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.
Expert advice, support services, and fund management for pediatric device innovators.
A pipeline of high-potential pediatric devices for all pediatric subpopulations.
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
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.
The investment will fund the company’s pilot study through the activities needed to support the submission of an FDA IDE application for its pivotal trial. To date, the firm said it has raised more than $59 million in funding.
WASHINGTON, July 24, 2019 /PRNewswire/ -- The Sheikh Zayed Institute for Pediatric Surgical Innovation at Children's National Health System announces its 7th Annual Pediatric Device Innovation Symposium is slated for Sunday, Sept. 22 in Boston, Mass., featuring a $150K medical device competition focused on innovations for neonatal and NICU care. Following the theme "Pediatric Device Clinical Trials: Forging a Better Path," this year's symposium explores the pediatric device clinical trial process, including progress insights, current challenges and potential solutions.
"The challenges inherent in the pediatric device clinical trial process can significantly impede the path to commercialization of much-needed medical devices for children," says Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children's National Health System. "At the symposium, our experts will provide the latest insights for biohealth innovators and clinicians on progressive methods of validating medical devices for children."
The symposium, which co-locates with AdvaMed's The MedTech Conference, presents multidisciplinary panel discussions that address critical issues related to pediatric device development, regulatory processes, device clinical trials and gaps in pediatric healthcare innovation. Key insights from the symposium will inform a white paper detailing best practices for stakeholders involved in stimulating pediatric device innovation and to bring solutions to market faster to benefit children.