Education

 

Regulatory

CDRH Learn: Video-based learning modules covering a range of topics such as regulatory overview, device classification, postmarket activities, and industry basics. The tool is intended to provide useres with information that is comprehensive, interactive, and easily accessible. View the modules here.

FDA Device Advice: The FDA's Center for Devices and Radiological Health (CDRH) offers comprehensive regulatory assistance through text-based resources that explain medical device laws, regulations, guidances, and policies, covering both premarket and postmarket topics. View the resources here.

Funding

PDC Direct Funding

The UCSF PDC is part of a national network of five pediatric device consortia funded by the FDA to support pediatric medical device development. All five consortia host annual or semi-annual grant competitions that provide grants of up to $50,000 per project. Learn more about the FDA Pediatric Device Consortia Program >>

  • UCSF-Stanford Pediatric Device Accelerator - Our program combines up to $50,000 in funding with customized clinical, engineering, regulatory, business, and product development advising from experienced innovators and industry leaders to help drive promising pediatric device ideas towards commercialization. The next cycle will be announced in January 2019. Learn about last cycle’s winners >>

  • Partner PDC Competitions - Our partner PDCs offer funding competitions throughout the year. Currently active project solicitations are listed below. Specific eligibility requirements may apply. Subscribe to our mailing list to receive alerts on funding opportunities as they are announced.

Other Federal funding 

In addition to funding distributed through the FDA’s PDC network, there are many other federal funding sources relevant to pediatric device research and development. The following mechanisms are particularly good fits for pediatric device projects: 

  • FDA Orphan Products Clinical Trials Grants Program (formerly known as Orphan Products Grants) - This program encourages the clinical development of products, including medical devices, for use in rare diseases or conditions. Learn more >>

  • Small Business Administration (SBA) - The SBA administers the federal SBIR and STTR programs, known as “America’s Seed Fund.” The National Institutes of Health (NIH) and National Science Foundation (NSF) tend to be the most common sources of SBIR/STTR support for pediatric device research and development. Learn more >>

    • Small Business Innovation Research (SBIR) - Encourages domestic small businesses to engage in federal research and development that has the potential for commercialization. The program is structured in three phases, with awards typically <$150,000 for 6 months in Phase I and <$1,000,000 for 24 months in Phase II. Learn more >>

    • Small Business Technology Transfer (STTR) - A sister program offering funding in federal innovation R&D and focused on public/private sector partnerships between small businesses and nonprofit research institutions. STTRs are structured similarly to SBIRs. Learn more >>

Other governmental agencies provide grants that may also be amenable to pediatric medical device research and development, depending on the specific nature of the technology or clinical application. Click the links below to learn more about current funding opportunities available from each agency:

Non-Federal Funding 

In addition to funding distributed through the FDA’s PDC network, there are many other federal funding sources relevant to pediatric device research and development. The following mechanisms are particularly good fits for pediatric device projects: 

UCSF Intramural Funding

For UCSF pediatric device innovators, there are several internal funding opportunities available to faculty

  • UCSF Catalyst Award - The Catalyst Award includes customized product development advice and up to $100,000 in funding to help drive promising early-stage technologies into patient benefit. Eligible projects have a clear clinical indication and early target validation or early proof-of-concept data. Learn more >>

  • Surgical Innovations Accelerator - The SI Accelerator provides seed funding, engineering support, and personalized consultation and advising to assist promising medical device ideas from UCSF faculty through the product development process towards market availability and patient benefit. Learn more >>

Stanford Intramural Funding

For Stanford pediatric device innovators, there are several internal funding opportunities available to faculty

  • Maternal & Children’s Health Research Institute - The MCHRI mobilizes Stanford discoveries and expertise to launch healthier lives through education, resources, and funding for faculty and trainees throughout the School of Medicine. Learn more >>

  • Stanford-Coulter Translational Research Grants - This program awards up to $800,000 a year to Bioengineering faculty members and their clinician researcher collaborators from the School of Medicine to establish innovative multidisciplinary partnerships, foster new technologies, and move medicine forward. Learn more >>

  • Spectrum Funding - Spectrum offers an Innovation Accelerator Pilot Program and Research Training Programs for researchers interested in developing solutions that improve health. Learn more >>

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.