Market Pathways

After a long career at CMS, including running the Coverage and Analysis Group for the past 10 years, Tamara Syrek Jensen can now candidly share her views on medical device reimbursement generally, particularly when it comes to Medicare. She provides a frank assessment on the systemic challenges, including highlighting key differences between CMS and FDA in terms of legal requirements and expectati...

Veteran medtech reimbursement executive Keely Scamperle talks about her newly launched Reimbursement and Market Access Professional Society, or RAMPSociety . She discusses the growth of reimbursement and market access as a distinct profession over her career and how she hopes the new group will help elevate its profile within the medtech industry and beyond, similar to what a group like RAPS does...

Scott Whitaker, president and CEO of AdvaMed, sits down with Market Pathways’ David Filmore to talk about hot topics in medtech policy, including the current situation with tariffs, future optimism for policies coming out of FDA and CMS, a Breakthrough Device coverage bill moving in Congress, AdvaMed at 50, and what to look and listen for at The MedTech Conference, in San Diego, October 5-8. Read...

A special panel from our Innovation Summit Dublin conference in April 2025 Pedro Eerdmans, MD, PhD, Director, Global Strategy Services at NAMSA Tom Melvin, Associate Professor in Medical Device Regulatory Science, Institute for Clinical Trials, University of Galway; Chair, Biomedical Alliance in Europe Christina Ziegenberg, Deputy Managing Director, Head of Regulatory Affairs, BVMed Petra Zoellner...

By Wendy DillerFollowing a robust 2024, the medical device sector continues to thrive in 2025 and remains somewhat insulated from dramatic shifts in healthcare policies, at least in the short term. Market Pathways and MedTech Strategist writer Wendy Diller spoke on March 3, 2025 with Ryan Zimmerman, a managing director and senior equity analyst--medtech at BTIG, in the lead up to one of the sector...

The use of real-world evidence is increasing rapidly throughout the device industry. Here we talk with Paul Coplan, who is leading that effort at J&J, which received the first FDA-approved label extension using real-world evidence. Our conversation embraces the breadth of real-world evidence uses, including the recent FDA guidance, as well as global applications of real-world evidence, and its...

FDA inspections are nobody’s idea of a good time. However, proper planning is crucial not only for ensuring baseline compliance, but also for establishing an effective corporate culture and building long-term company value. In this edition of Consultants Corner, we spotlight  advice from Jamie Harris and Nancy Lincé, who discussed the issue onstage last month at the MedTech Strategist Innovation S...

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.

This discussion with Stanford Biodesign director and co-founder Josh Makower highlights a recent Stanford report that found the median time for initial coverage of breakthrough devices was nearly six years. Here we discuss how this data, much like information from previous Stanford reports, can help drive change in the current debate over TCET (transitional coverage for emerging technologies) to h...

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 pat...

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.

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-changin...

The last few months have brought a flurry of MDR regulatory and  legislative activity, causing a morass of confusion. In this interview,  leading EU medtech lawyer Erik Vollebregt clarifies what the recent  spate of proposals and guidances mean for product companies and how they  should manage in these uncertain times, providing a look at what the  future looks like for me...

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 Leah...

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...

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 companie...

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. #medicaldevices #medtech #mdr #medicaldeviceregulation Vi...

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...

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 m...

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 McLellan weighs in on this and  other reimbursement and regulatory concerns facing the device industry.   #medtech #MedicalDev...

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 ag...

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. Read more...

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...

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...

This episode of the Market Pathways Podcast tackles the biggest problem facing device companies today: reimbursement. Ask medtech executives and investors the biggest change in the challenges currently confronting product companies compared with a decade ago and the overwhelming consensus response is that reimbursement has replaced regulatory as the biggest obstacle to successful commercialization...