Abstract / Summary
The 2025 CTIP Pediatric Device Innovation Symposium in Chicago, IL, convened a multi‑stakeholder community of clinicians, entrepreneurs, regulators, investors, and families to examine how pediatric medical devices traverse the "last mile" from regulatory clearance to real‑world adoption. The program featured a keynote fireside chat with Kolaleh Eskandanian, PhD, followed by four focused panels: (1) procurement, reimbursement, and clinical adoption barriers within children's hospitals; (2) pathways for licensing, M&A, and corporate accelerator partnerships; (3) lived regulatory experiences of CTIP portfolio companies across FDA programs; and (4) investing in pediatrics beyond traditional venture capital. A portfolio showcase highlighted five CTIP companies (WearableDose, Luminoah, Makani Science, Madison Scientific, Renata Medical), with an Audience Choice Award recognizing standout innovation. Cross‑cutting themes included the need for earlier engagement with supply‑chain and finance stakeholders at hospital systems; clear value propositions that link device benefits to total cost of care; creative coding and payer‑evidence strategies; right‑sized quality systems and evidence generation for small pediatric markets; and diversified, mission‑aligned capital stacks (family offices, foundations, strategic partners, and non‑dilutive funding). This manuscript synthesizes session discussions, draws actionable lessons for innovators and health‑system decision‑makers, and outlines near‑term priorities for accelerating safe, effective pediatric device availability and access.