Dr. Rob Swain is the founder of RESound Clinical Consulting, which helps medical device companies with their preclinical, clinical, and regulatory strategy. This episode taps into Rob's deep knowledge of the ins and outs of running a clinical trial. We get into many aspects of this topic including how to decide you are ready to run one, how to plan the study including selecting a facility, appropriate risk level, and study objectives, and how to run the study. This episode is on the longer side, but offers many important tips to medical device developers on a step that is crucial to get right for many devices to get to market. Whether you are in a startup or a large company, you will probably learn something beneficial from the conversation.