Transforming a concept on paper to a tangible and functioning medical device requires a lot of time and research. And even more money.
It could take an estimated profit margin of $500 million or more before a tech company will move to invest in a new medical device, the Star Tribune estimates. Finding funding to reach that point is difficult to say the least. That’s why Gwen Fischer, M.D., assistant professor in the Department of Pediatrics of the University of Minnesota Medical School, teamed up with medical device colleagues to form the Pediatric Device Innovation Consortium (PDIC). The consortium supports research endeavors exploring new pediatric medical devices.
“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 in a Star Tribune interview.
Because of the costs and regulatory barriers associated with developing a new device, many never make it to market. The PDIC aims to curtail that by helping simplify and support the process of creating and implementing new devices into clinical care.
“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,” Sandra Wells, Ph.D., told the Star Tribune. Wells is assistant director of the Office of Discovery and Translation (ODAT) in the Clinical Translational Science Institute (CTSI).
ODAT is providing funding for PDIC projects.
PDIC is also seeking out parents of patients to identify which devices to pursue next, based on what problems they face and how that might be improved.
“[PDIC] is asking them specifically to describe to us an unmet need,” Jodi Fenlon Rebuffoni told the Star Tribune. Rebuffoni is a project manager for ODAT. “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,” she said.
With a concentrated focus on creating and developing new devices, UMN researchers are taking an additional step to improve the lives of children with health needs.
ODAT and the PDIC have awarded funding for six projects so far.