Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)

Description

The purpose of this announcement is to encourage investigators to pursue translational activities and clinical feasibility studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. 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, as well as a subsequent clinical feasibility study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this NOFO or any of the companion opportunities. For more information see BP MedTech website.

Official source

Eligible beneficiaries

• Private institutions of higher education
• County governments
• Small businesses
• Public and State controlled institutions of higher education
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• For profit organizations other than small businesses
• City or township governments
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• State governments
• Native American tribal organizations (other than Federally recognized tribal governments)
• Others (see text field entitled "Additional Information on Eligibility" for clarification)
• Native American tribal governments (Federally recognized)
• Independent school districts
• Special district governments
• Public housing authorities/Indian housing authorities