Over the past decade, digital health has become a burgeoning sector and ubiquitous term within the medical device industry. As a mountain of new digital heath products are headed to market, everyone is looking to Bakul Patel, associate director for digital health at the Center for Devices and Radiological Health (CDRH), to help develop a new least-burdensome pathway that also ensures patients are kept safe.
In 2017, Patel spoke to a group of stakeholders at the AdvaMed Digital Medtech Conference where he acknowledged that unlike other medical devices, digital health products that are often based...