New Partnership to Accelerate Commercialization of Pediatric Technologies
The New England Pediatric Device Consortium (NEPDC), a non-profit research and education foundation aimed at dramatically improving commercialization of technologies and services for pediatric populations, was formally introduced. Founding members include The Center for the Integration of Medicine & Innovative Technology (CIMIT), The Institute for Pediatric Innovation (IPI), Massachusetts General Hospital for Children (MGHfC), Simbex, and the Dartmouth Institute for Health Policy and Clinical Practice (TDI).
NEPDC is a multidisciplinary, multi-institutional, collaborative consortium that provides infrastructure, expert consultation to innovators, and execution of technology translation and commercialization of pediatric technologies. “This powerful partnership provides a national resource to link the pediatric research, clinical care and innovation communities to industry, and will address the unique challenges surrounding the development and translation of pediatric products for clinical and consumer use“, stated NEPDC Co-Director Richard Greenwald, PhD.
There is a congressional mandate to support continued development and promotion of pediatric medical devices, which is overseen by the Office of Orphan Product Development (OOPD) at the FDA. MGHfC pediatric neurosurgeon and NEPDC Co-Director Ann-Christine Duhaime, MD, offered that “Although children represent 25% of the American population, pediatric product development lags far behind development of medical devices and drug products targeted for treatment of adults.” To combat this issue, NEPDC has the following mission:
- To evaluate the clinical, market and technology needs and opportunities for pediatric devices and technology solutions.
- To provide a targeted set of technology translation and commercialization services to pediatric technology developers
- To enable and encourage comparative effectiveness trials for pediatric technologies considered ready for clinical evaluation and use.
The FDA Safety and Improvement Act (FDASIA) reauthorized support for a section of the Pediatric Medical Device Safety and Improvement Act of 2007 which requires the US Department of Health and Human Services to provide demonstration grants to nonprofit consortia to promote pediatric device development. NEPDC recently applied to become a member of the FDA’s Pediatric Device Consortium infrastructure, a program operated since 2009 by the FDA OOPD, and which has included multiple non-profit centers based around academic and clinical centers.
“NEPDC will leverage significant technology commercialization infrastructure already developed at CIMIT, Simbex and IPI and combine that with the broad expertise in clinical needs evaluation and outcomes research from MGHfC and TDI to create four cores that form the foundation for the Consortium”, said Greenwald. “The expertise of the NEPDC team and our core partner organizations drive all areas of execution in the assessment of pediatric clinical needs, early stage product and market evaluation for small markets, technology assessment, regulatory pathway planning and implementation, prototype development, laboratory and animal testing, pre-clinical and clinical evaluation, comparative effectiveness clinical trial design, commercialization planning and transfer to manufacturing, and, ultimately outcomes assessment of the technologies introduced for pediatric populations. “
“This is a great opportunity to answer important questions related to pediatric device development, orphan technologies, and how to do technology transfer to move these technologies from bench to clinical use,” said Duhaime. “Together, we offer a unique team to rapidly advance scientific knowledge in pediatric device and orphan technology development.”