HEAL Initiative: Translational Development of Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed) | RFA EB 22 002

FAQs: HEAL Initiative - Translational Development of Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed) (RFA-EB-22-002)

What is the main goal of this funding opportunity?

The goal is to move promising pain-related medical devices from early proof-of-concept into clinical-grade prototype form. The program is designed to help teams bridge the gap between a lab prototype and a device that is mature enough to responsibly pursue first-in-human (FIH) testing later.

What kind of technologies does the program focus on?

The focus is on device-based diagnostic and therapeutic technologies for pain that are intended to be safe, effective, and non-addictive. Projects are expected to align with the NIH HEAL (Helping to End Addiction Long-term) Initiative objective of reducing reliance on opioid-based pain management.

Is this opportunity for basic research or translational development?

This opportunity is for translational development rather than basic discovery research. It is meant for teams that have already demonstrated initial feasibility or proof-of-concept and now need support to address engineering, usability, safety, performance, and readiness issues required to reach a clinical-grade prototype.

What does "Translational Development" mean in the context of this FOA?

It means turning mechanistic insights from modern pain neuroscience into practical diagnostic or therapeutic devices. The funded work is expected to strengthen target credibility and advance the device toward real-world use by improving design, performance, and readiness for future human testing.

How does the FOA define "target credibility" and why does it matter?

A key emphasis is that the biological or neural target should be well-supported and clearly relevant to pain processing. Applicants are expected to justify that the target is measurable and meaningful in a way that supports practical device development, not just scientific curiosity.

What kinds of pain pathways or biological targets are encouraged?

The FOA emphasizes targeting well-supported neural pathways involved in pain processing across the central nervous system, spinal circuits, and peripheral nerves, based on up-to-date understanding of pain anatomy and physiology.

Are clinical trials allowed under this grant mechanism?

No. Clinical trials are explicitly not allowed under this mechanism (R18 Clinical Trial Not Allowed). The intent is to fund development and preparatory work so that a first-in-human clinical study would be feasible after the award period, not to generate human efficacy data during the award.

If clinical trials are not allowed, what is the expected endpoint or deliverable?

The expected deliverable is a more mature, clinically suitable prototype and a clearer pathway to FIH readiness. The program supports de-risking work and development activities that position the device for a future clinical trial pathway.

What types of activities are considered in scope for this opportunity?

In-scope activities typically include technology development and optimization and other de-risking work needed to make a device ready for future first-in-human testing. Examples include improving device design and manufacturability, refining stimulation or sensing parameters, validating performance in appropriate bench or preclinical models, strengthening safety and reliability evidence, developing clinical-grade prototypes, and producing documentation and testing that support future regulatory submissions.

Does the FOA support regulatory preparation work?

Yes. The scope includes preparatory work needed to pursue human-use approvals, including generating testing and documentation that would support future regulatory submissions. The FOA frames this as part of the translational groundwork required before first-in-human studies can occur.

What stage of development is this grant best suited for?

It is best suited for the phase after initial feasibility or proof-of-concept has been shown, when teams need resources to solve the major engineering and translational challenges that separate a lab prototype from a clinical-grade device suitable for first-in-human readiness.

Does the FOA require alignment with the NIH HEAL Initiative?

Yes. The program is positioned within the NIH HEAL Initiative and emphasizes pain-related devices that can help reduce reliance on opioid-based pain management by providing safe, effective, non-addictive diagnostic or therapeutic alternatives.

What is the maximum award amount for this funding opportunity?

The award ceiling is $750,000.

What is the opportunity number and title?

The opportunity is titled "The HEAL Initiative: Translational Development of Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed)" and is identified as RFA-EB-22-002.

When was this FOA created and what is the listed closing date?

The FOA was created on August 23, 2022. The original closing date listed is June 17, 2025.

Who is eligible to apply?

Eligibility is broad. Eligible applicants include state, county, and municipal governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities.

Are minority-serving institutions and community-based organizations eligible?

Yes. The FOA highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations.

Are non-U.S. entities eligible to apply?

Yes. The FOA includes non-domestic (non-U.S.) entities among eligible applicants, and also highlights eligibility for U.S. territories or possessions.

Are federal agencies or regional organizations eligible?

Yes. The FOA explicitly lists eligible federal agencies and regional organizations among additional eligible groups.

Why does the FOA list multiple CFDA numbers?

The multiple CFDA numbers (including 93.121, 93.213, 93.273, 93.286, 93.393, 93.395, 93.846, 93.853, 93.865, 93.866, and 93.867) reflect that the opportunity is cross-cutting within NIH's research and development portfolio and connects to multiple program areas.

What makes a project a strong fit for this announcement based on the description?

A strong fit is a pain-related device concept with preliminary evidence that already cleared early feasibility or proof-of-concept, combined with a credible, well-justified neural or biological target. The proposal should focus on practical translation challenges like device optimization, safety and reliability evidence, manufacturability, performance validation in bench or preclinical settings, and preparation for a future first-in-human pathway.

What is this opportunity "not" intended to support?

It is not intended to support basic discovery research or clinical trials. The purpose is not to deliver human efficacy data during the grant, but to produce a clinical-grade prototype and the supporting evidence needed to make first-in-human testing feasible afterward.

How does this opportunity function as "bridge" funding?

It supports teams at a transitional point: the device concept has preliminary promise, but additional work is needed to reduce risk and close development gaps before entering first-in-human clinical testing under a future, appropriately designed clinical trial program.