The first open-source ventilator tested on human patients

https://github.com/makers-for-life/makair/

by baptistejamin • 6 years ago

182 24 6 years ago

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 devices without relying on a heavy veil of secrecy and NDAs, and give a much-needed leg up to projects developing devices like ultrasound imagers or EKGs/EEGs/etc.

Here's hoping they can clear the regulatory hurdles without much difficulty and let people buy them without MIT-style license disclaimers, but it looks like those problems will likely fall on local manufacturers.

Which raises an interesting question: is it smart to be the first company to start mass-producing an open-source medical device? You would need to foot the heavy certification bill as a large capital investment, while any future competitors wouldn't.

Dahoon• 6 years ago

They should just go for markets that aren't made up of lawyers that want to sue everyone and medical companies that want to rip everyone off. So somewhere outside the US. The EU would likely be a more welcoming market for open source.

emteycz3• 6 years ago

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.

emidln• 6 years ago

Would another manufacturer automatically inherit your certifications? I'm ignorant here, but I would be very surprised to learn that merely having the same basic schematics means no certification cost.

peterfield• 6 years ago

No they won't indeed. And that's a common misunderstanding within the "makers" community that Regulatory bodies approve or authorize a "Design". They approve a design and its supply chain, in the context of a specific market, intended use and indication for use.

mushufasa• 6 years ago

is it smart to be the first company to start mass-producing an open-source medical device?

Certainly none of the existing ventilator companies would have that incentive. The best case would be public funding -- a country with a large enough single-payer system could potentially justify as cost-saving and building supply chain resiliency.

A new company, that doesn't have to worry about cannibalizing its existing line of business, may be able to make it work also. Just because a business model is less lucrative than another doesn't mean it's infeasible.

hutzlibu• 6 years ago

"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.

Herodotus38• 6 years ago

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.

athriren• 6 years ago

ventilation is the standard course of care for ARDS and most covid crisis cases present as ARDS. it’s great. don’t look it up.

in the first few months, ventilation was used extensively as both a last line of defense and a preventative (maybe we can keep your spo2 above 60% and you will therefore have a better chance to survive).

covid presents very strangely for a respiratory infection, especially in regards to spo2 measurement where patients have greatly diminished capacity to carry oxygen but otherwise seem fine—having conscious conversation, walking. there were a couple of months of basically expert trial and error—take what we know of best practices and apply it in a real world setting with no ability to test effectivity other than whether or not your patient lives or dies. this has been awful for hc worker morale, stacked on top of all the other things (bad ppe availability, long hours for months with no end in sight, hospital administration getting paid while they fire hc workers due to lack of elective surgery, etc).

we are intervening earlier in more proven ways now (such as proning the patient with supplemental o2 rather than immediately ventilating). we know what we are doing better than we did in march (when we knew almost nothing). but it is still extremely difficult to intervene once a patient declines past a certain threshhold. ventilation is still being used as the “keep this patient alive and hope for the best”, but something like 50% of patients with ARDS die within 3 years anyway so you really don’t want to need to be vented.

everyone stay safe. i’m getting the war stories from my sister, who is an ER nurse at Vanderbilt—whose narrative has informed this post since i know fuck all about the application of medicine.

ThinkBeat• 6 years ago

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" ventilators in Norway and in a hurry.

There were many irregularities in the bidding process or rather lack there of and there were irregutlatires in how the -"winning". design was chosen"

Once they were made, doctors and nurses refused to ever use it on a patient.

Norway then tried to sell then to other countries (at a steep discount) and had no takers.

Norway then tried donating them and again no takers.

Now they are sitting in one or more warehouses somewhere in Norway.

As 2nd wave is making its rounds in Norway, if it should get as chaotic as last time maybe someone will try them.

https://www.ffi.no/en/news/emergency-ventilator-in-record-ti...

https://kommunikasjon.ntb.no/pressemelding/norsk-nodrespirat...

https://www.ffi.no/aktuelt/nyheter/ffi-svarer-pa-kritikken-m...

https://www.dagensmedisin.no/artikler/2020/04/01/anestesi-mi...

baptistejamin3• 6 years ago

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 easiest way to do a ventilator if a few weeks.

This idea is bad because it creates many different problems: - After 30 minutes, patients will start having high C02 levels - It spreads the virus in the hospital room - It can clog

At the beginning of the pandemic, we choose a completely different design and started something from scratch.

Our goal was to make a very safe ventilator, so we could be confident our ourselves, our parents, our family would have to use it.

We asked doctors, specialists, we quickly figured out that the best design was using a turbine design as most emergency ventilators come with turbines.

The big challenge was to finely the pressure very accurately: so we needed valves to manage the airflow.

All the Airflow systems needed to be biocompatible and no pressure valves existed on the market for that purpose.

We tried many ways doing that and engineers in the team found that the best way to make those valves was doing a "Pinch Valve"

The idea is you have a medical-grade flexible pipe, which is pinched using an excentric valve. This way you can finely tune the pressure.

Researchers and doctors tested early prototypes and they found the design was smart and very promising.

It was tested on very complicated lung simulators, and then two pigs.

Following those studies, french authorities started to look at our project and gave us funding (around 500k euros). Allowing us to have access to 2 ASL 5000, the rolls of lung simulators to try our prototypes.

Many different local companies (engineering, manufacturing) help us as well.

A complete team (5 people) made internally all the paperwork for French Health Authorities so they can approve clinical trials.

After a few months, the Makair was approved for Clinical trials and 2 hospitals started to try it on patients.

Meanwhile, we are working on CE marking and production lines. Multiple countries are interested.

If we had to start again, we would choose the same design.

panabee• 6 years ago

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?

Erlich_Bachman• 6 years ago

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

baptistejamin3• 6 years ago

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.

zabhi• 6 years ago

And it uses Rust!

The first open-source ventilator tested on human patients

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