Too bad you got junked. This was a major complaint from folks Peter Attia had on that trying to take a drug etc to market can cost hundreds of millions and years through the FDA process. It actually could have been David Sinclair that was saying that but I might be mistaken.
I'm sure the cost of these valves are not in the production but in the research of coming up with the design to produce and other things before production. So they price in order to recoup already spent money and get some profit on it too. For sure it doesn't cost them 11k to make.
Valves are mature technology. The expense to develop it is negligible. The expense to push it through regulatory apparatus might not be.
Most likely it is a trivial variation on an already approved design, varied solely for the purposes of obtaining a new patent, and of getting an exclusive requirement for it to be used on the machine.
There is no defensible reason to presume good faith on the part of a medical equipment manufacturer, even though a few do have it.
> There is no defensible reason to presume good faith on the part of a medical equipment manufacturer, even though a few do have it.
I agree and I also think it's incredibly shitty of a medical company to threaten to sue in these trying times. Really exposes what they are all about. I was just trying to see the coin from the other side, trying to understand.
Then maybe they can help them setup a way to license the 3D model so hospitals can print it themselves, but still pay. Whatever the price components are, clearly some innovation is needed here if there are not enough of these in hospitals.
"Maybe together they can cut production costs so this life saving equipment doesn't have to be sold for $11,000
It's not the unit cost, it's the R&D that's expensive.
The $5000 screwdriver definitely is a thing, if you need 5 Engineers to design it but only ever make 5 of them, to be used on the Space Shuttle for example.
For drugs, it's something like $2 billion up front before you sell a single pill. For medical devices it's not as much, but still can be in the tens to hundreds of millions.
Where did this company "threaten" to sue? All I can find is the following source
"Now, despite the country battling an unprecedented health crisis, there is potential for a legal battle with local media reporting that the manufacturers of the valves are refusing to share their blue print for further production and could potentially sue for copyright breaches."
> However, when the pair asked the manufacturer of the valves for blueprints they could use to print replicas, the company declined and threatened to sue for patent infringement, according to Business Insider Italia. Fracassi and Ramaioli moved ahead anyway by measuring the valves and 3D printing three different versions of them.
> Lui e i suoi collaboratori si sono recati in ospedale a Chiari ieri mattina (venerdì, ndr) e dopo aver chiesto all’azienda produttrice i file 3D per stamparli e aver ricevuto risposata negativa – anzi hanno ricevuto anche minacce di denuncia per violazione brevetto
Basically doesn't add anything - the company isn't named.
It's a really nice story though, a bright spot in very dark times.
This article feels like low quality clickbait to me. The company isn’t even named, and there’s no source given for the claim that a lawsuit was threatened.
At least in the US, I believe so long as you do not sell or transfer items, you can make them for your own use without licensing the patent. To win a law suit, the company would have to "show harm". They can't. They lost exactly zero sales.
May be having the inability to produce for the required (life-saving) demand should invalidate the “lost sales” argument. Anyways, wait for the deaths to mount and they will all come around in fear of retribution
Rough translation: Cannot punish someone for something if he did it to save himself or others from a grave damage, due to a danger he did not cause voluntarily, and not avoidable in other ways, if the thing done is proportional to the danger
Plus lets be honest (not sure if civil law still has jury trials), NO jury, not even if they imported a single person from several random countries would convict them. Not a single one.
FM is between parties to a contract. FM clauses allocate the risk of unforeseen events to the parties as per the language in the contract.
If FM is in play at all, it would probably protect the manufacturer by relieving it of its promise (if any) to provide the valves.
Note, I have no idea how contract law works in Italy or the EU.
However, in this case, there is probably an Italian or EU law that shields the hospital from liability. Especially if the hospital is part of a government health system. (The US has such laws)
I think you are wrong. The key I think is "for use". If you made patented item and are using it you can get sued. Of course nobody really gonna chase an individual but officially you can not.
35 USC 271: Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.
In the US a patent holder can absolutely exclude you from making or using their patented inventions.
However, the US gov can infringe at will without any court orders or special laws.
If a US gov agent (any low level CDC or health agency employee could do it) told the hospital to print valves, there is nothing the patent holder can do about it except get paid for the value of the valves sometime later.
$11,000 for a plastic valve. Unreal. No wonder hospitals are always stretched to the limit when they're being gouged like this.
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?
> 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.
Except, that the 3D printer plastic might not hold up to the medical grade plastic and might cause system wide infections that hadn't been accounted for culminating in a brain or spinal infection that leaves a person in a coma for the rest of their painful life while the family watches. The family then Sue's malpractice, doctor's lose their medical license and hospitals lose millions which could go to treat patients. Hypotheticals can go both ways.
Yes, this is a difficult decision. If you were a doctor what would you do? Let the patient die today, or try the newly 3D printed valve that looks and feels like the real one but may have unintended side effects?
As opposed to not having a valve at all? The hospital wouldn't need knockoff valves if they had the real thing. In such dire circumstances I don't think any judge would fault you for going the unconventional route to deliver results. It's similar to how captains on boats and airplanes are allowed to break almost any regulation in the book to ensure the safety of their passengers.
This. I have set this policy as the first rule of our SRE response teams to make it clear the broad extent of their power. Because it’s our written policy, it’s incorporated into our PCI and SOX compliance programs as well. The auditors don’t always love it, but we’ve always gotten them to understand.
> On top of that, you have to account for the potential lawsuit if your 3D-printed knockoff respirator valve fails and someone dies.
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.
> Where does this meme that companies get sued for parts made by completely independent third parties come from?
"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.
It's not $11,000 for a plastic valve. It's $11,000 for a plastic valve and the many thousands of hours of R&D, testing, validation, certification and risk.
And risk getting sued by extremely well funded corporations protected by broad scope patents. It may well be the case that it is prohibitive to get proper regulatory approval to sell such a device.
you forgot all the medical savings groups(cartels) that won't buy from you because they're paid commission that the hospitals have contracts with so they can't buy from you.
Ventilators are early 1900s technology. You're not *going to "get sued" for a basic unit.
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?
I've seen up close how medical devices are made. I've also been in a softdrink bottling plant. Based on those experiences I think your chances of acquiring some disease from a softdrink vs acquiring one from a medical device are about equal.
Coke cans don’t have the same regulatory hurdles and moreover there your coke can R&D is amortized over something like a trillion units. There’s a real argument for why this lawsuit is dumb, but this ain’t it.
Let's say the regulatory costs add up to $100,000,000 and the valve has a marginal cost of $1.00 to make and distribute. They would have to sell just 10,000 units to more than offset their investment. I think I'd wager the world needs more than 10,000 air valves.
How can one justify this kind of vicious exploitation of publicly funded healthcare?
"Let's say the regulatory costs add up to $100,000,000 and the valve has a marginal cost of $1.00 to make and distribute."
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.
The very likely overpriced. The healthcare industry made over $100 billion in the US only in 2018. I've experienced it first hand, UCSF tried to force me into buying a ($174) kneebrace for over $2400...
And the fact that they are threatening to sue for something they couldn't sell is disgusting.
“People don’t understand the development costs” sounds like intellectual onanism to me. You don’t know the cost of development yourself.
If you want people to understand, provide better numbers instead of masturbating harder.
In the meantime medical equipment executives have garages of luxury cars and mansions on Majorca. That money came from people seeking treatment for life threatening conditions.
I seriously doubt any critical medical part can be made for $1. If that part fails, there are likely serious consequences for the patient. Sure the plastic is cheap, but the manufacturer will likely do several expensive steps to reduce the failure rate:
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.
What specifically is this valve for? A lot of medical equipment is surprisingly low volume. The UK for instance has 5000 ventilators in the entire country. Ventec was interviewed on NBC News this evening, they said they normally produce 150 ventilators per month.
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.
> It's not $11,000 for a plastic valve. It's $11,000 for a plastic valve and the many thousands of hours of R&D, testing, validation, certification and risk.
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.
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.
> 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.
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.
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.
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?
> 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.
Seriously, unless the inside of that value is really, really, really complex, I can't imagine it would take that much R&D, relative to the rest of the machine. I would think relative to that, this value was dead trivial.
I wouldn’t feel too bad for the hospitals. They are happy to mark up prices by an outrageous amount. My company does medical devices. One device goes for around 20k to the hospital. I have heard that the hospital often charges 80-100k for the device plus the cost for doctors and facility which is often another 50k or more.
This was an Italian hospital, not an American one. Devices and drugs are dispensed at cost, or lower, and that number often comes out considerably less than the public list price.
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.
For what it worth the company might loose rights for their patent if it can be proven that it does not perform due diligence (chasing violators being one example).
"A patent owner (patentee) may be precluded from enforcing its patent against an alleged infringer after a period of time from the first notice identifying the patent and possible infringement (e.g., 4 ½ years) if the following conditions are met:
Misleading Conduct/Silence: The patent owner, through misleading conduct (or silence), leads the alleged infringer to reasonably infer that the patentee does not intend to enforce its patent against the alleged infringer (e.g., by sending a cease-and-desist letter followed by years of silence);
Reliance: The alleged infringer relies on that conduct; and
Prejudice: The alleged infringer will be materially prejudiced if the patent owner is allowed to proceed with its claim (e.g., alleged infringer has continued selling and expanding product lines).
This legal doctrine known as patent equitable estoppel applies on a case-by-case basis to each patent asserted by the patent owner. Therefore, a patent owner may have other patents to enforce which may not be barred by equitable estoppel." - http://www.patenttrademarkblog.com/consequences-of-patent-ow...
Again I am getting downvotes for reporting facts. I guess mob opinion rules.
Did I ever say I like the situation? We are literally surrounded bu stupid and sometime outright criminal (in a normal human sense) laws. Civil forfeiture alone - whoever came up with this brilliant idea deserves a jail time. Go call them a-holes. Feels better?
> A medical device manufacturer has threatened to sue a group of volunteers in Italy that 3D printed a valve used for life-saving coronavirus treatments. The valve typically costs about $11,000 from the medical device manufacturer, but the volunteers were able to print replicas for about $1 (via Techdirt).
Which company is suing over the 3D-printed valves? We need to name and shame. If we're unwilling to call out monopolists putting profits over even human life, then we, too, are complicit.
On another note, I'm of the increasingly-strong belief that patent suits should be deemed automatically dismissed if the "infringement" is a response to either an inability or unwillingness of the patent holder to actually use that patent productively (i.e. produce something using that patent). In this case, if the original manufacturer is out of stock, 3D printing replacements should be fair game. Likewise, if we don't have enough testing kits, making and distributing more should be fair game.
This part seems less than optimally ethical. If it's a choice between helping other hospitals to save lives and to avoid additional legal liability, this seems like a good hill to go bankrupt on.
But...if someone slipped the file to me I wouldn't publish it either. So I can't fault them for being as faulty as me.
This is adding nothing new over the previous BusinessInsider piece. It's just reporting (again) that this company asserted patent rights after the hospital and the 3D-printing firm requested the design in .STL format due to being unable to secure supplies in an unprecedented emergency. Which is what we knew already.
People are quibbling about money while millions of lives are at stake. We need tens of thousands of these medical devices and we need them fast. Like in the coming weeks.
If companies who suddenly find themselves in a strategic position don't get what they need to do, then the Government needs to take control using emergency powers, and use any available production capacity in the country to ramp up production, fast.
We'll also need to do many other things. We should adopt a wartime mentality, focus on solving the problems at hand, and stop wasting time. At least in Italy they get this now.
Having seen the prices charged for drugs and how they then calculate future prices (after the R&D costs have been recovered), I have a very sceptical view of any comments that say we need to consider R&D and regulatory cost recovery before complaining about the prices being charged for anything in the medical technology field. Having also discussed what was seen by someone I know who left the corrupt world of advertising to go to the medical technology world, I also consider anybody saying the same about recovery of R&D and regulatory costs to either being a liar or deluded. The gentleman in question went back to the advertising world because they were innocent children compared to the corruption and price gouging that went on inside the medical technology industries.
There is a captive market here and the seller can sell at any price they want and make any markup they want because they can. There are some very honourable people and companies who do not price gouge in the field. But it seems that these are a very small minority.
Now mind you, this kind of price gouging occurs anywhere there is a captive market. But some industries are more susceptible to it than others.
I'd like to see them try. To sell this kind of critical equipment to Italian hospitals you have to guarantee there will be no shortages even (especially) in critical conditions. They failed to uphold their part of the bargain with the country and at this moment both the government and the people are very short on patience. Probably, if they even try to sue the volunteers they are going to lose all their contracts with Italian hospitals in a matter of days.
Let them threaten. This is newsworthy when they actually sue. It would also require them to go on the record, with their names and the names of their executives and lawyers on full display. My money would be on that not happening.
I'm all for letting companies have a limited monopoly on innovations, but this just seems short-sighted. It's the kind of behavior that gets nations to pass something like "medical necessity" legislation allowing them to infringe patents under certain circumstances, or impose profiteering and price gouging statutes, or re-thing all of their health care systems' compensation levels for equipment & procedures. It's the sort of thing that can raise public ire against the entire medical device industry.
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[ 4.1 ms ] story [ 206 ms ] threadProduction costs don't really enter into it. The actual breakdown is probably more like:
Production costs: $25 FDA approval: $100 million dollars
This site has turned into a tech-flavored subreddit of Think Progress.
Most likely it is a trivial variation on an already approved design, varied solely for the purposes of obtaining a new patent, and of getting an exclusive requirement for it to be used on the machine.
There is no defensible reason to presume good faith on the part of a medical equipment manufacturer, even though a few do have it.
I agree and I also think it's incredibly shitty of a medical company to threaten to sue in these trying times. Really exposes what they are all about. I was just trying to see the coin from the other side, trying to understand.
It's not the unit cost, it's the R&D that's expensive.
The $5000 screwdriver definitely is a thing, if you need 5 Engineers to design it but only ever make 5 of them, to be used on the Space Shuttle for example.
For drugs, it's something like $2 billion up front before you sell a single pill. For medical devices it's not as much, but still can be in the tens to hundreds of millions.
"Now, despite the country battling an unprecedented health crisis, there is potential for a legal battle with local media reporting that the manufacturers of the valves are refusing to share their blue print for further production and could potentially sue for copyright breaches."
So they may have the option to sue?
Which links to https://it.businessinsider.com/coronavirus-manca-la-valvola-..., in Italian, and I don't understand Italian.
"having received a negative remarry - indeed they also received threats of complaint for patent infringement"
Coming from Massimo Temporelli, so checks out
Wat?
> risposata negativa
"Risposata" is "remarry." Presumably they wanted "risposta," which is "response." Probably just a typo.
I guess the parent post was to illustrate in a humorous manner the limitations of machine translation.
Basically doesn't add anything - the company isn't named.
It's a really nice story though, a bright spot in very dark times.
I think "Necessity" is more applicable https://en.wikipedia.org/wiki/Necessity_(criminal_law)
In italian: "Stato di necessità" https://it.wikipedia.org/wiki/Stato_di_necessit%C3%A0
Rough translation: Cannot punish someone for something if he did it to save himself or others from a grave damage, due to a danger he did not cause voluntarily, and not avoidable in other ways, if the thing done is proportional to the danger
(IANAL)
FM is between parties to a contract. FM clauses allocate the risk of unforeseen events to the parties as per the language in the contract.
If FM is in play at all, it would probably protect the manufacturer by relieving it of its promise (if any) to provide the valves.
Note, I have no idea how contract law works in Italy or the EU.
However, in this case, there is probably an Italian or EU law that shields the hospital from liability. Especially if the hospital is part of a government health system. (The US has such laws)
Here: "US law is more strict. It forbids anyone from making, using or selling the invention, even when the use is strictly personal." - https://www.iusmentis.com/patents/crashcourse/rights/
35 USC 271: Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.
https://www.law.cornell.edu/uscode/text/35/271
(July 19, 1952, ch. 950, 66 Stat. 811; Pub. L. 98–417, title II, § 202, Sept. 24, 1984, 98 Stat. 1603; Pub. L. 98–622, title I, § 101(a), Nov. 8, 1984, 98 Stat. 3383; Pub. L. 100–418, title IX, § 9003, Aug. 23, 1988, 102 Stat. 1563; Pub. L. 100–670, title II, § 201(i), Nov. 16, 1988, 102 Stat. 3988; Pub. L. 100–703, title II, § 201, Nov. 19, 1988, 102 Stat. 4676; Pub. L. 102–560, § 2(a)(1), Oct. 28, 1992, 106 Stat. 4230; Pub. L. 103–465, title V, § 533(a), Dec. 8, 1994, 108 Stat. 4988; Pub. L. 108–173, title XI, § 1101(d), Dec. 8, 2003, 117 Stat. 2457; Pub. L. 111–148, title VII, § 7002(c)(1), Mar. 23, 2010, 124 Stat. 815.)
However, the US gov can infringe at will without any court orders or special laws.
If a US gov agent (any low level CDC or health agency employee could do it) told the hospital to print valves, there is nothing the patent holder can do about it except get paid for the value of the valves sometime later.
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?
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.
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.
If you want people to understand, provide better numbers instead of masturbating harder.
In the meantime medical equipment executives have garages of luxury cars and mansions on Majorca. That money came from people seeking treatment for life threatening conditions.
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.
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.
"A patent owner (patentee) may be precluded from enforcing its patent against an alleged infringer after a period of time from the first notice identifying the patent and possible infringement (e.g., 4 ½ years) if the following conditions are met:
Misleading Conduct/Silence: The patent owner, through misleading conduct (or silence), leads the alleged infringer to reasonably infer that the patentee does not intend to enforce its patent against the alleged infringer (e.g., by sending a cease-and-desist letter followed by years of silence); Reliance: The alleged infringer relies on that conduct; and Prejudice: The alleged infringer will be materially prejudiced if the patent owner is allowed to proceed with its claim (e.g., alleged infringer has continued selling and expanding product lines). This legal doctrine known as patent equitable estoppel applies on a case-by-case basis to each patent asserted by the patent owner. Therefore, a patent owner may have other patents to enforce which may not be barred by equitable estoppel." - http://www.patenttrademarkblog.com/consequences-of-patent-ow...
Again I am getting downvotes for reporting facts. I guess mob opinion rules.
1. provided the STL files for the plastic valve when the hobbyist 3D printer asked for them
2. granted a no-cost patent licence.
That way the requirement by law to defend the patent does not arise in the first place.
What's the name of the manufacturer?
You're wrong. We're not living in some capitalist cartoon. Even the greediest CEO doesn't want to be a villain in a lifesaving story like this.
https://patents.google.com/patent/EP1852137B1/en
Which company is suing over the 3D-printed valves? We need to name and shame. If we're unwilling to call out monopolists putting profits over even human life, then we, too, are complicit.
On another note, I'm of the increasingly-strong belief that patent suits should be deemed automatically dismissed if the "infringement" is a response to either an inability or unwillingness of the patent holder to actually use that patent productively (i.e. produce something using that patent). In this case, if the original manufacturer is out of stock, 3D printing replacements should be fair game. Likewise, if we don't have enough testing kits, making and distributing more should be fair game.
This part seems less than optimally ethical. If it's a choice between helping other hospitals to save lives and to avoid additional legal liability, this seems like a good hill to go bankrupt on.
But...if someone slipped the file to me I wouldn't publish it either. So I can't fault them for being as faulty as me.
If companies who suddenly find themselves in a strategic position don't get what they need to do, then the Government needs to take control using emergency powers, and use any available production capacity in the country to ramp up production, fast.
We'll also need to do many other things. We should adopt a wartime mentality, focus on solving the problems at hand, and stop wasting time. At least in Italy they get this now.
The system itself is broken and should be abolished, as has been long and well argued.
The rules are basically if lives are in danger, anything goes.
There is a captive market here and the seller can sell at any price they want and make any markup they want because they can. There are some very honourable people and companies who do not price gouge in the field. But it seems that these are a very small minority.
Now mind you, this kind of price gouging occurs anywhere there is a captive market. But some industries are more susceptible to it than others.
[1] https://craphound.com/overclocked/Cory_Doctorow_-_Overclocke....
[2] E-book download: https://www.gutenberg.org/ebooks/19000
Their is no way this valve cost $11,000. A quick google search for PEEP valves for respirators sow that they sell for a few dollars, 20 at most.
It seems unlikely that any company would sue in such circumstances, it would be a PR nightmare.
If the story was true prices would most likely be listed in euros.
When this 3d printed valves story appeared a few days ago those exact figures were cited on Reddit as a joke.
How they ended up presented as "Facts" on TheVerge is anyone's guess.