Hang on, what about the part where the FDA only approved the thing for a 5 year use and essentially pushed the manufacturer into liability if they worked on it after that period? Maybe that’s the issue that needs repairing first.
It doesn't sound like a hard and fast rule. It seems like it's whatever the manufacturer asks for in terms of "intended working life." This _seems_ to be the original FDA certification for the device:
The problem here, of course, is it's not the device itself, but the simple remote control peripheral that is designed to switch device operating modes.
The FDA should force manufacturers of "two piece" systems like this to have backup controls on the device itself and to exclude these non-medical components designed for control from any regulation covering "intended design life."
It seems like a daffy middle ground that the FDA lets exist and manufacturers take advantage of when they can.
> It seems like it's whatever the manufacturer asks for in terms of "intended working life."
I would guess the FDA makes their certification easier or harder to pass based on how long the device is expected to last. If the 5 year lifespan is what hits the middle ground for that company between cost-of-certification and useful-product-life, then it's up to the FDA to make a longer lifespan feasible to get certified.
Your point is valid, and is improved when we recognize it's not an either/or blame game when acknowledging the parts of the system that need improvement for failures like this person experienced.
But he did have the right to repair... right? He just couldn't get the part. The article title is misleading. They don't support old medical devices, they were following the rules. Yes, they should have handled the customer service better. Escalated it. But it doesn't sound like some big evil company locking people out of their legs because they tinkered with them. Let's not lump it all in the same category.
Also, this line is beyond ridiculous:
"Straight’s path to paralysis started in the 1990s at the Saratoga Race Course".
My understanding of the issue was that he did not know what the part was. It was a connector and there is dozens if not hundreds different families of them. So very likely with suitable bill of materials which right to repair would have provided it could have been found ordered and replaced by third-party.
That depends on how exactly a right to repair law is going to regulate things. Will a company have to provide parts for older models forever? Because in the article it says that he was going to fix it himself but couldn't find the part that connects the battery to his controller watch.
Not sure about the US but in some countries this is regulated for cars. Companies are required to provide parts for a certain amount of years after discontinuation of the product.
It seems abundantly reasonable that a similar requirement be imposed for prosthesis. And it would also be very reasonable for the required period to be longer than that of cars.
So yeah, not forever, but definitely not a a short period either.
I think this was something that used to be regulated but is not now. There's plenty of financial justification for supporting cars 10 or more years by making parts, since most last longer than that. For niche products that are practically one-offs, I can see where it might need to be regulated because the economics won't encourage it.
They shouldn't be making such unnecessary proprietary components. For cases where there really is no way around using custom hardware, at end of life the specifications should be made public so that a third party can manufacture them.
In this specific case, the real issue is just the incredibly short service lifetime. While different medical devices are going to have different lifetimes, manufacturers need to continue to provide support for at least 36 months after reporting that they plan to discontinue support, which is 60% of the lifetime of this product. Typically medical devices are supported for much longer.
> They shouldn't be making such unnecessary proprietary components.
Perhaps not, but that's not right to repair. Pretty much everything in any modern smartphone is completely proprietary.
And as the article said, the battery wasn't proprietary. The missing part was the battery connector. That doesn't even suggest to me that it's wildly proprietary, just that it can't be found anymore. Lots of components that are easily sourced now would be challenging for an ordinary person to source in a decade.
> at end of life the specifications should be made public so that a third party can manufacture them.
This also isn't right to repair. In fact, it probably doesn't help much at all: a sufficiently specialized part on a specialized medical device is going to be so niche that the cost of an aftermarket part will be huge. There's probably what, twenty of these things in the wild? A hundred? How many aftermarket manufacturers will even pick up the phone for a one-off custom part, spec or no?
> manufacturers need to continue to provide support for at least 36 months after reporting that they plan to discontinue support, which is 60% of the lifetime of this product
The device was supported for the regulatory limit of five years, and the owner has been using it for ten. Assuming they did give three years of support after discontinuing the product, it's now two years beyond that.
For a product only approved to be sold for five years by a regulator, I think the fact that the only piece that couldn't be serviced after double that time is a battery connector is pretty impressive (all things considered). Customer service aside, I'm not sure how much more you could possibly ask from this company.
> How many aftermarket manufacturers will even pick up the phone for a one-off custom part, spec or no?
If you offered 1% of the entire device's replacement price, for a part that the average tinkerer could build, I think you'd find a stampede of competent offers. I'm sure much lower amounts would work too.
The point is there's a price where you could get the parts made, and that price is much much lower than a new model. A thousand dollars every few years is something that could go in a budget.
Don't focus too much on the exact number I used, I went on the high end just to make a point, also it's supposed to be a per-major-fix price not a per-part price.
> How many aftermarket manufacturers will even pick up the phone for a one-off custom part, spec or no?
That would depend entirely upon the part.
With (detailed) specs being available, quite a lot of skilled repair techs would be able to bodge something competent together (!) to meet those specs.
Re-manufacturing completely 100% good parts could be a thing sure, for sufficient volumes.
But real world situations for low volumes tend to be "lets get it working well enough using the tools we have available". Creativity is required. ;)
The results for those situations are improved dramatically if there's detailed, good quality docs easily accessible to the people working on it.
> Perhaps not, but that's not right to repair. Pretty much everything in any modern smartphone is completely proprietary.
That's exactly what right to repair refers to! Companies can't stop you from taking a screwdriver to an object in your possession, the issue is that by using non-standard components they make what should be an easy repair extremely difficult if not impossible without going through them, allowing them to effectively prevent repair. Smartphones are the poster child for lack of right to repair.
> That doesn't even suggest to me that it's wildly proprietary, just that it can't be found anymore.
If it wasn't proprietary, it would be able to be found. Off the shelf battery connectors are produced in the millions and remain available for decades. The whole reason for this issue was that instead of using one of those, they went with something non-standard that a person couldn't get, and despite having them on hand they wouldn't give one to the user.
> This also isn't right to repair.
Again, it is.
> In fact, it probably doesn't help much at all: a sufficiently specialized part on a specialized medical device is going to be so niche that the cost of an aftermarket part will be huge.
So long as the cost of replacing the part is less than the cost of replacing the entire system that depends on that part, it still makes sense. Aftermarket manufacturers specialize in making such one offs.
> The device was supported for the regulatory limit of five years, and the owner has been using it for ten.
The FDA doesn't have regulatory limits for how long products can be supported, it sets minimums for how long products need to be supported. The company chose to drop support after 5 years, it was not barred from providing support afterwards. If you read the article, the company both did provide the support requested and issued an apology for not doing so sooner.
> Assuming they did give three years of support after discontinuing the product, it's now two years beyond that.
Part of that end of life process is notifying operators of the devices that support will be ending, giving them time to get spare parts as needed. There is no indication that this was done.
> For a product only approved to be sold for five years by a regulator,
Again, not what happened.
> I think the fact that the only piece that couldn't be serviced after double that time is a battery connector is pretty impressive
There is no indication that any other part has been successfully serviced in that time period. The battery connector was the part that happened to fail, and when it did bricked the system. Other parts may have failed in a way that didn't render the system inoperable, and other critical components may have yet to fail.
> I'm not sure how much more you could possibly ask from this company.
Designing products to utilize source-able components and making specifications for custom components available after you stop manufacturing them are two things that can be asked of any company. It costs essentially nothing to do either. It even benefits the company to do so - using standard components reduces production costs and decreases supply chain risk, while publishing part specs allows a company to offload continuing support costs onto third parties.
I'm not going to read or respond to most of what you wrote because frankly I don't care to because a lot of it is nonsense (a real example: I'm not going to repair my $600 washer when the part I need costs $500), but I'll respond to this:
> Companies can't stop you from taking a screwdriver to an object in your possession, the issue is that by using non-standard components they make what should be an easy repair extremely difficult if not impossible without going through them, allowing them to effectively prevent repair. Smartphones are the poster child for lack of right to repair.
This is objectively wrong. You can't repair your own phone without voiding the warranty. Which is to say, you don't have the legal right to repair your own phone, even if you sourced compatible parts.
The right to repair is the right to repair your device on your own terms, and for other companies to be able to offer compatible parts. An iPhone screen that comes with DRM makes it impossible to do that. Licensing rules that prevent companies from offering service for devices (e.g., screen repair) makes it impossible to do that. Having a tricky PCB doesn't impede your rights.
The existence of proprietary parts doesn't in any way invalidate your right to repair unless those parts are specifically designed to make it physically impossible to repair your device. Hell, even the most technically complicated parts in popular consumer devices can be replicated by third parties and have been for years, but selling those parts is often illegal and the devices are designed to detect and reject those parts.
> You can't repair your own phone without voiding the warranty. Which is to say, you don't have the legal right to repair your own phone, even if you sourced compatible parts.
You have the legal right to void your warranty. You warranty likely voids itself in a reasonably short period of time regardless of whether you conduct repairs, and it would be absurd for the seller to offer a warranty that covers objects that have been arbitrarily tampered with. That's emphatically NOT what right to repair refers to.
> The right to repair is the right to repair your device on your own terms, and for other companies to be able to offer compatible parts.
Yes, this is the correct definition, and the one I have been using in this thread, and the one that mandates making replacement parts reasonably available.
> An iPhone screen that comes with DRM makes it impossible to do that. Licensing rules that prevent companies from offering service for devices (e.g., screen repair) makes it impossible to do that. Having a tricky PCB doesn't impede your rights.
Yes, these are all right to repair issues caused by the over-use of proprietary components.
> The existence of proprietary parts doesn't in any way invalidate your right to repair unless those parts are specifically designed to make it physically impossible to repair your device. Hell, even the most technically complicated parts in popular consumer devices can be replicated by third parties and have been for years, but selling those parts is often illegal and the devices are designed to detect and reject those parts.
I don't think you know what the word proprietary means. You are complaining about the use of proprietary components.
> And this is why right to repair laws are a thing.
Yes, and also why products should be open sourced and documented when they're declared obsolete by their manufacturer, or the manufacturer cease operations. Let people be responsible for all repairs they do to their devices; this man would probably not give a damn about regulations if the alternative was essentially to become paralyzed again.
He's not being blocked from repairing it, and he doesn't need to hack it.
He just needs a part. (They did eventually send it to him.) If they had not, he doesn't need the right to repair it, rather would need someone to manufacture the part.
Once again, that thing falls under FDA regulations. You’re telling us about a world with 3rd party mix and match components, all FDA approved in any and all combinations on 5 year plus old devices?
I'm supportive of the right to repair in every sense, but even the strongest right to repair laws would not have helped improve the outcome in this case.
The strongest right to repair law would probably require detailed schematics, BOMs, and (sufficiently detailed) manufacturing steps being available for all the parts.
That would enable people to organise getting replacements manufactured themselves. :)
I love that future, but that's not right to repair. It's simply not what that means. You can want open source manufacturing, and you can want that legally mandated, but not having manufacturing steps doesn't take away your right to repair something you own.
Right to repair, in a broad sense, also covers access to parts. This is definitely an edge case and we might want to just consider that if we're going to do experiments on disabled with the aim of helping them, and they want to continue using the tools, we might have to subsidize access to the parts until they die.
I don’t think it’s an edge case at all. Right to repair doesn’t require a manufacturer to continue making parts or spend their own money on creating a large inventory of them. It’s one thing to require Apple to sell you a phone screen they are still making, it’s another to require them to be able to sell any number of them at any time from ones they do not.
Right to repair is a negative right. There’s no reason to turn it into a positive one.
It's an edge case because the supply is so small and the hardware is so specialized. If this were an iPhone screen there's be a dozen companies in china capable of producing and selling them near cost if apple didn't interfere, and we'd have plenty of people willing to repair and resell the screens if apple would stop abusing US customs to seize repaired screens as they've done in the past.
The point still stands, no ‘right to repair’ can force manufacturers to stock X number of parts, or spin up production lines again, at some future date. Regardless of the company’s condition.
Even the pentagon can’t force that, they just pay a large amount of money to a new company to recreate the original part to the exact same spec.
Theoretically it’s possible to enact new legislation to mandate that something sufficient must be set aside in some sort of escrow system, and punish companies for not doing so, but that would probably result in most manufacturing companies fleeing the US….
I agree with that, and it's possible that half of what people buy and want to repair aren't going to be repairable under market conditions. Probably more; most of these cases it's just economically infeasible to repair anything that isn't new or produced recently, with supply lines still active, and it's fine when nobody wants to pay for it.
So for my definition, what makes this an edge case is specifically it's expensive medical equipment that a disabled user can't pay to acquire a part for, and companies aren't willing to produce anyway because it's so niche. 99% of equipment probably falls under "I want to repair it and someone (myself or a repair company) wants to fix it" or "I don't want to repair it because it's so expensive". The rest would be the edge case where you want to repair it and you literally can't afford to - even if you could produce the parts.
By the way, I hate this article, I just want the information and not have to parse an entire goddamn magazine to get to it.