CHOC is one of two pediatric healthcare systems in the nation directing a new effort to revolutionize how pediatric medical devices are brought to market.
The recently launched initiative is being led by the Foundation for National Institutes of Health (FNIH), a public-private partnership with the National Institutes of Health (NIH), and other government agencies to improve healthcare.
Two representatives from CHOC – Chief Scientific Officer Dr. Terence Sanger and Manager of Research Programs Nadine Afari – and one from Children’s National Hospital in Washington, D.C., are part of the 22-person committee that was announced in late September 2023.
The U.S. Food and Drug Administration (FDA) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) are co-leading the initiative.
“We’re sure this effort will have a significant impact on children’s health through greater availability of child-specific medical devices,” Dr. Sanger said. “We’re looking forward to collaborating with our colleagues across the NIH and FDA.”
The project is in the design phase, during which NIH and partners will develop a detailed plan to build and launch a partnership that will bring together the resources of U.S. government agencies and private-sector organizations, including industry and non-profits.
“It takes a village to support the development, evaluation, regulatory approval and commercialization of medical devices that meet the unique needs of children,” said Dr. Diana W. Bianchi, director of the NICHD. “We look forward to building a public-private partnership to enhance child health by increasing the number of approved medical devices for children.”
Few medical devices are designed and marketed specifically for children – instead, adult devices are often repurposed and used off-label in pediatrics, according to a paper published in the American Academy of Pediatrics in May 2022.
The paper, “Pediatric Medical Device Development and Regulation: Current State, Barriers, and Opportunities,” details how much work is needed to speed the process of bringing pediatric medical devices to market.
Pediatric devices number only one-quarter of those developed for adults and the availability and technological sophistication of pediatric devices lag behind their adult counterparts by as much as 10 years, the report said.
Clinically, innovators must adjust their products to address the smaller sizes, growth, and longer duration of use in children, the report said. Smaller sample sizes and population heterogeneity also challenge the ability to obtain sufficient safety data for regulatory submissions.
Financial concerns stem from lower pediatric reimbursement rates coupled with a lack of nationally standardized coverage, according to the report.
The report noted several promising initiatives, including the Pediatric Device Consortia Program, Early Feasibility Studies, and the new System of Hospitals for Innovation in Pediatrics – Medical Devices.
“However,” the report said, “the gap will likely not be narrowed without broad cooperation across stakeholders from industry, academia, patient advocacy groups, health care providers, investors, payors, regulators, and Congress.”
The FNIH creates and leads alliances and public-private partnerships that advance breakthrough biomedical discoveries and improve the quality of people’s lives.
Established by Congress in 1990, it is an independent non-profit that convenes public and private partnerships between the NIH, academia, life science companies, and patient advocacy groups.
“This is an opportunity to better understand the population differences within the pediatric subpopulations and educate our device innovators which is necessary to address the existing challenges and break down some of the long-recognized barriers,” Dr. Sanger said.
“CHOC also looks forward to sharing our research infrastructure best practices and our clinical expertise to support pediatric device development.”
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