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Advancing the Development of Pediatric Devices

NCC-PDI brings together teams with excellence and expertise in delivering business, regulatory, legal, scientific, engineering, and clinical services for children.

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Expert advice, support services, and fund management for pediatric device innovators.

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A pipeline of high-potential pediatric devices for all pediatric subpopulations.

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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).

In the News

Source: Mass Device

11 pediatric cardiovascular devices you need to know about

A bandage-sized heart monitor, an extracorporeal blood pump that mimics the human heart, and a heart valve that can grow with a child were among the six winners of a contest in Philadelphia for innovative pediatric cardiovascular devices. The Pediatric Device Innovation Symposium organized by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children's National Health System.

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Featured

Contest Opens to Stimulate Pediatric Device Innovations
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January 9, 2020

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.

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The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) serves as a critical device development resource by providing expert advice, support services, and fund management of pediatric device innovation.

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NCC-PDI@childrensnational.org

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