TherOx DownStream System® for TherOx® – Caster-based mobile Class III medical device used to hyper-oxygenate the patient's blood and deliver it to the coronary arteries for minimizing damage to the heart muscle after myocardial infarction. The system  uses a disposable DownStream Cartridge®. Omnica was hired to develop the clinical prototype into a manufacturable product. We also managed the project with complete FDA documentation as a focus. Our tasks were human factors, GUI, industrial design, re-iteration of electronics boards, mechanical engineering, fabrication of a full scale prototype, performance testing, DFM and transfer to a contract manufacturer.