Active and Project-Based Learning in Medical Device Design

The field of Biomedical Engineering has grown rapidly in recent years. The Bureau of Labor Statistics states that there were approximately 19,300 jobs in Biomedical Engineering in 2020 and that employment of Biomedical Engineers is expected to grow by approximately 6% over the next 10 years [1]. Many students in Biomedical, Mechanical, and Electrical Engineering pursue careers in the medical device industry after graduation. To properly prepare engineering students for careers in the medical device industry, students must complete multiple hands-on design projects and receive training on unique aspects of the medical device industry, such as design controls and FDA regulations. We developed a new one-semester course to give students experience in designing a medical device, while at the same time following FDA guidelines for medical device approval. Students first identify an unmet clinical need by interviewing members who work in health care fields or by interviewing patients who use a variety of medical devices. Students also participate in an active-learning curriculum based on the FDA approval process, computer-aided design, and material selection for medical devices. By the conclusion of the course, students are expected to develop a feasible design and in some cases a prototype. Furthermore, the students' design notebook is transitioned to a Design History File at the end of the semester. [1] https://urldefense.com/v3/__https://www.bls.gov/ooh/architecture-and-engineering/biomedical-engineers.htm__;!!KIFmrYtlezdzESbnm_I!Xs22vyy2cCz-ul-GcJzwrxbKhXG-78fyW1X5JiCTQx9wtisrm9OF4s-s7dGihC2PIxmriQ$