COVID-19
Accelerated Ventilator Development:
Questions to Consider
The COVID-19 pandemic has triggered numerous efforts to develop new ventilator designs for emergency production. This has been widely reported within the UK, with various consortia setting out to produce designs for the UK market, as well as several groups in industry and academia looking to develop designs for use abroad.
It is apparent that some of these projects are spear-headed by non-medical-industry companies or academic groups which are likely to have little or no experience of the detail of medical device development in an industrial or commercial context.
Nurtured Revolution has published this white paper, intended as a primer to help those diving into the medical space for the first time to understand the array of industry-specific aspects that need consideration in such an accelerated development. It is recommended reading for leaders of projects still in their early stages.
Last updated 14 April 2020
Useful resources
The following resources may also be of use to those developing ventilators or other equipment in response to COVID-19. While some of these are focused on the UK, the principles may be applicable to other markets where less guidance is available.
Guide on Human Factors design of ventilators for COVID-19:
Formative usability testing protocol for ventilators submitted to UK MHRA:
MHRA’s industry guidance on COVID-19 in the UK – see Medical Devices section for specifications for ventilators and CPAP systems and information on regulatory exemptions:
https://www.gov.uk/government/collections/mhra-guidance-on-coronavirus-covid-19
Various relevant standards are being made available free of charge:
· https://www.bsigroup.com/en-GB/topics/novel-coronavirus-covid-19/ventilators/
Free chat group and Slack resource, somewhat focused on devices for the USA:
UK government letter regarding legal indemnity for Rapidly Manufactured Ventilator Systems: