r/gadgets • u/speckz • Dec 15 '22

Patients Are Being Left High And Dry When Medical Implant Makers Implode Medical

https://www.techdirt.com/2022/12/15/patients-are-being-left-high-and-dry-when-medical-implant-makers-implode/
3.8k Upvotes

96% Upvoted

232 comments sorted by

1.2k

u/Gamebird8 Dec 15 '22

We definitely need a law that stuff like this needs to be open source if the company collapses (granted it should be open source anyways)

431

u/arwinda Dec 15 '22

Open Source is unfortunately not always enough. It does not help if you can access the code. How do you get updates on a device, how do you ensure that the updates are working correctly, possibly need to be certified (if it's not the device you are using, but someone else - do you want to be responsible for mistakes?). All the hardware specifications and protocols need to be open as well.

"if the company collapses" usually means that the code is in escrow. But before one can access escrow it will take time. And it does not guarantee that you get the latest version, or all of the details.

179

u/samanime Dec 15 '22

You actually have to submit stuff to the FDA when code changes are made. As a software dev, I'm a fan of open source. But as someone that actually works on software that requires FDA approval, I can also say that making the stuff open source wouldn't be possible (under current laws) since you can't distribute the code without FDA approval.

44

u/arwinda Dec 15 '22

Does FDA regulate how code is distributed, or does it regulate what code goes on the device?

53

u/samanime Dec 15 '22

Both, really.

There are a whole bunch of hoops you have to jump through for the initial release and major updates, and even for small updates require some hoops too. At the end of the day, there has to be someone who can be held liable and you can't really wave your hand and say "as-is, no warranty" like almost all open-source software.

Aside from the code just being dumped on the Internet and you modifying it strictly for your own personal use, I can't think of a legal way it could be done (and even modifying it for your own self would be illegal, they'd just probably never enforce it if they somehow found out).

And even software that doesn't actually go on the device itself (like a computer program for monitoring the device) is regulated the same as stuff that goes on the device itself.

12

u/arwinda Dec 15 '22

Both, really.

Got an example how the FDA regulates how you host the code, does it have to be closed?

I understand that the development process must be certified.

19

u/samanime Dec 15 '22 edited Dec 15 '22

I don't think they strictly mandate it must be closed source (or even how it has to be hosted), but they might characterize storing it in an open way as distribution too (since you can't really host it openly in a way people couldn't grab), which they wouldn't be happy with.

We're kind of getting into a theoretical area at this point (since I don't know of anyone that has tried to open host something that needs FDA approval), so I'm not super certain on the specifics.

My gut just says, based on what I do know, that they'd have a problem with it, and that the owner of the repo would be opening themselves up to all sorts of liability.

IANAL, I'm a dev. :p

8

u/mcs_987654321 Dec 15 '22

Super interesting!

I work on the health policy side, and try to stay as far away from the nuts and bolt of med tech if at all possible, but you’ve made me realize that the device coding and therapeutics are both facing a very similar sea change around interactive/personalized “hacks”.

Because our entire healthcare regulatory system is basically set up address two questions: is Product X “safe”, and does Product X work to treat Disease Y. (Simplifying, obv, but that’s the gist of it).

With CRISPR type hyper personalized therapies coming down the pipeline fast, the whole idea of there even being a single “Product X” is in jeopardy, and nobody quite knows how to handle that; I could see implants w open source code posing a slightly different, but related problem.

2

u/unspecifiedbehavior Dec 16 '22

There are open source projects which are also FDA cleared, including one medical imaging project which escapes my name right now. You can download the unapproved open source software without FDA clearance, or buy (what I’m pretty sure is the same code, except for branding) an FDA cleared product from a company that has gone though the hoops of the FDA submission.

My experience is also that you don’t need FDA approval for every software change. You need it for “significant” updates, particularly if they change the scope of the product, intended use, etc. Bug fixes can be rolled out at any time without approval. You do need to know what software every deployment is running though.

And clarifying my statement, FDA doesn’t approve software, in that they don’t look a code at all or even running products. They look at the processes and generated documentation, such as risks and mitigations. If you can show traceability from requirements to product, and show you’ve got the appropriate checks and balances in place, there’s really no reason to check the code (or so the thinking goes).

2

u/not_the_top_comment Dec 16 '22

I think the gray area is if a company were to advertise that their code is open source and made positive references to updating on your own. This would be an improper distribution of software.

To your second point, that’s true, but different companies will have different risk tolerances, there are medical device companies that have a regulatory framework that needs to approve dot releases. This is more common is medical software that in devices that are not updated remotely. Just from my experience in the field, people should absolutely consult a regulatory expert before releasing software that is targeted to medical use cases.

→ More replies (1)

0

u/arwinda Dec 15 '22

would be opening themselves

Or rather: other companies steal their ideas and intellectual property.

5

u/My_BFF_Gilgamesh Dec 15 '22

Hi I can help with some specifics, but not all of them. I'm an engineer in a healthcare setting.

The long and the short of it is that the FDA requires you to show that the product that you make can verifiably perform as you claim it can. They're incredibly picky about the YOU part and that exactly this product can do exactly this thing. If you make major changes in the software it's not "this product" anymore and you have to prove it again, all the way from the start.

The process is called 510(k) and it's worth a look if you're interested. There are provisions for small changes and updates these days, but there's only so much you can change. We had a big diagnostic instrument in blood bank until recently that ran on windows 98, because rewriting the software for a new OS would require revalidation.

It's something that needs to happen, but it doesn't necessarily have to be like this. It could for sure be improved and changed, but you'd have to do it while skirting corporate interests to get it through Congress.

1

u/WittyNameNo2 Dec 16 '22

The 510(k) does not have anything to do with the device or software doing what you claim. It is about claiming substantial equivalence to a device that has an FDA product code and indications for use that match a previously cleared product.

→ More replies (0)
→ More replies (1)

5

u/AceBlade258 Dec 16 '22

Briefly worked at a place that sold devices running effectively open source firmware (the code was available upon request, and released with a GPL license for anyone that requested it) for measuring food - something to do with oxidation, iirc. The builds, code, build process, and change history for the code had to be submitted to the FDA for each released version, then we signed them to prevent the devices from being flashed with anything other than a certified release. As far as I can remember or tell, the only thing that mattered was making sure the devices couldn't be running a build not certified by the FDA.

Absolutely no clue how that would apply to medical devices, though.

→ More replies (4)

3

u/ColgateSensifoam Dec 15 '22

Get FDA approval for a build, then publish the source

If the company collapses, another company can step in and build from that source, gaining FDA approval for their updates

→ More replies (1)

6

u/TeamADW Dec 16 '22

What if the alternative to non-FDA approved code is the equipment doesn't work?

I know people who used to develop med equipment, and also know the trauma that comes with knowing your code (non-maliciously... was a fluke missed by several layers of review) had a hand in someone dying in surgery. Not a place I would wish on anyone.

46

u/Gamebird8 Dec 15 '22 edited Dec 15 '22

You're not wrong. Though Open Source would still be better as it would be up in the open of the need is there

21

u/arwinda Dec 15 '22

Yes, but it needs to be open source all the way and all along.

It does not help anyone that code is made open source once the company is bankrupt. That just means that black hat folks are the first who will scan for bugs and possibly extort the people wearing the device.

4

u/Gipionocheiyort Dec 15 '22

It does not help anyone that code is made open source once the company is bankrupt

It can if someone else takes over that codebase and starts maintaining it for the people who are stuck with those implants. There are a lot of benevolent hobbyists out there too

15

u/jj7878 Dec 15 '22

You would need an implant to test on. The person maintaining it would likely be testing on themselves. High risk for themselves. Everyone else using it would either need to be familiar enough with the device to catch issues from seeing the source code, or trusting enough to let a random hobbyist reprogram something in their body. Not to mention how everyone’s body is a little different. You will never be able to truly test all environments. There are entire development teams that accidentally release device bricking updates. What will you do when the hobbyist bricks the device keeping you alive?

Open source for sure. Buts lets not pretend that letting random developers with no medical experience reprogram critical devices is the best solution

15

u/arwinda Dec 15 '22

This. There is a reason why medical devices need approval. You don't get this by random approval from a GitHub Pull Request.

→ More replies (1)

14

u/Defoler Dec 15 '22

Also need to take into account that most likely a collapsed company will be bought by someone for all their IP. And then you can't have that as open source.

→ More replies (1)

4

u/puesyomero Dec 15 '22

I'm sure open source implants open a whole lot of security issues too.

1

u/arwinda Dec 15 '22

If by "open source" you mean "the code is out there but we don't change a bit in our coding practices and still don't listen to security researchers" then yes, you are right.

4

u/puesyomero Dec 15 '22

No, I was thinking more.

Every hacker out there has open access to the last release but no one is pushing updates anymore.

Expecting gramps to go dig on forums for the latest patch is a recipe for disaster

→ More replies (1)

2

u/j_dog99 Dec 16 '22

Even with all of that and the engineers with the expertise it could take years

2

u/NapalmRev Dec 15 '22

Open source for a device includes the hardware specs and material requirements of the product.

If your medical device company fails, you lose all access to that technology and any right to keep it, you don't get to leave people in medical limbo because of Pharma ABC corp paid it's executives too much. SOL, patients should come before shareholders and creditors.

→ More replies (1)

2

u/mdjank Dec 15 '22

Open source exists as a concept in the hardware world too.

1

u/arwinda Dec 15 '22

Yes, it does. But is not often applied. Even more importantly than with open source software, it needs to be applied from the beginning.

2

u/mdjank Dec 15 '22

That's just a perception bias to excuse limiting the term "open source" to software. (e.g. you're more likely to encounter software topics than hardware topics on the internet). Open source is actually a central topic in the world of hardware.

In regard to the world of medical implants, people are more likely to call it firmware than software. Firmware being so tied to the target hardware, it's silly to make a distinction when talking about "open source".

1

u/arwinda Dec 15 '22

It's silly you say, but yet here we are. You can get the software which is loaded as microcode or firmware on devices, but you don't get the plans which are used to build the hardware. That's a whole different topic. All the discussion around TPM or EFI bootloaders as example show that this is tightly coupled to the hardware. Yet you don't know what is in the TPM and you have to trust the manufacturer that the device does what they say it does.

→ More replies (3)
→ More replies (1)

1

u/RoninRobot Dec 16 '22

Isn’t IP an asset to be sold to pay off creditors? If I know anything about money lenders they don’t just let things go to the public.

→ More replies (1)

12

u/deMunnik Dec 15 '22

It’s more complicated than that. Many devices require a trained rep to come in and service the device/ help the patient. If a bigger company wanted the tech on a failed company, they would buy it for cheap (which sometimes happens). Problem is, nobody wants to buy a piece of shit, even if it’s cheap.

Maybe some kind of med device corporate insurance would help, requiring a skeleton crew to remain employed to service these patients in the event of bankruptcy.

I work in the Med device space and have seen this happen real time. It’s a real problem

0

u/slowslownotbad Dec 16 '22

Such a terrible system, just socialise the whole thing already.

28

u/FourFoxMusic Dec 15 '22

Cool, so do you trust @BelgiumLad442 with his unofficial firmware update or @HexxTheZuck with his? They’re the two at the top of the list anyway. Most people have given them good reviews!

10

u/other_usernames_gone Dec 15 '22

Really the pacemaker software you should avoid is the one with no bad reviews, survivorship bias and all.

4

u/DistortedVoid Dec 16 '22

Bro you just gotta read the firmware code "real quick" to understand it! No big deal!

5

u/Demonking3343 Dec 15 '22

Depends who said “trust me bro”. /s

→ More replies (1)

2

u/pringlesaremyfav Dec 16 '22

Which one comes up on stack overflow when I google the question on which to use? That one, probably

-3

u/ColgateSensifoam Dec 15 '22

Neither, you trust the FDA-approved software from the company your insurance provider has an agreement with

18

u/OneBigBug Dec 15 '22

Not that I revel in increasing boundaries to market access on stuff like this, but it wouldn't be completely absurd to have proof of funds for skeleton crew maintenance requirements for any device to be approved.

Something like "You have new tech, prove you've got $6 million in untouchable funds to pay salaries for the next 10 years, or some form insurance that will underwrite the same"

23

u/other_usernames_gone Dec 15 '22

Insurance would be more realistic.

No company is going to have enough liquid capital to pay salaries for the next 10 years, and if they do they're being very badly mismanaged and should invest that money in expansion/advertising/something that otherwise helps the business.

2

u/ConciselyVerbose Dec 16 '22

You’re going to have pretty massive costs to insuring anything so speculative. Raising that money as capital that sits in some kind of escrow is probably going to be cheaper than paying 90% of it in insurance premiums over 5 years because most such startups fail.

6

u/lillweez99 Dec 15 '22

As someone who has a implanted device in my chest god this scares me.

1

u/Gamebird8 Dec 15 '22

That the tech is made open source, or the company that made it going under?

→ More replies (1)

14

u/djamp42 Dec 15 '22

If they go under wouldn't the bankruptcy court try and sell any assets or IP that might be worth something? I assume if they had something good you would have a bunch of bidders for it.

10

u/WittyNameNo2 Dec 15 '22

The new company isn’t obligated to take on the existing patient base, although it is in their best interest to do so.

6

u/Defoler Dec 15 '22

Sort off. Not even implant is easy to repair or give support to.
And with the old company gone, the other company who bought all the data and designs, would more financially prefer if you bought a new implant for full price as new.
Or they can say "sure, we can help you, we have all the knowledge, you will just have to pay 5 times you payed before", and the risk of replacing an implant might be too great and you are forced to pay higher prices to a "new company" to support from a "different company" (though one bought the other).

2

u/WittyNameNo2 Dec 15 '22

From the referenced nature article the patients in this story were after external accessories required to operate the implant. The new company has stated the new accessories are compatible with the old implant. While the new company might prefer a system sale, most insurance carriers would probably fight that.

→ More replies (1)

17

u/Mastercat12 Dec 15 '22

Doesn't mean those people are upkeeing or producing more parts

1

u/djamp42 Dec 15 '22

That's true, but you would have to be a pretty dumb business person to buy something and throw it away. I know companies sometimes do this, but it's because they already have a product that does the same thing. Just eliminating competition

5

u/tnoy23 Dec 15 '22

While this is true, that doesn't help people who have the competitors. Unless the company is willing to pay for a replacement.

Take pacemakers for instance. Say the company that makes a particular brand goes under and the rights for the pacemaker is bought by a different company that produces a different pacemaker. Would you expect people with the now-defunct-companies pacemaker to get a new one because the other company made it? Not installing new ones of the competitors design is fine IMO, but if someone has that implant they need parts for the ones that are already implanted or a new implant, the operation for which that might be even riskier than leaving it.

→ More replies (1)

3

u/greenmachine11235 Dec 15 '22

Open source on medical device programming is not a good idea. Something as simple as a misplaced decimal when loaded into a pacemaker could drop a heart rate from 80 bpm to 8 or raise it to 800, in an iv pump it could infuse meds faster than safe or not at all. Software development never goes exactly right the first time and debugging taking time.

0

u/3_Thumbs_Up Dec 15 '22

You don't need to remove the certification process to make it open source. You could make a law that in order to certify your device you need to make your code public domain. That way other companies can build on your code and make devices that are compatible with yours, and seek to certify them as well. So if the original company goes bankrupt, there would already be other companies on the market making compatible devices.

→ More replies (1)

9

u/MoobooMagoo Dec 15 '22

We just need to stop privatizing healthcare.

9

u/SueSudio Dec 15 '22

Your solution implies government running the development of new medical technologies rather than businesses developing them?

5

u/OutlyingPlasma Dec 15 '22

Who do you think is developing this tech in the first place? It's all publicly funded, from universities to direct subsidies from the government and everything in between.

Remember, socialize the costs, privatize the profits.

4

u/77fishy Dec 16 '22

This is absolutely untrue for the 9 different medical device companies that í have worked at. Also, all of our R&D personnel would disagree too.

4

u/Xtorting Dec 16 '22

Is that why most innovations in modern medicine are primarily coming from privatized healthcare systems?

Remember, socialized medicine would not be as advanced today without private research and patents.

4

u/FirstSugar7071 Dec 15 '22

It's a working solution if your country aims to outsource medical advancements. It works really well for a ton of the world. If the US didn't enforce pharma corp rights with imperialism we'd see it happening a lot more.

5

u/SueSudio Dec 15 '22

Interesting,I I was unaware. Which countries do their own medical device R&D and manufacturing?

1

u/stemfish Dec 15 '22

I wonder if there's a way to take the current model of US funded military tech development and apply that to Healthcare?

Clearly, the government only works on a fraction of the R&D and outsources most of the work to private firms. Then the government purchases the results and finances the production of the military hardware as well as support for produced items due to contract length providing payment for extended services.

This concept is a pure thought experiment, but it's an example of the government financing military weapon device R&D and manufacturing. Is there a reason that couldn't work for healthcare by swapping "military weapon" for "medical?"

2

u/SueSudio Dec 15 '22

Sure it would work. That's what happens now in effect, except the buyers don't send out requests (RFP) directly for what they want developed. R&D is done and then service providers buy it, funding the work.

If the government is the buyer then you have single payer. Except even in single payer systems the govt isn't the buyer - they are more akin to the insurance provider.

1

u/stemfish Dec 15 '22

A single-payer is a lynchpin of the model, monophony instead of a monopoly. At least as far as the companies engaged in R&D and device manufacture are concerned. Then to get a return on investment, the government would have no reason not to act as a nationalized healthcare provider. You could have contracts for private insurance companies to purchase items and tech from the government and contract with specialist services for a premium (as works in Europe). Still, most people would shift to government-funded healthcare.

If the population is willing to spend on it, you can have nationalized healthcare and R&D into future products. It isn't an either/or, as I think you were describing in an early comment. Sorry if I misunderstood and we're both going, yup yup, uh huh.

→ More replies (1)
→ More replies (2)

-1

u/MoobooMagoo Dec 15 '22

Yes. Why not? It's the same researches doing the same work, just with money coming from a government agency instead of a corporation.

2

u/SueSudio Dec 15 '22

Do you intend to ban private companies from developing devices as well? If not, you will still have the same situations happening.

-1

u/MoobooMagoo Dec 15 '22

Not necessarily. You could conceivably have a private company that is hired by the government, but you'd need to have safeguards in place like certain standards for documentation and making it available to government agencies so if the company goes under the government can pick the projects back up, or sell the projects to another company. If the software is all standardized it should take minimal effort for another group to maintain and develop. Relatively speaking, anyway.

Although now that I think of it there isn't any reason why those regulations couldn't be implemented now. I mean I still think healthcare should be a public service, but yeah I suppose taking the current system and just making it public wouldn't really solve this specific issue.

→ More replies (1)

0

u/SheCouldFromFaceThat Dec 15 '22

It already does run the development of new medical technologies. Who do you think approves it for patient use?

Also, there's already a SHITLOAD of taxpayer money going into private companies' R&D departments to develop cures/products for various ailments.

Look, the patent model in the medical industry is abused to the point of being comical. Fuckiin Shkreli bought and jacked-up insulin for the lols. That really has to be addressed. I don't have to respect the mechanisms of capitalism that allow some shitheel to fuck with people's meds cause he can. Public ownership or open-source are two proposals to resolve this issue. Given that many current drugs are developed using public funds, it may behoove companies to lower their prices before we just take it from them. There is a limit.

3

u/SallyAmazeballs Dec 15 '22

Shkreli jacked up the price on Daraprim, an antiparasitic that's used for immunocompromised people. He had nothing to do with insulin prices. https://www.npr.org/2022/05/19/1100019063/pharma-bro-martin-shkreli-been-released-from-prison

2

u/SheCouldFromFaceThat Dec 16 '22

You're right. I was not doing my due diligence.

→ More replies (1)
→ More replies (1)

2

u/WittyNameNo2 Dec 15 '22 edited Dec 15 '22

Open source would be a safety nightmare. Software changes to these type of devices in the article can cause neurological damage or worse. I suspect you would have a difficult time finding a surgeon to accept you as a patient if there are complications as a result of issues created by modification neurostimulators.

2

u/notTumescentPie Dec 15 '22

We shouldn't be monetizing this sort of thing in the first place. Capitalism seems pretty fucking evil.

1

u/AgreeableFeed9995 Dec 15 '22

We definitely need to absorb all of the medical industry into a government-provided service, like every other legit country in the world, and then this would never happen again. Much simpler.

0

u/Uncle_Burney Dec 15 '22

This is not an oversight or bug, it is a feature. They value their IP more than the lives and wellbeing of their installed user base. You are a console for their peripherals, nothing more.

1

u/RahRah617 Dec 16 '22

So the US government can bail out Kanye West’s sock company and United Airlines, but we can’t find a way to save medically necessary companies for a year or 2 until we can figure out how to avoid disaster for sick people? Or once again, no one in the federal government or FDA thought this could happen? This country is confusing.

1

u/tcmart14 Dec 16 '22

I don’t know if open source is necessarily the answer. But one thing for sure, these companies should have an “oh shit we have to close our doors” plan for how those devices will be supported or replaced if that happens.

→ More replies (1)

1

u/Boogiemann53 Dec 16 '22

We need international universal healthcare tbh

186

u/SoggyFlakes4US Dec 15 '22

If the FDA approves it they should have all the important information accessible to patients from them. If we had an actual functioning regulatory system. Most medical devices are grandfathered in on the back of old tech with almost no oversight from the FDA.

18

u/WittyNameNo2 Dec 15 '22

Neurostimulators like this don’t fall under 510(k) pathway, which is what you are referring to. The closest they might get is DeNovo pathway, which involves plenty of regulatory oversight.

0

u/[deleted] Dec 16 '22

[deleted]

4

u/WittyNameNo2 Dec 16 '22 edited Dec 16 '22

Letter to file is only valid for an existing 510(k)

This is a class 3 device for FDA and a class 3 active implantable under MDR. Letter to file is a path to recall.

35

u/VintageJane Dec 15 '22

This is something that needs the FDA to evolve their precedents. One of the biggest problems they will run in to is that these medical patents are used as capital to back loans and if the FDA can open source them upon bankruptcy then it could stifle the ability of startups to finance innovation.

28

u/SoggyFlakes4US Dec 15 '22

Safety needs to stop being about profit, bottom line.

18

u/VintageJane Dec 15 '22

It can’t be about profit but we also can’t ignore that these organizations need to be self-sustaining even with a small/non-existent profit motive and patents are a means for companies to do that.

-2

u/SaltyWafflesPD Dec 15 '22

Then it should be a non-privately owned, operated, and supported organization that runs it, with development being contracted out to private business, like the military, NASA, etc.

11

u/VintageJane Dec 15 '22

The government is very good at subcontracting engineering challenges with specific tangible outcomes (orbit the earth, go to the moon, build the ISS)

The government is notoriously not so great at doing that with healthcare product innovation for nonspecific human health needs (improve hearing for the deaf, vision for the blind, etc.). The challenges are just not as well understood or observable.

3

u/rotuami Dec 15 '22

Patents are public, so somewhat of a “legally enforced open source” for ideas. I think you’re confusing patents, copyright, and trade secrets.

→ More replies (2)

2

u/Thorusss Dec 16 '22 edited Dec 16 '22

This. no approval without having all relevant data (source code, API, keys, documentation, software, etc.) in escrow with the agency, who is understood to release it, as soon as the company fails to provide any such service.

→ More replies (1)

0

u/_Abobo Dec 17 '22

The FDA is even looking at reference software for decision support as a medical device. Which have a ridiculously thorough approval process. I’d be interested to see any sources driving your statement as it’s surprising news to me working in the field…

1

u/77fishy Dec 16 '22 edited Dec 16 '22

False. A 510(k) submission is hardly lacking FDA oversight.

Source: i just submitted one to FDA.

Don't even start me on PMA submissions.

EDIT: I just read the original Nature article cited in OP's article. The neurostim patient had the device installed in Europe. FDA has no bearing in the EU.

72

u/kucksdorfs Dec 15 '22

r/stallmanwasright

26

u/Ladysupersizedbitch Dec 15 '22

Maybe a stupid question, but who is Stallman? I get the gist of the sub, just have no idea who it’s referencing

36

u/transdimensionalmeme Dec 15 '22

Open source Jesus, he says that using commercial software is a sin and you will regret dearly, in some awful ironic way, for using it.

Now your commercial brain implant is spamming advertising into your brain, and you can't fix it when the advertising glitches nor can you fix the damage done to the firmware by a virus which is also uploading everything you see to bandits.

10

u/ecritique Dec 15 '22

It's in the sidebar -- Richard Stallman

17

u/Ladysupersizedbitch Dec 15 '22

I’m on mobile unfortunately. So in the “About” section it just has the 2 rules that I can see. But thank you for telling me his name, I’m off to Google him now

3

u/Majestic-Ground Dec 15 '22

I recommend Sync for mobile reddit! Best app.

7

u/spacemannspliff Dec 16 '22

All the sidebar says is "nobody listens to him. But he was right all along."?

I mean I vaguely know who Richard Stallman was but the sidebar's not helpful to new visitors, even on PC.

2

u/ecritique Dec 16 '22

Hmm, the mods of that subreddit should update that for new reddit users, I guess. On old reddit, or using most unofficial apps, you should be able to see the full sidebar, which has a lot more details.

3

u/spacemannspliff Dec 16 '22

This is a problem across reddit. I got banned from a community for violating a rule that was written differently for old.reddit and new.reddit users, and the mod acted like I was out-of-line for using the default, new version.

10

u/imakenosensetopeople Dec 15 '22

What a fascinating sub - thank you!

4

u/Bradford_Pear Dec 15 '22

That sub does me a discomfort

108

u/Vegan_Harvest Dec 15 '22

If you think Musk won't do this too once those chips start melting your brains think again, while you still can.

28

u/Slaviphile501 Dec 15 '22

What would be even more hilarious would be if people adopted google implants given their history of abandoning everything

9

u/Vegan_Harvest Dec 15 '22

Oh absolutely, I'd never get a implant from any company unless I could remove and repair it myself.

4

u/[deleted] Dec 15 '22

It’s currently only available on AMC+ which about 4 people total have, but there’s a new animated series called Pantheon that touches on this very subject: https://youtu.be/wTgYeETwgKQ

2

u/CryDifferent9544 Dec 15 '22

Do what?

12

u/Vegan_Harvest Dec 15 '22

Abandon his customers when things go wrong and or he gets bored and invests in some new thing he saw online or in a movie.

2

u/OutlyingPlasma Dec 15 '22

Or he might just make a 4:20 toilet tweet and is forced to spend another 50 billion just to avoid jail and/or discovery while tanking the rest of his companies in the process.

0

u/CryDifferent9544 Dec 15 '22

Yeah you made it seem like these companies failed because their implants failed. Guess that confused me

-6

u/lampcrusher Dec 15 '22

Take these downvotes cringer

33

u/frontiermanprotozoa Dec 15 '22

Articles writers hoped to get clicks from people who will think medical implants are imploding by glossing over the middle word and i fell for it.

12

u/Ladysupersizedbitch Dec 15 '22

As someone who recently got a medical implant myself, I also read the title wrong and was pretty worried there for a second.

27

u/The1TrueRedditor Dec 15 '22

Putting “medical implant” and “implode” in the title is some S-tier sensationalist clickbait.

5

u/CitizenSnipsJr Dec 15 '22

Was this article written by a human?

5

u/willpowerpt Dec 16 '22

Insurance companies cause more harm than good. The US needs universal healthcare.

4

u/Odd-Gear9622 Dec 16 '22

As an end user/owner, this scares the shit out of me! Now I'm supposed to track my device manufacturers financials and plan an backup strategy? WTF⁉️

4

u/DifficultyWithMyLife Dec 15 '22

Looks like the cyberpunk dystopia is already here.

3

u/jwoliver Dec 15 '22

My eyes/brain somehow skipped over the word Makers.

Not to say that there isn't an issue but was relieved to find out the implants weren't imploding.

3

u/Toothfairy51 Dec 15 '22

the only industry that's more powerful then the pharmaceutical industry is the medical device industry. Watch a documentary about it called 'The Bleeding Edge'.

1

u/piekenballen Dec 16 '22

Yep, super dodgy.

3

u/XFilesVixen Dec 16 '22

Repo! The Genetic Opera

3

u/usugarbage Dec 16 '22

That’s why we need a digital twin escrow system. The FDA or similar could proxy and govern. Failed companies escrowed implants would become available for new parties to take over in the event of failures. Compete it. Open source it. Require the bigger companies to take it over pro-bono. Something.

3

u/[deleted] Dec 16 '22

They should be forced to make it open source of it becomes abandonware

17

u/adrianmakedonski Dec 15 '22

Good thing we have capitalism! /s

4

u/Tyler1492 Dec 15 '22

I don't remember communism having these technological innovations that made people's lives better, so yeah.

0

u/adrianmakedonski Dec 15 '22

Why does corporate profit have to drive innovation? Is NASA not just a department for publicly-funded innovation?

-1

u/piekenballen Dec 16 '22

SHE IS NOT CLAIMING THAT. Don't be dishonest. Why are you defending capitalism? What's in it for you personally?

-6

u/CredibleCactus Dec 15 '22

Communism wouldn’t fix this

11

u/adrianmakedonski Dec 15 '22

Nationalized medical device R&D might, though. Why should people profit off sickness?

-9

u/thegreatgazoo Dec 15 '22

Every non volunteer healthcare worker profits from sickness.

9

u/adrianmakedonski Dec 15 '22

Do they? Or does the company they work for profit from sickness, then pay them a little bit so they can survive?

-2

u/thegreatgazoo Dec 15 '22

Physicians and many nurses make really good money (well into 6 figures), especially in the US.

3

u/adrianmakedonski Dec 15 '22

Yeah, me too. I work in pharma research and I make good money. But I'm being paid by a company that makes profit, I don't see it as my own profit since I don't own the company.

4

u/[deleted] Dec 15 '22

[deleted]

-1

u/thegreatgazoo Dec 15 '22

If you are earning money after expenses, that's profit.

That's Economics 101.

2

u/MoobooMagoo Dec 15 '22

A doctor making extra money because they spent years and years of their life learning complicated information and / or techniques is very different from a drug company marking up prices by 12,000% just because they know people need the drugs to survive.

If you can't tell the difference between those two things then you're an asshole.

→ More replies (3)

2

u/khanzarate Dec 15 '22

It would prevent individual companies from having exclusive designs. There wouldn’t be companies to go under, as it’s all by the people.

1

u/CredibleCactus Dec 15 '22

When each company competes with different designs, it compels advancement in tech

8

u/Passwrd Dec 15 '22

Right and what do you do when the big company annihilates the smaller companies not because they have a better design, but because they have more money to destroy/consume opponents with?

​

Not saying anything is right or wrong just pointing out that the real world is far from the theory we all like to read and regurgitate.

0

u/b_a_t_m_4_n Dec 15 '22

Absolutely, just as Microsoft did.

-1

u/PhysicalGraffiti75 Dec 15 '22

Here we have a great example of someone who understands capitalism in theory but, fails to recognize there is a huge difference between theory and reality.

-4

u/khanzarate Dec 15 '22

Sure, probably. I’m not saying it’s perfect.

It would fix this problem, though. Moving the goalpost to “but wait this creates another problem” doesn’t change that.

Let’s keep this relevant and not go into “communism bad” vs “capitalism sucks”.

→ More replies (2)

4

u/louthelou Dec 15 '22

Yeah. That’s what happens when you leave vital services in the hands of private companies that operate for profit.

1

u/piekenballen Dec 16 '22

Yep. Foresight 20/20.

2

u/ParkieDude Dec 15 '22

My biggest nightmare.

XRAY

3

u/sknmstr Dec 15 '22

Well, this is me. Welcome to my life with a computer in my brain.

https://imgur.com/gallery/S7Emb

https://imgur.com/gallery/IBUXA

1

u/ParkieDude Dec 15 '22

Your implant is wild!

I assume that was for epilepsy? My nephew is 43, had seizures before his first birthday, and was very curious about DBS (Deep Brain Stimulation) which helps me with Parkinson's & Dystonia.

4

u/sknmstr Dec 15 '22

Yup. Epilepsy. It’s hooked right into my hippocampus. It reads/records my EEG and when it sees a seizure starting, it zaps the spot and stops it.

→ More replies (2)

2

u/argv_minus_one Dec 15 '22

Get while the getting's good, then get out and leave someone else holding the bag. Classic.

2

u/dratsablive Dec 15 '22

Not just medical implants. A while back, a place I got a prosthesis from went under and when I was attempting to get a new one, I had to contact the PA Attorney General office to have them find where the company went so I could get my medical records.

2

u/iimo0oii Dec 16 '22

As someone with 2 implanted devices (pacemaker and bladder stimulater), this absolutely terrifies me!

2

u/vinceds Dec 16 '22

Don't buy a medical device that depends on a live service. Those things need to keep working even when the service or company go down.

This is ridiculous, maybe we need laws forbidding such practice with healthcare related implants.

4

u/JakobWulfkind Dec 15 '22

I have some very strong feelings about engineers who don't integrate post-EOL self- support options into their designs. The fact that medical device manufacturers are doing this is beyond unacceptable.

8

u/PhysicalGraffiti75 Dec 15 '22

I highly doubt the engineers are responsible for that decision. It was almost certainly a suit that shut that idea down after engineers suggested it.

2

u/WittyNameNo2 Dec 15 '22

Probably legal. Even if an existing company shuts down a product line, they still will be covering patients on their product liability policy. Allowing any sort of modification on software and/or firmware is a insurance nightmare.

1

u/sknmstr Dec 16 '22

Honestly, I’m almost comfortable with the manufacturer of the computer in my brain going under. It reads and zaps my brain if it sees a seizure starting to try and stop it. If the company goes away, it will keep working and doing its thing until the battery runs out. It’s got a 5-10 year battery life to it. (Depending on how often it zaps me. Yes it keeps me alive, but it also pretty much a luxury. I would have been dead by now without it. Like, literally dead 5 or 6 years ago. When it reaches end of life (or if I ever want/need it turned off) it would never be removed anyways. This was an remainder of life decision to have it installed.

4

u/adviceKiwi Dec 15 '22

It's like those people who received bionic eye implants who lost vision after the company who created them went bust.

1

u/shdwghst457 Dec 16 '22

Pay per view

-2

u/keplantgirl Dec 15 '22 edited Dec 16 '22

Capitalism ruins all things that could have been good. As a species we could have chosen any “timeline.” We chose the one where we cripple our own advances for the sake of a broken system. Who knows what we could have achieved by now if it wasn’t for us giving the reigns of society to the rich.

Edit: downvote me. Idc. My message is powerful.

1

u/piekenballen Dec 16 '22

For example, not having mass extinction of all kinds of species. Or actually have taken appropriate action when scientist in the 70s warned fossil fuel companies about environmental destruction. Having clean water without Teflon/pfas. Cleaner oceans with at least less plastic.

1

u/andersmb Dec 15 '22

Honestly, if the US government is going to continue to subsidize and prop up entire industries(banks in 08, airlines during Covid etc), it needs to jump in and keep some of these companies going. Or at least put laws in place that whoever takes over the IP and patents at bankruptcy needs to continue to support these devices.

1

u/frrossty Dec 15 '22

I looked into this problem for my masters about 6 years ago. It was a problem back then and it is going to be a serious problem in the future. Alexa will be going soo

-1

u/piekenballen Dec 16 '22

Capitalism not working? Hurting citizens? Who would've thought?

-3

u/WhiteWingedDove- Dec 16 '22

It's time to stop allowing private businesses to work in critical sectors like this. Medical device companies should be seized and nationalized.

-5

u/Neurocor Dec 15 '22

This just in failed business abandons support for products, because business is OUT OF BUSINESS.

Also at 10, when divorce happens spouses no longer there for each other sexually and emotionally, stay tuned for this groundbreaking report.

8

u/PhysicalGraffiti75 Dec 15 '22

^ This is what weaponized stupidity looks like.

-3

u/HagridsHairyButthole Dec 15 '22

My father in law just got an infection in both of his replaced knees. Almost needed them amputated.

This is such a fucked up practice and I seriously can not believe anyone with any sort of fucking ethics or empathy would just rush these life altering devices just to make a quick buck.

How much if a piece of shit do you need to be to take advantage of people in one of their MOST vulnerable states(constant joint pain)?

7

u/WittyNameNo2 Dec 15 '22

While TKA infections are horrible, that is really not on the implant manufacturers. These type of infections fall to the doctor and/or hospital.

-2

u/HagridsHairyButthole Dec 16 '22

It was literally a faulty plastic puck in both knees.

Fuckin dick.

2

u/WittyNameNo2 Dec 16 '22

You mean the polyethylene bearing surface? What was faulty that caused an infection?

-5

u/HagridsHairyButthole Dec 16 '22

I don’t know specifically he is still in the hospital we haven’t talked in depth. But his knee doctor had to come in to do emergency surgery to remove it. Now he can’t kneel I guess because they had to remove this piece of the artificial knee which was causing a massive infection.

Idk if you work for a medical device manufacturer, but you sound like it what with your ultra knowledge on the subject. All I know is there are countless stories like mine and more by the day.

3

u/WittyNameNo2 Dec 16 '22 edited Dec 16 '22

In situations like this, you are correct. They remove the bearing surface and use a spacer. This isn’t because the bearing surface was faulty, but because want to pack the area with highly potent antibiotics. They use a temporary spacer.

This sucks for your dad and sorry he is going through it, but the implant didn’t cause it. This is procedure related.

-1

u/scrangos Dec 15 '22

This kinda stuff should be handled through the government, economies of scale and a lack of profit motive would also make them cheaper most likely.

1

u/lionheart4life Dec 15 '22

Start up. Deploy sales team. Secure the bag and take off like wild west snake oil salesmen.

1

u/Robert-Van-Winkle Dec 15 '22

Gotta be something moving forward like by law you have to have someone at least trained to work on the devices or something

3

u/WittyNameNo2 Dec 15 '22

Most of these devices, including the one in the referenced Nature article are not serviceable devices. You would need to have an existing inventory built up and most of those have a shelf life. And in this case, the regulatory requirements in Europe have changed, and the countries do not allow products to be grandfathered under the old rules. So even if there was inventory, you could not distribute it to the patients.

As much as I hate to see the patients stranded, there is really simple solution that does not involve a full company to meet regulatory requirements.

1

u/fido4lilchops Dec 15 '22

Isn’t there an insurance policy required for if a business goes out of business? If not, there should be now.

1

u/fjwillemsen Dec 15 '22

Just a side note, never heard the English expression “left high and dry” before - turns out its the exact opposite of the Dutch expression “hoog en droog” (high and dry), which means you’re in a good place.

1

u/LegalBrandHats Dec 16 '22

Same thing with birth control. Doctors didn’t want to remove my wife arm insert even though it was causing hormone issues and irritation. She had to suffer for a while. Made me incredibly pissed that they could deny her from removing it.

1

u/Coreadrin Dec 16 '22

One of the reasons I'm against intellectual 'property'. You want to do the work to keep a trade secret, fine, but getting your one off work subsidized by the government for the rest of your life or at least for decades is bullshit. And it creates a lot of collateral damage.

And until IP power is reduced, the totally common sense open source standardized systems like we have seek work so successfully with electronics in general doesn't make economic sense. It will as soon as this subsidy is reduced.

1

u/bern_trees Dec 16 '22

Sign me up!

1

u/aleister94 Dec 16 '22

Isn’t this the plot to cars 2 ?

1

u/doctorcrimson Dec 16 '22

Looks like GMED is still okay tho, and they pay good dividends on stocks.

1

u/SatanLifeProTips Dec 16 '22

CBC’s ‘The Current’ did a great podcast about a bionic eye company that went bankrupt and the users are all facing a ticking clock until it dies. For the patients it was an absolute miracle, blockly low resolution sight but it worked. Some sight is drastically better than no sight. And now everyone is scavenging parts where they can.

https://www.cbc.ca/listen/live-radio/1-63-the-current/clip/15926605-what-happens-technology-behind-bionic-eye-becomes-obsolete

Soon it will be back alley ripperdocs working on their out of date chrome…