The University of Utah offers a two semester capstone biomedical engineering design course (bioDesign) where products are developed and prototyped using the guidance of FDA Design Control mandates. During the two semesters, students are required to develop a project plan, marketing requirements, specifications, test plan, results and working prototype. Additionally, design reviews are regularly held in order to provide student teams with constructive feedback from clinicians, coaches, and course instructors. To foster a rich environment for innovation and to better instruct students in problem based learning, we partner student teams with design ideas that have been conceptualized by clinical advisors. This collaboration creates high value relationships maximizing the students’ learning experience while exposing them to best practices. This course offers unique challenges to the students; they must balance the creativity and innovation of design work with the documentation and regulations mandated by the FDA and other regulatory agencies. Since the inception of this course, we have identified various problems with student learning. Over the past 25 years, educators have begun to understand the importance of hands-on, interactive learning experiences in the undergraduate engineering curriculum [1,2]. Therefore, by overcoming the teaching and learning issues associated with this program, we hope to develop a course that empowers student teams to become effective, innovative engineers.

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