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The A. James Clark School of Engineering and the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System have received a grant from the U.S. Food and Drug Administration (FDA) to form the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). The $700,000 grant represents the first part of an anticipated five-year award. Clark School Fischell Department of Bioengineering (BioE) professor and chair William E. Bentley serves as the consortium's co-PI.
The grant was awarded by the FDA’s Office of Orphan Products Development, which funds consortia that advance the development of pediatric medical devices. These consortia work with the FDA to help innovators effectively navigate existing laws, regulations and agency guidance that protect the health and safety of children.
The NCC-PDI partnership will include BioE, the Clark School's Maryland Technology Enterprise Institute (Mtech), and Mtech's Maryland Industrial Partnerships (MIPS) program.
“We are very pleased to partner with Children’s National Health System on this important new initiative that will drive forward new innovations that help save children’s lives,” says University of Maryland vice president and chief research officer Professor Patrick O’Shea.
“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,” says Peter Kim, M.D., C.M., Ph.D., vice president of the Sheikh Zayed Institute. “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.”
“This new consortium is an exciting, important advance in developing medical devices for children [that make] pediatric surgery more precise, less invasive, and pain-free,” says Kurt Newman, M.D., President and CEO of Children’s National. “I congratulate Dr. Peter Kim and his colleagues [for] securing this prestigious, highly competitive award.”
The 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 writingand 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; and
- provide counsel on accessing various federal and non-federal funding resources while assessing the scientific and medical merit of proposed pediatric device projects.
The consortium's for-profit, academic, and medical association partners 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).
Story based on the original press release by the Children's National Sheikh Zayed Institute.
October 8, 2013
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