Executive Summary: Human Factors is now becoming one of the most critical stages in the design process for medical devices. This is in part due to the FDA’s increased enforcement of Human Factors, as well as the industry’s realization that Human Factors can dramatically affect the success of a product. Introducing Human Factors early in the design process allows for usability testing with iterative prototyping, allowing bad designs to fail sooner, rather than later. Usability testing will also better prepare the product for submission to the FDA, answering any questions the FDA may have regarding safety and efficacy of the device with respect to usability.
For more information on Human Factors, the FDA’s approach to Human Factors, and how Usability testing can increase the success of a medical device, read Shannon Clark’s article in the latest WSGR Life Sciences Report.