Market Pathways

FDA’s CDRH just lost up to 10% of its staff, including key reviewers in AI, diagnostics, and medical imaging. With industry concerns growing, what do you think will be the biggest consequence? In this week’s Pathways Picks: FDA’s device center is hit hard by the Trump administration’s mass layoffs of government workers this weekend; AdvaMed implores newly confirmed HHS Secretary RFK Jr. to reverse the cuts; Medicare inpatient proposal is under White House review; China reports on 2024 device approval trends; ANVISA reconsiders procedures for borderline products; a new EU IVDR notified body; and more. #medtech #regulatory #medicaldevices #fda #ai

The impact of these cuts on device reviews, particularly in areas like #AI and #cybersecurity, will be important to monitor. The loss of experienced scientists and OSEL researchers raises questions about capacity and review quality moving forward. Looking forward to further insights as the situation develops.

This month’s Global Spotlight highlights Brazil, featuring ANVISA’s headquarters in Brasília. Here are key takeaways on regulation and market access: Regulation ANVISA, led by Antonio Barra Torres, turned 26 on January 26. Class I-II devices follow a simple notification process, while Class III-IV require technical file review. In 2024, ANVISA cut review times by ~80% for devices already approved in the US, Australia, Canada, or Japan via its Reliance program. New transparency rules require manufacturers of certain implantables to disclose pricing based on tech attributes. Market Access Nísia Trindade Lima, Minister of Health, oversees Brazil’s universal public health system. CONITEC assesses technologies to determine device use in public care. 25% of the population supplements public care with private insurance. For more insights, check out updates from Augusto Geyer and Market Pathways’ latest coverage. #medicaldevices #regulatoryaffairs #brazil #anvisa #marketaccess

EU Notified Body Guide, FDA Panel Postponed, UK Drops "Cost Saving" Factor, and More In this week’s Pathways Picks: The EU updates its notified body guidance to address structured dialogue and leverage prior evidence, formalizes its “scientific advance” program, and pilots multinational study assessments; FDA postpones the only device panel on its calendar, reposts some documents, and faces more pressures to cull workforce; the UK tech assessor NICE proposes removing “cost saving” as a condition for device adoption; and updates from South Korea and Saudi Arabia. #medtech #medicaldeviecs #notifiedbody #fda

Did you know that the U.S. medical device market is valued at approximately $156 billion, representing 40% of the global market? Despite this significant presence, obtaining reimbursement for innovative devices remains a formidable challenge for many companies. At the recent 19th annual Bohemian Medical Device Summit in Rome, industry leaders convened to address these hurdles. A key takeaway was the critical importance of integrating reimbursement strategies early in the innovation process. As Dr. Josh Makower emphasized, "Reimbursement is the single, largest challenge in patient access to important new medical technologies, and as such, it's also the single, largest challenge for innovators." By proactively engaging with policymakers and developing robust data to support coding, coverage, and payment, we can navigate the complex reimbursement landscape more effectively. This approach not only accelerates patient access to groundbreaking technologies but also ensures the sustainability and growth of the medtech industry. Let's prioritize reimbursement strategies to drive innovation and improve patient care worldwide. #medicaldevices #medtech #reimbursement #patientaccess Heather Simonsen Boomerang Medical Joseph Ferrara Veranex Josh Makower Stanford Mussallem Center for Biodesign Rob Fletcher Shockwave Medical

The Market Pathways Podcast dives deep into global regulatory, reimbursement, and policy issues, offering actionable intelligence that could catapult your market access career to new heights. Don't just stay informed—stay ahead. #medtech #medicaldevices #regulatory #reimbursement #policy

𝙁𝘿𝘼 𝘿𝙞𝙨𝙚𝙣𝙜𝙖𝙜𝙚𝙨 𝙞𝙣 𝙈𝙚𝙙𝙩𝙚𝙘𝙝 𝙎𝙩𝙖𝙣𝙙𝙖𝙧𝙙𝙨 𝙒𝙤𝙧𝙠, 𝙖𝙣𝙙 𝙈𝙤𝙧𝙚 - MedTech Strategist - Market Pathways - written by David Filmore The Trump administration has acted with lightning speed and this article highlights some of the impacts on the MedTech industry.  Standards work has been significantly impacted by the Trump administrations opening moves.  David Filmore interviewed two key figures in the Standards development process, Sarah Moeller, The Greenlight Group LLC, and Leonard (Leo) Eisner, 𝘁𝗵𝗲𝟲𝟬𝟲𝟬𝟭𝗚𝘂𝘆, Eisner Safety Consultants.  This article covers the impacts in the standards development work by these actions. What else has happened: • Webinars have been postponed • Meetings have been canceled • Temporary removal of a guidance and then reposted but the word "gender" was removed. • What's going to happen to MDUFA V and staffing? • And more. https://lnkd.in/gU_wZhKW

Orphan devices—specialized medical devices for rare conditions—face regulatory hurdles under the EU MDR. While new guidance allows some flexibility, challenges remain. How do you see this impacting innovation and patient access? #innovation #medtech #medicaldevices #regulatory #eumdr

Everyone can appreciate a two for one deal. And MyStrategist is your one digital home for two of the medtech industry's most trusted publications. On MyStrategist, you can access exclusive insights published by medtech's most experienced analysts in MedTech Strategist and Market Pathways. Through MyStrategist.com, you can search, filter, and save over 2,000 articles across dozens of topics including cardiovascular, medtech law and policy, market access, and more. Take a break. Log in to MyStrategist.com to access strategic medtech intelligence and stay informed today. #medtech #innovation #medicaldevices #marketaccess #marketresearch

Trump Transition Updates, Digital Health Picks, and More In this week's Pathways Picks: Trump transition updates, including a resignation at FDA, an appointment at CMS, document edits, a deregulation order, RFK Jr. clears committee, and more; digital health guidelines from Canada and the UK; the first provisions of the EU AI Act take effect; and more updates from Europe, the UK, and India. #medtech #innovation #donaldtrump #fda #digitalhealth