Human Factors Engineering for Medical Device Design and Development

During this two-day live training, ECRI’s human factors engineers will describe and demonstrate how to apply human factors engineering techniques to the design and evaluation of medical and drug-delivery devices. The instructors will present best practices for learning about target users and their work environments and explain how this information is used to support device safety, effectiveness, and ease of use. In addition, the instructors will introduce three different methods for evaluating the safety and usability of devices, explain what factors should be considered when selecting a method, and provide hands-on experience applying each of the methods through group activities. Finally, instructors will review FDA 510K guidance and requirements related to medical and drug delivery device design and evaluation, including how to communicate evaluation results and prioritize recommendations.