ARTICLE SUMMARY:
FDA plans to take big swings; EU policymakers shift focus to more fundamental regulatory reforms; reimbursement and global harmonization narratives evolve; artificial intelligence oversight advances; and more. The editors of Market Pathways identify the five top medtech market access policy issues, and some honorable mentions, that they will be watching this year.
Although wars and political volatility have dominated much energy and attention during 2023, there was another, more positive, global trend that has been adding some relative stability, in particular, to the medtech sector: the ebbing of COVID-19 as a global crisis. This has important implications for the medtech market access policies that we focus on at Market Pathways.
After years of COVID dominating health policy debates, federal agencies and others, over the course of 2023, have been able to broaden their aperture beyond pandemic-focused initiatives, resurfacing reform efforts that had been stalled by COVID or leverage new breathing space to reassess and rethink current policies. That shift, and other factors, has helped set up 2024 as a significant year for big-ticket medtech regulatory reform activities, particularly in the US and Europe.
Another macro trend that has major implications for the medtech sector is the accelerating developments in artificial intelligence/machine learning. Government efforts to properly regulate AI/ML will pick up substantially in the coming year in ways that have important implications for how medtech oversight evolves.
This is not to mention reimbursement, globalization, the fact that the US Environmental Protection Agency is preparing to issue a regulation with massive implications for medtech, among an array of other issues—from the broad-reaching to the highly focused—that will be important factors to the state of medtech market access over the coming year.
Here’s a spotlight on the most significant issues and developments that we’ll be keeping an on in 2024, including five top picks and some honorable mentions, as well as recent Market Pathways articles for context. Happy New Year!
