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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.

Thank you

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    Why are there regulations on such devices in your country if it does not entail a risk to the patient? You may want to consult your ethics board, in any case. Commented Aug 4, 2021 at 17:02
  • @CaptainEmacs If I were to give an analogy, imagine someone builds some little attachment device that goes onto an MRI machine and somehow allows the imaging to be faster and more accurate than normal (that's not what we did just a random analogy). Would such a device need approval to be used in the USA/Europe? That's basically what we are dealing with here and so far we've only been able to implement it in the lab and also in a medical institution in the authors home country. Commented Aug 4, 2021 at 17:08
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    I don't understand why you wouldn't just describe what you did and where. A citation is to reference some other published work. If your current paper is going to be the first publication and your coauthor has done this work themselves, then that work need merely to be described in sufficient detail in the current work.
    – Bryan Krause
    Commented Aug 4, 2021 at 17:10
  • @BryanKrause How exactly would we write up results for the actual implementation that was done in the other country? For example prior to this happening, our results section was simply 12 test cases done in the lab to show that it works. But now we are talking about potentially having used it over 20,000 times for real patients and judged by real doctors and getting excellent results. I don't know how to approach writing that in the results section. Commented Aug 4, 2021 at 17:13
  • This device - it's not a grid-independent blood centrifuge for malaria detection in remote locations, is it? Commented Aug 4, 2021 at 17:20

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