Hi All,
Is anyone aware of open hardware that is considered a medical device and has gone through the FDA gauntlet to be approved and commercialized? The more examples the better - and exactly how they did it – e.g. using the approval process as a barrier to competition, etc.
Thanks - Joshua
Hi Joshua
I’m aware of two examples:
The Glia stethoscope is manufactured in a facility approved by Health Canada, I don’t think to date they have FDA approval though:
Mechanical Ventilator Milano was approved by the FDA but I’m not sure how 100% open it is
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8060010/
Jenny
The Open Syringe Pump by Electrolab Nanterre.
It was actively used in French hospitals during the Covid-19 pandemic. I’m not sure if they have full certification, or if they used a lightweight process that was possible during that time.
Andreas
The UK based OpenBionics prosthetic arm 
started as opensource, won a Dyson award, grew commercially backed by Disney and has recently been approved by the NHS.
Thanks Everyone - this is very helpful!
Hello, during COVID, many of us were working on medical equipment, In particular, in my inter-institutional work group, we managed to get a robot used in hospital environments.
[https://www.lanueva.com/nota/2020-3-28-7-0-27-bahienses-disenaron-un-prototipo-de-respirador-artificial].
In my case with my team the objective was to use the RepRap concept, (print the parts with a prusa model and then use the printer parts to finish the robot)(https://visualdiabetes.onlyoffice.co/Products/Files/DocEditor.aspx?fileid=9853626&doc=bXdzRVZQbWw0dG1mL29jRVdMbkYvUmZJemViWHlabENjTURRb3lDL2JVTT0_IntcImVudHJ5XCI6XCI5ODUzNjI2XCIsXCJsaW5rXCI6XCJjMDIwMjdjZS0zZDdiLTQ2NjYtYjUyYS1kMjE5Njg2ODhjYTFcIn0i0)
In this pandemic context, Medtronics published, in response to hobbyist initiatives, the design and manufacturing documents for an obsolete design, "OUR VENTILATOR SPECIFICATIONS. YOUR INGENUITY."
https://www.tataconsultingengineers.com/wp-content/uploads/2023/01/Emergency-Ventilator-Research.pdf
What's important, besides understanding the arrogance of some, is to see the current barriers to approvals in design reviews.
On the other hand, I'm part of the #weAreNotWaiting diabetes technology movement. Last year, we invited Mathieu Tellier, who develops artificial pancreas algorithms used by hundreds of people, including children and pregnant women. (You can request the seminar privately.)
This is the testimony of the family that Mathieu mentions (https://archive.org/details/alex-appella-looping), as part of explaining interdisciplinarity/transdisciplinarity, concepts from my Introduction to Cyber-Physical Systems course in the Artificial Intelligence Engineering program.
Juan Esteban Carrique
https://sinc.unl.edu.ar/staff/juan-carrique/
“Entiendo->Comprendo->Comparto”
“…Dios no hace basura…"
“…Lo que sucede conviene…"
"…La acción más pequeña vale más que la intención más grande…”