Pediatric Medical Device Development
JLABS @ TMC hosted a discussion about pediatric medical device development on Thursday, Oct. 5. The event featured guest speaker Vasum Peiris, M.D., chief medical officer of pediatrics and special populations at the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), who discussed the FDA’s strategic direction and the current state of pediatric medical device innovation. Several panelists addressed device development and regulatory challenges, as well.
Peiris spoke about the CDRH’s continued efforts to invest in pediatric patients and to support a medical device ecosystem that benefits both children and adults. Current FDA initiatives to support the development and availability of pediatric medical devices include:
-Increasing the number of medical devices with labeling for pediatric patients by incorporating known information about device effects in other populations.
-Recruiting pediatric experts for FDA advisory panels when it’s likely that the device under discussion will be used for children.
-Protecting children who take part in clinical trials.
-Gathering data on the unmet needs for current pediatric medical devices and the barriers to the development of new pediatric devices.
“Imagine a world in which children have access to innovative medical devices at the same time as everyone else, but also imagine a world where medical devices were designed and evaluated before there are any immediate needs,” Peiris said. “This world really doesn’t exist. It probably seems as close as getting to Mars or trying to populate and colonize Mars. … I think we can get there. We just have to take the right steps.”
In the process of bringing ideas for new devices to fruition, PolyVascular cofounder and panelist Daniel Harrington, Ph.D., assistant professor of diagnostic and biomedical sciences at The University of Texas Health Science Center at Houston (UTHealth) and adjunct professor of biosciences at Rice University, emphasized the importance of understanding how exactly concepts and ideas in academia translate to the general population to have the most impact.
“I would encourage any folks who are thinking about going anywhere in this direction to add this into their education, elements of how you take something from academic level and build that out,” Harrington said. “It’s just not taught.”
For more information about pediatric medical device initiatives at the FDA, visit: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm135104.htm