Usability Testing of Medical Devices Used by Teams

Abstract

The current approach to validating the safety and effectiveness of most medical devices involves conducting usability testing with a single participant.However, this approach might not be appropriate for medical devices used by a team of individuals because it does not enable researchers to evaluate the impact of teamwork (e.g., collaboration, coordination, cross-checking) on the team’s use of the device. In this manuscript, we present four alternative approaches to conducting usability testing of medical devices used by teams, some involving a team of participants and some involving confederates who represent absent team members. We present important considerations for each approach and tradeoffs among approaches. Finally, we conclude by recommending an approach that best balances these tradeoffs.