Why MedTech Needs More Than Approval with Michael Branagan Harris of HealthTech Strategies | Ep. 68

About "Why MedTech Needs More Than Approval with Michael Branagan Harris of HealthTech Strategies | Ep. 68"

"Why MedTech Needs More Than Approval with Michael Branagan Harris of HealthTech Strategies | Ep. 68" is episode 1 of The Med Device Cyber Podcast, published on April 30, 2026, featuring Michael Branagan Harris (Founder, HealthTech Strategies, HealthTech Strategies). Host Christian Espinosa and the guest dig into the practical realities of shipping and maintaining secure connected medical devices - the kind of detail you only get from people who have done the work.

From the show notes: "MedTech companies often assume a better product should naturally win. In reality, healthcare systems change slowly, purchasing paths are layered, and the best technology can still stall if the story behind it is weak. Evidence has to do more than prove safety or performance. It h..."

This episode is tagged Penetration Testing. Browse those topic hubs for related conversations, or jump into the full episode catalog to find more on FDA premarket and postmarket cybersecurity, SBOM management, threat modeling, and medical device penetration testing.

MedTech companies often assume a better product should naturally win. In reality, healthcare systems change slowly, purchasing paths are layered, and the best technology can still stall if the story behind it is weak. Evidence has to do more than prove safety or performance. It has to explain why a payer should spend, why a provider should switch, and why the patient outcome is worth it. That is why market access cannot be treated as a late stage commercial task. It sits across product design, evidence generation, reimbursement planning, pricing logic, and market entry sequencing. Once teams understand that, they stop treating adoption as something that happens after approval and start building toward it from day one. The most useful framework here is simple and sharp. A technology has to work for patients, providers, payers, and the product business itself. In the United States, physician economics can add another layer. Miss one leg of that structure and the whole commercial case becomes unstable. For founders, the real takeaway is hard but useful. If you cannot explain who benefits, why they benefit, and how that benefit is proven, market access will remain a bottleneck no matter how promising the innovation looks. Episode Breakdown 00:00 Welcome 02:06 Why market access starts with the problem 09:02 Evidence beyond the trial mindset 12:45 Why some solutions fail despite good technology 14:16 The three part decision logic in market access 17:17 The patient outcome story 19:30 The four and five P framework 22:43 Why country economics matter 28:36 First market strategy 32:23 AI and digital health in different systems 33:52 The future of home based care 36:42 The price and access tradeoff 42:08 Final thoughts 48:30 Close 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

Sell the problem you solve not the product. We're all trying to solve population health problems. We all want to bring a technology into a population health problem, whether that's benign prostatic hyperplasia, liver cancer, there's no point in inventing things unless they solve a health care problem. Focusing on the problem as opposed to focusing on the solution. That is something that can really make or break a Medtech company. From a market access perspective, is there a particular market that's easier to access. You're having to really try and drive change by solving problems and understanding what's really going on in those countries. Healthcare systems are all different and it's trying to look at the evidence of what the thing does, how well it does and so which healthcare system would be able to benefit the most. Hi, welcome back to another episode of the Med Device Cyber podcast. Today we have a special guest coming all the way from the United Kingdom, Mike. And Mike has been in the industry for quite some time, so as it'll be interesting to hear his perspective on strategy and how a medtech innovator can be bringing a device to market effectively and efficiently. So maybe uh, we can kick it off to Mike and give a little background about yourself and then we can get started. Before I turned it over to you, I I will say I met Mike at Avamed, the conference in San Diego last year. And Melissa, my wife was wearing a Red Bull F1 jacket. And I thought Mike hated us because we were advertising Max Verstappen and he likes to say Max for smashen. So I thought he would never talk to us again, but somehow we became friends in the whole anti-Max and pro-Max uh, discussion. So I'll throw it over you, Mike, and you get a little intro and then we'll we'll get started here. Guest: An intro into Formula One or an intro... Yeah. No, that was a lot of fun that actually. And it's funny because we've been following each other around the world ever since, haven't we, uh, you guys. But yeah, so including Dubai and we got out there at the right time, didn't we? We'll got in and out at the right time. But yeah, so I'm Mike Branagan Harris. I've been in medical devices for 37 years, you can tell it, I've got no hair, unlike you guys, I'm very jealous. Host: 37 years, very precise. Guest: 37 years, yeah, 37 years of medical devices. So actually started selling wound dressings and various basic things and ended up um bringing in lots of technologies, endovascular technologies, endolaparoscopic technologies, ran a vascular company that was a big success, a company called Venus Medical that a lot of people may have heard of, a San Jose-based company that transformed the way that uh varicose veins or reflux or venous reflux is treated. So, um, was very successful in stopping the health care system in the UK called the NHS or National Health Service, um, took them away from doing a procedure they've been doing for decades that caused a lot of pain and discomfort and brought in a new treatment and we basically stamped out that treatment that had been around for many, many decades in this country. Within three years we'd stopped it by introducing new treatments. So I sort of learned ways of getting things paid for in our healthcare system. and a lot of it was around selling the problem you solve not the product. So how do we go into healthcare systems and solve problems instead of selling products. And understanding data, health economics brought me to the point that I set up a company in 2010 called Device Access UK which I sold a couple of years ago. And Device Access UK, using my existing network of companies and contacts um that I've built up over many years, I, I spent over two and a half years of my time in North America between sort of Minneapolis, Boston, California, Texas, Colorado, um finding really, really good companies and people, talking to them about bringing their technologies to the UK and European markets and actually helping to get over 58 approved for use in our healthcare system here in the UK. So my world's around finding the best things in North America, generally, and uh helping companies to develop their clinical economic evidence to get the thing paid for as quick as they can and survive. And and it's been a really, really great uh, you know, uh, 15, 15 years doing that, um working with so many technologies. And that brought me into programs like Medtech Innovator. So I'm a value coach for Medtech Innovator. I'm about to fly to LA for four days, um, which is going to be interesting as I've just come back from Singapore. But um, but yeah, 144 companies are going to be pitching their device to me and I'm judging them with a lot of other judges on the Medtech Innovator's radar scheme. So I really like meeting the innovators and I really like working with, with them and working with trusted partners like you at Blue Goat and others that we, we know, Franklin House and others that um that do a good job and and help to uh, reduce the risks for these companies and help them to get their technologies to patients faster. So that's the world I'm in. It's great to be on the podcast. Host: Well, that's awesome. I will be going to Singapore next Tuesday, so we're kind of doing the reverse schedule. And I think it's, um, it's interesting, you were in Melbourne, I missed you in Melbourne, Australia by a couple days. And then you took a cruise, didn't you, from Melbourne to Singapore? Guest: Uh went from Sydney to Singapore. Yeah. Host: Sydney, okay. Yeah. Guest: Yeah, yeah. which was great. Uh, what a great, what a great city. I mean, these Hong Kong, Sydney, um, was amazing. Singapore, I think it's just something else. Very different to Dubai. I mean quite different to Dubai now but... Uh you've been to Singapore Christian? Yeah? before or? Host: I've been to Singapore quite a bit. I was just there I feel like two weeks... I think two weeks ago. So yeah, I'm still jet lagged. I woke up uh, last night at uh 2:30 and couldn't go back to sleep. So I watched the, for some reason, I watched the Formula One movie again. Oh. And then went to bed at like, fell asleep at like 6:00 and then got up at 6:45 for a meeting at 7:00 and here we are. It's like 8:20 or so. So I'm still jetlagged. I just got back from Korea, I think Thursday. Guest: Right. so... Host: Yeah. Guest: I think it's a lot easier for me than you with the jetlag because you had to cross the date line and go that way, didn't you? You went across the other direction. Host: That's true. We do have to cross the, you don't have to cross the date line? I guess going from Korea, it's like a day in the future in Singapore as well coming back to the United States. So it's a little challenging, yeah. Trevor: I always think it's kind of funny leaving Asia. You fly out Sunday at 7 p.m. and then you usually get to the US Sunday at 5 p.m. Guest: Yeah. It's been, it's been a challenge to, to, to sort of, to have calls to people because I think I went across six different time zone changes with you get around to North Australia and there's a half an hour here and plus half an hour there and, but anyway, I'm back now and it's good that, but uh, but yeah, so you didn't watch the Grand Prix, the uh, the Japanese Grand Prix then? Host: I watched the highlights of it and uh, I watched it in Melbourne and I still don't know, understand why you don't like Max Verstappen so much. You were kind of hating the guy. I don't really understand it. Guest: I don't hate him. I just don't like what happened in, you know, that, that whole championship win that was given to him by Michael Masi that seems to have gone off the face of the earth. But no, I don't know. I'm not sure I like his style of driving. I know there's no doubt about it. Lewis Hamilton is the best driver in the world and I say that because I think it's an eight-year, eight, eight-championship winner. But also, um, there's not many racing drivers. uh, I was a big, uh, Michael Schumacher fan. Uh, I love the whole period he was with Ferrari and Benetton and that sort of thing. But the difference with people like Schumacher, he's the only person you could really compare it with was he had a teammate that was supporting him whereas Hamilton and Max Verstappen have had teammates that support him. So it's like, you know, he's been on his own, he's won lots of. I like the guy, I've met him a few times. But Max Verstappen, yeah, I'm not a fan. I don't like his driving. Anyway, I think he's given up because his car's no good. It's the last thing I heard, but um, anyway, you might need to get some Ferrari or McLaren shirts next time. Host: We do have a McLaren shirt because and I think Ferrari hat because Melissa likes to buy clothes. So. Ah, fantastic. I think we have I'm like we went to the Melbourne race at the at the Red Bull thing. I'm like you can't, it specifically says for the Red Bull energy zone, you can't wear any other team's merchandise or they'll kick you out. Uh huh. 'cause Melissa's about to put on like um a Mercedes hat or something. like you can't wear that in there. They'll kick you out. No. Guest: Well, I mean, it's interesting when when uh, when Lewis won in uh, the Italian Grand Prix a few years ago being in uh, in with all the Tifosi, I could wear a McLaren. I got out alive, but it was all, actually, no, it was Mercedes that he won. Um, but it was full of Ferrari fans, but I think they're friendly, generally, when they all get together these fans. So it's it's getting exciting. I just want anybody to win but Max Verstappen. I don't care who wins this year. It doesn't matter who else as long as, as long as it's not him. Right? Just don't like the 8pm, yeah, anybody but Max. But there you go. Cool. Host: So you talked, you talked a lot about uh in your intro about clinical evidence, like but like an episode before not, I think last week we recorded, uh we talked about, um, clinical trials. So from an evidence perspective, are you referring to like the data from a clinical study or a clinical trial? Guest: Yeah, absolutely. So a lot of the work I did and how I was very successful with my team in bringing technologies into the UK was, I said, I went back to saying, you know, sell the problem you solve, not the product. So when you when you can go into a healthcare system and understand what it does, who it treats, how it treats, what it costs and you know, how well that treatment does using real world evidence. That's another form of evidence. So understanding whether a healthcare system needs a product. And that's really interesting because when you look at the US, UK and Germany for example, you know, the the UK likes day case, ambulatory, office-based procedures because we don't have enough beds, our healthcare systems are around trying to get people in and out of hospitals as quickly as possible. Other healthcare systems in the world, like the US, um does ambulatory office based procedures, but they like to do lots of them because the doctor earns more money if they do lots of multiple procedures. In Germany, uh, well until fairly recently, they didn't like doing day-case ambulatory office-based outpatient treatments because the system is around patients staying into hospital for longer, which means the hospital earn more money. So all these healthcare are all different and it's trying to look at the evidence of what the thing does, how well it does and and try and then work out, okay, so which healthcare system would would be able to, you know, benefit the most. So the the strategies of market access are really around selling products to healthcare systems that need it with the least regulatory, with the least reimbursement barriers, with the highest population at the highest price. And and often that country is North America, which is where the work that I was involved in due to European regulations, uh we saw a decline of technologies coming to the UK and Europe because of the what's known as the EUMDR, which I think benefits you with your regulations when you're selling sort of cybersecurity and that sort of thing but for many companies they struggle with the timelines and costs and the difficulties of getting regulatory approval in Europe that's rather get it in the United States. So things change and they evolve over the time and for me, it's been a it's been a case of trying to continue to learn in the industry because I love the industry, I like what I do and working with partners and experts and offering the best services possible, um is is what I'm about. So the the answer is yeah, it's it's really looking at all forms of evidence um trying to help companies to develop it in the right way um in the fastest time because they've really got a runway of cash for so long and optimizing and maximizing access. You know, these companies that that spend millions and hundreds of millions on developing solutions and then go into healthcare systems and just saying we're better and cheaper isn't enough, you're having to really try and drive change by solving problems and understanding, uh, you know, what what's, what's really going on in those countries. And the more countries that have, you know, deep uh and and extensive levels of of real data to how those countries treat patients are really good ones to choose. So the UK, Sweden, other countries that have this real data, um, uh patient claims databases really help to formulate a plan to get in and get quick and get, uh, get products used. Trevor: I think it's a really good point that you bring up about focusing on the problem as opposed to focusing on the solution. And I think that is something that can really make a break a med-tech company. Yeah. Is, you know, obviously the technology is only going to be as great as the solution that it's providing there. You can have some incredible tools, some incredible device, treating some incredible problem. But if it's overly complicated to use, if it's cost prohibitive, if it's ineffective, if the problem is too small, or if the problem's not as, you know, significant as maybe you might seem it to be, then all of these situations are going to stack up and cause problems when you're trying to get to the, when you're trying to execute on that, go to market strategy, when you're moving towards commercialization. Um, and there are also a lot of cases where I'll see someone just inventing a problem. We'll say, well, we've got this crazy great solution for XYZ situation that just never comes up. And they're trying to sell a solution to something that really just doesn't happen. Guest: Absolutely. And I think it's best, there's a, there's an image I could share with you, I don't know if you, I'm trying to pull it up on screen in a second, that sort of describes what sort of market access is really, um, and and what you're trying to to solve. I can, shall I share it? Host: I think you can share screen. Uh, yeah, the bottom, there's a share button. Uh show window. Does it allow me to to everyone or I don't know. This is the show. Yeah this is very good actually. This is um, I don't know if you can see this this slide here, um It's a Venn Diagram, I can see it. Guest: It's a Venn Diagram. So so basically um what this is basically saying is the best decisions are made in a market access strategy. And I've got to thank my good friend um from OptiMax access for this one. So so what this describes is really we're all trying to solve population health problems. So we are to bring a technology into solve a population health problem, whether that's Benign prostate hyperplasia, liver cancer, whatever it might be. Um, you know, there's no point in in inventing things unless there's a super health care problem. Um but a lot of companies do is they say, well, we can solve this health care problem, but we're cheaper. This is fine. They don't focus on why a hospital, why a health care system should change to a new solution and that's got to be around the quality of care benefits for change. So what this is describing is the best um decision in a market access strategy are made when you look at you can actually solve a healthcare problem with the technology. You can demonstrate that there's quality of care improvements from changing to that healthcare system, to to that that that that product, it has to come with quality care benefits. They can be things like reduction of complications, reduction of pain, reduction of length of stay, fewer readmissions, um faster, safer, cleaner, whatever that might be. And all of those things come with real value. and it's turning that quality care into value and that's clinical and economic value. But it also has to be affordable for society. There's no point in inventing products that are una affordable for health care systems. So the strategy of around market access is really around looking at these three things, solving a health care problem, making sure you capture the quality of care benefits in your evidence and in your communication and make the technology affordable for society. The best decisions are made when all of those three things are looked at together. So, there you go. Just saw that. I don't know how to stop showing this screen, but um there you go. the bottom stop, there you go, stop sharing. So that's uh that's always useful, useful slide. Host: So I think it's interesting and something you said earlier kind of struck me about it kind of sounds like the hypocretic what is it called? The Hippocratic, hypocretic, not hypocretic, hypocretic oath that the doctor's supposed to take is is a thing of the past because it sounds like based on what you said a market access that even affordability, cost reimbursement, and evidence in UK versus the US, it's really about revenue and the business model. So where does the patient really come into that? If you said a couple of things, you said, you know, and from I think Germany, it's about keeping the patient in the hospital longer to generate revenue. Other countries, it's about having more repetitive, I guess, uh, checks to generate more revenue. So it's like, is the patient even like really factored into this stuff anymore? It it because it kind of seems like it's just about to generate revenue for businesses. Guest: Well, no, I mean I know we're focusing on the business of Medtech, but the patient is absolutely central to all of this. Um, and I think that that's a really good point actually, uh Christian and and we, you know, we, we, we spent some time a few weeks ago with um, with Amanda Hes from, uh, the sort of PR person and the power of the voice of patients and and it's so important they are caught to this, but often companies don't, don't use patient voice as well as they could do. And when I say patient voice, patient voice in, you know, they're wanting a new treatment or asking for a new treatment, but also capturing patient outcome data over a long period of time because if you want to differentiate your technology to another and you're able to demonstrate that you have real data coming from patients on a long-term basis that they've they've had a treatment a year ago and they're and they're back to normal activities, they can walk, they can go to work, they can they're pain free, they're active, you know, they can do things they couldn't do before a really valuable drivers that you can capture in what's known as electronic patient record and outcome measures, um capturing longitudinal data from patients through the care cycle is a is a really powerful way of reassuring um payers and and care providers that they've been given patients the right treatment. So in this world of digital, you know, there's so much more that can be done about collecting real world post-operative data from patients that could really help to increase the value proposition and reassure payers that they're paying for something that's working and patients are happy. So, so yeah, there's so much to this whole market access strategy and and I always talk about market access because it's not been properly defined as a science or anything, it's something I'm trying to work on but I see market access, we have the principles of marketing which is product, price, place, promotion and it's something that most companies do do. They they invent a product, they product price, they price it, they find a place and they promote it. That's sort of marketing strategies go back to, I guess it's probably 60s or 70s when marketing was the 4 Ps... Host: The four Ps. Guest: The four Ps. Absolutely. So product, price, place. I think when it comes to market access, it needs a totally different approach when it comes to medical devices because it involves patients and patients often hopefully live a long life and and it's much more long-term solution with with treating humans and it's more risky and it comes with bigger penalties and all the rest of it. But I see the principles of market access are around um another four piece and that's patient, um patient, provider, payer and product. Patients need to benefit from having the treatments, providers of care need to benefit from offering the treatments and treating patients with this new treatment, Payers need to benefit for paying for the treatment and that's long term in some care systems. Obviously in America, you've got insurance providers and people change insurance providers, but ultimately in a socialized health care system like the UK, the payer wants to pay for a treatment that's long that last long time, patients do well out of it, they get very few complications, to go back to work, they can be productive and pay tax. Uh and then the last P of the four piece of market access is um, is a product and that's about profit. There's no point in bringing technologies to market unless you're making a really good money out of it. Otherwise it's just a pointless exercise. So patient provider payer and product benefit to the principles of market access. However, there is one other P in the United States that has to benefit and that's a physician. So you have patient physician provider payer and product benefit because physicians in the United States get paid by doing procedures and the more they do, the more they earn and they need to benefit. So there's five piece in the United States and maybe other health care systems as well where physicians get paid to doing procedures that don't fall inside a socialized health care system like the UK. So and I've seen this over many technologies in the last 15 years where it's almost like uh, you know, it's like a chair if you haven't got, you know, four legs, it's unstable and can fall over. So I've seen uh, I've worked with technologies in the last 15 years where it's benefited patients and payers but the provider doesn't want to do it because they get more money by doing what they do today. And that's a very, very difficult scenario, but by trying to look at technologies and break down their, you know, look, look at those principles, try and understand do they benefit asking the companies, tell me how this benefits payers, tell me how this benefits patients, tell me what problem it solves, how tell me how it's gonna help a hospital be more productive, to reuse risks and and be, you know, be be a better operator of services. Um, are really good questions and help to draw out, you know, a strategy around how they can go to market quickly and and not um, not fall at the hurdles that a lot of these companies do. Trevor: I think that it's an interesting lens to take a look at this through since very often when we're talking about UK versus US versus EU versus, you know, pick a country. We're usually talking about the regulatory constraints and how different those are going to be. and that's still very much obviously the case. MD are compared to FD, they obviously have some similarities and they obviously have some stark differences as well. And so it's an interesting perspective to think not just about what is the process to get forward with your approval within that country, but how does it economically function differently from some of your other markets? And what are you going to have to do to try to cater that to a little bit of a different crowd? I know you mentioned that in the US we have the fifth P, the physician. And so you know, you can make an assumption that if you're creating a device that requires using it multiple times, going through multiple treatments, multiple administrations of therapy, it's likely going to be extremely appealing to a US physician where might not be as effective in the UK where they want to try to churn out these treatments as quickly as possible and free up space since I know space is a big constraint with the NHS. Yeah. Yeah. Guest: Absolutely. Trevor: And that's it's so complicated. Um and it involves so many different um people and offering and services really. And I suppose so coming out of, uh, you know, focusing just on the UK and focusing on getting products recommended by healthcare system and looking at, you know, having to deal with the evidence that I've been given by those companies, very few of them actually provide any economic, you know, proven economic evidence that their products are either affordable or good for payers. And and so the work I'm doing now with Rob and Franklin has been a really interesting insight into talking to these early stage companies and try and understand, you know, they're so focused on that, you know, let me get FDA, CE, TGA, whatever is approval, you know, it's it's making sure that they, they, they don't have to repeat evidence generation. If they knew their value drivers, if they knew who their counterparts were and what how well that technology needed to work to achieve a really high selling price and focus on those value drivers, um they could be far more successful in their value valuation of the company uh at the back end. So give having that knowledge and experience of dealing with evidence for reimbursement and going to those companies that are developing evidence for regulatory approval. It's been a really interesting time with Franklin and Rob and the team to to try and make sure that they do capture everything that they're doing the right studies and the right co-horts and the feasibility work's been done. So um so yeah, it gives us a lot of insight as a as a group as a network which, you know, we're all part of to to help companies along the way. You know, I think the evidence collection is a really important part. Um right after this call actually, I'm about to go jump on a plane and go get ready for an FDA inspection. and part of what I've been trying to talk about as the process that we need to adhere to is at this point the FDA, you know, whatever agency that if you're going through a submission process, if you're going for, you know, trying to figure out your reimbursement or if you're about to get hit with an audit, your process is already accepted. It's a matter of if you can follow through with the process. And so, you know, with what we often times see, that's where there's really the disconnect. And we're looking at through the narrow lens of cybersecurity. How can you create the evidence that you have gone through the full cybersecurity life cycle? You've addressed cybersecurity in an end-to-end fashion, you're actually remediating vulnerabilities when you say you're going to remediate vulnerabilities and if you can't generate this evidence, then, you know, the SOP at that point is only as good as the paper that it's written on. If you can't prove that you're actually adhering to all of these different processes that are required. Guest: Yeah, and that's just one part of it. It's very, very complicated, isn't it? Getting medical devices to market, you know, and you can talk about all of the different people, the materials testing, the, there's so much. But yeah, it's and it's becoming, you know, more and more complicated and regulations are forever changing sadly and it, it's really also, not just the regulations, but also looking at countries where there's an established mechanism of reimbursement as well because some countries like France and Germany and the United States have a very sort of relatively well-known pragmatic approach to, you know, evaluation of technologies for reimbursement approval, other countries don't and unfortunately the UK has moved that, you know, the the body that used to look at medical devices which was nice, have changed their processes and methods so much over the last, you know, five or six years, it's become very, very complicated to try and, you know, get that sort of reimbursement approval. Um so there's that on top of everything that these companies have to go through and often the companies are led by very bright successful sales people and and the whole function of market, as I see the whole function of market access and bodies everything, every component, every service and I'm trying to look at the word, every process involved in getting technologies to market should be, should be market access because it is all about getting in to to getting those technologies to market and going through those processes and and approvals. So it's it's got more and more complicated and of course, you know, again cyber security is is now such an important part of everybody's lives who've seen what what's happened recently with you know, I guess the disruption that striker I didn't read anything else about the fact they got hacks, but I mean the the actual effect of that on on patients, you know, if it means that these hospitals don't get products and can't treat patients, it's it's horrific. It's it's really bad. these, you know, these things can if companies don't have the right things in place and I'm not saying for a minute that did or didn't but whatever happened to them is been a bit of a wake up call I think for a lot of companies out there that um that provide technologies in a just in time fashion. Host: From a market access perspective, is there a particular market that's easier to access or would you suggest that a Medtech innovator starts with because of less, uh, bureaucracy, you know, simplified process. What do you think about that? Guest: Yeah, so a really good question. I, I'm sort of I I would probably say the United States is a good one to, I mean, it's where these companies, you know, I I was at Medtech strategist which is a big event held every year in Dublin and about four years ago, two of the biggest investors in the world stood up and said, you know, we will not invest in any technology that will be launched, you know, if it's not launched in the United States first then we're not we're not going to fund it. And that was a bit of a wake up call. And I think that, you know, the US has a, you know, it's good because medical devices is a big industry and I don't think it was easy a few years ago for the US to to to launch products in their own market and I and I think, you know, whatever's happened, um, they've realized it's a big industry and it employs a lot of people and employs a lot of scientists. It's a it's a great industry because it's solving healthcare problems for the future. And so I think that, you know, United States is is often the number one market and we're we're getting, you know, I talk to UK companies here and they're all going to the USA first because they see it as a established, valuable market that um, that really has got investment behind it. But other markets, it sort of depends, you know, in the UK, digital technologies are difficult to fund because there's not an established mechanism of funding technologies that aren't being used in hospital, for example. So often I would recommend companies go to the Netherlands for those other markets, you know, where you can get higher selling prices. You know, at the end of the day these companies got to generate revenue which keeps them going. There's no point in in selling into markets where you're not making money. So you're got to make money to keep the company's taking over and to invest into the next market. So there's so many factors, but it sort of depends on the technology and what grade it is and and, but often I think that the bit that's overlooked is really trying to understand whether a healthcare system needs as this solution and try and focus on that. So some of the work I did in the past with a company based in Minneapolis and in the golden years of when it was sort of Europe first and worked with a company um that had a device for benign hyperplasia and in the UK were able to find out that 1/3 of those treatments happened in 20 hospitals. So imagine being able to go to a healthcare to a country where you know that 1/3 of all the activity happens in 20 hospitals, well that helps you to think about how many sales people you need and how much time they need to spend on those 20 accounts to get a really good foot in the door and and you know grow market and and um get revenue into survive. So there's so many factors to it, not just the reimbursement but also, you know, how long is it going to take to win those top accounts and where are they? And the more information that's out there about what those healthcare systems do and how they treat people, where they treat people, what it costs, how well they're doing in treating that population and where the opportunities are for improvement is another really an often overlooked, um, science of of looking at real data where it's available to try and understand, you know, where to go and how to pitch and how you can go to a door of a hospital, get into the carpeted areas of hospitals that make the financial decisions or a payer and actually show them what difference your technology you've make, what problems it would solve. Trevor: I think that it's really important to make sure that we have all of these areas factored in. That's good to know about looking forward. You mentioned the Netherlands as a pretty good market to go for. Yeah. Yeah. And I think that's one thing when we're seeing some of these new technologies evolving and you know, obviously AI is kind of the current one. Um before this mobile mobile medical applications were a big one. But seeing how the regulators and seeing how different aspects of the Medtech industry try to evolve around this all the way from market access, reimbursement, regulatory approval, you name it there. There seems to be a bit of a lag in Medtech and I think it's due to how many moving parts there are, how much complexity there is. So to pick AI for an example and this is, you know, another case for going for the US market. Right now, it's west in the US. You can build, sell, do whatever you want with AI, but the European regulators have been clamping down pretty tight on it. And so we're not seeing that same level of uh I guess wild exploration within AI, which, you know, pros and cons to each approach. The US typically tends to clamp down once they see something go wrong. The European regulators are trying to be a little bit more proactive and focus on safety first. And who's to say what's going to be the most effective approach? I think it caters towards which is interest. The US is obviously free market, capitalist, do what you want, go make your money. And so that's the way that the regulations need to evolve for that to be effective. The European market, a little bit different, but I do think that's interesting to hear an example of, you know, even within just the digital health space. There are some places where this is going to be a little bit of an easier path, some places where it's a little more complicated. Guest: Uh you're absolutely right. And I think, you know, I go to Adame, I'm on the organizing committee again this year. And I was really impressed last year at San Diego where you know the FDA people stood up and said, look, we're really, we're really realized that, you know, we need to keep patients at home, which is pretty common sense. Hospitals are horrible places to go to. You get born there. Some people get born in hospitals which is probably a great experience but to arrive in the world but, but you know, you really want to stay out these places called hospitals and we've all got this, you know, particularly Japan for example has got real problems with a growing elderly population and few people being productive and and working, but really encourage me about the US was hearing, you know, the FDA presented at San Diego. I don't know if it was virtual or I think it was virtual at the time because of some restrictions or something but but talking about keeping people at home and and having sort of or telemedicine really systems that have been around for so long that we we on our wrist now that tell you where you are, what you're doing, whether you're stressed, whether you're cold, hot, you know, all of that heart, monitoring respiratory, sleep information. You know, there's so much more that can be done to help to keep people out of hospital, particularly the older people and have them monitored at home and managed at home and if something goes wrong, getting the sort of, you know, reactions in quickly and being able to care for people remotely. So I think the US is a great market for remote monitoring of patients and at home telemedicine which I think should should and hopefully will set a benchmark to the rest of the world that you can manage people at home, you can get them out of hospital sooner and then manage them post operatively, you know, in their own homes, keeping them. You know, all these things that can transform care and get people at home faster are going to be more and more important and I think the US is at the forefront of that. So in our country in the UK it's very difficult to manage patients because it's a question of who's funding it. And we don't have an established mechanism of reimbursement for managing people at home. Not that I know of and it's been something that I've been on about for 15 years is, you know, great, get people out to home monitor, but you know, what systems are in place to do that and how do you get them funded? You need to you need to really go in with a very strong argument to do it, which is possible where you can manage people out of hospital faster and free capacity for more patients to go into into their beds and get treated and cared for. So there's so many lessons we can learn from, you know, the US and in now you're at the forefront of new treatments and new technologies that um, that's really makes it exciting that that you're doing things first in the US and and the rest of the world I think should look at it is an example of of you know, taking a bit of risk but but trying to keep medicine moving forward and bringing in new treatments. Host: It's interesting you say we're doing things first in the US because from a healthcare perspective, I feel like on one hand, we have the best health care but on the other hand we have the worst. Yeah. From a, you know, cost perspective and accessibility perspective. and Trevor I remember you were like traveling and you said you were able to get some procedure done for like $10, which would have probably cost you $10,000 in the United States. So it's like, I don't know, it's an interesting dilemma from a market access perspective and just from a consumer perspective because I mean I I pay outrageous fees for health care and I have crappy health care in the United States. I think between Melissa and I, we pay about $30,000 a year and I had we went once to a urgent care because she had like throwing up and was sick and it we got a $10,000 bill even though we had the best insurance possible. And uh we're still fighting that um bill which we got it down to $4,000, but it's still like ridiculous. Guest: Believe me, I've experienced the United States healthcare system. I in 2016, 10 years ago I was in Tahoe and woke up with it got treated in Stanford where the doctor I knew and and that was a $75,000 bill for got my side back it's brilliant. Everything's good but in the UK that would have been about $7,000. And so yeah, it's over 10 times more. 10 times more, but I can tell you, I I could I could see the doctor on a Saturday morning. I could go into a clinic room and there'd be just me in there or your child. So you get the wait time is 10 times less but you pay 10 times more. Yeah. I mean yeah, but you say that but you know our taxes are going up in you know and they're going to continue to go up in the UK because the state of the economy. Uh God don't get me on to politics please but what a state running really bad. no politics or Max. We pay lots of taxes you know to fill to fill uh you know tank of gas for a for a you know relatively small car you're looking at you know $130 now with the increasing price but that's not going there. But you know we pay taxes in other ways. Um, I think the health care system if you can afford it is is probably, you know with the treatments you have there that we don't have here. Uh take for example, they just being today they're they're announcing they're doing a new treatment for hyperplasia but but you know some therapies we just don't have to get over here and we hear stories of people raising money to to get treated in America because that's where that technology exists and they raise money to get it. if you can't get it, you know, some people I know could probably survive people I've met in the last, you know, a year that I know have got cancer may may survive to go to America for certain treatment are available there that we don't get in Europe now because the regulations are put people off bringing their technologies to Europe in the way that they used to. So it's a really, really difficult conversation this, but my experience of US healthcare system has been pretty remarkable. Um for me I got great treatment, but yeah, I I know that I've worked with you know people have been on business with me from America and they fall and I've taken them to the ER and they've got their credit card out and they've got it all for free. Um you know in their Americans pretty complicated game the the business of of of medical devices and um and payers and providers.