Risk management in a medical device software: evaluation of the usability characteristics of a 3D viewer for reporting

The theme of usability in the medical field is becoming of vital importance for the development of new software and medical devices that can meet users’ needs. The main purpose of this work is to design a usability test of a 3D viewer for biomedical images, by following the guidelines for the development of usable software, and then to define the procedures that should be used for future usability evaluation. In our specific purpose, the fastest access to all basic functionalities of the viewer was identified as the goal. The entire usability evaluation was designed to test the software from this perspective. The test environment was setup with all equipment necessary to conduct the test, specific and exploratory tasks were defined, test administration and collection of results have been planned. Finally, participants have been recruited and a pilot test was successfully conducted, validating the designed usability test.