Case 7 “Ingredient Performance”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion


PICCNow the seventh area is ingredient performance. The brand example here is a PICC line or a peripherally inserted central catheter that was in development by a major medical device company.

This central catheter was made from a novel plastic compound as well as an anticoagulant coating that actually prevented clots in the patient. They had some very dramatic photographs showing side-by-side results of other catheters and the clots that actually formed around them versus this catheter that was made of the novel plastic and coating that did not have any of the blood clots.

However, when it came time to actually launch the product, these lab-based demonstrations were not able to be used in promotion because they did not pass the rigor of laboratory control and clinical trial parameters.

Therefore, the product was less than successful at launch than it could have been had the clinical demonstration been designed years previously to be more compelling and more regulatory acceptable.

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