4 ms·

Are the regulations very different in different countries? I can think of a few places where getting live-saving machines an order of magnitude cheaper with a s

Are the regulations very different in different countries? I can think of a few places where getting live-saving machines an order of magnitude cheaper with a small percentage increase in risk of causing harm might be an acceptable trade-off in some cases.

Arnt 11y ago
I've been to hospital in one of the places you're thinking of, and I noticed that phrases like "approved for use in the EU" were used as code for "this is not a scam". I fear the market niche between "scam" and "not a scam" might be very narrow.
- lazaroclapp 11y ago
  I mean, I was thinking less private-clinic of dubious standards in a city, and more "what can the national health services of developing countries reasonably deploy to most rural communities?". For example, I am from Mexico, and cysticercosis (a brain parasite infection) is not uncommon in rural areas in Mexico. MRI scanners, which can be used to detect it, on the other hand, are quite uncommon outside of major cities. This might or might not be a good example, since I don't know the cost/safety trade-offs for MRI or all the alternative solutions, but if one could get, say, $20,000 USD MRI scanners that are close to in practice to $1 million ones, it might be worth a small safety delta. Public health in Mexico at the national level also tends to fall under "generally trustworthy enough, but critically under-resourced". Edit: Again, not sure how realistic this particular scenario is, but I think in general getting cheaper equipment for national health services might be worth it in cases where having a lower-standard device can save an order of magnitude more lives than it harms.
HeyLaughingBoy 11y ago
This is not my area of expertise, but in speaking to Regulatory Affairs people when I was working in the field, most of the EU and some of Asia base their regulations on the US FDA, or at least have very similar regulations. In addition to FDA audits, we were also periodically audited by the regulatory bodies of other countries. However, in many countries, enforcement is lax, so you get lots of devices that don't come close to meeting whatever regulation is in place.

Arnt 11y ago

I've been to hospital in one of the places you're thinking of, and I noticed that phrases like "approved for use in the EU" were used as code for "this is not a scam". I fear the market niche between "scam" and "not a scam" might be very narrow.

lazaroclapp 11y ago
I mean, I was thinking less private-clinic of dubious standards in a city, and more "what can the national health services of developing countries reasonably deploy to most rural communities?". For example, I am from Mexico, and cysticercosis (a brain parasite infection) is not uncommon in rural areas in Mexico. MRI scanners, which can be used to detect it, on the other hand, are quite uncommon outside of major cities. This might or might not be a good example, since I don't know the cost/safety trade-offs for MRI or all the alternative solutions, but if one could get, say, $20,000 USD MRI scanners that are close to in practice to $1 million ones, it might be worth a small safety delta. Public health in Mexico at the national level also tends to fall under "generally trustworthy enough, but critically under-resourced". Edit: Again, not sure how realistic this particular scenario is, but I think in general getting cheaper equipment for national health services might be worth it in cases where having a lower-standard device can save an order of magnitude more lives than it harms.

HeyLaughingBoy 11y ago

This is not my area of expertise, but in speaking to Regulatory Affairs people when I was working in the field, most of the EU and some of Asia base their regulations on the US FDA, or at least have very similar regulations. In addition to FDA audits, we were also periodically audited by the regulatory bodies of other countries. However, in many countries, enforcement is lax, so you get lots of devices that don't come close to meeting whatever regulation is in place.