101–110 of 112 posts
Earlier quoted context omitted.
Yep. Sorry for transposing a few letters. It’s a tremendously beautiful and friendly place. I’d love to go back one of these days.
:) wasn't trying to criticize. Sorry if it came off that way.
This is really great. For those who aren't familiar with what these machines can do, the calculation of an athlete's Vo2 max really isn't all that useful. However, a breakdown of the fat and carbohydrate calories burned at various efforts can be incredibly useful for helping an athlete learn how to fuel correctly for performance over distance. I'm not a physiologist or physician (and I'm sure what I'm about to say ma…
could you kindly elaborate on why Vo2 max isn't useful for an athlete? naively, it seems measuring oxygen consumption would be useful.
That said, it does provide some correlation to an athletes performance “ceiling”, and you’ll typically find elite endurance athletes are naturally blessed with an impressive Vo2 max. You’re not going to win the Tour de France with a Vo2 max of 50 no matter how hard you train, just like you’ll never play Center in the NBA if you’re 6’1.
Earlier quoted context omitted.
You are assuming that the existence of regulations means that there’s testing required. You’d be surprised at how much is just about filling the proper paperwork, paying some fees and knowing the right people. The amount of independent testing is negligible.
I'm sorry, but this is just patently false. The FDA requires extensive V&V testing, especially for medical devices that have a significant chance to kill the people that it's used on. That, and you need to have a very sophisticated quality management system (QMS) in place that tracks all the changes you make during your design and test process, links up source requirements to passing test reports in an auditable way,…
Paperwork, they require paperwork.
It’s the same issues that plague FCC and CE, the amount of tricks and handwaving you can get approval for makes a lot of this (self performed/self directed) testing completely useless.
There’s a whole market of “expert consultants” whose job is gaming the tests and finding loopholes, and as long as tests are conducted in this manner, they will exist.
Earlier quoted context omitted.
I'm sorry, but this is just patently false. The FDA requires extensive V&V testing, especially for medical devices that have a significant chance to kill the people that it's used on. That, and you need to have a very sophisticated quality management system (QMS) in place that tracks all the changes you make during your design and test process, links up source requirements to passing test reports in an auditable way,…
> I'm sorry, but this is just patently false. [..] The FDA requires extensive V&V testing [..] and you need to have a very sophisticated quality management system (QMS) Paperwork, they require paperwork. It’s the same issues that plague FCC and CE, the amount of tricks and handwaving you can get approval for makes a lot of this (self performed/self directed) testing completely useless. There’s a whole market of “expe…
Like I said, the world of predicate devices is a different ball game, but you're not going to get by with hand waving on a device that can kill people.
I thought the DIY air-quality monitor earlier today was neat but this blows me away. Some serious next-level hardware hackers this generation. I get worried everyone is turning into dumb iphone+app users but this advanced creation stuff restores faith.
Earlier quoted context omitted.
> I'm sorry, but this is just patently false. [..] The FDA requires extensive V&V testing [..] and you need to have a very sophisticated quality management system (QMS) Paperwork, they require paperwork. It’s the same issues that plague FCC and CE, the amount of tricks and handwaving you can get approval for makes a lot of this (self performed/self directed) testing completely useless. There’s a whole market of “expe…
That's a little reductive. Companies get shut down all the time when their quality management is not up to snuff (for a high profile example of this, look at CMS' shutdown of the Theranos labs in 2015). The system generates the paperwork, and the data enclosed is generated by the processes you have to put in place to get approval in the first place. Like I said, the world of predicate devices is a different ball game…
That’s not a good measure for the performance of the regulation. In fact I’d like to see the numbers on the exact reasons for those shut downs, because I’m willing to bet they’re related to bad classification and other technicalities.
If the FDA were to be a test, you’d want it to have good discrimination at a low cost.
Anyone who has been involved in the process knows the cost is enormous, and scandals like Theranos (and good but extremely late good cases) show that discrimination is not that good to begin with.
Earlier quoted context omitted.
At least in the US, there's a fair amount of immigrant medical professionals who have the training, often the experience, but not the licensing.
What’s getting in the way of their american licensing ?
Earlier quoted context omitted.
That's a little reductive. Companies get shut down all the time when their quality management is not up to snuff (for a high profile example of this, look at CMS' shutdown of the Theranos labs in 2015). The system generates the paperwork, and the data enclosed is generated by the processes you have to put in place to get approval in the first place. Like I said, the world of predicate devices is a different ball game…
> Companies get shut down all the time when their quality management is not up to snuff. That’s not a good measure for the performance of the regulation. In fact I’d like to see the numbers on the exact reasons for those shut downs, because I’m willing to bet they’re related to bad classification and other technicalities. If the FDA were to be a test, you’d want it to have good discrimination at a low cost. Anyone wh…
These regulations are written in blood. They're difficult to comply with because if you invite poor engineering you will get poor engineering and dangerous devices.
Earlier quoted context omitted.
So can headphones and earbuds, and society seems to do just fine with the normal level of consumer electronics regulation. Is there really value in the medical device regulations for hearing aids beyond that?
> So can headphones and earbuds, and society seems to do just fine with the normal level of consumer electronics regulation. Do we? I was under the impression that there has been an uptick in hearing damage in young people due to them increasing the earbud volume above background noise levels (not so much of a problem in earphones that cover the ears as they block out outside noise). That's a medical problem that wil…
Earlier quoted context omitted.
For those interested, Jeff Volek's team published a study in 2016, "Metabolic characteristics of keto-adapted ultra-endurance runners" [1] that compared fax oxidation. One of the "fat adapted" participants Zach Kibbter, an ultra-marathon record holder, posted a personal writeup that included a table of his fat usage at various VO2 Maxes (a ridiculous 98% fat usage at 75% VO2max and 76% even at 84% of VO2max!)[2] [1]…
What would those numbers be for the general population or someone who is slightly fit but not a freak?
If you're interested in some of the other physiological impacts of keto adaptation, here's a presentation Volek gave a couple years ago that helps contextualize both the FASTER trial and a related TANK trial his team ran, as well as some other interesting related performance research: https://www.youtube.com/watch?v=BeS_dhM8dsY
[1] https://www.sciencedirect.com/science/article/pii/S002604951...
[2] https://www.sciencedirect.com/science/article/pii/S002604951...
[3] https://www.frontiersin.org/articles/10.3389/fphys.2018.0059...