Optimal Usability Test Procedure Generation for Medical Devices.

Medical device usability testing offers many benefits, including finding medical device usage errors and providing safety to users. As usability testing becomes mandatory for medical devices, manufacturers are increasing the cost burden. In order to perform a high-quality usability test, it is important to implement a usability test procedure, but guidelines for this are lacking. In this paper, we propose a method to systematically design and implement a usability test procedure. We propose methods to reduce test time-costs and apply them to implement the final procedure. Next, by applying the proposed method to sinus surgical navigation system, it is shown that the total time was reduced by 21% compared to the usability summative test procedure previously used in the same system.