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The first open-source ventilator tested on human patients

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Re: The first open-source ventilator tested on human patients

#11

Post by hutzlibu »

meekrohprocess wrote: post #2

Much respect to these people for continuing the project even after it became clear that ventilators aren't uniquely useful for treating covid. If they can get the relevant certifications and work out how to handle reliable servicing, it could be a significant boon to the medical community, especially in areas where cost is an issue. Better yet, it could show people that it is possible to develop critical medical devi…

"even after it became clear that ventilators aren't uniquely useful for treating covid."

Is that established knowledge now?

I remember the discussions about it here on HN quite early, but for example here in germany, I believe lung ventilators are still the tool of choice for serious cases. At least, I never found information, that they changed policy towards it.

Re: The first open-source ventilator tested on human patients

#12

Post by inglor_cz »

capableweb wrote: post #7
emteycz wrote: post #6

Earlier quoted context omitted.

The EU is about as hostile to open source as the US is, and it's also considerably anti-business compared to the US, which manifests e. g. as extremely complicated regulatory requirements, which is not really what open source shines at.

> it's also considerably anti-business [...] extremely complicated regulatory requirements Do you have any personal experience with starting a business in the EU and receiving hostility or dealing with complicated requirements? (asking emteycz here, no one else) I've started multiple businesses in different EU countries and never hit any "extremely complicated regulatory requirements" when I've done it. Basically sig…

IDK if "cz" means Czechia in the name of OP, but yes, once you employ somebody and are a VAT payer, your paperwork goes way up. You can outsource it to your accountant, though.

AFAIK employment is bureaucratically easier in the US and none of the US states even has VAT.

But other barriers have fallen recently. If you wanted to start a Ltd company here in Czechia around 2005, all the necessary paperwork took about 100 days to complete. This has been optimized, now it takes just several days and the fees have been cut in half.

Re: The first open-source ventilator tested on human patients

#13

Post by emteycz »

capableweb wrote: post #7
emteycz wrote: post #6

Earlier quoted context omitted.

The EU is about as hostile to open source as the US is, and it's also considerably anti-business compared to the US, which manifests e. g. as extremely complicated regulatory requirements, which is not really what open source shines at.

> it's also considerably anti-business [...] extremely complicated regulatory requirements Do you have any personal experience with starting a business in the EU and receiving hostility or dealing with complicated requirements? (asking emteycz here, no one else) I've started multiple businesses in different EU countries and never hit any "extremely complicated regulatory requirements" when I've done it. Basically sig…

I was born in, live, work and do business in the EU.

Perhaps you're talking about one of the 'free' sectors? My IT services business is as easy as you say, even being a VAT payer is not that bad to me (but is to others in different sectors).

Medical devices, or e. g. people transportation (which I have experience with) are the polar opposite.

Re: The first open-source ventilator tested on human patients

#14

Post by panabee »

baptistejamin wrote: post #10
ThinkBeat wrote: post #8

I do not have the backgrond to know much about this design. I do know that creating them is difficult and even small error can be fatal. I would not want to be a beta tester here if I could avoid it. There will be a long certification process and probably repeated in several different areas of the world. The Norwegian prime minister Erna Solberg decided during the 1st wave of the pandemic in Norway to make "her own"…

Hello. I am one of the members of this project. Your comment is totally accurate and a bad ventilator design or manufacturing can be fatal. The Norwegian ventilator design was a dead end since the beginning. Many different makers teams tried to create ventilators around the world by doing mechanization of "Ambubags" ( https://en.wikipedia.org/wiki/Bag_valve_mask ). Those makers chose this solution because it was the…

thanks for sharing so many details about the process.

1. quality controls for medical devices are necessary since they can be fatal as you said. that said, are there ways of accelerating the certification/control process without sacrificing quality?

2. it sounds like you had access to great local talent. how could we improve the collaboration process so other people could contribute to the design process?

3. if you were the head of the EU, what's the first change you would make to improve the innovation cycle for medical devices?

Re: The first open-source ventilator tested on human patients

#15

Post by baptistejamin »

panabee wrote: post #14
baptistejamin wrote: post #10

Earlier quoted context omitted.

Hello. I am one of the members of this project. Your comment is totally accurate and a bad ventilator design or manufacturing can be fatal. The Norwegian ventilator design was a dead end since the beginning. Many different makers teams tried to create ventilators around the world by doing mechanization of "Ambubags" ( https://en.wikipedia.org/wiki/Bag_valve_mask ). Those makers chose this solution because it was the…

thanks for sharing so many details about the process. 1. quality controls for medical devices are necessary since they can be fatal as you said. that said, are there ways of accelerating the certification/control process without sacrificing quality? 2. it sounds like you had access to great local talent. how could we improve the collaboration process so other people could contribute to the design process? 3. if you w…

1. What we did is we worked on certification and on the eneenering at the same time. We figured out that it was easier to certify an hospital ventilator rather than an emegerncy transport ventilator. An emergency ventilator needs to support 15G (so around 330KG in our case) accelerations. Quite a lot :) So, we choose to the "hospital ventilator" regulations then.

We unit tested everything using a lung simulator (ASL 5000) and that was a great help. When you can try your ventilator in almost real condition, that is change changer.

Then, we tried to make our ventilator exactly as an MVP. We implemented very few features at the beggining. Something very minimalistic. Only pressure control. It was our first version, and was certified for clinical trials in June. First patients in July then.

It's only later than we added new features, LCD Screen, new sensors, new metal valves, to make the ventilator better. We filed all the paper work again, and it got approved in september.

2. We used Slack. It works great, but at some point, we had to work all together. 30 people were lockdown together and worked in March/April on this project. It was a non-stop start-weekend and we slept only 5 hours per night, during more 30 days.

At the beggining of the project, we struggle on two essencial parts : Making the turbine, and the pressure valves.

Multiple engeenering teams work at them same time on different solutions. We used up to 30 3-D printers, lent from people/company.

At the core, we did all the integration tests, and tested all the solutions from the mechanical teams (different turbines / valves), as well as the software, electronics.

At the end, we had the right turbine, the right valves, the right electronics, and we just had to make integrate everything on the software.

3. The hardest thing was the software. Most of us are software developpers and we are used to deploy continuously. You can't do that here. You need the perfect software, immediately.

You can't do an OTA update on all the ventilators.

During the certifiation process, we had to change the software to do many improvements. I think regulatoriy authorities don't understand how software works. That was the hardest part: Explaining them that a software they don't understand is actually safe.

It is something that needs to change, because in the future, we will have more and more sotware in medical devices.

Re: The first open-source ventilator tested on human patients

#16

Post by Herodotus38 »

hutzlibu wrote: post #11
meekrohprocess wrote: post #2

Much respect to these people for continuing the project even after it became clear that ventilators aren't uniquely useful for treating covid. If they can get the relevant certifications and work out how to handle reliable servicing, it could be a significant boon to the medical community, especially in areas where cost is an issue. Better yet, it could show people that it is possible to develop critical medical devi…

"even after it became clear that ventilators aren't uniquely useful for treating covid." Is that established knowledge now? I remember the discussions about it here on HN quite early, but for example here in germany, I believe lung ventilators are still the tool of choice for serious cases. At least, I never found information, that they changed policy towards it.

Ventilators are useful, but now that we have more experience, we've learned that you don't need to intubate as early as originally thought, so the original concern that we will run out of ventilators is much less. In my experience, the biggest bottleneck for care has been nursing staff, especially critical care trained nurses.

Re: The first open-source ventilator tested on human patients

#17

Post by baptistejamin »

Erlich_Bachman wrote: post #9

Would it be possible to have a design that could be largely 3D-printed?

Our initial design was mostly based on 3D printed SLS bio-compatible parts.

The current design is still 3D-printable, but we had to go with metal valves for instance for long term usage, and mass-proction. 3D printed parts just don't scale.

When possible, we replaced some 3D parts with on-the-shelf parts, for instance for the medical 22mm tubing connectors.

Re: The first open-source ventilator tested on human patients

#18

Post by [deleted] »

hutzlibu wrote: post #11
meekrohprocess wrote: post #2

Much respect to these people for continuing the project even after it became clear that ventilators aren't uniquely useful for treating covid. If they can get the relevant certifications and work out how to handle reliable servicing, it could be a significant boon to the medical community, especially in areas where cost is an issue. Better yet, it could show people that it is possible to develop critical medical devi…

"even after it became clear that ventilators aren't uniquely useful for treating covid." Is that established knowledge now? I remember the discussions about it here on HN quite early, but for example here in germany, I believe lung ventilators are still the tool of choice for serious cases. At least, I never found information, that they changed policy towards it.

[deleted]

Re: The first open-source ventilator tested on human patients

#19

Post by p1necone »

emteycz wrote: post #13
capableweb wrote: post #7

Earlier quoted context omitted.

> it's also considerably anti-business [...] extremely complicated regulatory requirements Do you have any personal experience with starting a business in the EU and receiving hostility or dealing with complicated requirements? (asking emteycz here, no one else) I've started multiple businesses in different EU countries and never hit any "extremely complicated regulatory requirements" when I've done it. Basically sig…

I was born in, live, work and do business in the EU. Perhaps you're talking about one of the 'free' sectors? My IT services business is as easy as you say, even being a VAT payer is not that bad to me (but is to others in different sectors). Medical devices, or e. g. people transportation (which I have experience with) are the polar opposite.

Medical devices and transportation sound like exactly the kind of areas that should be heavily regulated (and are in the USA as well as the EU).

Re: The first open-source ventilator tested on human patients

#20

Post by donaltroddyn »

inglor_cz wrote: post #12
capableweb wrote: post #7

Earlier quoted context omitted.

> it's also considerably anti-business [...] extremely complicated regulatory requirements Do you have any personal experience with starting a business in the EU and receiving hostility or dealing with complicated requirements? (asking emteycz here, no one else) I've started multiple businesses in different EU countries and never hit any "extremely complicated regulatory requirements" when I've done it. Basically sig…

IDK if "cz" means Czechia in the name of OP, but yes, once you employ somebody and are a VAT payer, your paperwork goes way up. You can outsource it to your accountant, though. AFAIK employment is bureaucratically easier in the US and none of the US states even has VAT. But other barriers have fallen recently. If you wanted to start a Ltd company here in Czechia around 2005, all the necessary paperwork took about 100…

Only five US States don't have Sales Tax, and most counties and cities have their own, too.
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