AdvaMed’s new agenda seeks to transform U.S. healthcare by promoting access to advanced medical technologies and ensuring policy supports timely patient access and innovation in medical tech.
Transformative Vision for Healthcare Innovation
On March 3, 2025, AdvaMed unveiled its comprehensive Medical Innovation Agenda, marking a pivotal moment in healthcare policy development [1]. The organization’s President and CEO Scott Whitaker emphasized the transition from what he previously termed the ‘golden age’ of medical technology to what could become the ‘platinum age’ through strategic congressional action [2]. This ambitious agenda arrives at a critical juncture, with the U.S. currently representing 40% of the global medtech market [3].
Addressing Critical Healthcare Challenges
A pressing concern highlighted in the agenda is the significant delay in Medicare coverage decisions, with current median wait times for FDA-cleared medical technologies standing at 5.7 years [3]. To address this, AdvaMed is advocating for several key legislative proposals, including the National Coverage Determination Transparency Act, which would mandate 30-day response times for NCD applications [3]. The organization is also pushing for critical reforms in light of recent challenges, including the February 2025 layoff of 230-240 employees at the FDA’s Center for Devices and Radiological Health [4].
AI Integration and Supply Chain Resilience
The agenda places significant emphasis on artificial intelligence integration, noting that while the FDA has authorized over 1,000 AI-enabled devices, current policies haven’t kept pace with development [3]. In response to emerging trade challenges, AdvaMed is actively addressing new tariff concerns, including the recent increase to 20% on medical device imports from China and impending 25% tariffs on Canadian and Mexican goods [4]. The organization emphasizes the need for medical technology exemptions to protect healthcare supply chains [3].
Future-Focused Policy Initiatives
The agenda outlines concrete steps for strengthening America’s medical technology leadership, with particular attention to supporting small businesses, which comprise over 80% of the medtech industry [1]. Key recommendations include modernizing HIPAA standards for AI applications, developing clearer guidelines for patient data authorization, and establishing new pathways for algorithm-based healthcare services [3]. These initiatives aim to create a more efficient, innovative healthcare ecosystem while ensuring patient access to cutting-edge medical technologies [2].