Real-world considerations for the rapid prototyping and manufacture of a ventilator for the COVID-19 pandemic

BACKGROUND: In the COVID-19 pandemic, ventilators vital to keeping infected patients alive, were in short supply globally. Our aim was to rapidly prototype and implement production of basic ventilators to serve the local and regional needs in this emergency situation. METHODS: We adopted a supply-to-design approach, estimating the potential demand for ventilator units and sourcing for common off-the-shelf components available in the estimated quantities, to assemble ventilator units which met the essential requirements for clinical use. We determined the minimum requirements of a basic ventilator based on published specifications and clinician input. Building the ventilator involved interdisciplinary collaboration (between clinicians, industry, hospital innovation engineers and government partners), prototyping and repeated iterations, bench testing, animal testing, regulatory processes, ISO13485 quality management processes, licensing and user acceptability testing. RESULTS: We prototyped a limited feature ventilator to supplement hospital ventilators which could be manufactured in sufficient numbers within a short span of time from easily available component parts. Developed with close attention to clinician user input with compliance to ISO standards and quality management processes where possible, this ventilator system was composed of coupled resuscitation bags, motor systems, and pressure and flow sensors capable of delivering ventilator breaths within safe and clinically important targets. This system is functional on ambient air with or without low pressure oxygen supplementation. User feedback cited size, alarms and intuitiveness of controls as potential areas for improvement. CONCLUSIONS: Further modification based on user acceptability testing results are needed to refine the usability of this limited feature ventilator.