This is a government grant for small businesses working on creating medical devices to treat nervous system disorders. It supports activities like making prototype devices, safety testing, and clinical studies to get approval from the FDA. The grant is a cooperative program where the NIH helps plan and monitor the research. It also provides funding and access to experts for things like regulations, patents, and manufacturing. Small businesses with their device ideas or collaborations with manufacturers can apply for this grant to advance their projects. The deadline to apply is September 27.
The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) to pursue translational activities and limited-size clinical 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 leading to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) 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 (CROs) that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring.
SBCs developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities.
For more information see BP MedTech website: https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-medtech