Program seeks Council approval for an initiative titled “National Pediatric Medical Device Ecosystem”.
Medical technologies are transforming global healthcare, driving widespread adoption of medical devices to improve access to care, diagnosis, monitoring, treatment, and efficiencies. These advancements enhance clinical outcomes, extend lifespan and quality of life while reducing hospital stay and healthcare costs.
While the number of medical devices approved by the U.S. Food and Drug Administration (FDA) has steadily grown in recent years, those labeled for pediatric indications remain stagnant. Despite the recognized demand, device solutions are often unavailable for pediatric use, or devices approved for adult indications are used off-label with insufficient safety data, exposing children to inconsistent benefit-risk profiles. The rapid physiological and developmental changes in children, varying body sizes, and the absence of standardized endpoints exacerbate this issue. The shortage of pediatric-safe devices represents a major challenge for American children and for the healthcare system. Recognizing that children are not miniature adults, neonates are not miniature children, and preterm newborns are not small term infants and have unique needs distinct from older children, underscores the urgent need for medical devices specifically designed for, tested in, and approved for the intended pediatric populations. Dedicated pediatric medical device (PMD) solutions for prevention, early diagnosis, monitoring, and treatment of congenital and acquired conditions throughout childhood will significantly reduce the burden of chronic disease and improve long-term health outcomes.
U.S. Medtech innovation is driven by small businesses, who are vulnerable to failure due to costly and unpredictable product development and adoption, regulatory uncertainties and market entry barriers. PMD development is perceived as a high-risk and low-reward effort with high upfront costs for a low/unclear return on investment. Innovation and market growth have been hindered by a critical lack of unified national infrastructure to support the development, clinical validation, regulatory approval, reimbursement, and market entry of pediatric-specific medical devices.
This initiative will enable NICHD and NIH leadership in the implementation of a multi-stakeholder endeavor aimed at strengthening the national PMD ecosystem by: establishing a centralized infrastructure, adaptive processes and key operational capabilities to enhance the development, clinical validation, regulatory approval, and commercialization of pediatric devices; promoting synergies to improve utilization of existing resources, to avoid unnecessary duplication of support; facilitating the development of public-private partnerships; as well as granting access to specialized expertise for device developers. Ultimately, this infrastructure will enhance availability of safe medical device solutions for pediatric indications, transform pediatric healthcare and dramatically improve long-term health outcomes for American children.
This Initiative aligns with NIH and HHS priorities and the Presidential Executive Order on "Establishing the President’s Make America Healthy Again Commission;" with Goal 5 of NICHD Strategic Plan 2025: “Fostering Safe and Effective Therapeutics and Devices for Pregnant Women, Lactating Women, Children, and People with Disabilities;” and with OPPTB mission to “promote basic, translational, and clinical research to evaluate and improve the safety and efficacy of multiple types of therapeutics, such as (but not limited to) pharmaceutical drugs, biologics, medical devices, and regenerative tissue constructs.”
Program Contact
Antonello Pileggi
Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)
Back to Concept Review by Council
BACK TO TOP