Earlier quoted context omitted.
I think you are a bit confused about the position the country is in right now. Regulations and regulators can and will be damned in an emergency. Of course, all reasonable precautions should be taken when producing medical equipment. But if someone needs a ventilator, they are going to die without it. It doesn't matter that there is a small chance that complications arise or some flaw in the ventilator causes it not…
I agree that we are in a unprecedented situation but I am not sure that the regulations will just be “damned”.
GM’s CEO Offers to Make Ventilators in WWII-Style Mobilization
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Re: GM’s CEO Offers to Make Ventilators in WWII-Style Mobilization
#152Earlier quoted context omitted.
I think you can take this analogy too far. If I were to do so, I'd say that the OP is suggesting that Pearl Harbor was attacked, the President said it was no big deal, just one Japanese plane, and the country collectively twiddled their thumbs while the enemy advanced.
True. Not sure why everything is always compared to a war in any case? We have a war on this, a war on that. You can compare anything to a war, but that doesn't mean you're going to get useful insights out of the exercise. I mean, yeah, I suppose it's Pearl Harbor is attacked and we twiddled our thumbs, but what insights useful right now in dealing with this virus does that comparison uncover? It's kind of just noise…
Re: GM’s CEO Offers to Make Ventilators in WWII-Style Mobilization
#153Manufacture 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. I'd like to think t…
I think you are a bit confused about the position the country is in right now. Regulations and regulators can and will be damned in an emergency. Of course, all reasonable precautions should be taken when producing medical equipment. But if someone needs a ventilator, they are going to die without it. It doesn't matter that there is a small chance that complications arise or some flaw in the ventilator causes it not…
That being said, auto manufacturers likely have no experience manufacturing these devices. The don't know which optimizations will be dangerous. They may not recognize they are doing anything different from an experienced manufacturer.
When quality breaks down, it will be important to have appropriate records to know which other devices are also defective so that they can be replaced, repaired, or used with appropriate caution. If manufacturing is still ongoing, corrective action in the manufacturing plant will be needed. GxP regulations require this type of record keeping for very good reason.
An experienced manufacturer will be needed to get manufacturing going and to supervise it to ensure it has an acceptable level of quality. Even if the experienced medical device manufacturer has legal indemnity, failures of the temporary factory could stain its reputation. I find it unlikely that any reputable medical device manufacturer would want to take on supervision of an inexperienced workforce in an unproven facility without the force of the regulation they are accustomed to as a means to force behavior that they know leads to predictable outcomes. Surely, experienced members of a quality organization and the FDA will figure out how to right-size some of the practices called for by regulation.
Re: GM’s CEO Offers to Make Ventilators in WWII-Style Mobilization
#154Earlier quoted context omitted.
At the risk of being argumentative I would point out that many Americans died unnecessarily at the beginning of WWII as well. This is a common pattern in wars.
I think you can take this analogy too far. If I were to do so, I'd say that the OP is suggesting that Pearl Harbor was attacked, the President said it was no big deal, just one Japanese plane, and the country collectively twiddled their thumbs while the enemy advanced.
Re: GM’s CEO Offers to Make Ventilators in WWII-Style Mobilization
#155Manufacture 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. I'd like to think t…
Re: GM’s CEO Offers to Make Ventilators in WWII-Style Mobilization
#156Meanwhile, actual ventilator manufacturers are not getting many orders: https://www.washingtonpost.com/health/2020/03/18/ventilator-...
Right, because no one has stepped up to write a check. Hospitals are businesses, they're not going to do this on their own. GM is a business, they're not donating those ventilators, they're trying to make a sale into a new market. States, most of them, can't do it because their budgets are fixed by their constitutions and they can't take a loan or write a bond without a referendum. There's basically one entity in thi…
Re: GM’s CEO Offers to Make Ventilators in WWII-Style Mobilization
#157To everyone saying "great, but why didn't this start months ago?" Well, sure, but the second best time to start is now.
Re: GM’s CEO Offers to Make Ventilators in WWII-Style Mobilization
#158Earlier quoted context omitted.
I think you are a bit confused about the position the country is in right now. Regulations and regulators can and will be damned in an emergency. Of course, all reasonable precautions should be taken when producing medical equipment. But if someone needs a ventilator, they are going to die without it. It doesn't matter that there is a small chance that complications arise or some flaw in the ventilator causes it not…
Sure, the regulatory regime needs to be relaxed to quickly bring on more manufacturing capacity. I believe it will be. Throwing it out entirely and allowing anybody to manufacture and sell medical devices from their garage is not going to happen. That being said, auto manufacturers likely have no experience manufacturing these devices. The don't know which optimizations will be dangerous. They may not recognize they…
Given that this is a crisis, the existing ventilator manufactures need to send over a couple experienced ventilator engineers to help.
Re: GM’s CEO Offers to Make Ventilators in WWII-Style Mobilization
#159Earlier quoted context omitted.
Nonetheless ramping up supply still solves the problem by driving prices down
If any of them have half a brain, they are maintaining their regular prices and ramping up production and stockpiling them for the inevitable demand in a few more weeks.
Re: GM’s CEO Offers to Make Ventilators in WWII-Style Mobilization
#160Earlier quoted context omitted.
Elon Musk does not owe people anything. If he decides to produce them, that's fine, but he doesn't have to. But the governments should buy these ventilators from private companies, so private companies like Tesla or GM were incentivized to produce these ventilators. Edit: added and then removed a comment about downvotes
> if you decided to downvote, please at least explain why. Because I don't believe lefts conquered the HN. I downvoted because you assumed it was the “lefts” who were downvoting you.
What are the conditions on being able to downvote ?