Aspiring medical device entrepreneurs have received mentorship and other support through Northwestern University Feinberg School of Medicine in the past, but on a case-by-case, ad-hoc basis. Starting in the fall, the school will significantly ramp up and formalize such efforts through a fellowship program called the Center for Device Development (CD2), which will be housed within the Innovation and New Ventures Office (INVO) at Northwestern University.
Three fellows―one doctor and two engineers with complementary skill sets―will work as a team while receiving structured help during the one-year program with everything from developing links to industry partners and innovation experts, to creating business plans, navigating complex regulatory processes, and building a case toward receiving patents. They also will be mentored by industry partners and experts from Chicago Innovation Mentors (CIM), a consortium of Northwestern, University of Chicago, University of Illinois at Chicago, and Argonne National Laboratory that provides mentor teams to support university-based and other local technology innovation ventures.
The CD2 concept was borne out of NUvention Medical Innovation, a two-semester Northwestern graduate course that pairs medical, engineering, business, and law students in teams to develop new medical technologies. The class provides a solid understanding of the basics but “isn’t quite a deep enough dive,” says David Mahvi, MD, chief of gastrointestinal and oncologic surgery at the Feinberg School of Medicine and professor in surgery-surgical oncology at the Robert R. McCormick School of Engineering and Applied Science. “We took what we thought was the best of NUvention and used this to develop a curriculum and a rotation schedule for fellows.”
Pat McCarthy, MD, chief of cardiac surgery and NUvention Medical founder, sees the CD2 fellowship program as the next logical step. “We think these fellows might be able to come up with new, novel ideas and improve upon what exists,” he says. “Device development is a fairly complicated process. Most of us learned it in on-the-job training.”
Teamwork and Collaboration
Dan McCarthy, MD ’08, who graduated in 2013 from the Kellogg School of Management with a dual-degree master’s that combines business administration with engineering management, learned device development at Northwestern without the benefit of a structured program.
“Everything we know about innovation from other industries is that there has to be a team element for this to be successful,” Dan McCarthy explains. “Because CD2 has a built-in team, that’s going to be a big advantage for these fellows.”
Establishing CD2 in INVO, as a partnership with the McCormick School of Engineering, provides a framework to involve Northwestern University engineering faculty. And that connection will give fellows entrée to facilities like the machine shop and prototyping facility on the main campus in Evanston.
Chicago Innovation Mentors will be another pillar of the program. Mentors will typically meet with fellows monthly, talk about progress, and comment on project direction, says Maryam Saleh, PhD, INVO invention manager. “We will also work with medical device design firms and have a venture capitalist on the steering committee to advise fellows on different business opportunities,” she explains.
The three CD2 fellows, who officially begin on Sept. 1, say they’re eager to commence. The one MD, University of Colorado general surgery resident Dr. Whitney Halgrimson, McC’03,attended Northwestern for his bachelor’s in biomedical engineering and economics. Along with an interest in design and engineering, he brings an important clinical perspective and medical informatics experience. Prior to medical school, he implemented new electronic medical records and research tools for inpatient clinicians and hospitals with Epic Systems.
“My hope would be to develop something that could be commercialized and marketed,” he says. “A more realistic goal would be to come up with something with distinct promise that will require additional work to identify the market and apply the product. … This gives me the opportunity to kick-start the learning curve.”
Engineering fellow Adam Piotrowski has been involved with clinical medical devices for about a decade in a variety of capacities, including entrepreneurship and business development. He has completed a fellowship through the FDA, worked at medical device startup InSound Medical, was a manager at Stryker, and is founder and CEO of his own medical device startup, Slipstream Health. Nonetheless, he says, “medical device innovation is evolving, and CD2 is a tremendous opportunity.”
“The chance to engage with leading thinkers and minds, whether that’s an engineering professor or a surgeon, is one of the main attractions,” Piotrowski explains.
The other engineering fellow, Joan Apolinario, McC’13, recently received a combined bachelor’s and master’s degree in biomedical engineering. She has strong product/technology development experience. She designed and tested needle devices as an intern at Angiotech Pharmaceuticals and radiofrequency MRI coil sets for a rabbit brain model as an intern at the Center for Basic MRI Research at NorthShore University HealthSystem. She also has working knowledge of design controls.
Apolinario hopes to develop another device during her time in CD2. “It’s a great opportunity for me to see all sides of medical device innovation, not just engineering but also marketing, and the processes of intellectual property,” she says. “Having mentors from Northwestern and industry there to push us in the right directions—providing guidance and support―is really critical.”
Dr. Mahvi expects these fellows―and those who follow them―will develop products that change the practice of medicine. “It’s a more lofty goal than just training people,” he says of CD2. “It’s to develop things that matter. The training is great, and we want to do that … but we also want to use this as a way to develop Northwestern companies that go out and change things.”