GM’s CEO Offers to Make Ventilators in WWII-Style Mobilization
Manufacture of medical devices has specific regulation around Good Manufacturing Processes [1] (GMP, one of many GxPs).  This requires a Quality Management System [2] (QMS) and very specific training for everyone involved.  Pretty much any manufacturer that is not already manufacturing in accordance with 21 CFR Part 820 [3] and related regulations will have a ton of work to establish a suitable QMS.<p>I&#x27;d like to think that at least some auto workers already have some taste of working under the eye of regulators and auditors and as such their adjustment to GMP has the potential to be smooth.  The days of leaving empty beverage containers in the hollow of a door are long past, right?<p>Management that is not experienced in FDA regulations will try to ignore or short-cut them.  In the best of cases, this turns into fines and manufacturing delays.  In the worst of cases, it turns into deaths due to defective product or manufacturing delays.  Every level of management needs to be experienced in GxP.<p>The most reasonable path to getting a QMS in place and having compliant manufacturing would seem to be to have the manufacturing capacity be leant to an established manufacturer that has a solid QMS, the expertise to adapt it to the new reality, and a solid relationship with the FDA.  That is, the auto manufacturer&#x27;s management would need to be out of the picture or 100% subservient to the experienced medical device manufacturer.<p>Once that is worked out, I suspect that manufacture of the devices is comparatively easy.  Put another way, it&#x27;s probably easier to switch from sedans to tanks than it is to switch from SUVs to almost any medical gizmo.<p>1. <a href="https:&#x2F;&#x2F;en.wikipedia.org&#x2F;wiki&#x2F;Good_manufacturing_practice" rel="nofollow">https:&#x2F;&#x2F;en.wikipedia.org&#x2F;wiki&#x2F;Good_manufacturing_practice</a>
2. <a href="https:&#x2F;&#x2F;en.wikipedia.org&#x2F;wiki&#x2F;Quality_management_system" rel="nofollow">https:&#x2F;&#x2F;en.wikipedia.org&#x2F;wiki&#x2F;Quality_management_system</a>
3. <a href="https:&#x2F;&#x2F;www.accessdata.fda.gov&#x2F;scripts&#x2F;cdrh&#x2F;cfdocs&#x2F;cfcfr&#x2F;CFRSearch.cfm?CFRPart=820" rel="nofollow">https:&#x2F;&#x2F;www.accessdata.fda.gov&#x2F;scripts&#x2F;cdrh&#x2F;cfdocs&#x2F;cfcfr&#x2F;CFR...</a>