ARTICLE SUMMARY:
The pandemic continues to be a significant pressure point, but 2022 is, nonetheless, set to be a robust period of non-COVID medtech policy development and implementation. Here are the most important trends to watch and key Market Pathways’ articles from 2021 to make sense of it all.
2021 had a holding pattern feel to it. It was supposed to be the year that we all transitioned to a “new normal” as the pandemic subsided. And there is, of course, some progress in that direction. But there have been constant bouts of whiplash and restarts triggered by waves of COVID-19, new variants, and overwhelmed hospitals resulting in, among other problems, periodic pauses in elective procedures slowing growth across the industry and hindering a continued sense of forward momentum. That is certainly the case for government agencies and others that impact medtech market access. FDA, while taking some steps out of the 2020 shadows, hasn’t been able to transition as fully as it had hoped, hindered by the frequently changing facts on the ground of the virus. Efforts by European policymakers and notified bodies have also been slowed, and that has particularly impacted both the initial year of implementing the new Medical Device Regulation (MDR) and readiness for the upcoming In Vitro Diagnostic Regulation (IVDR). There are similar stories among regulators, payors, and other key institutions the world over.
It would be naïve for anyone to expect 2022 to be smooth sailing. But even with the likelihood of more pandemic setbacks, there are significant catalysts in play this year that will spur forward momentum on non-COVID medtech policymaking around the globe.
Here’s a spotlight on important medtech policy issues and developments to keep an eye on in the coming year and 2021 Market Pathways articles to provide context. Happy New Year.
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