Design controls designates the application of a proper process or method for the developmend of a product. It is mandatory to implement controls when designing and developing products within regulated industries such as medical devices. “The Food and Drug Administration has required that medical device manufacturers that want to market certain categories of medical devices in the USA follow Design Control requirements (21 CFR 820.30).” Therefore sufficent controls are always needed. When design controls are not sufficent all the blame falls in the company for the lack of meeting the standards. “This guidance is intended to assist manufacturers in understanding the intent of the regulation. Design controls are based upon quality assurance and engineering principles. This guidance complements the regulation by describing its intent from a technical perspective using practical terms and examples.” The FDA provides documentation to help firms. Therfore a insufficent design control and not following the FDA guidelines can lead to issue witht he atualy product and hinder its process to reach market. When the foundation of something is subpar, then everything built on top is under huge risk. Therfore, not having a good desgin control flow can lead to failure in many areas along the timeline.

https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170251.htm