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Podcast Episodes

Episode 27: A VC’s View of the Reimbursement Evolution: An Interview with Mike Carusi

Reimbursement has gone from being largely ignored to becoming top of mind for both product companies and investors. Mike Carusi was among the early proponents of understanding and improving the coding, coverage and payment processes. Here he takes us through the reimbursement evolution and delves into the current hot topic: TCET.

Episode 26: Reimbursement for Breakthrough Devices Still Lags—Need for TCET: An Interview with Josh Makower

Episode 25: Medtech in China: An Island of Relative Calm in a Sea of Volatility

This edition of the Market Pathways highlights how the opportunities for Western medtech companies looking to enter China are increasing at a time when US-China economic, political and military affairs are becoming increasingly volatile. While US-China relations remain volatile, the Chinese medtech market, although evolving both in terms of advancing product development and shifting investment patterns, is seeing lower barriers to entry emerging for western companies, particularly those with innovative technologies. Two China medtech experts, Ari Silverman and Olivier d’Arros, talk about the changes taking place in the Chinese market and how they expect it to progress in the face of continuing geopolitical tensions.

Episode 24: An Interview With Kevin Fu, The First Device Cyber Czar

In Episode 24 of Market Pathways, we sit down with Kevin Fu, a renowned cybersecurity expert and the former FDA/CDRH Acting Director of Cybersecurity, and is currently head of the Archimedes Center at Northeastern. Join us as we delve into the critical topic of healthcare cybersecurity and its implications for the market.

Episode 23: The Real World Impact of MDR: How CEOs and Investors are Adapting

This special episode of the Market Pathways podcast features a panel discussion from our recent Medtech Strategist Dublin Innovation Summit. This session brings together an experienced group of CEOs and investors discussing how the new Medical Device Regulation is impacting day-to-day decision-making in running their companies and deciding which start-ups they will invest in given the ever-changing regulatory climate in Europe.

Episode 22: Medtech Law & Policy - Clearing Up the Confusion on MDR: Where Do We Go From Here?

Episode 21: What Do the US Midterms Mean for Medtech?

Key retirements, important changes in leadership, and some surprising new faces. Now that the dust has almost settled, leaving just one Senate run-off and several House seats still to be settled, what does the election’s outcome mean for the medical device industry, both in terms of prospects for the rest of this year and for the new Congress in 2023? MDMA’s Mark Leahey and Advamed’s Greg Crist offer their perspectives on this podcast with Market Pathways editors Stephen Levin and David Filmore.

Episode 20: What in the (Medtech) World is Happening?

Summer’s over. A new school year is in session, and it’s time to get back to business. Market Pathways’ editors Steve Levin and David Filmore talk about global medtech policy issues they’ll be paying attention to this fall. We start with the FDA user reauthorization nail-biter in Congress, and then talk about what to expect from CMS on a new medtech coverage pathway. The ever-present tribulations in the EU come up, of course, and we finish with a quick check-in on India and China.

Episode 19: Tracking the Changing Reimbursement Landscape

Reimbursement has replaced regulatory as the leading barrier facing device companies today. Here several leading CEOs and entrepreneurs share the details of how they have successfully battled through the morass of acronyms and complexities to overcome the ever-changing intricacies of coding, coverage, and payment in the US and Europe, with the hope that other companies can benefit from their experience, avoid similar mistakes, and achieve comparable success.

Episode 18: Changes in China Present New Opportunities

Experienced medtech China hands discuss the opportunities opening up for Western companies to more easily enter that potentially huge market. These CEOs and advisers share how improvements in the regulatory and IP landscape make finding a reliable Chinese partner easier, while also highlighting how to avoid potential pitfalls along the way.

Episode 17: MDR is Here - Now What Does That Mean?

With the European Medical Device Regulation (MDR) now in effect in Europe we check back in with the experts in the space to provide an update on how MDR has been implemented and the issues that are arising.

MDR is Here: Now What Does It Mean?
Serge Bernasconi, CEO, MedTech Europe
Gloria Crispino, CEO, StasticaMedica
Jeff Jump, CEO, Medalliance
Marc-Pierre Möll, CEO, BVMed
Stephen Levin, Editor-in-Chief, Market Pathways (moderator)

Episode 16: Sandra Siami on the Promise and Challenges of Real World Evidence

The National Evaluation System for health Technology, or NEST, was set up to build a dependable real world evidence ecosystem to support development of devices and surveillance of device data. Sandra Siami leads NEST Coordinating Center from her perch at the Medical Device Innovation Consortium. In this episode, we spoke to Siami about the role NEST plays in industry, the multi-stakeholder challenges to establishing a robust real world evidence framework, and next steps and milestones.

Episode 15: Do We Need an Expedited Medtech Reimbursement Program? An Interview with Mark McClellan

One of the hottest issues in medtech reimbursement is whether there is a need for an expedited reimbursement program following the repeal of MCIT. In this episode of the Market Pathways podcast, former CMS Administrator and FDA Commissioner Mark McClellan weighs in on this and other reimbursement and regulatory concerns facing the device industry.

Episode 14: The Medical Imaging Perspective with Patrick Hope

Medical imaging equipment companies share some underlying policy goals with the broader medtech sector. But the realities of capital equipment intended primarily for diagnostic or screening applications also raise special considerations. We spoke to Patrick Hope, executive director of the Medical Imaging and Technology Alliance about the recently inked FDA user fee agreement, MITA’s legislative priorities for equipment servicing and cybersecurity, and the perspective of the imaging industry after two years in the pandemic.

Episode 13: Looking Ahead in MedTech Policy: Part 2 (Europe)

Market Pathways editors Steve Levin and David Filmore discuss important medtech regulatory and policy developments they are looking for in 2022. In this second of a two-part conversation, they delve into the EU picture, including the MDR, IVDR, and other oncoming regulatory challenges. Steve and Dave also talk about the very active regulatory reform efforts in China and the rest of Asia.

Episode 12: Looking Ahead in MedTech Policy: Part 1 (US)

Market Pathways editors Steve Levin and David Filmore discuss important medtech regulatory and policy developments they are looking for in 2022. In this episode, they delve into the US picture, including what to expect from Congress, FDA, and CMS. Check out the second part of the conversation, where they discuss the environments in Europe and Asia, in the next episode.

Episode 11: Bringing the Value of Medtech Regulatory, Reimbursement and Policy Issues to Innovators Through Data

In this episode of the Market Pathways Podcast, Stephen Levin talks with medtech entrepreneur/innovator/investor Josh Makower, MD. Makower recently returned to run the Stanford Biodesign program following the retirement of Paul Yock, MD, with whom he co-founded the program. Makower is looking to enhance the pre-eminent Stanford program by adding a focus on medical device regulatory, reimbursement and policy issues, which today are critical for a successful medtech entrepreneur to understand.

Makower talks here about the initial efforts Stanford Biodesign has launched to get the policy ball rolling, beginning with reimbursement, which has replaced regulatory as the biggest problem currently facing medtech companies. Kicking off this effort is a paper published recently in the Health Management Policy & Innovation Journal that makes the data-driven case for a need both on the part of patients and the innovation ecosystem for accelerated Medicare coverage of innovative technologies. (Keep an eye out for an article on this report in the February issue of Market Pathways.) The over-arching theme of this discussion is that, even with the recent improved transparency and accountability at FDA, major regulatory, reimbursement and policy hurdles remain for device companies and entrepreneurs with reimbursement being the next major obstacle. Makower is committed to using a data-driven approach – at a time when data and science generally are under attack – to add policy expertise to Stanford Biodesign’s armamentarium of resources for next-generation entrepreneurs and industry to call upon in addressing these challenges.

Episode 10: Bridging the Regulatory-Reimbursement Gap: Opportunities and Challenges

Our recent San Francisco Innovation Summit, held in November 2021, featured a reimbursement panel moderated by Stephen Levin, Market Pathways’ Editor-in-Chief, that highlighted perspectives from two companies with innovative cardiovascular technologies that have successfully navigated the reimbursement process, and an experienced consultant who has worked with many device companies to achieve payment for their products.

The panelists were Christopher Brooks, Director of Healthcare Economics for Impulse Dynamics NV (implantable device for heart failure), Heather A. Brown, SVP of Market Access and Reimbursement for Heartflow Inc. (non-invasive coronary artery disease diagnosis), and Adi Renbaum, president of ANR Consulting. An excerpt from this discussion also appears in the January 2022 issue of Market Pathways.

Episode 9: AdvaMed’s Scott Whitaker on Partnering and Advocacy

“We were forced to collaborate with such speed and collective work, and collective passion, and the results were very good. That’s going to shape how we think about public policy I think from this point on.” Scott Whitaker, president and CEO of AdvaMed, didn’t have “respond to a global pandemic” on his five-year strategy plan when he took the helm of the powerful device industry trade association in 2016. The unexpected challenges have been steep, with the industry he represents at the center of the pandemic narrative. But Whitaker has been heartened by industry’s ability to rally to the challenge. And he believes that his work, the work of government advocacy, has been strengthened by the experience. The need for industry to work with policymakers in new ways to achieve quicker action in response to the emergency has enhanced appreciation for productive partnerships on both sides, he says. He thinks that dynamic will be lasting, beyond pandemic policies.

More productive government-industry partnerships would certainly help over the next months, and year, as the device industry’s DC representatives face having to start from square one following CMS’ recent repeal of the Medicare Coverage of Innovative Technology program, bringing challenging user fee negotiations with FDA to a close, and engaging in what could be a very active congressional session for medtech in the mix of election-year politics. Whitaker talks about those issues and more with Market Pathways Executive Editor David Filmore.

Episode 8: FDA and Digital Medtech

Digital health is increasingly central to the overall medtech story, and FDA has placed a major emphasis on refining its approaches to meet the needs of this evolving space. In this panel discussion from the MedTech Strategist Innovation Summit San Francisco 2021 that took November 3, two regulatory affairs experts talk about FDA’s efforts. Yarmela Pavlovic, VP of regulatory strategy at Medtronic, and Ankur Kaushal, VP of Regulatory Affairs and Quality at Big Health, digital therapeutics company, discuss the agency’s special allowances for digital tools during the pandemic and how FDA may transition these policies as we eventually move beyond the public health emergency. The experts also offer insights on real-world evidence, the Precertification Program, AI/ML regulatory strategies, and the FDA experience seen through the eyes of start-ups versus big medtech. The discussion was moderated by David Filmore, Executive Editor of Market Pathways.

Episode 7: FDA's Revival of US Early Feasibility Studies; Can Industry Keep Up?

In this panel discussion from our virtual Dublin Innovation Summit Conference 2021 experts dive deep on FDA’s recent revival of early feasibility studies in the US. The initial findings from an MDIC working group indicate that FDA’s efforts to promote early feasibility studies appear to be working to increase both the number and efficiency of these trials in the US, demonstrating that, at least on occasion, regulators can be ahead of industry. Now the burden is on device companies to follow suit.

Episode 6: Appraising the Medtech Innovation Ecosystem with Nadim Yared

Nadim Yared is a medtech CEO who is not afraid of digging into the details—the regulatory details; the nooks and crannies of Medicare coverage, coding, and payment; the finer-points of p-values and novel clinical trial designs. He has dug in deep on these matters and more during his 15 years at the helm of CVRx Inc., which as recently transitioned to a commercial phase, public company with its Barostim Neo heart failure device. And he has also done so as part of his very active role in cross-industry endeavors on the boards of AdvaMed, the Medical Device Innovation Consortium, and, most recently, the CRO NAMSA, where is currently the board chair. In this conversation, Yared talks about the evolution and what to look for next at FDA, CMS, and in the clinical research realm.

Episode 5: A Look Ahead at the Coming Medtech “School Year”: A Conversation with MDMA’s Mark Leahey

As the calendar turns from summer to fall, there is no shortage of issues important to the medical device industry emerging on all fronts, addressing legislative, regulatory and policy matters. No one is better aware of the state of play of these issues than Mark Leahey, CEO of MDMA. Here Mark touches all bases with Medtech Strategist/Market Pathways editor-in-chief Stephen Levin

Episode 4: New Chinese Regulations Offer New Opportunities

China continues its recent trend of reforming its regulatory system to make it more attractive for Western companies to introduce innovative technologies to the Chinese market. This presents a window, particularly for small to mid-sized companies, to access what historically has been a difficult market to crack.

Episode 3: The Role of Health Tech Assessments in EU/UK Reimbursement

Episode 2: Jeffrey Shuren on FDA-Sponsor Interactions

The FDA device center director joined the Market Pathways Podcast to talk about how opportunities for device firms to interact with FDA during the development and review of new devices have evolved, and his vision for the future: CDRH’s TAP proposal. “We have been building to this moment for now basically a decade,” Shuren tells us.

Episode 1: How MDR is Shaping Europe with Serge Bernasconi