PC3017: Outcomes and Impact of the 2013-2018 FDA Pediatric Device Consortia Funding Cycle

Background: Device innovation for pediatric patients continues to lag behind the advances made for adults, primarily due to financial, technical, and regulatory barriers. The US Food and Drug Administration (FDA) launched the Pediatric Device Consortia (PDC) Grants Program in 2009 to provide funding to non-profit consortia to support and promote pediatric medical device development. The PDCs support US-based pediatric projects through advising, feedback, networking, clinical and research partnership development, financial and other non-financial mechanisms. Here we present the outcomes and metrics of the recently concluded 2013-2018 grant cycle.

Methods: A total of eight PDC sites were funded in the 2013-2018 grant cycle. Data was extracted from the annual reports submitted by each PDC, provided by FDA’s Office of Orphan Products Development (OOPD). Data extracts were harmonized and analyzed with the input of FDA and the PDCs. Descriptive statistics were used.

Results: The 8 PDCs engaged with 898 pediatric medical device projects across 41 states and the District of Columbia, with the most common states of origin being California (n=218, 23.5%), Massachusetts (n=121, 13%), and Pennsylvania (n=73, 7.9%) (Figure 1). From a regulatory perspective, of 898 total projects, the class categories were: 254(28%) Class 1, 430(48%) Class 2, and 70(8%) Class 3 devices (Table 1). The supported devices were intended for neonates 406(19%), infants 501(24%), children 651(31%) and adolescents 532(25%). The top clinical specialties reported were neonatology (106), cardiology (99), and diagnostics (98).

The PDCs awarded $4,777,232 in direct funding to 145 projects; 245 projects raised an additional $188,720,969. At the time of the last report, the majority of the projects were in prototype stage (375), followed by concept (193) and pre-clinical stage (143). PDCs provided a variety of regulatory assistance including facilitating 22 OOPD contacts, 100 CDRH interactions, and 43 pre-submission meetings with FDA. The PDCs also provided advice on 265 applications submitted to FDA. Of these, at least 35 new devices, intended to benefit pediatric patients, received marketing approval.

Conclusion: The gap in access to and availability of pediatric medical devices requires a multi-pronged approach that involves key stakeholders from multiple sectors. The PDC program is one strategy Congress has implemented to address this public health crisis. The program has made significant contributions to the field, including shepherding numerous devices to market. With an increase in funding and scope for the 2018-2023 cycle, an even larger impact is anticipated. As new regulatory and financial incentives become available, particularly systematic solutions like SHIP-MD, the PDCs will be well positioned to leverage their funding and FDA connections to better support novel pediatric medical devices through advising, networking, partnership development, and grant making.