UCSF-Stanford Pediatric Device Consortium

What UCSF-Stanford Pediatric Device Consortium does

The UCSF-Stanford Pediatric Device Consortium is a federally funded accelerator that helps pediatric medical device innovators move concepts toward commercialization. Established in 2009 as the UCSF Pediatric Device Consortium and expanded in 2018 through a partnership with Stanford University, the consortium is anchored at UCSF Benioff Children's Hospitals and Lucile Packard Children's Hospital Stanford and incorporates the Stanford Byers Center for Biodesign innovation methodology. Its core offerings are the PDC Accelerator Program (grants of up to $100,000 per project distributed through bi-annual pitch competitions), tiered advising (a Tier 1 weekly Innovators Forum and Tier 2 personalized coaching including up to 8 hours of support in regulatory, IP, reimbursement, prototyping, and market analysis), free Real-World Evidence consulting with facilitated access to FDA pediatric device officers, and educational resources covering regulatory pathways and SBIR/STTR funding.

The consortium is funded primarily by the U.S. Food and Drug Administration's Office of Orphan Products Development under grant P50FD007967, supplemented by matching contributions from the Frederick Gardner Cottrell Foundation and the Hooper Family. It takes no equity in its accelerator projects and distributes services and grants at no cost to qualifying U.S.-based applicants. Since founding, the program has assisted more than 100 pediatric device projects, advanced 10 devices to first-in-human trials, contributed to 6 FDA approvals (including the 2021 AtriCure cryoNB pediatric clearance grounded in PDC-developed real-world evidence), helped portfolio companies attract roughly $30 million in external follow-on funding, and hosts the annual Michael R. Harrison Innovation Symposium as its flagship pitch and convening event.

Name

UCSF-Stanford Pediatric Device Consortium

Legal name

UCSF-Stanford Pediatric Device Consortium

Website

https://pediatricdeviceconsortium.org

Company type

Private

Founded year

2009

Operating status

Operating

Short description

The UCSF-Stanford Pediatric Device Consortium is an FDA-funded accelerator that provides non-dilutive grants, tiered advising, and real-world evidence consulting to U.S.-based pediatric medical device innovators developing devices for children from birth to age 21.

Ownership category

akta.pro rank

Product category

Pediatric Medical Device Innovation Accelerator

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Biomedical Sciences & Medical Research Institutes (University-Based) (EDAHAGAI)

akta.pro secondary industry

Research & Science Grantmaking Foundations (BPAGAKAI)

Keywords

• Pediatric medical devices
• Device accelerator programs
• Medical device funding
• Regulatory consulting services
• Healthcare innovation support

Headquarters

HQ city

San Francisco

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Others

Revenue model

1. FDA Grant Funding: The UCSF-Stanford Pediatric Device Consortium is funded by the U.S. Food & Drug Administration's Office of Orphan Products Development under grant no. P50FD007967. The consortium provides grants of up to $100,000 per project to qualifying pediatric device innovators through its accelerator program, along with customized mentoring and commercialization services. The consortium takes no equity stake in its accelerator projects.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

The UCSF-Stanford Pediatric Device Consortium is a grant-funded accelerator that distributes FDA grant money (up to $100,000 per project) and provides advising, mentoring, commercialization coaching, and Real-World Evidence consulting to U.S.-based pediatric medical device innovators. It runs weekly Innovators Forum open meetings, tiered personalized advising using Stanford Biodesign methodology, bi-annual pitch competitions, and the annual Michael R. Harrison Innovation Symposium to move pediatric devices from concept toward FDA submission and market availability.

Product overview

The UCSF-Stanford Pediatric Device Consortium operates as a multi-faceted accelerator and support program for pediatric medical device innovation, funded by the FDA's Office of Orphan Products Development. The core offerings include: the PDC Accelerator Program providing up to $100,000 grants and commercialization coaching; Real-World Evidence (RWE) Consulting offering free regulatory strategy support for FDA filings; Tiered Advising services including weekly Innovators Forum and Stanford Biodesign Coaching; Education Resources with regulatory learning modules and funding guidance; and annual Pitch Competitions (including the Michael R. Harrison Innovation Symposium) that distribute funding to promising pediatric device projects. The consortium leverages partnerships with UCSF and Stanford University, incorporating Stanford Biodesign methodology to support device development from concept through commercialization.

Differentiator

Problem solved

Functional benefit

Brands

• RWE Consulting: Real-World Evidence consulting services for companies and innovators looking to use RWE to support pediatric indications in FDA filings
• PDC Accelerator
• Innovators Forum

Products and services

• PDC Accelerator Program A direct funding program offering grants of up to $100,000 per project along with mentoring, advising, and commercialization services, awarded to U.S.-based pediatric device innovators selected through bi-annual (Spring and Fall) pitch competitions. Open to academic, business, or independent startups at any stage of development.
• Real-World Evidence (RWE) Consulting Up to 20 hours of free consulting for companies and innovators looking to use real-world data to support pediatric indications in FDA filings, including RWE strategy definition and facilitation of interactions with FDA pediatric device officers. Candidates must be within approximately one year of an FDA submission with adequate regulatory and biostatistical capabilities.
• Tier 1 Innovators Forum Weekly open innovation meetings where pediatric device innovators receive assistance from experienced surgeons, clinicians, engineers, scientists, product developers, and industry experts committed to developing pediatric devices. Video conference is available for participants outside the Bay Area.
• Tier 2 Personalized Advising In-depth advising providing up to 8 hours of assistance per project with value analysis, regulatory and reimbursement strategy, IP/patenting, preclinical/clinical study design, manufacturing planning, rapid prototyping, and market landscape analysis. Reserved for projects demonstrating a strong value premise and market opportunity.
• Biodesign Coaching Weekly feedback and mentorship through all facets of medical device innovation over approximately one month, helping early-stage ideas become pitch-ready for investors and business competitions using the Stanford Biodesign methodology.
• Education Resources Online educational resources and video learning modules for pediatric device innovators covering regulatory topics (CDRH Learn, FDA Device Advice), funding opportunities (SBIR/STTR, FDA Orphan Products), and connections to federal and non-federal funding sources.
• PDC Accelerator Pitch Competition Bi-annual (Spring and Fall) pitch competitions where pediatric device innovators compete for funding awards of up to $100,000 per project; the 2025 competition hosted at Stanford University offered $400,000 in total funding.
• Michael R. Harrison Innovation Symposium Annual symposium hosting the flagship PDC Pitch Competition, panel discussions on pediatric device innovation and Real World Evidence, and keynote presentations by leading experts in pediatric healthcare and medtech.

Quantifiable outcome

• Over 100 projects assisted since founding in 2009
• +3 more outcomes

Named customers1 record

Segments1 record

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability8 records

Partnerships

17 partnerships are on record, tiered major, core and minor.

• AtriCuremajorStrategic or Co-development Partner · 4 January 2020Collaboration with AtriCure to expand labeling for its cryoICE CRYO2 cryoablation probe to adolescent patients using real-world evidence from Electronic Health Record data mining. The project demonstrated that cryoNB devices have equivalent safety and efficacy for adolescents as for adults.
• Stanford UniversitycoreStrategic or Co-development Partner · 1 January 2018In 2018, UCSF and Stanford University teamed up to become the UCSF-Stanford Pediatric Device Consortium, incorporating the unique innovation methodology of Stanford Biodesign. Stanford provides physicians, engineers, IT and industry experts, and clinical fellows from the Stanford Byers Center for Biodesign.
• Fogarty InnovationmajorImplementation/ SI/ Consulting Partner · 1 January 2018Fogarty Innovation, a non-profit medtech incubator based in Silicon Valley, provides selected PDC accelerator participants with commercialization guidance and support. Andrew Cleeland, CEO of Fogarty Innovation, serves on the PDC Advisory Core.
• UCSF Benioff Children's HospitalscoreStrategic or Co-development PartnerOne of the two premier children's hospitals serving as the Bay Area home base for the consortium, providing clinical expertise and patient access for pediatric device development.
• Lucile Packard Children's Hospital StanfordcoreStrategic or Co-development PartnerOne of the two premier children's hospitals serving as the Stanford home base for the consortium, providing clinical expertise and patient access for pediatric device development.
• Stanford Byers Center for BiodesigncoreStrategic or Co-development PartnerStanford Biodesign provides the consortium with its renowned innovation methodology for device development. Thomas Krummel, MD serves as Co-Director of Stanford Biodesign and is on the Commercialization Advisory Core.
• MedTech Strategy Advisors, LLCminorImplementation/ SI/ Consulting PartnerRegulatory & Reimbursement advisory firm in the PDC's Advisory Network providing expertise to innovators.
• TheraNovaminorImplementation/ SI/ Consulting PartnerMedical device incubator led by Dan Burnett (Business Development Lead for PDC) providing business development expertise to innovators.
• UCSF Surgical InnovationscoreStrategic or Co-development PartnerUCSF Surgical Innovations provides seed funding, engineering support, and personalized consultation and advising to assist promising medical device ideas from UCSF faculty through the product development process.
• UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI)minorImplementation/ SI/ Consulting PartnerPartner in the Real World Evidence project, contributing regulatory science expertise.
• Experien GroupminorImplementation/ SI/ Consulting PartnerRegulatory, quality and clinical consulting firm contributing to the RWE project for AtriCure cryoablation probe expansion.
• NESTccminorImplementation/ SI/ Consulting PartnerNational Evaluation System for health Technology coordinating center contributing to the RWE demonstration project.
• UCSF Benioff Children's Hospital Division of Pediatric SurgeryminorStrategic or Co-development PartnerDivision contributing to the Real World Evidence project with clinical expertise for the AtriCure cryoNB expansion.
• San Jose State UniversityminorStrategic or Co-development PartnerScience & Engineering advisory partner providing technical expertise in the consortium's advisory network.
• University of California, BerkeleyminorStrategic or Co-development PartnerScience & Engineering advisory partner in the consortium's advisory network for technical collaboration.
• University of California, Santa CruzminorStrategic or Co-development PartnerScience & Engineering advisory partner in the consortium's advisory network.
• CobiCureminorStrategic or Co-development PartnerPediatric healthcare non-profit focused on advancing development of pediatric medical devices. Emma Moran serves as strategic lead at CobiCure and judges PDC pitch competitions.

Scale indicators8 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• MedTech Innovator: Largest medical device accelerator globally, with overlapping accelerator/mentorship model and pediatric track, but operating at much broader scale across the entire medtech spectrum rather than pediatrics-specific.
• JLABS (Johnson & Johnson Innovation): Global network of life science and medtech incubators providing lab space, mentorship, and funding to early-stage companies; comparable incubator/advising model but at substantially larger scale and broader therapeutic scope than the pediatric-focused UCSF-Stanford PDC.

Emerging players

• Fogarty Innovation: Non-profit medtech incubator in Silicon Valley providing commercialization guidance to PDC accelerator participants; similar mission, Silicon Valley location, and active partnership with the UCSF-Stanford PDC.
• Stanford Byers Center for Biodesign: Stanford-based medical device innovation program whose methodology is embedded in the UCSF-Stanford PDC. Overlapping in talent pool, device development playbook, and pediatric/medtech focus, but with broader adult and digital health scope.
• UCSF Surgical Innovations: UCSF-based internal program providing seed funding, engineering support, and personalized advising to medical device ideas from UCSF faculty—parent/partner program sharing leadership (Usha Thekkedath) and overlapping applicant pool with the UCSF-Stanford PDC.

Direct peers

• CobiCure: Pediatric healthcare non-profit focused on advancing development of pediatric medical devices, with overlapping ecosystem role, pediatric device focus, and direct partnership/overlap with the UCSF-Stanford PDC (judges its pitch competitions).
• Philadelphia Pediatric Medical Device Consortium: FDA-funded Pediatric Device Consortium (Children's Hospital of Philadelphia) providing grants, advising, and development support to pediatric medical device innovators—comparable accelerator offering and federal funding structure.
• Midwest Pediatric Device Consortium: FDA-funded Pediatric Device Consortium (University of Michigan) supporting pediatric device innovation with funding and advising services—directly parallel in mission, federal funding model, and accelerator structure to the UCSF-Stanford PDC.
• Southwest National Pediatric Device Innovation Consortium: FDA-funded Pediatric Device Consortium based in Texas providing accelerator funding and advising to pediatric device innovators—direct sibling consortium with parallel mission, funding source, and program structure.
• Atlanta Pediatric Device Consortium: A fellow FDA-funded Pediatric Device Consortium (Georgia Tech + Children's Healthcare of Atlanta + Emory) that provides accelerator funding and advising to pediatric device innovators, directly comparable in mission, structure, and federal funding source to the UCSF-Stanford PDC.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/UCSFStanfordPDC

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds

Investors

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M&A

Investments3 records

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Frequently asked questions about UCSF-Stanford Pediatric Device Consortium