Development and/or Validation of Devices or Electronic Systems to Monitor or Enhance Mind and Body Interventions (R43/R44 Clinical Trial Optional) | PAS 18 120

Opportunity Information: Apply for PAS 18 120

This NIH Small Business Innovation Research (SBIR) funding opportunity, PAS 18-120, is aimed at helping U.S. small business concerns build and/or validate practical devices or electronic systems that can either measure what is happening in the body or behavior during mind and body interventions, or actively help people practice those interventions better so the outcomes improve. The program is framed around real-world technology development: creating brand-new tools, adapting innovative technologies that already exist, repurposing devices for a new mind-body use case, or testing components that could eventually become part of a longer-term integrated system. The announcement also notes that clinical trials are optional under this mechanism, meaning applicants can propose either non-clinical development/validation work or a clinical study if it is appropriate for the stage of the technology.

A central theme of the FOA is monitoring and enhancement. On the monitoring side, the NIH is looking for technologies that track biologically based processes (for example, physiological signals) or behaviorally based processes (for example, patterns of movement, adherence, engagement, or performance) that are relevant to mind and body interventions. This could include wearable, automated, or long-term monitoring tools that capture the mechanistic processes thought to drive outcomes, or that capture functional outcomes directly. On the enhancement side, the opportunity supports systems that help optimize the practice itself, such as tools that guide users, deliver stimulation or feedback, personalize training, or otherwise increase the efficacy of the intervention. The FOA explicitly allows work on single components or combinations of components, as long as the work is tied to a coherent device or system concept and is aimed at monitoring or improving mind-body intervention mechanisms or outcomes.

The mind and body interventions in scope are defined as non-pharmacological approaches, and the FOA lays out three broad categories. First are mind/brain-focused approaches like meditation and hypnosis. Second are body-based approaches such as acupuncture, massage, and spinal manipulation or mobilization. Third are combined mind-and-body meditative movement approaches like yoga, tai chi, and qigong. The practical implication is that proposed technologies should clearly connect to one or more of these intervention types, and the application should make a convincing case that what is being measured or optimized is actually meaningful for that intervention, either mechanistically (how it works) or functionally (what changes for the person).

From an eligibility and administrative standpoint, the applicant must be a small business concern, since this is an SBIR opportunity using the R43/R44 mechanisms. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, the FOA notes that foreign components may be allowed as defined in the NIH Grants Policy Statement, which typically means certain limited, well-justified activities performed outside the U.S. could be permissible if they are essential and appropriately described. The sponsoring agency is the National Institutes of Health, the activity category is health, and the CFDA listing associated with the opportunity is 93.213. The FOA was created on 2017-11-28, and the original closing date listed in the source data is 2020-07-05. The source data does not specify an award ceiling or expected number of awards, which usually means applicants need to refer to the full FOA and standard SBIR budget guidance for limits and expectations.

Overall, the opportunity is best understood as NIH support for commercialization-oriented R and D that brings objective measurement and technology-enabled optimization into mind-body practices. Strong applications would typically describe a clearly defined device or electronic system, explain the biological or behavioral processes it will measure or influence, show how it fits a specific mind-body intervention context, and lay out a development and validation plan that is appropriate for SBIR phases and milestones.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development and/or Validation of Devices or Electronic Systems to Monitor or Enhance Mind and Body Interventions (R43/R44 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213.
• This funding opportunity was created on 2017-11-28.
• Applicants must submit their applications by 2020-07-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAS 18 120

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: