Medical Company Threatens To Sue Volunteers That 3D-Printed Valves for Life-Saving Coronavirus Treatments (theverge.com) 367
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. From a report: The valve typically costs about $11,000 from the medical device manufacturer, but the volunteers were able to print replicas for about $1. A hospital in Italy was in need of the valves after running out while treating patients for COVID-19. The hospital's usual supplier said they could not make the valves in time to treat the patients. That launched a search for a way to 3D print a replica part, and Cristian Fracassi and Alessandro Ramaioli, who work at Italian startup Isinnova, offered their company's printer for the job. 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. Fracassi and Ramaioli moved ahead anyway by measuring the valves and 3D printing three different versions of them.
Quarterly report (Score:5, Funny)
Executive summary:
We achieved and additional $50 in net profit due to rigorous enforcement of our patents. However, the entire R&D staff ultimately died from indirect exposure to coronavirus. We will consider the net ROI determination "pending" for the purposes of this report...
Re:Quarterly report (Score:5, Insightful)
Also, a mob eliminated our C-Level staff and we didn't have to pay the considerable severance packages, netting another 100 millions in profits due to avoided expenses.
They should fire their lawyers (Score:3)
Because if they think there will be any jury or judge sympathetic to their " patents " during a time like this, they're insane.
Lessee:
Saving Patents or Saving Lives
I think I'm going to go with Saving Lives for $500 Alex . . . . . .
Re: (Score:3)
Depends on the life. Their C-Levels or real humans?
Re:They should fire their lawyers (Score:4, Informative)
Global Pandemic takes Precedent (Score:3)
Re:Global Pandemic takes Precedent (Score:5, Insightful)
There's a relatively simple solution. Most nations have laws on the books that allow them to commandeer resources during times of crisis. The message I'd send if I was a government was "Play nice right now and once things have returned to normal you can return to your profiteering ways, or, if you wish to play dirty, you get to explain to your shareholders how, in the national interest, your patents were struck down and any and all manufacturers will be free to use your designs."
In the immortal words of Anthony Hopkins' President Nixon "Presidents don't threaten. They don't have to."
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I know this is a story from
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Most jurisdictions have laws on the books that allow them to commandeer or requisition private property in the event of an emergency. This can mean anything from taking over hotels and arenas, to accessing other private resources. Normally it applies to war or civil unrest, but a pandemic seems to fit the definition well enough.
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What this asshole company deserves:
Use emergency powers to make supplies now while the patent is suspended and "accidentally" over-produce enough to supply demand until the patent expires.
An $11,000 valve? (Score:2)
I have a feeling there are going to be a few very pointed questions about some of these practices after the dust settles. Is there an equivalent Italian term for "Streisand Effect"?
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I think it's Streisando effecto.
But seriously, I surely hope this gets as much attention as the virus itself, and society passes laws to stop this kind of gouging, and with everything medical.
Necessity in an emergency should always win. (Score:5, Insightful)
Necessity in a real life or death emergency should always win out over the law. And if the law doesn't bend then it is the right of the people to make it bend.
Re:Necessity in an emergency should always win. (Score:5, Insightful)
Necessity in a real life or death emergency should always win out over the law. And if the law doesn't bend then it is the right of the people to make it bend.
I think it will in this case. The people 3D printing these things don't seem to be printing them for profit or to avoid buying them at $11K each. Where the company may have lost sales, it was for items they couldn't supply in the first place. Something tells me that the courts will take the situation into account and may find in favor of the complaint, but it won't be for much. After all, the guys doing this are unlikely to be worth anything. Winning a billion dollar suit is meaningless if the loser hasn't a penny to give you and will just go bankrupt.
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Necessity in a real life or death emergency should always win out over the law. And if the law doesn't bend then it is the right of the people to make it bend.
Exactly, 100% correct.
Dear corporations, please listen carefully: When it comes to a saving lives, fuck you, your patents, and your intellectual property. I'll do what I have to do, and you can wrap your lawyers in barbed wire and shove them up your ass.
Medical devices (Score:4, Insightful)
Lives and national security override patents. (Score:3, Informative)
What are the valves for? (Score:2)
You have to dig a little to get any detail. The summary does not explain what the valves are for and neither does the linked article. However one of articles that the linked article links to has this "breathing tubes for an intensive care machine"
I can understand an intensive care machine costing a lot and being worthy of patent protection. However a valve for the tubing of that machine does not seem to be a 10,000 euro item.
Re: (Score:3, Informative)
and to follow up this looks like a better summary of what happened
https://www.businessinsider.co... [businessinsider.com]
Re:What are the valves for? (Score:4, Informative)
ardmhacha noted:
The summary does not explain what the valves are for and neither does the linked article. However one of articles that the linked article links to has this "breathing tubes for an intensive care machine"
I can understand an intensive care machine costing a lot and being worthy of patent protection. However a valve for the tubing of that machine does not seem to be a 10,000 euro item.
The valves in question clearly are disposable parts for medical ventilators (i.e. - devices that inhale and exhale for patients with severely impaired lung function). They'd have to be disposable, because the business end of each valve is stuck down a patient's throat and, even if a particular patient's condition is not infectious (if he/she has end-stage COPD, for instance), they'd still have to be disposable, because, once they've been used, they would no longer be sterile.
That makes the valves "consumables." As for why their list price is so ludicrously high, insurance companies negotiate often-steep discounts from list prices for all kinds of medical consumables, just as they do for medications, so, presumably, the 11K Euro list price is essentially a negotiation tactic: ask for the Moon at the outset, settle for Mare Imbrium to strike the deal.
See also: printer ink cartridges.
(As for why the business end of the ventilator requires a valve, the last thing you want to have happen is to allow the patient's virulently-infectious exhalation to contaminate any part of the actual ventilator - as opposed to the designed-to-be-disposable valve - because you'd then have to destroy the machine itself each time you used one. So the valve prevents back-flow of contaminated air on the exhale part of each breath cycle. All of which is absolutely obvious, if you have any kind of understanding of how a medical ventilator has to be designed for patients' safety ... )
Laywer? (Score:2)
No Valve for you!
NEXT!
Need to create "Good Samaritan" Laws for this case (Score:4)
This is a case where laws have to be put on the books that indemnify people like Fracassi and Ramaioli of FabLabs when they provide products in emergency situations where the OEMs cannot step up.
Invalidate all patents (Score:4, Interesting)
Proper Solution (Score:2)
The Patent for these valves, or anything combating a pandemic are immediately moved to the public domain, at the very least for the duration of a declared emergency. This might be a good idea for all IP needed during a declared emergency.
If any company attempts to enforce a patent at this time, everyone involved... lawyers, patent owners, goto to jail for attempted slaughter... after a trial discovering if they are patent trolling that is.
Same law should be applied to people scalping products. Like that c
Sounds like a massive case of usury. (Score:2)
$11,000 for a piece of plastic that costs $0.11 in mass-production and $1 in the home shop, sounds like usury to me.
Usury when people's life depends on it, too. That borders on murder / failure to render assistance.
Yeah, how about the state takes your company as a first down-payment on your debt, and you go to prison? How does that sound? Or do you prefer being locked up on an island, with angry victims around you, and no laws?
From the sounds of it the solution is simple... (Score:5, Insightful)
Italy WANTED to buy them for 11k but couldn't because the MDM didn't have them.
Volunteers stepped in and supplied them at an effective cost of "free".
Italy still completes their original order and pays the company 11k each. And they replace the 3d printed ones with the MDM ones.
State of emergency folks. Bend over backwards to save lives then fix the economic impact when things clear up.
Re:From the sounds of it the solution is simple... (Score:4, Interesting)
The government healthcare system should set the pr (Score:3)
The government healthcare system should set the price on stuff like this and drugs.
Re:From the sounds of it the solution is simple... (Score:5, Insightful)
Clearly this device should not be $11,000.
Why not just write "I have no experience with designing medical parts or their certification process" It would have been shorter than all of the things you just wrote.
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"It's almost certainly the case that these valves are priced with high margins."
The process to bring something to market is expensive. You can't really count the "per item" cost being 500% or 1000% higher. The funding for stuff like this either needs to come from the government (which means slow, likely more expensive costs out of the public kitty and we also eat the losses for failed device research) or let private industry do it with the promise of limited time patents to recoop the costs. I like the l
Can't sue everyone (Score:3)
Spread the STL file and let everyone with a 3D printer print it.
Can't stop the signal.
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Can't certify medical products without a chain of provenance either. That's how you get things like melamine in baby food, only it would be medication instead.
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This is an emergency, and it's a mechanical device. While normally, one would want a device that has been quality checked etc, it is immediately apparent if/when the device fails and it can be swapped out. In this case it's a choice between using a device that might fail and if the nurses are too busy (imagine that during a huge medical crisis) the failure might ultimately harm or even kill the patient vs without the device the patient WILL die in the next couple hours.
Most people would take might die over
Feel the Bern (Score:5, Insightful)
Now you know why young people vote for Bernie. It's possible more gov't control will just change one set of problems for another, but big corporation dick-hood is at such a shameful level these days that they may no longer be able to bribe their way out of a big political backlash. [politico.com]
Fairly pointless ass covering. (Score:4)
It's not beyond belief that the company that makes these valves could be sued if they helped with the 3D printing effort and to be fair there help wasn't needed.
A threat to sue is a disapproval for 3d printing these valves. I doubt any court would find them liable for the 3d printed valves which they didn't approve , assist and discouraged the manufacture of them.
In practice what court in italy is going to find the 3d printers guilty, it is a national emergency and these valves are being used to save lives. They could apply to a court to stop the valves being 3D printed and no italian judge would grant that order, I doubt any compensation would be paid either other than a nominal amount say 1 euro the cost of producing 1 valve.
I don't blame the company for "defending" their patent, it's necessary for when we return to normality but they haven't a hope of winning a case now.
Faliure of medical capitalism (Score:5, Insightful)
RTFM: Not as in /. headline (Score:5, Informative)
No Threats Involved... RTFA! (Score:3)
Since a quick scan shows everyone in this thread ranting about TFT and TFS...
I actually read TFA and it specifically quotes the guys involved saying:
Romaioli denied they’d received threats. He said the company had simply refused to release design files, forcing them to reverse-engineer the valve. “I talked to an operator who told me he couldn’t give me the files, but after that we didn’t receive anything from the original company — so I can assure you we didn’t get any threat,”
Since they've violated a patent there is indeed the possibility they could be sued and due to the IP involved they had to reverse engineer the part themselves as the company would not provide the blueprints BUT... no actual threats were levied.
Now you can go back to the ranting I so rudely interrupted...
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It appears, that the story received an update some time later, and the update more or less refutes the original story. The update also mentions the name of the medical device manufacturer Intersurgical [intersurgical.com].
Re:Well of course (Score:5, Insightful)
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I guess msmash has yet to bother updating the summary...
Managing director Charles Bellm issued a statement to The Verge:
Just to confirm that recent reports from Italy are totally incorrect, we were contacted at the end of last week for manufacturing details of a valve accessory but could not supply these due to medical manufacturing regulations, we have categorically not threatened to sue anyone involved. The valve is an accessory supplied as part of a CPAP Hood system which alone costs a few euros.
Our Italian company has been doing their utmost to supply the hospitals at this time and have been supplying these free of charge in many cases to use with the CPAP Hoods. It is very disappointing that in the current climate this incorrect information is circulating, our focus as a company is to be able to supply the hospitals that require these and many other vital products and we are making every effort to ensure we can do so.
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I am pretty sure the AC was employing SARCASM, look it up
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And that...is why we have guns.
so you can take more stuff faster?
Re:Well of course (Score:5, Informative)
Nah the guns are due to fear, cowardice and tiny dick overcompensation, ditto the big trucks.
Re:Well of course (Score:5, Insightful)
Re:Well of course (Score:5, Insightful)
Well, it is certainly the Capitalist way, where increasing PROFITS is the be-all and end-all
Re:Well of course (Score:5, Informative)
IP laws are NOT socialist and you are an idiot.
socialism - a political and economic theory of social organization which advocates that the means of production, distribution, and exchange should be owned or regulated by the community as a whole.
Re:Well of course (Score:5, Insightful)
Re:Well of course (Score:5, Insightful)
While causing widespread death in the pursuit of greed does not suck?
You might wish to live in a country run by drug cartels, I would not.
Pretending Big Pharma and drug cartels are not the same is like pretending a "trek through the bush" is different from "a stroll though the countryside" in any other respect than climate and/or racism.
Re:Well of course (Score:5, Insightful)
Socialism... it has been tried... many times... all failures.
really? there are many co-ops that would disagree with you. highways, power grid, water systems, sewer systems, muni-internet are successful examples of socialism in action. If I was to fix your statement, it would look like...
Capitalism... it has been tried... many times... all failures.
Capitol, Labor, Customers are all needed for an economy to function. One part can not hold power over the other two without damaging an economy.
Re:Well of course (Score:5, Insightful)
But those billionaires didn't become billionaires by paying for everyone else.
ignoring your straw man math for the moment, Billionaires became billionaires because of rent extraction via magical financial instruments that suck money out of the economy.
Re: (Score:3, Informative)
Re: (Score:3, Insightful)
Re:Well of course (Score:4, Insightful)
Re:Well of course (Score:5, Insightful)
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There is a difference. There is only one piece of land. So I can use it only if I deprive you of using it. But if I use an idea, that doesn't stop you from using the same idea.
Patents would not exist in either pure socialism nor in a pure libertarian free-market utopia. Patents exist in the middle ground of regulated capitalism, which (so far) is the world's only successful economic model.
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The "failed communism" attempts have nothing to do with communism, but the idea a small group of people can "plan the whole economy". I don't really grasp why you Americans mix definitions. Communism does not mean totalitarian, it does not mean no free market it does not mean no elections. It only means that "means of production" are owned by the society or the state and that everyone gets a worthy minimum wage. That is all, super simple.
Re: Well of course (Score:3)
You don't know what words mean.
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"What the patent and copyright laws acknowledge is the paramount role of mental effort in the production of material values; these laws protect the mind’s contribution in its purest form: the origination of an idea. The subject of patents and copyrights is intellectual property." - Ayn Rand
Source: http://aynrandlexicon.com/lexicon/patents_and_copyrights.html
I do, however, agree that there is nothing inherently "capatalist" about dismissing context and enforcing your intellectual property rights during
Re:Well of course (Score:5, Insightful)
What "socialist economy" would allow charging $11,000 for a $1 part? For that matter, what "socialist economy" would put the profit of a single company over the good of society in general?
I suspect you really don't know squat about "socialist economies".
Re:Well of course (Score:4, Insightful)
Capitalism is about being able to decide how you work and being able to own the fruits of your labor.
Adam Smith would disagree. You might want to read this little piece of fluff that he wrote:
http://www.gutenberg.org/ebook... [gutenberg.org]
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How about we use them according to the dictionary?
Ok, you start first.
The rest of us who understand philosophy and these philosophical stances ( and have actually been using them properly) will be waiting.
Re: Well of course (Score:4, Informative)
OK, fine.
https://www.dictionary.com/bro... [dictionary.com]
noun
an economic system in which investment in and ownership of the means of production, distribution, and exchange of wealth is made and maintained chiefly by private individuals or corporations, especially as contrasted to cooperatively or state-owned means of wealth.
Nothing there about IP, sorry.
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Retardistanis always think of profit before lives, it’s the American way.
The company who's complaining isn't American... They are based in Luxembourg. .
Re:Well of course (Score:4, Informative)
> The company who's complaining isn't American... They are based in Luxembourg. .
You mean "based" in Luxembourg. That doesn't tell us where they are actually based, just that they like to dodge taxes. Amazon Europe, Fed Ex, Ikea and PepsiCo are also based in Luxembourg but no rational person believes they are actually "based" for operations or management there.
Re: Beijing Must Pay 100% of the Cost of the Valve (Score:3)
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No no, sue God. He created everything including viruses. And made people go round the world carrying them.
Re:Beijing Must Pay 100% of the Cost of the Valves (Score:4, Funny)
No no, sue God. He created everything including viruses. And made people go round the world carrying them.
IF you follow scripture on this, God isn't the author of sickness. What He created was perfect in every way, but man rejected the arrangement, so God threw him out of the garden and it's been down hill since.
Also, suing God is logically a really bad idea... If you manage to serve the papers to the right individual and bring your case to a court with sufficient jurisdiction, who do you think is going to be the Judge?
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If you manage to serve the papers to the right individual and bring your case to a court with sufficient jurisdiction, who do you think is going to be the Judge?
That's easy. It is us, that is humanity, mankind, or 'Man' (old meaning) in some poems. God made us with minds, so we can judge him as well. Sueing for damages however, it is admittedly something that will be difficult to enforce!
Again.. I said "IF you follow scripture".. You sir, will NOT sit in judgment of the God in Scripture, it's not logically possible. Of course you can try to argue you have standing, but if you allow that God exists, logically you have to define Him differently than Scripture does to stand in judgement of Him, and I'm not having that argument with you because it's pointless...
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> Chinese culture accelerated the propagation of the coronavirus from China to the rest of the world.
I know you're just some useless troll, but China hardly has the monopoly on accelerating the propagation. See the news helicopter shots of the beaches in Florida yesterday absolutely crowded with vacationers? People all over the world don't take it seriously until it's too late.
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Re:No point (Score:4, Insightful)
I'm all for making profit off of your work, however $11,000 for a fucking valve seems a bit much considering the materials cost is $1 to 3D print it. Are you telling me $10,000+ of R&D went into that valve?
Re:No point (Score:5, Insightful)
They've gotta pay for all those high-priced lawyers on retainer.
Development (Score:5, Insightful)
Are you telling me $10,000+ of R&D went into that valve?
Once you factor in the necessary certifications, saddly, yes you'd approach these type of numbers.
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Are you telling me $10,000+ of R&D went into that valve?
Once you factor in the necessary certifications, saddly, yes you'd approach these type of numbers.
Exactly this. The certifications and the insurance for product liability are killers..
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Yeah, thieves. Copying our unavailable piece of plastic for 1/10000 of the cost. And to save peoples lives no less! Somebody really needs to do something about this. People are living on without giving us extortionate amounts of money! Pay up or die!
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Yes, if the overhead due to research is $10,000 PER PART, and they produce millions of parts, then they are claiming over $10 BILLION in research costs
smells fishy
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In general, the cost of medical equipment is mostly due to a lot of testing because of the implications of what happens when the equipment fails and the ensuing lawsuits.
In other words, get rid of ridiculous and frivulous medical lawsuits and you can expect medical equipment to get cheaper. Why do you think medical equipment and medication can be gotten so much cheaper everywhere outside the US, i.e. everywhere where frivulous lawsuits are basically impossible?
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While the overhead is absurd, its equally absurd to get rid of liability with medical devices. If you or someone close were injured or killed due to cheap or shoddy medical equipment with unknown providence wouldn't you want justice?
There has to be a reasonable middle ground between certifying that everything is to a good enough standard without pricing items into the stratosphere.
Re:No point (Score:5, Insightful)
The hot coffee lawsuit always gets mentioned in these kind of discussions by people who don't know what the fuck they are talking about.
The temperature of the coffee was MUCH higher than coffee should ever be. McDonalds had been warned multiple times that they needed to reduce to temperature to avoid injury. They ignored those warnings. The spilled coffee wasn't a simple, "ouch that hurt and stained my clothes". It caused actual nerve damage.
Re:No point (Score:4, Informative)
It caused actual nerve damage.
This! Worth remembering the suit wasn't some get rich scheme. It was a suit for damages to cover medical expenses.
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The cost of medical equipment is mostly due to marketing junkets and lobbying and executive bonuses.. It take s a powerful and expensive government to keep profit margins this high and monopoly this strong. The lawsuits are fully justified.
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Re:No point (Score:5, Insightful)
Much that I hate to stick up for the patent holder here, it’s entirely possible for the valve to legitimately cost that much - on the face of it, the cheap 3D printed valves work fine, but do they really? Are the materials non-reactive with the fluids flowing through them? Are they safe from dissolving or particulate transfer over periods of time? Are they suitably non-porous to maintain a given pressure over given periods of time? Are they going to randomly break and send bits down stream? Etc etc etc.
These two individuals acted immediately and saved lives where the original manufacturer couldn’t, but that doesn’t mean they stumbled across a long term cheap alternative, or a price gouging supplier, at all. They shouldn’t be sued for it, certainly, but equally we shouldn’t necessarily be criticising the original cost (but I’m well aware that’s a common Slashdot pastime) because you don’t know what it consists of.
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I'm sure the patent holder valve is better just as much as I'm sure it doesn't cost anywhere near $11,000 to make. Given the article and the patent, I'm assuming they have zero competition. They charge as much as they can get away with to maximize their profits. Given it's Italy with a national health service, there's probably some pressure by the government to control the cost,
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this is false (Score:2)
In the past, you had no profit for medical instruments, but they were build anyway... there is demand, people are ready to pay. But then medical companies got greedy and now demand huge amount of money for medical supplies or medicines that have been paid long ago.
even if little profit exist, research is still done, universities and medicine companies will still do it, the first because it is own job an for fame and glory, the later for being relevant... like all business, if they do not update their portfo
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Without the profit motive, you're never going to get innovations like ED-209.
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I don't see many volunteer police officers, and "volunteers" in the military get paid. There are unpaid volunteer firefighters, but they're usually in small communities where they're protecting their own property and that of friends and family.
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Tom Hanks isn't really that old. He *looks* old. When I saw a picture of him I looked up his age and was rather surprised.
Re:Which company is this now? (Score:5, Insightful)
At this point, naming the company might considerably lower the life expectancy of their staff...
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Does sound a bit anonymous-sources-clickbait-ey. Maybe they don't want another medical company to come forward and call them on their bullshit.
Resellers of scarce supplies aren't the only scumbags profiting from the outbreak. Clickbait journalists are too.
Re:Which company is this now? (Score:5, Informative)
Or you could make a minimal effort to verify it, such as reading TFA and its links.
There are photos of the original valve and the 3D printed ones. They clearly exist and look 3D printed. Unfortunately you can't tell who the manufacturer is from the original valve but maybe someone can recognize it.
The minister for health publicly thanked them on Twitter. https://twitter.com/PaolaPisan... [twitter.com]
So while we don't have absolute 100% proof there is a lot of evidence that the major aspects of the story are true. It sounds entirely plausible, they apparently tried three different methods of 3D printing to see which worked best and are concerned that the valves cannot be reused due to sterilization damaging them. But still a lot better than nothing.
Re:Which company is this now? (Score:4, Interesting)
I'm surprised that they don't need sterilisation before the first use.
They come out of the printer sterile (except for maybe extreme stuff like hepatitis or prions).
As I understand it, filament printing plastics require a minimum of 180C and most work best at 220-230C or higher. Given that sea level boiling point is 100C and that kills most stuff, for most pathogens this is overkill.
Some of the materials also require the temperature be retained near that during printing, to avoid shrinkage and mismatch, or require slow cooling (mostly by using an enclosure to avoid rapid cooling by air currents). Even those that don't aren't harmed by being cooled gradually. So the printing process tends to leave most of the material near, though below, its melting point for considerable time.
Even Hepatitis B, a notoriously hard to kill virus, is denatured, not just beyond being infectious, but beyond the surface antigens being recognizable by antibodies, if heated to 132C for 30 minutes.
So I suspect that, if they're not contaminated during handling between printing and use, sterility of a newly 3-D printed air valve (I'm presuming this is for a ventilator or such) should not be a problem.
(If its job is to handle blood that goes back into the patient, you would need a higher level of sterilization.)
Re:Profiteers and Looters (Score:4, Interesting)
Except that in a free market other people would be able to undercut the company selling it for too high of a price. The patent system is a government restriction on the free market. It was put in place to encourage R&D and innovation for the ultimate benefit to society that the innovation brings.
So if a patent actually start harming society that's in a state of emergency, I don't see why the government can't simply suspend that patent.