Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional) | PAR 21 282

Opportunity Information: Apply for PAR 21 282

Blueprint MedTech: Small Business Translator (U44 - Clinical Trial Optional) is a National Institutes of Health (NIH) funding opportunity designed to push promising therapeutic and diagnostic medical devices for nervous system and neuromuscular disorders out of the early research stage and into real-world translational development. The core aim is to help small business concerns (SBCs) complete the practical, regulated, and evidence-driven steps needed to move a device toward human use, including building and refining clinical prototype devices, running targeted non-clinical testing to establish safety and performance, and completing design verification and validation work that supports a regulatory pathway. While clinical trials are optional under this announcement, the program allows for limited-size clinical studies when they are truly necessary to answer questions that cannot realistically be resolved through additional bench testing or animal studies, such as when the device is novel or its intended use creates uncertainties only human use can clarify.

A key feature of this opportunity is that it uses a milestone-driven cooperative agreement mechanism (U44). In practical terms, that means awardees do not just receive funds and operate independently; NIH program staff are actively involved. Before an award is made, NIH staff work with the applicant to negotiate and finalize the project plan and milestones, and they continue to monitor progress against those milestones over the life of the project. This structure is meant to keep projects tightly aligned with translational deliverables, reduce common development missteps, and ensure that the work stays focused on producing concrete outputs like validated designs, credible safety and effectiveness data packages, and submissions that enable clinical evaluation.

The work supported under the FOA specifically includes activities that move a device toward regulatory clearance to study in humans. Examples named in the opportunity include preparing for and leading into an Investigational Device Exemption (IDE) submission to the U.S. Food and Drug Administration (FDA) when that pathway is needed, or preparing an Institutional Review Board (IRB) submission for a Non-Significant Risk (NSR) clinical study when appropriate. The clinical component, if proposed, is expected to be limited in size and tightly justified: it should produce information about device function or final design decisions that cannot be obtained practically through non-clinical routes. In other words, this is not positioned as a large pivotal trial program, but as a translational bridge that helps innovators resolve the last major uncertainties before broader clinical development.

In addition to direct funding for work performed by the small business in its own labs and development environment, the Blueprint MedTech program adds structured expert support. Awardees collaborate with NIH-funded consultants who can advise on areas that routinely determine whether a device succeeds beyond the lab, including regulatory strategy, reimbursement considerations, intellectual property planning, commercialization approaches, and forming strategic partnerships. The program also gives participants the option to augment their efforts using NIH contract resources, including contract research organizations with specialized capabilities such as large animal testing, sterilization testing, biocompatibility assessment, manufacturing support, and medical monitoring. This combination of money plus hands-on translational assistance is intended to help small companies close gaps in expertise and infrastructure that often slow device programs down.

Eligibility is centered on small business concerns, and the announcement explicitly welcomes SBCs that are building their own devices as well as those that already collaborate with device manufacturers. The broader eligibility list provided in the source data is expansive and includes various government entities, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including those other than small businesses), and a range of mission-based or community-based organizations. It also highlights categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal governments and Tribal-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations. Even with that broad list, the program identity and primary target remain small businesses advancing devices in the neurology and neuromuscular space.

Administrative details from the opportunity record include the funding opportunity number PAR 21 282, the agency being NIH, the instrument type being a cooperative agreement, and the activity category being Health under CFDA 93.853. The record shows an original closing date of 2024-09-28, and it does not specify an award ceiling or expected number of awards in the provided fields. Additional program context and resources are referenced through the Blueprint MedTech site at https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-medtech, which is positioned as the central place to learn more about the program model and related companion opportunities.

Overall, this FOA is best understood as a structured translational accelerator for neurotechnology and neuromuscular device developers, combining milestone-based NIH oversight with funding, regulatory and commercialization guidance, and optional access to specialized testing and manufacturing resources. The intended endpoint is not just scientific knowledge, but a device development package that is mature enough to support an IDE or NSR clinical study authorization and to meaningfully de-risk the path to later-stage clinical testing and market entry.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2021-08-20.
• Applicants must submit their applications by 2024-09-28. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

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