Courtesy of Yale News

Each year, the Yale School of Engineering & Applied Sciences offers a popular course in medical device design. This semester, “Medical Device Design and Innovation” — cross-listed under the departments of mechanical engineering and biomedical engineering — focuses on addressing challenges and shortcomings of orthopedic medical devices through clinical mentorship.

The course encourages students to cooperate, working in teams of three or four, to develop a viable and sophisticated prototype of a medical device that addresses clinical needs. Key components of the course include an overview of concepts in medical device innovation — including intellectual property, Food and Drug Administration and regulatory affairs — and clinical trials, as well as an overview of medical devices, like used infusion pumps, and technologies currently in use.

“We introduce students to the design process in developing a medical device, testing the device, going through regulatory protocols and the entrepreneurial part of it,” said course co-instructor Steven Tommasini, a research scientist in the orthopedics and rehabilitation department at the School of Medicine.

Next, the students analyze why certain implant devices failed using computer simulations. Troubleshooting is one of the most important aspects of medical device innovation, according to co-instructor Daniel Wiznia ’06, a professor of mechanical engineering and materials science and an orthopedic surgeon at Yale. Wiznia said that one of the class projects involves computer simulations to determine the causes of total joint replacement failure.

According to Wiznia, replacement devices typically last 30–40 years. Analysis of the implants using both simulations and examination of material properties may allow engineers and orthopedic surgeons to understand why these implants have a limited lifespan.

Throughout the semester, students will be asked to assess practical needs of physicians and surgeons in the clinical setting and create a prototype for a device that addresses these needs.

Wiznia explained that he brings a few of his students into his operating room each week when he performs hip replacements to expose students to a surgical setting.

After spring break, students will break into five different groups to work on their own devices, starting from scratch. By the end of the course, the devices will be prototyped and ready to be sent out for modification.

“The prototype will be sent for bench testing and maybe even future clinical use,” Tommasini said.

Throughout the semester, students have the opportunity to be mentored by clinicians from Yale New Haven Hospital, Yale School of Medicine and Yale Health. These clinician mentors, which include Yale orthopedics and rehabilitation professors Michael Leslie, Brad Yoo, David Gibson ’78 and Kristaps Keggi ’55 MED ’59, show students their clinical settings and surgical rooms to help students better gauge the challenges of practicing medicine.

Several Yale alumni are helping to teach the course. Among these are Gibson and Keggi, who are co-mentoring students in the joint replacement section of the syllabus. Throughout the semester, Yale alumni working in the medical devices sector will also visit campus to talk about their work at companies such as Stryker, Orchid Orthopedic Solutions and Yale Office of Cooperative Research.

“Medical Device Design and Innovation” is taught at the Center for Engineering Innovation and Design.

Viola Lee |