SBIR Phase II: A novel and cost effective mechanical ventilator for pandemic preparedness and emergency stockpiling

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to develop a cost-effective mechanical ventilator designed specifically to address the need for pandemic stockpiling and surge capacity use. The output of this Phase will be a new ventilator ready for FDA clearance and market entry in 2017. US government planners have described a need for many thousands of additional ventilators in the event of a pandemic influenza or other large-scale medical emergency. Severe influenza often leads to respiratory distress which cannot be dealt with in the absence of mechanical ventilation. Given some time and a mechanical ventilator, the human body can often clear the infection on its own. Without help from the ventilator, patients may die. Manufacturers of current ventilators have attempted to reconfigure their existing offerings to meet the stockpiling demand. Unfortunately none of these devices are able to match the price/performance ratio needed to make stockpiling in large numbers economically feasible. Building upon an innovative platform for mechanical ventilation developed in Phase I, the project intends to develop a ?gold standard? device for pandemic preparedness and emergency use. The proposed project is to develop a novel and much needed medical device ? a mechanical ventilator suitable for pandemic use and emergency stockpiling. If a severe pandemic were to strike the United States, the number of patients in need of mechanical ventilation has been estimated to be over 700,000. Of these, the most severe cases are often in the very old and the very young. There are currently 62,274 ventilators in use in the United States, of which only 23,485 are capable of supporting pediatric patients. Research and development activities will provide opportunities for creating new intellectual property, new technology, and new clinical methods for managing respiratory distress. This research and development project is divided into two Aims. In the first, the company will conduct extensive design research to analyze and understand the clinical need and all product requirements. We will then design, build, and test a series of prototype concepts using sophisticated software modeling, benchtop test platforms including mechanical and electronic lung simulation, and real-world user feedback. In the second Aim the company will address manufacturing and supply chain requirements, integrate design for manufacturing, and build and test a final series of near-production prototypes. These late-stage test procedures will include clinical performance and accuracy in accordance with regulatory standards, electromagnetic interference, and mechanical durability including vibration, noise, and water ingress in preparation for FDA regulatory clearance.