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 attempting to produce designs for the UK market as well as several groups in industry and academia looking to develop designs for use abroad. New projects still continue to emerge, and it is apparent that some of these projects are spear-headed by non-medical-industry companies, volunteer efforts 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.
Medical device development is very complicated, and it is very important to familiarise your team with special considerations that are critical to introducing an appropriately safe and useful device.
I’m publishing a primer on important considerations for those entering the #medicaldevices industry for the first time, in the hope that it may be useful to projects still in their early stages.
Suggested updates to it will be gladly accepted. If you are an expert in this field, please consider reading it with a view to providing review comments.
The paper is available here:
I’m linking to another page rather than direct to the document, so that I can keep the available version updated as any review or new information becomes available.