When bionic implants getting obsolete - Page 1
Forum section: electronics / general

author: BU508A
author_rank: Super Contributor
timestamp: February 16, 2022, 01:50:55 pm
content: https://spectrum.ieee.org/bionic-eye-obsoleteMoney quote:"Yet in 2020, Byland had to find out secondhand that the company had abandoned the technology and was on the verge of going bankrupt. While his two-implant system is still working, he doesn’t know how long that will be the case. “As long as nothing goes wrong, I’m fine,” he says. “But if something does go wrong with it, well, I’m screwed. Because there’s no way of getting it fixed.” "

author: PlainName
author_rank: Super Contributor
timestamp: February 16, 2022, 03:49:12 pm
content: That article is worth a read. But I'm not sure this is dodgy technologyper se: the technology works fine, it's the company financials that don't.

author: BU508A
author_rank: Super Contributor
timestamp: February 16, 2022, 05:41:39 pm
content: I am of the opinion that especially with implants it should be ensured that they do not become obsolete, certainly not for financial reasons. It should be part of this technology that operation is guaranteed even if the manufacturing company has financial difficulties or no longer exists, after all, we are talking about people's lives and health here.

author: jpanhalt
author_rank: Super Contributor
timestamp: February 16, 2022, 06:12:33 pm
content: Those cases present a conundrum. Apparently, both patients were enrolled in research studies -- certainly the first who "helped develop" was -- and were informed of the risks. One would need to review those protocols. Moreover, by 2004 in the US and elsewhere, ethical review by a committee with lay membership was also mandatory. For example, if the device failed, would there be remediation (e.g., removal) or would the failed device be left until a better device was available? Second, to require that a company exist perpetually or have insurance to cover any eventually would not be reasonable in America nor likely in any dictatorship.In terms of advances, huge advances are being made in regenerative medicine, including retinal cell regeneration. Maybe deeper layers of the vision pathway will be next. Implants may become like Kodak film cameras.What about the "gap" between regenerative solutions and implants? In 2004, I can appreciate that the first patient opted for an implant. I would have probably done that too. Maybe in 2011 too. That gets back to mitigation. I think the target should be for the patient to be returned to no worse a condition than he/she was in before the implant, if possible. Is it more risky to remove or leave as is? I suspect the latter is the answer. If it's the former, then the company and its heirs should be responsible ethically for the costs. The procedures were probably performed in a hospital or eye center. Wherever the procedures were performed and the physicians who performed them share responsibility, which of course goes back to the research protocol.

author: SiliconWizard
author_rank: Super Contributor
timestamp: February 16, 2022, 06:17:44 pm
content: Quote from: BU508A on February 16, 2022, 05:41:39 pmOne thing to consider: those devices rarely have unlimited lifetime anyway. So at some point, they need to be replaced. Whether with a device from the same company, or from another one..."Neural" implants in general (with a few exceptions) are a problem, because replacing them, at least the part with the electrodes, in contact with neural tissue, is not always possible (it would destroy said tissue). But it doesn't always last forever...With that said, what do you suggest to guarantee continuous operation of a given company?

author: PlainName
author_rank: Super Contributor
timestamp: February 16, 2022, 06:43:02 pm
content: Isn't this essentially the same problem as having any implant: breasts, hips, teeth, pacemaker, etc. The differentiator is that these things are active rather than passive, but strip that off and I'm not sure there's a significant difference.

author: BU508A
author_rank: Super Contributor
timestamp: February 16, 2022, 11:58:03 pm
content: Quote from: SiliconWizard on February 16, 2022, 06:17:44 pmI do not have any concrete suggestions. I also do not know all the details about how and to what extent the patients were informed. Whether, for example, compulsory insurance for the company that manufactured these implants is a good idea, I am not in a position to judge conclusively. However, it would help if, for example, future measures were to become necessary, such as maintenance or replacement of the implant. It might also be a good idea to archive the know-how behind these implants so that possible successors would have access to them.In any case, I have the impression that not enough has been done to help these people well in the cases described in the article. Perhaps one of the lessons learned from this is that better precautions are needed for such cases and that future research should be taken into account as much as possible.This is all highly speculative and a lot depends on the details and circumstances of how the implantation happened. In any case, I hope that a way can be found to help these people.

author: SiliconWizard
author_rank: Super Contributor
timestamp: February 17, 2022, 06:43:11 pm
content: It's a general problem - putting one's life (or at least part of it) in the hands of a third party.I agree completely with the necessity of informing patients to the greatest extent possible before they make a decision. It's unfortunately not always the case.One thing that could be done from the perspective of the law is to force medical device companies that go bankrupt (and have no buyer) to release all relevant technical information in the public domain, at least for medical devices that are implantable, or otherwise have a major impact on patients' life and have no possible replacement on the market.

author: jpanhalt
author_rank: Super Contributor
timestamp: February 17, 2022, 07:29:32 pm
content: Quote from: SiliconWizard on February 17, 2022, 06:43:11 pmIn the US, it is required de facto by law, licensing, and our wonderful tort laws.

author: m98
author_rank: Frequent Contributor
timestamp: February 21, 2022, 03:32:44 pm
content: I think there should be a criminal law extending what we call "Garantenpflicht" to at least two uniquely responsible natural persons at any medtech company that manufactures active implants, like one medical doctor and the lead design engineer of every product.Those people would be personally responsible to provide ongoing product support in form of medical and technical advice for as long as any customer is still dependent on one of their products.

author: PlainName
author_rank: Super Contributor
timestamp: February 21, 2022, 09:56:12 pm
content: That's not going to be enforceable when they are destitute, suffering dementia or even singing with the heavenly choir. Or put away for 20 years because they won't help.It's is the knowledge that's important, not the people, so mandating that the product design documents are made available via escrow may help. But even then, just having the infor available doesn't achieve anything if it can't be used. Suppose no-one makes an 80186 any more and you really, really need one. Who are you going to convince to make one for you?

author: m98
author_rank: Frequent Contributor
timestamp: February 21, 2022, 11:22:58 pm
content: It certainly isn't the perfect solution, but it could be implemented easily enough since most legal systems already know the concept.There's always a fair bit of institutional knowledge never formally captured on paper. And who is even going to try answering any medical questions based on some collection of design documents? It's not like an ophthalmic surgeon or radiologist is going to look at some schematics or construction drawings.By keeping the people who should have the majority of the institutional knowledge on hook, it is insured that all patients are able to make the best possible decisions about further proceedings.

author: PlainName
author_rank: Super Contributor
timestamp: February 21, 2022, 11:34:03 pm
content: Could be something in it, then. It's not like the concept is unknown - CE marking involves personal responsibility with penalties. But, OTOH, it's also not unknown for the mark to be faked

author: AVGresponding
author_rank: Super Contributor
timestamp: February 22, 2022, 06:15:42 pm
content: Quote from: dunkemhigh on February 21, 2022, 09:56:12 pmPretty sure that could be emulated quite easily, but I take your point, there will no doubt be components that are far more difficult to match, emulate, or replicate.Still, better to make the effort to ensure these things are repairable in the future, than not to.