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.”
About New England Pediatric Device Consortium
NEPDC is a non-profit multidisciplinary, multi-institutional, collaborative consortium that provides infrastructure, expert consultation to innovators, and execution of technology translation and commercialization of pediatric technologies.http://www.nepdc.org
CIMIT is a non-profit consortium of Boston’s premier teaching hospitals, universities and labs founded by Mass General Hospital, Brigham & Women’s Hospital, MIT and Draper in 1998. CIMIT has grown to include Beth Israel Deaconess Medical Center, Boston Medical Center, Boston University, Boston Children’s Hospital, Harvard Medical School, Northeastern University, Newton-Wellesley Hospital, Partners HealthCare, and VA Boston Healthcare System along with an expanding network of international affiliates. CIMIT fosters collaboration among world-class experts in medicine, technology, and engineering, in concert with industry, entrepreneurs, foundations and government, to rapidly improve patient care by catalyzing the discovery, development, and implementation of innovative solutions to pressing clinical problems. CoLab is a secure, cloud-based platform that enables an institution to encourage, manage and measure innovation. CoLab provides a vehicle to connect the needs of healthcare institutions, universities, medical foundations, and other non-profits with the vast experience, insight and innovative talents of their staff, faculty, industry partners, advisors, and patients/families within or beyond their physical and/or virtual borders to accelerate and maximize the impact of innovations. To find out more about CIMIT, visit http://www.cimit.org. More information about CoLab is available at http://cimit.org/CoLab.html.
About Institute for Pediatric Innovation
Based in Cambridge, Mass., the Institute for Pediatric Innovation’s mission is to identify critical pediatric medical needs and catalyze the development of viable technologies through collaborations between key stakeholders. IPI’s initiatives focus on translating the needs for new pediatric technologies into products that are readily available commercially. The development of these products is made possible through collaborations with clinicians, hospitals, engineering and product development companies, and industry partners. The Institute was founded in 2006 by Don Lombardi who, after spending 15 years in intellectual property management and technology transfer at Boston Children’s Hospital, recognized a serious need for improving medical devices and reformulating drugs to better suit the needs of children. The Institute for Pediatric Innovation is a nonprofit 501(c)3 corporation. For more information, visit http://www.pediatricinnovation.org
About Massachusetts General Hospital
Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $600 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine. Additional information about Mass General is available at http://www.massgeneral.org/.
Simbex is a research and product development company whose core expertise is biomechanical feedback systems. The company develops marketable products and solutions from emerging technologies for active life improvement in the areas of prosthetics, sports injury prevention and rehabilitation. The founders are internationally recognized experts in their fields and have decades of experience in the area of functional evaluation and efficacy assessment of complex biomechanical systems for the sporting goods, orthopedic and exercise equipment industries. The research branch of the company is supported in part by grants from the National Institutes of Health, the National Science Foundation, and the Department of Defense. For further information about Simbex, visit the company’s Web site at http://www.simbex.com
About The Dartmouth Institute for Health Policy and Clinical Practice
The Dartmouth Institute for Health Policy and Clinical Practice (TDI) was founded in 1988 by Dr. John E. Wennberg as the Center for the Evaluative Clinical Sciences (CECS). Among its 25 years of accomplishments, it has established a new discipline and educational focus in the Evaluative Clinical Sciences, introduced and advanced the concept of shared decision-making for patients, demonstrated unwarranted variation in the practice and outcomes of medical treatment, developed the first comprehensive examination of U.S. health care variations (The Dartmouth Atlas), and shown that more health care is not necessarily better care.http://www.tdi.dartmouth.edu/