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.
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.
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.
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.
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...
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.
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.
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?
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.
I think this is wrong thinking. Software which drives safety critical systems needs to be perfect, and that is an impossible bar. Whether or not such a target is achievable, it is much MUCH harder if the software is under continuous development. It needs to take enough time to do it properly, and therefore software for critical systems ends up basically being your MVP. It does only what it must, but it does it right. You really don't get a second chance on safety critical systems.
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 sign some papers, pay the necessary fees (if even needed, not always a requirement) and make sure the company reports accurate numbers each quarter and you're basically good to go. Is it any easier in the US?
Or are you simply echoing other peoples opinions here?
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.
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.