Turning Problems into Prototypes

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.

“The level of feedback we were able to get from our clinical partners really helped reinforce how real some of our devices could actually be, where we could take it beyond a school project and actually make into something that we could market to the real world,” says Craig Warlen, MS’19.

“The program actually inspired me to go to medical school because now I do know for certain that I want to work with medical devices, but in working with Duke Hospital I realized I know basically nothing about medicine,” he says. “So I want to learn about medicine so I can bring engineering back into that and then create medical devices with a more thorough perspective.”

In addition to an advanced design and manufacturing course, master’s students have the option to take a suite of courses in partnership with the Design Health Program. During these courses, students work in teams to identify a problem from a clinical environment. Once the problem is identified, they collaborate with clinicians and engineers across Duke to develop a prototype, which they’ll continue to refine and improve based on feedback from stakeholders. To round out the certificate and underline its industry roots students, can also take a course in Quality Management Systems, where they learn how to work within a regulated environment. This course provides the framework within which the core Design Health project is developed.

Once these courses are complete, students finish their certificate with two advanced biomedical design courses. 

Although the program involves a demanding workload for three semesters, recent graduates have already used their time in the program to find success in the medical device design industry.

“The experience I gained through the certificate program surpassed what I thought was possible in three semesters,” says Anna Matthews, MEng’20, now an engineering & regulatory affairs consultant at the Durham-based medical device startup ColoWrap. “In that time, our team completely designed and developed our device–from identifying the user needs all the way to initiating and designing an IRB-approved trial currently being run at Duke Hospital to clinically evaluate the performance of the device.

“My time in the program gave me more confidence and allowed me to be a successful contributor in my career,” she says. “I have been recognized for the quality of work, resourcefulness, and initiative I’ve shown – all of which have been developed further because of the MDD program.”

“This ‘more than I thought possible’ message is one we hear frequently, and it underlines the goal of the program, which is to take all the knowledge and experience students bring from their undergraduate studies, add more at the graduate level and then, most importantly, teach students how to apply all of that knowledge to the real world, just like an R&D team would,” says Fearis.

Although the program is open to students with limited design experience, those with a design background have found great success, both during the program and after graduation.

“I was already working in the medical device industry, but I’d been considering pursuing a master’s degree and Duke’s program really piqued my interest,” said Shyam Patel, MS’19, now an engineer at the Duke-born startup Restor3D. “Working with a lot of clinicians and getting their input actually leads you to designing a better product. Although that makes a ton of sense, it’s not necessarily the norm for the medical device design industry.

“You have so many resources you can use and learn from in the program, from Paul and Eric to the design spaces to the Duke Health system just across the street. The medical device design certificate was on par with what you’d experience in the design industry, and I recommend it to anyone who’s interested medical device design.”

Click here to learn more about the Medical Device Design Certificate and apply for the program.