In September 2013, the Sheik Zayed Institute for Pediatric Surgical Innovation (SZI) at the Children’s National Health System and the University of Maryland A. James Clark School of Engineering received a U.S. Food and Drug Administration (FDA) P50 grant to form the National Capital Consortium for Pediatric Device Innovation (NCC-PDI).
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“Innovation plays an integral role when it comes to conduct in pediatric device trials. There are alternative methods to trials, such as data extrapolation from adult studies. If we can be well informed when mining that data, we shouldn’t put kids at risk and delay time to market.” A randomized clinical trial would be unethical if it involved using a medical device that a patient doesn’t need, she added. “It is a very different paradigm than that used for drugs.” She said that companies can also take advantage of solutions in FDA’s toolbox.
Six winners were named in a pitch competition for medical devices designed to improve care in the neonatal intensive care unit at the seventh annual Pediatric Device Innovation Symposium, hosted by Washington, D.C.-based Children's National Hospital.
Kolaleh Eskandanian, PhD, is the vice president and chief innovation officer of Children's National Health System in Washington, D.C.
Here, Dr. Eskandanian outlines the big cybersecurity challenges and how she expects her role as the chief innovation officer at Children's National to evolve over the next few years.
While medical device innovation is quite active—at the university level, within incubators, and even in the R&D labs of established firms—there is a substantial lack of products being developed for younger patients. Since pediatric devices have a limited patient base due to most children being relatively healthy (of course, a positive factor), it’s not a focus for a great number of companies as it does not offer the promise of a substantial financial return.
While FY2017's approvals notably served all four pediatric age groups, the majority of pediatric devices approved over the last decade are not indicated for children under the age of 12. What's more, a large portion of the devices indicated for FDA's 'adolescents' category are only authorized for use in patients 18 or older.
WASHINGTON, Sept. 23, 2019 /PRNewswire/ -- Children's National Hospital and the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announce the six winners of the $150,000 "Make Your Medical Device Pitch for Kids!" competition, each receiving a $25,000 award and the opportunity to participate in NCC-PDI's recently launched "Pediatric Device Innovator Accelerator Program" led by MedTech Innovator. The six winners, who presented medical devices designed to improve Neonatal Intensive Care Unit (NICU) care, emerged from a field of 11 finalists. Each participant delivered their five-minute live pitch presentation to a panel of 25 esteemed judges during the 7th Annual Pediatric Device Innovation Symposium hosted by Children's National.
"Congratulations to these outstanding innovators and startup companies for developing pioneering medical devices that can advance NICU care," says Kurt Newman, M.D., president and CEO of Children's National Hospital. "Our Children's National clinical team, which is ranked #1 nationally in NICU care, understands deeply the vital role of innovation and technology in providing the tiniest infants with the healthiest start possible. Three of our NICU clinicians participated in the judging and were inspired by the quality of the participants and the potential patient benefits of the innovations presented."
Nearly 400,000 babies, about 1 in 10, are born prematurely in the United States annually. The Centers for Disease Control and Prevention states that premature babies who survive can have breathing issues, intestinal problems and brain complications that can impact later development. The competition focused on NICU because the Food and Drug Administration (FDA) identifies the specialized pediatric market among those that still have a significant unmet need for devices designed for the youngest patients.