From MDR to Medicare to MDUFA, EU to Asia, AI to ethylene oxide, the editors of Market Pathways identify the five top issues, and five honorable mentions, to watch this year.
There could be an opportunity in 2023 for the dust to settle a bit in the regulation of medical devices after several volatile years. In Europe, an expected deferment on some Medical Device Regulation requirements could give gatekeepers and policymakers more bandwidth to figure out how best to oversee new innovative medtech as well as legacy products. More broadly, 2023 could be the year regulators transition from digging out of the COVID-era backlogs and actually adapt to that “new normal” people have been talking about for the past several years. US FDA, in particular, will be looking to leverage its new MDUFA V user fee income to both recapture some of its pre-pandemic successes and build new approaches to evolving technologies.
Reimbursement, as usual, is a more complicated issue to pin down. Clarity on the market-access economics for one type of medical technology in one country doesn’t necessarily translate to other situations. In the US, CMS may reach some important resolutions for the future of medtech in Medicare, but a lot of questions could also be left on the table. Digital health, and particularly AI/ML, is the technology area with the most to gain, and lose, from reimbursement and regulatory decisions that are on the line in 2023.
Here’s a spotlight on the most important medtech policy issues and developments to keep an eye on in the coming year, including five top picks and five honorable mentions, and recent Market Pathways articles for context. Happy New Year!