Roadmap to Early-Stage Medical Device Design through Experiential Learning and Role-Play

Purpose: Biomedical engineers that have the ability and skill sets to comprehend and retain basic anatomy and physiology (A&P) knowledge, apply fundamental engineering principles, use critical thinking, and communicate effectively across multiple disciplines to facilitate successful development and clinical translation of medical devices. The authors created an undergraduate medical device design course that follows a roadmap for developing novel devices and/or innovative technology from concept to clinical product with the course focusing on the early-stage of the development process. Methods: A holistic approach is taught from the unique perspective of inventors, investors, and surgeons (IIS) by integrating interactive presentations, guest lectures, labs, field trips, and role-playing activities into a 15-week curriculum and meets ABET student learning objectives. Individual assignments require oral presentations and written reports that mimic project leaders on design teams, and group assignments are completed through IIS role-playing. These activities culminate with individual student design projects that help build self-confidence in their ability to successfully jump into and navigate the medical device development process. This is accomplished by identifying a clinical need, formulating an innovative concept, defining design criteria, fabricating a prototype to demonstrate proof-of-concept, bench testing to demonstrate feasibility, completing an invention disclosure, making an elevator pitch with constructive classroom critique, and writing an executive summary and detailed report emulating a NIH SBIR Phase I grant. Results: Course effectiveness was demonstrated by: (1) 204% improvement in A&P knowledge, (2) positive role-playing evaluations (98.7% of students reporting that it was a useful educational experience, written feedback), and (3) favorable course evaluations. Conclusions: A roadmap for early-stage development of medical devices using a holistic, experiential learning approach is presented to prepare undergraduate bioengineering students for future healthcare careers as engineers, scientists, clinicians, and/or entrepreneurs.