NextTech: Translational Development of Next-Generation Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed)

The National Institutes of Health (NIH) is soliciting applications under RFA-EB-28-004 for the NextTech program to advance the development and translation of next-generation diagnostic and therapeutic devices. This initiative supports technologies designed to prevent, monitor, diagnose, and treat disorders aligned with the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) and Helping to End Addiction Long-term (HEAL) missions. The primary goal is to move new devices toward readiness for first-in-human clinical trials by focusing on technology optimization and regulatory preparation rather than basic biological research. The program has a total funding pool of 6,000,000 dollars, with an intent to fund approximately 4 to 12 awards, typically limiting direct costs to 750,000 dollars per year. Awards are determined through a two-stage process involving scientific peer review and a second-level review by the National Advisory Council for Biomedical Imaging and Bioengineering. Evaluation is based on scientific and technical merit, relevance to program priorities, and the specific advantage the device offers over existing clinical approaches. Applicants must provide a detailed Gantt chart, a needs assessment with quantifiable metrics, a data management and sharing plan, and a reasonable regulatory path to market. Eligible applicants include for-profit organizations and small businesses, provided they maintain active SAM.gov and eRA Commons registrations. Foreign subawards are prohibited. Awardees must also adhere to strict cybersecurity requirements, including the development of an incident response plan and a 48-hour notification window for security breaches.