"I don't know the exact pharma requirements for marketing things but I do know some about orthopedics and I'm on the fence regarding this.
Ortho:
1) The FDA requires you to meet some testing numbers (in orthopedics case, strength/fatigue or potentially wear) but is unwilling to tell you what they are upfront.
2) Ortho company creates product to meet hazy FDA requirements instead of patient needs or biological loading which in turn discourages supplementary testing because hey, mommy said it wouldn't hurt anyone."
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