Pediatric Medical Devices Design Phase

Overview

Despite numerous legislative, regulatory, and scientific efforts in the recent past, innovative pediatric medical devices (PMDs) have yet to be made timely available at the same rate as adult medical devices. In many cases, the cause of this disparity is not a lack of technologies but rather a lack of incentives for the industry to become involved in PMD R&D. Furthermore, many innovative medical devices approved for adult use have not been approved for pediatric use; when used “off-label” in children, it exposes children to a benefit/risk profile that has not been evaluated by the FDA, deepening the health inequities between these two populations. Over the past 13 years, the FDA Center for Devices and Radiological Health (CDRH) developed multiple programs for accelerating the innovation of PMDs. Nevertheless, medical device development for pediatrics has remained relatively stagnant, as evidenced by premarket approvals (PMAs) and humanitarian device exemptions (HDEs) with labeling for pediatric usage. During this period, at CDRH, approvals of PMAs and HDEs labeled only for adults increased at about twice the rate of devices labeled for both adult and pediatric use and about 21 times the rate of devices labeled solely for pediatric use. These data point to the persisting lack of availability, and subsequent access, to medical device options designed and approved for the pediatric population, which is even more dramatic for the youngest patients. This is a long-standing and significant public health problem.

To address this inequality in our healthcare system, from 2023-2025, the FNIH will lead the design of a full-scale public-private partnership (PPP), bringing together the resources of multiple U.S. government agencies and private sector organizations, including industry and non-profits. The Design Phase of the PMD project will assemble a governance structure incorporating and building on foundational elements developed during the System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) 2021 pre-consortium workshop and convening a series of meetings for up to six integrated workstreams (i.e., Navigation, Hospitals, Regulatory, Finance, Decentralized Health Innovation, and Reimbursement). Additionally, this phase will produce a white paper with a detailed plan to build and launch a multi-year PPP. The focus is on the critical primary processes of building the national pediatric medical device ecosystem, as proposed in the SHIP-MD framework, which would include a network of hospitals, as well as associated but decentralized elements, optimizing public and private financing and reimbursement for R&D of pediatric medical devices, and ultimately creating a self-sustaining entity that will administer and manage the partnership over the long-term to benefit pediatric patients.

With the goal of launching a full-scale PMD-PPP in 2025, the project aims to consolidate a national ecosystem that optimizes the translation of technological advancements in medical device design, evaluation, and approval for pediatric populations. The project will de-risk and streamline processes enabling the translation of medical advances from bench-to-bedside for medical devices for children. The PMD-PPP project will strive to develop a sustainable infrastructure for the successful development and commercialization of pediatric medical devices. Additionally, the project will integrate existing frameworks and the expertise and resources of the public and private sectors into a strategic and actionable plan. Ultimately this PPP will address the lack of access to medical device options designed and approved for the pediatric population. The PPP also will allow new, impactful synergies with other key players in the emerging national ecosystem, shaping and contributing to the success of the ongoing and new activities.

Events

Title: Pediatric Medical Devices – Public-Private Partnership (PMD-PPP) Design Phase Meeting
Date: June 17 & 18, 2024
Time: 8:00 AM EST to 4:00 PM EST
Location: Hybrid Event (In person: Washington D.C. area and Online via Zoom)
Note: This meeting is for official PMD-PPP partners. Both in-person and online registrations are open. Further details will be provided to confirmed participants.
Additional Information:
The discussions and outcomes of this meeting are crucial for the next stages of our collaboration. While attendance is limited to official members of the PMD-PPP, we are committed to transparency and engagement with the broader community. The whitepaper resulting from these discussions will be distributed widely and made available upon request. Stay tuned for more updates and information on accessing the whitepaper.