Government

The U.S. government supports a wide range of health-related research and development. There is no central source of government-related R&D funds, but rather individual government agencies set their own R&D budgets and focus. Within each agency, there may be a variety of funding platforms that have different requirements with respect to applicants, scope of research, and/or funding needs. As detailed below, there are specific funding mechanisms that are specifically targeted to advance small businesses in the medical device space.

Grants.gov is an invaluable resource to begin your search for potential government funding agencies. Below are several government agencies that have been known to support medical device research and development.

  • Defense Advanced Research Projects Agency (DARPA). DARPA is a research and development branch of the U.S. Department of Defense tasked with developing technologies for the military. This broadly applied mission may also include military family members. In addition to sponsoring academic research, DARPA also provides research funding, through the SBIR and STTR mechanisms, that supports the R&D efforts of small businesses.
  • The Food and Drug Administration (FDA). The FDA sponsors the development of pediatric medical devices through the funding of the FDA-initiated Pediatric Device Consortia (PDC). Highlighted here, the PDCs annually fund up to $50,000 for the development of a range of medical devices aimed at the pediatric patient population.
  • National Institutes of Health (NIH). NIH is the world’s largest source of research funding. In addition to sponsoring academic research, NIH also provides research funding, through the SBIR and STTR mechanisms, that supports the R&D efforts of small businesses.
  • The National Science Foundation (NSF). NSF funds research in most fields of science and engineering. Awards are made to academic institutions, K–12 school systems, and businesses. NSF also provides research funding, through the SBIR and STTR mechanisms, that supports the R&D efforts of small businesses.

Orphan Products Clinical Trials Grants Program:  Grants fund clinical studies of safety and effectiveness that work toward market approval of orphan products. The program is open to public and private applicants and applies to the study of drugs, biologics, medical devices, or medical foods. Grants are awarded based on technical and scientific review criteria. Successful grantees are paired with a project officer who ensures regulatory requirements are met and provides feedback as the project progresses.

Orphan Products Natural History Grants Program:  Established in 2016, the Orphan Products Natural History Grants Program supports studies that advance rare disease medical product development by characterizing the natural history of a specific disease or disorder that affects less than 200,000 people in the United States. The goal is to expand foundational disease knowledge to allow further diagnostic and therapeutic targets to be developed. Retrospective, prospective, and survey studies are eligible for funding.

Pediatric Device Consortia (PDC) Grants Program: Pediatric device development faces unique challenges not seen in the adult sphere, including small market size, need for multiple pediatric sizes, expensive trials, ethical barriers to enrolling children, and a lack of device trials infrastructure. The PDC Grants Program currently funds five pediatric device consortia, which provide a platform of experienced regulatory, business, and device development services, including intellectual property advising, prototyping, engineering, laboratory and animal testing, grant writing, and clinical trial design. In addition, up to $50,000 per project is available for direct device investment. The five currently funded PDCs are:

The Small Business Innovation Research (SBIR)Program. The SBIR program seeks to fund early-stage small businesses that seek to commercialize innovative biomedical technologies.

The Small Business Technology Transfer (STTR) Program. The STTR program is similar to the SBIR but requires that the small business formally collaborate with an academic institution.

Nonprofit Organizations

Nonprofit organizations can help advance the development of pediatric medical devices by providing funding, expertise, or other resources. Some nonprofits are focused on specific diseases and/or patient populations. In addition, some nonprofit organizations are dedicated to the pediatric patient population.

Disease-Specific Foundations dedicated to addressing healthcare issues involving a limited number of diseases and/or organ systems:

  • American Heart Association (AHA)
  • Juvenile Diabetes Research Foundation (JDRF)
  • Lupus Foundation of America (Lupus)
  • Raymond A. Wood Foundation (RWF). The Raymond A. Wood Foundation sponsors research directly related to pediatric hypothalamic-pituitary brain tumors.

  • Newborn Foundation (Newborn Foundation). The Newborn Foundation is a 501(c)(3) nonprofit organization that seeks to develop innovative pilot projects related to early detection and intervention of life-threatening diseases in the newborn patient population.
  • PediaWorks. PediaWorks is a 501(c)(3) nonprofit organization that supports projects, usually in the pediatric cardiovascular space, with the greatest clinical impact rather than profit potential. In addition, PediaWorks has provided pro bono commercialization guidance to early-stage pediatric device companies.
  • The Pediatric Device Innovation Consortium (PDIC). Based at the University of Minnesota, the PDIC seeks to address the gap in pediatric device research by forming innovative partnerships to advance the field of pediatric device development.

  • Science Center (Science Center)
  • The W.W. Smith Charitable Trust (W.W. Smith).The W.W. Smith Charitable Trust funds research in heart disease, cancer, and AIDS research. Awards are generally given to academic institutions within the southeast Pennsylvania region.

If your organization is interested in being added to this list, please contact us.