What are the differences between a usability test and a clinical investigation?

Usability testing and clinical testing are two different approaches to evaluating products, particularly in the context of medical devices. Usability testing focuses on how well a product can be used by users. This includes ease of use, efficiency and satisfaction. For medical devices, this includes aspects such as operation, comprehensibility of instructions and effectiveness of the user interface.

In contrast, a clinical trial is an in-depth investigation of the safety and efficacy of medical interventions such as drugs, in vitro diagnostics or medical devices. The focus here is on the effects on patient health. Participants are carefully monitored to collect data on efficacy and possible side effects.

Clinical trials must be advised by an ethics committee and require a qualified clinical trial manager.