NireBryce

reality is the battlefield

the first line goes in Cohost embeds

🐥 I am not embroiled in any legal battle
🐦 other than battles that are legal 🎮

I speak to the universe and it speaks back, in it's own way.

mastodon

email: contact at breadthcharge dot net

I live on the northeast coast of the US.

'non-functional programmer'. 'far left'.

conceptual midwife.

https://cohost.org/NireBryce/post/4929459-here-s-my-five-minut

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in reply to @NireBryce's post:

i think it was down to like 30 bucks a test but yeah.

but also like, i think thats part of it right? COVID restrictions slacken and all your 'we will make it less expensive as time goes on as initial costs are subsidized by early adopters' evaporates but you IPO'd in 2021 and now you're just fucked, so you cut costs and pull a boeing

Wow, making those changes without notifying the FDA was them just begging to have the book thrown at them.

I could see how it happened too. Management was probably leaning on engineering to fix an edge case that was causing a greater than expected number of QC batch rejections, while also leaning heavily on QC/QA to pass more batches because they probably cut the unit price below what would be profitable with their current reject rate.

And management probably wanted it all done yesterday too, so nobody finished the necessary FDA paperwork before they started shipping the changed devices to customers.

Medical devices companies are scummy. I have a list somewhere of the phrases that adorned banners and posters at one of the places I contracted at, and they were all things like "Don't put it in writing or an email until you talk to a manager."

Engineers at that place considered it inevitable that they would someday have to testify in court against their employer.