Featured Projects
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
Featured
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.
Developing medical devices in general is costly, but there is funding available for companies that are willing to create products specifically for pediatrics.
A total of $150K was awarded to six pediatric cardiovascular innovations during the medical device pitch competition at the 6th Annual Pediatric Device Innovation Symposium hosted by Children's National Health System.
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.
