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 in the regulatory arena. The new society will put a significant focus on credentialing, offering a new CRMA certification, and other community- and knowledge-building programs.
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 more about these topics in Market Pathways:
Medtech in Trumpland: Industry's DC Advocates Weigh In on Policy Paths Ahead
https://www.mystrategist.com/market-pathways/article/medtech_in_trumpland_advamed_and_mdma_leaders_weigh_in_on_policy_paths_ahead.html
MDUFA VI Watch: 5 Takeaways From the Public Launch of User Fee Reauthorization
https://www.mystrategist.com/market-pathways/article/mdufa_vi_watch_5_takeaways_from_the_public_launch_of_user_fee_reauthorization__.html
What’s Happening at CDRH? RIFs, Retirements, User Fees, and Unknowns
https://www.mystrategist.com/market-pathways/article/whats_happening_at_cdrh_a_look_at_post-rif_device_center_realities.html
TCET: Industry’s Underwhelmed, But It’s a New Tool to Tap Into
https://www.mystrategist.com/market-pathways/article/tcet_industrys_underwhelmed_but_its_still_a_new_tool_to_tap_.html
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, Regulatory Affairs (IVDR &MDR) Director, MedTech Europe
Stephen Levin, Editor-in-Chief, Market Pathways (moderator)
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’s most important medical meetings, the American Academy of Orthopedic Surgeons (AAOS) Annual Meeting, scheduled to take place March 10-13. The conversation took place the day before President Trump imposed hefty tariffs on goods from Canada and Mexico and increased the tariffs on goods from China. On March 5, following news of the tariffs, Zimmerman said his views fundamentally have not changed. The tariffs were expected, and “companies are dealing with it and managing through it. They, the Administration, believe they can get energy costs and taxes lower to offset it.”Threats of tariffs and cuts to Medicaid are adding some volatility, with some subsectors more affected than others. Healthcare system demand for capital equipment could come under pressure, depending on the policies enacted. Orthopedics and spine, for example, are less vulnerable to tariffs on goods made in China, Mexico and Canada, because the materials of choice for implants are largely titanium, which has not been mentioned in the tariff lists. Implementation of new local coverage decisions is delayed due to the Administration changes, which is expected, but one that seems likely to go into effect on April 13, 2025 will have a disruptive effect on the chronic wound care industry. Another, which improves reimbursement for foot bunions, which went into effect in January, is a big boost for foot and ankle surgeries. Zimmerman will also be attending the Society of American Gastrointestinal and Endoscopic Surgeons, which takes place at the same time in Los Angeles.A more expansive discussion with BTIG about the orthopedics industry is available to MedTech Strategist subscribers.medtechstrategist.com/trial
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 use in emerging areas like health equity and AI.
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 Summit in Dublin.
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 help speed this process.
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.
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-changing regulatory climate in Europe.
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 medtech regulation in Europe.
View the latest issue of Market Pathways: https://bit.ly/3M4gsLc
View more podcast episodes: https://bit.ly/3vgFTlT
About Market Pathways
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
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.
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.
nail-biter in Congress (1:47)
a new medtech coverage pathway (21:54)
tribulations in the EU come up (36:04)
check-in on India and China (46:50)
Here’s some Market Pathways content referenced in this episode:
Market Pathways Podcast episodes:
Jeff Shuren on FDA-sponsor interactions: Where they’ve been and where they’re going https://apple.co/3QY3n89
Do We Need an Expedited Medtech Reimbursement Program? An Interview with Mark McClellan https://apple.co/3LqhRMK
Market Pathways’ articles:
Germany and France Push to Move MDR Deadlines to Avoid Crisis https://bit.ly/3xCC5NE
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.
Read more about the changes in reimbursement: https://bit.ly/3QRMa0C
View the latest issue of Market Pathways: https://bit.ly/3M4gsLc
View more podcast episodes: https://bit.ly/3vgFTlT
About Market Pathways
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
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
View the latest issue of Market Pathways: https://bit.ly/3M4gsLc
View more podcast episodes: https://bit.ly/3vgFTlT
About Market Pathways 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
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)
#medicaldevices #medtech #mdr #medicaldeviceregulation
View the latest issue of Market Pathways: https://bit.ly/3M4gsLc
View more podcast episodes: https://bit.ly/3vgFTlT
About Market Pathways
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
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.
Read more about the topics discussed:
Keeping Medtech Real-World Evidence Real
https://bit.ly/3GhVK8V
MDIC: Breaking Down Silos Across Medtech to Spur Innovation
https://bit.ly/39UxgX4
Data Debate: Paclitaxel Device Meeting Shows Rift in Regard for Real-World Evidence
https://bit.ly/3MQJqyU
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 #MedicalDevices #FDA #CMS #MCIT
View the latest issue of Market Pathways: https://bit.ly/3M4gsLc
View more podcast episodes: https://bit.ly/3vgFTlT
About Market Pathways
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
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.
Read more about the topics discussed:
• 7 User Fee Riders to Watch: From Cybersecurity to Remanufacturing to Payor Comms
https://bit.ly/3OogYFV
• FDA Tries to Draw a Line on What Constitutes Regulated Remanufacturing
https://bit.ly/3OntTrA
• FDA Targets Medtech Cybersecurity: An Interview with Kevin Fu, the First Device Cyber Czar
https://bit.ly/3xtDQ0k
View the latest issue of Market Pathways: https://bit.ly/3M4gsLc
View more podcast episodes: https://bit.ly/3vgFTlT
About Market Pathways
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