BCM, TCH Southwest Pediatric Device Consortium receives FDA grant
The Southwest National Pediatric Device Innovation Consortium (SWPDC), a multi-institutional consortium led by Baylor College of Medicine and Texas Children’s Hospital, has received a Food and Drug Administration grant of $7.4 million to continue its support of pediatric device innovators to develop and commercialize much-needed pediatric medical devices. There is an immense need for medical devices designed for children, and this grant funding will assist pediatric device innovators in bringing devices to market that specifically address the unmet needs of children. SWPDC is one of five consortia in the FDA’s Pediatric Device Consortia (PDC) program and the only one in the Texas/Southwest U.S. region.
“Right now, we often must use devices that were not designed for kids since we don’t have the right sized devices. This grant allows us to continue to spur development of devices specifically designed for kids by providing funding, consulting, clinical expertise and other assistance, all of which is made possible by our co-existence in the healthcare innovation ecosystem of the Texas Medical Center,” said Dr. Chester Koh, SWPDC executive director and principal investigator, professor of urology at Baylor and a pediatric urologist at Texas Children’s.
SWPDC collaborates with local, regional and national institutional and innovation partners to assist innovators, including Texas Medical Center Innovation, JLABS@TMC, and Proxima CRO.
Core consortium members include engineering leaders from Texas A&M University, Rice University, University of Houston and its newest member, the University of Minnesota, as SWPDC expands into the Midwest U.S. region. SWPDC also includes a nationwide clinical network of children’s hospitals that represent more than 3,000 inpatient beds.
SWPDC received its first five-year grant in 2018, which led to a portfolio of over 200 pediatric device projects in all stages of development. These portfolio companies have raised more than $200 million in follow on funding with this assistance. Pediatric devices in development include synthetic pediatric heart valves, miniature injection devices and neonatal intensive care unit monitoring devices.
SWPDC also received additional funding to continue its real-world data/real-world evidence (RWD/RWE) demonstration projects for pediatric device development with an emphasis on pediatric postoperative cardiac care for this five-year cycle with the goal of assisting the FDA in its regulatory evaluation of medical devices across their total product lifecycle.