Grant boosts consortium’s pediatric device development
Pediatric medical device innovators across the Texas Medical Center—and beyond—will receive the critical support and resources needed to develop novel health care solutions for sick children thanks to a new $6.75 million, five-year grant.
The Southwest National Pediatric Device Consortium (SWPDC), anchored by Texas Children’s Hospital and Baylor College of Medicine, received a prestigious P50 grant from the U.S. Food & Drug Administration that begins on Sept. 1, 2018.
Often, surgeons shrink adult devices to fit children. Instead, Chester Koh, M.D., SWPDC founder and lead principal investigator, hopes device makers will do the opposite—start with pediatric-sized devices and scale up to adult. For example, some of the smallest heart valves available might be 8 millimeters in diameter, but need to be as small as 3 millimeters for an infant or child.
“It is well known, and acknowledged by the FDA, that pediatric devices are five to 10 years behind adult devices,” said Koh, who is also works as a pediatric urologist at Texas Children’s and professor of urology, pediatrics and obstetrics/gynecology at Baylor. “However, pediatric patients still need devices, so we need to serve our patients.”
The consortium includes clinical, scientific/engineering, investment, regulatory and academic partners in the Texas Medical Center, the greater Houston area and the southwestern U.S. The collaborative aims to address the shortage of needed devices for pediatric health conditions by supporting innovators.
The grant will enable the consortium to fund projects directly and bring in consultants to help with the devices, something innovators were not able to do before, Koh said.
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The collaborative will also attract what Koh calls “untapped resources” such as pediatric clinicians who see a need for a device but who may have not had development training. The consortium can provide the resources to help them develop a solution, build a prototype and proceed to the next steps of getting the device into clinics and operating rooms.
The primary consortium partners include Texas A&M University, Rice University, University of Houston and Fannin Innovation Studio, and includes others such as Biotex Inc., Children’s Hospital of San Antonio, Children’s Health in Dallas and Phoenix Children’s Hospital. SWPDC was selected as one of five national consortia that are addressing the shortage of pediatric devices.
The five principal investigators include Koh and Henri Justino, M.D., of Texas Children’s and Baylor; biomedical engineer Balakrishna Haridas, Ph.D., of Texas A&M University; bioengineer Maria Oden, Ph.D., of Rice University; and Michael Heffernan, Ph.D., also a bioengineer, of Fannin Innovation Studio in Houston.
Justino, director of the Charles E. Mullins Cardiac Catheterization Laboratories at Texas Children’s, was recently part of the TMC Innovation Institute’s TMCx medical device accelerator program with his company, Polyvascular, which creates tiny replacement heart valves for treating pediatric congenital heart disease.
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Koh said TMC Innovation, and its programs including TMCx, Johnson & Johnson Innovation’s JLABS @ TMC, and J&J’s Center for Device Innovation, will play a role in this initiative as well.
“This is really a collaborative effort across the Texas Medical Center to help accelerate the products,” Koh said. “We are basically going to serve as navigators to help pediatric innovators get the right expertise so they are able to go all the way from an idea to commercialization—what we call the total product life cycle.”