I believe no matter how flawless a medical device design and manufacturing process is, there is still potential for users to be harmed (e.g. use error). That said, the manufacturer is responsible for understanding all risks related to the medical device and controlling those risks (reducing them as far as possible) within an acceptable level. With regards to how processes can be improved, regulations are already clear and strict on requirements that manufacturers need to comply for development. FDA could improve their review process to ensure device testing was tested adequately before granting approval. On the other hand, I think the post market surveillance could be improved with regards to oversight by agencies. Manufacturers are required to have processes in place such as to address complaints, report device issues, etc. and document these through annual management reviews reports. However, FDA does a poor job overseeing the post market surveillance. This is one of the reasons that Medical Device Regulations are changing in EU to better enforce controls in the post market space and I believe FDA will soon follow.