I think the major differences in risk management with medical devices and pharmaceuticals comes down to the mode of action. Pharmaceuticals (in many cases) are chemically based and therefore rely on your bodies’ functions to break it down and utilize it effectively. There, the efficacy and risk of a drug is based solely on how it interacts with your body and how your body interacts with the drug. The drug does need to be administered appropriately, so that adds a level of risk but ultimately it is a relationship between your body and the drug. Medical devices on the other hand, are typically reliant on someone else, whether it be a surgeon or a doctor, to implant or place the device properly in order for it to function. There is a much higher risk of human error in medical devices for effectiveness of the product than with pharmaceuticals. Essentially, if a drug has proven it will work, then it will typically work for a large portion of the users. But, just because a medical device is proven to work, doesn’t mean it will work if the surgeon doesn’t implant the device properly.

-Kaitlin Connell