From left, students Erik Davis, Trong Dong, Bob Janisch, Maria Ghaderinejad, and Kenneth Karanja


First-class innovators

Students in the new Medical Device Innovation program are learning how to get ideas to market

By Eve Daniels
Monday, September 22, 2014

Erik Davis and his colleagues have an intriguing med-tech innovation. Davis is co-inventor, co-founder, and vice president of technology at Birch Narrows Development, a startup in Stillwater, Minn. Their invention? An all-in-one unit for blood glucose monitoring that’s about the size of a credit card.

Problem: Getting the product to market might require more ingenuity than the invention itself. That’s one reason why Davis enrolled in the recently launched Medical Device Innovation program at the University of Minnesota, offered through the Technological Leadership Institute (part of the College of Science and Engineering). Classes in the graduate-degree program, which requires 14 months to complete, kicked off in May with about 20 participants. 

For $37,500 in tuition, students like Davis hope to gain an “end-to-end” perspective on medical device innovation and learn how to accelerate commercial success. “Typically [it] can take 10 to 15 years to get experience in all the different areas,” says Davis. “The MDI program is designed to help us see that in 14 months.”

The program took about eight years to plan, develop, and launch and reflects input from more than 150 stakeholders, including Medtronic, Devicix, and Boston Scientific. A huge undertaking, but it was worth the return on investment, believes Massoud Amin, director of the Technological Leadership Institute. “In an increasingly competitive industry where change is the norm, many factors can make or break success for new medical devices,” he says. “This degree meets a growing need for an interdisciplinary approach to graduate education in the field.”

The MDI faculty bring a premium blend of academic credentials and business experience to the program. As they plan and deliver their courses, the instructors draw on the lessons they’ve learned in leadership roles at med-tech companies large and small. 

“Every day, as a member of a product development team or an innovator, you have to work with individuals cross-functionally,” says Dan Mooradian, a seasoned med-tech executive who’s leading the MDI program and also teaching some of its courses, in addition to serving as director of graduate studies. Having held senior positions with Boston Scientific, Synovis Life Technologies, and Innova Medical Design, he believes “being trained as a leader and communicator and understanding the diversity of roles is critical. That’s something we try to give our students.”

The professional needs of students are a key focus of the program. When they enroll, the participants identify their therapeutic areas of interest, ranging from diabetes to heart disease to Parkinson’s. The MDI faculty then creates themes based on those interests. “We want to teach our students within a framework that’s going to be valuable to them in their careers,” says Mooradian. 

Those careers hold great promise, despite the domestic industry’s valid concerns about excessive tax and regulation in the state and nation. In the first half of 2014, Midwest health care startups had their best half-year in nearly a decade, with 139 startups raising $777 million, according to BioEnterprise, a business-formation and acceleration program based in Cleveland. 

About $342 million of that was raised by the region’s medical device startups. Among those, Minnesota ventures led the way, including Holaira, which makes a device to treat chronic obstructive pulmonary disorder, and Inspire Medical Systems, a maker of implantable-stimulation devices.

Part of the reason for the sector’s strength is simply that we’re getting older. In Minnesota, more than 23 percent of the population will be 60 or older by 2030, based on projections by the U.S. Census Bureau in 2009. Even now, the U.S. spends about $2.6 trillion per year on health care, according to the World Health Organization, which on a per capita basis is more than twice what most other nations spend. 

“Over time, as our population ages and our use of health care increases, we have to get that cost per capita down,” says William Murray, president and CEO of the Twin Cities–based Medical Device Innovation Consortium. “I think medical devices are part of the solution, not part of the problem.”

Murray stresses the need to develop more cost-effective devices for mobile monitoring, early detection and diagnosis, targeted drug delivery to minimize side effects, and less invasive procedures to speed recovery. The medical device sector, he says, is “ripe for disruptive change and innovation in technology.” 

Those innovations won’t necessarily come from the U.S., as suggested by the MDI program’s international diversity. Among the students are entrepreneurs like Kenny Karanja, a Kenyan-born scientist who’s working on low-cost diagnosis of infectious diseases in developing countries, and Maria Ghaderinejad, an Iranian-born electrical engineer who just received her first patent for a solar-powered study lamp and has med-tech plans as well. There’s also intrapreneurs like Yusuke Nozaki, a molecular biologist who will return to his job at Tokyo-based Terumo Corporation with a broader knowledge base. 

These international students share a classroom and common goals with home-grown talent like Angel Adams, who made valuable connections even before classes began. During the MDI orientation in May, she had a chance to discuss her idea for a pediatric medical device tax credit with several members of Minnesota's life science community. She has since garnered so much support for both the credit and a related fund that she’s temporarily left the MDI program to focus her efforts on them. She intends to resume the program next year. 

Meanwhile she also works as a market development associate for medical device contract manufacturer Donatelle Medical. That role makes it easy for her to see the program’s value. “Sometimes medical device companies develop devices without knowing the actual needs of the market, and that’s why it’s important for [them] to communicate with end users who know the patient needs and use these devices every day,” she says. “This program will help students bridge that communication gap in the industry by providing an aerial view of the entire medical device industry.”

As with Adams, 27-year-old Davis is already experienced in many aspects of the industry. In addition to his part-time work with Birch Narrows, the Minnesota native works full-time as an engineer with Lifecore Biomedical, a Chaska-based company that manufactures sodium hyaluronate (the “goo behind your eye” used in cataract surgery). 

“Long term, I’d like to stay in Minnesota, move into more of a management/operations role, and further develop our product at Birch Narrows,” he says. “I’d like to work full-time doing that someday.”

Davis and his partners at Birch Narrows have one patent that’s gone through and another that’s pending (as of summer 2014), and they’re working on ways to get their tiny blood glucose monitoring kit to market.

They’ll need to define a clear path to commercialization, notes Mooradian. That entails creating a credible plan, meeting regulatory requirements, using convincing data, and effectively communicating with investors. “In many respects, Erik is ahead of the game,” he says. “But he’ll likely face a number of challenges with the startup.”

Mooradian recalls the early years of his own career. “As a scientist and an inventor, I imagined that my work in industry would be somewhat like my work at the university.” 

Of course, Mooradian came to realize that invention, while critical, is only one small part of innovation in the medical device industry. He aims to help students reach that realization as early as possible, making it more likely they’ll succeed further down the line. “So many of my colleagues in the industry have said, ‘I wish I had access to a program like this when I began my career.’ My sentiments exactly.”