This course will apply human factors engineering principles to the design of medical devices. Testing medical devices in a health care setting, with realistic users, will be emphasized to understand why devices fail to perform adequately. Students in this course will work in teams to complete an evaluation of a medical device design, existing prototype, or commercial product by conducting usability studies, with realistic users, to uncover use errors. Human factors engineering analysis will be used to propose and make design changes to improve the design and validation testing will be used to prove that design modifications yield a reduction in use-related errors. Throughout the course, topics will be covered as they relate to applicable medical device industry standards (e.g., quality and risk management of medical devices and usability and human factors engineering of medical devices) through lecture activities, examples, case studies, and the overarching design project.