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The importance, purpose and understanding of design control principles may not be consistent between the FDA and other roles within the medical device industry such as design engineers, managers and quality assurance representatives.

A design engineer that is new to the medical device industry may typically view design controls as a necessary evil. They take pride in their own engineering judgment, experience, designs and testing strategies. They may often think design controls requires excessive documentation and testing that would otherwise not be required. On the other hand, over the years an experienced medical device engineer will understand the value of implementing the design controls requirements and how it really can increase the probability of developing a safe and effective device.

A quality assurance representative/engineer will use the design control regulation and procedures as a design and development “Bible”, as they should. Their job is to make sure that procedures are being strictly followed. They accept design control procedures as the required method of ensuring the device is safe and effective and they tend to think that any deviation from the procedures could lead to user or patient harm. The quality assurance representative is also highly aware that the manufacturer may be at risk of receiving 483 observations or warnings from the FDA if not strictly followed. They are acutely in tune with the manufacturer’s compliance to the procedures because they are typically in the hot seat when inspected by the FDA. They are often the one that has to answer questions about why deviations were made or why procedures were not followed.

At times they may appear to only present obstacles of what can’t be done by pointing out procedures and regulations that seem to hinder the development process. On the other hand, a savvy quality assurance representative/engineer has the ability to provide guidance during development that will allow design teams to overcome regulatory hurdles yet still be able to stay within the bounds of the regulations and company procedures.

Like design engineers, inexperienced managers in the medical device industry may also see design controls as a necessary evil and will often not understand its intent or purpose. They may only see it as one more regulatory obstacle that must be overcome to launch the product on time. Seasoned managers that have experienced product recalls, consent decrees and potentially even patient deaths as a result of defective devices understand the importance of design controls both from a safety and business investment perspective. Besides the obvious fact that mangers do not want to see their customers harmed, they also realize that defective devices result in product recalls or consent decrees which can be detrimental to a the business’s bottom line and to a customer’s perception of the company’s product quality.


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