Industry Experience Enhances Critical Lessons for MedTech Design Students

There’s an old adage commonly used for people entering novel situations: You don’t know what you don’t know. This is especially true in highly complex, quickly evolving arenas such as medicine. Complicate matters more by trying to design a commercially viable product from scratch, and it’s easy to see why 75% of medical device companies fail—even if their products receive FDA clearance or approval.

That’s why Duke University’s Master of Engineering in MedTech Design program is built to fill in its students’ blind spots through a wealth of industry experience. For example, classes focused on large-scale manufacturing practices and business fundamentals may seem like strange additions at first glance. But graduates of the program all agree: Industry-focused classes led by industry-seasoned professors give them insights and experiences that students from many other programs can’t match.

“Our instructors aren’t just academics: They are veterans of the MedTech industry, who have navigated the complexities of product launches and regulatory hurdles,” said Mike Lynch, the W. H. Gardner, Jr. Associate Professor and Director of Master’s Studies at Duke BME. “This is, and always will be, a point of emphasis for our MedTech Design program.”

Advanced Design and Manufacturing

There’s an enormous difference between tinkering with test tubes while conducting research in a laboratory and mass producing 2.5 million medical devices in a year. If you do the math, that comes out to six per minute if you want to sleep at all. And yet, that is the gulf that many BME undergraduates try to leap after graduation when entering the medical technology job market.

Duke BME’s answer to this predicament is called Advanced Design and Manufacturing. Born from the skills that the program’s faculty themselves wished they’d had when starting their first jobs, the class has proven eye-wateringly popular with students for one main reason.

“We make them design a real medical device from scratch,” said Professor Paul Fearis, who leads the class with his 35 years of medical device design consulting industry experience. “The outcome is entirely up to them. There is not a right answer, which is why products from cars to toasters and ultimately medical devices look different from each other. It’s an exercise in their own imagination.”

The basis for the class is a project that Fearis himself completed during his time in industry; a product development brief for the treatment of benign prostate hypoplasia. But beyond the basic challenge, the route students take to a solution is completely up to them.

For students who have not been through the engineering design process before, the task can be daunting. But it can also be exhilarating.

Students are encouraged to think outside of the box, filling sketch books and orthographic projections alike, which then must be transferred into Autodesk Fusion—a 3D design software platform commonly used throughout engineering fields. Schematics are then rapidly prototyped on 3D printers, providing tangible feedback to otherwise digital concepts.

Once students have a design that they’re in love with, Fearis said, “Then we force them through a giant reality filter.”

Students have likely not yet thought through the full manufacturing implications of their design. Whether or not it will work with the limitations of injection molding. If materials choices will end up being too expensive to be commercially viable.

“Paul leaves space for us to think through the design ideas ourselves,” said Jessica Allen, a recent graduate who had little medical device design experience coming into the program but was able to catch up on the technical requirements quickly. “In this class, we learn medical device manufacturing requirements not only through lectures, but also by applying them in our projects, which really helps solidify the material.”

Figuring out what materials already exist out in the world that could work for your device while not going over budget. Choosing designs based on what is easiest to manufacture and assemble to cut down on production time. Keeping holes far enough away from the edges so that manufacturing tolerances don’t make thousands of devices unusable. These are just a handful of the real-world issues students learn to consider.

“By the end of the class, students actually have a real-world story to tell when they interview for an internship or a job,” Fearis said. “Not just what courses they took, but something they designed and the pain and agony it took to get it right—and the knowledge that the experience equipped them to do it better the next time.”

Business Fundamentals in MedTech

Even with a great design that is easy to use, costs little to produce in large quantities and gets the job done effectively, there are still a thousand other variables that can affect whether a new medical device is successful. That’s where Business Fundamentals in MedTech comes into play.

The class essentially bridges the gap between engineering and the boardroom. Understanding reimbursement models, IP strategy and venture capital is what turns an engineer into a leader in the medical technology sector. “Business fundamentals was one of my favorite classes I’ve ever taken,” said Dora Eng-Wu, who entered the program with a biomedical engineering background but little business experience. “It’s kind of a breather from engineering classes since you’re exploring issues from a business standpoint.”

“It was a pleasant surprise to have the opportunity to touch on the business and management side of the industry,” added Allen. “I am excited be equipped with the skills to create a startup, the knowledge gained in the class is invaluable.”

After going over the fundamentals of business, management, venture capital and similar topics, students are put into teams and pitted against one another in a competition that may not seem related to medical technology: selling 3D-printed bicycles.

“Some fundamental principles are easier to teach with other tried and true business examples other than medical technology,” said Professor Joe Knight, who brings more than two decades of industry experience to the class, including perspectives from his current role of CEO of Simpson Interventions. “The class is always oversubscribed—I could have taught two full sections of it this past semester.”

Throughout the six-week simulation, hundreds of decisions must be made. What types of bikes to try to make and sell, and what the market segmentation looks like for those options. How those choices affect the manufacturing process. Marketing the finished product to a specific audience.

Throughout the project, students take turns week-by-week filling each of the vice president functional area roles to gain exposure to making decisions in each aspect of a company. Based on those decisions and simulated outcomes, teams receive “investments” from a venture capitalist to continue to grow their company. The class ends with a final board meeting to hear how each team went about their strategies and their final results.

“This is a course that I wish I’d had when I was going through my own master’s program,” said Knight. “The first half is heavy on me giving the students information, and the second half is them working through and experiencing those business fundamentals for themselves. That’s when the real lessons are learned and earned.”

“Professor Knight is a really caring and passionate person, and his energy fostered enthusiasm throughout the cohort,” said Eng-Wu. “And that’s great because the program is not easy. Having professors who can work with you in a way that feels truly helpful without simply giving you the answer is a great way to learn these topics.”

Real-World Value

Students laud these two classes along with the rest of the MedTech Design curriculum as providing them with invaluable lessons for both their required internships and their efforts interviewing after graduation.

“While my role was primarily engineering-focused during my internship at Canon Medical Research USA, it felt refreshing to be included in high-level business meetings where I could follow the discussion and contribute to the device’s development,” said Eng-Wu.

“As a research and development intern at Terumo Neuro, I saw tons of numbers being thrown around during quarterly meetings,” added Allen. “I wasn’t intimidated by them anymore and I could digest what they meant for the company.”