C7 Blueprint MedTech FAQs

General Program & Eligibility | Budget & Contracts | Recent Changes | Sprinter-Specific | Full Proposal 

General Program & Eligibility

  1. Do you have any accessibility accommodations? Please email info@blueprintneurotech.org for instructions if your input devices are having trouble with the submission system. No material can be submitted directly to Hub staff, but staff can provide assistance. 
  2. Is this an NIH grant application? No. Solicitation and review is managed by the Blueprint MedTech Incubator Hubs (CINTA and NeuroTech Harbor). Awards will be made via subcontract and will comply with NIH policies. This application does not count toward the NIH application limit.
  3. How can I tell whether my product is mature enough for entry into Blueprint MedTech? We expect solution concepts that have both clinical and technical proof-of-concept. Your proof-of-concept demonstration is expected to rely upon established scientific or empirical results to the point where no further research is required, aside from a first-in-human demonstration of safety and efficacy which would follow the completion of the Optimizer award period. Degree and nature of proof-of-concept evidence (clinical and technical) should be clear in the proposal. This program does not support basic or applied research (e.g., a typical NIH R01). Please see the GAITS description of “proof-of-concept,” particularly the Technology “Demonstration Results” and “Key Component PoC Prototypes” descriptions for further guidance (www.gaits.org). We have developed this helpful graphic to help applicants determine which funding path is best suited for their needs. 
  4. How can I tell whether my product is too mature for entry into this incubator hub solicitation? If you are nearly ready for a clinical evaluation of safety and efficacy with a design-locked prototype, we recommend submitting a grant application to the companion Translator program (UG3/UH3). Please feel free to contact Blueprint-MedTech@nih.gov and include a draft of your Specific Aims. In general, the pre-clinical activities supported by the Translator NOFOs should involve few risks of failure (e.g., the design is frozen, and you need to build prototypes and perform GLP animal studies). 
  5. Who retains the rights to any intellectual property generated by a proposal? Intellectual property rights will be determined by the institutional policies of the proposing entity. 
  6. Should I disclose any unprotected proprietary information in the submission? Protecting proprietary information is the responsibility of the applicant and the applicant institution. Consistent with NIH policy, applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. However, when the application contains information that constitutes trade secrets, or information that is commercial or financial, or information that is confidential or privileged, identify the pages in the application that contain this information by marking those paragraphs or lines with an asterisk (*) at the beginning of the paragraph or line. See more detail for the full proposal in the section below. 
  7. What happens if I miss the pre-proposal deadline? Can I still submit a full proposal?  No. Pre-proposals are required. Full proposals are by invitation only.
  8. Who should I list as collaborators? List only individuals who are considered key personnel or significant contributors to the work that will be performed, and who have already agreed to their role. Avoid honorific collaborations. For all proposals, the review committee requires that investigators collaborate closely with clinicians and product development experts in the development of the proposal and the conduct of the work. The input of these collaborators must be clearly reflected throughout the application.
  9. May I include references?  You can include as many references as you would like.  
  10. Should I submit copies of relevant publications? All cited references should be readily available to reviewers through usual search mechanisms. Please do not submit copies of relevant publications. Standard citation of publications is acceptable. 
  11. Will you accept a video showing how my system works? Videos, images and additional information may be uploaded (file limitations apply). 
  12. Are there considerations specific to mental health projects? If your project addresses a mental health disorder, you are encouraged to use quantitative neural functional measures (e.g., fMRI), and cross-diagnostic measures that have been well-validated with clinical outcomes, i.e., a trait that occurs across different psychiatric diagnoses.
  13. Do I need to specify the medical condition addressed?  Yes. You are required to have a clear disease/disorder that would be addressed by your product, and to state that explicitly. While you may have plans to eventually expand into other indications, it is best to stay focused on your initial product launch.  
  14. Will I receive feedback on my pre-proposal? No feedback will be given in the pre-proposal stage. 
  15. Who are the participating NIH Institutes and Centers (ICs) and what are their missions and interests as they relate to this program? The full list of participating IC’s and specific interests can be found at this link.
  16. Who do I contact if my question isn’t addressed here? Please sign up for the informational webinar or contact info@blueprintneurotech.org. This soliciation is from the Blueprint MedTech incubator hubs, not NIH. You should only contact NIH personnel to determine if your product’s intended use is aligned with a specific Insitute or Center that participates in the Blueprint MedTech Program.
  17. What other guidance is there for submission? NIH will not consider applications that are either substantially developed by AI, or contain sections substantially developed by AI, to be original ideas of applicants.  For more information see the notice “Supporting Fairness and Originality in NIH Research Applications”. 

Budget & Contracts

  1. Are there budget restrictions or limitations?  Budgets are restricted to $100,000 total costs (direct and indirect) for Sprinter and $1,280,000 total costs (direct, resources, and indirect) per year for Optimizer. Capital equipment must be well justified to the purpose and exclusive need of the project. Facility alterations and renovations will not be supported.
  2. Are there budget restrictions for animal studies or human subjects research? Yes. Sprinter funding cannot be used for animal studies or human subjects research. Optimizer projects can support animal validation studies and limited human subjects research. Please see below for more information on allowable studies. 
  3. Are indirect costs provided? The total award amount for both Sprinter and Optimizer awards includes your institution’s indirect costs.  
  4. Who pays for Blueprint MedTech-provided resources? The applicant is expected to manage the $100,000 Sprinter and $1,280,000 Optimizer budgets including resources. However, teams may request assistance from the program to contract for resources at market cost. The only in-kind assistance provided beyond the $100,000 and $1,280,000 totals is mentoring. 
  5. When would I receive my funding? Projects are estimated to be selected for funding no earlier than July 2027. Your responsiveness to requests for administrative material will directly affect the timeliness of funding. For Optimizer awards, if your proposed work involves human subjects research or vertebrate animal research (including data or tissue derived from humans or animals), the  necessary IRB and IACUC approvals must be accepted by NIH prior to award. 
  6. Are there salary limitations for these awards? Yes. The current NIH guidance sets the cap at $228,000. Please see this page for additional info. 
  7. What are my reporting responsibilities if I receive an award? An annual report will be required in accordance with the terms and conditions of the award. Quarterly reports will be required to facilitate progress. Please include reporting, milestone tracking, and travel to the annual meeting in your full proposal’s budget. Project teams are expected to budget for and attend a one-day annual meeting hosted in either Boston or the Bethesda/Washington region.

Recent Changes

  1. What has changed from earlier cycles? New for cycle 7, Optimizer funding has increased from a maximum of four years to five years.
    • Three primary changes were made starting with cycle 6 that apply to cycle 7: 
      • A mandatory 30-minute interview has been added to the full application stage. 
      • Applicants selected to move forward after the full application review will receive a Sprinter Award. 
      • The admin/budget packet must now be included in the initial submission. 
  2. What is the purpose of the interview? The purpose of the mandatory 30-minute interview is to gather more detailed information about the product. An interview is a more efficient and effective way to gather information than from an expanded written application. 
  3. What can I expect during the interview? You will be asked to make a short presentation that will guide the discussion and show evidence of proof-of-concept (e.g., with a bench prototype). The interview will be conducted by two reviewers. If you are invited, we will send you more detailed instructions. 
  4. What is the Sprinter contracting process? You and your administrative staff will be expected to quickly negotiate a subcontract with the NIH-designated consortium manager. The subcontract will carry additional flow-down provisions from the parent contract. A common cause of delays is belated determination that the project involves unallowable human subjects research that needs to be negotiated out of the subcontract. 
  5. Is a no-cost extension (NCE) allowed for Sprinter projects? No-cost extensions are not allowed for Sprinter Projects as there is a fixed schedule for the Deep Dive process, which follows the Sprinter performance period. Sprinter projects will be assessed based on the progress made by the end of the performance period. Applicants are encouraged to carefully plan their Sprinter scope of work. 
  6. What is included in the total Sprinter award amount? The total award amount ($100,000) includes direct and indirect expenses. Mentoring is provided as an in-kind service and is not included in the total cost.  
  7. How are additional resources and support services obtained? Optimizer awardees can work with the NIH-sponsored resource provider to subcontract with service providers using a portion of their $1,280,000 award. The Incubator program has a vetted pool of providers with negotiated terms and can ensure all sub-contracting requirements are met. Funds from the total award are used to cover the cost of any subcontracts. For Sprinter awardees, the Incubator program can make recommendations for vendors that awardees may contact. 
  8. How does a Sprinter award differ from a Seedling award? In earlier cycles we issued Seedling awards to proposals which clearly demonstrated a proof-of-concept, though a critical commercialization gap was identified (e.g., missing KOL, unclear commercialization path, unclear regulatory strategy). There was a heavy emphasis on entrepreneurial education for these early-stage innovators. Successful Seedlings effectively had to re-enter the review process to be considered for an Optimizer award. Based on learnings from the three Seedling cohorts, all compelling projects will now receive Sprinter awards. All Sprinter projects will be evaluated by the Deep Dive panel after 20 weeks. Early-stage teams needing entrepreneurial training can refer to the educational material previously developed by the Seedling managers and https://www.neurotechcourse.org/.

Sprinter-Specific FAQs

  1. Can I skip the Sprinter phase and go directly to Optimizer? No, the Sprinter phase is integral to the Blueprint program and required to be considered for an Optimizer award (even if funded in the past as a Seedling). 
  2. Can I do animal or human subjects research in the Sprinter phase? No, animal and human subjects research will not be funded during the Sprinter phase. Such studies can be planned for Optimizer. 
  3. How do I determine the key deliverables and milestones for the Sprinter scope of work? The Sprinter phase is intended to de-risk the project and undertake the next critical steps towards developing the product. The overall objective is to provide reviewers confidence that the project is adequately de-risked and developed to justify an Optimizer award. Applicants are encouraged to conduct a risk assessment across technical, clinical, business, and regulatory domains and select the highest risk area(s) that can be mitigated during the Sprinter phase. The post-Sprinter Deep Dive evaluation will weigh remaining risks. Unaddressed critical risks will impact likelihood of Optimizer funding. Applicants may use funding and resources outside of that provided by Sprinter awards to address critical risks. 
  4. Can I carry over remaining Sprinter funds/resources into Optimizer? No, the projects are separately funded. Sprinters are not eligible for no-cost extensions. 
  5. What details are available regarding the Interview? The Interview will occur sometime between February 3 and February 23, 2027. Applicants must make themselves available to be interviewed by a two-person team for a 30-minute duration. A specific time and date will be identified that is mutually convenient. We ask that the Applicants keep their schedules flexible during those dates. Approximately one week prior to the scheduled Interview, applicants will be provided a template presentation and further instructions. 

Full Proposal FAQs

  1. Does this program impact Early Investigator Status? No, if you apply to this program and receive an award it does not change or count towards your ESI. 
  2. Who reviews the full applications? The Review Panels are made up of practicing clinical specialists, engineers, medical device entrepreneurs, and scientists with broad experience in neurotechnology and medical innovation. The review is run by CINTA and NTH. 
  3. Should I disclose unprotected proprietary information in the submission or the Research Plan? Protecting proprietary information is the responsibility of the applicant and the applicant institution. Consistent with NIH policy, applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. However, when the application contains information that constitutes trade secrets, or information that is commercial or financial, or information that is confidential or privileged, identify the pages in the application that contain this information by marking those paragraphs or lines with an asterisk (*) at the beginning of the paragraph. Indicate at the beginning of the Research Plan which pages contain asterisks and a note stating: “The following sections marked with an asterisk contain proprietary/privileged information that [name of applicant] requests not be released to persons outside the Government or the Blueprint MedTech incubator Hubs, except for purposes of review and evaluation.”  When information in the application constitutes trade secrets or information that is commercial or financial, or information that is confidential or privileged, it is furnished to the Government and the Blueprint MedTech incubator Hubs in confidence with the understanding that the information shall be used or disclosed only for evaluation of this application. If a grant is awarded as a result of or in connection with the submission of this application, the Government shall have the right to use or disclose the information to the extent authorized by law. 
  1. Are there any restrictions or limitations for Optimizer awards? Human subjects research will not be supported, except for IRB-exempt or minimal-risk clinical studies (as defined by IRBs), at the discretion of NIH. Minimal-risk clinical studies may be conducted by the NIH Validation Center, one of the core resources for the Blueprint Medtech program. These studies cannot support evaluation of your product’s safety or effectiveness. Proposers needing safety/effectiveness studies should apply to the Blueprint MedTech Translator NOFO (UG3/UH3). As a reminder, no animal or human studies can be conducted with Sprinter funding.