PROJECT SUMMARY
The proposed team-based Medical Device Design and Innovation course will prepare undergraduate junior
and senior biomedical engineering students with a robust toolkit to be innovators of medical technologies with
the skills necessary to design devices that reduce medical errors and device failure hazards. A summer clinical
immersion, with a focus on identifying potential sources of preventable complications from medical device
adverse events and failures, will provide the students a widened perspective regarding the safe delivery of
healthcare. In addition, training during the semester long course in analyses of common causes of medical
device failure will provide the students the skills to develop devices responsibly.
The program will start in the summer with a clinical immersion for up to 10 students rotating through an 8-week
long rotation with Yale physicians and surgeons from 6 different specialties. Students will work with their
physician mentors to identify causes of preventable medical/surgical errors, device user-related hazards and
device failure hazards, with the goal of addressing these preventable complications with medical device design
projects. In addition, students will participate in didactics with a structured summer curriculum focusing on
needs identification, assessment and risk management.
In the Fall, the 10 summer students will continue their clinical immersions by shadowing 1 day a week, and
participate in a campus wide “device design speaker series”. Within the Spring semester course, each summer
Fellowship student will form the nucleus of a design team of 3-5 members. Based on needs / problems /
preventable medical errors identified within the summer and fall clinical immersion, the students, following the
biodesign innovation process, will design a functioning prototype and commercialization plan. Concurrently,
throughout the Spring semester, students will work on a separate failure analysis project to learn how to
pinpoint and simulate potential critical medical device failure mechanisms. Didactic lectures will include topics
such as the device design process, regulatory affairs, human factors engineering, responsible conduct of
research, and off-campus trips to medical device R&D facilities. At the end of the course, open access content
will be published as a free online curriculum, and students will submit papers to PubMed indexed journals.
The innovation of this application is to embed engineering students within a clinical environment, exposing
them to potential sources of preventable medical complications and device failures, as well as teaching them
how to identify, simulate and model critical failure mechanisms. This course, which seeks to attract
underrepresented minorities, will result in an improved pipeline of future scientists whose practical experience
in a clinical environment will facilitate their entry into biomedical engineering careers. The course will utilize the
engineering, innovation and medical research resources at Yale University. The University biomedical
engineering ecosystem will also benefit from collaboration between engineering faculty and clinicians.
