Statistical Methods and Analyses for Medical Devices

This book provides a reference for people working in the design, development, and manufacturing of medical devices, covering topics such as statistical methods, receiver operating characteristic curves, accelerated life testing, sensitivity/specificity computations, Taguchi methods, and equivalence and noninferiority testing. It is designed to help those with no statistical experience gain insight into what methods are likely to help provide rationale for choices relating to data gathering and analysis activities for medical devices.

Format: Hardback
Length: 380 pages
Publication date: 25 April 2023
Publisher: Springer International Publishing AG

This comprehensive book serves as a valuable resource for individuals involved in the design, development, and manufacturing of medical devices. While there may not be specific statistical methodologies tailored exclusively for medical devices, there are widely applicable methods that can be utilized for various challenges in the field. The primary objective of this book is not to transform everyone working in the medical device industries into mathematical statisticians but rather to offer guidance in developing a statistical mindset and providing insights into where to seek answers to fundamental questions.

While there may not be dedicated statistical methods specifically designed for analyzing medical device data, certain approaches consistently arise in the context of medical devices. For instance, the assessment of receiver operating characteristic curves is crucial in the development of diagnostic tests, while accelerated life testing plays a vital role in assessing the shelf life of medical device products. Another example is the necessity of sensitivity/specificity computations in in-vitro diagnostics, where Taguchi methods can be highly valuable for designing devices. It is important to note that the interpretations of concepts such as equivalence and noninferiority in the medical device field differ from those in pharmacokinetics.

The book encompasses a wide range of topics, including dynamic modeling, machine learning methods, equivalence testing, and experimental design. It is designed to cater to individuals with varying levels of statistical expertise, from those with no prior statistical experience to those with a solid statistical background. By presenting these methods, the book aims to provide valuable insights into what approaches are likely to assist in providing rationale for decisions related to data gathering and analysis activities in the medical device industry.

Weight: 764g
Dimension: 235 x 155 (mm)
ISBN-13: 9783031261381
Edition number: 1st ed. 2023