A great need currently exists for medical devices designed specifically for children, which is most likely a result of economic, clinical, and regulatory challenges as well as a lack of established mechanisms for connecting pediatric device ideas with qualified individuals / programs and industry partners to create innovative, cost effective and clinically relevant pediatric devices.

There are currently 5 pediatric device consortia supported by FDA P50 Pediatric Device Consortia (PDC) grants (West Coast CTIP - Southern California, UCSF/Stanford – San Francisco Bay Area, Pennsylvania PDC (PPDC), National Capital Consortium PDI - Washington DC, and Southwest PDC (SWPDC) - Houston, Texas) that support pediatric device innovators to create novel pediatric medical devices with local, regional, and national institutional and innovation partners (pediatric clinicians and surgeons, academia, engineers, industry, entrepreneurs, investors, and other partners).

GOAL:

The Pediatric Device Innovators Forum (PDIF) is a recurring collaborative educational experience designed to connect and foster synergy among innovators across the technology development ecosystem who are interested in pediatric medical device development. Each PDIF meeting will focus on a topic of interest to device innovators and of relevance to pediatric care, and feature presentation(s) from experts followed by an interactive discussion among participants. Each of the 5 consortia will host a forum approximately once per year. The series will be broadcast by and among the PDC and their partners in partnership with the FDA PDC program (OOPD) and CDRH, and registration will be open and free for any interested stakeholder.

OBJECTIVES:

1. Develop a “first of a kind” open forum addressing pediatric medical device development topics from a collaborative scientific standpoint

2. Support development of medical devices labeled for pediatrics, a CDRH priority and public health need

3. Enhance synergy among the FDA-supported Pediatric Device Consortia as part of the PDC program maturation model, supporting development of a nationwide PDC network

4. To build a collaborative community around pediatric device development that fosters community and facilitate collaborative actions among stakeholders interested in pediatric and special populations across the medical device ecosystem

5. Deliver strategic information to drive and accelerate pediatric device innovation

6. Explore Real World Evidence (RWE) projects for pediatric devices

7. Identifying and addressing unmet needs

8. Understanding off label use and the need for increased pediatric specific labeling

9. Explore pathways for patient (and family) engagement and patient matched pediatric medical device development

The U.S. Food and Drug Administration (FDA) has awarded grants to Pediatric Device Consortia (PDC) across the country that provide advice and support services to innovators of children's medical devices.

Legislation passed by Congress in 2007 established funding to be distributed as grants for nonprofit consortia to help stimulate projects to promote the development and availability of pediatric medical devices. This legislation was re-authorized as part of the FDA Safety and Innovation Act of 2012 and the FDA Reauthorization Act of 2017. The program aims to enhance the development, production and distribution of pediatric medical devices and has awarded $37 million to various consortia since 2009.

The PDC Grants Program was launched in 2009, and 2018-2023 grant cycle is the fourth time the FDA has awarded grants. Annual funding is approximately $1 million to $1.35 million per consortium. Grant support is contingent upon annual appropriations, availability of funding and consortia performance.

The consortia have assisted or advised more than 1,000 medical device projects since the program began. As of September 12, 2018, at least 19 pediatric medical devices became available to patients as a result of the PDC grants program, including a needle-free blood collection device that attaches to peripheral IV systems for use as a direct blood draw device; a surgical vessel sealing system for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles and a rapid infusion device that delivers fluids to a patient’s vascular system.

The current five PDC grant recipients and their principal investigators are:

• Pennsylvania Pediatric Medical Device Consortium, Robert Levy, M.D.

• National Capital Consortium for Pediatric Device Innovation 2.0, Kolaleh Eskandanian, Ph.D., M.B.A.

• Southwest National Pediatric Device Consortium, Chester Koh, M.D.

• University of California San Francisco-Stanford Pediatric Device Consortium, Michael Harrison, M.D.

• The West Coast Consortium for Technology & Innovation in Pediatrics, Juan Espinoza, M.D.

The goal of the FDA’s Pediatric Device Consortia (PDC) Grants Program is to facilitate the development, production, and distribution of pediatric medical devices through funding of nonprofit consortia.

FDA funds consortia that provide expert advising and support services to innovators of children's devices. These services include business and regulatory consulting, as well as device testing capabilities.

Specific areas of expertise provided by the consortia include intellectual property advising; prototyping; engineering; laboratory and animal testing; grant-writing; and clinical trial design.

A successful PDC brings together individuals and institutions that can support pediatric medical device progression through all stages of development—concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization. The consortia are expected to support a mix of projects at all stages of development, particularly the later stages of clinical, manufacturing, and marketing.

To accomplish this work, the consortia unite individuals, groups, or institutions to provide the following capabilities: knowledge of the clinical needs for pediatric devices, business planning, regulatory advising, intellectual property protections and other legal expertise, as well as scientific, engineering, pre-clinical, and clinical capabilities.

This program is intended to further the development of multiple pediatric medical devices; thus, grants are not awarded to support the development of a single device project. Although administered by the Office of Orphan Products Development, this grant program is intended to encompass devices that could be used in all pediatric conditions and diseases, not just rare diseases.

The FDA definition of “pediatric”, for purposes of device development, encompasses devices used for patients who are 21 years of age or younger at the time of diagnosis or treatment.

The FDA’s Center for Devices and Radiological Health, defines “pediatric use” as any use of a medical device in a pediatric population in which there is a primary pediatric indication OR a more general indication where considerable pediatric application is anticipated.