In Silico Trials for Device Development and Regulatory Review: Outlining the Need for Global Acceptance

The medical device industry has traditionally relied on bench testing, animal testing, and clinical trials to guide the development and assessment of medical devices. Global regulatory authorities have therefore established their review and approval processes around these three sources of evidence. In silico trials are a form of so-called digital evidence that can replicate traditional bench testing paradigms or performance in the target patient population in a highly controlled digital environment, which complements the other traditional evaluation techniques. However, the lack of clear and concise guidelines regarding model validation/credibility has limited the global utilization of this new source of evidence.

The US FDA established computer modeling and simulation as a regulatory priority in 2011. Through internal efforts and partnership with various device industry stakeholders, there is now a regulatory pathway that guides the medical device industry on the predictable use of computational model results in device submissions. This pathway provides new opportunities for the medical device industry to accelerate the development and introduction of new devices with higher reliability and at lower cost, from submissions based on digital evidence to virtual patients to in silico clinical trials.

This session will review this framework and then discuss the need to scale this opportunity to global authorities.