The Intersection of Medical Device Usability and Risk Management

Today we’re going to be talking to our good friend Mike Drues from Vascular Sciences about the intersection of usability and risk management. There are so many tips and great pointers that you will not want to miss this show. Have a pen and paper or your note-taking device available, because this episode is chock-full of information that you won’t want to forget. Some of the highlights of the show include: ● What usability means and how it applies to the medical device production process. ● Where the FDA stands on the topic of usability and what types of guidance documents are available. ● How the topic is handled by international and world agencies in addition to the FDA, as well as how cultural differences can impact usability studies. ● The difference between a usability study and a clinical trial. A usability study is focused on the user and a clinical trial is focused on the patient, but today, the two are often one and the same. ● Why usability needs to be more “real-world.” Many times, what the engineer intends is not how the doctor or surgeon will actually use the device. ● The importance of instructions for use and labeling, and how that relates to risk management. ● The relationship between usability and product liability.