• 0 Posts
  • 107 Comments
Joined 1 year ago
cake
Cake day: June 18th, 2023

help-circle
  • 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.




  • 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.



  • Israel has already been fighting a war with Hezbollah that Hezbollah declared. These attacks were fairly specifically targeted at Hezbollah’s military equipment. They have been arguably successful at disrupting Hezbollah’s communications, and likely command and control systems. That by itself is a valid military objective.

    To the extent that these attacks directly hurt Hezbollah personnel, and to the extent that they damaged Hezbollah’s morale: those too are valid military objectives.

    So “war crime” gets thrown around here quite a bit just because there are high civilian casualties. The facts are twofold: Civilian casualties have always been a part of warfare; and there is no specific number or proportion that makes some act into a war crime. That’s just not how these kinds of laws are written.

    I have not yet seen a strong argument for a specific war crime rooted in a specific basis in international law. A lot of people bring up protocols 1 and 2 to the Geneva conventions, but Israel and the US have not ratified those.

    There are other conventions that regulate weapons of war, but I’m pretty sure none of them are going to address pager bombs directly. An argument there would have to be at least somewhat creative.



  • Question, when you move to a new place in Spain, do you need to register residency with the police?

    I don’t know if Spain does that or not, but I think Italy does some version.

    The United States doesn’t have that, and doesn’t have a national id card. Although most people effectively register themselves to get a driver license, that is only required if you drive. So voter registration nominally provides some way for the government to get the information on residency, which is important for figuring out which local elections you need to vote in.

    Now recently, in the last couple of decades, some states started requiring photo id verification to vote. This defeats the purpose of having a separate voter registration system, because you still have to go to the driver registration system to get either a driver license, or a non-driving photo ID. Nevertheless, the separate voter registration system has hung around in every single one of these states, because the real goal is to prevent people from voting.













  • Most of the regular crew gets a sleeping bag in a cupboard with some small locker space for personal effects.

    Wilmore has just the bag, off in the Japanese module. And I guess he has to store personal effects in the Starliner. Though presumably he only packed for 8 days.

    In climate controlled zero gravity, there’s no point to having more bedding than a light sleeping bag just to keep you from floating off somewhere. My guess is the big selling point on the cupboards is some noise damping, and maybe some protection from lighting. Spacecraft have noisy machines running all the time to keep you alive