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Coming from another highly regulated industry: Medical Devices, I think it is not uncommon that Bosses ignore processes and for the sake of numbers (cash & care

by esel2k 7y ago

Coming from another highly regulated industry: Medical Devices, I think it is not uncommon that Bosses ignore processes and for the sake of numbers (cash & career) would just override them. As long as they are protegee of any higher up on the ladder people generally don’t care and as long no serious lawsuit would put people into jail I am wondering if this is ever going to change. Anyone has made other experiences?

missosoup 7y ago
Yes. Spent some years working on an a class 2b diagnostic device. Potential for harm not that high, but the lack of rigour in testing leaves me wondering to this day whether it worked at all as advertised. If medical devices are ever open sourced, millions of critical bugs are going to fall out.
- Balgair 7y ago
  http://www.opensourcediabetes.org/ http://www.opensourcediabetes.org/ Already happening with Diabetics. I know a girl that has cracked her pump for closed loop performance and she says the results are mostly better, but take close monitoring and an active hand. It's a tricky thing still. Yes, the devices are buggy (all things are), but half of medical devices are used by people with below average intelligence (by definition). It's still a balancing act and is likely to be for a long time.
  - ZeikJT 7y ago
    That website is in a rough state. I tried to contact them regarding the fact that their url for jquery tools no longer resolves and that their SSL certificate has expired. I filled out the contact form and hit submit and then was presented with an empty results screen (probably because the js is broken). Hopefully they fix it up, but might not.
  - Franciscouzo 7y ago
    Why would that be true by definition? Diabetes and IQ could be somehow correlated [0] (and other disorders too). [0] https://diabetes.diabetesjournals.org/content/42/2/341.short https://diabetes.diabetesjournals.org/content/42/2/341.short
hos234 7y ago
It does change, things do get better, but it takes time to see the change. Years usually. In large orgs "conservative" managers who escalate and block issues usually don't get fired, they just get pushed to some other part of the org. And when/if the issue blows up, they get pulled back in to clean up the mess. Cause few others will have credibility. Same dynamic applies in reverse. The bunch that were in charge, during a blow up will be sent into the background. But will be pulled back when more "aggressive" management tactics are required.
jacquesm 7y ago
Just did tech DD on a medical device manufacturer. The CEO was very much on the ball to ensure that everybody kept patient safety as their #1 priority over commercial interests. I've also seen much worse...
seren 7y ago
This is not my experience so far, sure we have some pressure to deliver features in rather short time frame, but on the other hand, whenever the safety of the patient is involved, and indirectly the reputation of the company is at risk, this takes precedence above the bottom line. We just had a potential safety issue in the last few months because of a manufacturing process defect. While no one was injured, this was a potentially hazardous situation. The company stopped the production, and reworked every affected system on customer site. While our profit have taken a hit this year, at least I am glad the right decision was taken, and no one (that I know of) challenged it. To be fair, I don't know at which level above me the (costly) decision was taken, but at least someone had the courage to take it. But I am working at a fairly big company so likely it is easier to absorb an unexpected cost to defend the company brand, compared to a smaller company that have only one product line and that maybe can't afford it.
madaxe_again 7y ago
I am aware of a cover-up regarding a broadly deployed consumer medical device made by a giant American healthcare co., intended for internal use, which contained levels of lead exceeding allowed levels. Millions of units were shipped, many of them targeted at children. They screwed up using their materials management solution, and miscalculated. They realised about 18 months after it had hit the market. The revised product is safe. Regulatory bodies are aware but are sitting on it, as disclosure would be almost as damaging reputationally to them as to the manufacturer.
- vintagedave 7y ago
  > which contained levels of lead exceeding allowed levels... many of them targeted at children You know the catchphrase, "think of the children", often used to justify some kind of overreach? In this case, please, _think of the children_ and for the sake of us all, even anonymously, get that info to the media.
  - madaxe_again 7y ago
    I’m sitting on the fence. In this case, they were very, very marginally over the allowed levels, and it was essentially down to a bug in the standard, which when implemented in software allowed a product to qualify for an exemption when it shouldn’t have. In this particular case the lead is all pretty well away from where the device comes in contact with the body, so the health risk is pretty minimal. It’s still in the “shouldn’t have happened” category, and the manufacturer in question reported themselves, and steps have already been taken to prevent a recurrence, and similar potential bugs have been identified and addressed. It’s tough. There is a lot of political opposition from bad or amoral players to any regulation. They’re faced with the choice of voluntarily opening themselves up to fierce criticism over a, in the grand scheme of things, minor issue, or sweeping it well under the carpet, learning from it, and moving on, and spreading their reach for regulation and enforcement. It’s a trolley car problem if I’ve ever encountered one, and I am not confident that I could make a good call.
    - dannyw 7y ago

by esel2k 7y ago

missosoup 7y ago

Yes. Spent some years working on an a class 2b diagnostic device. Potential for harm not that high, but the lack of rigour in testing leaves me wondering to this day whether it worked at all as advertised. If medical devices are ever open sourced, millions of critical bugs are going to fall out.

Balgair 7y ago
http://www.opensourcediabetes.org/ http://www.opensourcediabetes.org/ Already happening with Diabetics. I know a girl that has cracked her pump for closed loop performance and she says the results are mostly better, but take close monitoring and an active hand. It's a tricky thing still. Yes, the devices are buggy (all things are), but half of medical devices are used by people with below average intelligence (by definition). It's still a balancing act and is likely to be for a long time.
- ZeikJT 7y ago
  That website is in a rough state. I tried to contact them regarding the fact that their url for jquery tools no longer resolves and that their SSL certificate has expired. I filled out the contact form and hit submit and then was presented with an empty results screen (probably because the js is broken). Hopefully they fix it up, but might not.
- Franciscouzo 7y ago
  Why would that be true by definition? Diabetes and IQ could be somehow correlated [0] (and other disorders too). [0] https://diabetes.diabetesjournals.org/content/42/2/341.short https://diabetes.diabetesjournals.org/content/42/2/341.short

hos234 7y ago

It does change, things do get better, but it takes time to see the change. Years usually. In large orgs "conservative" managers who escalate and block issues usually don't get fired, they just get pushed to some other part of the org. And when/if the issue blows up, they get pulled back in to clean up the mess. Cause few others will have credibility. Same dynamic applies in reverse. The bunch that were in charge, during a blow up will be sent into the background. But will be pulled back when more "aggressive" management tactics are required.

jacquesm 7y ago

Just did tech DD on a medical device manufacturer. The CEO was very much on the ball to ensure that everybody kept patient safety as their #1 priority over commercial interests. I've also seen much worse...

seren 7y ago

This is not my experience so far, sure we have some pressure to deliver features in rather short time frame, but on the other hand, whenever the safety of the patient is involved, and indirectly the reputation of the company is at risk, this takes precedence above the bottom line. We just had a potential safety issue in the last few months because of a manufacturing process defect. While no one was injured, this was a potentially hazardous situation. The company stopped the production, and reworked every affected system on customer site. While our profit have taken a hit this year, at least I am glad the right decision was taken, and no one (that I know of) challenged it. To be fair, I don't know at which level above me the (costly) decision was taken, but at least someone had the courage to take it. But I am working at a fairly big company so likely it is easier to absorb an unexpected cost to defend the company brand, compared to a smaller company that have only one product line and that maybe can't afford it.

madaxe_again 7y ago

I am aware of a cover-up regarding a broadly deployed consumer medical device made by a giant American healthcare co., intended for internal use, which contained levels of lead exceeding allowed levels. Millions of units were shipped, many of them targeted at children. They screwed up using their materials management solution, and miscalculated. They realised about 18 months after it had hit the market. The revised product is safe. Regulatory bodies are aware but are sitting on it, as disclosure would be almost as damaging reputationally to them as to the manufacturer.

vintagedave 7y ago
> which contained levels of lead exceeding allowed levels... many of them targeted at children You know the catchphrase, "think of the children", often used to justify some kind of overreach? In this case, please, _think of the children_ and for the sake of us all, even anonymously, get that info to the media.
- madaxe_again 7y ago
  I’m sitting on the fence. In this case, they were very, very marginally over the allowed levels, and it was essentially down to a bug in the standard, which when implemented in software allowed a product to qualify for an exemption when it shouldn’t have. In this particular case the lead is all pretty well away from where the device comes in contact with the body, so the health risk is pretty minimal. It’s still in the “shouldn’t have happened” category, and the manufacturer in question reported themselves, and steps have already been taken to prevent a recurrence, and similar potential bugs have been identified and addressed. It’s tough. There is a lot of political opposition from bad or amoral players to any regulation. They’re faced with the choice of voluntarily opening themselves up to fierce criticism over a, in the grand scheme of things, minor issue, or sweeping it well under the carpet, learning from it, and moving on, and spreading their reach for regulation and enforcement. It’s a trolley car problem if I’ve ever encountered one, and I am not confident that I could make a good call.
  - dannyw 7y ago