Critical Innovations is currently developing multiple medical devices toward regulatory clearance. The company focuses on task-shifting evidence-based interventions to earlier echelons of care and more general specialty levels, to simplify management and allow for rapid provision in emergency and combat environments. To date, the company has worked under more than 40 different Department of Defense awards from all military branches charged with medical technology development (i.e. U.S. Army, Air Force, Navy, and Space Force), including such agencies as the Air Force Medical Support Agency; Army Medical Research and Development Command; Defense Health Agency; and, Office of Naval Research. Contract types have included Small Business Innovation Research (SBIR), Joint Warfighter, Congressionally Directed Medical Research Programs, and Other Transactional Authority. As a prime contractor, Critical Innovations has a 99.5% rate of on-time program deliverable achievement. For Phase II awards, the company has 100% transition rate to Phase III funding. As a fully turnkey company, Critical Innovations possesses all the necessary capabilities and experience to guide a product seamlessly from proof-of-concept through to manufacturing, regulatory clearance, and commercialization.
Winner of the MTEC 2020 Prototype of the Year Award, Critical Innovations LLC is an ISO 13485:2016 certified, 21 CFR§820 QSR (cGMP) and DCAA compliant, medical research and development company focused on creating cutting-edge solutions to health threats that span the pre-hospital, hospital, and military environments. The FDA-registered small business employs an iterative development methodology focused on agile engineering to rapidly advance products.
Critical Innovations LLC has strengths in medical device, software, and therapeutic development, including experience with:
Laboratory, preclinical, and clinical research
Cost, reimbursement, intellectual property, and market analysis
FDA quality system regulations
Manufacturing set-up and transition
Unique challenges to military systems, environments, and program management
Traumatic Brain Injury
Damage Control Resuscitation
Prolonged Field Care
CD010 Rev.K 2023-09-15