Wish I could give you an npm package for that, but best I can do is a process:
[0] keep a log / journal
[1] make a change
[2] observe the result
[3] iterate
[0] is to raise awareness and detect cause and effect. Keep it minimalist. I once went overboard with a whole spreadsheet. Plain text turned out better. What to track? Inputs (food, media, activities) and outputs (physical and psychological state).
[1] Try eating better, exercise, changing media exposure, time outside. If you go down the supplement rabbit hole, start with simple things like magnesium. Attach new, better habits to your existing routine.
[2] Watch out for delayed reactions. For instance, what I ate 48 hours ago has significance.
[3] while(true)
Random bonus: if there is something that negatively affects you, seek out its polar positive opposite. I'm very easy bothered by sounds. Leaf blowers shall die. But this also means sounds have a strong positive leverage on my mental state:
https://youtu.be/gKdFbdrk-58
Does anyone else find themselves performing a UML-like design phase, but with code?
I like to create classes/methods with little/no/mock implementation to see how it will fit together. If there's something where I'm not sure how it works (third party API/lib I've not used before) I'll get more granular with it.
There's tooling to produce diagrams from code if someone really wants it. But either way my design phase is now usable code.
That being said, I still have to admit this rarely survives contact with actual implementation. It just feels better.
I'm a deep state employee of an as yet unacknowledged three letter agency whose propaganda blog received no traffic from this page until grandparent posted the link. I am a master strategist, playing chess in dimensions string theorists only dream of.
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.
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.
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.
Software "engineering" will definitely need to be looked at differently from physical, but there are still things we can do.
Critical systems (or at least the critical subsystems) must not allow any unapproved/untested changes. Hence why it's better for safety controls to be hardware/firmware and not part of a general-purpose OS.
It's one reason why you see separate payment terminal hardware on self-checkout kiosks. The payment hardware is more tightly controlled whereas they can modify the kiosk much faster.
There are also RTOS (real time OS) that offer execution time guarantees. Used in aerospace.
Hardware came from oversees and there was no licensed PE on the US side. But you're right, there should have been.
This was before the device was submitted to the FDA for approval. Chance they would have rejected it. A fallback position for a developer not willing to Play It Hard would be to make sure the risk docs submitted to FDA document this failure path. There is a whole process you are supposed to go through to analyze risks / harms and whether your controls are adequate.
I took an Ethics for Engineers course as an elective in college (sometime during the stone age). Wrote a paper on Therac-25. Had I not, I may not even been cognizant of the risk involved.
A single week lecture on this topic could move the needle.
Or regulators like FDA could demand to see corporate training materials given to software "engineers" (I concur on the quotes) on how to promote product safety.
[0] is to raise awareness and detect cause and effect. Keep it minimalist. I once went overboard with a whole spreadsheet. Plain text turned out better. What to track? Inputs (food, media, activities) and outputs (physical and psychological state). [1] Try eating better, exercise, changing media exposure, time outside. If you go down the supplement rabbit hole, start with simple things like magnesium. Attach new, better habits to your existing routine. [2] Watch out for delayed reactions. For instance, what I ate 48 hours ago has significance. [3] while(true)
Random bonus: if there is something that negatively affects you, seek out its polar positive opposite. I'm very easy bothered by sounds. Leaf blowers shall die. But this also means sounds have a strong positive leverage on my mental state: https://youtu.be/gKdFbdrk-58