81 karma · joined September 29, 2020
www.diapason.consulting pierre -at - diapasong.consulting https://www.linkedin.com/in/diapason/ https://twitter.com/diapasonconsult
https://www.washingtonpost.com/news/wonk/wp/2015/12/02/inter...
For the other point - the FDA has oversight into R&D when human are concerned - even if the requirements are not the same than for market clearance.
You can volunteer here: www.tinyurl.com/openhealthtech
Same thing for the Theranos scandal. Financial regulators have done better for the safety of the patients than the FDA!
Other regulators in the world are worst sadly. The European framework is a mess - stuck in between 2 revisions of their dogma and in the hand of Notified Bodies which are running a private business of setting up the benchmark of safety and efficacy for health-tech, without any accountability mechanism in place.
I could go for hours on that.
Note that there are great people and initiative too (there's one coming up at the FDA on 14 OCT).
These institutions are sadly not "fit" for the upcoming intelligence explosion. Everyone is asking for more regulation of AI but we need to learn how to be efficient at regulating fast!!
PS: I laughed more from the xkcd link posted before by u/ignoranceprior https://xkcd.com/1263/
* Axiomatic design https://www.sciencedirect.com/topics/engineering/axiomatic-d...
* C-K Theory https://en.wikipedia.org/wiki/C-K_theory
Does the system allow for specific regulatory/quality assurance requirements - e.g. a filter feature so a medical device manufacturer can limit their search to ISO13485 approved suppliers, or to specify bio-compatibility testing requirements for the parts/material they look for (e.g. ISO10993) ?
Happy to elaborate in PM :)
The animated graph for instance in https://cognicull.com/en/8e2konlv that shows "If the width of the change stepwise in the time direction is narrowed as follows, it will be a very smooth curve. You can't see the change stepwise, but the last smooth curve is also a digital signal."
-> their bit depth is ALSO changing in their animated picture. So even if the text that follows further addresses that - they are completely missing the point of a good explanation with their illustration.
I have since acquired more confidence language-wise, but it did not solve my 'confusion' (a la Travolta 404). I realized that what I was lacking was the negative feedback loop. I haven't had a long career in France before emigrating, but I had been through a large variety of student/casual jobs and a few short term engineering and project/program management roles. Enough to get accustomed to a French "professional context" in which I recall having professional reviews where negative feedback was given formally, and open discussions where employees would criticize the proposal made by a manager, or when a supplier was late in delivering - loud words would be exchanged on the phone. I haven't seen any of these in the past 15 years. Political correctness rules. Last time my temper took over and I inadvertently let a bit of my irritation be heard on the phone with a late supplier - they literally clammed down and it just added to the late schedule another 10 days of silence from them until they delivered. To quote Jeff Atwood - this is exactly the feeling I have at work sometime: "If a post has zero upvotes, does that mean it’s bad? incorrect? uninteresting? mediocre? There’s no way to tell, because zero has multiple meanings. [...] Downvotes give you the critically important ability to distinguish between the good, the bad, and the ugly. Without downvotes, how can you possibly tell the difference between a post that is harmless but uninteresting, and one that is actually wrong or harmful?"
Am I hallucinating ? I'd be curious to here about other emigrants/multicultural peeps' experience here.