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.
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 would cover up to $500,000 in direct costs per year for up to four years; seedlings would receive $50,000 for additional early-stage development.
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 opens on July 31, with applications due by August 25, 2023 NOTICE: The Cycle 3 deadline has been extended through Sunday, August 27, 5 p.m. EDT. Following review of the pre-proposals, a subset of applicants will be invited to submit a full proposal in early October.
We recommend applicants first look at NIH Institute/Center specific interests to align their application with NIH's interests.
For more information, read this science highlight article and visit the solicitation webpage.
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)
Blueprint MedTech Resources
- Regulatory Advising – Contract (75N95022D00020) with PPD
- Clinical Advising – Contract (75N95023D00011) with PPD Development
- Biocompatibility and Sterilization Testing and Animal Studies Advising
Blueprint MedTech Staff
Program Directors:
Leonardo Angelone, Ph.D.
Ruben Alvarez, Ed.D.
Nick Langhals, Ph.D.
Michael Wolfson, Ph.D.
Program Officers:
Stacie Gutowski, Ph.D.
Yordan (Dan) Kostov, Ph.D.Scientific Project Managers:
John M. Greene, Ph.D.
Elyse K. White, Ph.D.