CRITICAL INNOVATIONS LLC — Department of Defense SBIR Phase I: DHP16-011

Description

Defense Health Program (DHP) seeks to develop a new and innovative medical device tailored to prevent or treat accumulation of blood in the pleural space after chest trauma or surgery (i.e. retained hemothorax). Critical Innovations, NeoMatRx, Milestone Strategies, and The FDA Group, in addition to consultant Captain David Plurad, MD, FACS (USN, Ret.), have formed a team of medical device experts to address this important medical need. We are fortunate in being able to apply our previous analytical and technical work to the solution; having encountered and overcome many of the initial design hurdles reduces risk for DHP and should expedite program development. During this Phase I project, the team will develop a functional prototype with the identified discriminating capabilities (TRL 4), perform bench top and simulator testing, initiate regulatory guidance, and seek evaluation and feedback from subject matter experts. The result of the Phase I project will be a clear direction for manufacture and testing of the identified device. In Phase II and beyond, the team will provide the necessary design, manufacturing, legal, quality, regulatory, marketing, and sales capabilities to drive the technology into full commercial application.