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HEAL Initiative: Optimization of Therapeutic Medical Devices through Team Science Mechanistic Research (RM1)

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Contract Overview

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

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The National Institute of Neurological Disorders and Stroke (NINDS), in collaboration with other NIH Institutes and Centers, plans to issue a Notice of Funding Opportunity focused on understanding the mechanisms by which therapeutic medical devices produce beneficial effects. The initiative targets improving clinical outcomes by enhancing device-based interventions through a deeper knowledge of how these devices interact with physiological markers of neurological conditions. Despite the widespread availability of medical devices, many have demonstrated inconsistent or limited efficacy in preclinical and clinical settings. The program aims to address these gaps by encouraging innovative mechanistic research that could lead to optimized therapies, new device designs, and better patient care. Applications will be sought from interdisciplinary teams with expertise spanning engineering, biology, surgery, clinical care, computational modeling, artificial intelligence, regulatory science, and more. Research may encompass FDA-approved devices currently in clinical use, as well as investigational devices, including mechanistic clinical trials, animal research, and computational or simulation studies. Although applications are not currently being accepted, this advance notice serves to allow prospective applicants ample time to build collaborative teams and develop projects that align with the goal of transforming the clinical utility of therapeutic medical devices. The effort underscores a commitment to advancing translational research that bridges scientific understanding and practical patient benefits.

General Info

NINDS seeks interdisciplinary research to improve therapeutic medical devices' mechanisms and clinical outcomes.

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
NINDS Translational Devices Team
contact@example.gov

Full Description

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The National Institute of Neurological Disorders and Stroke (NINDS), with other NIH Institutes and Centers (ICs), intends to publish a Notice of Funding Opportunity (NOFO) to investigate the mechanisms of action of therapeutic medical devices with the overall goal of improving clinical outcomes with device-based approaches. Medical devices are essential in managing health conditions, complementing drugs and behavioral interventions, and often offer unique benefits. Despite the commercial availability of numerous medical devices and ongoing development of new technologies, many have shown inconsistent results in preclinical studies, failed translation to humans, and exhibit varied patient outcomes. To overcome these challenges, it is crucial to understand the mechanisms by which medical devices produce a therapeutic effect, to identify physiological markers of neurological conditions, and to assess how device-based therapies influence these markers. Advancing this knowledge will improve device-based interventions, inspire new device designs, and optimize current clinical approaches.

Applications will be invited from interdisciplinary teams pursuing innovative research on how medical devices produce a therapeutic effect. Applicant teams will likely exhibit expertise in areas such as engineering, biology, pathophysiology, surgery, clinical care, healthcare delivery, biostatistics, software development, computational modeling, artificial intelligence, regulatory science, and clinical trials. This program will accept projects on investigational devices and those already FDA-approved and in clinical use. Applications are expected to include strategies for developing or optimizing therapies that could significantly improve patient care. Supported research may include mechanistic clinical trials, animal studies, and computational modeling or simulation. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

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