I have been in the medical device industry for 14 years and have worked on many aspects of design controls. Most of our recent projects have been where instead of developing a device from the beginning internally, we purchase a device that was developed by a smaller company. This device may already be on the market or may be nearing launch. A lot of my work includes taking the design controls that were created by this other company and transfering them into our quality system. In some cases we can take the design control documents and put them directly into our system, in other cases documents need updated and some testing needs to be repeated or completed. For example we may require this device to be compatible with our accessory devices. This would require us to do some sort of validation testing to ensure that a stent systems is compatible with our guidewire/guide catheter/introducer sheath. This would also mean updates to Design inputs and outputs. I definitely see these design controls as necessary in industry. I don’t have a lot of experience in other industries but I would hope in any industry where lives are put at risk (construction, aerospace, etc) that similar controls are used.