Each year fewer medical devices are approved by FDA for children which means that pediatricians don’t always have top-notch tools available to address medical challenges in babies and kids.
A team of scientists and physicians are going to collaborate to address the problem. Stanford University http://med.stanford.edu and the University of California San Francisco https://www.ucsf.edu are working to develop new medical devices through the “UCSF Stanford Pediatric Device Consortium” (PDC) https://www.pediatricdeviceconsortium.org established in 2018 with a FDA grant award for $6.7 million.
James Wall, MD, Assistant Professor of Surgery leading the Stanford side of the collaboration reports, “The lack of pediatric medical devices creates two challenges. Often physicians end up having to use adult-sized devices that are not the right size for children. Also, there are pediatric-specific diseases that have no adult diseases so there not an appropriate medical device that has been developed.”
The Consortium has built a three phase process for spurring pediatric innovation. For example, the Consortium hosts a monthly forum for innovators seeking ideas for pediatric devices. After the participants receive mentoring during the forum, they have the opportunity to take their ideas to the second stage referred to as concept development along with hold discussions on device prototyping and regulatory consulting. The third stage includes seed funding for promising projects.
According to Dr. Wall, “Today one project team is developing a device to enable nonsurgical closure of feeding tube sites in children. Children often have feeding tubes removed but end up with a leaking site in their abdomen but the team has an idea for a device to close these sites without the need for surgery.”
As another example, “Another team is working on a monitoring system for babies with reflux. Spitting up is common in newborns and usually goes away on its own. However, in about 1 in 1,000 babies who spit up develop pathologic reflux. Diagnostic tools are needed that are the right size and contain data on the physiology of infants to determine when reflux will become a problem.”
On March 29, 2019, the UCDF-Stanford PDC hosted their second “Annual Pediatric Innovation Showcase”. Professionals in pediatric medicine and innovators gathered to see prototypes in development and the attendees were able to network with researchers and innovators to learn about new pediatric devices that are in various stages of development.
Email innovation@stanfordchildrens.org for more information on the “Annual Pediatric Innovation Showcase” and details on the companies that received the funding to help their companies accelerate the next generation of pediatric medical devices.