P50FD007962

Southwest National Pediatric Device Innovation Consortium (SWPDC) - 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 represent 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 supports 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-world 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.

Baylor College Of Medicine

TO ASSIST INSTITUTIONS AND ORGANIZATIONS, TO ESTABLISH, EXPAND, AND IMPROVE RESEARCH, DEMONSTRATION, EDUCATION AND INFORMATION DISSEMINATION ACTIVITIES, ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS), BIOLOGICS, BLOOD AND BLOOD PRODUCTS, THERAPEUTICS, VACCINES AND ALLERGENIC PROJECTS, DRUG HAZARDS, HUMAN AND VETERINARY DRUGS, CLINICAL TRIALS ON DRUGS AND DEVICES FOR ORPHAN PRODUCTS DEVELOPMENT, NUTRITION, SANITATION AND MICROBIOLOGICAL HAZARDS, MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS, RADIATION EMITTING DEVICES AND MATERIALS, FOOD SAFETY AND FOOD ADDITIVES. THESE PROGRAMS ARE SUPPORTED DIRECTLY OR INDIRECTLY BY THE FOLLOWING CENTERS AND OFFICES: CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER), CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH), CENTER FOR VETERINARY MEDICINE (CVM), CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN), NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR), THE OFFICE OF ORPHAN PRODUCTS DEVELOPMENT (OPD), THE CENTER FOR TOBACCO PRODUCTS (CTP), AND OFFICE OF REGULATORY AFFAIRS (ORA), AND THE OFFICE OF THE COMMISSIONER (OC). SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMS: TO STIMULATE TECHNOLOGICAL INNOVATION, TO ENCOURAGE THE ROLE OF SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION BY MINORITY AND DISADVANTAGED PERSONS IN TECHNOLOGICAL INNOVATION. FUNDING SUPPORT FOR SCIENTIFIC CONFERENCES THAT ARE RELEVANT TO THE FDA SCIENTIFIC MISSION AND PUBLIC HEALTH ARE ALSO AVAILABLE.

93.103 - Food and Drug Administration Research

FDA Office of Acquisition and Grant Services (OAGS) [HHS - FDA]

FDA Office of the Commissioner [HHS - FDA]

Houston, Texas 770303411 United States

Single Zip Code

Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional (RFA-FD-23-024)

Amendment Since initial award the total obligations have increased 200% from $1,483,333 to $4,449,999.