Usability Validation of Complex Medical Systems

The end goal of the application of Human Factors to the development of a safety-critical medical device is to validate the device’s safety and effectiveness in the hands of intended users. Generally, the complexity of validation studies varies according to the device intricacy. In the case of complex medical systems, such as a robotic surgical system which can be used for prolonged periods by multiple user groups at the same time and may interact with other devices in the operating room, the planning and execution of such studies require much more thinking, organization, and resources. Bearing that in mind, we have grouped the effort involved in validating complex medical systems into four categories for an optimized, practical approach. This paper discusses these four categories and provides essential guidance, based on our experience.