Matt Singer co-wrote this blog post with Sundeep Karnik.
Recently, the FDA announced new steps to modernize its 510(k) regulatory clearance pathway. This is the first major overhaul of a process that has been in place since 1976. The FDA intends to implement three major changes:
Medtech has always been known as an innovative industry. Most organizations are primarily focused on the next growth-driving product launch, whether it is an entirely new product category or a simple line extension. While this approach has been immensely successful in the past, many organizations are being forced to rethink their product strategy as the medtech environment changes.