The Evolution Of Medical Device Clinical Trials: Adapting To Regulatory Changes

By James Jardine, Staff Writer, MasterControl

Groundbreaking technologies are altering the very definition of what is considered a medical device, and these dynamic changes necessitate the evolution of medical device clinical trials. Wearables, Software as a Medical Device (SaMD) products, and other innovations are transforming the regulatory landscape. At this rapidly accelerating pace, conducting clinical investigations for a new device in accordance with the latest regulatory requirements and industry standards is a challenge. It often seems that the speed of innovation is far outpacing regulators’ ability to provide up-to-date clinical guidance, which creates ambiguity. To minimize uncertainty and start getting a feel for the current regulatory climate, it’s helpful to first examine some of the characteristics that distinguish medical device clinical trials from other clinical investigations.