Statistical Methods and Analyses for Medical Devices (eBook)

This book provides a reference for people working in the design, development, and manufacturing of medical devices. ?While there are no statistical methods specifically intended for medical devices, there are methods that are commonly applied to various problems in the design, manufacturing, and quality control of medical devices. The aim of this book is not to turn everyone working in the medical device industries into mathematical statisticians; rather, the goal is to provide some help in thinking statistically, and knowing where to go to answer some fundamental questions, such as justifying a method used to qualify/validate equipment, or what information is necessary to support the choice of sample sizes.

Scott Pardo has been applying statistical methods to a wide variety of problems, from military communications networks to pacemaker longevity to pharmacokinetics to injection molding of syringes, for over 40 years. He has spent most of the last 32 years working in the medical device industries, including pacemakers, in-vitro diagnostics, and blood collection tubes. He has written several books on various statistical topics, including Equivalence Testing in Engineering and Problems in Behavioral Ecology (Springer). Dr. Pardo has a Ph.D. in Industrial Engineering (Engineering Statistics) from the University of Southern California, and is a Six Sigma Master Black Belt. He is the author of Equivalence and Noninferiority Testing for Quality, Manufacturing, and Test Engineers, Empirical Modeling and Data Analysis for Engineers and Applied Scientists, Statistical Methods for Field and Laboratory Studies in Behavioral Ecology and Statistical Analysis of Empirical Data: Methods for Applied Sciences.