[Mahler9th]

Some of the global efforts to expand availability are based on new designs and some on existing designs. I reckon' most are the latter. The former carries significant risk.

In the US, the design and approval process for ventilators is highly regulated. FDA is the agency. The process is too complex to describe easily-- it might be helpful to picture that medical equipment like ventilators (i.e., those in regulatory Class III) go through a process like an airplane or space shuttle.

Pretty much all user training materials like manuals are also reviewed by FDA in the design process.

There are rigorous processes for QC at the end of manufacturing (before units can be shipped).

And don't forget ... units in the field have to be maintained and likely that includes some type or types of calibration. So service folks and in-house biomedical engineers need to be available and trained.

Yes biomedical engineers and manufacturer service folks are also key players in the availability of ICU/ventilator capacity. So it is not just medical folks!

Most folks don't know much about this... I have 40+ years in this industry...