# Medical Device Consortium at the Children's Hospital of Philadelphia

> **NIH FDA P50** · CHILDREN'S HOSP OF PHILADELPHIA · 2022 · $999,999

## Abstract

Abstract/Summary
Addressing unmet needs for treating childhood illnesses lead to the creation of the Philadelphia Pediatric
Medical Device Consortium (PPDC) 4.5 years ago. Founded at the Children’s Hospital of Philadelphia (CHOP)
with funding from the FDA Pediatric Device Consortia (PDC) program, the mission of the PPDC is to provide
seed funding and business, legal, marketing, clinical, engineering and scientific resources to inventors of
promising pediatric medical devices that will benefit children and have a strong commercialization potential.
CHOP has national prominence in both clinical care and research, and combined with the vibrant medical
device development ecosystem that is developing in our region, we have found success. Over the past 5
years, the PPDC has assisted more than 60 devices along the development pathway, and compared to our 7
peer PDCs, the PPDC has been responsible for responsible for half of the Investigational Device Exemption
applications, 20% of 510Ks, and 71% of pre-submission meetings.
The support offered by the PPDC network of preeminent experts in their field who volunteer their time to advise
PPDC device innovators has allowed the PPDC to be a leader with parsimonious use of federal funds. From
PPDC inception, NAMSA - the world’s largest contract research organization specializing in medical devices –
has assisted every device project that the PPDC has considered for support. Our Clinical and Scientific
Advisory Committee – clinicians and scientists who are thought-leaders in their fields – evaluate the technical
merit of every device project. Our Oversight Committee – consisting of luminary CEOs, Investors, and other
medical device business leaders – evaluate the value proposition, reimbursement, regulatory, marketing and
business strategy of each proposed device. All of these services are provided free of charge by the PPDC.
Building on the aforementioned success, we propose new initiatives and enhanced partnerships that will
increase our ability to assist innovators. First, we are partnering with the University of Pittsburgh’s McGowan
Institute, a global Class III medical device development enterprise which has been at the forefront of
investigating, testing and translating medical devices that have played a critical role in regenerative medicine
for the past twenty-five years. McGowan’s partnership brings two strategic advantages to the PPDC: 1)
McGowan’s Class III device development capabilities expands the capability of the PPDC. 2) McGowan has a
pediatric device initiative in which their outstanding faculty are adapting adult devices for the pediatric
population. The PPDC will continue our partnerships with Philadelphia-based academic, engineering, business
and medical experts. We will enhance our ties with the University of Pennsylvania and Drexel University. The
University of Pennsylvania has just launched “Penn Health-Tech,” to catalyze medical device innovation, and
the PPDC is partnering with this eff...

## Key facts

- **NIH application ID:** 10466822
- **Project number:** 5P50FD006427-05
- **Recipient organization:** CHILDREN'S HOSP OF PHILADELPHIA
- **Principal Investigator:** Robert J Levy
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $999,999
- **Award type:** 5
- **Project period:** 2018-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10466822

## Citation

> US National Institutes of Health, RePORTER application 10466822, Medical Device Consortium at the Children's Hospital of Philadelphia (5P50FD006427-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10466822. Licensed CC0.

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