In design control, there are “checks” to verify that everything (mostly) is accounted for. Companies must question whether the design outputs conform to the design inputs. Was the design done right? Was the right device designed? That being said, it seems like companies get tripped up when design verification and validation are not up to par. Other issues can arise from not having effective periodic design reviews during the design process.

Insufficient design control can lead to added stress post market. The finalized product may not even be fit for use. It might be too late to be able to change the design entirely (just like the Samsung smartphones.) A company with insufficient design controls can receive many CFR and ISO violations as well. Insufficient design controls also make it difficult to improve on post market products in the future.

The current events mentioned by others show that poor design control is something that is not just limited to the medical device industry. It’s ALL industries.