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Comment by OnlineCourage | Hacker News Reader

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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Nobody has mentioned how much an entire ventilator costs. Best I can find is between $5-50k usd. For example a Puritan Bennett 980 quoted as around $50k (by the manufacturer) with a $2k a year service contract.

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...

> So why is a valve $10k? Note that a replacement battery for the above ventilator costs < $1k.

I'm guessing the valves are single-use (due to contamination), so the cost is passed along to the customer. They can't charge every customer for a battery (I mean, they could prorate it, but that's not how medical billing works). The hospital doesn't care what a valve costs if they're passing-along 100% of the cost to you.

If that is the case, then I have even less sympathy for the manufacturer.

> The entire medical regulatory and compliance system is overly complex.

And big companies take advantage of their position as the only ones who can navigate such a system to justify their sky high prices, and then they lobby to maintain that position.

The valve in question looks to be for IV drug delivery, which is not a new technology. It's probably just a simple check valve.

> And big companies take advantage of their position as the only ones who can navigate such a system to justify their sky high prices, and then they lobby to maintain that position.

This is something most people don't comprehend. People tend to think that it's the government putting in place these regulations and the companies are against them, but more often than not the regulations exist at the behest of the incumbents to constrain competition.

It's hard to climb up, but it's harder to stay at the top, so they put barriers behind once they have reached high enough.

In a sense, it's the government. It's just that, thanks to massive donations, committee stuffing and other shenanigans, they got to write the regulations themselves.

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