5 ms·

I used to be terrified of that as well, until meeting many former medical device engineers in the Denver area who got out for moral reasons. However shit you t

I used to be terrified of that as well, until meeting many former medical device engineers in the Denver area who got out for moral reasons. However shit you think the community code is, the official code is probably worse. Like kills people and hide behind lawyers already worse. It's not uncommon for these engineers to have a 'if I am incapacitated, do not hook me up to these devices' card in their wallet like you'd normally see for alllergies for products they've worked on.

disabled 5y ago
Just FYI, the European Union made such projects illegal as of 26 May 2021. See Medical Devices Regulation (MDR) EU 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELE... Also, these projects were designed on purpose to circumvent or in some cases break the law, which is the wrong approach to medical device design. It's dangerous and designs kill, as you know. See this stipulation (and control/command + f = "commercial" in paper): 27) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; Also: 46) ‘investigational device’ means a device that is assessed in a clinical investigation Also: 1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, Also: (19) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device.
- netr0ute 5y ago
  Sad, Big Pharma strikes again.
  - OJFord 5y ago
    Did people start sentences with 'Sad' like this before Trump's presidency? I don't know if it's a (an American) colloquialism I simply hadn't noticed prior to that, or a more personal quirk that caught on? I don't mean to single out you specifically, I keep noticing it now.
    - netr0ute 5y ago
      Trump is more associated with "SAD!" but with how many sad privacy/freedom violations there are nowadays, it could be because of that.
    - meowster 5y ago
      Yes, it's been used that way in American venacular for at least several decades.
      - OJFord 5y ago
        Thanks, it was an honest question, something I've noticed a few times and wondered about. I was going to say (did type) that I can't think of another word that's used in the same sort of declaratory way - but actually, as I wrote, it occurred to me that 'funny' is too. 'Funny, I just never noticed it with 'sad' until a few years ago.'
    - OneLeggedCat 5y ago
      It became a lot more common around 2015.
    - dTal 5y ago
      Let me put it this way. How linguistically innovative do you think Trump is?
- 5y ago
mattrj 5y ago
Fascinating. Want to know another secret about code quality? Custom software for banks generally sucks as well. That's your money it's messing with. am: "Let's try it in production" pm: We are going to need you to write a script to put everything back where it was.
- deleted 5y ago
  [deleted]
rcxdude 5y ago
Yeah, I think the nature of the medical device development process is that with competent engineers and managers it makes it possible to develop a safe device. It does not make it guaranteed to be safe regardless of the competency of the organisation.

disabled 5y ago

Just FYI, the European Union made such projects illegal as of 26 May 2021. See Medical Devices Regulation (MDR) EU 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELE... Also, these projects were designed on purpose to circumvent or in some cases break the law, which is the wrong approach to medical device design. It's dangerous and designs kill, as you know. See this stipulation (and control/command + f = "commercial" in paper): 27) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; Also: 46) ‘investigational device’ means a device that is assessed in a clinical investigation Also: 1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, Also: (19) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device.

netr0ute 5y ago
Sad, Big Pharma strikes again.
- OJFord 5y ago
  Did people start sentences with 'Sad' like this before Trump's presidency? I don't know if it's a (an American) colloquialism I simply hadn't noticed prior to that, or a more personal quirk that caught on? I don't mean to single out you specifically, I keep noticing it now.
  - netr0ute 5y ago
    Trump is more associated with "SAD!" but with how many sad privacy/freedom violations there are nowadays, it could be because of that.
  - meowster 5y ago
    Yes, it's been used that way in American venacular for at least several decades.
    - OJFord 5y ago
      Thanks, it was an honest question, something I've noticed a few times and wondered about. I was going to say (did type) that I can't think of another word that's used in the same sort of declaratory way - but actually, as I wrote, it occurred to me that 'funny' is too. 'Funny, I just never noticed it with 'sad' until a few years ago.'
  - OneLeggedCat 5y ago
    It became a lot more common around 2015.
  - dTal 5y ago
    Let me put it this way. How linguistically innovative do you think Trump is?
5y ago

mattrj 5y ago

Fascinating. Want to know another secret about code quality? Custom software for banks generally sucks as well. That's your money it's messing with. am: "Let's try it in production" pm: We are going to need you to write a script to put everything back where it was.

deleted 5y ago
[deleted]

rcxdude 5y ago

Yeah, I think the nature of the medical device development process is that with competent engineers and managers it makes it possible to develop a safe device. It does not make it guaranteed to be safe regardless of the competency of the organisation.