Research Project
10247485
ABSTRACT NCC-PDI?s mission is to facilitate the development and commercialization of devices that are indicated for use in pediatric patients or that are intended to treat, diagnose, or cure diseases from which pediatric patients suffer. The Consortium has served as an accelerator to medical device innovators that intend to label their device for use, in the United States, in the general pediatric population or a subpopulation. The Food and Drug Administration?s report to Congress on ?FY 2016 Premarket Approval of Pediatric Uses of Devices? indicates that over a 9-year period (2008-2016), an average of almost nine devices were approved per year that were indicated for pediatric patients; this equated to an average of 20.5 percent Pre-market Approvals (PMAs) and Humanitarian Device Exemptions (HDEs) over this time. This represents a formidable progress that was achieved thanks in large to the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. A closer look at the data, however, suggests that the majority of these approved devices are labeled for the adolescent subpopulation (12 years through 21 years of age) in addition to older adults. There still remains a significant unmet need for devices labeled for subpopulations of neonates (birth until 1 month of age), infants (1 month until 2 years of age), and children (2 years until 12 years of age). NCC-PDI?s long-term goal under this RFA is to contribute to the national effort to address this gap and help bring more devices to market. Our short-term and operational goals are to continuously enhance our capabilities in providing expert advising and support services to innovators of pediatric medical devices, focusing on the total product life cycle for medical devices from concept, through pre-market development, to commercialization. We will reach our long-term and short-term goals by achieving the following specific aims. Specific Aim 1. Enhance the pipeline of high-growth pediatric device entrepreneurs with special considerations given to those who focus on the unmet needs of subpopulations of neonates, infants, and children. Specific Aim 2. Foster the advance of pediatric medical devices through access to a platform of experienced business, regulatory, reimbursement, medicine & science, engineering & prototyping, and trials design. Specific Aim 3. Through implementation of demonstration projects, develop, verify and operationalize methods of evidence generation and data usage, and demonstrate scalability across diverse devices and diseases. Our Consortium consists of lead members (Children?s National Health System and University of Maryland), members (BioHealth Innovation, MedTech Innovator, HealthCore/NERI, and Resnick, Chodorow, & Associates), and extended members (Smithwise, Cadence, I-ACT, PEDSnet, Bear Institute/Cerner, Digital Infuzion, Epidarex, Medical Murray, SFA Regulatory, CTSI-CN, CALCE, M-CERSI).
