Pre-Clinical Performance Testing

#1
We are doing device verification and need to outsource the bench testing portion of it to a certified lab. I was under the impression the various tests such as tensile, torsion, etc. should be done initial production units or prototypes. When shopping around for quotes the testing people acted like it was highly unusual to do this on an actual device. Instead they asked if I could get them standard material sample referenced in the relevant ASTM standards. The samples ASTM illustrates are usually either rectangles or dog bone shaped pieces of a material. These are all nationally (US) known labs.

Am I missing something here? If so, can someone please explain to me why we would use a material sample of arbitrary dimensions to determine that our device meets its design inputs and outputs?
 
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monoj mon

Quite Involved in Discussions
#2
So far I have never encountered such situation, we have always conducted testing on final, finished devices. But, FDA's guidance does mention about use of 'device material composition'. Perhaps it is device specific issue, and seems the testing labs you approached have prior experience to do so. Please ask them to point out the exact reason behind this and also please let them know about your current and future target markets where you would be seeking approval. This should clear the doubts between you and the testing lab of your choice. But do keep in mind that you may need to explain why did you conduct the testing on material composition rather than final, finished device and how does the finding extrapolate to the final, finished device.
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#3
Thank you for your response. We insisted on sending in useable prototypes for the testing. The prototypes are as near production units as feasibly possible and there shouldn't be a problem explaining clinical relevance. We still haven't gotten a good reason for the labs wanting 'generic' material samples opposed to actual devices. The material and shape of the device should be easy enough to handle. Maybe with Covid caused material bottlenecks the labs changed their procedures? If so, I would think the FDA would have issued an update on this too.
 

Watchcat

Trusted Information Resource
#4
I usually don't get involved in the details of the bench testing, but this also surprises me a bit. It makes me wonder about the labs., by which I don't mean whether they were competent, but, for example, how much experience they have with medical devices. Some engineering tests are done for a lot of different kinds of products, not just medical devices. Maybe what they were saying was that it was unusual for them to do testing for medical devices. Also, established device companies are usually set up to do a lot of their own bench testing inhouse so maybe some labs just don't see a lot of medical devices.

As for the material, yes, as monoj mon has highlighted, you can test materials, components, etc. The important thing is to test what needs to be tested, based on intended use. A good argument can sometimes be made for some tests to be done only with materials, or a single part or component. But when you start talking about doing all or most bench tests with something other than the finished device...I'm inclined to become more and more skeptical that you are testing what needs to be tested, based on intended use.
 
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