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by renewiltord 779 days ago
This is a great project. I didn't realize that FDA Class I regulations were this easy to comply with.
1 comments

>I didn't realize that FDA Class I regulations were this easy to comply with.

They definitely won't be once this open source effort shows any sign of success. You can't solve political problems with technical solutions. At best, you may be able to displace them, but even that is rare.

> You can't solve political problems with technical solutions.

Yes, that's what I've been thinking too. Tom Quiter even mentions in the interview that there already have been companies which tried to offer cheap wheelchairs, but the quasi-monopolists had the FDA alter the regulations in a way with which the newbies couldn't comply.

However, since the MIF already attracted suppliers, I hope they can gain some leverage.

I only just noticed that the wheelchair https://libertymemesfoundation.org/donations/endurance-the-o... is actually a Class 2 device. That sounds really hard to get past the FDA. I think it's pretty cool still because folks with the knowhow could make their own, but the disabled are probably SOL because you can't really make these for sale without that.

I suppose the FDA's reasoning is that they're better off having no mobility than having a device that doesn't work properly.

Without commenting on the specific standards and regulations, the parade of horribles that could go wrong with a powered wheelchair is pretty extensive, when realizing that when a wheelchair goes wrong the user cannot move away from it. Consider the risks of a battery fire you can't escape, a drivetrain that could grab loose clothing around a pair of immobile legs, or a user whose wheelchair dies on an empty street at night at -10°F because it couldn't handle the cold for long enough. This doesn't mean the incumbents aren't fixing the regulations to ensure they've got a manufacturing moat -- this being healthcare, I assume that's exactly what they're doing -- but the FDA definitely has reasons to make sure these are regulated.
Do they?

I don’t think the FDA is in a position to asses whether those risks versus the benefits of mobility are an appropriate trade off for any individual.

The FDA is deciding that some people should have no mobility so that others have… what, exactly?

The people who bought $65,000 chairs still could — and they’d be equally reliable. But because one person needs to use it in Alaska, all people need to pay a premium… even if they live somewhere that cold rating is completely irrelevant and adding a needless $5000-10000 to the price.

While there’s a reason to regulate for truth in advertising and basic safety, eg, not catching fire on its own, the actual regulations extend far beyond that into adjudicating personal risk management without clear benefit.

I’m not a fan of technocracy — I think people themselves know what’s best for them.

Under that model, what about the people who can't afford a more reliable wheelchair because insurance is no longer obligated to cover it?
> I don’t think the FDA is in a position to asses whether those risks versus the benefits of mobility are an appropriate trade off for any individual.

Why wouldn't the FDA, which employs experts for that exact task, assess risks? Who is in a better position?

> I think people themselves know what’s best for them.

How can anyone but an expert evaluate the safety of a powered wheelchair?

I don't think powered wheelchairs should be Class II, but we should be a bit kinder to the FDA.

The FDA is not comparing no mobility and simply an inoperable device, the FDA is comparing no mobility vs the possible outcomes of an malfunctioning device. Like perhaps what happens if the throttle gets stuck on forward.

The FDA serves many compromised purposes that, in sum, prioritize the interests of the capitalists who predominately control it. The same can be said for the entire US government.
Everyone keeps repeating it, but could you give evidence of that happening? Who are the commissioners? What about the staff?
The rich keep getting richer faster at the expense of everyone else.
I can assure you that the FDA does no such thing, as I have been through a very difficult 510k at a previous employer.
When replicators are invented, most political problems will disappear. Star Trek got it right.
Star Trek style replicators can't be invented. The laws of physics won't allow it. It will always cost more energy and be vastly less efficient to assemble a cup of coffee atom by atom than it would to just grow the beans, have them picked, packaged and shipped, and make it yourself, and unlike in Star Trek, energy in the real world isn't free.

You might say we could come close with advanced 3D printing and some kind of nanotech,but no such technology will ever be so cheap or ubiquitous as to render politics obsolete. History is replete with advancements and inventions which were supposed to usher in utopia, and all they have ever done is further the means by which the powerful enslave and control us. Technology cannot solve human nature.

>History is replete with advancements and inventions which were supposed to usher in utopia, and all they have ever done is further the means by which the powerful enslave and control us. Technology cannot solve human nature.

humans are more sovereign than ever before in most calculable metrics.

What "calculable metrics?" By what definition of "sovereign?" Objectively, this is a meaningless statement to me.
Which countries force you where to live and what job to work at?
> energy in the real world isn't free.

That's because we haven't figured out how to harness it.

For example, 99.9999% of the sun's energy just disappears off into space.

We sit on a hot planet, all that's needed to drive our energy needs is to drill a hole through the mantle. But nobody has figured out how to do that yet.

Energy in Star Trek is not free either, just too cheap to meter. They use fusion and matter-antimatter reactors. Once we get there we will also have more than enough energy to power the potential replicator.

Though I agree we probably won't be using it to replicate a cup of Earl Grey for a very long time.

growing the beans, having them picked, packaged and shipped and making them yourself is assembling building coffee atom by atom. What do you think those plants are doing growing those beans? What do you think pouring that hot water onto the grounds is doing?