4 ms·

> Medicare said it would start paying for 80 percent of exoskeletons, which at Lifeward cost about $100,000. > And although that coverage doesn’t extend to par

> Medicare said it would start paying for 80 percent of exoskeletons, which at Lifeward cost about $100,000. > And although that coverage doesn’t extend to paraplegics who have injuries to their spine as high up as Straight Oh man, i feel for everyone who live in the USA and require any sort of medical help. Either you spend all your hard earned money or you got to get in a though fight with the medical administration.

exolymph 2y ago
While the US healthcare system does suck in numerous ways, is this kind of thing even available elsewhere, via socialized medicine? (Maybe the answer is yes, which would be great!)
- aucisson_masque 2y ago
  Yes it does. https://www.francetvinfo.fr/sante/politique-de-sante/sante-la-revolution-des-exosquelettes_5627849.html https://www.francetvinfo.fr/sante/politique-de-sante/sante-l...
- yesco 2y ago
  Oftentimes the big issues with the development of new Medical Devices are pre/post market studies and data collection for those studies. The regulatory path for this ends up quite complicated & contradictory when juggled with HIPPA, GDPR and the various rules around how these studies are executed. This means there is a lot of tricky nuance to what markets a Medical Device company might try to target. While I certainly wouldn't call myself an expert on this, having worked within the industry I've been able to make the following observations: - Novel medical devices are often created by very small startups, who in essence exist solely to create a PoC. A larger Medical Device company then buys them to actually start walking through the regulatory hurdles which will bring them to market. - The market it gets initially released in is rarely connected to the location it was invented (ex: Invented by European startup but released in the US is weirdly common). But if a product is successful enough then an even larger Medical device company with access to more international markets might swoop in and purchase the mid sized company. - European regulatory agencies will oftentimes be lenient on products that have received FDA approval, but the reverse is less clear cut. So going through the FDA first can be more efficient, especially when considering the market size of the US along with the fact that you only need to support one language. In practice this pushes out the timeline for the first European release of a device. - GDPR is actually not very different from HIPPA, perhaps not even as strict, but it is more ambiguous and that's a problem. The key difference is that, right now, everyone knows exactly how to follow HIPPA but the reverse is not true for GDPR. Some things that might be allowed by one might subtly contradict the other and there is no third party Medical Device companies can throw money at that will absorb the liability of this by saying whether or not they are GDPR compliant. - Since Medical Device companies live & die on their study data, this data collection paradox has further pushed out timelines for when medical devices are first released in Europe. - A European might see a cool new Medical device from a startup in their local newspaper but then never actually gain access to it for another 20 years. So personally I'd say it largely reduces down to the regulatory environment + market size. The US can be among the strictest, but not only is getting past that worth it for market access, but by passing those strict hurdles, releasing to other international markets becomes much easier since you got the hard part over with. Not to mention the fact that, in a similar way a popular programming language might have more "community resources" and a larger hiring pool, the same could also be said for navigating regulatory environments. So popularity has a self-amplifying effect.
kortilla 2y ago
> you got to get in a though fight with the medical administration. This is the only option in other countries with gov provided healthcare.
- aucisson_masque 2y ago
  Oh no. You get what is owed to you very easily and very quickly, whatever how much it cost. I've got relatives who got cancer medication just like that, appointment to the doctor, go to pharmacy and pay nothing at all. In a day he got it.
  - kortilla 2y ago
    No, not when it comes to stuff deemed “unnecessary” for improvements to life like this.
    - aucisson_masque 2y ago
      Well it is in France and we definitely got social healthcare. https://www.francetvinfo.fr/sante/politique-de-sante/sante-la-revolution-des-exosquelettes_5627849.html https://www.francetvinfo.fr/sante/politique-de-sante/sante-l...

exolymph 2y ago

While the US healthcare system does suck in numerous ways, is this kind of thing even available elsewhere, via socialized medicine? (Maybe the answer is yes, which would be great!)

aucisson_masque 2y ago
Yes it does. https://www.francetvinfo.fr/sante/politique-de-sante/sante-la-revolution-des-exosquelettes_5627849.html https://www.francetvinfo.fr/sante/politique-de-sante/sante-l...
yesco 2y ago
Oftentimes the big issues with the development of new Medical Devices are pre/post market studies and data collection for those studies. The regulatory path for this ends up quite complicated & contradictory when juggled with HIPPA, GDPR and the various rules around how these studies are executed. This means there is a lot of tricky nuance to what markets a Medical Device company might try to target. While I certainly wouldn't call myself an expert on this, having worked within the industry I've been able to make the following observations: - Novel medical devices are often created by very small startups, who in essence exist solely to create a PoC. A larger Medical Device company then buys them to actually start walking through the regulatory hurdles which will bring them to market. - The market it gets initially released in is rarely connected to the location it was invented (ex: Invented by European startup but released in the US is weirdly common). But if a product is successful enough then an even larger Medical device company with access to more international markets might swoop in and purchase the mid sized company. - European regulatory agencies will oftentimes be lenient on products that have received FDA approval, but the reverse is less clear cut. So going through the FDA first can be more efficient, especially when considering the market size of the US along with the fact that you only need to support one language. In practice this pushes out the timeline for the first European release of a device. - GDPR is actually not very different from HIPPA, perhaps not even as strict, but it is more ambiguous and that's a problem. The key difference is that, right now, everyone knows exactly how to follow HIPPA but the reverse is not true for GDPR. Some things that might be allowed by one might subtly contradict the other and there is no third party Medical Device companies can throw money at that will absorb the liability of this by saying whether or not they are GDPR compliant. - Since Medical Device companies live & die on their study data, this data collection paradox has further pushed out timelines for when medical devices are first released in Europe. - A European might see a cool new Medical device from a startup in their local newspaper but then never actually gain access to it for another 20 years. So personally I'd say it largely reduces down to the regulatory environment + market size. The US can be among the strictest, but not only is getting past that worth it for market access, but by passing those strict hurdles, releasing to other international markets becomes much easier since you got the hard part over with. Not to mention the fact that, in a similar way a popular programming language might have more "community resources" and a larger hiring pool, the same could also be said for navigating regulatory environments. So popularity has a self-amplifying effect.

kortilla 2y ago

> you got to get in a though fight with the medical administration. This is the only option in other countries with gov provided healthcare.

aucisson_masque 2y ago
Oh no. You get what is owed to you very easily and very quickly, whatever how much it cost. I've got relatives who got cancer medication just like that, appointment to the doctor, go to pharmacy and pay nothing at all. In a day he got it.
- kortilla 2y ago
  No, not when it comes to stuff deemed “unnecessary” for improvements to life like this.
  - aucisson_masque 2y ago
    Well it is in France and we definitely got social healthcare. https://www.francetvinfo.fr/sante/politique-de-sante/sante-la-revolution-des-exosquelettes_5627849.html https://www.francetvinfo.fr/sante/politique-de-sante/sante-l...