Blueprint Medtech Incubator Hub Cycle 3 Funding Solicitation
Posted July 31, 2023 (UPDATED: August 23, 2023)
The Center for Innovative NeuroTech Advancement (CINTA) & NeuroTech Harbor (NTH) announce the Cycle 3 Award Competition supported by the NIH Blueprint MedTech Program.
This program is seeking collaborative projects aimed at developing emerging technologies into commercially viable, clinically focused solutions for disorders of the nervous system that are aligned with the mission and interests of the participating NIH institutes and centers.
NOTICE: The Cycle 3 deadline has been extended through August 27, 5 p.m. ET.
[The next solicitation is expected to be announced February 2024.]
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.
Awards will rarely exceed $500,000 in direct costs per year for a period of up to 4 years. In addition to monetary support, resources necessary for translation will be available from third-party-providers (BP MedTech Resources and Support Services). Awardees will also receive ongoing, specialized support from mentors experienced in commercializing medical devices. The mentors will work with awardees throughout the project to focus on business, regulatory, clinical, and technical factors necessary for commercialization.
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.
The Blueprint MedTech Hubs and NIH encourage applications from women, underrepresented racial and ethnic groups, as well as individuals with disabilities.
Review Process and Eligibility
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.
July 31, 2023: Pre-proposal submission opens
August 2023: Weekly informational webinars and Office hours by appointment sign up here
EXTENDED: August 27, 2023: Pre-proposal submission deadline
October 3, 2023: Submission opens for full proposals (by invitation only)
October 30, 2023: Full proposal submission deadline
January-February 2024: Deep Dive Assessment
June-July 2024 (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 additional Blueprint Medtech funding.
- 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.
CINTA and NTH are seeking proposals leading to commercialization of groundbreaking preventative, therapeutic, and/or diagnostic medical devices. At a minimum, projects should have already clearly demonstrated proof-of-concept. The technologies proposed must have a pathway to a prototype ready for first-in-human testing within 4 years and have a viable pathway to commercial development. 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 involving the nervous system or consequences of such a disease or injury in 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 strongly encouraged to find clinical partners prior to submitting a pre-proposal.
- Address an area of interest of the NIH Participating Organizations.
- Identify the Beachhead Marketfor 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 demonstrated proof of concept with enough confidence that the remaining challenges are primarily related to building a prototype in preparation 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 510(k) requiring clinical data).
- Propose solutions that are equitable, affordable, and accessible to all clinically relevant communities, including underserved and vulnerable populations.
Applications will NOT be considered for:
- Products not regulated by the FDA.
- Fundamental basic/applied research projects prior to proof of concept.
- 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.
- Projects focused on technologies for functional augmentation of healthy individuals.