One of Your Biocompatibility Endpoints Has Failed. What Now?
A complete biocompatibility evaluation profile is an essential step in gaining regulatory approval of your new medical device. What happens when you find out that the device your company is riding on fails a biocompatibility endpoint evaluation? How could this happen? What are you to do next? Not every failure is real. Not every failure is relevant. Not every failure is the end of the line. Every failure, however, must be addressed and how you address it could be worse than the failure itself.