When does a medical device need preclinical evaluation, what do GLP studies involve, and how should founders plan for them?
Before a device is used in people, regulators often expect evidence from preclinical studies showing it is safe and performs as intended.
These studies are planned around the device's intended use. Surgical models, performance evaluation and safety studies are designed together with the research team and reviewed by an ethics committee.
Studies run under Good Laboratory Practice (GLP) principles produce data that regulators can rely on, while non-GLP studies are useful earlier, for refining a design.
Founders who involve a preclinical facility early can design studies that answer the right questions the first time.
