Richard Kotz retired from the FDA in 2015 after 25 years as a statistical reviewer and manager in the Center for Devices and Radiological Health. During his last 10 years at the FDA he managed a team of statisticians that reviewed hundreds of clinical trials for ob/gyn, urology, gastroenterology, renal, respiratory, diabetes, oncology, anesthesiology, infection control and general surgery devices. In this capacity, he and his team worked closely with clinicians, engineers, scientists, and statisticians in the medical device industry to develop efficient pilot and pivotal clinical trials. He also served in leadership roles in several statistical organizations, including president of the FDA Statistical Association and chair of the Medical Device and Diagnostic Section of the American Statistical Association. In 2016, he was awarded the FDA’s prestigious Lifetime Achievement Award. He currently works as a Senior Medical Research Scientist at NAMSA, an international medical device research organization.