Defining Innovation in Digital Health Technologies
What is digital innovation? During the roundtable, digital health and social pharma innovator Shwen Gwee framed digital innovation as “The successful implementation of a creative new [digital] solution for a traditional problem.”
He also separated the types of innovation relevant to a corporation’s activities: incremental or disruptive, both of which are important to drive clinical trials forward.
Former FDA commissioner Scott Gottlieb, MD, expanded upon this idea, stating that real disruption leads to data collection that is more clinically relevant. One example would be developing a test capable of capturing biophysical performance in a longitudinal manner that is not episodic. For example, a patient who performs a six-minute treadmill test during a protocol-specified visit in a muscular dystrophy trial may experience fluctuations in performance or motivation. Capturing data only at regularly scheduled visits may not show improvement. Developing a tool that periodically records performance outside of a typical site environment could lead to more clinically relevant data if validated to a level of regulatory rigor.