Elective course in biodesign enables students to expand their abilities as medical device innovators

Educators at the Renaissance School of Medicine (RSOM) at Stony Brook University highlighted the success of their three-year, elective course in biodesign that has enabled students to expand their abilities as innovators to creating potential medical devices for the future. In a paper in Academic Medicine, a leading journal in medical education, the authors describe the program and approach, which may serve as a model for advancing medical education in the area of collaborative work using technology to design new medical devices.

As society moves further into the 21^st Century world of technology, physicians will play a growing role as clinician-innovators. Yet, few medical school curricula provide students with opportunities to learn the conceptual framework for clinical needs and prototyping of medical devices and what that involves, including intellectual property management.

Lead author Lauren M. Maloney, MD, Clinical Assistant Professor in the Department of Emergency Medicine and Adjunct Assistant Professor in the Dept of Biomedical Engineering, and colleagues point out that such programs are needed for medical training at the undergraduate level. A 2016 survey of 158 allopathic medical schools in the United States revealed that only 13 such programs existed supporting the learning of medical device innovation.

From 2017 to 2021, the RSOM program enrolled five cohorts totaling 37 medical students. The first full entering cohort of 12 students produced eight biomedical engineering projects.

One of these projects involved developing a shield that attaches to a syringe to reduce needle-stick injuries when giving medication injections, such as a vaccination. This team went on to file for a provisional patent, presented at the 47^th Annual Northeast Biodesign Conference, and recently received first place at the 2022 Stony Brook University Small Business Development Center Entrepreneurs Challenge. Two of the undergraduate team members are now graduate students in the Department of Biomedical Engineering.

Another project involved a team of students who created an adaptor for a tool used in neurosurgery to reduce tension placed on tissues; this team won the Stony Brook University WolfieTank Competition in 2019 and went on to file a provisional patent. Two of the team members who were at the time biomedical engineering undergraduate students have now joined the RSOM, entering in fall 2021.

Students reflecting on the course reported a change in their attitude towards existing medical problems, felt better-equipped to collaboratively design solutions for clinical needs, and considered a potential career path in device design."

Dr. Lauren M. Maloney, Lead Author

She and co-authors also point out that the Covid-19 pandemic highlighted the value of training future physicians in medical device innovation as limited availability of life-sustaining and protective equipment early in the pandemic drove many to develop temporary solutions – a scenario that underscores the need for skills that are necessary for developing medical device innovation.

The RSOM program is novel in that it lasts for three years during a medical students academic training and involves interdisciplinary work in areas such as biomedical engineering, computer engineering, and multiple clinical areas. The students work collaboratively in the biodesign process in four stages: seminars and small group work; shared clinical experiences and needs assessment and findings; concept generation and product development; and reflection and mentorship around the created innovation.

The authors say that the elective course offers medical students and clinical faculty a creative outlet that "embraces interdisciplinary collaboration and develops a shared language of medical device innovation."

In the future, they hope to create a space within the RSOM and hospital to provide rapid prototyping tools such as 3D printers, electronics stations and sewing machines that are readily available, along with dedicated space for students and faculty to develop their device innovations.

This published study was supported in part by a National Institutes of Health (NIH) R25 grant titled "Development of a comprehensive biodesign curriculum to promote biomedical innovation."