Project Summary / Abstract: An urgent need currently exists for medical devices developed specifically for children. Barriers to pediatric device development include economic, clinical, regulatory, reimbursement, and business model challenges, combined with a lack of established mechanisms for connecting pediatric device ideas with qualified individuals, programs, and industry partners. The smaller population and market sizes associated with pediatric devices can prevent progression through market-based approaches used to commercialize adult devices. The Southwest National Pediatric Device Innovation Consortium (SWPDC) supports regional and national pediatric device innovators with product and technology acceleration services and business acceleration services with its existing translational and commercialization network to help novel pediatric medical devices progress to commercialization and clinical use. SWPDC has been improving children’s health by facilitating partnerships between the faculty, students, and resources of the largest children’s hospital in the U.S., a growing hub-and- spoke network of children’s hospitals, and established academic engineering programs at major universities, as well as supporting pediatric device innovators with comprehensive pediatric device development services to create novel pediatric medical devices with local, regional, and national institutional and innovation partners. The consortium also includes local device development firms offering clinical, scientific, business, financial, regulatory, reimbursement, engineering, ISO13485-compliant product design and manufacturing, and intellectual property expertise in the Southwest/Midwest U.S. regions. The consortium will also work to identify and address current barriers to the development and commercialization of pediatric devices, with a particular focus on establishing a productive needs-driven pipeline of new pediatric medical devices. SWPDC will also continue its work to foster collaboration, diversity, equity, and inclusion toward creating a national network for pediatric device development that benefits all pediatric patients including those in underserved populations and which utilizes the existing expertise and infrastructure of U.S. children’s hospitals to support the accelerated development of innovative pediatric devices in partnership with public and private sector stakeholders. Furthermore, the consortium’s Real World Evidence demonstration projects represents a continued collaboration between a large children’s hospital health system and a large engineering university with its National Science Foundation-funded Engineering Research Center, PATHS-UP, for a comprehensive and scalable Real-World Data/Evidence demonstration projects program that support pediatric device innovation at various stages that also promotes inclusion, engagement, and participation of diverse and inclusive populations. This will contribute to the creation of a national service center for pediatric real word data/evidence projects that support medical device companies and startups with evidence generation towards pre/post regulatory approval, value analysis, pediatric labeling expansion studies, and market adoption.

Project Narrative: The Southwest National Pediatric Device Innovation Consortium’s goals are to utilize a multi-disciplinary network of stakeholders at Texas Children’s Hospital/Baylor College of Medicine and affiliated institutions and local device development partners in the Southwest/Midwest U.S. regions, as well as regional business and investment communities, to provide pediatric device innovators with product and technology acceleration services and business acceleration services to promote the development of pediatric devices that address critical unmet needs through the consortium’s extensive advisory network as well as direct device funding. It is anticipated that public health will benefit from the sustainable and productive needs-driven pipeline of new pediatric devices that will arise from consortium assistance given to pediatric device innovators at all stages, allowing devices to progress toward commercialization and clinical implementation.