Southwest Pediatric Device Consortium receives FDA grant to expand development of medical devices for children

August 24, 2018
| By: Aubrey Bloom

The Southwest National Pediatric Device Consortium (SWPDC), anchored by Texas Children’s Hospital and Baylor College of Medicine and including Texas A&M University, recently received a prestigious P50 grant from the U.S. Food & Drug Administration (FDA). The five-year, $6.75 million grant will begin on Sept. 1.

SWPDC supports pediatric device innovators with the goal of addressing the shortage of needed novel medical devices for children, a public health problem that has been acknowledged by the FDA. 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 primary partners are Texas A&M, 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, with additional future sites. SWPDC was selected as one of five national consortia that are addressing the shortage of pediatric devices.

“A great need currently exists for medical devices designed specifically for children,” said Dr. Chester Koh, founder of SWPDC and lead principal investigator, as well as a pediatric urologist at Texas Children’s Hospital and professor of urology, pediatrics and OB/GYN at Baylor. “Pediatric device development is challenging, but with this support from the FDA, our consortium will continue to assist pediatric device innovators along all stages of development with the goal of improving our care of pediatric patients.”

With the P50 grant support, SWPDC will leverage its ongoing activities to expand its footprint to accelerate the development of much-needed medical devices. The five principal investigators include Koh and Dr. Henri Justino of Texas Children’s Hospital and Baylor, Dr. Balakrishna Haridas of Texas A&M, Dr. Maria Oden of Rice University and Dr. Michael Heffernan of Fannin Innovation Studio.

“Significant technical (design and manufacturing), preclinical testing, clinical and regulatory testing challenges exist in the field of pediatric devices,” said Haridas, co-founder and co-PI of SWPDC, lead PI at Texas A&M and professor of practice in biomedical engineering at Texas A&M. “This FDA-funded SWPDC is uniquely positioned to address these challenges across the pediatric device development and clinical translational cycle to deliver significant advances in treatments tailored for pediatric patients.”

SWPDC will provide services in several areas: unmet needs assessment, prototype development, product and technology acceleration services, and business acceleration services. The SWPDC members will evaluate and support projects, as well as advise innovators throughout the total product life cycle. Based on individual project needs, the consortium will direct investigators to specific resources, collaborators and industry experts, and will coordinate the services offered by its member programs to identify, evaluate and assist pediatric device projects.

Additional work within the consortium involves a Real World Evidence (RWE) demonstration project with Texas Children’s and Texas A&M that builds upon the work of the PATHS-UP Engineering Research Center led by Texas A&M. PATHS-UP is supported by a 10-year, $40 million National Science Foundation grant. Advanced patient care algorithms and novel devices will be developed for improved continuous glucose monitoring in children with diabetes to avoid the complications associated with inadequate glucose control.

To learn more about the Southwest Pediatric Device Consortium, visit swpdc.org.

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