Translational Devices

Translational Devices

General Information

Chart displays the Translational Devices program provides support for the development, optimization, translation, and first-in-human testing of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The program consists of funding opportunities for investigator initiated projects at the NINDS (RFA-NS-18-011 / RFA-NS-18-012), as well as in the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) (RFA-NS-18-021 / RFA-NS-18-022 / RFA-NS-18-023) and Helping to End Addiction Long-Term (HEAL) (RFA-NS-19-016 / RFA-NS-19-017 / RFA-NS-19-018) Initiatives. An NIH Blueprint for Neuroscience Research R25 program to create a course on the development and translation of medical devices was also recently released (RFA-NS-20-003).

The Translational Devices program provides support for the development, optimization, translation, and first-in-human testing of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The program consists of funding opportunities for investigator initiated projects at the NINDS (RFA-NS-18-011 / RFA-NS-18-012), as well as in the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) (RFA-NS-18-021 / RFA-NS-18-022 / RFA-NS-18-023) and Helping to End Addiction Long-Term (HEAL) (RFA-NS-19-016 / RFA-NS-19-017 / RFA-NS-19-018) Initiatives. An NIH Blueprint for Neuroscience Research R25 program to create a course on the development and translation of medical devices was also recently released (RFA-NS-20-003).

Program Snap Shots

Program Snap Shots - NINDS Translational Neural Devices to BRAIN Initiative Generation Devices to HEAL Initiative Devices to Treat Pain

  • All funding opportunities for investigator-initiated projects use cooperative agreement mechanisms and are milestone-driven. This type of mechanism involves NIH program staff's participation in developing the project milestones and plans, monitoring the research progress, and making go/no-go decisions.
  • For projects that have completed all non-clinical testing necessary to obtain an IDE or obtained NSR designation from a local IRB, straight to clinical options (UH3 and SBIR U44 Phase II) are available in the BRAIN and HEAL Initiative programs.
  • Phased cooperative agreement mechanisms (UG3/UH3 and SBIR U44 Fast-Track) support pre-clinical/translational device activities, including translational bench and animal studies, and are expected to lead to an Investigation Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to support a small clinical trial, or a Non-Significant Risk (NSR) designation from an Institutional Review Board (IRB) in the first phase. The subsequent phase supports the small clinical study or trial to collect safety and effectiveness data required to support a marketing application, or to inform final device design.

NIH Blueprint for Neuroscience Research Education Program on Translational Devices (R25)

- Research Education Grant (R25) to develop and implement a short course focused on  (1) steps required for successful neural medical device development and translation, (2) common technical and strategic challenges, and (3) best-practices and resources for each stage in the process.

- Short course should address a broad audience, including senior post-doctoral fellows, independent academic researchers, clinician scientists, and small business entrepreneurs interested in developing and translating medical devices to diagnose or treat a nervous system disorder.

- Budget: $250,000 direct costs/yr up to 2 yrs

- CT Not Allowed

 Applicants are strongly encouraged to contact translational device staff prior to applying.