Philadelphia Regional Pediatric Medical Device Consortium Receives FDA Funding Receives FDA Funding

For medical devices, as with many medicines, the market for children is a small fraction of the adult market, and there are far fewer child-sized devices. But, of course, the need exists, even if proper devices may not.

“It’s not simply a matter of scaling down adult equipment for pediatric use,” said Matthew Maltese, PhD, a bioengineer at The Children’s Hospital of Philadelphia (CHOP). “Pediatricians have long known that children are not just small adults, and adults are not just big children.”

Maltese is the principal investigator of the Philadelphia Regional Pediatric Medical Device Consortium (PPDC), which brings together engineers and biomedical researchers from CHOP, Drexel University and the University of Pennsylvania to address the shortage of medical devices designed for children.

The PPDC recently received a $1.5 million, five-year grant from the U.S. Food and Drug Administration (FDA). One of only seven pediatric device consortia nationwide recently funded by the FDA, the Philadelphia consortium will provide clinical, business and regulatory expertise, as well as seed funding, to help translate promising, innovative ideas into commercial devices for use in young patients.

“For a variety of reasons, it is difficult to advance pediatric medical devices beyond the idea stage,” said Maltese. “We provide innovators with the support they need to transform concepts into practical and available medical devices that benefit children.”

Robert Levy, MD, William J. Rashkind Endowed Chair in Pediatric Cardiology at CHOP and a co-principal investigator of the Philadelphia PDC, also sees opportunities to help children, saying, “The Consortium will help to address unmet needs for pediatric medical devices.” Like Maltese, in addition to his CHOP position, Levy is on the faculty of the Perelman School of Medicine at the University of Pennsylvania.

Levy’s experience is reflected in his 35 issued U.S. patents that have led to extensive licensing activities, both to established medical device companies and to startups. One such example is the CHOP spinout firm, Vascular Magnetics, which is developing magnetically guided devices to precisely deliver drugs to injured arteries in children and adults.

Maltese and other CHOP investigators have expert collaborators in the Coulter-Drexel Translational Research Partnership, led by Banu Onaral, PhD, director of the School of Biomedical Engineering, Science and Health Systems at Drexel University.

The Coulter-Drexel Partnership provides expert business, regulatory and intellectual property advice to promising projects with a potential to be translated into commercial products.

“We are proud to join CHOP and the University of Pennsylvania in this consortium,” Onaral said. “The collaboration between Drexel and the PPDC augments Drexel’s translational research capabilities with the know-how of institutions from around the nation. The PPDC has adopted the Coulter-Drexel translational research process in order to ensure that the promising work of this consortium will have a good chance of making it to the physicians, clinicians and patients who need it.”

Through the Coulter-Drexel program, research is already under way that could help children with Attention Deficit Hyperactivity DisorderADHD and dyslexia. In addition, technology is being developed under the guidance of this program that will help pediatricians better monitor the movement of babies in the womb and in improving the difficult procedure of placing an endotracheal tube in an infant.

“The Philadelphia Regional Pediatric Device Consortium’s partnership with the Coulter-Drexel program will be a positive development for both groups,” said Davood Tashayyod, Coulter project director at Drexel’s School of Biomedical Engineering. “The Consortium includes some of the top innovators and clinicians in pediatric device development today. That, combined with the detailed diligence that the Coulter-Drexel program performs before considering any projects, will serve to maintain the high quality of products that come through the PPDC program.”

Rounding out faculty support for the Consortium are members of the University of Pennsylvania’s School of Engineering and Applied Science and Penn’s Perelman School of Medicine. As the center of the nation’s largest pediatric care network, CHOP offers a large, diverse pool of pediatric patients, allowing for carefully regulated clinical trials to test potential medical devices.

Maltese draws on his own experience adapting medical devices for children, in his position in Critical Care Medicine at CHOP. CHOP is currently collaborating with industry partners to develop pediatric versions of existing FDA-approved CPR quality feedback tools developed for adults. These smart phone-sized devices measure motion and force on a patient’s chest during CPR to rapidly produce sound and visual prompts that improve the quality of CPR and save lives.

The PPDC has formed advisory committees to assess proposals for both scientific and business potential, to provide bridge funding up to $50,000 to qualified projects, and to connect inventors with investors and the medical device industry.

“Some clinicians and investors have argued that pediatric medical devices are not commercially profitable, and thus most pediatric devices are adaptations of adult applications,” said Levy. “Not so,” he counters, adding that “Catheter-deployed artificial heart valves and Rashkind balloon atrial septostomy are examples of innovations that were used first in children and then spread to adult use.”