In Reply to Parent Post by Roland Cooke
I hasten to add:
a) those questions were off the top of my head!
b) I am not an orthopaedics product specialist
c) I am not a metallurgist
It may well be that the final customer is expert on all this stuff - that will make your client's job very easy. My point is that it is important (from an ethical standpoint, if nothing else), to not automatically assume that is indeed the case.
I learned too many years ago that I assume at my own peril. I am not certain how to quantify what is or isn't ethical except to say I believe we are all obligated - standards notwithstanding - to give 110%, to always strive to do better, to never do that which we know is wrong or which we believe might be wrong: in essence to never do anything that will not pass the smell test.
My chief concern for my small clients, who are low on the medical device supply chain, is not the requirements of the standards. I/We can always learn how to do that which is required - thanks to folks like yourself. That part we can control.
What we cannot control is the "blood-in-the-water", litigious environment that surrounds this industry in the USA. My clients' only protection from this uncontrollable plague, aside from insurance, is that they are small(er) fish and do not present as rich a feast as do the OEM's.
I have been through major product litigation in the past where, after two years, we were dismissed from the suit and learned that insurance doesn't cover the disruption. It was as if management's time and attention were sucked into that black hole for the duration. Day to day business suffered from it while the business' progress was put on hold.
Being a conservative, old codger I suppose my clients'
"risk appetite" is far greater than mine.