Pediatric devices stall after FDA clearance: symposium maps the last mile

A one-day symposium in Chicago has confronted one of pediatric medicine’s most stubborn paradoxes: a medical device can clear every regulatory hurdle and still never reach a sick child. The 2025 Pediatric Device Innovation Symposium, convened on August 14, 2025 by the Consortium for Technology & Innovation in Pediatrics (CTIP), gathered clinicians, entrepreneurs, regulators, investors, supply-chain leaders and families to examine what organizers call the “last mile” — the tangled stretch between FDA clearance and real-world adoption inside children’s hospitals. The proceedings, published as a meeting report in BMC Proceedings on October 12, 2026, distill the day’s discussions into practical lessons for innovators and health-system decision-makers.

The scale of the problem is structural. Most medical technologies are designed, tested and labeled for adults, leaving pediatrics to rely on off-label use or legacy equipment, often trailing adult solutions by a decade or more. Small and heterogeneous patient populations, continuous developmental change and distinct pediatric risk–benefit profiles complicate evidence generation, which in turn complicates regulatory and reimbursement decisions. Even after FDA clearance, adoption can stall where misaligned incentives and low volumes magnify friction: value-analysis committees, supply-chain and Group Purchasing Organization (GPO) processes, staff training, and payer coverage and coding. The gap is most acute, CTIP executive director Juan Espinoza told attendees, for the youngest patients — infants and neonates — and the sickest children.

The federal response to this gap has been the Pediatric Device Consortia (PDC) program, established by Congress in 2007 to fund hubs that provide end-to-end support for pediatric device development, from need finding and prototyping to regulatory strategy, reimbursement and business development. The legislation was re-authorized under the FDA Safety and Innovation Act of 2012, the FDA Reauthorization Act of 2017 and the Food and Drug Omnibus Reform Act of 2022. CTIP is one of five currently FDA-funded PDCs and is now in its third funding cycle. Begun in 2011 as an internal grant between Children’s Hospital Los Angeles and the University of Southern California, it received its first FDA grant in 2013, expanded across the West Coast in 2018, and transitioned in 2023 to Ann & Robert H. Lurie Children’s Hospital of Chicago. Today it unites 25 partner organizations across eight states, has supported more than 220 pediatric device projects, contributed to the market entry of 33 devices, and helped portfolio companies raise over $500 million in combined capital, including $40 million in federal non-dilutive grants.

Espinoza framed the obstacles facing pediatric devices in four categories. Scientific and engineering challenges arise because children’s physiology and neurodevelopment change over time, demanding specialized materials, miniaturization and longitudinal human-factors work. Ethical challenges stem from children’s status as a protected class, requiring careful attention to consent, assent and the parent–child dyad in research. Regulatory challenges are stark: unlike drugs, there are no pediatric-specific FDA device testing requirements or pathways. And financial challenges reflect chronic under-investment and heterogeneous reimbursement. Development costs can range from roughly $30 million for many Class I and II devices to $200 million to $300 million for complex Class III devices, typically over three to more than ten years, while coverage and payment under Medicaid and commercial insurance remain variable and unpredictable.

The keynote fireside chat featured Kolaleh Eskandanian, now Chief Strategy & Innovation Officer at Compremium AG, whose career path ran from physics and mechanical engineering through telecommunications and strategy consulting into healthcare leadership at Children’s National Hospital. There she founded Innovation Ventures, the hospital’s commercialization arm, and catalyzed programs including the FDA-funded Pediatric Device Consortium, the BARDA-supported SPARK accelerator for pediatric countermeasures, and JLABS @ Washington, DC — the first life-sciences incubator on a pediatric hospital campus. She argued for durable financing models blending public incentives, mission-aligned private capital and philanthropy, earlier and systematic engagement with payers and health systems, greater reliance on pragmatic and real-world evidence in small populations, and intentional use of partnerships and accelerators to de-risk development. Devices designed, evaluated and labeled for children from the outset, she emphasized, demonstrably improve safety and equity.

The first panel tackled the last mile directly, and its central message was blunt: coverage — more often than coding or payment — is the dominant barrier for pediatric devices. Ryan Nolan of PRIA Healthcare urged startups to articulate the current standard of care and position their technology within the full patient-journey and payment pathway even before FDA clearance, and to design studies that yield safety, effectiveness and value data — utilization, care-team time, avoidable procedures — within a single program of evidence. Allen Passerallo of Vizient explained that pediatric volume constraints do not preclude GPO contracts when credible clinical differentiation exists, but that companies err by treating GPOs as mere intermediaries rather than conveners of clinicians and operational leaders. Katelyn Storton of Lurie Children’s described how Value Analysis Committees, multidisciplinary groups spanning infection prevention, administrators and practicing clinicians, are critical decision points where pediatric devices frequently stall; the single most important success factor, she said, is a clinical champion who can articulate value to administrators and peers. Cross-panel policy suggestions included requiring formal data submission for devices marketed off-label for extended periods, a standardized common application for hospital value-analysis and security reviews, and a pediatric analogue to Medicare’s transitional pass-through payment, since state Medicaid programs lack comparable mechanisms.

A second panel of attorneys, investors and industry executives examined how innovators reach scale through licensing, mergers and acquisitions, and corporate accelerators. Executive polling revealed consensus that large enterprise organizations consistently play critical roles as customers, development partners or acquirers across successful commercialization pathways, though timing perspectives varied. From the corporate side, acquisitions streamline intellectual property control and accelerate product integration, particularly when internal development capabilities are constrained; for founding teams, premature exits raise strategic concerns, but when scale requirements, quality infrastructure or market access become limiting factors, acquisition often provides the most efficient path to patient impact. Panelists emphasized rigorous strategic alignment assessment to prevent post-transaction product discontinuation, and recommended expanding narrow device concepts into platforms or service offerings, embedding corporate partnership roadmaps in investor presentations, and recruiting seasoned commercial leadership. Bootstrapping, they noted, is rare in MedTech; non-dilutive sources suit niche problems, and out-licensing deserves consideration.

The third panel turned to lived regulatory experience, and its case studies were striking. Linear Health Sciences’ Orchid Safety Release Valve for IV lines was accepted into FDA’s Safer Technologies Program and received 510(k) clearance for adult use in 2022; although designed to improve outcomes in children, the bar for pediatric-specific labeling proved so high that pediatric approval required a second 510(k) submission the following year. PyrAmes, which develops continuous non-invasive blood pressure monitoring for babies in the NICU including extremely low-birth-weight infants, received Breakthrough Device designation for its Boppli Monitor, secured 510(k) clearance in 2023, and learned that early FDA discussions should focus on study protocol and sample-size expectations rather than software algorithm details. Most dramatically, Renata Medical’s Minima Growth Stent — designed for implantation in neonates and infants, and capable of periodic re-expansion as a child grows, eliminating repeated stent-replacement surgeries — received Premarket Approval in late 2024, which the company characterized as an unprecedented achievement for a high-risk implantable device and a break from the long-standing practice of using adult devices in children off-label.

With HealthTech venture activity tightened since 2021 and capital gravitating toward later-stage, lower-risk companies, the fourth panel explored financing beyond traditional venture capital. Panelists noted that early pediatric deals face higher standards for novelty, market appeal and pathway to reimbursement, and that investors want clear connections to revenue-generating service lines plus data demonstrating economic impact such as cost avoidance and fewer complications. Alternatives discussed included family offices, which increasingly fund mission-driven early-stage MedTech and may accept less favorable terms when a deal aligns with solving significant problems; angel and physician investors; grants, recoverable grants and program-related investments from foundations and donor-advised funds; and incubators and accelerators. The symposium closed with a portfolio showcase of five CTIP companies — WearableDose, Luminoah, Makani Science, Madison Scientific and Renata Medical — where Luminoah, developer of the world’s first closed-loop enteral nutrition delivery system, won the Audience Choice Award of $10,000 in consulting services. The event drew 217 attendees from 23 U.S. states and three countries, earned an average rating of 4.8 out of 5 and a Net Promoter Score of 9.6, and left organizers with a shared aim: to shorten the distance between innovation and the children who need it most.

Subject of Research: Barriers to adoption and commercialization of pediatric medical devices discussed at the 2025 CTIP symposium

Article Title: Proceedings from the Consortium for Technology & Innovation in Pediatrics (CTIP) 2025 annual pediatric device innovation symposium

Article References: Espinoza, J., Zapotoczny, G., Riello, B., Afari, N., Christmas, M., Cashwell, J., Bent, M., & Bar-Cohen, Y. (2026). Proceedings from the Consortium for Technology & Innovation in Pediatrics (CTIP) 2025 annual pediatric device innovation symposium. BMC Proceedings, 20(S37), Article 39. https://doi.org/10.1186/s12919-026-00402-3

Image Credits: AI Generated

DOI: 10.1186/s12919-026-00402-3

Keywords: pediatric medical devices, FDA regulation, medical device innovation, health technology reimbursement, value analysis committees, venture capital, Pediatric Device Consortia, children's hospitals, medical device commercialization, CTIP symposium, health economics, MedTech partnerships