How’s about you guys spend some of that budget on QA?
How’s about you guys spend some of that budget on QA?
Most places in the US will have nothing about severance written down anywhere, but it’s very common to actually pay severance in a mass layoff situation (unless the whole business is going under).
Current IT best practice is that passwords should never expire on a set schedule, but they should expire if there is evidence they’ve been breached.
Medical devices are required to comply with 21 CFR 820 in the United States, which establishes quality management standards. This includes minimum standards for the software development lifecycle, including software verification and validation testing.
In the EU, broadly equivalent standards include ISO 13485 and IEC 62304.
If an OEM wants to do a software update, they at minimum need to perform and document a change impact analysis, verification testing, and regression testing. Bigger changes can involve a new FDA submission process.
If you go around hacking new software features into your medical device, you are almost certainly not doing all of that stuff. That doesn’t mean that your software changes are low quality–maybe, maybe not. But it would be completely unfair to hold your device to the standard that the FDA holds them to–that medical devices in the United States are safe and effective treatments for diseases.
This may be okay if you want to hack your own CPAP (usually a class II device) and never sell it to someone else. But I think we all need to acknowledge that there are some serious risks here.
“Look, we’ve only got the one engineering set, so we’d better use it.”
Man, I remember reading about all this home automation stuff in Compute’s Gazette for the Commodore 64. It’s been around forever and a day.
According to the non canon Star Trek Technical Manual, the transporter physically disassembles your particles, moves them to the destination location, and reassembles them with quark level accuracy. So-called “Heisenberg compensators” are a key technology to allow this to occur.
The on screen canon is at least somewhat consistent with this, but maybe not entirely.
I thought they catch fire and burn down slowly.
Correct. Both the recent pager and radio attacks, and the 1996 cell phone attack, were performed by planting military explosives inside the devices in advance.
There is no magical way to hack the electronics to make a lithium battery straight up explode.
Also, Israel already assassinated someone by exploding their cell phone way back in 1996.
Technically I think that’s still “put us first on the search bar” money. You’re giving the real under-the-table explanation.
criminal lawsuit?
What? Do they mean “criminal prosecution?”
Every computer on TOS fits into room sized cabinets and has rows of blinkenlights on the front panel. This is what computers looked like when the show aired.
The blinkenlights are there to report the contents of the registers in binary code. This helps a lot when you are debugging by single-stepping the entire computer one instruction at a time. Any programmer today would think this is incredibly quaint.
The show completely missed the microcomputer revolution that was brewing in the real space program at the same time they were on the air. There was a period where Apollo Guidance Computer was consuming nearly the entire national supply of integrated circuits.
This episode aired in 95, though.
Well it probably wasn’t a Vic Mackey-style rubber hose attack, because it sounds like this chump is getting hauled into court.
I dunno. Hang out around Trekkies and you can meet some real knuckleheads. People who seem to have missed the whole point.
I’m thinking of highly niche industrial and embedded products who are likely to be left behind.
A major traditional selling point for Windows has always been the backwards compatibility.
Yeah. This sounds a lot like some PM type thinks they’re gonna get rid of control panel, and they just don’t know what all is actually in there.
And not to mention the custom control panel applets hanging around out there from who-knows-what vendors.
Prison rules. Tether them to the work station.
Here’s my guess. I don’t know anything about this particular device, but I have worked with medical devices.
A powered exo-skeleton sounds like it might be a class II medical device. Being a medical device, the OEM was required to produce a safety risk analysis per ISO 14971 in the EU and 21 CFR 820 in the US. I don’t know what all was listed, but probably one of the safety risks was thermal runaway from the (assumed) lithium ion batteries.
Lithium ion battery packs have a well known problem with occasionally overheating and catching fire. This famously delayed the launch of the 787 Dreamliner. This is also why you can’t put your phone or laptop battery into your checked luggage.
In the original risk analysis, there will be a number of mitigation steps identified for each hazard. For the lithium thermal runway, these probably include a mix of temperature monitoring, overheat shutdown, and passive design features in the battery pack itself to try to keep the impacts of over temperature and fire away from the patient.
So how does the price get to 100k? It could be some kind of unique design features that are now out of production and the original tooling is not available. The 100k cost is probably something like to redesign the production tooling, particularly if you have to remake injection molds.
You can’t just use any off the shelf battery pack, because that would invalidate the risk analysis. You’d need to redo the risk analysis, repeat at least some amount of validation testing, and possibly resubmit an application to the FDA.
TLDR: you can get some MEs and EEs together to solve this problem, but once they’re on the case, you can blow through 100k real fast.