Guidelines for the development of a critical software under emergency.

Area of Science:

• Medical Device Development
• Software Engineering
• Public Health Technology

Background:

• The COVID-19 pandemic necessitated rapid development of critical medical devices.
• An international team created an open-source, low-cost mechanical ventilator (MVM) for intensive care units, suitable for resource-limited settings.
• The project faced challenges typical of emergency development: time constraints and a heterogeneous volunteer team.

Purpose of the Study:

• To extract and validate lessons learned from the MVM development and software certification process.
• To provide practical guidelines for engineers developing safety-critical medical devices in emergency situations.
• To share experiences in certifying healthcare software under strict time pressures.

Main Methods:

• A comprehensive case study was conducted.
• Access was granted to all project deliverables, including source code, documentation, and communication records (60 total).
• Lessons learned and guidelines were validated through expert review.

Main Results:

• A validated set of lessons learned from the MVM project.
• A validated set of practical guidelines for emergency medical device software development.
• Discussion of the benefits and risks associated with each guideline.

Conclusions:

• The experience highlights the feasibility of developing and certifying critical medical devices under emergency conditions.
• The shared guidelines are expected to assist engineers in future emergency medical device development.
• This work contributes valuable insights into managing software certification for healthcare devices produced rapidly with volunteer teams.