HUMAN FACTORS ENGINEERING IN MEDICAL DEVICES
Human Factors Engineering (HFE) is the application of knowledge about human behavior, abilities and limitations to the design and evaluation of products and systems. HFE draws upon a number of disciplines, such as biomechanics, anthropometry, design, physiology and psychology to improve performance, reduce human error and enhance safety. The application of HFE to medical devices is critical to their effective and safe use. This is recognized by industry and regulatory agencies. In fact, all medical devices that are used by patients or clinicians are required to have a human factors evaluation in order to be approved by the Food and Drug Administration (FDA). This course focuses on the application of HFE in design, development and evaluation of medical devices. The educational goals are: a) to learn the fundamentals of HFE relevant to medical devices, and b) to understand the HFE process in medical device design and evaluation according to the Food and Drug Administration (FDA). The course will include didactics and hands-on experience.