Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)

Blueprint Medtech: Small Business Translator is a Funding Opportunity Announcement (FOA) targeting Small Business Concerns (SBCs). Its aim is to encourage the pursuit of translational activities and small-scale clinical studies to foster the creation of diagnostic and therapeutic devices for disorders affecting the nervous or neuromuscular systems.

The program supports a variety of activities including the development of clinical prototype devices, non-clinical safety assessments, design verification, and validation activities. It can lead to the submission of an Investigational Device Exemption (IDE) to the FDA or an application for a Non-Significant Risk (NSR) study to an Institutional Review Board (IRB).

The intention behind the clinical studies is to extract information about the functionality or final design of the device that cannot be feasibly gained from extra non-clinical evaluations such as bench top or animal studies. This is primarily due to the originality of the device or its proposed usage.

The FOA operates as a milestone-based cooperative agreement program. It involves intervention from NIH program staff, both in finalizing the project plan before the award and in monitoring the research's progress.

Blueprint Medtech offers funding for all the proposed activities, which are to be conducted in the recipient's own labs. Additionally, program participants will collaborate with NIH-funded consultants to receive guidance in special areas like regulatory concerns, reimbursement issues, intellectual property, commercialization, and strategic partnerships.

Participants can also strengthen their project by working with NIH-contracted research organizations specializing in large animal testing, sterilization testing, biocompatibility evaluations, manufacturing, and medical monitoring.

SBCs that are developing their own devices or have already formed collaborations with device manufacturers are invited to apply directly to this FOA or any of the associated opportunities. More information can be found on the program's webpage: https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-medtech