3 ms·

> Does the video linked look like the result of "an all nighter and a 3D printer" to you? As you might understand from the language used and your failure to se

> Does the video linked look like the result of "an all nighter and a 3D printer" to you? As you might understand from the language used and your failure to see a 3D printer, my description is what you may describe as a hyperbole. But still, to put it in terms you might better understand, why do you think that medical devices take years to design and develop and get to the market? There are more things to it other than the old tinfoil stories.

HideousKojima 7y ago
>But still, to put it in terms you might better understand, why do you think that medical devices take years to design and develop and get to the market? Because of insane regulatory hurdles, and a refusal to adopt standards accepted by other nations' comparable regulatory agencies? See, for example, KN95 masks. Or for a non-coronavirus example, look at how slow the FDA has been to approve SLIT immunotherapy methods for allergy treatment, despite European agencies having approved them for decades. Which results in Americans seeking allergy immunotherapy to either get off-label prescriptions for SLIT therapy, or they have to get the much more expensive injections that require multiple visits a week to a doctor's office and supervision by trained (and therefore expensive) professionals.
- ardy42 7y ago
  > See, for example, KN95 masks. IIRC, the issue with KN95 respirators is not the standard itself, but a massive problem with not-up-to-spec counterfeits being offered on the market.
heleninboodler 7y ago
This sounds a little like an argument that it's simply impossible to get this done any faster, so we shouldn't try. I mean, I like to think we have clear enough standards for reliability and testing that if we manage to perform some excellent engineering and meet all of those standards in record time, and the federal government is willing to expedite the approval red tape, there's no technical reason we shouldn't be able to get it done a lot faster than what is typical without sacrificing safety. Or put another way: I really hope the safety of our existing medical devices isn't simply based on the process being slow.

HideousKojima 7y ago

>But still, to put it in terms you might better understand, why do you think that medical devices take years to design and develop and get to the market? Because of insane regulatory hurdles, and a refusal to adopt standards accepted by other nations' comparable regulatory agencies? See, for example, KN95 masks. Or for a non-coronavirus example, look at how slow the FDA has been to approve SLIT immunotherapy methods for allergy treatment, despite European agencies having approved them for decades. Which results in Americans seeking allergy immunotherapy to either get off-label prescriptions for SLIT therapy, or they have to get the much more expensive injections that require multiple visits a week to a doctor's office and supervision by trained (and therefore expensive) professionals.

ardy42 7y ago
> See, for example, KN95 masks. IIRC, the issue with KN95 respirators is not the standard itself, but a massive problem with not-up-to-spec counterfeits being offered on the market.

heleninboodler 7y ago

This sounds a little like an argument that it's simply impossible to get this done any faster, so we shouldn't try. I mean, I like to think we have clear enough standards for reliability and testing that if we manage to perform some excellent engineering and meet all of those standards in record time, and the federal government is willing to expedite the approval red tape, there's no technical reason we shouldn't be able to get it done a lot faster than what is typical without sacrificing safety. Or put another way: I really hope the safety of our existing medical devices isn't simply based on the process being slow.