Gift Of Sight Stolen As Medical Implant Company Implodes
from the the-future-is-now dept
Techirt has long discussed how in the modern era, the things you buy aren't actually the things you buy. And the things you own aren't actually the things you own. Things you thought you owned can be downgraded, bricked, or killed off entirely without much notice. That game console with backward compatibility? It no longer has backward compatibility. That smart home hub or smart speaker at the heart of your living room setup you've enjoyed for years? It not long works. The movies and books you thought were permanently in your personal catalog? Sorry, they aren't anymore. That perfectly good two-year-old phone? It no longer gets security updates, putting you and your data at risk.
This is all bad enough when talking about smart home hubs or smart refrigerators, but it's quite another thing entirely when it comes to medical implants. IEEE Spectrum has the Cory Doctorow-esque cautionary tale of Second Sight Medical Products whose Argus optical implants were commonly installed in patients in the early aughts to help them see. Accurately heralded as immeasurably innovative at the time, these devices may soon no longer work or be supported because the company that made them is going bankrupt:
"Terry Byland is the only person to have received this kind of implant in both eyes. He got the first-generation Argus I implant, made by the company Second Sight Medical Products, in his right eye in 2004 and the subsequent Argus II implant in his left 11 years later. He helped the company test the technology, spoke to the press movingly about his experiences, and even met Stevie Wonder at a conference. “[I] went from being just a person that was doing the testing to being a spokesman,” he remembers.
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."
Users went from the miracle of suddenly being able to see their first Christmas tree, to the terror of the gift being taken away from them with absolutely no recourse. Not only that, the systems that were installed create new health complications if they're left installed but stop working, and are difficult to remove -- a cost that has to be eaten by the patients. The company's patients went from having their lives revolutionized by technology to, well, the opposite:
"These three patients, and more than 350 other blind people around the world with Second Sight’s implants in their eyes, find themselves in a world in which the technology that transformed their lives is just another obsolete gadget. One technical hiccup, one broken wire, and they lose their artificial vision, possibly forever."
It's quite the cautionary tale for the entire electroceutical sector, and those who assume the cutting edge technologies that help them today will stick around for tomorrow. It's one thing for your flip phone or Betamax player to become irrelevant, it's another thing for essential health devices embedded in your skull to simply stop working because their manufacturer couldn't keep their finances in order.
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Filed Under: argus i, optical implants, ownership, right to repair
Companies: second sight medical products
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When Musk wants to put a chip in your brain, another reason to flip him two birds over one offense.
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Re:
Easier said than done.
Imagine you're a paraplegic. There's this wonderful new tech which will let you walk again. Only problem is that miracle will be courtesy of an implant which is owned, maintained and operated by a private company whose highest priority is to squeeze you for as much value as possible and will drop support in a heartbeat the very second your existence ends up on the black side of the ledger.
We've already seen that Musk can do anything he likes and there will still be a horde of people aggressively defending him. Some no doubt due to simple fanboyism, but how many do so because they've sunk their pension savings into Tesla and SpaceX stock?
Imagine a future where the average citizen literally faces the choice between upholding their chosen corporate overlord at any cost or being effectively crippled.
I swear, the older I get the more left I swing in politics, because the future I see emerging here is the absolutely worst of Gibson-esque dystopias.
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Horrible, but begs the question.
As someone with a degenerative vision condition, my deepest sympathies to those who might also be losing their vision (and far more dramatically than mine!).
But this begs the question to me...why the hell do these implants have an external dependency? Or need external access for that matter, other than perhaps some kind of battery replacement/charging?
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Re: Horrible, but begs the question.
The external electronics may also need repair, or the software need settings changed, and that requires documentation, not just manufacturer supplied tools.
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Re: Horrible, but begs the question.
A) No electronic system will operate forever without upkeep. A need for Maintenance and repair should be assumed. Maintenance and repair of an electronic device will need to involve software intended to communicate with the eye's software and produce human readable feedback. If you haven't considered that yet, and your statement indicates you haven't, your commentary is half-baked.
Medical devices are very closely regulated. This means the manufacturer gets the advantage of being able to avoid competition. There is no such thing as a generic cochlear implant, for instance. All repairs and maintenance need to go through the specific manufacturer of your device in one way or another. Once the manufacturer goes under, much like with an old video games console, any failure may mean the device ceases functioning. Tools and software will slowly become insecure as vulnerabilities continue to be discovered, and slowly begin to lose compatibility with modern computers as the software ages. Repairs may be so specialized as to be impossible, particularly lacking spec sheets, diagrams, or detailed tear down instructions.
And medical devices actually face the kinds of deadly fears manufacturers use in their FUD to prevent right-to-repair, making them the most resistant to right-to repair legislation which would alleviate the issue.
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Re: Horrible, but begs the question.
There is a processing unit that takes the input from the camera & translates it to the input required for the implant and then transmits that signal to the implant.
The "vision" supplied originally was just a few points of 'light'
The first unit was only 16 electrodes, the 2nd a 60 pixel array.
There were planned upgrades to the VPU to make it 'see' more, but that vanished about the time people discovered the company was done from outside sources rather than the company responsible for putting implants in their heads.
This was early tech research so they hadn't moved towards making it a small easy convenient thing yet. They had started working on a different implant but that seems stalled as the company that acquired and mothballed everything is more interested in their implantable drug delivery system.
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Re: Re: Horrible, but begs the question.
I would be willing to bet also, that there is a bespoke component to this: that every person in who the technology was implanted has to have unique software to drive it, or at the very least, unique configuration information.
What would be the crowning tragedy would be if the purchasing company were to C&D the recipients when they try repairing/replacing broken stuff.
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Re: Horrible, but begs the question.
I have a medical implant. It's not for sight like in this case.
It's to help prevent severe migraines from nerve issues.
So, I'll share my case as a general idea of what it entails.
There are three internal pieces:
In my temple, I have electrodes..one running from near my ear to my eye and another running from my ear down my jaw line.
From there, there are control wires that run from my temple down the side of my neck to my chest.
In my chest, close to over my heart, there's a control device/battery. It's where they would generally put a pacemaker.
In addition to the internal components, there are three other external pieces.
The first is my charger. I use an inductive charger that I use to recharge the battery. Depending on the intensity that the device is using, it can hold anywhere from a few days to about a week of charge at a time. Generally, I just charge it overnight.
The second is a remote. Each case is different so it's a bit of trial and error to see where, when and how often to stimulate the nerve. The implanted control device holds up to five programs at a time. The remote allows you to choose the program and the intensity.
The third one is the one that I don't have any control over. That's reprogramming the control device. I spent about a year working with the support team to find the best settings. I would have to schedule an appointment with them. They would wireless connect to my device and reprogram it. Then I'd use the remote to test the set of five programs to determine the best and feed this info back to them to determine how to tweak future program. Basically about a monthly appointment.
So, if the company goes out of business, I'll have issues with:
Any damage or fault with the control device
If the charger device fails
If my condition degrades, causing the nerves to change, then I can't reprogram the device.
As others have mentioned, medical devices goes under strict regulation, so other companies most likely don't want to deal with the liability of replacement parts for another company.
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Re: Horrible, but begs the question.
"But this begs the question to me...why the hell do these implants have an external dependency?"
Maintenance. As anyone with a relative bearing a hearing aid can attest, the damn thing has to be frequently tuned and checked. Software glitches start creeping in and hardware components start giving way to simple wear. Anyone who owns an SSD in their rig knows that solid state technology doesn't often suffer catastrophic malfunction but it degrades at a predictable rate.
Consider that a pacemaker is to be regularly checked once every six months to monitor battery charge and has to be replaced every 5-15 years or so...the thing is that almost all truly compact tech doesn't have replaceable batteries or exchangeable components. Once their lifespan is up, a new device is needed.
The people in the OP who received this tech are now on a timer where at some point they either get their implants replaced, or they go back to being functionally blind.
And because the tech is proprietary and has turned out not to be a cash cow my guess is that at some point enough incredibly wealthy people will require such implants to buy up the patents and the devices will be available again. At Shkreli-level markups.
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One partial solution for medical devices is to requires that the software source code and hardware design are held in escrow and released if the manufacturer goes out of business or refused to continue to support the device.
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Right to repair is more important than ever for the folks affected.
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Great but for one thing
That's fine and all, but you cannot modify the hardware or software without exorbitant fees and testing.
Why?
Because the moment you make a change, the device is no longer FDA approved and would have to go through a certification cycle, which isn't cheap or quick.
What might be a way out is manufacturers of these devices would be compelled to contribute to a "Medical Superfund" pool, which would be used to remove (and/or replace) their devices from patents' bodies if the original company goes belly up.
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Re: Great but for one thing
The design data is also required to enable repairs, and I presume that less onerous rules apply to the parts of the system that are outside the human body.
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Re: Re: Great but for one thing
Only if the parts outside the human body can't cause parts inside the human body to malfunction in a way that would injure said human body. Establishing that this isn't so may be more expensive than just certifying the whole system, and if so wouldn't be done.
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Re: Great but for one thing
"What might be a way out is manufacturers of these devices would be compelled to contribute to a "Medical Superfund" pool..."
I'm reminded of the aviation patent pool the US government enforced way back when. For those ignorant of history the US had to fly european planes in World War 1 as the patent wars around aviation on US soil kept the US from building any viable form of combat aircraft. The US government solved this by forcing every aviation patent into a common pool with licensing guidelines.
This one stroke is by many believed to be the primary reason the US not only caught up with the rest of the world but became the world's first and strongest air power in both commercial and military areas.
Problem is still that we're talking about literal cybernetics here. A patent pool won't solve the issue of patients facing the choice of having to defend their specific chosen corporate overlord come hell or high water, or actually having their sight or ability to walk taken away...
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One would think that the company should acquire an investment that holds the money it would cost to have the implants removed if it all goes to hell.
Some people are already stuck with disabled implants but can't afford removal.
In the linked story one of the people using this needed an MRI to check for brain cancer... the only information was to contact the company to find out if it was MRI safe... pity there isn't anyone there to answer those questions so getting the detailed test is off the table and a lesser scan has to be used that might not show everything.
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Re:
The obvious problem with that: what about all the other source code the dead company depended on but didn't own? Eg., proprietary tooling needed to recompile the thing. One shouldn't have to agree to arbitrary terms to repair their own sight.
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NIH Policy for Data Management and Sharing
Given most medical industries receive public money from the NIH, one first step could be the new data sharing mandate at NIH.
https://www.nature.com/articles/d41586-022-00402-1
https://grants.nih.gov/grants/guide/notice-f iles/NOT-OD-21-013.html
Clinical trials already have wide-ranging deposit mandates.
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Re:
You know the answer to that. The lobbies will start screaming about socialism, the US right will accuse anyone daring to float such legislation of trying to convert the western world into a communist protectorate and the left (in the US at least, what passes for the "left") will mainly be conspicuously silent because they need still need their campaigns funded.
India and Africa may pull the "compulsive licensing" trick through the WTO again if this turns out to be a thing for more than just optic devices, which it likely will be.
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Wait what?!
OK well we certainly would never place burdensome government regulation in the way of things like this happening. Just tell Byland the free market will fix his problem. He'll probably be greatly relieved.
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Similar to what one of the AC's above noted if there was ever a time to put software and hardware specs into the public domain this would certainly be a prime case, a company going bankrupt should never leave one or more people wondering if they'll be able to continue to see as a result of that.
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Turns out hiding the secret to life altering medical technology behind a paywall was a bad idea. Who could have predicted that?
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Can better disclosure solve this?
It seems to me this problem is partly (mostly?) insufficient disclosure to buyers about what they're getting.
I don't think anybody expects their Alexa or Google Home to keep working if Amazon or Google goes out of business, any more than people think that (purchased, wired) telephones will keep working if the phone company goes out of business (or owners don't they don't pay their bill). I think people know these are just "terminals" for a backend service.
But for things like "purchased" books or films on streaming services, that clarity doesn't seem to be there. If there were more required disclosure about what you're getting I suspect buyers would flock to services that offer a plan for how the buyer keeps their purchase in the event of service provider bankrupcy, etc.
I'm a fan of free markets, but not of fraud - markets work only when the rules of honest dealing are enforced by government.
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Re: Can better disclosure solve this?
What services are those?
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Re: Re: Can better disclosure solve this?
The new ones that would be started to take advantage of the customers looking for that. If buyers knew what they were, and weren't, getting.
Don't underestimate the power of money sitting on the table waiting to be picked up.
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Re: Re: Re: Can better disclosure solve this?
I think perhaps your theory that adding more detail to the fine print of a digital "purchase" would result in the entrenched book publishers and movie studios deciding to release their products DRM-free on some as-yet-nonexistent new market, which would then grow to compete with the entrenched media platforms, is a little optimistic.
Hell, if Comixology is any indication, the likelier outcome is that Amazon would buy it up and nuke the DRM-free download option.
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Re: Re: Re: Re: Can better disclosure solve this?
A correction: Amazon did not nuke the DRM-free download option on Comixology purchases, it just stuck it in a non-obvious place. (Go to Account, Comixology settings, View your Comixology books, and then there's a Backups tab where you can download DRM-free comics as CBZ or PDF.)
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Re: Re: Re: Re: Re: Can better disclosure solve this?
Just saying.... You can also just DeDRM it.... along with regular Amazon book purchases. :)
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Re: Re: Re: Can better disclosure solve this?
"The new ones that would be started to take advantage of the customers looking for that. If buyers knew what they were, and weren't, getting."
There is none.
Within every business sector in the US today profit margins determine whether a given tech has investor attraction. This kind of tech has very slim margins and requires excrutiatingly high investments not just to develop but to maintain.
Meanwhile those same investments will bring a hundred times as high margins by lobbying for higher use of oxicontin or other highly addictive hard legal drugs. Martin Shkreli is not an aberration, he's the norm.
"Don't underestimate the power of money sitting on the table waiting to be picked up."
Look at the timelines here. This tech is 20 years old. This pile of money has been sitting on that table for all that time with no takers because the roi is too small to interest anyone.
Here's my prediction. This tech will be picked up by the nationalized health services of other OECD nations because that's what happens when vitally important yet fundamentally unprofitable technology emerges. The US will once again be left completely behind with this tech being something the 1% send their kids to get from the UK, Germany or France while the american consumer in general has to remain on whatever treatments the market deems profitable enough.
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Re: Re: Re: Re: Can better disclosure solve this?
[Addendum]
And by "whatever treatments the market deems profitable enough." my money is on that being a "treatment" consisting of happy pills prescribed by a US doctor highly incentivized to push as many patients as possible onto a diet of high-priced pharmaceutica meant to take the edge off the patients misery for as long as their medical insurance holds up.
The ongoing opioid crisis, part 2, in other words.
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Re: Can better disclosure solve this?
Its not really disclosure that's the issue. Its the issue that the device's upkeep and maintenance relied on these business remaining a going concern, something which no one can know if it is the case. Cochlear implant patients know how reliant they are on the manufacturer. And these devices are so life changing, and so expensive, that many will simply assume the manufacturer will remain a going concern, because how could they not, even if someone sat them down and told them it was a possibility. Its not even fraud, unless you are claiming Second Sight Medical Products was committing financial fraud and thats why they collapsed.
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Next...
You don't own the implant, you are just leasing it. If you don't pay your monthly fee, it would be a shame if it just stopped working. Pay us more and we'll unlock upgrade features. We'll be tracking everything you do and selling the data. We reserve the right to remove features you paid for at any time. Want it removed? Ha ha!
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Re: Next...
Now if only someone will create the artificial heart / lung / brain.... *evil laugh*
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Too soon?
Looks like removing these eyes will cost an arm and a leg.
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Right on Cue,..
just as microFlaccid announced their shackling of winX+1 users per the Ars article: https://arstechnica.com/gadgets/2022/02/new-preview-build-adds-microsoft-account-requirement-to-wind ows-11-pro/
[next will be that can NOT log even into your PC until you update your subscription payment info] i.e. "All Your Files are Belong to Us."
in ALL cases, removing one's ability to MANAGE one's own devices as well as their OWN Children[per KOSA], all for the purpose to make ever the worse, present situation(s).
Rather an effective means to dissuade one from purchasing new gear, as well as having children,... at least in the venue of the cesspools called cities.
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Re: Right on Cue,..
Are you high?
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Re: Re: Right on Cue,..
why yes, yes i am; currently with an Elevation of 200 ft. above sea level ;)
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The BBC has a story on this as well, https://www.bbc.co.uk/news/technology-60416058
Elizabeth M Renieris, professor of technology ethics at the University of Notre Dame, in the US, described the development as a cautionary tale.
She told the BBC: "This is a prime example of our increasing vulnerability in the face of high-tech, smart and connected devices which are proliferating in the healthcare and biomedical sectors.
"These are not like off-the-shelf products or services that we can actually own or control. Instead we are dependent on software upgrades, proprietary methods and parts, and the commercial drivers and success or failure of for-profit ventures."
Ethical considerations around such technology should in future include "autonomy, dignity, and accountability", she added.
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"Lowes has announced that on March 31st, 2019 that they will be shutting down the Iris smart home platform and all of the related services."
Take a good look at your eyes. Specifically, the iris. If there's an "Iris by Lowes" logo on either or both of your eyes, expect everything to go dark very soon.
Oh, and thank you for shopping at Lowes.
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Re: If there's an "Iris by Lowes" logo
" on either or both of your eyes, expect everything to go dark very soon."
That's because they Don't Want the World to See (Me).
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Late to the party here but you know what would prevent such issues? Public health care with the govt having skilled doctors that could at the very least remove or better, provide maintenance to the implants. That's the issue when some private company screws up and goes bankrupt. When you are dealing with life support stuff it's very, very problematic. Specially when you have proprietary components/hardware and software that go dark with the company.
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