Activities supported in this program include commercialization planning, clinical prototype devices, non-clinical safety and efficacy testing, or design verification and validation activities that provides the data to apply for U.S. Food and Drug Administration Investigational Device Exemption (IDE) or, in the case of digital health products, application for a non-significant risk study. NIH program staff provide close monitoring and technical assistance to projects to help them achieve established milestones. 

Participants in Blueprint MedTech receive funding for research activities and collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. 

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