Dr. Gwenyth Fischer, director of The Pediatric Device Innovation Consortium at the University of Minnesota, thinks the seven year old group gives their inventors an edge.
The advantage could be summed up in one word: “location.”
Minneapolis-St. Paul is a major U.S. medical device hub — a tight-knit community of people with product development, regulatory, reimbursement and other expertise. The PDIC is able to focus not only on funding but on getting doctors and other academics with innovative ideas linked with Twin Cities experts to get their concepts commercialized. There’s also tight project management, with weekly, sometimes daily, calls and frequent advisory board meetings.
“We understand that academics have a lot of strong skill sets, but getting a device to market in those later stages is not what a lot of academic centers have the ability to do,” Fischer said.
[See Fischer discuss the health provider perspective of the medical device industry at DeviceTalks Minnesota, June 4–5 in St. Paul.]
“The idea is .01% of the total package,” Fischer said. “We have a lot of great ideas all the time. But the fact of the matter is that unless you have a strong development plan and a team willing to follow through, your idea is worth nothing.”
Fischer suggests that the PDIC is able to give their inventors prime access to medical product development expertise because of their location in Minnesota. Indeed, Minnesota — along with California and Massachusetts — is one of three major medical device manufacturing hubs in the United States. As of 2016, the North Star State had 29,790 medical device industry workers and 444 medical device establishments, according to state economic development data.
“It’s a huge medical device community, but it’s sort of a small person community in that I have gotten so much individual help and assistance and people connecting me to other people,” Fischer said. “Everybody knows everybody in this town, which I think is a major resource. People are very willing to help. You don’t see a cutthroat attitude here.”
Pediatric device innovation is needed because large legacy medical device companies are hesitant to spend resources on devices that only go to a portion of the population, according to Fischer. (They do have an interest in contributing, she said.) She started the consortium in 2011 while finishing her clinical fellowship in pediatric ICU at the University of Minnesota, because she was well aware of the needs.
“I was jerry-rigging devices. … I was using duct tape and cut out pieces from styrofoam cups trying to make this respiratory device fit this kid. And I realized how far back we actually are from adult [devices],” said Fischer, who became an assistant professor of pediatrics at the university in 2012.
The idea was offering free resources and expertise to helped pediatric device inventors accelerate through the “valley of death.” The consortium helped more than inventors over a few years before linking with university’s Office of Discovery and Translation, part of the NIH-granted Clinical and Translational Science Institute. The partnership in 2014 provided project management support, office space and funding for further growth.
The consortium presently has three programs for delivering funds to pediatric inventors: funds for faculty, outside industry partnering with faculty, providing a voice to patients and caregivers in the community. There are about 20 board members and $200,000–$250,000 spent annually on pediatric device innovation.
In one industry-academic partnership, Maternova (Providence, R.I.) is working with the PDIC and Dr. Tina Slusher to re-envision their Thermospot technology so that it can provide parents in developing countries an easy-to-use, low-cost adhesive temperature monitor. The monitor will alert parents if their infants’ temperatures are too low or high. “This is important because this is frequently the first sign of a serious infection in infants and would require a medical visit,” Fischer said.
Slusher and Dr. Ife Ojo will be conducting a clinical trial on the device soon, now that they have prototypes. PDIC is providing funds and project management support.
It’s but one example of what the consortium is able to do.
“We’ve grown substantially, and we’ve applied for some outside funding, because I think our next step is to take this model that we have at the U and to apply it to completely external projects,” Fischer said.