Innovators developing groundbreaking medical device technologies face several challenges along the translational path from bench to bedside. The NIH Blueprint MedTech: Incubator Hubs aim to address such challenges by accelerating the development of cutting-edge medical devices to diagnose and treat disorders of the nervous system or consequences of such a disease or injury. This program will catalyze the translation of novel technologies from early-stage development to a prototype ready for first-in-human-testing and will provide: (a) non-dilutive funds to support medical device development activities, (b) ongoing, specialized support from experienced executive mentors and (c) additional resources and support services including, but not limited to:

• Assistance from Hubs and consultants (e.g., on design, regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues).
• Resources to plan and support concept development, team building, needs assessment, and other early translational activities.
• Other resources listed on the Blueprint MedTech Website

The Center for Innovative NeuroTech Advancement (CINTA) and NeuroTech Harbor (NTH) are the two NIH-funded Incubator Hubs that will provide funding and in-kind resources to innovator teams. The objective of Hub support is to develop and de-risk these groundbreaking technologies to the point of first-in-human-testing. By the conclusion of CINTA or NTH funding, it is anticipated that all projects will have non-governmental funding secured or be ready for entry into the companion solicitations from NIH:

• Blueprint MedTech: Translator (UG3/UH3)
• Blueprint Medtech: Small Business Translator (U44)

These companion solicitations support first-in-human evaluations of safety and effectiveness.

CINTA and NTH seek groundbreaking collaborative projects to improve the prevention, diagnosis, and/or treatment of disorders involving the nervous system or consequences of such a disease or injury. The technologies proposed in applications must have a pathway to a prototype ready for first-in-human testing within 4 years. Projects should be viable candidates for commercial development.

Awards from NTH or CINTA will rarely exceed $500,000 in direct costs per year for a period of up to 4 years. In addition to monetary support, awardees will receive ongoing, specialized support from mentors experienced in commercializing medical devices. Awardees will work with their individual mentor each week to focus on business, regulatory, clinical, and technical factors that may impede commercialization.

The Blueprint MedTech Hubs and NIH encourage applications from women, underrepresented racial and ethnic groups, as well as individuals with disabilities.

Applicants must submit pre-proposals, which will undergo review by CINTA, NTH, and NIH program scientific staff. Pre-proposals are submitted through equivalent to approximately 4 pages.

A subset of applicants will be invited to submit full proposals through the same online application system. The full proposal form is equivalent to approximately ten pages. A subset of the applicants who submit full proposals will be selected to participate in an advanced, interactive “deep dive” evaluation, which is the final stage of review prior to funding decisions.

Another subset of the applicants who submit full proposals will be invited to participate in the companion Seedling program and be awarded up to $50,000 total cost. The Seedling program is akin to a planning grant that will provide training and mentoring to help applicants refine the intended target product profile and regulatory and reimbursement strategies in order to strengthen subsequent applications to the program.

Principal Investigators (PIs) from academic institutions, industry, and non-profit organizations are invited to apply. Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Principal Investigator(s) is (are) invited to work with their organization to develop and submit a proposal.

Applicants should consider avenues to support diversity, equity, inclusion, and accessibility in their proposals. This may be addressed by including team members or collaborators from groups that are traditionally underrepresented in the translational workforce or by considering population factors such as racial and ethnic groups, gender, and disabilities. Proposals that address conditions or clinical indications where current diagnostic or treatment options disproportionately fail to serve underrepresented populations are encouraged.

All pre-proposals, full proposals, and deep dive discussions will be conducted on a confidential basis.

February 16, 2023: Pre-proposal submission opens

February - March 2023: Informational webinars and Office hours by appointment sign up here

March 16, 2023: Pre-proposal submission deadline

April 12, 2023: Submission opens for full proposals from invited pre-proposal applicants

May 15, 2023: Full proposal submission deadline

July 2023: Deep Dive Assessment Phase

August-September 2023 (estimated): Final projects selected for funding

The above graphic represents the stages starting from pre-proposal to program selection. Seedlings will need to re-apply to a future solicitation cycle to be eligible for project funding.

• Pre-proposals must be submitted through the online application no later than 11:59 pm ET on March 16, 2023. The goal of projects should be a prototype ready for first-in-human studies.
• Applicants will be notified by April 12, 2023, as to whether they are invited to submit a full proposal. Invitations will be sent by email both to the PI and to the administrative contact listed in the pre-proposal.
• Invited full proposals must be received by 11:59pm ET on May 15, 2023. Full proposals are also submitted through the online proposal submission system.
• All applicants will be informed of review decisions by the end of June 2023.
• Selected full proposals will proceed to a “deep dive” review stage that is expected to take approximately two weeks, during which time applicants will need to commit significant effort to respond to the deep dive team's inquiries.
• The earliest anticipated start date for funding for selected full proposals is November 2023.
• The anticipated performance period is up to 12 months, which can be renewed for up to an additional three 12-month periods with CINTA, NTH, and NIH approval.
• Awards will rarely exceed $500,000 per year in direct costs. Indirect costs will be provided at your institution’s Federally negotiated rate. We expect to make up to 15 awards from this solicitation.
• The earliest anticipated start date for Seedlings will be November 2023.

CINTA and NTH are seeking proposals leading to commercialization of groundbreaking therapeutic and/or diagnostic medical devices. At a minimum, projects should have already demonstrated proof-of-concept. Projects that are nearly ready for first-in-human testing will be redirected to the companion NIH Blueprint MedTech: Translator FOAs.

Applications must focus on a disorder of the nervous system or consequences of such a disease or injuryin an area of interest of the Participating Institutes/Centers. Since applications outside the mission of these participating Institutes/Centers will not receive funding, applicants are encouraged to review the Institutes’ website. For questions about mission fit, contact the points of contact listed on the Blueprint MedTech website prior to submitting a pre-proposal and indicate which specific disease is targeted by your product. All other questions should be submitted to info@blueprintneurotech.org.

Applicants must have collaborative teams incorporating product development and clinical expertise. Input from these collaborators must be clearly reflected throughout the application and proposed scope of work. CINTA and NTH can assist in connecting potential applicants with potential collaborators if requested. Applications from teams without clinical expertise are discouraged.

Applications should:

• Address an area of interest of the NIH Participating Organizations to ensure mission fit.
• Identify the target indication for the proposed device.
• Clearly define the current state of the art, and its limitations, and highlight how the proposed technology will advance patient care.
• Include data showing that the diagnostic or therapeutic technology has already been demonstrated (proof of concept) with enough confidence that the remaining challenges are primarily related to building a prototype for first-in-human studies.
• Propose medical devices with first-of-its-kind technologies, novel intended use, new safety aspects (typically De Novo, PMA, or possibly 510K requiring clinical data).
• Propose solutions that are equitable, affordable, and accessible by all clinically relevant communities, including underserved and vulnerable populations.

Applications will NOT be considered for:

• Products not regulated by the FDA.
• Device technologies that do not significantly advance the state of the art (e.g., device technology that proposes minor modifications to FDA-approved/cleared medical device technology).
• Animal model development: all in vivo animal models must be well established and characterized, and available to the applicant.
• Fundamental basic/applied research projects prior to proof of concept.
• Projects focused on technologies for functional augmentation of healthy individuals.

To sign up for upcoming webinars, please click here. Or access a recent recording and current slides of the Informational Webinar.

To schedule time for office hours with program staff, please click here.

Please contact info@blueprintneurotech.org if you have any questions about the program.