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Guidelines for the development of a critical software under emergency.

Andrea Bombarda1, Silvia Bonfanti1, Cristiano Galbiati2,3,4

  • 1Department of Management, Information and Production Engineering, University of Bergamo, Bergamo, Italy.

Information and Software Technology
|September 12, 2022
PubMed
Summary

This study shares lessons learned and guidelines for developing critical medical devices, like the open-source mechanical ventilator (MVM), during emergencies. These insights aid engineers in creating safety-critical healthcare technology under pressure.

Keywords:
GuidelinesHealthcareLessons learnedSafety–critical systems developmentSoftware certification

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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.