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by CryptoPunk 2744 days ago
>>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.

4 comments

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.

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?

If the doctor was doing good work, they should have no issue defending the work in a civil trial. Of course that's costly, but then again we have given a state-granted monopoly to lawyers: private bar associations that grant access to courts.
Well in an ideal world, sure.

Waiting five years for it to go to any kind of trial and then potentially being found guilty anyway because the jury sees an evil insurance corporation and an evil for-profit corporation and an evil, manipulative doctor trying to further his own career...

You’re going to lose anyway, and in the intervening 5 years you’re unemployable... and no matter how the trial turns out you’re also unemployable. That’s a lose-lose, and that’s why they always settle.

This hack isn't necessary in the US because the hospitals can afford (and already have) the proper bubble CPAP devices, which are more effective than hacked-together shampoo bottles anyway.

It's a good thing there's regulations in place here preventing the use of less effective hacks when better devices exist. And yeah, it's not just regulation but also legal liability that comes into play here; in the long run it's more expensive to use cheap hacks and risk many-million-dollar lawsuits if they kill someone than to pony up the thousands of dollars for the correct equipment.

>This hack isn't necessary in the US because the hospitals can afford (and already have) the proper bubble CPAP devices, which are more effective than hacked-together shampoo bottles anyway.

They can only afford it because we spend such an absurd amount of money on healthcare.

In this case it’s arguably one of those “well, it’s worth it” scenarios because there is evidence that the expensive version is better than the cheap version (though arguably perhaps not better enough to justify the cost).

The situation gets turned on it’s head when it’s an experimental procedure, though. “Insurance wouldn’t pay for x because it was experimental!” is an all too frequent complaint (it’s even the entire catalyst for the show Leverage).

Well, why do you think they don’t pay for it? Not only is it always insanely expensive, but it’s also got a 40% chance of success according to the doctor who wants to perform it (who is incentivized to keep his stats up) and it’s not endorsed by anyone... and that is a huge liability.

So I suppose my point here is that, for the armchair physicians online, every chance there is to save $1k there’s a chance to spend $100k. If you remove regulation you’re not just accomplishing savings on one thing, you’re opening up a pandora’s box of expense on another.

No, it can be afforded because a multi-use $6k device is well worth it if it can help save infants' lives.

I don't understand your argument at all. Of course it's worth it that this device exists. It works. And it only exists because we've spent money on development and acquisition. This is exactly when higher spending on healthcare is beneficial. Contrast with Bangladesh, where they can't afford these devices and as a consequence many more infants die (or they have to hack together inferior replacements from shampoo bottles that don't work as well).

My argument is that if this device could be produced and work using a shampoo bottle then it can be produced for less than $6000 and still be as effective. The problem of course is all of the hoops that need to be jumped over to get approval for even the simplest devices.
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.
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-darapri...

Yep, or extra deaths like Vioxx: 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.

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.

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.
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).

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.

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.

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.