This expanded and updated edition includes the many innovations and clinical research methods that have developed since the first edition as well as current information on the regulatory legal and reimbursement environment for medical devices. The authors summarize the key principles and approaches employed in medical device clinical trials and illustrate their uses in a revealing series of detailed real-world case studies. Highlights include new information on the requirements and process for gaining reimbursement from Medicare and private insurers on new products -including new case studies of research specifically designed for this purpose-and new statistical methods applied to medical device trials.