Think of it this way, a hospital could buy 10 valves or hire a physician for a year. Are these valves typically re-used? Are they going through them faster because they don't want to risk infecting other people?
Either which way, typical healthcare profiteering is not going to end well here. There is simply too much on the line to allow people to block or threaten progress.
And yeah, it costs a ton of money to get regulatory approval.
So where do you think all that money comes from? Think maybe they have to build that into the price of the ventilator, so maybe it's not so "overpriced" at all? Maybe?
How can one justify this kind of vicious exploitation of publicly funded healthcare?
My point is that people saying that it is overpriced don't understand the input costs of medical devices.
That's two numbers relating to the cost of production. The second is the cost that a 3D printer doing one off prints actually costs (it's in the article, as a rough estimate.) The first number is a deliberately chosen "insane" example figure to show the absurdity of an $11,000 part. A medical test n license for a single part of a device does not cost anything like $100M.
Now as to the market for these things - the third number. Nearly 8,000 people have died so far. I can't be arsed to extrapolate further but I recall reading that these are single use devices.
And the fact that they are threatening to sue for something they couldn't sell is disgusting.
Each part is traceable from all raw materials to finished product
Each part is manually tested/calibrated
Each part may be tested with non-destructive testing (x-ray, ultrasound, dye crack inspection etc)
For every lot of parts, several parts will be tested destructively
Each part comes with liability, so the manufacturer will likely purchase liability insurance
Also, the regulatory costs are paid years in advance of a single unit being sold. Once the device is approved (that is, if it's approved at all), the units are sold slowly over years. So the regulatory costs must be financed.
Absolutely. Why does the "financing" in this case have to go through a hospital's purchasing department? The obvious reason for why they charge such incredible amounts per unit is because they can. If there was any amount of competition or marketplace for it, it would be cheaper. There clearly isn't.
Explain to me how this way of doing things is not holding the public hostage.
Seems like these things that were 3D printed could be. At least at a marginal cost.
There are tons of medical devices that are low enough volume that most hospitals don't even have a single unit. There's a reason why we have hospitals with varying levels of status, capabilities, and specialties. There are fairly common surgeries that require equipment that only exists in 2 or 3 digit quantities in the entire world.
They are hideously expensive because so few are bought.
Nope. Sorry. Not buying that argument this time. I accept that argument for patent exclusion periods and high prices on medication, because the R&D has enormous risk costs when medications don't work or don't get approval. Allowing pharmaceutical companies to recoup those costs is vital to innovation and public health. This is a piece of plastic that's part of a larger machine. There was no enormous R&D budget required to develop the replaceable component. By all means let them make money on the machine, but the argument doesn't hold up for this simple maintenance component.
Are you sure about this? Just because it is one small part of a complex device doesn't make it low cost.
> By all means let them make money on the machine
Ok...so the machine becomes (for example) $1m instead of $10k. The financial cost to use the machine remains the same.
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.
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.
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...
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.
On top of that, you have to account for the potential lawsuit if your 3D-printed knockoff respirator valve fails and someone dies.
In that case, the alternative was a few people over there going to die by slow asphyxiation, so the 3D-printed knockoffs were a really good thing, even if some of them failed.
The aviation law: https://www.law.cornell.edu/cfr/text/14/91.3
Where does this meme that companies get sued for parts made by completely independent third parties come from?
The most obvious reason that wouldn't be true is that without a patent on the part or similar, companies generally have no right to prevent third parties from making replacement parts for their equipment. It would be pretty silly to impose liability for something they have no control over.
"Meme"?
Where does your your that malpractice lawsuits are just "memes" come from? Because I can assure you that they exist in the real world. As do massive fines for using equipment that hasn't been FDA approved.
From then on, which should be like after a week, every single dollar is profit.