The Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System has received a grant from the Food and Drug Administration (FDA) to form the National Capital Consortium for Pediatric Device Innovation. The grant is for $700,000 for FY2013, as part of an anticipated five year award.
“This new consortium is an exciting, important advance in developing medical devices for children and toward fulfilling our vision of making pediatric surgery more precise, less invasive, and pain-free,” said Kurt Newman, MD, President and CEO of Children’s National Health System. “I congratulate Dr. Peter Kim and his colleagues in our Sheikh Zayed Institute on securing this prestigious, highly competitive award.” The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) will address four primary goals:
- Provide a platform of experienced regulatory, business planning and device development services (such as intellectual property counsel, prototyping, engineering, laboratory and animal testing, grant writing, and clinical trial design) to foster the advancement of medical devices for pediatric patients
- Bring together individuals and institutions that can support pediatric medical device progression through all stages of development—ideation, concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization
- Support a mix of projects at all stages of development, particularly the later stages of clinical, manufacturing, and marketing
- Provide counsel on accessing various federal and non-federal funding resources while assessing the scientific and medical merit of proposed pediatric device projects
“We are excited to unite within this consortium the diverse strengths of our distinguished partners and collaborators, to bring important advances to medical devices for children,” said Peter Kim, MD, CM, PhD, Vice President of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National. “In pediatrics, we know that children are not simply small adults, so the FDA’s support for this area of innovation is particularly important to address this critical but largely unmet need.” The NCC-PDI will be a collaboration of Children's National Health System with the University of Maryland A. James Clark School of Engineering and its flagship institutes: Maryland Industrial Partnerships (MIPS) and Maryland Technology Enterprise Institute (Mtech).
For-profit, academic, and medical association partners in the consortium include Arent Fox, Oblon Spivak, Medical Murray, Key Tech, Philips, Cook Medical, Medtronic, QUASAR, Root3 Labs, Weinberg Medical Physics, JustRight Surgical, Georgetown University Medical Center, The George Washington University School of Business and School of Medicine and Health Sciences, George Mason University, Howard University College of Medicine, Anne Arundel Medical Center, Howard Hughes Medical Institute, Virginia Tech, Vanderbilt University, Johns Hopkins University, Sickkids Toronto, Texas Scottish Rite Hospital for Children, American University Kogod School of Business, National Institutes of Health/Clinical Center, Medical Device Manufacturers Association (MDMA), The World Federation of Associations of Pediatric Surgeons (WOFAPS), and American Pediatric Surgical Association (APSA).
The grant was awarded by the FDA’s Office of Orphan Products Development in its third round of funding since 2009 to consortia that advance the development of pediatric medical devices. The 2013 grants were awarded to consortia that brought together teams with excellence and expertise in delivering business, regulatory, legal, scientific, engineering, and clinical services for children. All consortia work collaboratively with the FDA to help innovators effectively navigate existing laws, regulations and agency guidance to protect the health and safety of children.