Leaving aside for a second that this post is clearly an ad.
There are reasons why you can't just say "here's a new wheelchair, have fun suckers!" and that's because a medical device is major part of someone's life and disruptions that would annoy healthy people can be life threatening to them. Worst case scenario you end up in a Second-Sight situation [1].
Let's take a random example: the page says "If you're heading down a steep slope, the powered wheels ease the descent". When the brakes of my bike suddenly stopped working on a steep slope I could just throw myself to the side and brake with my legs. If you're a using this "mobility device" as a wheelchair and this happens to you well, tough luck. You should have bought a wheelchair instead.
Do not "move fast and break things" when the things are actually people.
> There are reasons why you can't just say "here's a new wheelchair, have fun suckers!" and that's because a medical device is major part of someone's life and disruptions that would annoy healthy people can be life threatening to them. Worst case scenario you end up in a Second-Sight situation [1].
Exactly. All this simplistic and puerile "regulation is bad" talk is a clear tell of how any anti-regulatory talk is rooted in ignorance and bad faith, and is mainly driven by mindless ideological fundamentalism.
As a resident of an independent living facility, I live among a lot of people who use various makes and models of powered chairs. And a great many who have the joystick dislike it immensely, and would prefer to have the handlebars-style navigation. But it's kind of the only way to have the "chair" style, nothing in front of you design. Some of the more scooter-style have rotating chairs, so you can park parallel to a table and turn, but that depends on lower limb mobility, so no easy solutions here.
The "climb a 13° slope, clear a 2-inch curb and cross a 4.7-inch gap" is quite impressive.
Reminds me of the situation with hearing aids. They're not particularly complicated devices compared to, say, $130 apple airpods. But because they were regulated as medical devices they often cost $3000 or more.
This has changed somewhat since 2022 now that they allow OTC hearing aids, although I believe they're still more expensive than airpods.
The $3000 aids are also behind a gatekeeper wall of aid technicians. After an audiologist creates a hearing profile, a technician is needed to program it with proprietary cable and software.
New aids have a highly configurable user experience that will be deeply personal to the user: what do various taps and gestures do and how sensitive are they, what are the different discrimination modes (party, music, conversation, car, etc), and how to get to them, automatic behaviors etc. There's usually a user BT app but it's usually a horrible vast subset designed to keep the gatekeeping intact.
There's some disruption to be had here somewhere between the $3000 gate-kept experience and the $130 airpod one. It should include some open hardware and protocols, let the user adjust all the user knobs, but should retain the audiologist's role regarding the actual hearing profile and safety.
> But because they were regulated as medical devices they often cost $3000 or more.
This is a rather miopic and biased opinion, one that is focused on supporting a personal assertion that regulation is bad instead of actually exploring why medical devices are expensive.
To start off, what is the difference between hearing aids and airpods? If your answer is "they are basically the same thing" then that should tell you more about what you might be getting wrong, and regulation ain't it.
> This has changed somewhat since 2022 now that they allow OTC hearing aids, although I believe they're still more expensive than airpods.
I don't think this means what you think it means. The regulatory change that introduced over the counter hearing aids only had an impact on what classified as prescription hearing aids. I'm practice you would buy any non-compliance device, except you couldn't get your health insurance foot the bill.
The impact of OTC hearing aids is that medical insurance can pay for your device if it's a lower tier one (low power, doesn't require fitting, etc).
But I stress that both then and now you could buy your hearing aid alternatives without requiring a doctor's prescription. You simply had to pay for it.
> Let's say you've assembled a team and designed an awesome powered wheelchair. One that works better than incumbent designs and is easy on the eyes.
Well, have they? The article lists some very cool features, but those are also points of failure. They review process for medical products is onerous and could definitely be improved, but it does serve an important purpose.
The chair seems to put the user in a higher and more upright position than most, for example, which could make it easier to fall out.
The scenario seems like the system working perfectly as designed: enthusiasts have the opportunity to buy it on the open market, and once it's proven and makes it through the review process, it'll be more widely available through insurance as well.
I can't stand the word "incumbent" anymore. I have only ever seen it in election contexts.
Now that Claude is using it as a fancy shortcut to "current", it's everywhere. I even hear people who would never think to use this word say it in face to face conversations.
During the last quarter of century there has been a huge consolidation by mergers and acquisitions in all markets, so in most of them only 2 or 3 big incumbents have remained, where in the 20th century there were dozens of competitors.
I have nothing with the word "incumbent" but I do not like the incumbents themselves, because unlike during the previous century, today it has become far more difficult for any newcomer to displace an incumbent, due to both dubious laws and unfair business practices that are tolerated now.
It's used all the time in mathematical optimization, referring to the best feasible solution found so far and therefore the "answer" until/unless something better appears. If you work with people in that space, it leaks out to mean anything "current" you're trying to improve upon.
That regulation is onerous on purpose, to prevent fly-by-night tech companies to sell expensive medical equipment that may end up hurting people. The medical devices industry runs slowly by design (see the cheap-wheelchair episode of Seinfeld for one example of how this goes wrong)
The obligations of organizations (insurance, federal, local and state governments, etc.) is the major reason wheelchairs are classified as medical devices.
As always you can get whatever you want if you are willing to pay out of pocket. But when someone else pays, you can't.
Leaving aside for a second that this post is clearly an ad.
There are reasons why you can't just say "here's a new wheelchair, have fun suckers!" and that's because a medical device is major part of someone's life and disruptions that would annoy healthy people can be life threatening to them. Worst case scenario you end up in a Second-Sight situation [1].
Let's take a random example: the page says "If you're heading down a steep slope, the powered wheels ease the descent". When the brakes of my bike suddenly stopped working on a steep slope I could just throw myself to the side and brake with my legs. If you're a using this "mobility device" as a wheelchair and this happens to you well, tough luck. You should have bought a wheelchair instead.
Do not "move fast and break things" when the things are actually people.
[1] https://news.ycombinator.com/item?id=30349871
> There are reasons why you can't just say "here's a new wheelchair, have fun suckers!" and that's because a medical device is major part of someone's life and disruptions that would annoy healthy people can be life threatening to them. Worst case scenario you end up in a Second-Sight situation [1].
Exactly. All this simplistic and puerile "regulation is bad" talk is a clear tell of how any anti-regulatory talk is rooted in ignorance and bad faith, and is mainly driven by mindless ideological fundamentalism.
As a resident of an independent living facility, I live among a lot of people who use various makes and models of powered chairs. And a great many who have the joystick dislike it immensely, and would prefer to have the handlebars-style navigation. But it's kind of the only way to have the "chair" style, nothing in front of you design. Some of the more scooter-style have rotating chairs, so you can park parallel to a table and turn, but that depends on lower limb mobility, so no easy solutions here.
The "climb a 13° slope, clear a 2-inch curb and cross a 4.7-inch gap" is quite impressive.
Reminds me of the situation with hearing aids. They're not particularly complicated devices compared to, say, $130 apple airpods. But because they were regulated as medical devices they often cost $3000 or more.
This has changed somewhat since 2022 now that they allow OTC hearing aids, although I believe they're still more expensive than airpods.
The $3000 aids are also behind a gatekeeper wall of aid technicians. After an audiologist creates a hearing profile, a technician is needed to program it with proprietary cable and software.
New aids have a highly configurable user experience that will be deeply personal to the user: what do various taps and gestures do and how sensitive are they, what are the different discrimination modes (party, music, conversation, car, etc), and how to get to them, automatic behaviors etc. There's usually a user BT app but it's usually a horrible vast subset designed to keep the gatekeeping intact.
There's some disruption to be had here somewhere between the $3000 gate-kept experience and the $130 airpod one. It should include some open hardware and protocols, let the user adjust all the user knobs, but should retain the audiologist's role regarding the actual hearing profile and safety.
...the irony of how many peeps will read this comment through luxotica lenses.
> But because they were regulated as medical devices they often cost $3000 or more.
This is a rather miopic and biased opinion, one that is focused on supporting a personal assertion that regulation is bad instead of actually exploring why medical devices are expensive.
To start off, what is the difference between hearing aids and airpods? If your answer is "they are basically the same thing" then that should tell you more about what you might be getting wrong, and regulation ain't it.
> This has changed somewhat since 2022 now that they allow OTC hearing aids, although I believe they're still more expensive than airpods.
I don't think this means what you think it means. The regulatory change that introduced over the counter hearing aids only had an impact on what classified as prescription hearing aids. I'm practice you would buy any non-compliance device, except you couldn't get your health insurance foot the bill.
The impact of OTC hearing aids is that medical insurance can pay for your device if it's a lower tier one (low power, doesn't require fitting, etc).
But I stress that both then and now you could buy your hearing aid alternatives without requiring a doctor's prescription. You simply had to pay for it.
And that's not a regulatory problem.
> Let's say you've assembled a team and designed an awesome powered wheelchair. One that works better than incumbent designs and is easy on the eyes.
Well, have they? The article lists some very cool features, but those are also points of failure. They review process for medical products is onerous and could definitely be improved, but it does serve an important purpose.
The chair seems to put the user in a higher and more upright position than most, for example, which could make it easier to fall out.
The scenario seems like the system working perfectly as designed: enthusiasts have the opportunity to buy it on the open market, and once it's proven and makes it through the review process, it'll be more widely available through insurance as well.
I can't stand the word "incumbent" anymore. I have only ever seen it in election contexts.
Now that Claude is using it as a fancy shortcut to "current", it's everywhere. I even hear people who would never think to use this word say it in face to face conversations.
During the last quarter of century there has been a huge consolidation by mergers and acquisitions in all markets, so in most of them only 2 or 3 big incumbents have remained, where in the 20th century there were dozens of competitors.
I have nothing with the word "incumbent" but I do not like the incumbents themselves, because unlike during the previous century, today it has become far more difficult for any newcomer to displace an incumbent, due to both dubious laws and unfair business practices that are tolerated now.
It's used all the time in mathematical optimization, referring to the best feasible solution found so far and therefore the "answer" until/unless something better appears. If you work with people in that space, it leaks out to mean anything "current" you're trying to improve upon.
[dead]
Ahhh, the "chocolatey frozen dessert" of wheelchairs.
Gotta love it when regulation meant to clarify, bring order and protect just ends up getting in the way and preventing entering the market.
That regulation is onerous on purpose, to prevent fly-by-night tech companies to sell expensive medical equipment that may end up hurting people. The medical devices industry runs slowly by design (see the cheap-wheelchair episode of Seinfeld for one example of how this goes wrong)
The obligations of organizations (insurance, federal, local and state governments, etc.) is the major reason wheelchairs are classified as medical devices.
As always you can get whatever you want if you are willing to pay out of pocket. But when someone else pays, you can't.