Few medical devices are approved specifically for babies and children. An FDA grant to fund a collaboration between Stanford and UCSF for developing pediatric devices aims to fill the gap.
February 5, 2019 - By Erin Digitale
Each year, far fewer medical devices are approved by the Food and Drug Administration for children than adults. This means pediatricians don’t always have top-notch tools available to address medical challenges in babies and kids.
Now, a team of scientists and physicians at two of the Bay Area’s leading research institutions are collaborating to address the problem. Researchers at Stanford University and the University of California-San Francisco are nurturing the development of new medical devices through the UCSF-Stanford Pediatric Device Consortium, established last year with an award of $6.7 million from the FDA.
“When you look historically at the approvals of devices that have specific pediatric indications, they’re abysmal — essentially flat-lined,” said James Wall, MD, assistant professor of surgery, who leads the Stanford side of the collaboration. The Bay Area group is one of five consortia receiving FDA funding across the country to try to bolster development of pediatric devices.
The dearth of pediatric medical devices creates two challenges, Wall said. “We often end up having to cobble together workarounds to use adult-sized devices that are not the right size for our patients,” he said. “There are also pediatric-specific diseases that have no adult correlate, for which appropriate medical devices have never been developed.”
‘Right time for a big push’
“This is the right time for a big push in pediatric technologies,” said Paul Yock, MD, director of the Stanford Byers Center for Biodesign and an adviser to the consortium. Not only could pediatric devices fill gaps in hospital care, they could also help monitor children’s health and keep them out of the hospital in the first place, said Yock, who is also a professor of bioengineering and of medicine.
The consortium has built a three-phase process for spurring pediatric innovation, drawing on the strengths of UCSF’s history as a hub of pediatric device design and Stanford’s successful biodesign center. (Wall helps direct the Stanford Biodesign Innovation Fellowship.)
The consortium hosts a monthly forum for innovators with ideas for pediatric devices. Those who participate receive feedback and mentoring during the forum, as well as the opportunity to take their ideas to the second stage: concept development. This stage includes funding for services such as device prototyping and regulatory consulting. The third stage includes seed funding for promising projects. This year, more than $300,000 in funding will be awarded at the consortium’s first pitch competition, to be held March 29 at the Li Ka Shing Center for Learning and Knowledge at Stanford as part of the consortium’s annual Pediatric Innovation Symposium.
At present, one project team is developing a device that would enable nonsurgical closure of feeding tube sites in children. Adults often receive feeding tubes as part of end-of-life care, whereas children are more likely to use a feeding tube temporarily, Wall said. “Kids often have them removed but end up with a leaking site in their abdomen,” he said. “One of our teams has an idea for a device to close these sites without the need for surgery.”
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, but about 1 in 1,000 babies who spit up develop pathologic reflux. “It’s very hard to know who they are because we don’t have diagnostic tools that are the right size, or data about the physiology of infants to determine when reflux will become a problem,” Wall said, adding that FDA-approved devices already exist for diagnosing pathological reflux in adults.
Drawing on strengths of both universities
The consortium draws on strengths of both universities, Wall said. “UCSF has experts who have figured out the local infrastructure for developing pediatric devices, and has great clinical strengths,” he said. “We bring the strength of our biodesign process — of infusing discipline early into the innovation process to understand the downstream barriers to product development, such as regulatory hurdles, clinical trial requirements to drive adoption and insurance reimbursement challenges.”
Because most children are healthy, the market for many possible pediatric medical devices is small, he added. “There’s not as much room for error,” Wall said. “You have to be very strategic in how much money you spend to deliver a product to a relatively small number of patients. But Stanford is well-known for developing health technologies, and now we have a mechanism to highlight pediatrics as an opportunity. We want innovators to know that it can be done — it should be done — and our team can help.”
Stanford Medicine integrates research, medical education and health care at its three institutions - Stanford School of Medicine, Stanford Health Care, and Stanford Children's Health. For more information, please visit the Office of Communications website at http://mednews.stanford.edu.