Four people sit over their laptops around a table in a cramped office on the University of Minnesota campus. It’s the weekly meeting of the Medical Devices Fellows and these aspiring innovators are reviewing their projects. Over the course of a year, the fellows will brainstorm hundreds of ideas, doggedly research them, and mercilessly cull the list to the best bets. They will read hundreds of papers, talk to scores of clinicians and develop multiple prototypes in a quest to build better medical “mousetraps.”
“The primary objective of this program is to be smart about what you’re inventing,” said Christopher Scorzelli, M.D., as he sits at the conference table with his colleagues. “Not just do it willy-nilly, but to have a calculated path about where you’re going.”
In the darkened room at the University’s Shepherd Labs, an overhead projector beams a spreadsheet listing dozens of tasks and projects. Some are identified only by code words because the fellows operate in stealth mode to protect their intellectual property and the University’s. Others are bizarre, such as the line item about buying a roast from Rainbow supermarket to test a prototype hemorrhoids product. Rump roast anyone?
Most fellows are professionals in their 30s and 40s who work for a fraction of what they might make in private industry. In exchange, they have an opportunity to innovate with freedom rarely afforded in the working world. Although only in its second year, the fellows program has already produced results: 15 provisional patents, one startup, one product license and three ideas being considered for licensing by major companies.
The office has the feel of a dorm room-meets-bootstrap company: two small rooms crowded by desks—one raised on blocks—espresso machines, a conference table and mountain bike. On the cinderblock walls, whiteboards are scrawled with notes. Cables and wires snake along walls and ceilings.
“To me, this fellowship really means teamwork,” said Karl Vollmers, a mechanical engineer Ph.D. and current fellow. “We are four very unique individuals. Put us all together in one very small room, apply a little bit of pressure, shake and see what kind of ideas explode out.”
The Discipline of Innovation
Founded in 2008, the Medical Devices Fellows Program allows four mid-career professionals from engineering, medicine, or biosciences to spend a year learning the discipline of innovation.
“Our primary goal is to educate the next generation of leaders on state-of-the-art medical devices,” said Marie Johnson, director of the fellows program. “Our second goal is to create commercializable intellectual property.”
The program is one of only a handful in the nation. It is modeled on a similar initiative at Stanford University, where Johnson did a postdoctoral fellowship after earning her biomedical engineering Ph.D. at the University of Minnesota. While at Stanford,Johnson approached Art Erdman, director of the Medical Devices Center and pitched an idea: why not start a medical device fellowship in Minnesota?
It was a natural fit because Minnesota is a hotbed of medical innovation. Over the last half-century, Minnesotans have pioneered open heart surgery, the pacemaker and countless medical devices. Minnesota has more than 500 FDA-registered medical device companies including Medtronic, Boston Scientific, St. Jude Medical, and countless small startups. The medical device industry represents three quarters of the biobusinesses in Minnesota.
The fellows program found a home in the Medical Devices Center, which is part of the Institute for Engineering and Medicine, jointly sponsored by the College of Science and Engineering and the Medical School. According to Johnson, the fellows program has a budget of $600,000 per year, mostly for salaries and prototyping (in addition to University funding, the program also is supported by Boston Scientific, St. Jude, and Symbios Clinical). Johnson hopes the program will become self-funding within five years through revenues from innovations produced by the fellows. The first class of fellows began in the 2008-2009 academic year.
The program has ambitious goals: to produce the next generation of medical device innovators and entrepreneurs. The fellows are tasked to identify fundamental technology needs and the technical barriers—and surmount them. They are encouraged to think broadly, work across disciplines, and cultivate interdisciplinary networks. Their goals: 20 viable devices by the end of the year, some of which hopefully lead to startups or licenses other companies.
There is stiff competition for the four fellowship spots. Last year, there were 80 applicants, 12 of who were invited for full-day interviews with a panel of industry executives, academics, venture capitalists, cardiologists, and current fellows. Afterward the judges retire to a room and evaluate applicants one-by-one in vetting that Johnson calls the “sorority download.”
“We’re looking for the perfect combination of team player, innovator, and tinkerer. We are also looking to balance the team with engineering and clinical expertise,” said Johnson.
The program looks for a combination of degrees in engineering, medicine, biosciences (most have M.D.s or Ph.Ds) and product development experience. They also try to balance personalities. Each applicant takes a Myers-Briggs test and Johnson consults with an industrial psychologist and tries to balance the personality types so they complement each other—and hopefully don’t drive each other nuts while working cheek-to-jowl 10 or 12 hours per day. As Johnson said, “We put them together, and we pray.”
The fellows begin with a bootcamp—and that term is not entirely an exaggeration. In eight weeks, the fellows meet with 110 guest lecturers, including many leading lights of the local medical device industry like Bill Hawkins, CEO of Medtronic, Manny Villafana, founder of St. Jude Medical, plus numerous vice presidents, researchers, physicians, entrepreneurs, patent attorneys, and venture capitalists. “Most days, it was four lectures per day, two hours apiece,” said Vollmers. “You’d go home and your head would be exploding.”
Next comes clinical immersion. The program takes advantage of the resources available at a major research institution. Fellows don scrubs and observe surgeries and accompany doctors on rotations. They visit medical device companies. The rest of the year is spent on identifying medical needs—the goal is 200 ideas—filtering them to a list of 20 and then drilling down one-by-one to devise solutions.
“We dispel the myth that it doesn’t take that much work, and it just takes a great idea,” said Johnson. “We drill down the fact that it takes a ton of work.”
Fellow Eric Little, a Ph.D. mechanical engineer and lawyer, was struck by the extent to which medical specialties were isolated from one another. “The number one surprise was the siloed-ness of the medical industry,” said Little, who became interested in medical devices when his 9-month-old son was diagnosed with unilateral hearing loss.
“The cardiologists are very focused on the heart, pulmonologists are very focused on the lungs, and nephrologists are very focused on the kidneys. Many times, there’s not a lot of interaction between the various specialties.”
On the bright side, that means those who can work across disciplines—as the fellows are trained to do—can see new possibilities. “It opens up a wonderful opportunity,” said Little, “because, if you can bridge some of those gaps, not only do you get better health care but you get some pretty neat products too.”
Some fellows like to say the program gives them license to ask dumb questions, which may provoke smart answers. Christopher Scorzelli always asked too many questions in medical school—a habit that sometimes annoyed his instructors and classmates.
“I was always directed away from asking too many ‘why’ questions—why do we do it this way? Why don’t we do it that way?—when I saw inefficiencies and problems treating patients,” he recalls.
Scorzelli wasn’t a cookie cutter med student; he had worked as an artist and house remodeler before enrolling in St. George’s University School of Medicine in Grenada, West Indies. He also was a handyman with a knack for building homemade devices such as a contraption to hold a bottle for his infant daughter and a ski-borne baby stroller.
“It’s the first time in a long time I’ve been in a position where creativity and innovation are greatly encouraged,” Scorzelli said of the fellowship. “It’s been a long time since I felt that way.”
Innovation at Work
Nobody likes pulling teeth—especially from dead people.
But that’s the problem the funeral industry was facing because of concerns about mercury pollution from the burning of dental fillings in crematoriums. Ultimately, the first class of fellows in 2008-09 devised a solution, which resulted in the program’s first license.
The Minnesota Funeral Directors Association approached the Medical Devices Center seeking a solution. At first, everybody assumed the task was building a dental device to extract teeth from the deceased. The fellows began brainstorming how to design a better tooth puller. One evening, they gathered around the table trying to hammer out a definition of the problem before heading home. They realized the task wasn’t necessarily preventing mercury from entering the furnace; rather it was to prevent mercury from being incinerated.
2008-09 Fellow Ben Arcand, a mechanical engineering Ph.D. and former research and development engineer at Boston Scientific, had a notion. Years earlier, he’d taken a class on blacksmithing for artists and had learned about fireproof ceramics. Could they fireproof the teeth? If so, there would be no need to pull them.
Fast forward through a lot of brainstorming, research, cadavers, and prototyping to the solution: a caulk gun-like device that allowed funeral homes to encase teeth with fireproof cement. According to Arcand, the lump doesn’t burn and can be removed from the ashes and disposed. The university donated the solution to the Minnesota Funeral Directors Association. As Johnson recalls, “The funeral directors gave the fellows a standing ovation at the Minnesota Funeral Directors Association (MFDA) annual conference.
Learning the Business
The fellowship repeatedly drives home one lesson: innovation is 99 percent perspiration.
In the course of researching a specific topic, each fellow may read 100 papers and talk to dozens of clinicians. They might watch surgeries, examine cadavers, and go through multiple prototype designs. As Johnson said, “If you define a problem well enough, the solution falls out automatically.”
Johnson pushes fellows to focus their ideas, pinpoints weaknesses in their arguments, and teaches the technologists the realities of business. “I force them to dig in and find the very specific place we’re going to sell this thing,” she said. “If it can be applied everywhere, in general you’ve applied it nowhere.”
Only a small percentage of ideas survive the scrutiny. They will kill ideas if they lack a clear entry point, if the market is too small, if the intellectual property is already claimed or if the fellows lack personal interest. Sometimes a good idea is not viable simply because it is unlikely to get insurance reimbursement.
Along the way, fellows can tap the resources of a major medical university. They have access to the Medical Devices Center and its state-of-the-art facilities for designing, prototyping, and testing new medical devices. They can consult colleagues at the Carlson School of Management for business advice and market research. They can rely on the university’s Office of Technology Commercialization and Venture Center for advice about patents and funding.
One example of an innovation cycle at work occurred when the 2008-09 fellows developed a device to treat chronic sinus infections. The idea began with a casual conversation when Johnson mentioned that her husband had sinus problems. The fellows added it to their growing list …and then forgot about it.
The idea sat on back burner for months before the fellows began sniffing around for a solution. They talked about nasal irrigation and removing mucus with vibrations, but none of the early ideas seemed feasible.
One day, Arcand and a colleague donned medical garb and latex gloves and went to the cadaver lab at Jackson Hall. Arcand brought along some pieces of wire, rulers, and started probing the nasal passages. He bent the wire into a fishhook and—voila!— it slipped into the maxillary sinus ostium. They realized it was easier to access the sinuses through the backdoor: inside the mouth.
“That was the eureka moment,” Arcand recalls. “The rest of the tool got designed around that idea.”
Next came another long grind of developing the product. They met with ear, nose and throat doctors at the University. They tested prototypes. Eventually they arrived at a design that combined Arcand’s fishhook shape with a balloon that inflates to clear the sinuses (similar to angioplasty). The device enables minimally invasive accesses to the maxillary sinus and can be used in an office setting—without surgery or drugs. In 2009, Arcand founded Labyrinth Medical, LLC, which he hopes will provide the vehicle to develop the technology.
Will it Fly?
This past year’s fellows hope for similar successes. They began with a goal to generate 200 ideas. They came up with 800.
They sifted the list to 20, which span a wide range of areas including cardiology, orthopedics, radiology, ENT, hematology, vascular, urology, dentistry, neurology, and dermatology. They began work on three projects involving a catheter, pulmonary hypertension, and women’s health.
“We’re all hoping that one of these projects we work on ends up giving us the technology to run with and actually start a company that will enhance people’s lives,” said fellow John Scandurra, a veterinary doctor and former mechanical engineer.
An entrepreneur must be a master of many trades, and fellows learn to approach problems from multiple perspectives: engineer, user, entrepreneur, healthcare provider, regulator, insurer, venture capitalist, and so on. They wear many caps; Vollmers even has a baseball hat that says “engineer” hanging by his desk.
“The center operates like a startup,” said Vollmers, who learned about being a Jack-of-all-trades while growing up on a farm. “There’s not a lot of money, so if you want something done you have to do it yourself.”
So they do. One recent morning after their weekly meeting, the fellows dispersed to their various tasks. Vollmers worked on a prototype catheter that he planned to show to a doctor later that afternoon. Scorzelli retreated to his “room of tranquility”—a quiet space down the hall—to write up disclosures. Scandurra scanned an email from Marie Johnson, with a detailed critique of one of their projects with point-by-point instructions. At the bottom, Johnson playfully signed off, “Your Tormentor, M.”
Scandurra sighed, "It's probably going to be a week's worth of work."