One of the most problems common with design controls is that medical devices companies put emphasis on following the regulation rather than understanding the intent. For instance, some of the regulations are vague and contain scant details about what manufacturers ought to do to meet the requirements. While manufacturers are required to come up with design control systems that comply with the relevant regulation, the most important aspect is that they design the products in the most prudent way possible.
I agree with the comments above that inadequate design controls lead to lower quality and the possibility of developing dangerous products. Many FDA warning letters and product recalls cite insufficient design control procedures, something which companies can easily overcome. While it is not unusual to find one or two companies with design controls in trouble, having adequate design controls in place means that your product will be released to the market. From this, it becomes apparent that failure to release products to the market is a consequence of inadequate design controls.