Prior to joining NAMSA, Richard worked for 25 years at the U.S. Food and Drug Administration (FDA) as a Statistical Reviewer and Manager at the Center for Devices and Radiological Health’s (CDRH) Division of Biostatistics. During his last 10 years with the FDA, he managed statisticians reviewing clinical trials for OB/GYN, urology, gastroenterology, renal, respiratory, diabetes, oncology, anesthesiology, infection control and general surgery devices. Richard and his team reviewed hundreds of clinical trial protocols and worked closely with clinicians, engineers, scientists and counterparts in the medical device industry to develop efficient pilot and pivotal clinical trials to evaluate medical devices.

Richard has also been involved in several regulatory and statistical organizations in various capacities, including president of the FDA Statistical Association and recent chair of the Medical Device and Diagnostic Section of the American Statistical Association. In 2016, he was awarded FDA’s prestigious Lifetime Achievement Award. He has also served on over a dozen Data and Safety Monitoring Boards (DSMBs) for a wide variety of medical devices.

CORE COMPENTENCIES

• Advising sponsors on strategy for FDA submissions, FDA meetings and clinical trial designs, and representing them at FDA meetings

• Advising on and preparing clinical trial protocols and statistical analysis plans (SAPs) for a wide variety of devices

• Serving as a statistical member on Data and Safety Monitoring Boards (DSMBs) for a variety of medical devices

• Supervising the review of over 500 medical device protocols for urology, gastroenterology, OB/GYN, respiratory, dialysis, infection control, organ preservation, diabetes, dental, general surgery and anesthesia devices

• Overseeing the review of over 25 medical device premarket approvals (PMAs) and statistical presentations at more than 15 FDA advisory panels and made major contributions to FDA regulatory approval/non-approval decisions on significant risk medical device products

• Reviewing over 250 Investigation Device Exemption (IDE) clinical trial protocols and 75 PMA and 510k study results for new medical devices in the areas of OB/GYN, gastroenterology, urology, infection control, pulmonology, anesthesiology, obesity, organ preservation, dentistry, ENT and radiology

RECENT PROJECTS

• Advised Sponsors on clinical trial designs and data presentations and provided support for FDA regulatory submissions for a variety of therapeutics

• Advised a Sponsor on a data presentation for an FDA submission for a sleep apnea diagnostic device

• Currently serving on DSMBs for urinary incontinence, cochlear, respiratory, gastroenterological, neurological and cardiovascular devices, among others

PUBLICATIONS

• “Can Sequential Parallel Comparison Design and Two-Way Enriched Design be Useful in Medical Device Clinical Trials?” A Ivanova, X Zhang, L Thompson, R Kotz and X Fang; Journal of Biopharmaceutical Statistics, Vol. 26, January 2016
• “A Causal Model for Joint Evaluation of Placebo and Treatment-Specific Effects in Clinical Trials” Zhiwei Zhang, Richard M. Kotz, et. al., Biometrics 2013 Jun; 69(2):318-27.
• “Inference and sample size calculation in the fit assessment of filtering face piece respirators” by Z. Zhang and R. Kotz. Journal of Biopharmaceutical Statistics, 18(4), 713-723, 2008
• “Effects of Storage, Materials, and Stress on Glove Integrity,” by Walsh, Schwerin, Chwirut, Varney, To, and Kotz, DMMS Report # 01-01, FDA/CDRH/OST/DMMS, Nov. 8, 2000.
• “Latex Rubber Condoms: Predicting and Extending Shelf Life” by M. Free, V. Srisamang, J. Vail, D. Mercer, R. Kotz, and D. Marlowe, in Contraception, 53:221-9, 1996.
• “PolyurethanesModulateHumanMonocyte-derivedMacrophageSuperoxideResponse”by Picciolo, Kaplan, Kotz, et. al., The 20th Annual Meeting of the Society of Biomaterials, Boston, MA, 1994.