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.

Upcoming Events

Title: Public Engagement Session on Final Outputs of Workstreams
Date: June 17 & 18, 2024
Time: 9:00 am EST to 5:00 pm EST
Location: Hybrid Event (In person: Washington D.C. area) and Online (Zoom) – Both registrations and more information will be available soon)
Agenda: To be announced – Stay tuned for more details

Design Phase Partners

Public-Sector Partners

Private-Sector Partners

* Provides financial support for this Design Phase.

For more information about the project including options to join as a partner, please contact the Strategic Alliances & Advancement lead.

FNIH Contacts

  • Courtney Silverthorn, Ph.D.,
  • Vice President, Strategic Alliances & Innovation, [email protected]
  • Juan Esparza-Trujillo, M.S., GLPCP, GMPCP, Senior Project Manager, Science Partnerships, Translational Science, [email protected]
  • Heidi Blythe, MPA, Director, Strategic Alliances and Advancement, [email protected]

Resources

Pediatric Medical Devices 1
Developed from data  in CDRH’s/FDA’s annual pediatric medical device reports to Congress, 2021 (Click to enlarge)
Pediatric Medical Devices 2
Developed from data in  CDRH’s/FDA’s annual pediatric medical device reports to Congress, 2021 (Click to enlarge)

Private Partner Design Phase Benefits

  • Develop a cutting-edge program, as proposed by the SHIP-MD framework, to accelerate and enhance the development of devices for pediatrics and address a long-standing market failure and public health concern
  • Collaborate with public and private sector colleagues to forge a diverse and sustainable pediatric medical device ecosystem
  • Engage in scientific discussions on safely translating existing test methods to pediatric populations for regulatory submissions
  • Engage with regulatory partners and receive insights on pathways
  • Ensure that your organization and industry’s voice is heard in designing a system to serve a broad group of partners with diverse sizes and missions
  • Contribute to lowering the burden of market entry and creating new risk-sharing options.
  • Provide inputs that will address health inequities in high-risk/high-benefit areas (e.g., class III devices)
  • De-risk and streamline processes to enable the translation of medical advances from bench to bedside
  • Understand the capabilities and resources of federal partners that can be leveraged as part of a more significant public-private partnership infrastructure

Design Phase Workstreams

Each Design Phase workstream supports the overall device development pathway, from ideation to financial reimbursement.

Design Phase Workstreams

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