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.
Competition for startups aims to increase the pace of development and commercialization of critically needed pediatric medical devices.
In the world of innovation, devices used for pediatric medical care, particularly the very young, are lagging behind those created for adult purposes. A contest is now open, inviting innovators to do something about it. Top contenders will be awarded with support from an innovation accelerator to further develop their device and an opportunity to win up to $250,000 in grant money.
Applications for the contest, operated by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), in collaboration with MedTech Innovator, are due by February 15. The competition focuses on pediatric devices in three areas of critical need: Cardiovascular, orthopedic and spine, and neonatal intensive care unit (NICU).
“While there is a great need for pediatric devices in many specialty areas, the development and commercialization process is very challenging because of the small market size and dynamic characteristics of the patient population,” says Kolaleh Eskandanian, PhD, MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI, in a news release.
On average over the past decade, only 24% of life-saving medical devices approved by the Food and Drug Administration (FDA)—that go through premarket approval (PMA) and humanitarian device exemption (HDE) regulatory pathways—have an indication for pediatric use, according to NCC-PDI. Of those, most are designated for children age 12 or older.