SBIR-STTR Award

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.

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.