An exoskeleton let a paralyzed man walk, then its maker refused repairs

Really, there are cases where this is obviously a change that needs to happen. Eg, if a company holds personal data, the agreements that allowed a company to obtain it should live across bankruptcy with the data, not be terminated if it is transferred.

This sort of arrangement is common in real property. For example, if you buy a house where you have to access it via some other private land, the agreement that you can do so is arranged in such a way that it can't be voided when that land is sold, even during bankruptcy. You can't do that for data AFAIK (would love for a lawyer to comment). It needs to be enabled and made mandatory in cases like this.

There is some limited ability to do this: creditors can get a "charge" registered against intellectual property, so theoretically in the OP's case one might be able to design a legal construct that would cause a bankruptcy court to give rights to some special purpose vehicle that is set up (in advance) to represent the patients. But I don't know if that would work in all cases

I don't think it would be unreasonable to mandate software for hardware products be pluggable in such a way that you can modify the runtime with hooks.

During the commercial, supported life of the product the consumer doesn't know any different. But at EOL, repair shops can make a market for "modules" that can do things like change the remote server a IoT device talks to. Removes requirements for DRM, fixes bugs etc.

Threat to commercial interests is really low here in my view, an average consumer pays for a product and pays for the SaaS portion because its convenient and provides value. Then the product reaches EOL and the aftermarket takes over. No different to say the long, exhaustive use of used cars (at least in the decades prior to digital integration in cars, it remains to be seen how the next two decades go re:software services ridden cars.)

I don’t know enough about how courts split up intangible assets like IP to suggest how to bundle it with this proposed liability, but I think it can be pushed up to insurance carriers like warranties are. Make the insurers liable so that they push the requirements downstream and make them first in line for the relevant IP as creditors. Allow them to argue in front of the bankruptcy court to define what bundle they are entitled to as creditors and them allow them to fire sale that bundle as part of the rest. If they can’t get enough to cover their calculations, they can dump it on the agency/NGO for free. (IANAL and I dont know what I’m talking about)

It's relatively straightforward. You put the code or whatever else your customers need into escrow with a third party. The code gets released if you discontinue the product or it otherwise leaves the market.

You then market that you're doing this, so that everyone A) knows they can pursue getting access to the escrowed stuff, B) it's a selling point to remove some of the vendor risk, and C) it's not just a capricious action to undermine creditor rights.

Of course, it may be harder to borrow money if you do this. And customers are generally not savvy enough to require this (though if you do a large enterprise deal, requiring code escrow is not an unknown term).

I don't think this is accurate. I think they are proposing priority for the consumer in the hierarchy of creditors that is a little more specific about assets than the usual hierarchy.

All IP and licensing rights to IP could become specially encumbered during bankruptcy to enable a consumer priority on it, etc. I don't think it would be more difficult than some of the existing setup, but naturally much of the existing setup is more in theory than in practice.

I don't know that this is how things are currently structured, but if a company was required to submit a device's source code as a condition of receiving a 510(k) clearance perhaps there should also be a condition that the FDA can release this code in instances where the public interest in doing so would outweigh the IP interests of some piece of abandonware.

Yeah who am I kidding that won't happen.

That's actually my point. There's an interesting policy discussion to be had here, and instead of starting it, they just decided to smear a company.

> Like, if the metal fails and you have a horrible fall and break your hip and shoulder, that's pretty different from an iPhone that won't turn on.

> If this is only approved for 5 years, shouldn't the guy be replacing it rather than repairing it? And shouldn't health insurance be covering that, at least beyond the deductible or whatever?

Probably, but (to throw out a hypothetical alternative) you can also imagine a situation where e.g. inspection can tell him if the whole device actually needs replacement.

I don't have the answer here - I just know I'd like the discussion to revolve around the merits of the situation.

This seems like a stretch for anything other than cars, pcs, and large appliances. I doubt this has been true for a long time for anything under $100 and more electrically complicated than a switch and a motor.

Forcing companies to support cutting-edge prototypes (like exoskeleton) for decades is the best way to ensure there won't be any company making 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.

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.

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.

https://www.accessdata.fda.gov/cdrh_docs/reviews/den130034.p...

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.

why is that ridiculous? seems tragic to me; not to mention the horse broke his neck as well.

https://www.francetvinfo.fr/sante/politique-de-sante/sante-l...

While I certainly wouldn't call myself an expert on this, having worked within the industry I've been able to make the following observations:

- Novel medical devices are often created by very small startups, who in essence exist solely to create a PoC. A larger Medical Device company then buys them to actually start walking through the regulatory hurdles which will bring them to market.

- The market it gets initially released in is rarely connected to the location it was invented (ex: Invented by European startup but released in the US is weirdly common). But if a product is successful enough then an even larger Medical device company with access to more international markets might swoop in and purchase the mid sized company.

- European regulatory agencies will oftentimes be lenient on products that have received FDA approval, but the reverse is less clear cut. So going through the FDA first can be more efficient, especially when considering the market size of the US along with the fact that you only need to support one language. In practice this pushes out the timeline for the first European release of a device.

- GDPR is actually not very different from HIPPA, perhaps not even as strict, but it is more ambiguous and that's a problem. The key difference is that, right now, everyone knows exactly how to follow HIPPA but the reverse is not true for GDPR. Some things that might be allowed by one might subtly contradict the other and there is no third party Medical Device companies can throw money at that will absorb the liability of this by saying whether or not they are GDPR compliant.

- Since Medical Device companies live & die on their study data, this data collection paradox has further pushed out timelines for when medical devices are first released in Europe.

- A European might see a cool new Medical device from a startup in their local newspaper but then never actually gain access to it for another 20 years.

So personally I'd say it largely reduces down to the regulatory environment + market size. The US can be among the strictest, but not only is getting past that worth it for market access, but by passing those strict hurdles, releasing to other international markets becomes much easier since you got the hard part over with.

Not to mention the fact that, in a similar way a popular programming language might have more "community resources" and a larger hiring pool, the same could also be said for navigating regulatory environments. So popularity has a self-amplifying effect.

I've got relatives who got cancer medication just like that, appointment to the doctor, go to pharmacy and pay nothing at all. In a day he got it.