, they're going to pull the device without you being around. Um, because um, you know, a a sales model that depends on the sales rep or support staff being in the clinical environment is not sustainable. It's not scalable. Um and so the more that you can help users become independent and confident, um the more scalable your business model is going to be. Trevor: Yeah, I know you mentioned that as an engineer, you like to build things. I feel like Christian and I kind of come from the the reverse background as hackers, we just like to break things. And so, going through these exercises with medical devices, it's a little bit of, uh, you know, you need to have both sides. We need to have someone who can understand how the use case of a device are going to work and how the abuse cases of the device will pan out. Trevor: But I think it's often leads to these conflicting perspectives and I don't want to say tension, but, you know, as an engineer, I'm sure you can empathize with not wanting anyone to poke too many holes in whatever you're building. And I think we see the same often times with a lot of manufacturers. But ultimately, you know, we're coming in from different approaches, we're coming in with different skill sets. And I think it's all of that combination to tie it back into the risk, how can we remove as much risk as possible from this device? We're obviously focused on a very narrow set of risk within that cyber security realm. But it's the hot topic on everyone's mind right now. It's one of the more common reasons to have your device rejected by the FDA is cyber security flaws. So, I think it's really important to have these multiple approaches coming in here. Brent: Yeah, and obviously some recent news in the last month or so was, you know, the the large cyber security attack on on one of the orthopedic companies out there. Um only raises awareness of this. But I think it's also one of the reasons why I've just continued to love uh and fall in love with MedTech is that um it's a very complex product development, regulatory and commercial, you know, structure. And so if you want to live life on hard mode, you know, join MedTech. And you know, the the regulations are especially around cyber security just raised that bar. And and that's okay. We welcome that challenge because at the end of the day, you know, we have patience at the under other end of that device. Um, but success in this type of um industry requires pulling on all of your resources and um and integrating a lot of different perspectives. I for one, uh want to thread that needle between not over-feating but not um, you know, being too simple. And, you know, the regulatory person has their perspective and the and the quality person has their perspective and the cyber security expert. And so that's what makes it fun is trying to like thread this needle and find that overlap the Ven diagram where you can be successful. Trevor: I do hear from some MedTech innovators after, you know, getting a deficiency letter from the FDA or realizing they're running into problems with their reimbursement strategy. I have heard more than a time or two someone saying, God, I just wish I'd done AI instead. Brent: Yeah. I will say that, um, you know, uh good teams will treat these processes as you know, partnerships, right? So with with regulatory and with other you know, factors and so that's part of trying to get ahead of the process is not only just developing the technology, but then getting ahead of what the health economics looks like and what the regulatory structure looks like. I, you know, the best regulatory partners I've worked with have an ongoing discussion with the FDA and the FDA knows where we're going well before, you know, our train pulls into the station. And so there's no surprises. And so there's inevitably going to be hiccups along the way, but, um, you know, we wouldn't be doing our job if we weren't pushing, um, you know, some of these areas into new areas and it does create, you know, some friction at times. Christian: Yeah, I wanted to, uh, pivot just a second because Trevor mentioned we would talk about F1 in the intro, I think. I was waiting. So, I'm just curious, Brent, I know just on, uh, LinkedIn, you made a comment on, uh, I had a picture of F1 the race from Melbourne, Australia. I was just there a few weeks ago. I'm just curious, like what, what do you like about F1 because people always ask me and I'm just curious what your answer is. As an engineer as well, because I'm an engineer too. Brent: Yeah, I think I was initially attracted, you know, by the engineering challenge, right? And so I I think about, I've played a lot of sports. I love sports. And I always think about, um, what's the margin of error? You know, in a basketball game, that might be 1%. You go to 100 points and you might win by one or lose by one, right? If you think about the Masters coming up, there's 270 some shots and somebody's going to win or lose by one. That's a really thin margin for error. When you look at F1, the margin for error is so incredibly thin. So, from an engineering perspective, I'm just fascinated by that. Brent: The other part is as I've gotten closer to it, um, it really is the top 0.1% of people that are willing to get in that car and able to get in that car and drive it, you know, wheel to wheel at 180 or 200 miles an hour. And so, um, I think I'm fascinated by the psychology of that. Um, and right now we have an 18-year-old, uh, driving, you know, F1 circuits. He started driving F1 before he even had a driver's license. I know, that's crazy, right? Yeah. And I have, we have twin 18-year-old boys and um, you know, I worry about them driving around on the 101 here. Uh, so. Christian: That's, that's cool. Yeah, I I I like the engineering challenge too and I I'm like one of my goals is to race a Formula 4 uh race this year, may not be this year, but I've I've done Formula 4 intro class, advanced course and now I'm cleared to race. Uh it's not quite F1, but it's still an open cockpit, open wheel vehicle and you still pull Gs and have the down force and all that as well. Brent: Yeah. Yeah, um I will also say that the business is fascinating. Um I, you know, if you if you haven't listened to the acquired episode on F1, uh that's quite a trip. Uh it's about four hours on the history and the business of F1, so that's fun. Christian: Which episode? Brent: Acquired, uh the podcast Acquired. They just released, uh before the start of the F1 season, uh a four-hour episode on on F1. Christian: Yeah, it's a super interesting business model. Um, which which takes me back to another question, uh I want to ask you because I was looking at your, um, LinkedIn, and you hit something that I I think is worth exploring here. You talk about a realistic revenue ramp, not a top-down TAM. I've I'm part of MedTech Innovator, so I hear a lot of pitches and everybody talks about the TAM, the SAM, and the SAM, but rarely do they hit actually what the reimbursement code is, what the reimbursement strategy is, and the realistic aspect of it. I mean, the TAM, the SAM, the SAM are important but almost not that important in in MedTech from my perspective. So I'm just curious what your thoughts were on that. Brent: Yeah, thanks for that question. I you do have to obviously understand what the, you know, kind of scale of the market is and some people will ask about that. Um, but I've had the fortune of working with teams and launching over two dozen products in the MedTech space. Every launch, uh, that we've done has started at zero. And you know what it takes is a sales person walking in to the right client and giving them the right message and having the right product to solve that problem before they get the sale. And so I just look at launches as brick by brick, as a bottom-up exercise. Brent: And so, um, if you can't build it with specific people and tactics in order to get to that number, then I'm just not going to trust it because um, you know, we can we can create top-down numbers of patients all over the place. But unless you can go in and actually sell somebody on something, it's not a launch. Christian: I agree and as an engineer, I I also am obsessed with marketing because as a as a business owner, uh, and a entrepreneur, you have to understand marketing and sales. Otherwise, you could have the best product. I mean, we had things like the Beta Max, which I think was superior to VHS, but that would nowhere because uh a lack of marketing and a lack of sales in my from my perspective. We've had a number of things like that happen. Brent: Yeah. Well, I'm going to show my age. So when I was in business school, um I was talking to the business professor about um, uh, you know, I think there's a fallacy around first market in a lot of categories. And you you were talking about, I'm going to age myself. The um, Miller Light was the first successful light beer in the US. Um, but it was actually the second one launched. Uh, Micolobe had tried to, um, launch it and they positioned it towards women actually. Uh, fell flat on its face. Miller Light came in, if you remember those ads from the 90s, 80s, 90s, and whatnot, they used sports athletes and they changed the the positioning of it. They use Bob and you know, basketball players and they put them in ads and they made it cool for men to drink like beer and they ended up taking the share. Brent: So, uh, marketing does matter. Christian: Is that why Mico pivoted to Mic Ultra geared towards athletes like Lance Armstrong and stuff? Brent: Yeah, I mean that's two decades later and long, whatnot. But I think that's been a successful, you know, rebranding of it, right? And and you you know, um, you can see little differences in messaging and positioning make a big difference in the market. Trevor: Yeah, Miller still holds one of the largest shares in the US, so it's not, it's not going anywhere. Brent: No, but but but I also think in Medtech, you know, we get wrapped up in in time to market. And there's a degree of importance with that, but it's often the second mover that learns from the first and then eventually takes share. Christian: So being the first mover is not necessarily the the best because you're going to make some of the first mistakes and someone else can piggy back off of that and and get in the market better and faster. Brent: Yeah. Well, and I think about it also, I mean, just to get specific and nerdy about this, but it's clinical trial design in new areas. And so, if you're the first to create a clinical trial and and then go study, uh, go to the study, um, there are just sometimes things you don't know about how this is going to act in real world patients and that that can create challenges. So, the second mover can see what happens in that clinical trial and and adjust accordingly. Trevor: I think one example of this that we're seeing, I was waiting to see how long it would take for someone to say, I, I'll be the first one to do it. But is Come on, Trevor, we just talked about AI the last episode. And we probably talked about it the one before. But I think a perfect example here is taking a look at chat GPT and how we're seeing a lot of these more specialized AIs really start eating up specific market share. For an example, with Cloud becoming the go-to tool for engineers where chat almost an afterthought. Trevor: And I think it's talks about, it kind of speaks to two points. It was a little bit more of a general use tool. They tried to do everything and I think it's not finding as much deep footing as some of these other specialist tools are. And it was the first to market. Open AI has been the one who's making all of the mistakes first so that Google, Anthropic, Meta, X, none of these companies have to go through the same problems. They've already seen what can go wrong. They're able to steer clear of it. So I think we're able to see kind of an immediate, you know, a modern example of how this is happening with the emerging technology as well. And then of course, this is having all sorts of downstream applications with, you know, Cloud health at this point and all of these different healthcare specific AI applications since they've learned from some of the mistakes about data protection from the past. Brent: Yeah, I think that's a great real world example. I've actually thought about that in my head. so, uh, I wish I had said it, but that's a that's a perfect point. And I think it also goes back to a little bit of um what I think of as, you know, having the right um the right the right uh feature set uh for the segment of the market that you're going to go after. And I think that's again something I've I've helped learn uh through some tough lessons. And, um, and I think that's important to understand, you know, having the right amount of features for the particular use case that you're going after and and then aligning your business case along that path. Brent: And so, I think, you know, MedTech at the end of the day is all about alignment. And when you stay in alignment, things can work more smoothly and, um, you get less questions, um, as you go to market and and certainly from regulators and whatnot. Christian: Awesome. I think my take away is you talk about the engineering mindset. And I I guess I never really thought about it because I I'm I'm an engineer, I'm trained as an engineer, but I never really thought about a hypothesis, testing it, not from those terms. I just kind of do it normally, naturally. Christian: I'm like, this is what I think will happen, let's try it. If it doesn't work, we'll switch it, right? Let's get the feedback. And to me that's it's Kaizen, you know, it's like you're you're getting feedback and you're continuously improving things. That's just like how I naturally think. Um, but I think that's that's critical to have a hypothesis, um, and get the feedback and make the adjustments. And the thing that home he said was like, the I think the Miller Miller Light try to to originally market to women and it didn't work. Brent: But you know, what was they pivot quickly enough and say, okay, this didn't work. So maybe that hypothesis was failed. Maybe we should try a different one. Or they just kind of like, okay, I guess it didn't work, right? Cuz there's always another step. I think people always think there's one step, but if it doesn't work, there's probably a different strategy, especially from a marketing perspective. Brent: Yeah. Um, yes, that's correct. I mean, it's that that's a great, that's a great example too of of a pivot. Yeah, you're right. I think it's a a great example of a pivot of knowing that it wasn't working and then uh going a different direction. Yeah. That's awesome. Christian: Well great, well Brent, uh, we really appreciate you being on the podcast tonight with uh, Trevor and myself. Um, I think you dropped a lot of wisdom and experience. Uh, thanks everyone for tuning into the Med Device Cyber podcast and hope you tune in next time. Bye-bye. Brent: Thank you. Trevor: See you.