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. 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. Human subjects research beyond usability studies or studies classified as IRB-exempt are unlikely to be supported through this funding. By the conclusion of funding, it is anticipated that all projects will be ready for entry into the companion solicitations from NIH (which support first-in-human evaluations of safety and effectiveness):

• Blueprint MedTech: Translator (UG3/UH3 – Clinical Trial Optional)
• Blueprint Medtech: Small Business Translator (U44 – Clinical Trial Optional)

or have secured or be ready to apply to other NIH or non-governmental funding sources.

Applicants must submit pre-proposals, which will undergo review by CINTA, NTH, and NIH program staff. Pre-proposals are submitted through a simple online application form equivalent to approximately four 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  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 this or other translational funding programs.

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 preventative, 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.

• Pre-proposals must be submitted in English through the Blueprint MedTech: Incubator Hubs Program online application system at https://colab.secure-platform.com/a/solicitations/126/home no later than 5:00 pm ET on August 27, 2023. The goal of projects should be a prototype ready for first-in-human studies.
• A subset of pre-proposals will be invited for full proposals, which are also submitted through the online proposal submission system.
• Selected full proposals will proceed to a “Deep Dive” review that is expected to take approximately two weeks. During this time applicants will need to commit significant effort to respond to the Deep Dive team’s inquiries.
• Applicants will be informed of review decisions by the end of February 2024.
• The earliest anticipated start date for funding for selected full proposals is March 2024.
• 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 or, if none, a de minimis rate of 10%. We expect to make up to 10 awards from this solicitation.
• The earliest anticipated start date for Seedlings will be May 2024.