Usability assessment of an intraoperative planning software

Usability is a crucial aspect of medical device safety. The brand-new European Regulation requires the manufacturer to assess the usability of the new medical devices. In this study, we evaluate the usability of a new medical device intended to assist the intraoperative planning with the visualization of 3d patient-specific organ models. The usability study started from the early stage of the device design and iterated through an early formative, completed with desk-based activities, late formative, completed with a focus group, and summative phase, that comprised a user test, and questionnaire filling. The identified usability issues are mitigated, the safety of the device user interface is confirmed and the training contents are defined and confirmed. Additional information regarding the user experience is collected and analyzed to identify further improvements of the device.