As has already been stated in the posts above, Regulatory Compliance is a tedious, expensive, and lengthy task which can prove to make the engineers’ job full of obstacles and headaches in order to make sure that a new product is compliant with FDA standards, and that products already on the market remain compliant. With this task it is the engineer’s job to provide proof that all product specifications are met and that designs are validated. However, when you focus only on the day to day items (and the obstacles that need to be overcome to demonstrate compliance), it is easy to lose sight of the reason the devices are so highly regulated in the first place: to ensure that when a product is used on a patient it will be made correctly, perform reliably, and overall help accomplish something that leaves the patient better off. If your product fails in the field, it could be disastrous for both the patient and your company.

The daily meeting that ala26 described is a good way to keep things in perspective for everyone in the company. It demonstrates the importance of quality control for catching the defects before the product was shipped, while also provides other departments with motivation to improve processes to avoid defects and make an overall safer product for the patient/end user.

My company recently conducted a company wide survey and one of the main feedback points was that the employees did not feel like what they were doing was connected to the end user. The company addressed this by publishing weekly “success stories” on the intranet page to demonstrate how one of the company’s products save someone’s life. They also have TVs in the lobby of the building that show the devices in use in places like operating rooms and in ambulances providing life saving support for the patients they are being used on. I think that this is a good way to remind employees that the challenges they face on a day to day basis, which could seem annoying, are all for the good of the patient in the end.