Blueprint FAQs - POCTRN
Frequently Asked Questions
- 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 entity responsible for the proposal.
- 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. 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, 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 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.
- Who can apply for the NIH Blueprint MedTech Pilot? To be eligible, academic Principal Investigators must hold a faculty appointment at an institution of higher education or medical center in the United States. PIs from industry are not required to hold a faculty appointment.
- Are institutions/organizations outside of the United States eligible to participate? Unfortunately, the awards are only currently available for institutions and organizations based in the United States. Foreign applicants may learn more about future opportunities: NOT-EB-21-018.
- When are applications due? Pre-proposals are due by 11:59pm ET Monday, June 21, 2021. Full proposals are due by 11:59pm ET Friday, July 23, 2021.
- How much funding is available? Do you give multi-year Grants? Applicants may request up to $100,000 in total costs per project. Indirect costs are provided at the performance sites’ Federally-negotiated rate. Currently, only one-year applications are accepted.
- What else does the Blueprint MedTech Pilot provide to awardees? The program will provide: (a) non-dilutive funds to support medical device development activities led by investigators, and (b) additional resources and support services including, but not limited to
- Planning resources to support concept development, team building, needs assessment, and other early translational activities.
- Assistance from consultants (e.g., on regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues).
- Advice from industry experts (e.g., meetings with an external oversight committee).
- Where do I submit my pre-proposal? All pre-proposal information must be submitted through the online submission system. Pre-proposals may take approximately 1-2 hours to complete.
- When will I be notified if my Pre-proposal has been selected to submit a Full Proposal? All Pre-proposal applicants will be notified on or before Friday, June 25, 2021 as to whether or not they have been selected to advance to the Full Proposals phase.
- My pre-proposal was accepted and I have been invited to submit a full proposal. Now what? If you are invited to submit a full proposal, it must be submitted through the online submission system no later than 11:59pm EST Friday, July 23, 2021. Follow the step-by-step instructions on the online submission system. The application is 6 pages long and should take between 1-6 hours to complete. The proposal does not need to be completed all at once. The PI may log on as many times as he or she wishes until the application is submitted.
- Where and how do I submit my full proposal? All full proposal information must be submitted through the CIMIT proposal submission system. Instructions will be provided on the website. No material can be submitted directly to CIMIT staff.
- Who reviews the applications? The Review Panels are made up of practicing clinical specialists, engineers and scientists with broad experience in neurotechnology and medical innovation. Full proposal applicants can suggest reviewers, though no assurance is given that suggested reviewers will be utilized. Applicants can also provide names of potential reviewers who they would prefer not be used, and every effort will be made to accommodate these requests. These requests should be included in a letter uploaded with the other supporting documents.
- Is there anything "special" that applicants should know? In support of the Blueprint MedTech Pilot, the Point of Care Technology Research Center (POCTRN) at CIMIT seeks groundbreaking collaborative research projects in the early stages of translation to improve the diagnosis and/or treatment of disorders of the nervous system. Applications must present potentially transformative solutions to unmet needs with an ultimate goal of improving healthcare outcomes. If successful, projects should be viable candidates for commercial development. Awards will be up to $100,000 in total costs for a period up to 12 months.
In addition to monetary support, awardees will receive ongoing, specialized support from mentors experienced in commercializing neurotech devices. Awardees will work with their individual mentor several hours each week to help address any business, regulatory, clinical, and technical issues surrounding their projects. Mentorship will include a one-day meeting, required for all awardees, to kick-off the program.
- 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 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.
- I am writing a pre-proposal - may I include several references? You can include as many references as you would like.
- Should I submit copies of relevant publications? Please do not submit copies of relevant publications. Standard citation of publications is acceptable.
- Will you accept a video showing how my system works? Videos, images and additional information may be uploaded (file limitations apply).
- 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. Be sure to ask your research administration office how much lead time they need to process this form in the event you are invited to submit a full proposal so that you can submit all your documents before the deadline. Signature from an authorized business official must be received prior to the proposal deadline.
- Are there any budget restrictions or limitations? Capital equipment must be well justified to the purpose and exclusive need of the project. Alterations and renovations will not be supported.
- Are indirect costs provided? 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 10%. Applicants may choose to waive their indirect costs.
- When would I receive my funding? The timeliness of your revisions to the administrative materials, should any be needed, and any necessary protocol approvals, will affect when you receive your award, which would not be sooner than September 27, 2021. If your work involves human subjects, data or tissue derived, or live animals, the necessary IRB and IACUC approvals must be received by CIMIT prior to the award.
- What are my reporting responsibilities if I receive an award? An annual report is required to be submitted by investigators in accordance with the terms and conditions of the award. Quarterly reports will be required to facilitate progress and integration with the overall program.
- Does the NIH Blueprint MedTech Pilot support software development? Reviewers will distinguish between routine software engineering (data processing, interfacing, simple signal processing), and research software in which new algorithmic approaches are required to solve a clinical problem. Like any other task, software engineering may be supported when it is necessary to meet project objectives. Research software projects must be approached in the context of a clinical purpose or care pathway, and the project must involve direct collaboration with a physician. The NIH Blueprint MedTech Pilot does not support classic Information Technology projects (electronic patient record, data mining for decision support, etc.) because institutions and industry groups are already investing significant resources in these areas. Blueprint MedTech does not support SaMD. There has to be hardware as some part of the product.
- How does the NIH Blueprint MedTech Pilot relate to the Notices of Intent to Publish listed on the Blueprint MedTech website? The Pilot is an active solicitation to provide immediate support to applicants, though it has a very limited duration and limited scope. This solicitation is being run by CIMIT (recipients of NIH grant 5U54EB015408), and all awards from this solicitation will be managed by CIMIT. While the Notices lay out a more comprehensive program, applications are not being solicited at this time. Please contact Blueprint-MedTech@nih.gov if you have any questions about the Blueprint MedTech program.
- Does the NIH Blueprint MedTech Pilot support early-stage research? Projects should be viable candidates for commercial development within1-2 years at the end of the award period, therefore applications to support early-stage research are not encouraged. Applicants interested in exploratory (e.g., R21) or research (e.g., R01) grants should contact the appropriate Institute or Center at NIH for advice.
- Does the NIH Blueprint MedTech Pilot support safety and effectiveness research? It is anticipated that NIH will publish Funding Opportunity Announcements this summer. Applicants are encouraged to read NOT-NS-21-057 and NOT-DA-22-050, and to contact Blueprint-MedTech@nih.gov if you have any questions.
- What are the general criteria for entry? Please visit this page for the general criteria.
- What are the non-responsive activities? Please review the non-responsive activities on this page.
I'm interested in serving as a reviewer - who should I contact? If you are interested in serving as a reviewer, please reach out to CIMIT's Chief Academic Officer Steve Schachter, MD at email@example.com by June 25.