I believe one of the most important mistakes mentioned was how risk management is not a life cycle process. It should be a living a document and updated accordingly. Complaints and feedback from the users should be heard; the market size is usually much larger than the risk management staff and could see potential risks that the company may have missed. Another factor is as time goes on, new technology could be invented that could either enhance a products risks or be used to decrease certain risks. If the process was ongoing, risk management would be able to enhance their products and minimize risks. To add to the list of mistakes mentioned I found another big one was that many medical device companies are staffed with engineers from non-medical device industries who aren’t aware of, aren’t convinced of, or simply don’t believe that the engineering process for medical devices needs to be well defined, executed, managed, and documented.

http://www.inea.com/PDF/how_to_avoid_the_biggest_mistakes_in_medical_device_development.pdf