Putting Regulatory Science to Practice for Medical Devices

ACTP01What is the opportunity?

Demands for medical device evidence development addressing patient safety, therapeutic efficacy, and cost-benefit determinations are increasing. These evidence demands are well-documented drivers of medical device clinical trial size, complexity, timelines and costs. At the same time, and seemingly paradoxically, patient and provider demands for faster treatment access, and innovative treatment options are increasing. Given the legitimacy of these stakeholders’ data demands, combined with the realities of resource (budget and time) limitations, historical data acquisition techniques will soon no longer meet patient and provider needs.

While numerous solutions have been hypothesized in the literature, adoption of clinical trial solutions which both make clinical trials more efficient, and provide the data necessary to show safety and efficacy, has been scarce.