As 2022 comes to a close, we reflect on the significant accomplishments that AdvaMed and its member companies have achieved on behalf of the medtech industry and patients everywhere this year. Because of the hard work of AdvaMed staff and our dedicated member companies, we have advanced public policy beneficial for patients, secured historic funding for innovative technologies, found solutions to supply chain issues, and much more.

1: Medtech Wins in MDUFA V

After two years of congressional negotiations and dedicated work from member companies, AdvaMed secured a clean reauthorization of MDUFA V, which Congress passed and the President signed into law in October. MDUFA V grows FDA’s base funding level to help meet our industry’s increase in device review submissions and provides FDA the opportunity for additional incentive funding. The agreement includes many “firsts” for greater accountability, predictability, and consistency within FDA.

2: Advanced Good Governance Policies with FDA

The FDA oversees many top priorities of the medical technology industry. AdvaMed succeeded in securing reforms to FDA policies, including:

• Clinical Laboratory Improvement Amendments (CLIA) waivers,
• Issuance of Certificates to Foreign Governments for medical devices manufactured outside of the United States in select circumstances,
• Evaluation of third-party research on medical devices used for regulatory decision-making, and
• Allowance of predetermined change control plan submissions to ensure the thorough review of possible changes to a device without burdening FDA resources in future updates.

3: Unraveling Global Supply Chain Shortages

This year, AdvaMed staff serving on the White House’s Joint Supply Chain Resilience Working Group and advising FDA’s Supply Chain Resilience Program worked tirelessly to address the global and domestic supply chain challenges as well as the pressures they place on our member companies and the patients we serve. Team members held numerous meetings with federal government officials and key suppliers including representatives from the semiconductor industry and chemical industry to urge them to prioritize their health care customers who rely on these inputs and materials for their medical devices and work to prevent disruption in patient care.

4: A New Pathway for Emerging Technology

AdvaMed led an ongoing advocacy campaign urging the Centers for Medicare and Medicaid Services (CMS) to create a predictable pathway to Medicare coverage for new and innovative medical devices. In response, CMS has taken steps to develop a proposed rule called “Transitional Coverage for Emerging Technologies” (TCET) by its target date of Spring 2023.

5: The Future of Medtech R&D

AdvaMed’s advocacy for medtech R&D led to the creation of the first ever Directorate for Technology, Innovation, and Partnerships within the National Science Foundation. The $20 billion allocation established grants and incentives for domestic device R&D, manufacturing, and STEM education and placed medical technology as a top strategic priority for investment.

6: Support for Small Medtech Businesses

Following more than a year of AdvaMed and member engagement with congressional leaders, the Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) programs, vital resources to small and emerging growth medtech companies, were reauthorized for three years in September.

AdvaMed also worked with Deloitte and our members to update a white paper on the investment ecosystem and stave off changes to the qualified small business stock provisions in the tax code—preserving valuable provisions that encourage investment in these businesses and the recruitment of talent.

7: Addressing the European Union’s Medical Device Regulation Bottlenecks

AdvaMed’s advocacy efforts on the global stage, including in coordination with Medtech Europe, contributed to broad support in the European Union for legislative solutions to resolve the Medical Device Regulation (MDR) bottlenecks, with nearly all EU Health Ministers supporting an extension of the MDR transitional provisions. The proposed three-to-four-year extension still needs to be finalized through the EU legislative process and once implemented, would provide EU patients continued access to critical medical devices.

8: Greater Investments in Domestic Semiconductor Manufacturing

AdvaMed’s advocacy for increased investment in the domestic manufacturing of semiconductors, an essential component of tens of millions of medical devices, contributed to the passage of the bipartisan CHIPS Act, including $52 billion in investments and signed into law in August. Currently, AdvaMed staff is working with Commerce and DOD to steer those investments into chips manufacturing that will benefit our industry.

9: Addressing Racial Disparities in Health Care

AdvaMed’s widely-sourced report, “Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities,” presented thoughtful approaches to improving representation in clinical research to eliminate health disparities throughout the medtech industry.

10: Medtech Wins at the State Level

AdvaMed’s State Affairs team worked to ensure that right-to-repair mandates exempt critically important medical devices and blocked restrictions on health-related data-sharing. The team protected medical technologies from newly passed PFAS bans and disclosure mandates, in addition to increasing patient access to medical technology, such as biomarker testing. 

“Because of the hard work of AdvaMed staff and our dedicated member companies, we have advanced public policy beneficial for patients, secured historic funding for innovative technologies, found solutions to supply chain issues, and much more.” 

––Scott Whitaker, President & Chief Executive Officer, AdvaMed