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Small Business Translator: MedTech and Digital Health Technologies

Active
Grant

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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This funding opportunity from the National Institutes of Health aims to support small business concerns in advancing medical technologies focused on preventing, monitoring, diagnosing, and treating neurological and other health disorders aligned with participating NIH programs such as the BRAIN Initiative and HEAL Initiative. Eligible applicants are encouraged to engage in translational research and clinical studies involving devices like wearables, digital health tools, diagnostic and therapeutic devices, implantable systems, and related technologies. The program supports activities ranging from clinical prototype implementation and safety testing to obtaining regulatory approvals and conducting clinical trials that assess the safety, usability, and efficacy of these innovations. This cooperative agreement offers milestone-based funding, with close involvement of NIH staff in project planning and progress monitoring. Funding covers work performed within applicants' laboratories and may extend to collaboration with specialized consultants for regulatory, reimbursement, intellectual property, and commercialization guidance. Additionally, applicants can access contract services for preclinical testing, manufacturing, and clinical support. Both small businesses developing proprietary devices and those partnering with device manufacturers are encouraged to apply, fostering innovation in the medtech and digital health sectors targeting neurological and related disorders.

General Info

NIH funding supports small businesses developing neurological health devices through translational research and clinical trials.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) View NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

forecast

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUS
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health
Office AddressUS
Contacts
Nicholas Langhals PhD National Institute of Neurological Disorders and Stroke (NINDS
contact@example.gov
+1 (555) 000-0000

Full Description

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The purpose of this Notice of Funding Opportunity (NOFO) is to encourage eligible small business concerns (SBCs) to pursue translational activities and clinical studies to advance the development of technologies to prevent, monitor, diagnose, and treat disorders within the missions of participating Institutes, Centers, and Offices. The NOFO will include participation from trans-NIH initiatives including the Blueprint for Neuroscience Research, the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and The Helping to End Addiction Long-term (HEAL) Initiative. Technologies responsive to the program may include diagnostic, therapeutic, rehabilitative, and/or monitoring devices including wearables, digital health tools, imaging-based biomarkers, in vitro diagnostics, medical-device-development-tools (MDDT), implantable or non-invasive systems, clinical tools, and other device-related technologies. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study. Clinical studies and trials addressing safety, usability, feasibility, and/or efficacy of these technologies would also be included. This is a milestone-driven cooperative agreement program and will therefore involve participation of NIH program staff in negotiating the final project plan before award and monitoring research progress. Participants in the program will receive funding for all activities to be conducted in their own laboratories. In addition, applicants may request support to collaborate with consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also request access to contract services that specialize in animal testing, sterilization, biocompatibility, manufacturing, and clinical support/medical monitoring. SBCs developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this NOFO.

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