The first open-source ventilator tested on human patients

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.

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.

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.

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...

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.