FAQ

Blueprint MedTech FAQs

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? Solicitation, review, and oversight of awards is managed by the Blueprint MedTech Incubator Hubs, CINTA and NeuroTech Harbor. Since funding for the Hubs is provided by NIH, the Hubs must comply with the NIH grants policy and flow these policies down to funded projects. These policies include financial management, protection of animal and human subjects, and other reporting requirements. If you are selected for funding, one of the two Hubs will administer your project, and they will help you navigate these policies.
  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. 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. BPMT C6 innovation flow infographic
  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 or U44). 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? Management of intellectual property 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. See more detail for the full proposal in the section below.
  7. Are institutions/organizations/individuals outside of the United States eligible to participate? As of May 1, 2025, NIH does not allow the hubs to fund foreign projects, as per NOT-OD-25-104.
  8. Are we allowed to use foreign consultants and vendors to support our project? Yes, NOT-OD-25-104 allows the hubs to purchase goods and services from foreign consultants and vendors in support of awarded projects. The prohibition only applies to subawards to foreign institutions for collaboration activities.
  9. What happens if I miss the deadline for submitting a pre-proposal? Can I still submit a full proposal? Pre-proposals are required. Full proposals are by invitation-only.
  10. 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.
  11. I am writing a pre-proposal, may I include several references? You can include as many references as you would like.
  12. Should I submit copies of relevant publications? Please do not submit copies of relevant publications. Standard citation of publications is acceptable.
  13. Are there any considerations specific to projects addressing mental health disorders? 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.
  14. Will you accept a video showing how my system works? Videos, images and additional information may be uploaded (file limitations apply).
  15. Do I need to specify what medical condition would be diagnosed and/or treated by my product? 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.
  16. Will I receive feedback on my pre-proposal? No feedback will be given in the pre-proposal stage.
  17. Who are the participating NIH Institutes and Centers (IC’s) 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 and are briefly outlined below. Please reference the link for the most up-to-date information.
    • Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative: Novel invasive neurostimulation, novel invasive brain recording devices and non-invasive brain stimulation devices for the human central nervous system.
    • National Center for Medical Rehabilitation Research (NCMRR): Assistive and rehabilitation technologies to improve the function of people with physical disabilities and that are related to the mission of the National Center for Medical Rehabilitation Research.
    • Helping to End Addiction Long-term (HEAL) Initiative: Devices for the diagnosis and treatment of pain and opioid use disorder or other groundbreaking neurotechnologies that fit the mission of the HEAL.
    • National Center for Complementary and Integrative Health (NCCIH): Technologies that can facilitate the integration of complementary and integrative health approaches to enhance diagnosis, prevention, or treatment of diseases and/or associated symptoms, or promotion of well-being and whole person health relevant to the nervous and neuromuscular systems as well as integration of technologies with multisystem studies to understand the connections and interactions across systems involving the brain and the rest of the nervous system such as interoception, and/or the impact of multi-component interventions.
    • National Eye Institute (NEI): FDA Class III medical devices, as well as invasive ocular implants and prosthetics that can stimulate retinal or cortical neurons to produce visual percepts.
    • National Institute of Biomedical Imaging and Bioengineering (NIBIB): Broadly applicable products, where the disease or organ being targeted is used as an initial model and could be adapted to other indications in the future.
    • National Institute of Dental and Craniofacial Research (NIDCR): Technologies for oral somatosensory or autonomic nerve stimulation to enable diagnosis and/or treatment of motor and sensory conditions, biofeedback & multimodal neurofeedback technologies for treatment of facial nerve disorders, as well as neurological and non- facial pain, novel technologies to promote prevention and treatment of orofacial and craniofacial nerve injuries, including nerve regeneration, and technologies that improve the accuracy and validity of dental, oral or craniofacial clinical pain measurements.
    • National Institute of Mental Health (NIMH): Novel brain stimulation/modulation technologies for use in the treatment of psychiatric disorders, or in targeting specific domains of clinical functioning across psychiatric disorders, devices capable of both recording and stimulating neural activity, with the ability for closed-loop control.
    • Office of Behavioral and Social Sciences Research (OBSSR): Technologies that enhance the impact of health-related behavioral and social science research.
    • National Institute of Neurological Disorders and Stroke (NINDS): Technologies that reduce the burden of neurological disease for all people.
    • National Institute on Aging (NIA): Innovative technology for early diagnosis and treatment of age-related disorders, Alzheimer’s Disease and related dementias.
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA): Technologies that relate to the causes, consequences, prevention, diagnosis, progression, and treatment of alcohol-related problems across the lifespan.
    • National Institute on Drug Abuse (NIDA): Novel medical devices intended for use in the diagnosis of, or in the cure, mitigation, treatment, or prevention of Substance Use Disorder.
  18. Who do I contact if my question isn’t addressed in the FAQ? Please sign up for the informational webinar or contact info@blueprintneurotech.org. This solicitation 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 Institute or Center that participates in the Blueprint MedTech program.

 Budget & Contracts

  1. Are there any budget restrictions or limitations? Budgets are restricted to $100,000 (Sprinter) and $1,285,000 (Optimizer) respectively. 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? 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 must be divided by your institution into direct and indirect costs. Indirect costs will be provided at your institution’s Federally negotiated rate. If your institution does not have a Federally negotiated rate, indirect costs may be provided up to 15%. Applicant institutions may choose to waive their indirect costs.
  4. Who pays for hub-provided resources? You must include the cost of these resources in your $100,000 (Sprinter) and $1,285,000 (Optimizer) budget. Your mentor and the hubs’ resource core will help you develop a budget.
  5. When would I receive my funding? Projects are estimated to be selected for funding no earlier than May 2026. 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 received prior to award.
  6. Are there salary limitations for these awards? The current NIH guidance sets the cap at $225,700.
  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 annual meeting expenses in your full proposal’s budget. Project teams are expected to attend an annual meeting hosted in either Boston or the Baltimore/Washington region.

New for Cycle 6 

  1. What has changed for this cycle? Two primary changes were made for this cycle:
    • A one-hour interview has been added to the full application stage.
    • Applicants selected to move forward after the full application review will receive a Sprinter Award.
  2. What is the purpose of the interview? The purpose of the one-hour interview is to gather more detailed information. 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 three 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 an agreement with either Johns Hopkins University or Massachusetts General Hospital. The agreement will carry additional flow-down provisions from the parent NIH grants, which fund CINTA and NTH. Extended subcontracting delays may impact the 20-week Sprinter award period
  5. Is it possible to get a no cost extension (NCE) for a Sprinter Project? 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.
  6. What is included in the total Sprinter award amount? The total award amount ($100,000) includes direct and indirect expenses, and the cost of any additional resources and support services obtained through the hubs. Mentoring is provided as an in-kind service and is not included in the total cost. Your mentor will help you derive the best use of your funds.
  7. How are additional resources and support services obtained? Awardees can work with the hubs to subcontract with service providers. The hubs have 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.
  8. How does a Sprinter award differ from a Seedling award? 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 lean on the educational material previously developed by the Seedling managers and https://www.neurotechcourse.org/.

Full Proposal FAQs

Full Proposal FAQs

  1. The budget has a character limit of up to 500 words and no specific budget template – is there guidance on how it should be created? Budgets can be presented in a variety of ways but should aim to describe costs based on milestones summarized per year. If character limits allow, a further breakdown of costs can be developed by grouping into cost categories such as personnel/effort, fringe, materials/supplies, travel, indirect costs, etc.
  2. What is an institutional sign-off page? It is the official sheet from your research administration office indicating that your full proposal is approved by your institution. Signature from an authorized business official is needed once your proposal has been selected to move forward. If your project is selected, your team lead will advise regarding the timing of the institutional support letter. For small businesses that do not have an institutional sign-off process, endorsement by signature from a member of the company’s leadership is acceptable. Institutional sign-off for pre-proposals is not needed.
  3. 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.
  4. Should I disclose any 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.
  5. Are there any study 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). Minimal-risk clinical studies may be conducted at Georgia Tech HomeLab, 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 NOFOs: UG3/UH3 or U44.