NIH Blueprint MedTech Translator (PAR-25-383): The Complete Startup Guide to the UG3/UH3 Medical Device Funding Opportunity
What is the NIH Blueprint MedTech Translator program?
The NIH Blueprint MedTech Translator (PAR-25-383) is a milestone-driven UG3/UH3 cooperative agreement that funds medical device companies and academic innovators to take a novel device from late preclinical development through FDA regulatory clearance to conduct a clinical study, and then through that first clinical study in humans. It is one of the few federal programs that pays for the expensive, unglamorous middle of device development: GLP large animal safety testing, design verification and validation, biocompatibility, cybersecurity, quality systems, IDE preparation, and the first-in-human trial itself.
Two things make it unusual. First, application budgets are not capped. Second, NIH pays a network of contract research organizations and expert consultants directly, outside your budget, so a startup gets prototyping, bench testing, animal studies, regulatory consulting, reimbursement strategy, IP counsel, and clinical trial support at no cost to the award.
The funding is non-dilutive. You keep your equity and you keep your intellectual property.
Next application deadline: September 28, 2026. Subsequent deadlines run through January 28, 2028.
Blueprint MedTech Translator at a glance
Here are the core facts a founder needs before deciding whether to pursue this opportunity.
Funding Opportunity Number: PAR-25-383
Title: Blueprint MedTech Translator (UG3/UH3, Clinical Trial Optional)
Agency: National Institutes of Health, Department of Health and Human Services
Activity code: UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement
Announcement type: Reissue of PAR-21-315
Posted: June 17, 2025
Expiration: January 29, 2028
Award budget: not limited, but must reflect the actual needs of the project
Cost sharing: not required
Project period: UG3 phase up to four years, UH3 phase up to four years, five years total maximum
Application types allowed: New, Resubmission, Revision
Clinical trial: Optional at the UG3 stage, required in the UH3 stage
Letter of intent: encouraged, not required
Assistance Listing Numbers: 93.853, 93.372, 93.213, 93.279, 93.866, 93.273, 93.286, 93.242, 93.865, 93.121, 93.867
Program email: Blueprint-MedTech@nih.gov
Which NIH Institutes and Centers participate in Blueprint MedTech?
Ten Institutes and Centers participate, and your device must address a disease or disorder within the mission of at least one of them. The Office of Behavioral and Social Sciences Research may co-fund awards.
Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative
There is a need to help transition BRAIN Initiative-relevant technologies from early device development to first-in-human studies. Projects that fit the following categories can be submitted through the Blueprint MedTech Program. BRAIN will support the following efforts coming into the BP MedTech UG3/UH3 funding opportunity:
Projects developing novel invasive neurostimulation devices for the human central nervous system (CNS).
Projects developing novel invasive brain recording devices for the human CNS.
Projects developing novel non-invasive brain stimulation devices for the human CNS. These devices should aim to achieve brain stimulation resolution of sub-millimeter at the cortical surface and depth. These approaches may incorporate electromagnetic, mechanical, or combination biological and device means (e.g., optogenetics).
National Center for Medical Rehabilitation Research (NCMRR)
The National Center for Medical Rehabilitation Research within NICHD supports assistive and rehabilitation technology to improve the function of people with physical disabilities. NICHD will only accept applications related to the mission of the National Center for Medical Rehabilitation Research.
Helping to End Addiction Long-term (HEAL) Initiative
Through Notice of Special Interest NOT-NS-24-075, the NIH HEAL Initiative encourages the development and translation of novel neurotechnologies, funded through the Helping to End Addiction Long-term (HEAL) Initiative and overseen by the NIH Blueprint MedTech program. Academic institutions and Small Business Concerns (SBCs) are encouraged to submit grant applications that propose non-clinical development and validation activities for subsequent clinical feasibility studies of medical devices for the diagnosis and treatment of pain and opioid use disorder (OUD). Applications supporting the development and translation of groundbreaking neurotechnologies that fit within the mission of the HEAL Initiative are encouraged.
National Center for Complementary and Integrative Health (NCCIH)
The National Center for Complementary and Integrative Health (NCCIH) supports the development and validation of 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. In addition, NCCIH supports the 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 on multisystem connections and interactions in pre-clinical models or human subjects. NCCIH will not support clinical efficacy studies or pivotal trials of an intervention.
Complementary health approaches include a broad range of practices and interventions that are not typically part of conventional medical care. They can be classified by their primary therapeutic input, including nutritional (e.g., special diets, dietary supplements, herbs, probiotics, and microbial-based therapies), psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, other force-based manipulations, or devices related to these approaches), or a combination of psychological and physical (e.g., yoga, tai chi, dance therapies, some forms of art therapy such as music-based interventions).
National Eye Institute (NEI)
The National Eye Institute is requesting applications for the development of FDA Class III medical devices, as well as invasive ocular implants and prosthetics (retinal or cortical) that can stimulate retinal or cortical neurons to produce visual percepts. NEI is not interested in projects focused on developing diagnostic/imaging devices or assistive devices through this program.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to transform, through technology development, our understanding of disease and its prevention, detection, diagnosis, and treatment. NIBIB may support the development of 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. Before contacting NIBIB, applicants should first discuss the initial target with the Institute and/or Center on this page that is most relevant to the disease(s) being addressed by the proposed product.
National Institute of Dental and Craniofacial Research (NIDCR)
Development of technologies for oral somatosensory or autonomic nerve stimulation to enable diagnosis and/or treatment of motor and sensory conditions, such as bruxism, sleep apnea, temporomandibular/facial pain, swallowing reflex, salivary gland production, and other dental, oral, and craniofacial related conditions and disorders related to the nervous system. These technologies can include the integration of intra- and extra-oral sensors and relevant treatment delivery mechanisms controlled by software systems that allow capture, analysis and display of target biosignatures including but not limited to neural activity.
Biofeedback & multimodal neurofeedback technologies for treatment of facial nerve disorders, as well as neurological (e.g., trigeminal neuralgia, peripheral neuropathy associated with Sjogren’s syndrome, burning mouth syndrome) and non-neurological (e.g., vascular/muscular, immune) facial pain. These technologies can include wearable and embeddable devices as well as virtual or augmented reality technology to address acute and chronic conditions.
Development, validation and testing of novel technologies to promote prevention and treatment of orofacial and craniofacial nerve injuries, including nerve regeneration.
Development, validation and testing of technologies that improve the accuracy and validity of dental, oral or craniofacial clinical pain measurements.
National Institute of Mental Health (NIMH)
NIMH is specifically interested in novel brain stimulation/modulation technologies (invasive or noninvasive) for use in the treatment of psychiatric disorders, or in targeting specific domains of clinical functioning across psychiatric disorders, when appropriate (see RDOC). Devices capable of both recording and stimulating neural activity, with the ability for closed-loop control are also of interest (including synchronizing dense behavioral quantification with neural data); these devices should be able to demonstrate clear capability to record oscillations of interest to mental health applications. Devices can target specific age ranges, including vulnerable populations (pediatric, geriatric). Note: Animal studies to assess “efficacy” must follow NIMH criteria. Please contact NIMH staff above to ensure your project fits NIMH priorities, prior to application submission.
Office of Behavioral and Social Sciences Research (OBSSR)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
NIA, as the primary federal agency for aging and Alzheimer’s Disease and related dementias (AD/ADRD) research, supports the development and application of innovative technology for early diagnosis and treatment of age-related disorders and AD/ADRD.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIAAA’s mission is to generate and disseminate fundamental knowledge about the adverse effects of alcohol on health and well-being and to apply that knowledge to improve diagnosis, prevention, and treatment of alcohol-related problems, including alcohol use disorder (AUD), across the life span. NIAAA is interested in wearable devices that can monitor blood alcohol concentration in real time, non-invasive methods for the treatment of fetal alcohol spectrum disorders (FASD) in children and adults, and in the treatment of AUD.
National Institute on Drug Abuse (NIDA)
NIDA will support applications aiming to develop novel medical devices intended for use in the diagnosis of, or in the cure, mitigation, treatment, or prevention of Substance Use Disorder (e.g., Opioid Use Disorder, Stimulant Use Disorder). See the NIDA Mission for additional details.
Projects may also fall under the NIH BRAIN Initiative (Brain Research through Advancing Innovative Neurotechnologies) or the HEAL Initiative (Helping to End Addiction Long-term). A Notice of Special Interest, NOT-NS-24-075, specifically invites HEAL-aligned diagnostic and therapeutic device applications through this NOFO.
Each participating Institute publishes its own interest statement with additional requirements, clinical study limitations, and budget guidance. Reading the interest statement for your target Institute before you write anything is not optional in practice. Two applications with identical technology can succeed or fail on Institute fit alone.
How much funding can a startup receive from Blueprint MedTech Translator?
There is no published budget cap. NIH states that application budgets are not limited but need to reflect the actual needs of the proposed project, and that applicants should propose a budget that is reasonable and appropriate for completion of the research.
That freedom comes with four practical rules that shape every Blueprint MedTech budget.
Rule one: your budget covers only your own work. Application budgets should only cover work performed by the Program Director or Principal Investigator and their staff. NIH pays Blueprint MedTech contractors and consultants directly for their work, so those expenses must not appear in your budget. This is the single most common budgeting error on this NOFO. Startups accustomed to SBIR budgeting will instinctively line-item a CRO for large animal work or a regulatory consultant for the pre-submission, and both belong outside the budget here.
Rule two: requests of $500,000 or more in direct costs in any single year require advance permission. If you plan to request $500,000 or more in direct costs in any year, excluding consortium facilities and administrative costs, you must contact a Scientific or Research Contact at least six weeks before submitting and follow NIH policy on acceptance for review of applications requesting $500,000 or more. Skipping this step can cost you the cycle.
Rule three: funding may be throttled to $100,000 until FDA weighs in. Applicants who do not already have sufficiently relevant FDA feedback covering all planned activities will be expected to obtain it as the first milestone of the award. Until FDA feedback is received and is consistent with the likely success of the regulatory path to market and the overall device development plan, funding may be restricted to a maximum of $100,000 in direct costs. If FDA feedback contradicts the plan in the application, program staff will evaluate the concerns and the change of scope required, and any remaining funds from the original award will not be released.
Rule four: budgets are negotiated, not simply awarded. As a cooperative agreement, milestones and budget are negotiated with NIH program staff before award, and the budget for the UH3 clinical phase is renegotiated at the transition point.
Because Institute-specific budget expectations vary widely, contacting the program officer at your target Institute is the only reliable way to calibrate the number.
What free resources does the Blueprint MedTech program provide?
This is the part founders consistently undervalue. Beyond the cash award, Blueprint MedTech participants get streamlined access to NIH-funded service providers and contract research organizations that NIH pays for directly. The program provides:
Design optimization, prototype development, and pilot-scale manufacturing
Bench and safety testing
Biocompatibility, sterilization, and large animal testing
Clinical study advising and clinical trial support, including medical monitoring
Commercialization planning and business development
Regulatory, quality system, and reimbursement support
Legal support and intellectual property protection
Access to industry expert mentors and meetings with an external oversight committee
Planning resources for concept development, team building, and needs assessment
For a seed-stage medtech company, the in-kind value of GLP large animal safety studies, biocompatibility panels, and regulatory consulting can rival or exceed the cash award.
Applicants are required to submit a Resource Checklist attachment identifying which of these resources they intend to use. NIH encourages a specific statement along these lines: "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."
What is NIH actually looking for in a Blueprint MedTech application?
NIH is looking for a device that is nearly finished, aimed at a real clinical gap, backed by real data, and blocked mainly by the cost of regulatory-grade testing and a first clinical study.
More precisely, the program wants novel medical device technologies that advance patient care toward new or improved therapeutics or diagnostics that are safe and effective. Responsive applications propose devices expected to be regulated by the FDA that present first-of-its-kind technologies, new safety questions, or new regulatory questions. Applications may also refine existing technologies toward a new intended use or use in a novel setting, for example translating a neuromodulation device approved only for healthcare settings into a home-use device.
Expected regulatory pathway
Proposed devices and indications will likely follow the De Novo or Premarket Approval (PMA) pathways. Devices that fit an existing 510(k) pathway may still be accepted, but only if the application demonstrates clear clinical and technological innovation beyond the state of the art of existing FDA-cleared predicates. Such devices should reasonably be expected to provide new clinically meaningful diagnostic or therapeutic options, or to improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations.
Device maturity requirements
Devices within scope of this program must meet at least one of three conditions:
The device is very close to the final system and is manufactured using very close to the same manufacturing process as the device that will be marketed or studied in a larger clinical trial after this project, or
The device has received Pre-Submission feedback from the FDA, or
The device requires early feasibility clinical data to inform the final device design or manufacturing processes.
Entry criteria
For entry into the program, projects should have all three of the following:
Comprehensive supporting data based on bench, in vitro, and in vivo models representative of the intended patient population and indication
One or more clinically meaningful device outcome measures identified with input from key stakeholders including clinicians, patients, and caregivers, supported by literature
A compelling case for a successful IDE submission for a Significant Risk study, or IRB approval for a Non-Significant Risk study, by the end of the UG3 phase
For novel devices, proof-of-concept data on device function is required, obtained using a prototype close to the final device design anticipated for clinical testing, ideally tested in an in vivo animal model representative of the intended patient population. For first-in-human studies, preliminary human data is not required.
A note on market size
NIH explicitly states that the market for these device categories may be small compared with other markets, and that applications should not be penalized for a comparatively smaller market provided the market is sustainable. NIH supports research for both rare and high incidence disorders within its mission. This is a meaningful opening for rare disease device companies that struggle to raise venture capital on total addressable market alone.
How does the UG3 and UH3 phased structure work?
Every project must have two phases, and every project starts in the UG3 phase. The UH3 phase is not guaranteed. Transition happens only after NIH administrative review.
UG3 phase: get to an IDE or IRB approval
The UG3 phase supports the translational device work needed to obtain an IDE and IRB approval for a Significant Risk clinical study, or IRB approval for a Non-Significant Risk study. Duration depends on project maturity at entry and the specific indication, and ranges from one to four years.
Activities appropriate to the UG3 phase include:
Non-GLP animal studies to develop surgical techniques, optimize therapeutic or diagnostic parameters, and refine device design ahead of GLP testing
Bench-top and animal testing to demonstrate compliance with FDA Recognized Standards
GLP-compliant large animal safety testing of an implanted device
Activities to become current Good Manufacturing Practice (cGMP) compliant
Activities to bring development under Design Control and Quality Systems
Usability and acceptability studies
Device, software, firmware, and cybersecurity design verification and validation
Development of packaging, connectors, and accessories needed for translation
Regulatory activities including FDA pre-submission meetings, IDE submission, Humanitarian Device Exemption, Request for Risk Designation, 513(g) submission, and Breakthrough Device Designation
UH3 phase: run the clinical study
The UH3 phase supports a clinical study leading to one of three outcomes: a marketing application, if the study is sufficiently powered to demonstrate safety and effectiveness for regulatory approval; a larger clinical study that will lead to a marketing application; or use of the clinical experience to inform device design decisions. The UH3 phase can last up to four years.
The clinical study must provide information about device function or final design that cannot practically be obtained through additional bench or animal work, because of the novelty of the device or its intended use.
Activities appropriate to the UH3 phase include:
Optimization of device design with respect to human functional anatomy
Identification of the simplest, most reliable, and most cost-effective device configuration for advanced clinical studies and eventual market approval
Studies of key physiological variables that may affect device function in humans
Initial device safety assessments, but only in conjunction with obtaining enabling data about device design or function
What determines whether you transition from UG3 to UH3?
Program staff conduct an administrative review, with possible input from independent consultants. The decision rests on:
Successful achievement of the defined UG3 milestones
The competitive landscape
Programmatic priorities and current portfolio balance
For Significant Risk studies, documentation of final or conditional IDE approval from FDA
IRB approvals
Submission of the final clinical protocol and supporting documents to NIH for administrative review, and NIH notification of approval
Agreement on updated timeline, milestones, and budget for the clinical study
Availability of funds
NIH is direct about the implication: expectations align with industry norms for advancing devices through the development pipeline, and an inherent rate of attrition is possible within this program. Not every UG3 award becomes a UH3 award. Build your company plan accordingly.
Why milestones decide the outcome of a Blueprint MedTech award
Blueprint MedTech is a milestone-driven cooperative agreement, which means milestones are not a formality in the application. They are the operating contract for the award.
Each Specific Aim in the application should have at least one milestone associated with it. Each milestone should tie to tangible deliverables that are specific, measurable, achievable, relevant, and time-bound. NIH treats milestones as go or no-go decision points where significant uncertainty for the project is resolved. Applicants are advised to include aims, milestones, and deliverables addressing both technical and commercial feasibility.
Two milestones are effectively mandatory in Year 1:
For projects that need non-clinical testing to support an IDE, an FDA pre-submission meeting with NIH program staff in attendance must be a Year 1 milestone. FDA feedback from that meeting must clearly indicate that the proposed non-clinical testing plan is sufficient to support a successful IDE submission by the end of the UG3 phase.
For projects requiring non-clinical testing to support an IRB Non-Significant Risk designation, preliminary communication with the IRB about what non-clinical testing will be necessary must be a Year 1 milestone.
After award, NIH program staff evaluate progress toward milestones every year and recommend whether further funds should be released. If a project does not meet its milestones, funding may be discontinued. Continued funding also depends on the overall robustness of the entire data package, overall progress, portfolio balance and program priorities, the competitive landscape, and availability of funds.
Milestones are negotiated with NIH program staff before award and are written into the Notice of Award. In rare, well-justified cases, future-year milestones may be renegotiated based on data obtained during the previous year.
Blueprint MedTech Translator deadlines and timeline
Applications are due by 5:00 PM local time of the applicant organization. When a due date falls on a weekend or federal holiday, the deadline moves automatically to the next business day.
Upcoming due dates and review cycles
September 28, 2026 submission. Scientific merit review March 2027. Advisory Council review May 2027. Earliest project start July 2027.
January 28, 2027 submission. Scientific merit review July 2027. Advisory Council review October 2027. Earliest project start December 2027.
May 28, 2027 submission. Scientific merit review November 2027. Advisory Council review January 2028. Earliest project start April 2028.
September 28, 2027 submission. Scientific merit review March 2028. Advisory Council review May 2028. Earliest project start July 2028.
January 28, 2028 submission. Scientific merit review July 2028. Advisory Council review October 2028. Earliest project start December 2028. This is the final due date before the NOFO expires on January 29, 2028.
The same dates apply to new, resubmission, and revision applications. There are no AIDS-related deadlines for this opportunity.
The timeline you should actually plan against
Count backward from the deadline, not forward from today.
Twelve weeks before the due date: contact NIH program staff at your target Institute. NIH states that when possible, applicants should contact program staff at least twelve weeks before a receipt date. Early contact is how you learn whether your indication fits, what the Institute expects on clinical study design, and what budget range is realistic.
Six weeks before the due date: if you are requesting $500,000 or more in direct costs in any year, this is your hard deadline for contacting a Scientific or Research Contact.
Six weeks or more before the due date: begin System for Award Management registration if you are not already registered. NIH warns that registration can take six weeks or more, and that failure to complete registrations in advance is not a valid reason for late submission.
Two weeks before the due date: eRA Commons accounts can take up to two weeks to obtain. Every Program Director or Principal Investigator needs one, and their eRA Commons ID must appear in the Credential field of the Senior/Key Person Profile form.
Several days before the due date: submit early. Errors found during the Grants.gov and eRA Commons validation process must be corrected and a changed or corrected application resubmitted on or before the due date and time.
Add roughly nine to ten months from submission to earliest award start. A September 2026 submission that succeeds starts in July 2027.
Who is eligible to apply for Blueprint MedTech Translator?
Eligibility is broad, and startups are explicitly welcome. Individuals, institutions, and businesses developing their own devices, or that already have established collaborations with device manufacturers, may apply directly.
Eligible organizations include:
Higher education institutions, both public and private
Nonprofits with and without 501(c)(3) status
For-profit organizations, including small businesses
Local, state, county, city, township, and special district governments
Federally recognized and other Native American tribal governments and organizations
Eligible agencies of the federal government
U.S. territories and possessions
Independent school districts, public housing authorities, faith-based and community-based organizations, and regional organizations
Non-domestic (non-U.S.) entities, including foreign organizations and foreign components of U.S. organizations
Foreign components as defined in the NIH Grants Policy Statement are allowed.
What this means for a venture-backed startup
Three points matter for founders comparing this to SBIR and STTR.
First, this is not an SBIR or STTR program. The SBIR ownership and size restrictions do not apply here, so majority venture-owned and larger private companies that have aged out of SBIR eligibility can still compete.
Second, cost sharing is not required.
Third, an organization may submit more than one application as long as each is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time.
Required registrations
All registrations must be complete before the application is submitted:
System for Award Management (SAM), which must be renewed at least annually and which assigns a CAGE code for domestic organizations
NATO Commercial and Government Entity (NCAGE) code for foreign organizations, in lieu of a CAGE code
Unique Entity Identifier (UEI), issued through the SAM registration process, which must match the identifier in eRA Commons
eRA Commons, requiring at least one Signing Official and at least one Program Director or Principal Investigator account. If the PI is also the Signing Official, two distinct accounts are required.
Grants.gov, which requires an active SAM registration first
Applications may be submitted through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
What attachments does a Blueprint MedTech application require?
This NOFO has an unusually heavy set of required attachments with strict page limits. Missing or oversized attachments cause withdrawal without review. Treat this list as a compliance checklist.
Required attachments
Needs Assessment, three pages maximum, filed as "Needs Assessment.pdf"
IP Strategy, three pages maximum, filed as "IP Strategy.pdf"
Gantt Chart, one page maximum, filed as "Gantt.pdf"
Long-term Care Plan for Patients, three pages maximum, filed as "Long-term Care.pdf"
Resource Checklist, three pages maximum, filed as "Resource Checklist.pdf"
UG3 Milestone Plan, included in the Research Strategy
UH3 Milestone Plan, attached at Section 2.7 Study Timeline in the PHS Human Subjects and Clinical Trials Information form
Team Management Plan, two pages maximum, attached at Section 3.5
Data Safety and Monitoring Plan, attached at Section 3.3
Data Management and Sharing Plan, required regardless of direct costs requested
Optional attachments with enforced page limits
Exceeding these limits also causes withdrawal.
Schematics, two pages maximum, filed as "Schematics.pdf"
IRB Communications, five pages maximum, filed as "IRB Communications.pdf"
FDA Communications, ten pages maximum including a one-page summary, submitted only in Section 4.5.a or as post-submission material. Pre-submissions themselves should not be included.
What goes in the harder attachments
Needs Assessment. Establish performance requirements with clear, quantifiable metrics. Identify significant issues faced by patients, clinicians, caregivers, and customers. Critically evaluate primary or secondary data used to identify deficiencies in current capabilities. Describe the beneficiaries and how their needs were identified. Distinguish wants from needs. Describe how finite resources will be deployed. Identify human factors and ergonomics incorporated into the design.
IP Strategy. Describe the IP landscape around your device, including known constraints such as restrictions under transfer or sharing agreements, your own prior filings and publications, and similar patented or marketed technologies. If you are using technology your institution does not own, address anything that could constrain your freedom to operate, and include a letter from the IP owner stating whether they will provide the technology, any limits on studies performed with it, agreement on public disclosure of results including negative results, and whether an agreement is already in place. Give filing dates, patent types, application status, and USPTO links for relevant filings, and describe future filing plans. Academic applicants should prepare this with their technology transfer office.
Long-term Care Plan for Patients. Describe anticipated care needs of participants after the trial ends that relate to their participation, such as continued device access, device maintenance, and explant. Consider post-trial scenarios including device or trial failure, success, regulatory approval options, and a manufacturer decision to discontinue the product. Then describe the actual plan, which may include explant of indwelling devices, surgical removal of batteries and capping exposed metals from leads and IS-1 connectors, manufacturer-supported device maintenance for responders, or manufacturer support for compassionate use exemption filings. Address post-trial obligations including hardware and software maintenance and device-related medical expenses.
Team Management Plan. Define team structure and relationships, illustrated with an organizational chart. Describe governance, communication plans, decision processes for scientific direction and intellectual property, and conflict resolution procedures. Address authorship policies and decisions about what to publish, consistent with the interests of commercial partners. The plan must establish and name a Scientific Steering Group of senior and key team members that meets regularly. If organizations are partnering, the Scientific Steering Group must include representatives from each. Technology transfer officials are encouraged to be members.
Neuroethics section. Within Protection of Human Subjects, describe ethical considerations related to the design and conduct of the study, for example therapeutic misconception where research is ancillary to a clinical procedure or offers no prospect of participant benefit, and the long-term implications of the study, such as psychosocial or legal implications of predictive biomarkers for pre-symptomatic individuals. Reference the Neuroethics Guiding Principles for the NIH BRAIN Initiative.
Letters of support
Include letters from consultants, contractors, and collaborators. Academic applicants must include a letter from the technology transfer official managing the project's IP. Multi-institution projects need a letter from each institution clarifying how IP will be shared or managed. Collaborations with private entities need a letter stating whether the entity will provide the device or technology, limits on studies, limits on data sharing, and whether licensing agreements are in place. CRO and CMO letters may summarize test results but should not contain detailed results of all testing, and generally run two pages maximum.
What makes a Blueprint MedTech application non-responsive?
Non-responsive applications are withdrawn and never reviewed. There are three categories.
Activities that make an application non-responsive
Animal model development. All in vivo models must be established, characterized, and available to the applicant.
Projects focused on technologies for augmentation of healthy individuals
Delayed-onset clinical studies
Device technologies not regulated by the FDA
Omissions that make an application non-responsive
Specific Aims that do not cover activities for both the UG3 and UH3 phases
Failure to plan a delayed-start clinical study or trial in the UH3 phase, including all required supporting documentation
Missing any required attachment listed above
Missing a UH3 Milestone Plan
Formatting failures that make an application non-responsive
Any required or optional attachment that exceeds its page limit
Note the distinction NIH draws between delayed onset and delayed start. A delayed-start study is one that can be described in full but will not begin immediately, which is exactly what the UH3 phase requires. A delayed-onset study is one that cannot yet be described, and those are not accepted.
How is a Blueprint MedTech application reviewed?
Applications are evaluated for scientific and technical merit by an appropriate Scientific Review Group under NIH peer review policy, using the revised NIH review framework that took effect for due dates on or after January 25, 2025.
Reviewers consider three factors. Factors 1 and 2 each receive a separate factor score, and all three inform the overall impact score.
Factor 1: Importance of the Research (Significance and Innovation)
Reviewers assess whether the work addresses an important gap, solves a critical problem, or creates a valuable conceptual or technical advance, and whether it applies novel concepts, methods, or technologies.
Specific to this NOFO, reviewers evaluate:
Whether there is a significant advantage over all existing clinically available approaches for the same indication, regardless of class, including drugs, biologics, and competing devices
Whether the device reduces a known serious adverse event, a known device failure mode, or a use-related hazard or error, or improves the safety of another device or intervention
For devices improving on earlier generations, whether the advantages are justified and whether the changes are likely to succeed where the predecessor did not
Whether proof-of-concept data for a novel device was obtained with a prototype close to the final design
Whether the device and its capabilities are described in enough detail to judge appropriateness for the proposed clinical study
Whether the approach, targets, and patient population are justified
Whether there are adequate plans to engage FDA early
Whether the Needs Assessment incorporates input from patients, clinicians, and caregivers on device performance requirements, and identifies beneficiaries and their needs
Factor 2: Rigor and Feasibility (Approach)
Reviewers assess whether the work will produce unbiased, reproducible, robust data, whether design and controls are sound, whether sample size is sufficient and justified, and whether the studies can be done within the proposed timeframe.
Specific to this NOFO, reviewers evaluate:
Whether the regulatory plan is reasonable in terms of the path to market and FDA data requirements for the applicable standard, meaning reasonable assurance of safety and effectiveness for PMA or substantial equivalence for 510(k)
Whether the estimated timeline for clinical adoption reflects feasible benchmarks
Whether and how key stakeholders will be engaged at each step
Whether the project plan and timeline make an IDE at the end of the UG3 phase, or IRB approval for a Non-Significant Risk study, likely
Whether neuroethical concerns are adequately addressed
Whether any large animal safety study uses GLP and the final device design, or whether a clear reason it is unnecessary is provided, such as an FDA communication
Whether the Long-term Care Plan anticipates key patient needs, is reasonable, and addresses financial liability for injury, device removal, device revision, and management of indwelling devices
Whether the Gantt chart provides sufficient detail and demonstrates feasible plans
Whether milestones are timely, robust, and tied to clear quantitative go or no-go criteria
Whether milestone timelines are realistic, inclusive of necessary steps, and free of unnecessary ones
Whether milestones reflect planned regulatory requirements such as FDA pre-submission meetings and IDE submission
Whether potential challenges and solutions are presented, including strategies for enrollment shortfalls
Factor 3: Expertise and Resources (Investigators and Environment)
Reviewers assess investigator background and training, the leadership plan for multiple-PI applications, and institutional resources. Specific to this NOFO, reviewers evaluate whether the selection of Blueprint MedTech resources is adequately justified, whether team governance is appropriate, and whether the Scientific Steering Group members are appropriate and constitute an interdisciplinary team.
Additional considerations
Reviewers also consider, without scoring, the IP Strategy attachment, including whether IP landscape issues and barriers are addressed, whether known constraints could impede device development, whether filing plans are well described, and whether IP sharing across multiple institutions is adequately addressed. Human subjects protections, vertebrate animals, biohazards, authentication of key resources, and budget and period of support are also considered.
After peer review
Applications may undergo a committee process in which only those with the highest merit, generally the top half under review, are discussed and scored. Recommended applications then receive a second level of review by the appropriate national Advisory Council or Board. Funding decisions weigh scientific and technical merit, availability of funds, and relevance to program priorities.
What does the cooperative agreement mean for your company?
A cooperative agreement is not a grant you receive and then execute independently. NIH program staff have substantial programmatic involvement beyond normal stewardship. Founders should understand what they are signing up for.
What you retain
Custody of and all rights to the data and technology developed under the award, subject to government rights of access consistent with HHS, PHS, and NIH policy
Responsibility for defining objectives and approaches, planning, conducting, analyzing, interpreting, publishing, and sharing results
The right and encouragement to pursue patent protection
The program strongly encourages recipients and their collaborators to obtain and retain IP developed around the device during the project period, and to identify and foster relationships with licensing and commercialization partners early.
What NIH expects from you
Developing and proposing rigorous milestones
Progress reports complete enough to include experimental design, assumptions, results, interpretations, and a conclusion on whether milestones were met. If program staff request raw data, you agree to provide it.
Participation in virtual progress meetings with NIH staff at least twice a year
Communicating regulatory meeting dates and agendas to NIH program staff and inviting their participation
Sharing CRO study reports, meeting minutes and data packages, letters, and other FDA communications, and providing IDE or IND numbers and ClinicalTrials.gov registration numbers
Providing regulatory and clinical documents required for administrative review
Verifying the clinical study follows Good Clinical Practices and Institute-specific data and safety monitoring guidelines
Collaborating and communicating effectively with NIH service contractors
What NIH does
NIH program staff provide input on milestones and recommend their finalization, assess progress toward milestones, recommend whether further funds should be released, participate with your team in meetings with regulatory agencies, and may consult independent specialists under confidentiality agreements to protect intellectual property. In rare, well-justified cases, program staff may add critical experiments as additional milestones, sometimes with additional NIH funds.
A Program Officer handles normal stewardship, but the Associate Division Director overseeing the program makes final decisions on project continuation, a second level of approval designed to mitigate perceived bias. Disagreements can be escalated through other Associate Division Directors to the Institute Director. A formal Dispute Resolution Panel process exists for scientific or programmatic disagreements. Final NIH decisions regarding a discontinuation are not appealable.
Quality and compliance requirements
Use of Design Control and Quality Systems processes to the degree specified by FDA is required. Intermediate steps such as design reviews, design verification, design validation, and design transfer should appear in annual milestones where appropriate, along with IDE submission. NIH recognizes the required degree varies substantially by device, and encourages applicants to discuss this with FDA and regulatory consultants before submitting so the extent of the requirement is clearly defined and verifiable in the application.
Applicants should consider Quality System requirements at the IDE stage when planning device development activities, and should follow Institute-specific guidelines and policies for monitoring clinical research when forming a data and safety monitoring plan.
How to build a competitive Blueprint MedTech application
Six moves separate funded applications from withdrawn ones.
Call the program officer first, not last. NIH says twelve weeks before the deadline. This program is a negotiated partnership, and the negotiation starts before you write. Program staff will tell you whether your indication fits their Institute's mission, what clinical study requirements apply, and what budget is realistic. The Institute contact list is published on the Blueprint MedTech website.
Get FDA feedback before you submit if you possibly can. Pre-submission feedback is encouraged rather than required, but the alternative is a Year 1 milestone and a possible $100,000 funding restriction until FDA responds. Applications that arrive with approved pre-submission minutes showing FDA agreement on the non-clinical testing plan are substantially stronger and start faster.
Write your milestones like an operating plan, not a research schedule. Every Specific Aim needs at least one milestone. Every milestone needs quantitative go or no-go criteria. Cover technical, regulatory, and commercial feasibility. These become the terms of your award and the basis of every annual funding decision.
Build the whole application around one Institute's mission and one indication. Your device may have several uses. The application must focus on a disease or disorder within the mission of a participating Institute, and the target patient population and intended use should drive both device design and the proposed clinical activities.
Treat the attachment checklist as a go or no-go gate. Five required other attachments, two milestone plans, a team management plan, a DSMP, and a data management and sharing plan, each with page limits that are enforced by withdrawal rather than by a request to fix. Assign an owner and a deadline to each one.
Budget only your own work, and claim the free resources explicitly. Leave NIH-paid contractors and consultants out of the budget, name the Blueprint MedTech resources you will use in the Resource Checklist, and justify why you are not using the ones you skipped.
Frequently asked questions about the Blueprint MedTech Translator (PAR-25-383)
What is the deadline for PAR-25-383?
The next application deadline is September 28, 2026. Additional deadlines follow on January 28, 2027, May 28, 2027, September 28, 2027, and January 28, 2028. All applications are due by 5:00 PM local time of the applicant organization. The NOFO expires January 29, 2028.
How much money can I request from Blueprint MedTech Translator?
There is no budget cap. NIH states that application budgets are not limited but must reflect the actual needs of the proposed project. If you request $500,000 or more in direct costs in any single year, you must contact a Scientific or Research Contact at least six weeks before submitting and follow NIH policy on acceptance of applications requesting $500,000 or more.
Can a startup or small business apply to Blueprint MedTech Translator?
Yes. For-profit organizations, including small businesses, are explicitly eligible. Individuals, institutions, and businesses developing their own devices, or that already have established collaborations with device manufacturers, are welcome to apply directly. Foreign organizations are also eligible.
Is Blueprint MedTech an SBIR or STTR program?
No. Blueprint MedTech Translator is a UG3/UH3 cooperative agreement, not an SBIR or STTR award. SBIR ownership and company size restrictions do not apply, so companies that are majority venture-owned or otherwise ineligible for SBIR can compete here. Note that Blueprint MedTech also offers companion SBIR opportunities, so confirm which mechanism fits your company with program staff.
Do I need FDA feedback before applying?
Not strictly, but it matters a great deal. Applicants are encouraged, though not required, to consult FDA through a Pre-Submission meeting. If you do not have sufficiently relevant FDA feedback covering all planned activities at the time of application, obtaining it becomes your first milestone, and funding may be restricted to a maximum of $100,000 in direct costs until FDA feedback consistent with your regulatory path and development plan is received.
How long does a Blueprint MedTech award last?
The UG3 phase may run up to four years and the UH3 phase may run up to four years, but the total combined project period may not exceed five years. UG3 duration depends on how mature the project is at entry and on the specific indication, and can be as short as one year.
Is the UH3 clinical phase guaranteed?
No. All projects start in the UG3 phase. Only UG3 projects that meet defined criteria are eligible to transition after an NIH administrative review that considers milestone achievement, the competitive landscape, programmatic priorities and portfolio balance, IDE and IRB approvals, the final clinical protocol, agreement on updated timeline and budget, and availability of funds. NIH states plainly that an inherent rate of attrition is possible.
What is the difference between a Significant Risk and Non-Significant Risk study here?
A Significant Risk study requires an Investigational Device Exemption from FDA before the clinical study can begin, so the UG3 phase must deliver an IDE. A Non-Significant Risk study does not require an IDE, so the UG3 phase must deliver IRB approval instead. Your milestone plan, regulatory milestones, and non-clinical testing plan differ accordingly.
What kinds of devices are in scope?
Devices expected to be regulated by FDA that present first-of-its-kind technology, new safety questions, or new regulatory questions, and that address a disease or disorder within the mission of a participating Institute or Center or the BRAIN or HEAL Initiatives. Devices refining existing technology for a new intended use or a novel setting, such as moving a clinic-only neuromodulation device to home use, are also responsive. Expected pathways are De Novo or PMA, with 510(k) devices accepted only when innovation clearly exceeds the state of the art of existing cleared predicates.
What will make my application be rejected without review?
Four activity categories are non-responsive: animal model development, technologies for augmentation of healthy individuals, delayed-onset clinical studies, and device technologies not regulated by FDA. Applications are also withdrawn for missing Specific Aims that cover both phases, missing a planned delayed-start UH3 clinical study, missing any required attachment, missing a UH3 Milestone Plan, or exceeding any attachment page limit.
Do I have to include a clinical trial?
The NOFO is Clinical Trial Optional at the application stage, but in practice the structure requires a clinical study in the UH3 phase. Applications must include Specific Aims covering both phases and a delayed-start clinical study or trial planned in the UH3 phase with all required supporting documentation.
What free services does Blueprint MedTech provide, and do they come out of my budget?
Blueprint MedTech provides design optimization, prototype development and pilot-scale manufacturing, bench and safety testing, biocompatibility and large animal studies, clinical support, business development, regulatory and quality systems support, legal and IP support, and expert consultants. NIH pays these contractors and consultants directly, so those costs must not be included in your application budget. You identify what you plan to use in the required Resource Checklist attachment.
Who owns the intellectual property?
You do. Recipients retain custody of and all rights to data and technology developed under the award, subject to government rights of access consistent with HHS, PHS, and NIH policy. The program strongly encourages recipients and collaborators to obtain and retain IP developed around the device, and expects Principal Investigators to work closely with technology transfer officials on royalty agreements, patent filings, and commercialization plans.
Is cost sharing required?
No. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.
Can I submit more than one application?
Yes, provided each application is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time, and will not accept a new application submitted before the summary statement issues from an overlapping application under review.
Is a letter of intent required?
No. A letter of intent is not required, is not binding, and does not enter into review, but NIH asks prospective applicants to submit one so staff can estimate review workload. Send it to Blueprint-MedTech@nih.gov with the descriptive title, PI names and contact information, other key personnel, participating institutions, and the funding opportunity number and title.
How long does it take to get funded?
Roughly nine to ten months from submission to earliest possible start. A September 28, 2026 submission goes to scientific merit review in March 2027, Advisory Council review in May 2027, and has an earliest start date of July 2027.
Does a small market hurt my application?
No. NIH states directly that the market for these device types may be small compared with other markets, that applications should not be penalized for a comparatively smaller market provided the market is sustainable, and that NIH supports research for both rare and high incidence disorders within its mission. For rare and ultra-rare diseases where commercialization is challenging, NIH encourages applicants to discuss alternative strategies with Scientific and Research staff.
How much NIH involvement should I expect after award?
Substantial. Expect virtual progress meetings with NIH staff at least twice a year, NIH participation in your FDA meetings, sharing of CRO reports and FDA communications with program staff, annual milestone evaluations that determine whether further funds are released, and the possibility that program staff request raw data. Milestones are negotiated before award and written into the Notice of Award.
What registrations do I need and how early should I start?
You need active SAM, UEI, eRA Commons, and Grants.gov registrations, plus an NCAGE code if you are a foreign organization. NIH warns that SAM registration can take six weeks or more and eRA Commons accounts up to two weeks. All registrations must be complete before submission, and incomplete registration is not a valid excuse for a late application.
Who do I contact at NIH about Blueprint MedTech?
The program email is Blueprint-MedTech@nih.gov. Institute-specific scientific contacts include Nick Langhals at NINDS, Leonardo Angelone at NIDA, Erin Burke Quinlan at NCCIH, Tony Douglas Gover and Paekgyu Lee at NEI, Elizabeth Powell at NIAAA, Eunyoung Kim at NIMH, Michael Wolfson at NIBIB, and Melissa Ghim at NIDCR. NIH recommends contacting program staff at least twelve weeks before a receipt date.
Key NIH contacts for PAR-25-383
Program email for all inquiries and letters of intent: Blueprint-MedTech@nih.gov
Scientific and research contacts
Nick Langhals, PhD, NINDS, 301-496-1779, Blueprint-MedTech@nih.gov
Leonardo Angelone, PhD, NIDA, Blueprint-MedTech@nih.gov
Erin Burke Quinlan, PhD, NCCIH, 301-451-0636, erin.quinlan@nih.gov
Tony Douglas Gover, NEI, 301-529-7370, tony.gover@nih.gov
Paekgyu Lee, NEI, 301-435-8164, paek.lee@nih.gov
Elizabeth Powell, PhD, NIAAA, 301-443-0786, elizabeth.powell3@nih.gov
Eunyoung Kim, PhD, NIMH, 301-496-3513, eunyoung.kim@nih.gov
Michael Wolfson, NIBIB, 301-451-4778, michael.wolfson@nih.gov
Melissa M. Ghim, PhD, NIDCR, ghimm@mail.nih.gov
Application submission support
eRA Service Desk, 301-402-7469 or 866-504-9552
General NIH grants information, GrantsInfo@nih.gov, 301-480-7075
Grants.gov customer support, 800-518-4726, support@grants.gov
Is Blueprint MedTech Translator right for your company?
This program is a strong fit if you have a device that works, data that proves it works, a clear FDA pathway, and a funding gap between your last preclinical result and your first patient. It is a poor fit if your animal model is not yet established, your device is not FDA regulated, your technology targets enhancement of healthy people, or you cannot yet describe the clinical study you intend to run.
The application is demanding. Between the two milestone plans, five required attachments with hard page limits, a needs assessment grounded in stakeholder input, an IP strategy prepared with counsel, a long-term patient care plan, and a team management plan naming a Scientific Steering Group, this is a substantially heavier lift than a standard R01 or SBIR submission. It also rewards the work: uncapped budgets, free access to CROs and regulatory consultants, and a federal partner with an interest in getting your device to market.
BW&CO helps deep tech, biotech, and medtech founders win non-dilutive federal funding. We have helped clients secure more than $350 million in funding across NIH, NSF, DoD, NASA, DOE, and ARPA-H. If you are evaluating Blueprint MedTech Translator for the September 28, 2026 deadline or a later cycle, the first step is a mission-fit conversation with the right Institute, and the second is an honest read on whether your data package clears the entry criteria.
