NEPDC Receives FDA Innovation and Commercialization Award

 In News

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, has been awarded a grant of up to $3.6M from the FDA Pediatric Device Consortium program through the Office of Orphan Product Development (OOPD). NEPDC member institutions include Massachusetts General Hospital for Children (MGHfC), The Center for the Integration of Medicine & Innovative Technology (CIMIT), the Institute for Pediatric Innovation (IPI), 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. “We are honored that the FDA found NEPDC’s approach to pediatric device commercialization innovative and worthy of participation in their broader Pediatric Device Consortium program. We are able to leverage the unique expertise of our Consortium partners to reduce the commercial risk and accelerate the delivery of pediatric devices and services to the clinical community and to consumers“, stated NEPDC Co-Director Richard Greenwald, PhD. “We are pleased that the grant will enable us to provide assistance to innovators and companies throughout the nation”.

The partner organizations that comprise NEPDC have significant technology commercialization infrastructure and experience across the medical device marketplace. NEPDC will work 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, and to enable and encourage comparative effectiveness trials for pediatric technologies considered ready for clinical evaluation and use.

MGHfC pediatric neurosurgeon and NEPDC Co-Director Ann-Christine Duhaime, MD remarked that “Devices that help children have the potential to affect their entire lives. Children make up a quarter of the population, but device development specific for and appropriate to children’s needs have lagged behind those of adults.” 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. “We are enthusiastic about adding the broad clinical experience and scientific expertise available at MGHfC to this effort, which we see as a major opportunity to improve health care for children”, said Duhaime.

NEPDC will participate as one of seven FDA selected sites to provide commercialization expertise and services to innovators from the clinical, bioengineering, and public sectors with devices and technologies to solve a wide array of medical needs in the pediatric population. “Significant progress can be made in the translation of technologies to the market with a focused effort on the specific commercialization challenges that pediatric medical device innovations must overcome. Understanding, qualifying and quantifying the specific clinical needs and problems to be solved are at the core of this effort”, added Don Lombardi, CEO of the Institute for Pediatric Innovation in Cambridge, MA.

Mike Dempsey, Entrepreneur in Residence, leader of the Accelerator program at CIMIT and director of NEPDC’s technology sourcing and evaluation core noted that “CIMIT’s mission is to accelerate healthcare innovation and improve patient care by facilitating collaboration between clinicians, technologists and entrepreneurs. Our proven track record of success in nurturing products from the idea stage into clinical practice and our focus on improving pediatric care allows CIMIT to bring unique expertise to the NEPDC. We are very pleased to add our capabilities and those of CIMIT’s global healthcare innovation partners to this effort, and are enthusiastic about the outcome.”

NEPDC will evaluate concepts and solutions across the commercialization spectrum, from raw ideas to near-to-market devices, and provide rapid and targeted assistance to the innovators, including limited funding support where appropriate, to move the concept more quickly to a solution that can be translated to clinical use. Products and services that require specific engineering development will be guided by the NEPDC Pediatric Device and Development core, led by Lebanon, NH based product development firm Simbex. “Pediatric medical device development fits clearly in our mission to develop products that improve the lives of individuals and we are excited to support and contribute to NEPDC’s mission”, added Jeff Chu, Simbex Vice-President of Engineering. “By leveraging our existing product development ecosystem that includes neighboring institutions such as Thayer School of Engineering at Dartmouth and our extensive entrepreneurial networks, including CIMIT and the Office of Entrepreneurship & Technology Transfer at Dartmouth, we will be able to source creative solutions for needs identified by our advocacy group partners and the clinical community, and subsequently bring these solutions from ideation to product verification through a rigorous and well-defined process.”

A unique aspect of NEPDC offerings includes the partnership with The Dartmouth Institute for Health Policy and Clinical Practice, a world leader in outcomes research. Through The Dartmouth Institute’s Comparative Effectiveness Research (CER) Program, investigators from across the Institute are working together to find the best approaches for providing care to individual patients and populations. The CER Program is committed to building a strong evidence base to inform patients and policy makers by pursuing innovative approaches to finding out “what works,” in both clinical and economic terms. Jon Lurie, MD, MS, leader of the NEPDC comparative effectiveness research core, noted “we are excited and honored to bring the experience and expertise of the Dartmouth Institute’s CER program to the important work of the NEPDC.”

“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“, said Greenwald.

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