1. When are Translator applications due?
Upcoming application due dates for PAR-21-315 Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional) and PAR-21-282 Blueprint MedTech: Small Business Translator (U44 - Clinical Trial Optional) are both on February 20, 2024; Additional dates are listed in the NOFOs.
2. I didn't submit a letter of intent by the deadline, can I still submit an Translator application?
Yes. Letters of intent help us learn more about which applicants may be submitting, so we can build the most appropriate Translator peer review panel. We also strongly encourage all potential applicants to contact us to ensure their project is in scope for our program and to answer any questions that they may have. That said, letters of intent are not required or binding.
3. Who do I talk to for questions about the BP MedTech funding opportunities?
Please email the BP MedTech core team (Blueprint-MedTech@nih.gov) and we’ll get back to you shortly. We are happy to set up a time to answer questions and provide programmatic technical assistance. For questions related to whether your device might address a disorder supported by this program, please contact the most appropriate point of contact at BP MedTech Participating Institutes/Centers and Contacts.
4. What are the general criteria for entry?
Applications to the BP MedTech program must include novel medical device technologies that will advance upon current neurotechnology. Applicants should:
- clearly define the current state of the art and highlight how their proposed technology will advance patient care for a specific indication.
- propose medical devices, expected to be regulated by the FDA, with first-of-its-kind technologies, unique and novel intended use, new safety questions, and/or new regulatory questions.
Responsive applications may also pivot and refine existing technologies toward new intended use and/or use in novel settings (e.g., innovating and translating a neuromodulation device approved for healthcare-setting only to home-use). Please contact us if you have any questions.
5. My device meets the entry criteria for Blueprint MedTech, but we do not have a human-grade prototype and are not ready to start a clinical trial. How do I apply?
The Blueprint MedTech program supports prototype development activities through the Incubator Hubs (i.e., the Hubs will solicit, evaluate, and manage efforts to develop prototypes). More information about how to apply is provided by the Incubator Hubs at https://blueprintneurotech.org/.
6. What are non-responsive activities?
Applications that include the following activities will not be reviewed:
- Animal model development: all in vivo models must be established and characterized, and available to the applicant;
- Efforts to develop neurotechnology for fundamental study of the nervous system;
- Fundamental basic/applied research projects that employ existing market approved devices for their labeled uses;
- Projects focused on technologies for augmentation of healthy individuals;
- Delayed-onset clinical studies for either Translator NOFO;
- Clinical evaluation of safety and effectiveness for the Incubator Hubs NOFO;
- Device technologies where the Small Business Concerns do not have the needed intellectual property (IP) to enable further development/commercialization;
- Device technologies not regulated by the FDA.
7. Is my technology a medical device?
We suggest that you consult this FDA video on Is My Product a Medical Device? as well as How to Determine if Your Product is a Medical Device. Other valuable links are to be found within the CDRH Learn resource from FDA and at the FDA Digital Health Policy Navigator for software, especially the section on What regulatory policies apply to my product?
8. Our technology is a drug not a device, does this fall outside the scope of the funding mechanisms?
Although the Blueprint MedTech program only supports medical devices, our sister program Blueprint Neurotherapeutics for Small Molecules supports therapies based upon small molecules. After you review the BPN-small molecules website, please feel free to contact Dr. Cywin to answer any other questions you may have.
9. Our technology is a biologic not a device, does this fall outside the scope of the funding mechanisms?
Although the Blueprint MedTech program only supports medical devices, our sister program Blueprint Neurotherapeutics for Biologics supports therapies based upon biologics. After you review the BPN-biologics website, please feel free to contact Dr. Boshoff to answer any other questions you may have.
10. [Revised 9/2/21] Our technology is a combination device, does this fall outside the scope of the funding mechanisms?
We encourage you to contact FDA Office of Combination Products to discuss the jurisdiction of your product to ensure that the product review will be led by CDRH. If the primary technical and regulatory challenges are related to medical devices and the product review is CDRH-led, then please contact us to discuss. Otherwise, we'd encourage you to reach out to our sister programs on small molecules and biologics for products where the device is incidental to the novelty of the small molecule or biologic. We encourage you to contact FDA Office of Combination Products to discuss the jurisdiction of your product to ensure that the product review will be led by CDRH.
11. [Revised 9/2/21] Are there budget limits for BP MedTech Translator awards?
Application budgets are not limited but must reflect the actual needs of the proposed project. Budget requests must be well justified and reflect the work that will be conducted by the applicant organization(s). For U44, NIH has received a waiver from SBA, as authorized by statute, to exceed these total award amount hard caps for specific topics. The current list of approved topics can be found at SEED Small Business Funding. Navigate to the current "SBA approved topics list for budget waivers."
Resources provided by BP MedTech contractors will be paid directly by the NIH. Budgets for the Translator UG3/UH3 and U44 cooperative agreements are not anticipated to exceed $500,000 direct costs per year for the UG3 Phase/U44 Phase I and up to $1,500,000 total cost per year for U44 Phase II, assuming all work is conducted by the applicant organization(s). If applicants anticipate that BP MedTech resources will be provided by NIH (as identified on the Resource Checklist), the budget for those resources should not be included in the application. Please contact us if you have any questions
12. What resources are available through the BP MedTech program?
BP MedTech provides several resources and services to support device development and optimization through incubator hubs and Clinical Research Organization (CROs). These include services for design prototyping and bench testing, business development, biocompatibility and animal studies, regulatory, compliance, and quality and clinical support. Assistance and advice from consultants and industry experts will also be provided. For more information on the resources provided, please visit BP MedTech Resources and Support Services. UG3/UH3 and U44 applications must include a Resource Checklist attachment.
13. Is our project a good fit for the BP MedTech program?
The best way to determine if your project is a good fit for the MedTech program is to review the participating BP MedTech Institutes and Centers (IC)s’ interest statements related to the proposed device's target system. All BP MedTech projects must fall under one of the IC's missions and be directed towards a specific medical indication(s).
Applicants are also encouraged to contact the IC's BP MedTech representative to gauge their level of interest, whether the proposed technology aligns with their mission and if the IC would be supportive if the project were to potentially be funded. IC Interest statements and MedTech contacts can be found at BP MedTech Participating Institutes/Centers and Contacts. If you are unsure which ICs to contact, let us know what indication(s) you're considering along with a draft of your Specific Aims, and we will direct you to the best point of contact.
14. What are the entry criteria for Optimizer subprojects via the Incubator Hubs?
Optimizers “are expected to provide comprehensive supporting data based on bench, in vitro, and/or in vivo models representative of the intended patient population and indication.” Optimizers should only have one remaining research question: “Will it be at least as safe and efficacious in humans using a human-grade prototype as it is in the lab?” If additional R01-equivalent research questions need to be addressed prior to demonstrating that there exists a credible ”deviceable target,” then Optimizers are not ready for entry to Blueprint MedTech.
In other words, Optimizers that need further R01-equivalent research are better served by R01-equivalent grants. The Incubator Hubs serve only to support the “D” in R&D. If you need help finding the most appropriate basic research funding announcements, please send us a draft of your Specific Aims via Blueprint-MedTech@nih.gov.
15. We have an established proof of concept and published papers using a similar technology for a different indication, but we do not have proof of feasibility to demonstrate its applicability to a new indication. Would we still be eligible for this program?
The entry criteria for BP MedTech requires applicants to “include data showing that the diagnostic or therapeutic intervention has already been demonstrated to address the targeted indication in silico or in vivo with enough confidence that the remaining challenges are primarily related to building a commercializable prototype and demonstrating its safety and effectiveness.” If such data are not available, we encourage you to conclude the basic research before submitting an application to BP MedTech. Please contact us to discuss if you need help finding the most appropriate NIH funding opportunity.
16. Will BP MedTech support the development of products intended solely for use in a research environment?
No, the program will only support the development of commercial products for diagnosis and treatment of nervous system disorders.
17. What happened to the Notice of Funding Opportunity for the Blueprint MedTech Prototype Developer (U18)?
We previously released a Notice of Intent to Publish a Funding Opportunity to support the development of human-grade medical device prototypes using resources from incubator hubs in preparation for first-in-human studies. These opportunities will now be solicited, reviewed, and managed by the BP MedTech-funded Incubator Hubs.
18. Is there anything else I should know?
We encourage all applicants to carefully review the NOFO and include all required sections, including Section V that provides instructions to peer reviewers on how they should score your application.
Translator Projects (UG3/UH3; PAR-21-315 and U44; PAR-21-282)
1. What are UG3/UH3 and U44 awards, and how do they compare to an R01 grant?
The UG3/UH3 is a phased cooperative agreement mechanism. The U44 is a phased Small Business Innovation Research (SBIR) cooperative agreement mechanism. BP MedTech uses the UG3/UH3 and U44 awards to pay for work that will be conducted by the Principal Investigator (PI) for translation-stage projects. The UG3 phase and U44 Phase I support the PI's activities for non-clinical testing to support an Investigational Device Exemption (IDE) submission for the clinical study or an Institutional Review Board (IRB) Non-Significant Risk (NSR) designation. The UH3 phase and U44 Phase II support subsequent clinical study work leading to a larger clinical study that will lead to either a marketing application or use of the clinical experience to inform device design decisions. BP MedTech applicants can request up to four years of UG3 support. For the U44, applicants can request up to 2 years for Phase I and up to 3 years for Phase II support. The combined duration of the UG3 and UH3 awards (or, in the case of U44, Phase I and II awards) cannot exceed five years.
NIH is more involved in the management and oversight of research funded by cooperative agreements than by typical grants. The cooperative agreement mechanism enables NIH program staff participation in negotiating project and milestone plans before award, monitoring research progress, and making go/no-go decisions.
2. If I plan to use BP MedTech resources, do I need to budget for them, and how?
BP MedTech provides additional resources and services at no cost to UG3/UH3 and U44 awardees. While these resources should not be budgeted, applicants to the Translator NOFOs (PAR-21-315 and PAR-21-282) must include a resources checklist indicating which resources will be used as well as justification for any resources not being utilized. We highly encourage applicants to indicate that these resources will be provided by BP MedTech by inserting a statement along the lines of "If selected for funding, we expect that the following resources will be made available to this project by the Blueprint MedTech program. Since the program will provide these resources at no cost, this application does not request any labor or budget associated with these resources."
3. Can I request funding to do all of the work myself and/or with CROs that I select and pay directly?
Yes. However, we strongly encourage applicants to take advantage of the availability of BP MedTech consultants to add to your own expertise.
4. What are the criteria for translation stage projects (UG3/UH3 and U44 Phase I/II)?
- Comprehensive supporting data based on bench, in vitro, and/or in vivo models representative of the intended patient population and indication.
- Identified one or more clinically meaningful device outcome measures based on input from key stakeholders (e.g., clinicians, patients, and caregivers) as well as supporting literature.
- A compelling case for a successful IDE submission for an SR study or IRB approval for an NSR study. Required regulatory approvals for clinical studies must be in place prior to the start of the UH3 /U44 Phase I cooperative agreement.
- Applicants are encouraged, but not required, to consult with FDA via a Pre-Submission meeting, study risk designation request, and/or 513(g) submission prior to applying. Applicants who do not have sufficiently relevant feedback from the FDA regarding all planned activities prior to application for funding will be expected to do so as the first milestone of the UG3 phase of the award. Funding may be restricted to a maximum of $100,000 in direct costs until FDA feedback that is consistent with the likely success of the regulatory path to market and overall device development plan outlined in the grant application is received.
5. What is the purpose of the UG3 and U44 Phase I?
The purpose of these phases is to identify and conduct all non-clinical testing necessary to obtain approval to conduct the subsequent clinical study. For example, these phases could serve to complete testing to support an investigational device exemption (IDE) submission to the FDA or to obtain Institutional Review Board (IRB) approval for a non-significant risk (NSR) clinical study.
6. What kind of work can be done during the UG3 phase or U44 Phase I?
Examples of studies that may be proposed during the UG3 phase include, but are not limited to
- Non-Good Laboratory Practice (GLP) animal studies to develop surgical techniques relevant to the device, optimize relevant therapeutic or diagnostic parameters, and refine device design as necessary for subsequent GLP testing or additional clinical studies for regulatory approval.
- Bench-top and animal testing to demonstrate compliance with FDA Recognized Standards.
- GLP compliant large animal model safety testing and/or testing of an implanted device.
- Activities to become current Good Manufacturing Practice compliant.
- Activities to bring the development process under Design and Quality Systems Control.
- Studies addressing usability or acceptability
- Device, software, firmware, and cybersecurity, design verification, and validation activities.
- Development of packaging, connectors, and other accessories necessary for the translation of the technology.
- Regulatory activities, including pre-submission meetings with FDA, IDE submission, or other FDA regulatory submissions (e.g., Humanitarian Device Exemption (HDE), Request for Risk Designation, 513(g) submission).
7. My project already meets the program requirements to initiate a clinical study. Can I skip the UG3 phase or U44 Phase I?
No. All translation projects must include UG3 Phase or U44 Phase I activities and enter through these initial phases. Projects for which only a clinical phase is proposed are outside of the scopes of these funding opportunities.
8. What if my budget is above $500K direct costs for the UG3/UH3 (PAR-21-315)?
Applicants for UG3/UH3 requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact us at least six weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or more in Direct Costs, as described in the SF424 (R&R) Application Guide.
9. I have an academic lab and IP licensed to my start-up. Is there a preference for academic vs. start-up funding?
Although there is no preference between academic or start-up applicant organizations, there is an expectation that eventually, the product will be made available for broad clinical use.
10. How do the MedTech Translator funding opportunities (UG3/UH3 and U44) differ from the regular NINDS funding opportunities?
The BP MedTech Translator opportunities differ from NINDS opportunities in that awardees will have access to several translational resources. The BP MedTech opportunities also support the missions of all fourteen Blueprint Institutes and Centers (IC)s. The NOFOs have some similarities to existing programs (e.g., BRAIN, HEAL, TND) but cover the interest areas of all the Blueprint ICs.
Additionally, the scope of the technologies supported is more narrowly focused on novel medical device technologies that will advance upon current neurotechnology. The devices are expected to be first-of-its-kind technologies with unique and novel intended uses or address new safety or regulatory questions. Please contact us if you have any questions.
11. Are foreign organizations eligible for Translator funding opportunities (UG3/UH3 and U44)?
The Translator funding opportunity PAR-21-315: Blueprint MedTech: Translator (UG3/UH3) is open to foreign applications. The key phrase to look for in NIH NOFOs is in the "Eligible Organizations" section, where it says "Non-domestic (non-U.S.) Entity (Foreign Organization)."
However, PAR-21-282: Blueprint MedTech: Small Business Translator (U44) is only open to U.S.-based small business concerns.