Although children represent 25% of the American population, pediatric product development lags far behind development of medical devices and drug products targeted for the treatment of adults. The applicant specifies that the main reason for this disparity is that the pediatric marke represents a small fraction of the whole medical market resulting, potentially, in a low return on investment for these companies and less incentive to invest in new pediatric product development. The applicants state that the New England Pediatric Device Consortium (NEPDC), an infrastructure resource center, will provide a national resource for pediatric and orphan technology researchers, clinicians, bioengineers, and technology inventors for translation and commercialization of pediatric and orphan technologies. The expertise and core partner organizations will provide analysis of clinical needs, early stage product and market evaluation, technology assessment, regulatory pathway planning and execution, prototype development, laboratory and animal testing, pre-clinical and clinical evaluation, comparative effectiveness clinical trial design, commercialization planning and execution, and outcomes assessment. The applicants indicate that the NEPDC will link the pediatric research, clinical care and innovation community to industry, and will address the unique challenges surrounding the development and translation of pediatric products for clinical and consumer use.
