Market Pathways

Breaking into China's medtech market? Here's what you need to know. China’s medtech landscape is evolving fast, with regulatory and market access shifts shaping opportunities for innovators. Here are three key takeaways: ? Regulatory Strategy Matters – The NMPA fast-tracks innovative devices, but lower-risk domestic products follow a different approval path. ? Market Access is Changing – The NHSA is driving a shift to DRG/DIP payment models, with policies favoring domestic procurement. ? Localization is Key – Companies investing in local partnerships and approvals gain a competitive edge. ?? Want the full picture? Check out this month’s Market Pathways Scorecard. Link in comments. Images feature Zhang Ke, National Human Services Assembly (NHSA) Commissioner and Li Li, NMPA-National Medical Products Administration Commissioner #medtech #medicaldevices #marketaccess #regulatorystrategy #localization

FDA TAP Leader Departs, Oz Heads to the Hill, Global Picks, and More In this week’s Pathways Picks: Douglas Kelly, MD leaves FDA, while the Trump administration extends buyout offers to many in the agency; Dr. Oz’s confirmation hearing is scheduled; updates from the IMDRF harmonization meeting in Tokyo, where FDA didn’t show up, but Russia’s regulators did; and more from the US, Singapore, Brazil, and Europe. ?? Scroll to comments for link to Pathways' Picks. #medtech #regulatory #trump #droz #fda

It's interesting that FDA revised this 2024 white paper on AI and Medical Products last month not only to remove DEI references (which has become standard recently) but also to excise any references to the agency engaging in international cooperation. For instance, the new version of the paper is missing this sentence: "As we move forward, we will maintain open channels for engagement with both U.S. and global parties." This caught my attention as I try to follow along (for Market Pathways) with this week's International Medical Device Regulators Forum gathering in Tokyo, with no FDA staffer at the meeting. #IMDRF #medtech #harmonization #globalization #AI #digitalhealth

Medtech innovation is moving fast—clinical trials aren’t. With a record 124 new devices FDA-approved in 2023, trials still take up to 7 years to complete. How can companies speed up the process? A Phase 0 analysis helps streamline implementation and improve study efficiency. By Nicole Bongers, Veeva MedTech. #medtech #clinicaltrials #innovation #digitaltransformation

Be the expert in any room. Stay ahead of the curve in medtech regulatory, reimbursement, and policy analysis with Pathways' Document Depot. ?? Scroll to link in comments to get the link. #medtech #regulatory #policy

***I've updated this article and this post to reflect less assurance that FDA will be participating in the closed-door sessions at the IMDRF meeting. Stakeholders have received more mixed messaging since I originally posted the article**** FDA will not be onsite and will not provide updates during the public sessions of next week's IMDRF meeting in Tokyo. Its still possible agency officials may participate virtually in closed-door committee sessions at the global harmonization meeting, but that is not guaranteed, according to non-FDA participants heading to the meeting. https://lnkd.in/gfyvQwch Market Pathways #medtech

NEW on the Market Pathways Podcast: BTIG Weighs In on Whether Trump Policies Can Dent MedTech’s Healthy Run By Wendy Diller Following 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. ?? Scroll to comments to get the link to the podcast episode. #medtech #marketaccess #medicaldevices #orthopedics

Federal agencies including FDA have retreated from various forms of public and stakeholder engagement during the opening weeks of the Trump administration. In medtech, that’s starting to impact global standards development efforts, among other technical activities underpinning regulation and product development. #medtech #fda #regulatoryaffairs #productdevelopment

No FDA in Tokyo, Capitol Hill Picks, and Updates From the EU and UK In this week’s Pathways Picks: CDRH staffers won’t be in Tokyo for next week’s IMDRF meeting; no De Novo authorizations since January 20; FDA standards work still limited; HHS signals less public comment periods coming; AdvaMed’s legislative priorities; structured dialogue, a new data regulation, and IVDR reference labs in Europe; and updates from the UK. Here are some important dates to remember for the month of March. #medtech #regulatory #reimbursement #medicaldevices #fda

Explore the barriers and opportunities learn directly from key decision-makers, and read stories of companies that are persevering along every pathways of the medtech market with Market Pathways. Our editors David Filmore, formerly the Executive Editor of The Gray Sheet, and Stephen Levin of MedTech Strategist leverage nearly 50 years of combined experience covering the device and diagnostics industries. ?? Head to the comments for the link to get started. #medtech #medicaldevices #diagnostics #marketaccess