7 ms·

I work in Biotech and every time I read one of these articles/posts about how somebody hacked their insulin pump people start asking why there aren't already af

I work in Biotech and every time I read one of these articles/posts about how somebody hacked their insulin pump people start asking why there aren't already affordable closed-loop pumps on the market if people are hacking their own with raspberry pis and the like, and they clearly don't understand the regulatory process or the level of clinical testing that's needed to validate something that, if it malfunctions at night, can kill you.

0xDEFC0DE 7y ago
To be fair that same process allowed hackable (malicious or not) devices out into the world https://www.webmd.com/diabetes/news/20190628/fda-recalls-insulin-pump-over-security-concerns https://www.webmd.com/diabetes/news/20190628/fda-recalls-ins...
- Konnstann 7y ago
  Believe me I'm not saying the FDA is some perfect organization that can do no wrong but they do exist for a reason. There definitely needs to be more scrutiny as tech (read:computers/AI) start making their way into therapeutic devices.
dlphn___xyz 7y ago
this implies that if a medical device (or pharma) passes through the regulatory process it will never malfunction which is absolutely not true.
- merpnderp 7y ago
  It doesn't imply it will never malfunction. It implies it went through a scientifically rigorous process to minimize the chances it will malfunction.
  - Cthulhu_ 7y ago
    And often that there's warranties in place - that is, if it does fail under normal operation, you can sue them and get millions. Which won't buy your loved one back but it's a strong deterrent for the company to not try and palm off dysfunctional shit.
    - dlphn___xyz 7y ago
      that doesnt help if youre dead or severly injured...besides how many of these cases actually go to court and win?
      - ceejayoz 7y ago
        It doesn't fix those things, but it does help deal with them, at least where the long-term financial impacts are concerned. You're not going to squeeze a lifetime worth of lost salary out of a random Redditor who told you how to tweak your insulin pump.
- dllthomas 7y ago
  It really just implies that the odds are sufficiently improved. Which may or may not be true, but which has a much better shot at it.
  - dlphn___xyz 7y ago
    often times products are expedited through this ‘scientific process’ to get on the market faster. if the regulatory process is truly about safety why does this exception even exist?
    - ceejayoz 7y ago
      > if the regulatory process is truly about safety why does this exception even exist? Because the risk is worthwhile at times. The exceptions typically apply to rare diseases that impact a population too small to be profitable enough to justify the $1B or more it may cost to shepherd a device or medication through the normal process. These are populations who would be potentially unserved otherwise. (I'm of the personal opinion that this is where the government should step in instead of private industry, but I'm pretty left of center.) https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-humanitarian-use-device-hud https://www.fda.gov/industry/developing-products-rare-diseas... IIRC, an exception of this sort was used to expedite an Ebola vaccine due to the recent outbreak... because, well, Ebola.
    - dllthomas 7y ago
      Whether it's actually a good idea isn't something I know enough of the real numbers to comment on, but it seems plenty possible that an expensive step that substantially reduces risk might be appropriate in some circumstances and not in others.
C1sc0cat 7y ago
Yes makes me shudder thinking of what could go wrong . I spent a year hooked up for 8 hours a night to a CPD dialysis machine - I read the massive manual and there is a long section on what can go wrong including "Death" - no way would I start hacking on that. Though I did think about using a camera and ML to monitor the waste output for signs of contamination.
pedrocr 7y ago
While I understand the issue in general it seems it should be relatively simple to validate that a closed-loop insulin pump is at least no worse. Isn't the objective of the closed-loop to just do finer control? So can't you just have the same hard limits as the normal pump and then allow the potentially buggy software to just fine-tune within a generally safe range?
danielschonfeld 7y ago
As opposed to not doing anything which is the current state of Diabetes for the most part, which too, kills you and if not outright kills you then slowly does via financial ruin. How many episodes of hypoglycemia do you think one needs to have, in an utterly broken healthcare system in which being ordered paramedics and given sugar pills costs you $XXXX per occurance. And if you're gonna talk to me about responsbility and healthy living please join the real world some time. That's why people choose to take actions into their own hands. Because being a victim of a system that just doesn't care enough leads you to either take the handles or down under.
- deleted 7y ago
  [deleted]
- hnal943 7y ago
  That doesn't address his point, which is that a programmable pump isn't something you could sell because of the liability involved.
  - hk2001 7y ago
    It is something you can sell, and is currently in development by major pharmaceutical companies.
    - TeMPOraL 7y ago
      Not end-user programmable, though.
- wukerplank 7y ago
  I think the parent did not criticize the DIY community, only stating that different rules apply to biotech companies. I know many people who use the loop system and their health benefits immensely from it.
- Konnstann 7y ago
  What does this even mean? Hacking an open-loop insulin pump and making it closed-loop doesn't eliminate the need for insulin, did you misread me as saying insulin prices are A-OK and diabetics should just eat healthy? All power to these knowledgeable, individuals, for doing something dangerous but potentially great. This is HN, full of smart people who understand the risk of failure and will monitor the crap out of their system and adjust and tinker until it's ok. The problem is people making tutorials and publicizing their work, which leads to people not as smart following their tutorial and thinking it will be alright. There are tons of papers on closed-loop systems, and probably clinical trials are happening as I write this comment. Medicine isn't one of the industries to "disrupt" though, as much as people on here want to believe.
segmondy 7y ago
Lot's of things can kill us. People have been changing their car brakes for a long time. If your car breaks fails, it can kill you, your passengers and other's outside of your car. People have been fixing their electrical appliances, it can electrocute you. Gas lines and furnace can explode. There's a lot that we do that can kill us if done incorrectly. This doesn't mean that we shouldn't do it. At the end of the day it's humans that built it.
- gclaugus 7y ago
  I don't understand the justification. Because people do dumb things, we should do more dumb things? >This doesn't mean that we shouldn't do it. Why should she put her son at risk for a science experiment?
  - JeremyBanks 7y ago
    Because the risks of not doing so are even worse. If it seems horrible, that's because the reality that diabetics have to live with is horrible.
  - ryandrake 7y ago
    Are you saying that changing your own car brakes and fixing your own electrical appliances are “dumb things” to do?
    - OJFord 7y ago
      Crossing the road turns out to be pretty dumb too, let's just stay at home in future.
      - roribob 7y ago
        Dying is dumb, living is dumb. Nothing is intelligent.
- kyleperik 7y ago
  I see your point and agree... there should be no difference. But I think a lot of times it's not WYSIWYG when it comes to software, because there is so much hidden infrastructure on top of something simple.
sp332 7y ago
And yet MANY people willingly make that tradeoff. https://www.usatoday.com/story/tech/2019/06/05/diabetics-forgoing-new-tech-hacking-into-insulin-pumps/1256667001/ https://www.usatoday.com/story/tech/2019/06/05/diabetics-for... Also with CPAP devices, which are less likely to kill you but it's still possible. https://piunikaweb.com/2019/02/21/rise-and-fall-of-sleepyhead-how-community-backed-cpap-hacking-got-jeopardized/ https://piunikaweb.com/2019/02/21/rise-and-fall-of-sleepyhea...
- hk2001 7y ago
  People also tend to greatly underestimate the risk of negative outcomes.
GiorgioG 7y ago
It's a trade-off. You can choose to wait for something to come to the market and suffer the potential consequences, or you can go the DIY route and reap the benefits today. There are risks either way. My wife and I aren't willing to experiment with our son's life. If it were for myself, I'd absolutely give OpenAPS a shot. My son has a Dexcom & a Tandem x2 pump, and in Q4 they'll deliver a software update that will provide a basic closed-loop system. 'Basic' in the sense that it will only be able to reduce the likelihood of a high blood sugar. We're still waiting for the dual-hormone pumps that will be able to control blood sugar in both directions. Prior to this pump + Dexcom, he had a Medtronic 530g + glucose monitor. It was not internet connected out of the box, it required a $100 gadget that would transmit his blood sugar to his cell phone and then to medtronic's awful website. Fortunately folks developed Nightscout to scrape Medtronic's website and provide a much better experience. With Dexcom being a much more modern option (the CGM transmitter has built-in bluetooth) - we don't really need Nightscout, but it's convenient for me to watch his sugar on my 2nd monitor when he's at school (he's only 7.) The problem is not in my opinion regulatory processes or clinical testing. It's been simply a lack of urgency/competition. Beta Bionics has started to make Medtronic and other competitors step up their game in recent years. https://www.betabionics.com/ https://www.betabionics.com/
- ryandrake 7y ago
  The situation reminds me of the regulatory environment in aviation. Aviation in general is super regulated for the usual “people could die” set of reasons. If you buy a normal certificated airplane like one from Cessna or Piper, you are subject to heavy regulations around what you can do to it in terms of maintenance. You can’t do much as run a USB charger to the cockpit panel without the FAA coming down on you like a ton of bricks. You have to go to people with the right government $tamp to get anything fixed. It’s a huge burden but it’s all in the name of safety. The FAA does however have a parallel track, called Experimental-Amateur Built (E-AB) where if you build the airplane yourself for educational or recreational purposes, it’s subject to a mostly separate set of rules. They are generally more relaxed in terms of what maintenance and modifications you can do but stricter in terms of what you can do while flying (can’t take passengers for hire, for example). Most pilots prefer the certified/safety-first/highly regulated track, but the government recognizes it’s a trade-off and offers the other option for those who prefer a more DIY-friendly world. Not saying this would necessarily work for medical devices, but there is precedent for acknowledging the trade-offs when it comes to DIYing safety-critical stuff.
cat199 7y ago
> I work in Biotech and every time I read one of these articles/posts about how somebody hacked their insulin pump people start asking why there aren't already affordable closed-loop pumps on the market if people are hacking their own with raspberry pis and the like, and they clearly don't understand the regulatory process or the level of clinical testing that's needed to validate something that, if it malfunctions at night, can kill you. plenty of closed loop feedback systems we are all hooked up to which can malfunction and kill you.. casually thinking of automotive industry I can come up with: - abs brakes - engine control units - transmission control units - power steering - traffic lights and that's just one sector, let alone aviation, mass transit, power plants, etc etc etc. granted the malfunction:fatality ratio is probably different, but not so altogether crazy to think that 'closed loop is impossible' .. though perhaps you are strictly speaking w/r/t regulatory climate.. that said, we have had pacemakers for many years..
- jdsully 7y ago
  The alternative to a pacemaker is death from an irregular heartbeat. The alternative to closed loop insulin is a lower quality of life. The FDA is setup to optimize survival not quality of life. The standards will be much higher for these pumps.
kragen 7y ago
It's understandable that the regulatory process errs way on the side of restrictiveness: if someone dies because it's not restrictive enough, that's easy to identify, and it can become a lawsuit and a political campaign, Senators can get involved, agency heads can resign, civil servants can get fired. Meanwhile, the people who die because it's too restrictive are much more difficult to identify, and their deaths can't be blamed on a single decision. (Maybe the unapproved treatment wouldn't have worked anyway, and maybe nobody even knows it could have existed.) So, given that whatever decision they make will kill masses of people, regulators have very strong incentives to kill them by being too restrictive, rather than kill a different mass of people by not being restrictive enough. The solution to this problem is clear: the person with the strongest incentive to keep you alive is you. Any regulator or drug-company executive will reliably put other considerations above your survival under some circumstances. So, except in cases of people who really cannot be trusted with life-and-death decisions — children and some severely mentally impaired people — you should have the final say on what medical treatments you try or don't try. In short, the whole regulatory structure should be scrapped. We still need clinical trials, but not before new treatments become available; after. This sounds like a radical proposal, but in fact it's how the process worked in the US during the time that we owe most of our revolutionary medical treatments to, the 1920s through the 1960s. That's when most (all?) of our currently marketed antibiotic families were discovered, when one dude spent a couple of years prototyping the pacemaker in his barn and then convinced his friend at a hospital to start trying it in patients, when artificial joints were developed. We're still coasting on the legacy from that era.

0xDEFC0DE 7y ago

To be fair that same process allowed hackable (malicious or not) devices out into the world https://www.webmd.com/diabetes/news/20190628/fda-recalls-insulin-pump-over-security-concerns https://www.webmd.com/diabetes/news/20190628/fda-recalls-ins...

Konnstann 7y ago
Believe me I'm not saying the FDA is some perfect organization that can do no wrong but they do exist for a reason. There definitely needs to be more scrutiny as tech (read:computers/AI) start making their way into therapeutic devices.

dlphn___xyz 7y ago

this implies that if a medical device (or pharma) passes through the regulatory process it will never malfunction which is absolutely not true.

merpnderp 7y ago
It doesn't imply it will never malfunction. It implies it went through a scientifically rigorous process to minimize the chances it will malfunction.
- Cthulhu_ 7y ago
  And often that there's warranties in place - that is, if it does fail under normal operation, you can sue them and get millions. Which won't buy your loved one back but it's a strong deterrent for the company to not try and palm off dysfunctional shit.
  - dlphn___xyz 7y ago
    that doesnt help if youre dead or severly injured...besides how many of these cases actually go to court and win?
    - ceejayoz 7y ago
      It doesn't fix those things, but it does help deal with them, at least where the long-term financial impacts are concerned. You're not going to squeeze a lifetime worth of lost salary out of a random Redditor who told you how to tweak your insulin pump.
dllthomas 7y ago
It really just implies that the odds are sufficiently improved. Which may or may not be true, but which has a much better shot at it.
- dlphn___xyz 7y ago
  often times products are expedited through this ‘scientific process’ to get on the market faster. if the regulatory process is truly about safety why does this exception even exist?
  - ceejayoz 7y ago
    > if the regulatory process is truly about safety why does this exception even exist? Because the risk is worthwhile at times. The exceptions typically apply to rare diseases that impact a population too small to be profitable enough to justify the $1B or more it may cost to shepherd a device or medication through the normal process. These are populations who would be potentially unserved otherwise. (I'm of the personal opinion that this is where the government should step in instead of private industry, but I'm pretty left of center.) https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-humanitarian-use-device-hud https://www.fda.gov/industry/developing-products-rare-diseas... IIRC, an exception of this sort was used to expedite an Ebola vaccine due to the recent outbreak... because, well, Ebola.
  - dllthomas 7y ago
    Whether it's actually a good idea isn't something I know enough of the real numbers to comment on, but it seems plenty possible that an expensive step that substantially reduces risk might be appropriate in some circumstances and not in others.

C1sc0cat 7y ago

Yes makes me shudder thinking of what could go wrong . I spent a year hooked up for 8 hours a night to a CPD dialysis machine - I read the massive manual and there is a long section on what can go wrong including "Death" - no way would I start hacking on that. Though I did think about using a camera and ML to monitor the waste output for signs of contamination.

pedrocr 7y ago

While I understand the issue in general it seems it should be relatively simple to validate that a closed-loop insulin pump is at least no worse. Isn't the objective of the closed-loop to just do finer control? So can't you just have the same hard limits as the normal pump and then allow the potentially buggy software to just fine-tune within a generally safe range?

danielschonfeld 7y ago

As opposed to not doing anything which is the current state of Diabetes for the most part, which too, kills you and if not outright kills you then slowly does via financial ruin. How many episodes of hypoglycemia do you think one needs to have, in an utterly broken healthcare system in which being ordered paramedics and given sugar pills costs you $XXXX per occurance. And if you're gonna talk to me about responsbility and healthy living please join the real world some time. That's why people choose to take actions into their own hands. Because being a victim of a system that just doesn't care enough leads you to either take the handles or down under.

deleted 7y ago
[deleted]
hnal943 7y ago
That doesn't address his point, which is that a programmable pump isn't something you could sell because of the liability involved.
- hk2001 7y ago
  It is something you can sell, and is currently in development by major pharmaceutical companies.
  - TeMPOraL 7y ago
    Not end-user programmable, though.
wukerplank 7y ago
I think the parent did not criticize the DIY community, only stating that different rules apply to biotech companies. I know many people who use the loop system and their health benefits immensely from it.
Konnstann 7y ago
What does this even mean? Hacking an open-loop insulin pump and making it closed-loop doesn't eliminate the need for insulin, did you misread me as saying insulin prices are A-OK and diabetics should just eat healthy? All power to these knowledgeable, individuals, for doing something dangerous but potentially great. This is HN, full of smart people who understand the risk of failure and will monitor the crap out of their system and adjust and tinker until it's ok. The problem is people making tutorials and publicizing their work, which leads to people not as smart following their tutorial and thinking it will be alright. There are tons of papers on closed-loop systems, and probably clinical trials are happening as I write this comment. Medicine isn't one of the industries to "disrupt" though, as much as people on here want to believe.

segmondy 7y ago

Lot's of things can kill us. People have been changing their car brakes for a long time. If your car breaks fails, it can kill you, your passengers and other's outside of your car. People have been fixing their electrical appliances, it can electrocute you. Gas lines and furnace can explode. There's a lot that we do that can kill us if done incorrectly. This doesn't mean that we shouldn't do it. At the end of the day it's humans that built it.

gclaugus 7y ago
I don't understand the justification. Because people do dumb things, we should do more dumb things? >This doesn't mean that we shouldn't do it. Why should she put her son at risk for a science experiment?
- JeremyBanks 7y ago
  Because the risks of not doing so are even worse. If it seems horrible, that's because the reality that diabetics have to live with is horrible.
- ryandrake 7y ago
  Are you saying that changing your own car brakes and fixing your own electrical appliances are “dumb things” to do?
  - OJFord 7y ago
    Crossing the road turns out to be pretty dumb too, let's just stay at home in future.
    - roribob 7y ago
      Dying is dumb, living is dumb. Nothing is intelligent.
kyleperik 7y ago
I see your point and agree... there should be no difference. But I think a lot of times it's not WYSIWYG when it comes to software, because there is so much hidden infrastructure on top of something simple.

sp332 7y ago

And yet MANY people willingly make that tradeoff. https://www.usatoday.com/story/tech/2019/06/05/diabetics-forgoing-new-tech-hacking-into-insulin-pumps/1256667001/ https://www.usatoday.com/story/tech/2019/06/05/diabetics-for... Also with CPAP devices, which are less likely to kill you but it's still possible. https://piunikaweb.com/2019/02/21/rise-and-fall-of-sleepyhead-how-community-backed-cpap-hacking-got-jeopardized/ https://piunikaweb.com/2019/02/21/rise-and-fall-of-sleepyhea...

hk2001 7y ago
People also tend to greatly underestimate the risk of negative outcomes.

GiorgioG 7y ago

It's a trade-off. You can choose to wait for something to come to the market and suffer the potential consequences, or you can go the DIY route and reap the benefits today. There are risks either way. My wife and I aren't willing to experiment with our son's life. If it were for myself, I'd absolutely give OpenAPS a shot. My son has a Dexcom & a Tandem x2 pump, and in Q4 they'll deliver a software update that will provide a basic closed-loop system. 'Basic' in the sense that it will only be able to reduce the likelihood of a high blood sugar. We're still waiting for the dual-hormone pumps that will be able to control blood sugar in both directions. Prior to this pump + Dexcom, he had a Medtronic 530g + glucose monitor. It was not internet connected out of the box, it required a $100 gadget that would transmit his blood sugar to his cell phone and then to medtronic's awful website. Fortunately folks developed Nightscout to scrape Medtronic's website and provide a much better experience. With Dexcom being a much more modern option (the CGM transmitter has built-in bluetooth) - we don't really need Nightscout, but it's convenient for me to watch his sugar on my 2nd monitor when he's at school (he's only 7.) The problem is not in my opinion regulatory processes or clinical testing. It's been simply a lack of urgency/competition. Beta Bionics has started to make Medtronic and other competitors step up their game in recent years. https://www.betabionics.com/ https://www.betabionics.com/

ryandrake 7y ago
The situation reminds me of the regulatory environment in aviation. Aviation in general is super regulated for the usual “people could die” set of reasons. If you buy a normal certificated airplane like one from Cessna or Piper, you are subject to heavy regulations around what you can do to it in terms of maintenance. You can’t do much as run a USB charger to the cockpit panel without the FAA coming down on you like a ton of bricks. You have to go to people with the right government $tamp to get anything fixed. It’s a huge burden but it’s all in the name of safety. The FAA does however have a parallel track, called Experimental-Amateur Built (E-AB) where if you build the airplane yourself for educational or recreational purposes, it’s subject to a mostly separate set of rules. They are generally more relaxed in terms of what maintenance and modifications you can do but stricter in terms of what you can do while flying (can’t take passengers for hire, for example). Most pilots prefer the certified/safety-first/highly regulated track, but the government recognizes it’s a trade-off and offers the other option for those who prefer a more DIY-friendly world. Not saying this would necessarily work for medical devices, but there is precedent for acknowledging the trade-offs when it comes to DIYing safety-critical stuff.

cat199 7y ago

> I work in Biotech and every time I read one of these articles/posts about how somebody hacked their insulin pump people start asking why there aren't already affordable closed-loop pumps on the market if people are hacking their own with raspberry pis and the like, and they clearly don't understand the regulatory process or the level of clinical testing that's needed to validate something that, if it malfunctions at night, can kill you. plenty of closed loop feedback systems we are all hooked up to which can malfunction and kill you.. casually thinking of automotive industry I can come up with: - abs brakes - engine control units - transmission control units - power steering - traffic lights and that's just one sector, let alone aviation, mass transit, power plants, etc etc etc. granted the malfunction:fatality ratio is probably different, but not so altogether crazy to think that 'closed loop is impossible' .. though perhaps you are strictly speaking w/r/t regulatory climate.. that said, we have had pacemakers for many years..

jdsully 7y ago
The alternative to a pacemaker is death from an irregular heartbeat. The alternative to closed loop insulin is a lower quality of life. The FDA is setup to optimize survival not quality of life. The standards will be much higher for these pumps.

kragen 7y ago

It's understandable that the regulatory process errs way on the side of restrictiveness: if someone dies because it's not restrictive enough, that's easy to identify, and it can become a lawsuit and a political campaign, Senators can get involved, agency heads can resign, civil servants can get fired. Meanwhile, the people who die because it's too restrictive are much more difficult to identify, and their deaths can't be blamed on a single decision. (Maybe the unapproved treatment wouldn't have worked anyway, and maybe nobody even knows it could have existed.) So, given that whatever decision they make will kill masses of people, regulators have very strong incentives to kill them by being too restrictive, rather than kill a different mass of people by not being restrictive enough. The solution to this problem is clear: the person with the strongest incentive to keep you alive is you. Any regulator or drug-company executive will reliably put other considerations above your survival under some circumstances. So, except in cases of people who really cannot be trusted with life-and-death decisions — children and some severely mentally impaired people — you should have the final say on what medical treatments you try or don't try. In short, the whole regulatory structure should be scrapped. We still need clinical trials, but not before new treatments become available; after. This sounds like a radical proposal, but in fact it's how the process worked in the US during the time that we owe most of our revolutionary medical treatments to, the 1920s through the 1960s. That's when most (all?) of our currently marketed antibiotic families were discovered, when one dude spent a couple of years prototyping the pacemaker in his barn and then convinced his friend at a hospital to start trying it in patients, when artificial joints were developed. We're still coasting on the legacy from that era.