Simulating Workforce Design Teams in Biomedical Engineering Education

PROJECT SUMMARY Engineering education must prepare trainees to meet the nation's workforce demands. Biomedical engineering students require early, practical experience to develop the technical skills, knowledge of regulatory pathways, and training in teamwork necessary to solve future unmet clinical needs. The undergraduate biomedical engineering capstone design course is often used as a “catchall” to develop these critical professional skills; however, in order to build competency, it is recommended that these skills be practiced throughout the curriculum, not just at the end. Our goal is to develop a core, sophomore-level, medical devices course in which students simulate the engineering teams found in industry in order to build workplace-ready skills. To accomplish this goal, we will implement innovative instructional methods. Sophomore-level students will work in teams, each with a defined engineering role. Teams will work through three medical device modules, and each module will consist of four main phases: needs identification, design requirements, regulatory, and ethics. Student teams will 1) evaluate how the engineering design process applies to the development of medical devices, with an emphasis on defining the unmet need, developing design requirements, and applying the voice of the customer; 2) create dimensioned models of medical devices by using computer-aided design; and 3) explain U.S. regulatory approval requirements to market different FDA classes of medical devices. We will leverage existing partnerships between the University of Delaware Biomedical Engineering Department and several local clinical sites to develop short videos of stakeholder perspectives of existing medical technologies, which will allow us to scale up some of the benefits of traditional clinical immersion courses and bring the voice of the customer to the students. Students will perform “device dissections” to take apart existing technology and learn how the medical devices work, benefiting from a hands-on experience that develops their engineering professional identities. Students will measure medical device components and recreate engineering drawings, building industry-valued computer-aided design skills. Embedded throughout the semester are professional proficiency lessons on high-performance teamwork and project management. Through this process, students will evaluate the broader context of medical devices, including regulatory, business, and ethical considerations. Overall, these approaches allow for explicit training in teamwork prior to capstone, scalable instructional methods, and early introduction to medical device design. Combined, we expect students to have increased biomedical engineering professional identity, industry-relevant skills, teamwork abilities, and identification of medical device career opportunities, leading to enhanced retention and representation in the biomedical engineering workforce.