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Your premium guide to global medical device regulation, reimbursement and policy. Market Pathways delivers incomparable intelligence exploring the people, challenges, and opportunities impacting the global medtech regulatory and reimbursement community. View the latest issue of Market Pathways on MyStrategist.com
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The need for important changes to MDR has been clear since its enactment in 2017. EU authorities have been reluctant to make substantive revisions, content to do nothing more than extend regulatory timelines. Now, however, there seems to be newfound resolve in Brussels to engage in fundamental refo…
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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, in…
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…
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, AdvaM…
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 E…
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…
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 us…
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 Harr…
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 i…
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 hel…
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