By Barbara Drosey
You’re a renowned pediatric plastic surgeon with a novel idea: a noninvasive solution to correct infant ear deformities that can save a child from potential self-esteem and functional issues. After creating a simple prototype of a molding device, you know you’re on the right track, but what are the next steps to ensure this solution reaches the right patients?
For starters, you could follow the lead of Scott Bartlett, MD, director of the Craniofacial Program at Children’s Hospital of Philadelphia and inventor of the molding system, and reach out to the Pennsylvania Pediatric Medical Device Consortium (PPDC) at CHOP, focused solely on bringing pediatric medical device concepts to fruition. The dearth of medical devices designed for pediatric patients necessitates inviting novel ideas and providing a forum for inventors. Of great importance for families is that insurance companies may not provide reimbursement for devices not specifically approved for use in children.
One of five consortia currently funded through the U.S. Food and Drug Administration’s Pediatric Device Grants Consortia Program, the PPDC receives and reviews applications for its own grant awards. In addition to grant awards, the PPDC has a new early stage development program in partnership with the Philadelphia-area medical device design company, Archimedic. This program’s goal is to take pediatric medical device ideas from concept to feasibility with expert engineering assistance.
By brokering partnerships within the business community, helping match innovators with funding, introducing them to a medical device developer, and arranging a presubmission meeting prior to seeking FDA approval, the PPDC is prepared to guide applicants through every step of their innovation journey.
New Name, Broader Reach
The consortium’s recent name change — it was formerly called the Philadelphia PDC— reflects a new partnership and statewide expansion. The renewal of its five-year grant made this a fortuitous time to solidify a partnership with colleagues and collaborators with University of Pittsburgh-based McGowan Institute for Regenerative Medicine and sciVelo.
“During the first five years [of the grant], we had a fair number of interactions with the University of Pittsburgh,” said Robert Levy, MD, William J. Rashkind Endowed Chair in Pediatric Cardiology and PPDC principal investigator. “It was a natural progression to make the partnership official.”
The PPDC’s Clinical and Scientific Advisory Committee (CSAC), which Dr. Levy chairs, is comprised mainly of CHOP faculty from a broad range of departments. But occasions arise where a specialty area or potential conflict of interest require review by another source unrelated to CHOP.
Through existing professional connections and relationship building, University of Pittsburgh and McGowan Institute colleagues were already sharing their expertise as part of CSAC. George Gittes, MD, director of the Richard King Mellon Institute for Pediatric Research at Children’s Hospital of Pittsburgh, and William Wagner, PhD, director of the McGowan Institute, now CSAC co-chair, had been involved in reviewing proposals.
“Everybody volunteers their time because they know the issue is important and they want to help,” Dr. Levy said.
From Concept to Implementation
While a large part of the consortium’s success is about putting the right people together, it’s also about continuous work with innovators. Once the CSAC reviews an application, looking at unmet clinical needs and the technical and medical considerations, the individuals on the PPDC Oversight Committee bring their business and entrepreneurial acumen, as well as their expertise in working with the FDA. If feasibility studies are needed, the PPDC assists with writing a phase one small business innovation grant (SBIR), after which a larger phase 2 grant may be sought to ready a device for clinical testing.
“The oversight committee does a great deal to really help the inventors and companies elevate things,” Dr. Levy said. “Dr. Bartlett's invention of the infant ear mold is a good example of this. We interacted with him through three iterations of his application over a two-year period. And then Shahram Hejazi, PhD, chair of the PPDC oversight committee, decided to support the project with his venture fund.”
Representatives from the five consortia participate in a quarterly meeting with FDA officials. Dr. Levy views the appointment of Vasum Peiris, MD, MPH, FAAP, FACC, FASE, as chief medical officer of Pediatrics and Special Populations at the FDA as encouraging.
“Trained as an interventional pediatric cardiologist, he has a lot of clinical experience and is active in advocating for pediatric devices and urging pediatric labeling,” Dr. Levy said.
The most standout pediatric medical device concepts merge innovative solutions with real-time clinical needs, and they have broad-reaching, cost-effective implications. For instance, among the nearly 100 devices the PPDC has supported is a portable, battery-powered, phototherapy system for treating high bilirubin levels in newborns. The company, Little Sparrows Technologies, that created the device received a 2018 Patents for Humanity award from the United States Patent and Trademark Office.
As lead PI of the PPDC, Dr. Levy looks forward to guiding the future of the consortium by continuing a project he and founding director Matthew Maltese, PhD, initiated.
“With genetic diseases and congenital malformations, there are many circumstances where off the shelf products just don't work,” Dr. Levy said. “The opportunity for us to set up a model to show how you can create personalized pediatric medical devices on a routine basis is one of the main goals I would like to accomplish over the next five years.”
In the course of the last FDA funding cycle, the PPDC acquired a 3D printer and medical grade polymer to create prototypes for anesthesia use in collaboration with Jorge Galvez, MD, MBI, anesthesiologist in the Department of Anesthesiology and Critical Care Medicine at CHOP. Dr. Levy considers this a good start.
“I don't think five consortiums are going to solve the pediatric device problem, but I'm hoping that the methods and approaches we have at CHOP and the other FDA-supported programs, which are sound in terms of how we help device innovators, get adopted by other institutions,” Dr. Levy said.