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by OnlineCourage
2289 days ago
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You don't get to, "not buy the argument," because R&D costs are constrained by layers of unimaginably complex legislation and compliance. The company had to jump through ridiculous hoops for every component of said machine. Until you pull out the book and say, "Nope, see here Section 93...they did not have to do X, it's needless," you don't really have a good counterpoint because this is the case for all medical equipment. You can't just out of the blue say, "Yeah but not this one!" The entire medical regulatory and compliance system is overly complex. You're making the $10000 toilet seat argument...yeah, well the toilet seat needed to be delivered to a highly regulated aircraft. Ironically those $10,000 toilet seats are now $300 because they are 3d printed. |
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https://www.medtronic.com/covidien/en-gb/products/mechanical...
So why is a valve $10k? Note that a replacement battery for the above ventilator costs < $1k.
Is the valve a disposable part (at 20% cost of the whole unit?) Is it some special valve that is the core IP (that other medical valves can't replace?) Is it made from some special material? Do they have to make each one from scratch? Does individual certification cost a fortune (and maybe this is a fixed cost regardless of what you're testing)? How much does a similar replacement valve cost for a similar ventilator?
Bear in mind that $10k implies a $3k cost to the company, at a typical hardware engineering markup.
I don't think we can handwave "Rnd" or some mystical "compliance" cost without knowing more details.
Seems like a valve for anaesthesiology is a Class II medical device, which may be a start?
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...