As my classmates mentioned above, insufficient design control would lead to a production failure at one point. And as FDA stated on their website: “Design control does not end with the transfer of a design to production. Design control applies to all changes to the device or manufacturing process design, including those occurring long after a device has been introduced to the market. Thus, the design control process is revisited many times during the life of a product.” This ensures the importance of a sufficient control design for any medical device in the industry.
Multiple issues could arise if the design controls were used insufficiently, this includes device safety mandatory recalls, increase the need for beds and rooms in the hospital, more nurses are needed (more staff), low level of effectiveness and efficiency, more treatment and recovery time, etc. FDA statistics showed that 3,202 medical devices were recalled in 2017. This high number in the healthcare industry did cost companies a huge amount of money, time, effort, etc. This could have been avoided with a better and sufficient design control process which assure that the device meets the patient’s intended needs uses and the specified requirements.
I found this FDA PDF really helpful for this topic.

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf