4 ms·

The problem I'm pointing out is the device makes it through QA, testing and is in production in a hospital. Then, one day a Windows driver update comes down and

The problem I'm pointing out is the device makes it through QA, testing and is in production in a hospital. Then, one day a Windows driver update comes down and bricks the device. That is indefensible, regardless of whether it's right or wrong to use counterfeit parts.

malka 11y ago
I'd say the problem is pushing updates to a life critical system without testing it on a pre-production system that will behave the exact same way.
- fennecfoxen 11y ago
  > a pre-production system that will behave the exact same way So what if all of your preproduction systems have a genuine FTDI chip in them, and many of your millions of deployed production systems have counterfeits that you don't know about? That'll be exciting. Quality is a matter of defense in depth. You can't rely on your preproduction system running the exact same way as production. You strive for consistency, but ultimately each chip in each computer is a unique physical object made with different silicon crystals, and being identical is impossible. You want a system that's robust against a variety of subtle differences. FTDI is just doing their small bit to make everything just a little more fragile and unpredictable where their chips are concerned, and as such their products ought to be shunned.
  - malka 11y ago
    I see your point, and, well, agree with it. The only opposition I could see would be to make sure all your system incorporating FDTI chips comes from the same batch, and to change them all when you change one. Not realistically doable imo.
    - HeyLaughingBoy 11y ago
      It's entirely doable and manufacturers of safety critical equipment the world over are doing it daily and recording the batch information Just In Case.
  - HeyLaughingBoy 11y ago
    That'll be exciting. I agree with your premise, but in this case, for a medical device it would also be a Quality Systems failure. Any change in a component is scrutinized and analyzed for impact. You have no idea how many times (as a software dev for medical devices), I've had someone from Manufacturing or Purchasing come to ask me "if we change (trivial part X) to a new vendor, what can go wrong and how can we test it?" as a precursor to executing a Change Plan. I'm not kidding. Even something as seemingly trivial as changing the type of paint used on an enclosure can trigger weeks or months of analysis depending on what's in that enclosure.
Tomte 11y ago
Again: installing non-validated Windows updates is indefensible! Safety-critical and safety-related applications are a totally different game than what most HNers are used to!
- rhinoceraptor 11y ago
  I don't disagree, it's also indefensible to ship counterfeit parts. But it's likely to happen anyways. It's clearly unsafe to not wear a seatbelt, but it's also clearly wrong to build a device into cars that kills occupants that get in a crash if they aren't wearing one.
nradov 11y ago
Medical devices don't run Windows Update. Changes are tested and controlled, exactly for scenarios like this.
- chillingeffect 11y ago
  The fact that your have/had net downvotes for your comment demonstrates that consensus reality is not always reality. As an embedded medical devices engineer, I know you are exactly right. For safety-critical devices, control of the supply chain is beyond good practice, it's required by federal law, precisely so bad actors can't interfere with peoples' lives. The long list of requirements around approving a vendor are tiring and result in epic stories like the $500 toilet seat, etc., but they prevent stuff like this FTDI debacle from happening. You know it's going to be a toilet seat when the box arrives. The medical device industry is a massive cultural shift from the majority of the HN crowd (e.g. startups and cloud services). In the world of PCs and servers, disruption is, literally, the name of the game. In IEC62304 land though, everything has to be on the straight, narrow and predictable path. This is why medical devices are expensive, laggy and not very startup-compatible. The FDA's system is actually more secure than Europe's. Take that, socialized medicine! So it's not always wild and fun here in medical-land. It's like being a cop vs. a cowboy. You're not paid to sling your guns, but to de-escalate. But thank the conservative practices next time your elderly or congenitally defective family members found themselves in the hospital!
  - kalleboo 11y ago
    And yet, it still happens http://abcnews.go.com/Blotter/counterfeit-chinese-parts-slipping-us-military-aircraft-senate/story?id=16403599 http://abcnews.go.com/Blotter/counterfeit-chinese-parts-slip...
  - kalleboo 11y ago
    I can only imagine the military has the same stringent requirements on their vendors, yet it still happens there http://abcnews.go.com/Blotter/counterfeit-chinese-parts-slipping-us-military-aircraft-senate/story?id=16403599 http://abcnews.go.com/Blotter/counterfeit-chinese-parts-slip...

malka 11y ago

I'd say the problem is pushing updates to a life critical system without testing it on a pre-production system that will behave the exact same way.

fennecfoxen 11y ago
> a pre-production system that will behave the exact same way So what if all of your preproduction systems have a genuine FTDI chip in them, and many of your millions of deployed production systems have counterfeits that you don't know about? That'll be exciting. Quality is a matter of defense in depth. You can't rely on your preproduction system running the exact same way as production. You strive for consistency, but ultimately each chip in each computer is a unique physical object made with different silicon crystals, and being identical is impossible. You want a system that's robust against a variety of subtle differences. FTDI is just doing their small bit to make everything just a little more fragile and unpredictable where their chips are concerned, and as such their products ought to be shunned.
- malka 11y ago
  I see your point, and, well, agree with it. The only opposition I could see would be to make sure all your system incorporating FDTI chips comes from the same batch, and to change them all when you change one. Not realistically doable imo.
  - HeyLaughingBoy 11y ago
    It's entirely doable and manufacturers of safety critical equipment the world over are doing it daily and recording the batch information Just In Case.
- HeyLaughingBoy 11y ago
  That'll be exciting. I agree with your premise, but in this case, for a medical device it would also be a Quality Systems failure. Any change in a component is scrutinized and analyzed for impact. You have no idea how many times (as a software dev for medical devices), I've had someone from Manufacturing or Purchasing come to ask me "if we change (trivial part X) to a new vendor, what can go wrong and how can we test it?" as a precursor to executing a Change Plan. I'm not kidding. Even something as seemingly trivial as changing the type of paint used on an enclosure can trigger weeks or months of analysis depending on what's in that enclosure.

Tomte 11y ago

Again: installing non-validated Windows updates is indefensible! Safety-critical and safety-related applications are a totally different game than what most HNers are used to!

rhinoceraptor 11y ago
I don't disagree, it's also indefensible to ship counterfeit parts. But it's likely to happen anyways. It's clearly unsafe to not wear a seatbelt, but it's also clearly wrong to build a device into cars that kills occupants that get in a crash if they aren't wearing one.

nradov 11y ago

Medical devices don't run Windows Update. Changes are tested and controlled, exactly for scenarios like this.

chillingeffect 11y ago
The fact that your have/had net downvotes for your comment demonstrates that consensus reality is not always reality. As an embedded medical devices engineer, I know you are exactly right. For safety-critical devices, control of the supply chain is beyond good practice, it's required by federal law, precisely so bad actors can't interfere with peoples' lives. The long list of requirements around approving a vendor are tiring and result in epic stories like the $500 toilet seat, etc., but they prevent stuff like this FTDI debacle from happening. You know it's going to be a toilet seat when the box arrives. The medical device industry is a massive cultural shift from the majority of the HN crowd (e.g. startups and cloud services). In the world of PCs and servers, disruption is, literally, the name of the game. In IEC62304 land though, everything has to be on the straight, narrow and predictable path. This is why medical devices are expensive, laggy and not very startup-compatible. The FDA's system is actually more secure than Europe's. Take that, socialized medicine! So it's not always wild and fun here in medical-land. It's like being a cop vs. a cowboy. You're not paid to sling your guns, but to de-escalate. But thank the conservative practices next time your elderly or congenitally defective family members found themselves in the hospital!
- kalleboo 11y ago
  And yet, it still happens http://abcnews.go.com/Blotter/counterfeit-chinese-parts-slipping-us-military-aircraft-senate/story?id=16403599 http://abcnews.go.com/Blotter/counterfeit-chinese-parts-slip...
- kalleboo 11y ago
  I can only imagine the military has the same stringent requirements on their vendors, yet it still happens there http://abcnews.go.com/Blotter/counterfeit-chinese-parts-slipping-us-military-aircraft-senate/story?id=16403599 http://abcnews.go.com/Blotter/counterfeit-chinese-parts-slip...