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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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The Small Business Translator: MedTech and Digital Health Technologies program is a milestone-driven cooperative agreement issued by the National Institutes of Health under the Department of Health and Human Services. It aims to support eligible small business concerns in advancing translational activities and clinical studies for technologies that prevent, monitor, diagnose, and treat disorders. This initiative involves several trans-NIH efforts, including the Blueprint for Neuroscience Research, the BRAIN Initiative, and the HEAL Initiative. Eligible technologies include wearables, digital health tools, imaging-based biomarkers, in vitro diagnostics, and both implantable and non-invasive systems. Supported activities range from the implementation of clinical prototype devices and non-clinical safety testing to obtaining IRB approval or IDEs for clinical studies focusing on safety, usability, and efficacy. Funding is provided for internal laboratory activities, and applicants may request additional support for consultants specializing in regulatory affairs, intellectual property, and commercialization, as well as contract services for animal testing and manufacturing. Because this is a cooperative agreement, NIH program staff will be actively involved in negotiating project plans and monitoring research progress.

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)

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUSA
Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health
Office AddressUSA
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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