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  • Poor planning can definitely lead to a lack of proper design controls and therefore a medical device lacking in quality, as others have mentioned. As you mentioned in your example, when the people responsible for development & documentation of the device are not on the same page as the clinical team, it could cause misalignment and the necessary steps could potentially be skipped to deliver the product to the clinic. Rushing the product to the clinic is never a good idea because it compromises product quality and patient safety.