Innovation like this is facilitated by the lack of medical device regulations in Bangladesh.
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.
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...
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.
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?
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.
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.
They can only afford it because we spend such an absurd amount of money on healthcare.
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.
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).
Also physicians can file INDs with much less paperwork than a company could. But it’s nonzero, so doesn’t happen all that often.
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).
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.
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.