An FDA-supported consortium anchored at Texas Children’s Hospital supports innovation and development of new pediatric devices

The Southwest National Pediatric Device Innovation Consortium (SWPDC), anchored by Texas Children’s Hospital and Baylor College of Medicine, is a virtual accelerator for innovators focused on developing novel devices for pediatric care nationwide. They are one of five Food and Drug Administration (FDA)-supported national consortia that are addressing the national shortage of much-needed innovations in pediatric devices, a public health problem acknowledged by the FDA.

The consortium was founded in 2018 by Texas Children’s pediatric urologist, Dr. Chester Koh who is also the executive director of SWPDC and director of the Pediatric Robotic Surgery program. The five-year, $6.75 million P50 grant from the FDA allows SWPDC to support pediatric device innovators with its clinical, scientific, engineering, business, investment, regulatory, reimbursement and academic partners in the Texas Medical Center, the Greater Houston area, and the Southwestern US as well as nationally. The primary 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, Phoenix Children's Hospital, and Arkansas Children’s, with additional future sites.

SWPDC developed from the local maturation (‘Third Coast’) of medical device development in Houston, with a medical ecosystem that includes the world’s largest medical complex, the Texas Medical Center (TMC), and its associated Texas Medical Center Innovation Institute (TMCx) and JLABS@TMC. SWPDC also has active hubs in Phoenix, Dallas, San Antonio, and Little Rock, and provides assistance to pediatric device developers locally, regionally, as well as nationally.

Since pediatric device projects often cannot progress through the standard market-based approach that adult device projects follow, SWPDC supports innovation, mentoring, and collaborations among pediatric clinicians and surgeons, engineers, industry, and other partners with an emphasis on an extended life cycle of pediatric device projects in the children’s hospital / academic setting before exposure to the external market. Pediatric device innovators have access to comprehensive assistance from SWPDC members and others to help them progress towards commercialization and clinical implementation. Specific ways that SWPDC can assist in a non-dilutive and “no-strings attached” manner include:

• Direct device / seed funding ($300,000 in seed awards each year)
• Consulting assistance (regulatory, intellectual property, commercialization, manufacturing, reimbursement, etc.)
• Engineering / design assistance
• Potential clinical collaborators
• Connections to other local programs and resources

“Pediatric device development is challenging, but with this ongoing support from the FDA Pediatric Device Consortia program, SWPDC / Texas Children’s Hospital / Baylor College of Medicine can continue to assist pediatric device innovators along all stages of development with the goal of improving our care of pediatric patients,” Koh said. “SWPDC is uniquely positioned to address the various challenges innovators face during the various stages of development including device development and clinical translational testing. We provide services in several areas: unmet needs assessment, prototype development, product and technology acceleration services, and business acceleration services. SWPDC members evaluate and support projects, as well as advise innovators throughout the total product life cycle. Based on individual project needs, the consortium directs investigators to specific resources, collaborators and industry experts, and coordinates services offered by its partners to identify, evaluate and assist pediatric device projects”.

SWPDC’s portfolio companies have raised over $109 million in additional funding and SWPDC has supported over 100 device innovators since its inception that has led to several pediatric devices in development such as a non-operative ureteral stent removal system, a pediatric urinary sphincter device, and many others.

In collaboration with the American Academy of Pediatrics Section on Urology (AAP SOU), one of the SWPDC Spring 2021 seed funding opportunities will focus on pediatric urologic devices. Up to $20,000 in seed funding will be available to pediatric urologic device innovators who are AAP SOU members through this opportunity. The application cycle will open in late February with applications due by March 22, 2021. The awardee(s) will be announced by late April 2021. Interested applicants can apply here.