Italian hospital needed an $11K part for its ventilators, volunteers 3D printed them at $1 each, original manufacturer threatened to sue

A short object lesson in who, in fact, has all the lawyers, guns and money seems in order here. Be nice to see that happen to folks who need it for a change, no?

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Well that isn’t the answer.

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This is why you burn the paper copyright laws are written on. Copying is a human right.

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This is good news. I hope using a 3D printed part doesn’t cause damage to the patient (or the device for that matter). Certainly if it were a blood pump rather than a ventilator I’d worry that it might cause clots.

Maybe someone at the manufacturer was being a jobsworth, or simply an asshole. Or maybe they were worried that porous, striated printed valves could harbor deadly fungal infection. Or who knows.

In any case, let’s hold off a month or two before launching a jihad against ventilator manufacturers.

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Linux and all that free stuff thrive because of IP, not in spite of it.

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It’s interesting to look at how we got here. We’ve all seen the ads for lawyers who promote class-action lawsuits against medical equipment manufacturers. The sad reality is that we expect perfection of these companies. Why wouldn’t a consumable valve for a ventilator cost $10k? People’s lives literally depend on this thing never failing.

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I protest the use of We in that comment.

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That’s not how the equipment manufacturers see it.

And that’s not how “society” see it either.
(and to clarify, society usually doesn’t like when products or things cause people to die when they are supposed to help them live.)

It’s like safety culture - all accidents can be prevented. I mean hind-sight is 20/20 and all, but really?

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Yup. With pretty much anything medical you’re paying far more for the assurance the item works and is exactly what it’s supposed to be rather than the actual production cost of the item. I do suspect cost-shifting is at work here, though, like we see with printers and ink.

Personally, I think both copyright and patent should be based on reasonable availability. If you market the item and fail to actually be able to deliver (and no dodges like charging an exhorbinant cost) it’s not a violation for someone to make their own. (I say if because this wouldn’t apply to in-house stuff you didn’t sell in the first place. You patent a widget-maker and only use it in your own widget factory, nobody else gets to copy it because they can’t buy it.)

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When the manufacturer’s lawyers and PR dept really discuss it, they’ll probably see reason. The Italian parliament, in a state of emergency, could cancel that patent or nationalize it in a blink of an eye.

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In my opinion it would be better than internet censorship that EU recently decided to implement or patents on algorithms or surgical procedures. While balanced IP laws would be best, the current ones have grown so malignant that they do more harm than good.

While copyright generally helps (but that will probably change soon too), I’d say that Linux and free software is effectively made illegal by software patents.

Even without any lawsuits, it still applies. It’s a big numbers and expected reliability problem.

With 160,000 ventilators in the US, used every day all year would be 58,400,000 days of use every year.

  • At 99% reliability, 1% failure, that’s 584,000 failure days every year. Clearly not the specification.
  • At 99.999% reliability, 0.001% failure, that’s 584 failure days every year. Still means one fails more than every day, for someone.
  • At 99.99999% reliability, 0.00001% failure, we finally get to 6 failure days every year.

It may be a $1 part, but it’s got $10K worth of QA supporting it, just to meet the expected specification, before any extra lawsuits drive up the price.

The 3D printer part doesn’t come with any of the QA. It’s still better than not having anything. But, it’s a triage solution when you’ve determined you cannot get the part with the supporting QA and MUST have something.

It’s like measuring uptime in IT system planning. Every time you add another 9, the cost goes up dramatically. Also why most IT systems aren’t life critical rated.

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Especially if the OEM sues and it goes to a trial…

I read it, and it looks like it can only apply to the specific case of infringement, and generally only for past infringements (and not future ones). I didn’t see anything in there that indicated it would weaken their patent claims against any other parties.

Additionally, it seems to only deal with edge cases where the delay in enforcement was either intentional to benefit the patent holder’s eventual case, or when the delay caused issues with the defendant’s defense.

It still in no way is something that will cause the loss of the patent itself.

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Actually, that’s the exact point of patents. They were never intended to cover end products, but only the process of making them. Objects are only supposed to be able to be patented if they’re part of that production process (which this widget-maker would be). The idea being that the widget isn’t the innovative thing here, it’s just a product - it’s a novel way of creating the widget that is deserving of the protection.

This changed in more recent times as the product and the invention started to have a more fuzzy distinction between them (and often been one and the same), and corporations have continuously pushed for a further blurring of that line over time in order to lock up industries and preclude any and all competition.

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More importantly, that’s not how plaintiff’s lawyers see it. Any deviation from standard practice opens us up to liability, and in the coming tsunami, not deviating will probably open us to liability as well. Lawyers love this kind of shit.

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I think that’s a stretch. If a workable replica can be made on a 3D printer, then it can only be so complicated. Sure the official product doesn’t cost 1 Euro to produce, but I’d think 100 would be resonable.

Of course this depends on the company’s revenue model. Perhaps this a consumable or routinely replaced item and they sell the ventilator at a steeply discounted price making this the actual revenue stream. IMO that is a shitty revenue model for medical equipment (shitty in general, but much more so here.)

I would say that the general population or “society” would view medical equipment as being something that doesn’t fail. That doesn’t mean it’s reality and obviously that’s why there are tons of laws, regulations, and insurance that float around these kinds of issues. But society also doesn’t like to talk about things like cost vs benefit. Now I do say this from a US point of view, but from what I hear and see here, the over all feeling is no one should die and everything should just work. You can call that denial, wishful thinking, or a fantasy, but that’s how I feel a lot of people view the medical system.

To your numbers, is 584 failures days per year that bad? If the failure mode introduces a situation that is easily identified by other monitors a patient would be on and can be easily corrected, is it worth spending 5x more on the part to improve quality control that much? There is a point of diminishing returns on everything. The problem is when that failure can lead to death, so the cost always seems to justify the spend.

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If only capitalism – or the people being greedy asshats in a time of crisis – could be put on faulty ventilators.

Yeah, except for the fact they want to charge $11,000 per part, and the 3D printed part can be made 11,000 times for that price. They gouge because they can gouge. It doesn’t matter who they license it to. We see this as a crisis, they see it as a jackpot.

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