# UCSF-Stanford Pediatric Device Consortium

> **NIH FDA P50** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2021 · $1,330,001

## Abstract

PROJECT SUMMARY
The UCSF-Stanford Pediatric Device Consortium (PDC) will leverage the established device innovation talent
of two world-class universities and an unsurpassed entrepreneurial network in the heart of Silicon Valley to
equip pediatric innovators at all stages of development to translate their innovations into high-value,
commercially viable products. Combining the experience and resources of the eight-year-old FDA-funded
UCSF Pediatric Device Consortium and the long-established and world-renowned Stanford Biodesign
program, the new “UCSF-Stanford PDC” features an emphasis on concept-stage market assessment and
value analysis; in-house product development, regulatory, patenting, and entrepreneur-in-residence (EIR)
services; a hands-on Commercialization Advisory Board to create situation-specific go-to-market strategies;
and a deep and committed network of external medtech advisors and product development resources in the
world's innovation capital.
Veteran UCSF device innovators Michael Harrison, MD (Pediatric Surgery) and Shuvo Roy, PhD
(Bioengineering) are joined by Stanford's James Wall, MD (Pediatric Surgery), Assistant Director of Stanford's
Biodesign Innovation Fellowship Program. Senior medtech industry professionals Chris Jones (Product
Development), Michael Billig (Regulatory Affairs), David Levine (Intellectual Property), Daniel Burnett
(Entrepreneur-in-Residence), and Douglas Crawford (Chair, Commercialization Advisory Board) will provide
director-level support. The UCSF-Stanford PDC offers a wealth of expertise that is easily accessed through its
weekly `open innovation' meetings, interactive web portal, comprehensive advising services, and semiannual
Pediatric Device Accelerator pitch competition, which provides expert consulting, commercialization
mentorship, and direct funding to advance pediatric device projects with strong market potential. In addition to
the PDC's in-house services, pediatric innovators will benefit from partnerships with esteemed Bay Area
medical device incubators Theranova (San Francisco) and the Fogarty Institute for Innovation at El Camino
Hospital (Mountain View).
Since its founding in 2009, the UCSF PDC has advanced 10 internally developed pediatric devices from the
concept stage to first-in-human trials, guided three devices to market availability, and leveraged over $30M in
external funding to support continued development of its technologies. Stanford's Biodesign program has
established an internationally recognized model for device innovation and development, having launched 46
successful startup companies whose technologies have now reached over a million patients. In the next PDC
grant cycle, these two innovation programs will combine their respective strengths and infrastructures to create
a powerhouse program accelerating high-impact, value-based pediatric device solutions to commercialization
and patient impact.

## Key facts

- **NIH application ID:** 10247487
- **Project number:** 5P50FD006424-04
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** MICHAEL R HARRISON
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $1,330,001
- **Award type:** 5
- **Project period:** 2018-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247487

## Citation

> US National Institutes of Health, RePORTER application 10247487, UCSF-Stanford Pediatric Device Consortium (5P50FD006424-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10247487. Licensed CC0.

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