Head of Medical Safety, Roche Diagnostics Diabetes Care

My name is Christen Rees. I work for Roche Diagnostics Diabetes Care and I'm the head of Medical Safety. Medical safety is making sure that the products that we develop are safe for our users and our end customers. And what my department and role entails is overseeing the safe development and the safe use of our products by our customers. So not only when they're being developed internally but also after they launch, making sure that our patients understand how to use them correctly and that they are working as intended. While they're in development, we do testing with human factors, so we have people come in and test models of our products to make sure that they understand how they work and understand how to use them appropriately. We also do lots of testing on our products, just testing them over and over and over to make sure that everything is working as it's supposed to before they launch. It's called Customer Care. We have a 1-800 number on all of the products that we sell and if a user thinks that they're not working appropriately, they call that number. And then we have a troubleshooting guide that every call center operator uses to identify if there is something that needs to be investigated with that product or if not. And then those get escalated based on if something might not be working properly and then my department would then investigate that from a medical perspective to see if there is a chance that a patient or a user would be at risk, based on how that device was functioning. And then it just goes on from there. There's a whole decision tree of how everything takes place. But we basically assess it from a medical point of view to see if there's any risk to the patient and then take action based on that decision.