I also work as an R&D engineer for a medical device company, and one thing I have noticed in my company is a lack of brainstorming to identify potential risks. I have found that many times our QA department just uses a lot of data from previous projects and automatically applies it to the new device since most of our devices are quite similar in their design and application. However, I don’t think this is the best way to go about identifying risk, because especially with different surgical approaches there may be the potential for different risks. Therefore I think it is very important to engage the full project team to brainstorm about all the potential risks that could occur.