CONTRACT RESEARCH ORGANIZATION (CRO) SUPPORT FOR BLUEPRINT MEDTECH (BPMT) REGULATORY AFFAIRS SUPPORT AND RELATED SERVICES. REGULATORY PATHWAY AND MARKET ACCESS SUPPORT. TASK ORDER 03. 04/09/2024 - 04/

NIH RePORTER · NIH · N02 · $169,638 · view on reporter.nih.gov ↗

Abstract

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. https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-medtech/blueprint-medtech

Key facts

NIH application ID
11210479
Project number
75N95022D00020-P00003-759502400001-1
Recipient
PPD DEVELOPMENT LP
Principal Investigator
MATTHEW KIRKBY
Activity code
N02
Funding institute
NIH
Fiscal year
2024
Award amount
$169,638
Award type
Project period
2024-04-09 → 2029-04-08