Pathological Approval Need in Medical Device Companies

A common issue seen in medical device companies is the pathological need for approval from someone else, which can harm the quality instead of improving it. This need for approval often leads to delays because the approver may not give a thorough review and merely provide a signature to fulfill internal policies. This approach does not enhance quality and is primarily driven by a misconception of regulatory requirements. Regulatory bodies like the FDA prioritize actual quality over checkbox compliance and do not necessitate unnecessary approval processes.