# Southwest National Pediatric Device Innovation Consortium (SWPDC)

> **NIH FDA P50** · BAYLOR COLLEGE OF MEDICINE · 2024 · $1,483,333

## Abstract

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 servi...

## Key facts

- **NIH application ID:** 10922820
- **Project number:** 5P50FD007962-02
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** Gwenyth A Fischer
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $1,483,333
- **Award type:** 5
- **Project period:** 2023-09-01 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10922820

## Citation

> US National Institutes of Health, RePORTER application 10922820, Southwest National Pediatric Device Innovation Consortium (SWPDC) (5P50FD007962-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10922820. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*