[Construction of a methodology for clinical evaluation of medical devices using simulation tools and illustration through three studies]

Abstract

Introduction: European regulations have recently moved towards more stringent requirements for demonstrating the safety and performance of medical devices (MDs).

Objective: To apply an innovative testing method using medical simulation to the evaluation of three medical devices at different stages of their life cycle.

Method: The methodology for evaluating DMs using simulation is based on seven stages: definition of the context, training, construction of a scenario to test the DM, validation of the scenario, realization of the scenario, evaluation of the scenario by the players and validation and exploitation of the results.

Results: Our evaluation methodology enabled us to assess three DMs at different stages of their development: a respiratory protection device at the initial stage (prototype definition), a respiratory protection mask (prototype optimization) and bottle adapters (post-marketing).

Conclusion: Simulation is a valuable tool for evaluating DM. The proposed methodology enables it to be used and adapted to different contexts. It responds to the specificities of clinical evaluation of this class of products, and helps to better anticipate certain risks.

Keywords: Clinical evaluation; Dispositifs médicaux; Medical devices; Simulation; Évaluation clinique.