SBIR Phase I: A novel and cost effective mechanical ventilator for pandemic preparedness and underserved communities

This Small Business Innovation Research (SBIR) Phase I project will support development and testing of a novel cost-effective mechanical ventilator. The H1N1 pandemic ignited concern in the healthcare community over the state of preparedness of our nation?s healthcare system in the event of a critical care emergency. If a 1918-like flu pandemic were to occur today, tens of millions of people could die from respiratory distress. Unfortunately, the United States does not have enough ventilators to support patients with respiratory distress. When considered on a global scale, the disparity in critical care and emergency resources between wealthy and impoverished nations is alarming. The goal of this proposal is to progress from a high-level prototype to pre-production status. Iterative performance testing and redesign will be followed by human factors validation and interface design with simulated use modeling. Completion of Phase I will place the company in a position to begin verification testing and validation of mechanical components and software in Phase II. The next step is regulatory approval following a 510k pathway and sales expected to begin within 2 years of the Phase I start date. The broader impact/commercial potential of this project is to conquer one of the most difficult problems in critical care: delivering high precision, high reliability and low cost in a mechanical ventilator. If a flu pandemic were to occur today, millions of people could die from respiratory distress. Unfortunately, the United States does not have enough ventilators to support patients with respiratory distress in even a mild pandemic. Respiratory illness is a leading cause of hospitalization and death in emerging nations. Each year thousands of patients die in rural community hospitals because of lack of access to mechanical ventilation. Despite improvements in infrastructure and economies, ventilators remain out of reach for many hospitals. At present, the mechanical ventilation market is more than $2 billion globally and growing at 7%. Commercialization of this novel ventilator design would provide a viable option for stockpiling ventilators in the event of a mass casualty event and hospitals in emerging markets will finally be able to afford high performance ventilation for their intesive care units.