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.”
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, Feb. 11, 2020 /PRNewswire/ -- The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced today that the application deadline for its annual "Make Your Medical Device Pitch for Kids!" competition is extended one week to Feb. 22 at midnight EST. Innovators and startup companies with devices in the pediatric cardiovascular, orthopedic and spine, or NICU sectors are invited to apply for a share of up to $250,000 in FDA-funded awards and access to a newly created NCC-PDI pediatric device accelerator program led by MedTech Innovator. Submissions are being accepted now at https://medtechinnovator.org/pediatricapply/
"This year's competition focuses on three medical device areas of critical need for pediatric patients, so we want to give innovators as much time as possible to prepare their submissions," said Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children's National Hospital and principal investigator of NCC-PDI . "Our goal is to support devices that will improve care for children by helping them advance on the pathway to commercialization. We have seen how this competition can provide significant momentum for pediatric innovations, so we want to encourage as much participation as possible."
To date, NCC-PDI has mentored over 100 medical device sponsors to help advance their pediatric innovations, notes Eskandanian, with six devices having received either their FDA market clearance or CE marking. Along with the positive exposure of presenting at this competition, she notes that the success of NCC-PDI's portfolio companies is attributed to funding, mentorship, support from partners and facilitated interactions between device innovators and potential investors.