Design Phase of Public-Private Partnership Project Will Support the Development of Pediatric Medical Devices
North Bethesda, MD, November 20, 2023 – The Foundation for the National Institutes of Health (FNIH) is leading the design phase of a public-private partnership (PPP) to address the lack of availability of pediatric medical devices (PMDs) for children in the United States.
The initial phase of this project brings together the National Institutes of Health (NIH) and partners, including the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) as well as the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority’s (BARDA) Division of Research, Innovation, and Ventures (DRIVe), part of the Administration for Strategic Preparedness and Response (ASPR). These partners will provide funding and scientific and regulatory insight and expertise for the endeavor, with additional support from a diverse group of private sector partners, who will contribute supplementary funding and expertise.
Pediatric medical devices are tools used to treat, monitor or diagnose diseases and conditions from birth through age 21. Although there have been legislative, regulatory, and scientific efforts to support the innovation of PMDs, the availability of these devices for children is still lacking compared to adults. Challenges in developing these technologies can be due to child-specific characteristics—including physical and physiological factors and frequent developmental changes —and concerns about device longevity and long-term exposure to implanted materials. While some of these products are repurposed or modified from adult applications, they have not been approved for such “off-label” pediatric use, thus exposing children to a risk-benefit profile that the FDA has not evaluated. Further deepening this issue is a lack of incentives for pediatric medical device research and development within the industry.
The goal of the current phase of this project is to develop a comprehensive plan to build and launch a partnership that coalesces the resources of national government agencies and private sector organizations, including industry and non-profits. Additional aims include the assembly of a governance structure that will integrate and build on foundational elements developed through the System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) framework, initially proposed by CDRH and further developed with stakeholders across the nation (2021 pre-consortium workshop); the convening of a series of meetings for up to six integrated workstreams (for examples, Navigation, Hospitals, Regulatory, Finance, Decentralized Health Innovation, and Reimbursement); and the production of a white paper with a detailed plan to build and launch a multi-year public-private partnership.
“A national ecosystem that supports the development of pediatric medical devices from idea to patient use is critical to address the needs of pediatric populations,” said Joseph P. Menetski, PhD, Senior Vice President, Chief Translational Science Officer. “At FNIH, we are excited to support this public-private partnership that brings together all stakeholders in pediatric device development, distribution, and use to solve the health challenges affecting these kids and their families.”
A full-scale PMD-PPP to translate technological advancements in medical device design, evaluation, and approval for pediatric populations is expected to follow the design phase PPP. Ultimately, the project will support the creation of a sustainable infrastructure for the successful development and commercialization of PMDs to address the dearth in availability of medical devices specifically for the pediatric population.
- NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and National Institute of Biomedical Imaging and Bioengineering (NIBIB)
- Administration for Strategic Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA)
- U.S. Food and Drug Administration (FDA)
Additional NIH institutes and centers contributing funding for the design phase of the PMD project include the National Center for Advancing Translational Sciences (NCATS); the National Cancer Institute; the National Heart, Lung, and Blood Institute (NHLBI); the National Institute of Neurological Disorders and Stroke (NINDS); the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); and the National Institute of Mental Health (NIMH).
- Berlin Heart Inc.
- Children’s National Hospital
- Children’s Hospital of Orange County (CHOC)
- Johnson & Johnson
- Veeva MedTech
For more information about the project, including options to join as a partner, click here.
About the Foundation for the National Institutes of Health (FNIH)
The Foundation for the National Institutes of Health (FNIH) builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH), life sciences companies, foundations, academia, and regulatory agencies, including the Food and Drug Administration and European Medicines Agency. Through team science, we solve complex health challenges and accelerate breakthroughs for patients, regardless of who they are or what health challenges they face. The FNIH accelerates new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and helps train the next generations of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org.