6 ms·

Who pays the price when cochlear implants go obsolete?

85 points by PebblesRox 3y ago

TazeTSchnitzel 3y ago
Perhaps medical implants should be legally required to have open-source hardware and software.
- skyyler 3y ago
  Could something be done about "planned abandonment"? It's too tempting a profit source.
  - Izmaki 3y ago
    Have the authorities change the requirements for EOL. Hearing Health companies just follow the instructions, pretty much...
- ekianjo 3y ago
  "security" by obscurity is the golden standard here. You don't want to see the massive incompetence at play if everything was open.
  - bombcar 3y ago
    I think, as a society, we do want to see it, slowly, over time. Perhaps requiring they be open sourced after a point in time or to be eligible for medicaid, etc. Maybe only new ones - but eventually we need to clean this up; as we're creating a digital superfund site each time, only covered up by people disposing of them or dying.
    - rektide 3y ago
      Allowing/affording society some ability to come in, to see, to form opinions seems so elemental to progress in general. Pay no attention to the man behind thr curtain forever & ever, everywhere, does not seem like a great strategy for keeping & maintaining a society.
  - bitwize 3y ago
    Gonna go out on a limb and guess that it's enough to send shivers down anyone who's heard the Therac-25 story...
  - rektide 3y ago
    confidence through obscurity? actually a semi interesting argument, which seems likely to be widely accurate in many places.
  - Izmaki 3y ago
    Auditing is a mess more so than security by obscurity. Source: employee.
- RajT88 3y ago
  It's interesting, because in some fashion the private industry has a practice which is designed to prevent against software obsolescence or the failure of their vendor company: Code Escrow. I would love to see a nonprofit/NGO/TLA dedicated to getting such defunct tech open sourced. I am sure lots of great stuff gets archived in hopes of selling/licensing the IP later, and then it never sees the light of day again. To the extent such things get archived at all. This came up in another thread here the other day in fact. And before the same guy chimes in to suggest that governments ruin everything they take on because of corruption: You're still wrong, and you can take that defeatism elsewhere.
- ajsnigrutin 3y ago
  And spare parts and built for repairability. Batteries are practically guaranteed to degrade after a few hundred charge cycles, and totally fail after a few hundred more... with daily charging, that's a timeline of a few years. And with all the breakthroughs in technology, we've gone from replacable batteries everywhere, even with waterproof devices, to impossible or very-hard-to replace batteries, even in large, non-waterproof stuff such as laptops.
- sigstoat 3y ago
  open source doesn’t make modifications free. who is going to take the liability of distributing modifications for other people’s medical devices even with a “no warranty expressed or implied” license? who is going to load “no warranty expressed or implied” software onto their kids brain implant?
- m00x 3y ago
  A much better idea is to have the implant part require a standard connector, while the outside part could be upgraded later on. Medical devices take a TON of money to develop and license, so companies aren't going to open source them.
  - Izmaki 3y ago
    That is exactly how they work. The implant is incredibly "dumb" and very future proof.
    - elzbardico 3y ago
      Exactly. The problem is that the processor is absurdly expensive, up to 10 thousand dollars range in the US if you self-pay.
      - Izmaki 3y ago
        ...and the manufacturing price is so low it makes me physically sad to think about.
    - m00x 3y ago
      Nice, thanks for the info!
- pie_flavor 3y ago
  R&D is financed by the profiteering. Having companies legally on the hook for abandoning their clients is a great idea, but demanding that they allow anyone else to manufacture their design is a great way of ensuring vastly fewer designs.
  - elzbardico 3y ago
    In practice, a lot, and I mean, A LOT of research and development in health is done by universities under government grants from the NIH. Like this https://twin-cities.umn.edu/news-events/university-minnesota-lead-97-million-nih-grant-improve-hearing-restoration https://twin-cities.umn.edu/news-events/university-minnesota...
    - pie_flavor 3y ago
      Universities make good idea guys, but they're not so good at turning them into products. The foundational R is done at universities, and then sold to companies so they can do the specific R and all of the D.
- alvarezbjm-hn 3y ago
  Yes, it would be convenient to treat prostetic devices as drugs and allow generics to be manufactured.
- Izmaki 3y ago
  A lot of OSS is used in modern hearing aids, actually. A hearing aid is closer to a small computer these days than you'd think.
  - ksaj 3y ago
    They fully are computers. I wear hearing aids, and for example, one setting will glom onto voices in the stereo field and track them so the voice remains clear if they are moving around, while damping everything else. They do quite a lot, actually. They typically have 4 settings that the wearer can opt for. Some are "smarter" than others. The one I described is one of the more advanced functions.
LemonLeaf 3y ago
I wonder how companies go about retiring these sound processors on the technical level. Are those in need of continuous updates to keep working? Do they receive a final update one day which bricks them? Since the consequences seem so heartbreaking I would imagine that unofficial ways of prolonging the life time of this hardware do exist?
- pkaye 3y ago
  Probably it will still work but no replacements parts for repair at some point. I know regular hearing aids can be quite moisture sensitive (though new ones are getting much better) so I don't know if these sound processors are the same.
- Izmaki 3y ago
  The firmware on most modern hearing aid devices can be easily updated. These updates may include updates for the sound processing as well, indeed. However, you can't easily "replace the chip" like you can just swap out an old SSD drive with a new, faster model. To the best of my knowledge (first hand experience from the industry), they receive a final update one day and will then only be updated in extreme situations, like, say, imagine you plug in your devices one day and suddenly get a max volume high pitched feedback screech in your ears (this should never happen, ever, mind you). But I'm only guessing here. However, just like my old trusty iPod Touch 1st Generation, they are due an upgrade eventually if you want to use the latest features (my iPod still works, it's just not very fancy anymore...).
floxy 3y ago
Does anyone have insight into the whole story here? There are so many unanswered questions. >Their child’s current processor—a “basic” model designed for the developing market—was becoming “obsolete” and would no longer be serviced by the company. The family would need to purchase another one, said to be a “compulsory upgrade.” ...from the quote above, it doesn't sound like there is anything wrong with their existing hardware. And it doesn't seem like the existing hardware is broken. It sounds like a pushy sales department is trying to scare these people into upgrading to the latest-and-greatest version? Or is there some supposed medical reason you need to adjust the parameters of the device on a regular basis? >In one especially devastating case, a father lamented that his daughter, who had been doing well with her implant, could no longer hear since her device had become obsolete. Is there a timer in the existing hardware that is shutting things off after a certain amount of time? Or it phones home somehow, and gets instruction from the mother ship that it should stop working? Is there more than this one case? I guess the article keeps using the term "planned obsolescence", but I need some more evidence to go on here. Could it be that in this one case, the kid dropped the external processor in the river, and now it doesn't work? And the article also keeps mentioning continued maintenance, but seems to be conflating maintenance with upgrades. Maybe these people are showing up at the audiologist for a "check-up", and the audiologists are bricking the devices in the name of upgrades?
- bentcorner 3y ago
  I think it could be something as simple as the rechargeable batteries no longer hold a charge and they don't manufacture the receiver unit anymore. If you clicked the link [1] in the article, it sounds like designing them to survive regular day-to-day usage is important. Components will wear down over time and replacing them is inevitable. [1] https://www.indiamart.com/proddetail/cp-802-sound-processor-21009148912.html https://www.indiamart.com/proddetail/cp-802-sound-processor-...
  - floxy 3y ago
    >I think it could be something as simple as the rechargeable batteries no longer hold a charge and they don't manufacture the receiver unit anymore. If that was the case, then the author missed a big opportunity use this one sentence to spell this out and lend a whole lot of credibility to the article (that the article is currently missing).
flerchin 3y ago
It's not explained in the article how these compulsory upgrades are being forced. These are not net enabled devices. Perhaps the idea is that the receiver is no longer for sale and cannot be replaced once it has eventually broken?
- elzbardico 3y ago
  Your old processor needs a new battery. it gets damaged. But it was EOL'd a few months ago. No spare parts, no servicing. You need a new one.
Izmaki 3y ago
Here's the thing about cochlear implants that the article at first glance does not tell the reader: * you undergo a VERY expensive surgery. * in the surgery you get installed the actual cochlear implant. * the implant itself is VERY basic and is designed to work with future models of the hearing aid (the one behind the ear). It is therefore, unlike what the article seems to suggest at first glance, not the case that families spend money (a lot of it - upwards $50,000 per ear iirc), only to be told later that they have to go through it all again. I bet what this family experience is a sales department telling them the very real situation that hearing aids - just like smart phones - improve over time and that old models reach an end of life date eventually. There's nothing new here although hearing aids are arguable much more expensive than smartphones - not that they had to be, Hearing Care Professionals make a lot of money per hearing aid. But that's a story for another time.
- firstlink 3y ago
  > families spend money (a lot of it - upwards $50,000 per ear iirc), only to be told later that they have to go through it all again You make it sound like the surgery is the expensive bit, but as you pointed out, the implant is very basic electronics. The medical procedure is certainly expensive, but the processors are the truly expensive physical product.
  - m00x 3y ago
    Do you have a link to a processor with the price? It doesn't sound that complicated to make tbh. It might just all be FDA approvals.
  - Izmaki 3y ago
    The surgery is the expensive bit. It's a 10-to-1* kind of expense compared to the hearing device you attach to the head. * Rough guess based on the price of regular, high-end "in-the-ear-canal" hearing aids.
    - firstlink 3y ago
      > Rough guess based on the price of regular, high-end "in-the-ear-canal" hearing aids. This guess completely missed the point. Cochlear implants are not audio amplifiers like hearing aids are. They must convert sound into electrical impulses which are sent more or less directly at the user's sense organ, via a relatively dumb implant. Now, on the one hand you could say, "yeah well that's just a Fourier transform" but that would also miss the point. A cochlear implant only creates impulses at a limited discrete set of points, and the way those points map to frequencies is not going to obey a nice consistent function. This means the processor must be programmable to adjust the mapping of desired frequency (which may not be the input frequency) to electrodes, which already puts us into needing a rather fancier microprocessor than a hearing aid needs. Moreover, the limited set of frequencies causes a massive loss of signal-to-noise ratio. The processor has to compensate for this intelligently filtering the sound to make the result useful. For example, it may need to detect and filter background noise. It is not really even attempting to replicate natural hearing because that's impossible; it may be more helpful to think of it hijacking the user's aural sense to do something almost totally different with it, but staying just close enough to natural hearing that the brain has a fighting chance of making sense of the inputs.
firstlink 3y ago
The article barely touches on it but the real threat isn't from the manufacturers producing newer and better processors, but rather from insurers/single payers not covering the cost of new processors. I deliberately use the word "threat" to answer the question that several other comments ask, or rather point out it's the wrong one: "Why does the processor need to be replaced with a newer model?" In ideal circumstances, it doesn't. But if the insurer/single payer has declared they will not pay for a new one for some ridiculous amount of time like 10 or 15 years after the previous are bought, then the user is under the constant threat that the old ones will break but not be replaceable.[0] That is only tangentially related to old models being replaced with new ones, although this may be the excuse that insurers/single payers use not to replace lost or broken processors, e.g. by insisting that the old ones be repaired even though that's no longer an option (granted, this example would be a combined problem with the payers and the manufacturers). Apparently the upgrade threat is such an issue that the way even exceptional insurance avoids the issue (per my family's experience) is to purchase the user an extra processor at the same time as the processor is first purchased (or, eventually, upgraded): a preemptive replacement/backup unit. This way presumably the payer doesn't have to have on the books a difficult-to-quantify liability from needing to replace a lost/damaged processor with an unknown future model. [0] Critical context: Unlike a hearing aid, the process of getting a cochlear implant physically destroys any residual hearing the user may have had. When the processor is not present and functioning, the user is completely deaf. And that's little-d deaf, which is the problem: cochlear implant users have explicitly chosen not to enter the big-D Deaf world (which largely rejects implants anyways), and so are completely dependent upon their devices functioning correctly.
friend_and_foe 3y ago
Any company that brings a medical implant device to market should be required by law to establish a trust to fund continued support of the device for the natural lifespan of the youngest/longest lived recipient, period. Also, all designs, software and patents should be open sourced/released to the public domain if the company goes bankrupt or the product line gets sunsetted. This is surgery, these are peoples lives. These are their organs. People that make executive decisions like this are subhuman scum.
- RecycledEle 3y ago
  Putting a requirement to support a product for another 80+ years will prevent small volume product from ever hitting the market and will increase the cost to the consumer. What if we decrease the regulation on things that do not harm the patient when they fail, so they can but a device for $100 on Amazon rather than $10k at the hospital?
  - friend_and_foe 3y ago
    Sure, glasses, hearing aids, that's all fine. If your product needs to be surgically installed in a patient, if you can't afford to support it for the lifetime of the patient the product isn't viable and shouldn't be brought to market.
dusted 3y ago
It should be illegal to implant anything that does not have open documentation and source code available into the human body.

85 points by PebblesRox 3y ago

TazeTSchnitzel 3y ago

Perhaps medical implants should be legally required to have open-source hardware and software.

skyyler 3y ago
Could something be done about "planned abandonment"? It's too tempting a profit source.
- Izmaki 3y ago
  Have the authorities change the requirements for EOL. Hearing Health companies just follow the instructions, pretty much...
ekianjo 3y ago
"security" by obscurity is the golden standard here. You don't want to see the massive incompetence at play if everything was open.
- bombcar 3y ago
  I think, as a society, we do want to see it, slowly, over time. Perhaps requiring they be open sourced after a point in time or to be eligible for medicaid, etc. Maybe only new ones - but eventually we need to clean this up; as we're creating a digital superfund site each time, only covered up by people disposing of them or dying.
  - rektide 3y ago
    Allowing/affording society some ability to come in, to see, to form opinions seems so elemental to progress in general. Pay no attention to the man behind thr curtain forever & ever, everywhere, does not seem like a great strategy for keeping & maintaining a society.
- bitwize 3y ago
  Gonna go out on a limb and guess that it's enough to send shivers down anyone who's heard the Therac-25 story...
- rektide 3y ago
  confidence through obscurity? actually a semi interesting argument, which seems likely to be widely accurate in many places.
- Izmaki 3y ago
  Auditing is a mess more so than security by obscurity. Source: employee.
RajT88 3y ago
It's interesting, because in some fashion the private industry has a practice which is designed to prevent against software obsolescence or the failure of their vendor company: Code Escrow. I would love to see a nonprofit/NGO/TLA dedicated to getting such defunct tech open sourced. I am sure lots of great stuff gets archived in hopes of selling/licensing the IP later, and then it never sees the light of day again. To the extent such things get archived at all. This came up in another thread here the other day in fact. And before the same guy chimes in to suggest that governments ruin everything they take on because of corruption: You're still wrong, and you can take that defeatism elsewhere.
ajsnigrutin 3y ago
And spare parts and built for repairability. Batteries are practically guaranteed to degrade after a few hundred charge cycles, and totally fail after a few hundred more... with daily charging, that's a timeline of a few years. And with all the breakthroughs in technology, we've gone from replacable batteries everywhere, even with waterproof devices, to impossible or very-hard-to replace batteries, even in large, non-waterproof stuff such as laptops.
sigstoat 3y ago
open source doesn’t make modifications free. who is going to take the liability of distributing modifications for other people’s medical devices even with a “no warranty expressed or implied” license? who is going to load “no warranty expressed or implied” software onto their kids brain implant?
m00x 3y ago
A much better idea is to have the implant part require a standard connector, while the outside part could be upgraded later on. Medical devices take a TON of money to develop and license, so companies aren't going to open source them.
- Izmaki 3y ago
  That is exactly how they work. The implant is incredibly "dumb" and very future proof.
  - elzbardico 3y ago
    Exactly. The problem is that the processor is absurdly expensive, up to 10 thousand dollars range in the US if you self-pay.
    - Izmaki 3y ago
      ...and the manufacturing price is so low it makes me physically sad to think about.
  - m00x 3y ago
    Nice, thanks for the info!
pie_flavor 3y ago
R&D is financed by the profiteering. Having companies legally on the hook for abandoning their clients is a great idea, but demanding that they allow anyone else to manufacture their design is a great way of ensuring vastly fewer designs.
- elzbardico 3y ago
  In practice, a lot, and I mean, A LOT of research and development in health is done by universities under government grants from the NIH. Like this https://twin-cities.umn.edu/news-events/university-minnesota-lead-97-million-nih-grant-improve-hearing-restoration https://twin-cities.umn.edu/news-events/university-minnesota...
  - pie_flavor 3y ago
    Universities make good idea guys, but they're not so good at turning them into products. The foundational R is done at universities, and then sold to companies so they can do the specific R and all of the D.
alvarezbjm-hn 3y ago
Yes, it would be convenient to treat prostetic devices as drugs and allow generics to be manufactured.
Izmaki 3y ago
A lot of OSS is used in modern hearing aids, actually. A hearing aid is closer to a small computer these days than you'd think.
- ksaj 3y ago
  They fully are computers. I wear hearing aids, and for example, one setting will glom onto voices in the stereo field and track them so the voice remains clear if they are moving around, while damping everything else. They do quite a lot, actually. They typically have 4 settings that the wearer can opt for. Some are "smarter" than others. The one I described is one of the more advanced functions.

LemonLeaf 3y ago

I wonder how companies go about retiring these sound processors on the technical level. Are those in need of continuous updates to keep working? Do they receive a final update one day which bricks them? Since the consequences seem so heartbreaking I would imagine that unofficial ways of prolonging the life time of this hardware do exist?

pkaye 3y ago
Probably it will still work but no replacements parts for repair at some point. I know regular hearing aids can be quite moisture sensitive (though new ones are getting much better) so I don't know if these sound processors are the same.
Izmaki 3y ago
The firmware on most modern hearing aid devices can be easily updated. These updates may include updates for the sound processing as well, indeed. However, you can't easily "replace the chip" like you can just swap out an old SSD drive with a new, faster model. To the best of my knowledge (first hand experience from the industry), they receive a final update one day and will then only be updated in extreme situations, like, say, imagine you plug in your devices one day and suddenly get a max volume high pitched feedback screech in your ears (this should never happen, ever, mind you). But I'm only guessing here. However, just like my old trusty iPod Touch 1st Generation, they are due an upgrade eventually if you want to use the latest features (my iPod still works, it's just not very fancy anymore...).

floxy 3y ago

Does anyone have insight into the whole story here? There are so many unanswered questions. >Their child’s current processor—a “basic” model designed for the developing market—was becoming “obsolete” and would no longer be serviced by the company. The family would need to purchase another one, said to be a “compulsory upgrade.” ...from the quote above, it doesn't sound like there is anything wrong with their existing hardware. And it doesn't seem like the existing hardware is broken. It sounds like a pushy sales department is trying to scare these people into upgrading to the latest-and-greatest version? Or is there some supposed medical reason you need to adjust the parameters of the device on a regular basis? >In one especially devastating case, a father lamented that his daughter, who had been doing well with her implant, could no longer hear since her device had become obsolete. Is there a timer in the existing hardware that is shutting things off after a certain amount of time? Or it phones home somehow, and gets instruction from the mother ship that it should stop working? Is there more than this one case? I guess the article keeps using the term "planned obsolescence", but I need some more evidence to go on here. Could it be that in this one case, the kid dropped the external processor in the river, and now it doesn't work? And the article also keeps mentioning continued maintenance, but seems to be conflating maintenance with upgrades. Maybe these people are showing up at the audiologist for a "check-up", and the audiologists are bricking the devices in the name of upgrades?

bentcorner 3y ago
I think it could be something as simple as the rechargeable batteries no longer hold a charge and they don't manufacture the receiver unit anymore. If you clicked the link [1] in the article, it sounds like designing them to survive regular day-to-day usage is important. Components will wear down over time and replacing them is inevitable. [1] https://www.indiamart.com/proddetail/cp-802-sound-processor-21009148912.html https://www.indiamart.com/proddetail/cp-802-sound-processor-...
- floxy 3y ago
  >I think it could be something as simple as the rechargeable batteries no longer hold a charge and they don't manufacture the receiver unit anymore. If that was the case, then the author missed a big opportunity use this one sentence to spell this out and lend a whole lot of credibility to the article (that the article is currently missing).

flerchin 3y ago

It's not explained in the article how these compulsory upgrades are being forced. These are not net enabled devices. Perhaps the idea is that the receiver is no longer for sale and cannot be replaced once it has eventually broken?

elzbardico 3y ago
Your old processor needs a new battery. it gets damaged. But it was EOL'd a few months ago. No spare parts, no servicing. You need a new one.

Izmaki 3y ago

Here's the thing about cochlear implants that the article at first glance does not tell the reader: * you undergo a VERY expensive surgery. * in the surgery you get installed the actual cochlear implant. * the implant itself is VERY basic and is designed to work with future models of the hearing aid (the one behind the ear). It is therefore, unlike what the article seems to suggest at first glance, not the case that families spend money (a lot of it - upwards $50,000 per ear iirc), only to be told later that they have to go through it all again. I bet what this family experience is a sales department telling them the very real situation that hearing aids - just like smart phones - improve over time and that old models reach an end of life date eventually. There's nothing new here although hearing aids are arguable much more expensive than smartphones - not that they had to be, Hearing Care Professionals make a lot of money per hearing aid. But that's a story for another time.

firstlink 3y ago
> families spend money (a lot of it - upwards $50,000 per ear iirc), only to be told later that they have to go through it all again You make it sound like the surgery is the expensive bit, but as you pointed out, the implant is very basic electronics. The medical procedure is certainly expensive, but the processors are the truly expensive physical product.
- m00x 3y ago
  Do you have a link to a processor with the price? It doesn't sound that complicated to make tbh. It might just all be FDA approvals.
- Izmaki 3y ago
  The surgery is the expensive bit. It's a 10-to-1* kind of expense compared to the hearing device you attach to the head. * Rough guess based on the price of regular, high-end "in-the-ear-canal" hearing aids.
  - firstlink 3y ago
    > Rough guess based on the price of regular, high-end "in-the-ear-canal" hearing aids. This guess completely missed the point. Cochlear implants are not audio amplifiers like hearing aids are. They must convert sound into electrical impulses which are sent more or less directly at the user's sense organ, via a relatively dumb implant. Now, on the one hand you could say, "yeah well that's just a Fourier transform" but that would also miss the point. A cochlear implant only creates impulses at a limited discrete set of points, and the way those points map to frequencies is not going to obey a nice consistent function. This means the processor must be programmable to adjust the mapping of desired frequency (which may not be the input frequency) to electrodes, which already puts us into needing a rather fancier microprocessor than a hearing aid needs. Moreover, the limited set of frequencies causes a massive loss of signal-to-noise ratio. The processor has to compensate for this intelligently filtering the sound to make the result useful. For example, it may need to detect and filter background noise. It is not really even attempting to replicate natural hearing because that's impossible; it may be more helpful to think of it hijacking the user's aural sense to do something almost totally different with it, but staying just close enough to natural hearing that the brain has a fighting chance of making sense of the inputs.

firstlink 3y ago

The article barely touches on it but the real threat isn't from the manufacturers producing newer and better processors, but rather from insurers/single payers not covering the cost of new processors. I deliberately use the word "threat" to answer the question that several other comments ask, or rather point out it's the wrong one: "Why does the processor need to be replaced with a newer model?" In ideal circumstances, it doesn't. But if the insurer/single payer has declared they will not pay for a new one for some ridiculous amount of time like 10 or 15 years after the previous are bought, then the user is under the constant threat that the old ones will break but not be replaceable.[0] That is only tangentially related to old models being replaced with new ones, although this may be the excuse that insurers/single payers use not to replace lost or broken processors, e.g. by insisting that the old ones be repaired even though that's no longer an option (granted, this example would be a combined problem with the payers and the manufacturers). Apparently the upgrade threat is such an issue that the way even exceptional insurance avoids the issue (per my family's experience) is to purchase the user an extra processor at the same time as the processor is first purchased (or, eventually, upgraded): a preemptive replacement/backup unit. This way presumably the payer doesn't have to have on the books a difficult-to-quantify liability from needing to replace a lost/damaged processor with an unknown future model. [0] Critical context: Unlike a hearing aid, the process of getting a cochlear implant physically destroys any residual hearing the user may have had. When the processor is not present and functioning, the user is completely deaf. And that's little-d deaf, which is the problem: cochlear implant users have explicitly chosen not to enter the big-D Deaf world (which largely rejects implants anyways), and so are completely dependent upon their devices functioning correctly.

friend_and_foe 3y ago

Any company that brings a medical implant device to market should be required by law to establish a trust to fund continued support of the device for the natural lifespan of the youngest/longest lived recipient, period. Also, all designs, software and patents should be open sourced/released to the public domain if the company goes bankrupt or the product line gets sunsetted. This is surgery, these are peoples lives. These are their organs. People that make executive decisions like this are subhuman scum.

RecycledEle 3y ago
Putting a requirement to support a product for another 80+ years will prevent small volume product from ever hitting the market and will increase the cost to the consumer. What if we decrease the regulation on things that do not harm the patient when they fail, so they can but a device for $100 on Amazon rather than $10k at the hospital?
- friend_and_foe 3y ago
  Sure, glasses, hearing aids, that's all fine. If your product needs to be surgically installed in a patient, if you can't afford to support it for the lifetime of the patient the product isn't viable and shouldn't be brought to market.

dusted 3y ago

It should be illegal to implant anything that does not have open documentation and source code available into the human body.