Volunteers produce 3D-printed valves for life-saving coronavirus treatments

Image: Massimo Temporelli

Update, March 18th 5:30PM ET: A group of Italian volunteers distributed 3D-printed versions of a vital medical device — but it doesn’t appear that the original manufacturer threatened a legal crackdown. As we reported earlier, Cristian Fracassi and Alessandro Romaioli used their 3D printer to create unofficial copies of a patented valve, which was in short supply at Italian hospitals. Business Insider Italia quoted Massimo Temporelli, the Italian professor who recruited the pair, saying that the device maker threatened them with an infringement claim.

But in an interview with The Verge, 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,” he said. “They said they couldn’t give us the file because it’s company property, but that’s all.” While earlier reporting said the original valve cost over $10,000, Fracassi also told Fast Company that this number was inaccurate.

Temporelli gave The Verge a more ambiguous account of the call, which he says he wasn’t directly involved in. “The group we asked for the files refused and said it was illegal” to copy the valves, he said. He stopped short of calling the statement a threat. “Let’s say the risk to be sued exists since they bypassed a patent, but that’s it.”

Manufacturing company Intersurgical says it had no intention of making a threat. 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.

Romaioli and Temporelli have emphasized that both devices serve a purpose: the official product is the better long-term solution, but for now, hospitals can use this printed alternative to fulfill a sudden, drastic demand.

The original article follows below.


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).

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, according to Metro. That launched a search for a way to 3D print a replica part, and Cristian Fracassi and Alessandro Romaioli, who work at Italian startup Isinnova, offered their company’s printer for the job, reports Business Insider.

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 Romaioli moved ahead anyway by measuring the valves and 3D printing three different versions of them.

So far, the valves they made have worked on 10 patients as of March 14th, according to Massimo Temporelli, the founder of Italian manufacturing solutions company FabLab who helped recruit Fracassi and Romaioli to print the replica valves.

“[The patients] were people in danger of life, and we acted. Period,” said Fracassi in a Facebook post. He also said that “we have no intention of profit on this situation, we are not going to use the designs or product beyond the strict need for us forced to act, we are not going to spread the drawing.”

Here’s a good look at the valves, shared by Italy’s Minister of Technological Innovation Paola Pisano on Twitter.

Italy has more than 31,500 confirmed infections of COVID-19, the disease caused by the novel coronavirus, and more than 2,500 confirmed deaths. Both figures trail only China.

Comments

Global pandemic? Time to flex those patents, who cares if people are actually dying.

This company should be dissolved.

Frankly, selling it before for $11,000 a pop was also insane. Glad people are thinking quick and doing what needs to be done. These guys are heroes.

I currently am working with electronics used in nursing stations, and each computer monitor (4:3, not even 1080p) costs $8k USD. The reason for cost is that they are custom made with materials that can be sanitized according to the local health system’s specifications, as well as support and maintenance for x number of years after deployment, on top of getting certified for use within hospitals.

I can’t say whether this is the same reason for these valves ($11k per valve vs $8k per monitor?!), and this company sounded like a dick to respond immediately with lawsuit, but my point is that medical equipment tend to be expensive for a reason.

So here’s the million dollar question, now that we know a $1 valve could replace a $11k valve, which startup is going to come in here and undercut the established player? Perhaps one that’s ‘only’ $500 each but can be easily sanitized, that also meets local health regulations? Exciting times

maybe it’s better for society to permit undercutting these kinds of business models.

Permitting undercutting discourages the innovation in the first place. This is the whole point of parents.

On the other hand patent trolls are a thing. Best is to balance return on investment vs innovation gating. Simply put, there should be a time/profit limit before the patent is lifted.

Not sure about the profit limit, as it would be hard to determine, but we definitely should ensure that patent length would be more appropriate. Despite all the hate the pharmaceutical industry gets, the idea that it takes quite a while to recoup the total R&D investment through the couple of projects that succeed makes a lot of sense. On the other hand, when it comes to most software patents it also totally makes sense for there to be a period of exclusivity, but that one should last a couple of years at most. So yeah, per sub industry patent length would be a good start.

I think its pretty obvious software patents should be straight up abolised. Thats not even controversial outside the patent troll community.

If this company is the designer and the manufacturer, they aren’t a patent troll.

No, but by failing to provide what’s needed in an emergency, people are going to step up like this anyway, patents be damned…

Theres no evidence for that assertion, and it seems contrary to economic common sense.

Patents don’t "enourage innovation", they just encourage monopolies.. A competitive market encourages innovation.

If someones undercutting you, then either lower your price, or come up with a better product.

There is economic sense in my view – it’s simply a risk = reward situation. If the reward isn’t there (e.g. exclusivity to produce that product and generate profit using a patent to prevent others doing so) for the risk (e.g. spending effort to design, develop, market and sell the product) – then nobody will want to take a big risk, and you slow innovation.

If I was an inventor, who created a brand new style of microchip that tripled clock speed and reduced heat by 95%. I don’t want Intel then replicating it and cutting me out of my reward. If there was no patent to protect me, then why should I bother spending my time and money creating it? I’d let Intel do it themselves.

Rollback time further – if I figured out how to attach a pair of stone wheels to a horse carriage using an axle and sold that carriage for fruit and clothing. If my caveman neighbour copied it and undercut me, I’d beat them to death with a rock (e.g. in modern world – patent litigation).

The balance is tricky obviously – personally I think:

1. A time-limit should be long enough for the patent owner to get sufficient reward. This might be as a % of R&D, or a duration agreed with the patent office – no more than 30 years.

2. Patent licensing should be law. E.g. all patent owners must offer their patent to be used by other companies, but are paid a cut of revenue generated by the competitor, up to the time-limit. If this is legally enforced, then all ideas can be shared and the original creator still gets a reward.

Key word is cut of revenue – because even if a competitor produces the product for a fraction of the cost, logic holds they will sell a LOT of said product, thus have high revenue. If they are forced to pay a license fee to the patent holder, then they should increase the price to compensate.

The situation it doesn’t work in is where a patent holder may rely on exclusivity as a means to generate profit, because of the brand that they carry. Allowing competitors to make sub-par replicas means it damages their brand / reputation. But then…who cares about branding!

You spend a million dollars designing something novel, you manufacture it with $1 worth of materials and sell it for $5. You now need to sell 250,000 units to break even on your initial investment.

Someone else copies your design, manufactures knockoffs at the same cost of $1 in materials, and starts selling them for $2.

If you patented your design, you’re likely to be protected. If you aren’t allowed to patent your design, there’s no reason to invest that $1 million in development.

Parents encourage innovation. This isn’t debatable.

monopolies

You keep using that word. I don’t think you know what that word means.

This probably has nothing to do with patents—there are many successful businesses with patents that do not resort to suing people to oblivion because their business require selling something priced at ridiculous levels.

It’s like you patent a key which unlocks your product, not that the product itself is novel.

How do you know the pricing is ridiculous? Do you know what their development costs and sales volumes are?

Yes, as inferred from this article. Those tubes shouldn’t cost $10000.

How do you know the pricing isn’t ridiculous?

Yes, as inferred from this article.

The article doesn’t discuss the reasons for the pricing. It may be unreasonable, it also might not.

How do you know the pricing isn’t ridiculous?

I don’t, and I’m not claiming to.

At $1 a pop vs $11,000 who needs sanitization? They’re disposable now.

Well I can tell you right off the bat that that is wrong. I have a dozen Itero Element intraoral scanners (certified for hospital and clinical use), and the all in one computer that runs that with a pretty great looking monitor is less than $5k for the whole setup, and it can survive cavicide all day every day for years. You’re getting ripped off.

I work on the software side, don’t have much information on why the company chose those specific monitors.

To be fair, a portion of that 11K goes to being ready for a lawsuit if one of those valves fails. The people who made it for a buck likely don’t have to worry about that.

Does this count as price gouging? Because charging $11,000 for a $1 tube sounds like price gouging in times of emergency.

And I can’t believe their PR thought suing was a good idea.

I don’t really want to say they’ve been price gouging without knowing more about the specific valve. For one thing, you probably couldn’t actually 3d print and sell these to hospitals around the world for $1, that’s just raw material cost, which is only a tiny component of the price for most parts. I worked for a company that machined precision screws for medical devices, and honestly even a tiny custom titanium screw (which only costs a couple bucks in raw material) can easily cost over a $1000 a pop before assembly, R&D, or delivery of the final product.

If these are simple injection-molded plastic valves? Then it’s probably price-gouging. If these have to be precision milled, finished, tested, and have tons of specific properties, then it’s arguable.

Remember that the 3d print is a make-do here. Those are probably way less safe to use than the specialized versions, if nothing else as a matter of sterilization (I have questions about how well they can ever clean something with print lines like this that can’t be baked). But when there’s no alternative, good enough is good enough.

Interesting, thanks for the insight!

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