Project Summary
The purpose of this program is to educate upper-division biomedical engineering undergraduate students in the
area of biomedical device design and development. The development pathway typically includes discovery and
ideation, invention and prototyping, pre-clinical and clinical testing, regulatory decision making, and
commercialization. We expect the training will lead to well-rounded biomedical engineers, who can recognize
specific needs in a biomedical problem, and develop a proper procedure to design and achieve a solution. The
specific aims of this proposed work are to enhance problem recognition by clinical observations and effective
peer and multi-disciplinary communications; to improve students’ ability to propose and validate solutions for
identified problems; and to integrate multidisciplinary training in research, development, prototyping, pre-clinical
testing, regulatory decisions, and social responsibility into one complete program. To accomplish the aims, we
provide a linked training experience to enhance student engagement and maintain project continuity. The training
includes six phases over the span of a year: (1) clinical workshopping in which the students interview clinicians,
discover problems, ideate on solutions, and define their year-long projects; (2) a numerical simulation course in
which simulation is integral to the design process; (3) summer clinical immersion in which the students attend
clinical conferences, view surgeries, and receive more in depth training on clinical aspects of biomedical
engineering; (4) capstone design course in which students work in larger multidisciplinary teams on detailed
design, prototyping, and testing; (5) regulatory affairs course including an FDA workshop and mock FDA
submission; and (6) commercialization training. A diverse group of ten students per year participates in the full
program including clinical immersion, but these students will work in larger multidisciplinary teams during the
class projects and capstone design course, thus broadening impact of the program. Besides technical skills, we
also consider development of leadership, teamwork and self-direction skills. By the end of the training, we expect
participants will be able to apply knowledge learned to a device development process in a self-directed manner.
We also expect that the training program will provide a broader impact to the department and institution, and
hopefully to future biomedical engineering undergraduate education.
