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Tell HN: Duty of care

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41–50 of 55 posts

Re: Tell HN: Duty of care

#41
In one case I came across a premature engineering sign-off to confirm production readiness could be averted simply by asking the manager (who himself had the required credentials) to sign off on the change himself.

Re: Tell HN: Duty of care

#42
I am very suspicious of this post.

First, there's your story. To describe it as vague would be an understatement. What was the medical device? If the device does something important for the patient, wouldn't a big red button also be dangerous? You wouldn't want it turned off accidentally. Also the machine needs a button or switch to turn on, right? So why not have that component be the physical switch? And if the kill switch is on the touch screen, wouldn't that take up valuable pixels that could be used for other purposes? It would also make accidental triggering more common.

And you claim the button removal request was from the Chairman of the Board of Directors of a different company, who was a major shareholder? The board of the company you worked at, the C-level executives, and management all caved to him but you didn't, and you kept your job? That makes no sense. Someone with that much influence should have no problem getting an individual contributor let go.

Then there's you. Your Twitter account was created in September of 2017, but either you never tweeted until September of 2022 or your tweets auto-delete. Maybe you changed your username because neither archive.org nor archive.is have any history for your Twitter handle.

Your domain[1] was registered on September 22nd of this year, and it contains some general-sounding activism-du-jour. One might even call it "current thing". If anything it seems quite contradictory. Liberty does not march abroad... except when fighting a proxy war in Ukraine? OK, I guess.

I know my comment is controversial, but your post is exactly what I would write if my goal was to create perfect HN bait. It seems much more likely that someone lied on the internet than that things actually happened as described.

1. https://ldnma.com/

Re: Tell HN: Duty of care

#43
Been in a similar situation where customer wanted me to implement supporting fishy, I asked my boss to confirm by email but he never did and told me to do it orally in vague term. I just didn't do it and told them to find someone else, they did find someone.

Always keep in mind that when shit hits the fan they throw your name very quickly and you are going to stand in court to defend yourself. That's what happens when you work on devices which can kill people.

I learnt that they cannot reproach you to stay ethical and they know it is very difficult to make someone do something which goes against his values, it is easier to find someone else.

Re: Tell HN: Duty of care

#44
That's a nice story... it's also possibly true.

But that's not how things work in most medium-large companies. I was asked to implement some telemetry in our client applications that I considered was going too far (clearly designed to get more information than was strictly required for feature function). I said no, manager said ok and assigned the task to John. John said sure boss and come end of year also got a promo. The telemetry is still there, now piped into a "personalization" feature; all above board (ToS-wise) of course.

Re: Tell HN: Duty of care

#45
post #42

I am very suspicious of this post. First, there's your story. To describe it as vague would be an understatement. What was the medical device? If the device does something important for the patient, wouldn't a big red button also be dangerous? You wouldn't want it turned off accidentally. Also the machine needs a button or switch to turn on , right? So why not have that component be the physical switch? And if the ki…

But why?

Re: Tell HN: Duty of care

#46
post #26

Earlier quoted context omitted.

What happens in other engineering disciplines is the government revokes your license if you make a decision that violates your discipline's standards. Companies can't generally just force their engineers to do irresponsible things because even if they fired you and hired someone new, that new person would be putting their own future employability on the line by conceding. Better to get fired from a bad firm than to h…

The caveat is very true, and I think that I would be unhappy if a licensing body told me I'm suddenly "not qualified" to do the work I've been doing well for many years. Besides, it wouldn't be just for me to bear licensure costs (whether direct or indirect by being out of work while I get licensed) to correct an ethical fault in companies. Perhaps licensure could be an effective solution, but one that is not very em…

The profession and the state have to choose between freedom and regulation - or some hybrid compromise. For computer types, the profession and the state have opted for freedom. I'd say that on balance it was the right decision. For other professions (doctors, layers, accountants) that balance has been achieved and codified over may generations.

For egregious ethical violations, the whistleblower act provides a remedy.

Re: Tell HN: Duty of care

#47
post #42

I am very suspicious of this post. First, there's your story. To describe it as vague would be an understatement. What was the medical device? If the device does something important for the patient, wouldn't a big red button also be dangerous? You wouldn't want it turned off accidentally. Also the machine needs a button or switch to turn on , right? So why not have that component be the physical switch? And if the ki…

I don't believe I said the Chairman was from a different company. He was from the same company. He certainly could have had me fired, at the expense of destroying their schedule. As I stated at the outset, I left out details as to not identify the company (although there is enough here for a former colleague to put it together). Medical devices are a small world with often only 2 companies seriously competing per type.

Your due diligence data is largely correct and I complement your research. I repurposed this twitter account from one I created in 2017 and used as read-only in the intervening time. Also worth pointing out my HN account is quite new.

Wasn't great to cross the wires of my advocacy and technology, but I used the account I had. Didn't expect my twitter comment to be noticed.

I didn't promote my blog at all in this post, but since you mention it, if you read it more carefully I think you will find I take care to distinguish the Ukraine conflict from prior US interventions. Namely, one is a defense of a democracy which invited us whereas others (Iraq, Afghanistan) were not. US troops are not marching into Ukraine. It's even less direct support than the French provided the US revolutionary war.

I don't take issue with your questioning except - the presumption that someone is lying before they have even had a chance to respond to your information.

Edit: removed redundant sentence

Re: Tell HN: Duty of care

#48
post #43

Been in a similar situation where customer wanted me to implement supporting fishy, I asked my boss to confirm by email but he never did and told me to do it orally in vague term. I just didn't do it and told them to find someone else, they did find someone. Always keep in mind that when shit hits the fan they throw your name very quickly and you are going to stand in court to defend yourself. That's what happens whe…

Yea it's a red flag when someone only verbally responds. A countermeasure is to send a nicely worded email summarizing the discussion and inviting any corrections. But unless someone could be seriously injured, I'd just find another job. Not worth it.

Re: Tell HN: Duty of care

#49
post #35

In the USA FDA would need to approve such a change for a device that could possibly kill the patient. And would be unlikely to say yes. I once designed a hardware state machine out of TTL (no CPU, except a network interface that could only passively read and transmit the state) to ensure that a pressure vessel was safe (and this was ahead of the mechanical safety devices). Regularly someone would ask why we had this…

This occurred before the device was submitted for its first 510(k) approval.

Also, companies have some discretion in what changes they re-submit to the FDA and what the decide to just document internally. There are guidelines, like if you change the OS you better resubmit, but there is a wide swath of gray area. The FDA is not looking at every code/hardware change request. They audit your process.

Edit: typos

Re: Tell HN: Duty of care

#50
post #35

In the USA FDA would need to approve such a change for a device that could possibly kill the patient. And would be unlikely to say yes. I once designed a hardware state machine out of TTL (no CPU, except a network interface that could only passively read and transmit the state) to ensure that a pressure vessel was safe (and this was ahead of the mechanical safety devices). Regularly someone would ask why we had this…

This occurred before the device was submitted for its first 510(k) approval. Also, companies have some discretion in what changes they re-submit to the FDA and what the decide to just document internally. There are guidelines, like if you change the OS you better resubmit, but there is a wide swath of gray area. The FDA is not looking at every code/hardware change request. They audit your process. Edit: typos

Yeah, I'm on the small molecule side but did a combo device years ago and was shocked at how slack the device rules were compared to the drug side.
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