FDA Inspections Getting Prepped and Avoiding Pitfalls

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 reforms. Three leading experts on European medtech regulation discuss what possible restructuring could occur and when it might happen.

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 expectations, and what product companies can do to improve their relations with both agencies.

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 Aheadhttps://www.mystrategist.com/market-pathways/article/medtech_in_trumpland_advamed_and_mdma_leaders_weigh_in_on_policy_paths_ahead.htmlMDUFA VI Watch: 5 Takeaways From the Public Launch of User Fee Reauthorizationhttps://www.mystrategist.com/market-pathways/article/mdufa_vi_watch_5_takeaways_from_the_public_launch_of_user_fee_reauthorization__.htmlWhat’s Happening at CDRH? RIFs, Retirements, User Fees, and Unknownshttps://www.mystrategist.com/market-pathways/article/whats_happening_at_cdrh_a_look_at_post-rif_device_center_realities.htmlTCET: Industry’s Underwhelmed, But It’s a New Tool to Tap Intohttps://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 2025Pedro Eerdmans, MD, PhD, Director, Global Strategy Services at NAMSATom Melvin, Associate Professor in Medical Device Regulatory Science, Institute for Clinical Trials, University of Galway; Chair, Biomedical Alliance in EuropeChristina Ziegenberg, Deputy Managing Director, Head of Regulatory Affairs, BVMedPetra Zoellner, Regulatory Affairs (IVDR &MDR) Director, MedTech EuropeStephen 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.