4 ms·

Why in the world did the reporters not try to investigate the FDA rules that supposedly prevents this, instead of trying to shame the company? Either the compan

Why in the world did the reporters not try to investigate the FDA rules that supposedly prevents this, instead of trying to shame the company? Either the company is wrong, or that's the real story here.

Me000 2y ago
[flagged]
fakedang 2y ago
My thoughts exactly. But then again, journalists have long ceased to be investigative or technologically versed.
- jonny_eh 2y ago
  It's almost like there's no money left in the profession, so there's no more expertise or time available to do proper investigating or writing.
  - thaumasiotes 2y ago
    If that were true, the job would be done by someone who took a personal interest in the subject and didn't need to be paid for reporting it. This is the opposite; it's someone doing a bad job because there's money in the profession and they want to get some of it without actually doing the work that would earn it.
    - paulryanrogers 2y ago
      Perhaps. Yet more likely that they're pressured into publishing so often they have little time for thorough investigations. If there were more money in it more people could afford to do it full time, and quality could improve.
    - kevinventullo 2y ago
      So by that logic, public defenders are your best bet if you get arrested?
    - surgical_fire 2y ago
      > job would be done by someone who took a personal interest in the subject and didn't need to be paid for reporting it. You mean that the job would be done by shills then? Why would anyone provide free labor otherwise?
      - thaumasiotes 2y ago
        Why did you write your comment?
        surgical_fire 2y ago
        I am not performing a job, if that is what you are implying.
    - xeromal 2y ago
      OR it pays near nothing so the bottom of the barrel gets hired at low wage to keep the ghost shipping running
    - deleted 2y ago
      [deleted]
    - consteval 2y ago
      > the job would be done by someone who took a personal interest in the subject and didn't need to be paid for reporting it I think we already have this, it's marketing and advertising. People are happy to report on things they care about, even burning money to report on it. It's just that the reason they care is because it's their thing, and they want you to buy it.
crazygringo 2y ago
I mean, I guess it does make me curious how you should go about regulating a device like this. Like, if the metal fails and you have a horrible fall and break your hip and shoulder, that's pretty different from an iPhone that won't turn on. If this is only approved for 5 years, shouldn't the guy be replacing it rather than repairing it? And shouldn't health insurance be covering that, at least beyond the deductible or whatever?
- dataflow 2y ago
  > I mean, I guess it does make me curious how you should go about regulating a device like this. That's actually my point. There's an interesting policy discussion to be had here, and instead of starting it, they just decided to smear a company. > Like, if the metal fails and you have a horrible fall and break your hip and shoulder, that's pretty different from an iPhone that won't turn on. > If this is only approved for 5 years, shouldn't the guy be replacing it rather than repairing it? And shouldn't health insurance be covering that, at least beyond the deductible or whatever? Probably, but (to throw out a hypothetical alternative) you can also imagine a situation where e.g. inspection can tell him if the whole device actually needs replacement. I don't have the answer here - I just know I'd like the discussion to revolve around the merits of the situation.
- deleted 2y ago
  [deleted]
- aaron695 2y ago
  [dead]
- jkestner 2y ago
  What other $100K products do you throw out after five years? I suppose if the insurance is on the hook, they might require repairability.
  - crazygringo 2y ago
    How many lightweight hinged products do you have that support your body weight for five years?
Dylan16807 2y ago
It's hard to track down a vague insinuation of a rule. If the company wants to use it as a defense, I think it's okay to put the burden on them to be specific.
- notatoad 2y ago
  they didn't appear to do that either though - they just uncritically report that it is an FDA rule preventing this company from doing repairs.
  - notjulianjaynes 2y ago
    Speaking from experience these types of technical details often get cut from news reporting anyways. I wouldn't be surprised if the author of this peice did in fact look that up but it got cut from the final copy. I think this is likely the relevant regulations: https://24x7mag.com/standards/servicing-legislation/how-the-fda-distinguishes-servicing-from-remanufacturing/ https://24x7mag.com/standards/servicing-legislation/how-the-... " the FDA believes the following types of activities, in general, involve changes that affect the legally marketed device’s performance or safety specifications and are likely to constitute remanufacturing: . . . Changes to the device’s control mechanism, operating principle or energy type." If the company was no longer maintaining OEM parts for the older model device it might be prevented from using slightly different parts from newer models to repair the older model without basically needing to have the older device + new part be cleared as a completely different medical device. I'm speculating and this might not be entirely accurate. Edit: actually it appears that the company marketing this device did not comply with an FDA order to conduct a postmarket surveilence study to asses its risks. In September 2015 the "FDA informed ReWalk that its noncompliance with the postmarket surveillance study deadline rendered the device misbranded." This is from a 2020 class action lawsuit against the company which was dismissed but it's not clear to me that the misbranding issue was ever taken care of, which could be the reason the company was initially hesitant to provide service to the device? This is not entirely clear to me one way or the other. https://casetext.com/case/yan-v-rewalk-robotics-ltd-3 https://casetext.com/case/yan-v-rewalk-robotics-ltd-3
toofy 2y ago
yeah, it would have been interesting to have seen some deeper digging. for instance, did the fda simply not renew because the company didn’t try? was this just the company being lazy and attempting to deflect blame onto a spoooooky faceless gov agency? it the company actually gave a good faith attempt, was there some reason the fda said “nope?” tangential but related, this highlights why we need better funded journalistic institutions rather than lowest tier trash because it’s “free”, journalists need to be able to afford to dig deeper to tell us who is screwing us over in situations like this. it’s hard for us (society) to advocate for something if we don’t know what the real story is because our investigators (journalists) are hamstrung by lack of funds. journalist institutions being underfunded only helps crooked governments and crooked company owners keep us in the dark.

Me000 2y ago

[flagged]

fakedang 2y ago

My thoughts exactly. But then again, journalists have long ceased to be investigative or technologically versed.

jonny_eh 2y ago
It's almost like there's no money left in the profession, so there's no more expertise or time available to do proper investigating or writing.
- thaumasiotes 2y ago
  If that were true, the job would be done by someone who took a personal interest in the subject and didn't need to be paid for reporting it. This is the opposite; it's someone doing a bad job because there's money in the profession and they want to get some of it without actually doing the work that would earn it.
  - paulryanrogers 2y ago
    Perhaps. Yet more likely that they're pressured into publishing so often they have little time for thorough investigations. If there were more money in it more people could afford to do it full time, and quality could improve.
  - kevinventullo 2y ago
    So by that logic, public defenders are your best bet if you get arrested?
  - surgical_fire 2y ago
    > job would be done by someone who took a personal interest in the subject and didn't need to be paid for reporting it. You mean that the job would be done by shills then? Why would anyone provide free labor otherwise?
    - thaumasiotes 2y ago
      Why did you write your comment?
      - surgical_fire 2y ago
        I am not performing a job, if that is what you are implying.
  - xeromal 2y ago
    OR it pays near nothing so the bottom of the barrel gets hired at low wage to keep the ghost shipping running
  - deleted 2y ago
    [deleted]
  - consteval 2y ago
    > the job would be done by someone who took a personal interest in the subject and didn't need to be paid for reporting it I think we already have this, it's marketing and advertising. People are happy to report on things they care about, even burning money to report on it. It's just that the reason they care is because it's their thing, and they want you to buy it.

crazygringo 2y ago

I mean, I guess it does make me curious how you should go about regulating a device like this. Like, if the metal fails and you have a horrible fall and break your hip and shoulder, that's pretty different from an iPhone that won't turn on. If this is only approved for 5 years, shouldn't the guy be replacing it rather than repairing it? And shouldn't health insurance be covering that, at least beyond the deductible or whatever?

dataflow 2y ago
> I mean, I guess it does make me curious how you should go about regulating a device like this. That's actually my point. There's an interesting policy discussion to be had here, and instead of starting it, they just decided to smear a company. > Like, if the metal fails and you have a horrible fall and break your hip and shoulder, that's pretty different from an iPhone that won't turn on. > If this is only approved for 5 years, shouldn't the guy be replacing it rather than repairing it? And shouldn't health insurance be covering that, at least beyond the deductible or whatever? Probably, but (to throw out a hypothetical alternative) you can also imagine a situation where e.g. inspection can tell him if the whole device actually needs replacement. I don't have the answer here - I just know I'd like the discussion to revolve around the merits of the situation.
deleted 2y ago
[deleted]
aaron695 2y ago
[dead]
jkestner 2y ago
What other $100K products do you throw out after five years? I suppose if the insurance is on the hook, they might require repairability.
- crazygringo 2y ago
  How many lightweight hinged products do you have that support your body weight for five years?

Dylan16807 2y ago

It's hard to track down a vague insinuation of a rule. If the company wants to use it as a defense, I think it's okay to put the burden on them to be specific.

notatoad 2y ago
they didn't appear to do that either though - they just uncritically report that it is an FDA rule preventing this company from doing repairs.
- notjulianjaynes 2y ago
  Speaking from experience these types of technical details often get cut from news reporting anyways. I wouldn't be surprised if the author of this peice did in fact look that up but it got cut from the final copy. I think this is likely the relevant regulations: https://24x7mag.com/standards/servicing-legislation/how-the-fda-distinguishes-servicing-from-remanufacturing/ https://24x7mag.com/standards/servicing-legislation/how-the-... " the FDA believes the following types of activities, in general, involve changes that affect the legally marketed device’s performance or safety specifications and are likely to constitute remanufacturing: . . . Changes to the device’s control mechanism, operating principle or energy type." If the company was no longer maintaining OEM parts for the older model device it might be prevented from using slightly different parts from newer models to repair the older model without basically needing to have the older device + new part be cleared as a completely different medical device. I'm speculating and this might not be entirely accurate. Edit: actually it appears that the company marketing this device did not comply with an FDA order to conduct a postmarket surveilence study to asses its risks. In September 2015 the "FDA informed ReWalk that its noncompliance with the postmarket surveillance study deadline rendered the device misbranded." This is from a 2020 class action lawsuit against the company which was dismissed but it's not clear to me that the misbranding issue was ever taken care of, which could be the reason the company was initially hesitant to provide service to the device? This is not entirely clear to me one way or the other. https://casetext.com/case/yan-v-rewalk-robotics-ltd-3 https://casetext.com/case/yan-v-rewalk-robotics-ltd-3

toofy 2y ago

yeah, it would have been interesting to have seen some deeper digging. for instance, did the fda simply not renew because the company didn’t try? was this just the company being lazy and attempting to deflect blame onto a spoooooky faceless gov agency? it the company actually gave a good faith attempt, was there some reason the fda said “nope?” tangential but related, this highlights why we need better funded journalistic institutions rather than lowest tier trash because it’s “free”, journalists need to be able to afford to dig deeper to tell us who is screwing us over in situations like this. it’s hard for us (society) to advocate for something if we don’t know what the real story is because our investigators (journalists) are hamstrung by lack of funds. journalist institutions being underfunded only helps crooked governments and crooked company owners keep us in the dark.