This Cycle 6 funding solicitation has changed significantly from previous Blueprint MedTech funding cycles. Potential applicants are encouraged to thoroughly review this page and the associated FAQs.

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 that will prevent, diagnose, and/or treat disorders involving the nervous system or consequences of such a disease or injury. Examples of fitting projects include but are not limited to:

• Addressing early and accurate diagnosis or early selection of the most effective therapy.
• Facilitating the deployment of long-term therapy for those with persistent neurologic deficits, including technologies for home-based interventions that address motor, cognitive, and language impairments.

This program will catalyze the translation of novel technologies from proof-of-concept to a prototype ready for first-in-human testing and will provide: (a) non-dilutive funds to support medical device development activities, and (b) ongoing, specialized support from experienced executive mentors. The Hubs can also assist innovators in obtaining additional resources and support services from a pool of vetted providers. These resources and support services can assist on design, regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues as well as commercialization plan development, team building, needs assessment, and other early translational activities.

The Center for Innovative NeuroTech Advancement (CINTA) and NeuroTech Harbor (NTH) are the two NIH-funded Incubator Hubs that will provide funding, mentoring, oversight, and in-kind resources to innovator teams. The objective of Hub support is to further develop and de-risk these groundbreaking technologies to the point of readiness for first-in-human testing (i.e., ending prior to any evaluation of safety or effectiveness in humans). By the conclusion of Hub funding, it is anticipated that projects will have secured non-governmental funding or be ready to apply for funding for a companion Translator solicitation from NIH (“Blueprint Medtech: Translator UG3/UH3 – Clinical Trial Optional” which supports first-in-human evaluations of safety and effectiveness), or other NIH funding sources. Human subjects research other than surveys or user interface studies cannot be supported through the Hubs. For further details about support of human subjects research, please see the FAQs.

As outlined in the figure below, applicants first submit a pre-proposal. NIH program staff will determine whether the pre-proposal fits within the interests of the participating NIH institutes and centers and is aligned with the scope of the Blueprint MedTech program. Pre-proposals are submitted through the simple online application form and are equivalent to approximately three pages. Applicants are encouraged to gather input from the community for the target clinical condition to better understand their individual experiences and unmet needs.

Selected pre-proposal applicants will be invited to submit full proposals through the same online application system. The full proposal form is equivalent to approximately ten pages and will undergo review by CINTA and NTH. As part of the review process, applicants are required to participate in a one-hour interview with reviewers to clarify information submitted in their application. Applicants must prepare a presentation for the interview process and participate in the interview (see Timeline section below for dates).

Reviews of the full application and interview are used to determine which applications are appropriate for a Sprinter award. Sprinter awards are utilized to address gaps and risks identified in the review process and to complete an initial milestone in the development pathway.

Upon successful completion of the Sprinter project, applicants must participate in an interactive “Deep Dive” evaluation, which is the final due diligence stage of review prior to funding decisions on Optimizer projects. Deep Dive evaluations will undergo review by CINTA and NTH. NIH will make the final funding decision.

All reviews and discussions regarding pre-proposals, interviews, full proposals, and deep dives will be conducted on a confidential basis.

The above graphic represents the stages starting from pre-proposal to Optimizer award.

Full proposals will be assessed by CINTA and NTH for the project’s commercial viability, including but not limited to the likelihood of technical de-risking and achieving a prototype ready for first-in-human testing, market need, regulatory pathway, potential clinical impact and for reducing treatment gaps, and projected costs to the payer. Reviewers are chosen based on their expertise in one or more of these areas and their comments and critiques focus on these aspects. Applications do not receive an overall impact score and are only provided a brief review summary. Award decisions are made by NIH and issued and managed by CINTA and NTH.

• Pre-proposals must be submitted through the Blueprint MedTech Incubator Hubs Program online application system. Projects must have demonstrated proof-of-concept with the goal of developing a prototype ready for first-in-human studies.
• A subset of pre-proposals will be invited to submit full applications, which are also submitted through the online proposal submission system. Complete plans must be provided in the application for advancing the technology to a prototype ready for first-in-human testing within four years. Applicants must prepare for and participate in a one-hour interview. Applicants must make themselves available during assigned time periods (see Timeline).
• The performance period for Sprinters is 20 weeks. Sprinter support consists of $100,000 total cost and mentor support. We expect to make up to 20 Sprinter awards from this solicitation.
• Sprinter funding cannot be used to support animal or human subjects research.
• Following completion of the Sprinter project, applicants will proceed to a “Deep Dive” review that is expected to take approximately six weeks. During this time applicants will need to commit significant effort to work with the Deep Dive team and respond to the team’s inquiries.
• The performance period for Optimizer projects is one year with the potential for up to three additional years of continued funding depending on results from the prior year and availability of funding. Annual Optimizer support consists of no more than $1,285,000 total cost and mentor support.
• During the Optimizer performance period, human subjects research (other than surveys or user interface studies) cannot be supported through the Hubs. For further details about support of human subjects research, please see the FAQs.
• Sprinter and Optimizer funding cannot be used to develop products for a new clinical condition, unless prior approval is granted from the NIH.