Episode 69 · April 30, 2026 · 48m listen · 9,567 words · ~48 min read
Why MedTech Needs More Than Approval with Michael Branagan Harris of HealthTech Strategies | Ep. 68 - Full Transcript | The Med Device Cyber Podcast
Read the complete, searchable transcript of Episode 69 of The Med Device Cyber Podcast - expert conversations on medical device cybersecurity, FDA premarket and postmarket guidance, SBOM management, threat modeling, and penetration testing.
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Episode summary
In this episode of The Med Device Cyber Podcast, host Christian Espinosa and guest Michael Branagan Harris of HealthTech Strategies delve into the intricate world of market access for medical devices, emphasizing that regulatory approval is merely the first step. Michael, with 37 years of experience in MedTech, highlights the critical importance of solving healthcare problems rather than just selling products. He introduces two key frameworks: the 4 Ps of Market Access (Patient, Provider, Payer, Product) and the 5 Ps for the United States, which adds “Physician” due to the unique revenue generation models. The discussion traverses the differing economic models of healthcare systems in the UK, US, and Germany, explaining how these influence market access strategies and product viability. Michael also stresses the necessity of robust clinical and economic evidence, including real-world data and patient-reported outcomes, to demonstrate value and secure reimbursement. The episode touches on the challenges of an evolving regulatory landscape, such as the EUMDR, and the emerging role of digital health and remote patient monitoring, offering a comprehensive look at what it truly takes for MedTech innovators to achieve success beyond just product approval.
Key takeaways from this episode
Medical device companies must focus on solving healthcare problems rather than simply selling products to achieve market success.
Market access strategies need to consider the unique economic models of different healthcare systems, as priorities for reimbursement and adoption vary significantly between countries like the US, UK, and Germany.
Developing strong clinical and economic evidence, including real-world data and patient-reported outcomes, is crucial for demonstrating value and securing reimbursement from payers and providers.
Understanding and catering to the
4 Ps of Market Access (Patient, Provider, Payer, Product) or 5 Ps (adding Physician for the US) is essential for a comprehensive market entry strategy.
The US market, despite its high costs, is often the preferred initial launch market for MedTech innovators due to its established investment and revenue-generating potential.
Digital health technologies, including remote patient monitoring and telemedicine, represent a significant area for growth and innovation, though reimbursement mechanisms for these still vary widely across regions.
Full episode transcript
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Sell the problem you solve, not the product. We are all trying to solve population health problems. We all want to bring a technology into a population health problem. Whether that's benign prostatic hypoplasia or liver cancer, there's no point in inventing things unless they solve a healthcare 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? We'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 of benefit the most.
Hello, 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. Mike has been in the industry for quite some time, so 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 we can kick it off to Mike and get a little background about yourself, and then we can get started.
Before I turn it over to you, I will say I met Mike at the AIME conference in San Diego last year. 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 Smashing. So, I thought he would never talk to us again, but somehow we became friends in the whole anti-Max and pro-Max discussion. So, I'll throw it over to you, Mike, and you give a little intro, and then we'll get started here.
An intro into Formula 1 or into... Yeah, no, that was a lot of fun actually. And it's funny because we've been following each other around the world ever since, haven't we, you guys? But, uh, yeah, so including Dubai, and we got out there at the right time, didn't we? We got in and out at the right time.
But yes, so I'm Michael Branagan Harris. I've been in medical devices for 37 years. You can tell I've got no hair, unlike you guys. Very jealous. 37 years. Very precise.
37 years. Yeah, 37 years of medical devices. So I actually started studying wound dressings and very basic things, and ended up bringing in lots of technologies: endovascular technologies, endolaparoscopic technologies. I ran a vascular company that was a big success, a company called VenaSeal, that a lot of people may have heard of as a San Jose-based company that transformed the way that varicose veins or reflux or venous reflux is treated.
So I was very successful in stopping the healthcare system in the UK called the NHS, or National Health Service. I took them away from doing a procedure they'd been doing for decades that caused a lot of pain and discomfort, and brought in a new treatment. 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 treatment.
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?
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 that I built up over many years, I spent over two and a half years of my time in North America between Minneapolis, Boston, California, Texas, Colorado, 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 is around finding the best things in North America generally and helping companies to develop their clinical economic evidence to get the thing paid for as quickly as they can and survive. And it's been a really, really great 15 years doing that, working with so many technologies. 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. It's going to be interesting as I've just come back from Singapore.
But yeah, 144 companies are going to be pitching their device to me, and I'm judging them with a load of other judges on the MedTech Innovator's radar scheme. So I really like meeting the innovators, and I really like working with them and working with trusted partners like you at Blue Go and others that we know, Franklin Health and others, that do a good job and help to reduce the risks for these companies and help them to get their technologies to patients faster. So that's the world of mine. It's great to be on the podcast.