Guidelines for the development of a critical software under emergency.

Context: During the first wave of the COVID-19 pandemic, an international and heterogeneous team of scientists collaborated on a social project to produce a mechanical ventilator for intensive care units (MVM). MVM has been conceived to be produced and used also in poor countries: it is open-source, no patents, cheap, and can be produced with materials that are easy to retrieve. Objective: The objective of this work is to extract from the experience of the MVM development and software certification a set of lessons learned and then guidelines that can help developers to produce safety-critical devices in similar emergency situations. Method: We conducted a case study. We had full access to source code, comments on code, change requests, test reports, every deliverable (60 in total) produced for the software certification (safety concepts, requirements specifications, architecture and design, testing activities, etc.), notes, whiteboard sketches, emails, etc. We validated both lessons learned and guidelines with experts. Findings: We contribute a set of validated lessons learned and a set of validated guidelines, together with a discussion of benefits and risks of each guideline. Conclusion: In this work we share our experience in certifying software for healthcare devices produced under emergency, i.e. with strict and pressing time constraints and with the difficulty of establishing a heterogeneous development team made of volunteers. We believe that the guidelines will help engineers during the development of critical software under emergency.

Mechanical Ventilator Milano (MVM):A Novel Mechanical Ventilator Designed for Mass Scale Production in response to the COVID-19 Pandemics

We present here the design of the Mechanical Ventilator Milano (MVM), a novel mechanical ventilator designed for mass scale production in response to the COVID-19 pandemics, to compensate for the dramatic shortage of such ventilators in many countries. This ventilator is an electro-mechanical equivalent of the old, reliable Manley Ventilator. Our design is optimized to permit large sale production in short time and at a limited cost, relying on off-the-shelf components, readily available worldwide from hardware suppliers. Operation of the MVM requires only a source of compressed oxygen (or compressed medical air) and electrical power. The MVM control and monitoring unit can be connected and networked via WiFi so that no additional electrical connections are necessary other than the connection to the electrical power. At this stage the MVM is not a certified medical device. Construction of the first prototypes is starting with a team of engineers, scientists and computing experts. The purpose of this paper is to disseminate the conceptual design of the MVM broadly and to solicit feed-back from the scientific and medical community to speed the process of review, improvement and possible implementation.