11 ms·

Sometimes I wonder if the way to bypass the insane regulations around medical devices is to just publish them online for anyone to build themselves. Sure I won

Sometimes I wonder if the way to bypass the insane regulations around medical devices is to just publish them online for anyone to build themselves. Sure I won't have the minutes detail of million dollar medical equipment, but maybe I don't need all that precision, or maybe that's better than having no access at all to the measurements at all

csdvrx 5y ago
We need a currently "missing" network effect that cheap 3d printer supporting everything from more flexible plastics to metal will eventually provide.
- nexuist 5y ago
  Wake me up when we can 3D print pills and I can craft the perfect Tylenol or 5 hour energy from some React app. Now that'll be a medical revolution!
  - csdvrx 5y ago
    Once this is done, printing chemicals might be achievable too (thanks to the network effect of lots of people already having 3d printer to produce the required hardware), but maybe not immediately :)
  - nradov 5y ago
    You don't need a 3D printer. Just order bulk acetaminophen and caffeine powder, then put as much as you want into capsules. (Don't poison yourself.)
NationalPark 5y ago
What are the devices you have in mind? It doesn't seem like the intersection between "people with biomedical engineering skills" and "people who need treatment limited by the expense of the equipment" would be that large. I suppose I can imagine a sort of shadow economy of cheap medical treatment on home-built equipment, but surely the providers would be uninsurable and sued into oblivion at the first mistake.
- guelo 5y ago
  Ones that immediately comes to my mind are ultrasound,and hearing aids. If they were unregulated there would be cheap OTC devices available.
  - complexworld 5y ago
    I work on a handheld ultrasound device that attached to a phone or a tablet. It is much easier to use than traditional ultrasound machines, because of the attention paid to the UX off the app, and the familiar smartphone UI. That being said I will haven't learned how to use it in a meaningful way myself. Getting a good image, and then interpreting the 2d video stream requires training! Making ultrasound easy enough for non specialists to use will require an AI that guides the user and interprets the images. I'm not convinced skipping FDA approval would be a good idea in this case.
    - j-bos 5y ago
      At least in the US, there's a fair amount of immigrant medical professionals who have the training, often the experience, but not the licensing.
      - dijonman2 5y ago
        What’s getting in the way of their american licensing ?
        labcomputer 5y ago
        The AMA.
        j-bos 5y ago
        If they didn't finish their school their studies are often regulatorily worthless in the US, if they did there's still massive hurdles to jump without existing relationships/wealth to aid the transition.
    - 5y ago
pkaye 5y ago
What are the insane aspects of the regulations?
- hprotagonist 5y ago
  Most of them are written in blood.
  - Karunamon 5y ago
    I don't think I can accept that, especially with regard to items like hearing aids. There's a fundamental difference between things like implants and surgical tools and relatively simple devices like CPAP machines and hearing aids; things where the harm of a failure scenario is extremely limited. This is a government at the end of the day. It would be imprudent to not consider the effects of regulatory capture, cronyism, and so forth.
    - hprotagonist 5y ago
      do you have experience in the discipline? It doesn’t sound like you do. I have some experience, and i can think of about a half dozen ways cpap machines and hearing aids could cause serious harm as a result of design flaws or lack of QA that would be de rigeur if not for regulatory pressure.
      - Karunamon 5y ago
        What are some of those ways that are not addressed by regular old (non-medical-specific) electronics/safety regulation? Most of the ways I can think of a CPAP failing would be extremely obvious with equally obvious and relatively low-impact effects (I get a crappy night's sleep or wake up in the middle of the night).
        aenis 5y ago
        Recent case involving very popular Philips Respironics machines: the foam used for internal insulation was degrading and getting into the stream of air, landing those particles in patients lungs. Huge recall, etc. The kind of problem that testing imposed by regulators can detect. Incorrect use of CPAP can lead to development of central apnea. (Even APAP machines can be programmed to keep the pressure too high which is long term unhealthy). With that, I am all for liberalization of the laws. My GP did not prescribe me a CPAP machine despite obvious signs of apnea. "Lose some weight instead" (that despite me having apnea even when I had a BMI of 21). I never felt as much of a positive difference on my life as when I started using the machine and had my first good night of sleep in decades. I wish my govt would let me buy an insulin measurement device, but nope, those too are regulated and not available for the general public.
user48289223 5y ago
I think this would really be great. The extra regulations of the FDA are showing to be more and more of a burden as years go on (let's not get into their corruption). Something like a chip and a device sold separately but trivially put together. I myself ran into this problem when trying to buy a blood lactate meter as an American, which can be trivially purchased all across Europe and Asia.
- yeetaccount4 5y ago
  It’s ironic that a lot of their approval process amounts to filling out paperwork without any verification or testing on their part. Source: I know people.
nradov 5y ago
Most of the commercial devices used to measure VO2 Max aren't regulated medical devices.
hffftz 5y ago
tootie 5y ago
I think it's less about regulation and more about liability. Giving inaccurate medical information can be pretty dangerous.

csdvrx 5y ago

We need a currently "missing" network effect that cheap 3d printer supporting everything from more flexible plastics to metal will eventually provide.

nexuist 5y ago
Wake me up when we can 3D print pills and I can craft the perfect Tylenol or 5 hour energy from some React app. Now that'll be a medical revolution!
- csdvrx 5y ago
  Once this is done, printing chemicals might be achievable too (thanks to the network effect of lots of people already having 3d printer to produce the required hardware), but maybe not immediately :)
- nradov 5y ago
  You don't need a 3D printer. Just order bulk acetaminophen and caffeine powder, then put as much as you want into capsules. (Don't poison yourself.)

NationalPark 5y ago

What are the devices you have in mind? It doesn't seem like the intersection between "people with biomedical engineering skills" and "people who need treatment limited by the expense of the equipment" would be that large. I suppose I can imagine a sort of shadow economy of cheap medical treatment on home-built equipment, but surely the providers would be uninsurable and sued into oblivion at the first mistake.

guelo 5y ago
Ones that immediately comes to my mind are ultrasound,and hearing aids. If they were unregulated there would be cheap OTC devices available.
- complexworld 5y ago
  I work on a handheld ultrasound device that attached to a phone or a tablet. It is much easier to use than traditional ultrasound machines, because of the attention paid to the UX off the app, and the familiar smartphone UI. That being said I will haven't learned how to use it in a meaningful way myself. Getting a good image, and then interpreting the 2d video stream requires training! Making ultrasound easy enough for non specialists to use will require an AI that guides the user and interprets the images. I'm not convinced skipping FDA approval would be a good idea in this case.
  - j-bos 5y ago
    At least in the US, there's a fair amount of immigrant medical professionals who have the training, often the experience, but not the licensing.
    - dijonman2 5y ago
      What’s getting in the way of their american licensing ?
      - labcomputer 5y ago
        The AMA.
      - j-bos 5y ago
        If they didn't finish their school their studies are often regulatorily worthless in the US, if they did there's still massive hurdles to jump without existing relationships/wealth to aid the transition.
  - 5y ago

pkaye 5y ago

What are the insane aspects of the regulations?

hprotagonist 5y ago
Most of them are written in blood.
- Karunamon 5y ago
  I don't think I can accept that, especially with regard to items like hearing aids. There's a fundamental difference between things like implants and surgical tools and relatively simple devices like CPAP machines and hearing aids; things where the harm of a failure scenario is extremely limited. This is a government at the end of the day. It would be imprudent to not consider the effects of regulatory capture, cronyism, and so forth.
  - hprotagonist 5y ago
    do you have experience in the discipline? It doesn’t sound like you do. I have some experience, and i can think of about a half dozen ways cpap machines and hearing aids could cause serious harm as a result of design flaws or lack of QA that would be de rigeur if not for regulatory pressure.
    - Karunamon 5y ago
      What are some of those ways that are not addressed by regular old (non-medical-specific) electronics/safety regulation? Most of the ways I can think of a CPAP failing would be extremely obvious with equally obvious and relatively low-impact effects (I get a crappy night's sleep or wake up in the middle of the night).
      - aenis 5y ago
        Recent case involving very popular Philips Respironics machines: the foam used for internal insulation was degrading and getting into the stream of air, landing those particles in patients lungs. Huge recall, etc. The kind of problem that testing imposed by regulators can detect. Incorrect use of CPAP can lead to development of central apnea. (Even APAP machines can be programmed to keep the pressure too high which is long term unhealthy). With that, I am all for liberalization of the laws. My GP did not prescribe me a CPAP machine despite obvious signs of apnea. "Lose some weight instead" (that despite me having apnea even when I had a BMI of 21). I never felt as much of a positive difference on my life as when I started using the machine and had my first good night of sleep in decades. I wish my govt would let me buy an insulin measurement device, but nope, those too are regulated and not available for the general public.

user48289223 5y ago

I think this would really be great. The extra regulations of the FDA are showing to be more and more of a burden as years go on (let's not get into their corruption). Something like a chip and a device sold separately but trivially put together. I myself ran into this problem when trying to buy a blood lactate meter as an American, which can be trivially purchased all across Europe and Asia.

yeetaccount4 5y ago
It’s ironic that a lot of their approval process amounts to filling out paperwork without any verification or testing on their part. Source: I know people.

nradov 5y ago

Most of the commercial devices used to measure VO2 Max aren't regulated medical devices.

hffftz 5y ago

tootie 5y ago

I think it's less about regulation and more about liability. Giving inaccurate medical information can be pretty dangerous.