Lessons Learned from the Development of a Mechanical Ventilator for COVID-19

During the COVID-19 pandemic, many researchers all over the world have offered their time and competencies to face the heavy consequences of the disease. This is the case of a group of physicists, engineers, and physicians that around the middle of March 2020 started to develop a simplified mechanical lung ventilator, called MVM (Mechanical Ventilator Milano), to answer the high request of ventilators for Acute Respiratory Distress Syndrome (ARDS) in intensive care units. A prototype was ready in around one month. Since medical software malfunctions can lead to injuries or death of patients, before marketing MVM ventilators and distributing them in hospitals, software certification in accordance with the IEC 62304 standard was mandatory to guarantee system reliability. The team was then complemented by computer scientists specifically devoted to this task. The software re-engineering process, which lasted around two months from the end of the prototype, brought to a strong re-implementation of the device software components, which involved all the stakeholders in a continuous integration setting. In this paper, we report the experience of the MVM control SW re-engineering necessary to show evidence that the SW adheres to the standards and to consequently obtain the certification. We share results and lessons learned from this social project, where more than 100 volunteer researchers worked towards software certification at the extreme of their strength to get a real device finished in a rush since strongly required to support physicians in treating COVID-19 patients.