Innovators developing groundbreaking medical device technologies face a number of challenges along the translational path from bench to bedside. The Blueprint MedTech program is an NIH incubator that aims to address such challenges and support the innovators by accelerating the development of cutting-edge medical devices to diagnose and/or treat disorders of the nervous system. The mission of the program is to catalyze the translation of novel technologies from early-stage development to readiness for first-in-human clinical studies. The program will provide: (a) non-dilutive funds to support medical device development activities led by investigators, and (b) additional resources and support services including, but not limited to:
- Planning resources to support concept development, team building, needs assessment, and other early translational activities.
- Streamlined access to translational services and expertise (e.g., design and prototyping, bench testing, large animal testing, biocompatibility assessment, manufacturing, medical monitoring).
- Assistance from consultants (e.g., on regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues).
- Advice from industry experts (e.g., meetings with an external oversight committee).
The overarching goal of the Blueprint MedTech program is to accelerate patient access to groundbreaking, safe, and effective medical devices. The program will provide support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government.
See the announcement of the first Blueprint MedTech Awards in this NIBIB Science Highlight and in the Blueprint MedTech Awards item in the menu at left.
The Blueprint MedTech Program is structured in two main components: 1) Blueprint MedTech Incubator, and 2) Blueprint MedTech Translator, described as following:
1. Blueprint MedTech Incubator:
Two Incubator Hubs for Blueprint MedTech have launched a funding opportunity on behalf of the NIH program. This program will catalyze the translation of novel technologies from early-stage development up to readiness for first-in-human clinical studies. Funding for late-stage development as Optimizer projects would cover up to $500,000 in direct costs per year for up to four years; Seedling awards provide support for six months, a $25,000 stipend, and $25,000 to hire subject matter experts. For these, mentors will work with awardees to help resolve specifically identified gap(s) on the path to commercialization.
In addition to funding, the selected teams will receive ongoing, specialized support from mentors experienced in commercializing neurotech devices. The program seeks to increase the participation of applicants from underrepresented minorities and groups including women, Blacks, Latinx, and other communities of color.
The next round of solicitations for pre-proposal applications is now open! - see Blueprint MedTech Incubator Hubs for how to apply. Following review of the pre-proposals, a subset of applicants will be invited to submit a full proposal.
2. Blueprint MedTech Translator:
The purpose of these Notices of Funding Opportunities (NOFO) is to encourage investigators (UG3/UH3 mechanism) and Small Business Concerns (SBCs) (U44 mechanism) 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.
- Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional; PAR-21-315)
- Blueprint MedTech: Small Business Translator (U44 - Clinical Trial Optional; PAR-21-282)
See the announcement of the first Blueprint MedTech Awards in this NIBIB Science Highlight!
Blueprint MedTech Staff
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