The role of usability testing and documentation in medical device safety

Usability testing is a technique that can be used to identify problems users have with a device. If usability testing is employed early in the development cycle, it can identify potential use-related problems and hazards so that they can be addressed early in the design and/or development process. The FDA's Center for Devices and Radiological Health has published a document that provides guidance on medical device use-safety and describes the benefits of usability testing to identify potential hazards. This paper describes the application of usability testing to the design, development, and use of a functional neuromuscular (cough) stimulator and the accompanying documentation. The purpose of the user testing was to observe participants using a device in a realistic situation. Iterative design and user testing is an effective way to 1. reduce or eliminate use-related hazards, 2. make an interface intuitive, 3. alert users to errors, and 4. provide aids for safe operation.