Stanford and UCSF Receive FDA Grant to Pursue Pediatric Device Innovation

Stanford University School of Medicine will receive a portion of a $6.7 million grant to the newly named UCSF-Stanford Pediatric Device Consortium, to enable the development of new devices for pediatric care. The grant from the U.S. Food and Drug Administration, announced Aug. 23, 2018, will be received over five years, in accordance with a program launched in 2009 under a mandate from Congress to stimulate the development of devices for the underserved pediatric market.

James Wall, MD, pediatric surgeon at Lucile Packard Children’s Hospital Stanford and assistant director for the Stanford Biodesign Innovation Fellowship, will lead the Stanford team and stated in a press release issued September 4, that he is, “excited by the collaboration as an opportunity to join the efforts of two great children’s hospitals.”

“The pediatric medical device market is too often underserved by industry and entrepreneurs due to its small market size,” Wall stated in the release. “Developing better health technologies for children requires scale that can be achieved through this type of regional partnership, in conjunction with strong support from the FDA.”

Solving health care problems

Stanford participants include physicians, clinicians, engineers, IT and industry experts, and clinical fellows from the Stanford Byers Center for Biodesign, a hands-on, interdisciplinary training program that teaches aspiring innovators to solve health care problems through technology innovation.

At Biodesign, Wall helps fellows and trainees identify and address unmet needs in pediatric care. For example, in 2011-12, a Biodesign student team discovered that umbilical cord catheters, used to provide food and medication to fragile, low birthweight newborns in the NICU, are notorious culprits of catheter-related bloodstream infections. The consequences of these infections were serious and largely preventable. The team set out to design a device that would reduce the likelihood of infection by better supporting and protecting the umbilical line, and is expecting FDA approval for their device this fall.

Other children’s health start-up companies launched by Biodesign trainees are addressing needs in asthma management and sleep disorders, among others.

In joining the UCSF consortium, the teams will participate in weekly think tank meetings where clinicians will discuss barriers to providing pediatric care. The groups expect to go from those meetings and begin developing early prototypes within a few weeks.

Learn about the inaugural Stanford Children’s Health Pediatric Innovation Symposium