Education Program on Translational Devices (R25 Clinical Trial Not Allowed) | PAR 22 146

Opportunity Information: Apply for PAR 22 146

The National Institutes of Health (NIH) is offering a Research Education Grant (R25) opportunity titled "Education Program on Translational Devices (R25 Clinical Trial Not Allowed)" under Funding Opportunity Number PAR-22-146. The program is designed to fund the development and delivery of a short, targeted educational course that helps trainees and professionals understand how to move medical devices from early concept through translation and ultimately toward commercialization, specifically for devices intended to diagnose or treat disorders of the nervous system. The emphasis is practical and stage-based: applicants are expected to teach the key steps in the device development pathway, highlight common technical and business hurdles that derail promising technologies, and provide best-practice guidance along with concrete resources that participants can use at each phase.

A central goal of this FOA is to strengthen the translational "know-how" of a broad and diverse audience that often participates in medical device innovation but may not have formal training in the full end-to-end process. The intended participants include senior postdoctoral fellows, independent academic researchers, clinician-scientists, and small business entrepreneurs who are actively interested in developing, translating, and/or commercializing device technologies relevant to neurological indications. While the core requirement is the short course itself, applicants may also choose to incorporate an extended mentorship component if they believe it will improve outcomes, for example by pairing participants with experienced device developers, regulatory experts, industry partners, or commercialization professionals to guide follow-on planning beyond the course.

From a content standpoint, the course is expected to cover the real-world sequence and decision points involved in translational device development. That typically includes topics such as identifying clinical needs and defining a clear use case, designing for safety and usability, prototype development and iteration, verification and validation planning, preclinical testing strategies where relevant, quality systems and design controls, regulatory pathways and submission strategies, clinical considerations without running a clinical trial under this award, reimbursement and coding landscape awareness, intellectual property planning, manufacturing scale-up considerations, risk management, and go-to-market strategy. The FOA also explicitly calls for discussion of common technical and strategic challenges, which often include feasibility constraints, human factors issues, evidence generation expectations, stakeholder alignment (clinicians, patients, payers, hospital procurement), funding gaps between early research and commercialization, and the operational realities of building a multidisciplinary team. Importantly, the opportunity is labeled "Clinical Trial Not Allowed," meaning the funded activity is educational in nature and cannot support clinical trial execution.

Eligibility is broad and includes many types of U.S.-based organizations and institutions. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations other than small businesses; and small businesses. Native American tribal governments (federally recognized) and tribal organizations (including those other than federally recognized governments) are also eligible, along with public housing authorities and Indian housing authorities. The FOA additionally highlights eligibility for a range of mission-focused institutions and organizations, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

At the same time, there are clear geographic limitations. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible. However, foreign components are allowed as defined in the NIH Grants Policy Statement, which generally means a U.S. applicant organization may include certain foreign activities or collaborations when they are well-justified and consistent with NIH policy, even though the applicant institution itself must be domestic.

The opportunity is categorized as a discretionary grant within the NIH education funding activity area (with CFDA numbers listed as 93.279, 93.286, 93.847, and 93.853). The award ceiling is stated as $250,000. The posting shows an original closing date of 2022-07-29 and a creation date of 2022-04-28, indicating when this specific FOA cycle was made available and when it was originally due. Overall, the program is aimed at building a stronger pipeline of researchers and entrepreneurs who can realistically navigate the technical, regulatory, and commercialization steps needed to turn neuroscience-focused device ideas into products that can reach patients.

• The National Institutes of Health in the education, food and nutrition, health sector is offering a public funding opportunity titled "Education Program on Translational Devices (R25 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279, 93.286, 93.847, 93.853.
• This funding opportunity was created on 2022-04-28.
• Applicants must submit their applications by 2022-07-29. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $250,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 22 146

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