Jodi Fenlon Rebuffoni’s 3-year-old son, Maceo, couldn’t sleep.
He was supposed to be taking part in a medical study of his sleeping problems, but all the wires and electronic gizmos glued to his body kept the Minneapolis boy awake. Rebuffoni’s frustration reached the breaking point when she realized the tech industry had made sure she could use her phone to turn up her stereo speakers, yet no one had invented truly wireless monitors so kids like Maceo could sleep during sleep studies.
Over at the University of Minnesota, pediatric critical care physician Dr. Gwenyth Fischer experienced a different aspect of the same problem. She invented a device to prevent adrenaline overdoses in children having heart attacks, but commercial interest in testing and selling it was nil.
The problem in both cases is the “home run” model of medical device innovation. The venture investors that pay for much of the early-stage medical device innovation in the U.S. typically insist on strong financial projections before backing a device because the risk of failure is high. Profit targets of $500 million or more for a new medical device are often mentioned.
Kids’ wireless sleep-study monitors and preloaded adrenaline syringes are unlikely to ever produce the kind of profits that someone could retire on. But rather than just vent about the well-documented challenges facing pediatric medical devices, Fischer in 2011 founded a volunteer group that uses the resources of the University of Minnesota and the local medical-device industry to get such devices on the market.
The group, called the Pediatric Device Innovation Consortium (PDIC), is using traditional methods like grants and close collaboration with inventors to kick-start new devices. For 2016, the group is planning to offer access to a pediatric device incubator plus a public outreach program to solicit ideas from not just engineers and doctors, but concerned parents.
The university’s Office of Discovery and Translation, where Rebuffoni is project manager, will provide about $250,000 in 2016 to fund PDIC programs with the goal of overcoming regulatory, scientific and financial barriers that keep lifesaving devices for children off the market.
“What we’d like to do is take products as far as possible with university help, so that when they exit the university system into industry, they are much more likely to succeed,” Fischer said. “Essentially, the more hurdles we can take on for industry, the more likely they are to take that product and run with it.”
PDIC is publicly funded with federal and university money, channeled through the U’s Clinical and Translational Science Institute, which then provides it the Office of Discovery and Translation for PDIC projects. PDIC itself holds no money, and the group has no paid staff.
Its 14-member board of directors includes physicians, executives, academics and lawyers who can provide feedback to inventors for free, regardless of whether a grant was provided.
Although big medical device companies may not be scouring the Earth for low-margin pediatric medical devices to license, they are at least at the table. PDIC’s board includes representatives from Boston Scientific, Medtronic and trade group LifeScience Alley.
For projects that receive grant funding, the U and PDIC expect the work to lead to “significant progress” toward forming a start-up company or licensing the idea to another company that will use it for pediatrics.
A diverse mix of projects
The six projects backed by the consortium so far range from bioengineering at Nils Hasselmo Hall to develop human-tissue heart valves that can grow inside a young person’s body, to a machine being tested in Uganda that can be built from locally available materials to treat breathing problems in preterm infants.
Other projects include a device to deliver drugs to patients on breathing tubes in neonatal intensive-care units and 3-D printed stents customized for a child’s anatomy to hold airways open.
Three new grants of up to $50,000 are planned for 2016, plus a new program to offer “kick-start” grants of up to $15,000 for promising pediatric device ideas presented at the U’s Design of Medical Devices Conference in April.
Keys to commercial success
Sandra Wells, assistant director at the Office of Discovery and Translation, said the modest grants represent only part of what PDIC does for applicants. In some cases, advice from experienced industry officials at PDIC may be more critical.
“Really, the biggest gap at this stage is expertise and knowing the right things to be doing with your small amounts of money,” Wells said. “If you don’t set that project up to be going on a track to be commercializeable … then it doesn’t matter how much money you put into it. If there is no [regulatory] pathway for it to get to patients outside of research, you could put millions into something and it’s never going to get there.”
Last month, the group quietly voted to collaborate with the local nonprofit DesignWise Medical to give PDIC-backed projects access to consultants and facilities that can incubate or accelerate new medical technologies for children.
“The advantage of this is instead of getting stuck in a university system, where it percolates for a long period of time, we will have industry people who are fast-tracking some of those high-impact needs and devices, with the purpose of getting it out and commercialized,” Fischer said.
The PDIC’s most radical idea, compared to other pediatric-device consortia around the country, may be its upcoming project called the Community Discovery Program for Child Health Innovation.
The program will encourage parents of kids at Twin Cities hospitals to submit their ideas about ways that technology could improve their children’s health care. Although ads will be posted in university hospitals, the portal to submit ideas on PDIC’s homepage, www.pdicmn.org, will be open to anyone.
“It is not asking them to have the idea for a device. It is asking them specifically to describe to us an unmet need,” said Rebuffoni, whose experience with her son’s failed sleep-apnea test inspired the Community Discovery program. “I’m sure many parents feel like there must be a better way to do this and they just don’t have any vehicle to move that forward.”