Key Dates

NOT-EB-21-019 - Notice of Intent to Publish a Funding Opportunity Announcement for Blueprint MedTech: Incubator Hubs (U54 - Clinical Trial Not Allowed)

NOT-NS-21-057 - Notice of Intent to Publish a Funding Opportunity Announcement for Blueprint MedTech: Translator (UG3/UH3 - Clinical Trial Optional)

NOT-DA-22-050 - Notice of Intent to Publish a Funding Opportunity Announcement for Blueprint Medtech: Small Business Translator (U44 Clinical Trial Optional)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Complementary and Integrative Health (NCCIH)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

The NIH Blueprint for Neuroscience Research, with participating NIH Institutes and Centers (ICs), intends to promote the new Blueprint MedTech program by publishing a Funding Opportunity Announcement (FOA). The FOA is expected to be published in Summer 2021 with an expected application due date in Fall 2021. This FOA will utilize the U18 activity code. This FOA will support development of human-grade medical device prototypes. Leveraging resources from the BP MedTech program, projects will complete product definition and development (e.g., needs assessment, product design, prototype development, and bench testing). The end goal is to prepare for first-in-human testing via other FOAs within the BP MedTech program. Details of the planned program are provided below.

This Notice is being provided for informational purposes to allow potential applicants additional time to develop responsive applications and meaningful collaborations. NIH reserves the right to modify the scope and objectives as described in this Notice. Final scope, objectives, and requirements will be set forth in the published FOAs.

The NIH Blueprint for Neuroscience Research is a collaborative framework through which 14 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/).

Innovators developing groundbreaking medical device technologies face a number of challenges along the translational path from bench to bedside. The Blueprint MedTech program is an NIH incubator that aims to address such challenges and support the innovators by accelerating the development of cutting-edge medical devices to diagnose and treat disorders of the nervous system. The mission of the program is to catalyze the translation of novel neurotechnologies from early-stage development to first-in-human clinical studies. The program will provide: (a) non-dilutive funds to support medical device development activities led by investigators, and (b) additional resources and support services including, but not limited to:

• Planning resources to support concept development, team building, needs assessment, and other early translational activities.
• Streamlined access to translational services and expertise (e.g., design and prototyping, bench testing, large animal testing, biocompatibility assessment, manufacturing, medical monitoring).
• Assistance from consultants (e.g., on regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues).
• Advice from industry experts (e.g., meetings with an external oversight committee).
• Access to NIH staff to assemble a resource package tailored to each team’s particular needs.

The overarching goal of the Blueprint MedTech program is to accelerate patient access to groundbreaking, safe, and effective medical devices. The program will provide support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government.

The Blueprint MedTech program structure involves multiple FOAs:

• [NOT-EB-21-019 ] U54 centers will coordinate and manage resources for the Blueprint MedTech program (a.k.a. "incubator hubs"). Hubs will be responsible for providing innovators with resources to support development of human-grade prototypes.
• [NOT-EB-21-018] U18 projects will support the development of human-grade medical device prototypes using resources from U54 centers, in preparation for first-in-human studies via the UG3/UH3 or U44 components of BP MedTech.
• [NOT-NS-21-057] UG3/UH3 projects will support late-stage technology development/optimization and first-in-human clinical studies.
• [NOT-DA-22-050] U44 projects will support late-stage technology development/optimization and first-in-human clinical studies for small businesses.

Researchers planning to apply are strongly encouraged to visit the Blueprint MedTech webpage and contact NIH program staff to learn more about the scope and breadth of the program, anticipated resources provided, and other FOAs. Please direct all inquiries to: [email protected]

https://neuroscienceblueprint.nih.gov/blueprint-medtech

Applications are not being solicited at this time.

Please direct all inquiries to:

Michael Wolfson, Ph.D.

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

301-451-6987

[email protected]