Before they set foot in a design lab, master’s students in the Medical Device Design program at Duke University are already hard at work. Before the fall semester, students are immersed in the clinical environment––observing surgeries in the operating room, monitoring the daily activities in an ICU, and watching the every day activity of the Duke University health system.
During this time the students will take extensive notes, detailing things like how many tools are used for different procedures, sketching their surroundings and writing minute-by-minute accounts of what they see to identify potential unmet, underserved and unarticulated needs.
Is a surgeon having a difficult time handling a large tool? Are certain devices always in the way? Does a procedure always take a longer time than expected?
“By embedding ourselves in the clinical environment, we can begin to see real behavior rather than a set piece or training behavior, and you begin to see that what you expect and what actually happens are not always aligned, which is what we call discontinuities,” says Paul Fearis, a senior lecturing fellow in Duke Biomedical Engineering and one of the program’s leaders. “Those discontinuities may be opportunities, and as engineers, innovators and business people, we look at those opportunities and think how we can create solutions that will help.”
Led by Fearis, Eric Richardson, an associate professor of the practice in Duke BME, Joseph A. Knight, an adjunct professor in the Pratt School of Engineering and a faculty member in Duke’s Innovation & Entrepreneurship Initiative, and Kristy Fearis, an instructor in Duke BME, the master’s certificate in medical device design was created to prepare students for careers in the ever-growing medical device industry. The course sequence does this by closely following industry practices and taking students through the entire development process from upstream marketing, through design and prototyping to commercial, regulatory, quality management and manufacturing aspects.