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.