Notice of Intent to Publish a Funding Opportunity Announcement for Blueprint MedTech Prototype Developer (U18 Clinical Trial Not Allowed)
Notice Number:
NOT-EB-21-018

Key Dates

Release Date:
May 14, 2021
Estimated Publication Date of Funding Opportunity Announcement:
July 15, 2021
First Estimated Application Due Date:
October 20, 2021
Earliest Estimated Award Date:
June 01, 2022
Earliest Estimated Start Date:
July 01, 2022
Related Announcements

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)

Issued by

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)

Purpose

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.

Research Initiative Details

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: Blueprint-MedTech@nih.gov

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

Funding Information
Estimated Total Funding

TBD

Expected Number of Awards
TBD
Estimated Award Ceiling

TBD

Primary Assistance Listing Number(s)

TBD

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Eligible Agencies of the Federal Government
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Small Business
U.S. Territory or Possession

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Michael Wolfson, Ph.D.

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

301-451-6987

Blueprint-MedTech@nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices