Ties that bind
A DEVICE FOR HEALING FRACTURED JAWS BECOMES THE U OF M INNOVATION FELLOWS’ FIRST PRODUCT TO REACH MARKET
In 2012, head and neck surgeon Alan Johnson sketched out a number of new and promising concepts for medical devices. At the time, he was only a few days into the University of Minnesota Earl E. Bakken Medical Devices Center’s Innovation Fellows Program.
But as Johnson learned more about what it takes to turn a lab invention into a commercial product, he started to see technological, financial, and regulatory hurdles looming. One by one, he crossed ideas off the list. At the end, one promising concept remained: a new, noninvasive method for safely and securely closing the jaw to help it heal after a fracture.
Five years later, Johnson’s invention became the first technology developed through the fellowship program to enter the marketplace. Following a licensing deal with St. Paul-based Summit Medical Inc. and clearance from the U.S. Food and Drug Administration (FDA), the device is ready for use in surgeons’ offices, hospitals, and clinics across the country.
A better way
Jaw fractures most commonly result from blunt force trauma, such as vehicle crashes, sports injuries, and physical assault. Keeping a fractured jaw closed helps it heal properly, but the conventional metal wiring method presents problems. For the patient, a wired jaw is uncomfortable, can lead to irritation of the lips and gums, and can even contribute to gingivitis. For surgeons, the wires’ sharp tips are a safety hazard. One poke creates a risk for disease transmission.
Johnson’s invention is a set of smooth, blunt-tipped sutures inserted between the teeth that securely close the jaw with less discomfort and fewer dental hygiene problems than metal wires. A surgeon can apply these sutures more quickly and safely than wires, and may even be able to put the device on a patient in a clinic setting, reducing costs and minimizing treatment delays.
Keeping safety a priority and costs down could be good not just for patients and surgeons, but for hospitals and insurance companies as well. “We hope that this can decrease the cost of care by eliminating some operating room trips,” Johnson says. “That’s really why this technology has worked; all of the key stakeholders win.”
Woodshedding an idea
The Innovation Fellows Program caught Johnson’s attention when it was created in 2008. While doing his otolaryngology residency at the U, he spent time with the first class of fellows learning about what they were doing. When he joined the program after residency, he found it to be an immersive experience.
“The fellowship was extremely engaging, a very exciting, challenging, and humbling experience,” says Johnson, who now practices in Grand Forks, North Dakota. “You get exposed to all sorts of things, not just those in your particular field.”
The Minne Ties Agile MMF device wouldn’t exist today had it not been for philanthropic gifts.
The technology was developed through the U of M’s Earl E. Bakken Medical Devices Center Innovation Fellowship, a program that brings engineers, medical device professionals, physicians, and scientists together for a year to work on product development. The fellowship is funded in part by the Frank J. and Eleanor A. Maslowski Charitable Trust.
Head and neck surgeon Alan Johnson, who studied engineering as an undergraduate and led the device’s development team, learned of the program during residency at the U. “I had looked long and hard for opportunities to meld my medical and surgical training with my engineering background,” he says. “This was a prime opportunity to bring those backgrounds together to innovate.”
Johnson credits financial support from donors, as well as the help of volunteers from within the University and the medical device community, for making the idea a reality. “It takes a broad network of people committed to the concept and dedicated to the idea that the United States and the U should be a source for medical innovation,” he says.
Arthur Erdman, director of the Medical Devices Center (MDC), says Johnson’s work as an Innovation Fellow included finding out whether his approach to treating jaw fractures was sufficiently different from any existing patented technologies. He also had to ensure it would fit the teeth and gums of various people.
“When Alan started to explore the original idea, the potential medical impact was apparent to me based on my many past dental-related R&D projects,” says Erdman, who is the Richard C. Jordan Professor and Morse Alumni Distinguished Teaching Professor in the College of Science and Engineering. “The concept was simple and elegant, but he still faced significant engineering and manufacturing challenges.”
The program helped Johnson overcome those obstacles. He had the opportunity to test his prototypes extensively and gather feedback from medical device professionals and members of the University research community. Johnson also worked closely with co-inventors Laura-Lee Brown and Christopher Rolfes, both Innovation Fellows, and Samuel Levine, professor in the Department of Otolaryngology, Head, and Neck Surgery.
Partnering to reach the market
Erdman says Johnson and his collaborators’ ample testing and prototyping of the device helped them reach the point where industry partners would be more interested in adopting the technology through a licensing agreement.
“Alan took full advantage of the prototyping facilities at MDC,” Erdman recalls. “It seemed that each time I looked at the mechanical fabrication lab across from my office, I would see Alan busy making improvements on earlier prototypes.” He says the numerous design-build-test cycles resulted in a finished proof-of-concept that potential manufacturers could evaluate Johnson worked closely with the U’s Office for Technology Commercialization to patent the technology and, ultimately, to negotiate the license deal with Summit Medical.
Once Summit Medical licensed the technology, Johnson advised on many aspects of research and development. He assisted with instruction materials, bench testing, and FDA clearance requirements.
Ultimately, this collaboration resulted in the Minne Ties Agile MMF (maxilla-mandibular fixation) device. With FDA clearance, the device can now be used to treat jaw fractures in a safer, more com-fortable way.
“I hope that it’s adopted in a widespread fashion, and that patients and physicians feel that it’s better than what we’ve had before,” Johnson says.
Kevin Coss is a writer in the U’s Office of the Vice President for Research. A version of this story was originally published in the online publication Inquiry.
THE EARL E. BAKKEN MEDICAL DEVICES CENTER INNOVATION FELLOWS PROGRAM AT A GLANCESince its inception in 2008, there have been:
6 start-up companies
200+ invention disclosures
88 patent applications
5 patents issued
26 products licensed, optioned, or donated