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>>The hospital now deploys it routinely and the number of children who die there from pneumonia has fallen by three-quarters. That means the survival rate in th

>>The hospital now deploys it routinely and the number of children who die there from pneumonia has fallen by three-quarters. That means the survival rate in the Dhaka Hospital is today almost on a par with that of children treated in rich-world facilities, using conventional ventilators. Innovation like this is facilitated by the lack of medical device regulations in Bangladesh.

geon 8y ago
More like it was facilitated by the need. Had they had as low fatality rate as developed countries, I doubt weak regulation would have spurred innovation. Which is supported by the fact that fatality rates now almost match developed countries. If it was the weak regulation that spurred innovation, the rate should continue to fall.
- xyzzy123 8y ago
  Relatively weaker regulation (coupled with need!) allowed a doctor to deploy an unapproved pediatric device. You might get away with this once or twice but if you were a company making this thing in the west you would get rightfully sued into a smoking crater. I think the fallacy in your reasoning is to assume that innovation is “proportional” to death rate somehow. Doing it cheaper (or even at all!) under the constraints you have is still innovation. Put another way I think we have different definitions of innovation. The way I think of it, equivalent outcome for way less cost still counts.
xyzzy123 8y ago
I don’t think you deserve to be downvoted for this. A $5 hack is not really possible in the west, and that is definitely a thing worth thinking about. You might not get stopped from doing it if it was immediately obvious that it was effective but eventually hundreds of thousands if not millions would be spent on studies or approvals before a “proper” device made its way into the supply chain at 10000x markup over injection moulding cost.
- hopler 8y ago
  The challenge is that without regulation you get $5 life-saving shampoo hacks, but you also get lots of shake oil that is useless or harmful.
  - syn0byte 8y ago
    And with regulation you get...lots of snake oil this is useless to harmful. Prozac, Phenfen, etc. Even device and equipment makers like Theranos. You also get Pharma-Bro types selling medication WHO considers "essential" for 750 dollars a pill. Only the one company has(had) the regulatory approval to make a drug so basic Aussie school kids can make in chem class[0]. [0] https://qz.com/851416/why-martin-shkreli-and-turings-daraprim-still-costs-750-in-the-us-when-australian-schoolkids-can-make-it-for-2/ https://qz.com/851416/why-martin-shkreli-and-turings-darapri...
    - RA_Fisher 8y ago
      Yep, or extra deaths like Vioxx: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1779871/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1779871/ Or, take high insulin prices caused by a government-granted oligopoly from the FDA. The FDA maintains high barriers to entry. We all suffer from artificially high prices and reduced access.
- chrismeller 8y ago
  Also, is it really worth it to a doctor in the US? Even if I _know_ for a fact that it would work 100% absolutely the same as the multi-million dollar device, that's not the accepted procedure. I could still do it and save thousands of lives, but as soon as _anything_ goes wrong there's going to be a lawsuit and the fact that I used this crappy looking $5 thing is going to be a huge part of it, even if it had absolutely nothing to do with the death. Even if your motives were good, you were arguably doing what is best for society, and the device had nothing at all to do with the situation your career is over... Who in their right mind is ever going to do that?
  - 8y ago
gumby 8y ago
Actually a doctor could probably do this in the us too. Weird stuff gets rigged up all the time, it’s just not as common as elsewhere because bugbhospitals have a ton of random stuff in inventory and cost is not constrained. Also physicians can file INDs with much less paperwork than a company could. But it’s nonzero, so doesn’t happen all that often.
- onetimemanytime 8y ago
  US doctors would lose their license, savings and home. As soon as a child dies--bound to happen--they'll look for a reason to sue. I guess a US doctor might do a hack like this and called a hero, if the child was born in an airplane or cave somewhere and had no access to a hospital.
  - gumby 8y ago
    Have you ever been in a US emergency room, especially a rural one? The regulations are stiff, but not necessarily rigid, as the law is not a theorem-proving system. Disclaimer: I am not an MD, but I used to work in drug and medical device development, where the regs did have to be followed strictly to the letter, and became quite familiar with where flexibility was and was not). (And I meant IDE -- device exemption -- not IND, which is a drug exemption).
TheCoelacanth 8y ago
More likely it is facilitated by the cheapness of labor in Bangladesh. Bubble CPAP takes a lot of work to get set up correctly. In rich countries, it's not worth it to use a cheaper device if it takes more labor to get it to work. In Bangladesh, where labor is a tenth of the price, it is worth it.

geon 8y ago

More like it was facilitated by the need. Had they had as low fatality rate as developed countries, I doubt weak regulation would have spurred innovation. Which is supported by the fact that fatality rates now almost match developed countries. If it was the weak regulation that spurred innovation, the rate should continue to fall.

xyzzy123 8y ago
Relatively weaker regulation (coupled with need!) allowed a doctor to deploy an unapproved pediatric device. You might get away with this once or twice but if you were a company making this thing in the west you would get rightfully sued into a smoking crater. I think the fallacy in your reasoning is to assume that innovation is “proportional” to death rate somehow. Doing it cheaper (or even at all!) under the constraints you have is still innovation. Put another way I think we have different definitions of innovation. The way I think of it, equivalent outcome for way less cost still counts.

xyzzy123 8y ago

I don’t think you deserve to be downvoted for this. A $5 hack is not really possible in the west, and that is definitely a thing worth thinking about. You might not get stopped from doing it if it was immediately obvious that it was effective but eventually hundreds of thousands if not millions would be spent on studies or approvals before a “proper” device made its way into the supply chain at 10000x markup over injection moulding cost.

hopler 8y ago
The challenge is that without regulation you get $5 life-saving shampoo hacks, but you also get lots of shake oil that is useless or harmful.
- syn0byte 8y ago
  And with regulation you get...lots of snake oil this is useless to harmful. Prozac, Phenfen, etc. Even device and equipment makers like Theranos. You also get Pharma-Bro types selling medication WHO considers "essential" for 750 dollars a pill. Only the one company has(had) the regulatory approval to make a drug so basic Aussie school kids can make in chem class[0]. [0] https://qz.com/851416/why-martin-shkreli-and-turings-daraprim-still-costs-750-in-the-us-when-australian-schoolkids-can-make-it-for-2/ https://qz.com/851416/why-martin-shkreli-and-turings-darapri...
  - RA_Fisher 8y ago
    Yep, or extra deaths like Vioxx: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1779871/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1779871/ Or, take high insulin prices caused by a government-granted oligopoly from the FDA. The FDA maintains high barriers to entry. We all suffer from artificially high prices and reduced access.
chrismeller 8y ago
Also, is it really worth it to a doctor in the US? Even if I _know_ for a fact that it would work 100% absolutely the same as the multi-million dollar device, that's not the accepted procedure. I could still do it and save thousands of lives, but as soon as _anything_ goes wrong there's going to be a lawsuit and the fact that I used this crappy looking $5 thing is going to be a huge part of it, even if it had absolutely nothing to do with the death. Even if your motives were good, you were arguably doing what is best for society, and the device had nothing at all to do with the situation your career is over... Who in their right mind is ever going to do that?
- 8y ago

gumby 8y ago

Actually a doctor could probably do this in the us too. Weird stuff gets rigged up all the time, it’s just not as common as elsewhere because bugbhospitals have a ton of random stuff in inventory and cost is not constrained. Also physicians can file INDs with much less paperwork than a company could. But it’s nonzero, so doesn’t happen all that often.

onetimemanytime 8y ago
US doctors would lose their license, savings and home. As soon as a child dies--bound to happen--they'll look for a reason to sue. I guess a US doctor might do a hack like this and called a hero, if the child was born in an airplane or cave somewhere and had no access to a hospital.
- gumby 8y ago
  Have you ever been in a US emergency room, especially a rural one? The regulations are stiff, but not necessarily rigid, as the law is not a theorem-proving system. Disclaimer: I am not an MD, but I used to work in drug and medical device development, where the regs did have to be followed strictly to the letter, and became quite familiar with where flexibility was and was not). (And I meant IDE -- device exemption -- not IND, which is a drug exemption).

TheCoelacanth 8y ago

More likely it is facilitated by the cheapness of labor in Bangladesh. Bubble CPAP takes a lot of work to get set up correctly. In rich countries, it's not worth it to use a cheaper device if it takes more labor to get it to work. In Bangladesh, where labor is a tenth of the price, it is worth it.