My research group has developed a novel medical device that is much needed in the area of diagnostic laboratory medicine that we are working in. We are writing a paper on this device and its results in a high impact journal and currently have a small sample of results we are discussing in the paper.
However, one of the authors was able to get this device in full operation in a medical facility in his home country, which is a 3rd world country that does not have strict regulations on such devices. It's been operational for over a year and has produced amazing results with no problems thus far.
Would I cite the medical institution and country it was used at? The medical professionals opinions who made use of it? How do I prove we even did this rigorously?
How can I cite this result in the paper? How can I say "We actually built it and used it on real world medical samples for a long period of time and it worked great" Since that wouldn't exactly be allowed here with all the regulations that exist.
Note that this device is for post processing and does not have any risks of usage or affect the patient in any way so I doubt there is any ethics issue (is there?). It's more like a faster algorithm for diagnosing something that relies on a physical device we built.
This device would fit under FDA Class I medical device or EU IVD certification. But we don't have that yet. (We will soon). Yet in the country it was used we did not have this prior to using it.