UMD and Sheikh Zayed Institute at Children's National Health Receive FDA Grant for Pediatric Devices

Collaboration will focus on medical device design, production and regulation.

MEDIA ADVISORY  October 8, 2013

CONTACT:
Faye Levine

flevine@umd.edu

College Park, Md.—The University of Maryland (UMD) 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. 

The NCC-PDI will be a collaboration between Children's National, UMD's A.  James Clark School of Engineering, and the Clark School's flagship institute, the Maryland Technology Enterprise Institute (Mtech). The partnership will also involve the Clark School's Fischell Department of Bioengineering, chaired by professor and NCC-PDI co-PI William E. Bentley, and the 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,” said UMD 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,” said Peter Kim, M.D., C.M., Ph.D., 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.”

“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, M.D., President and CEO of Children’s National. “I congratulate Dr. Peter Kim and his colleagues in our Sheikh Zayed Institute on 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 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; 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).

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.

About the University of Maryland's Fischell Department of Bioengineering

Housed in the A. James Clark School of Engineering’s Clark Hall, the Fischell Department of Bioengineering at the University of Maryland, College Park is the home of an emerging academic discipline and exciting interdisciplinary degree programs. The department includes laboratory and research space for the development and translation of next-generation medical devices and serves as the home for the Robert E. Fischell Institute for Biomedical Devices, as well as the new NIH-funded Center for Engineering Complex Tissues.

The department’s faculty members are also dedicated to engineering entrepreneurship – getting science out of the lab and into the hands of doctors, care providers, and consumers. Combining engineering principles with a strong foundation in biology, researchers at the Fischell Department of Bioengineering are developing new technologies and devices aimed at improving human health throughout the world.