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:
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:
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.
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 firstname.lastname@example.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.
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 email@example.com if you have any questions about the program.