Overview
- Focuses on methods useful for medical device development and manufacturing
- Provides R code for all methods, with sample datasets
- Guides readers to methods relating to data gathering and analysis activities for medical devices
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Table of contents (18 chapters)
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Front Matter
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Back Matter
Keywords
About this book
While, there are no statistical methods specifically designed for analysis of medical device data, there are some methods that seem to appear regularly in relation to medical devices. For example, the assessment of receiver operating characteristic curves is fundamental to development of diagnostic tests, and accelerated life testing is often critical for assessing the shelf life of medical device products. Another example is sensitivity/specificity computations are necessary for in-vitro diagnostics, and Taguchi methods can be very useful for designing devices. Even notions of equivalence and noninferiority have different interpretations in the medical device field compared to pharmacokinetics. It contains topics such as dynamic modeling, machine learning methods, equivalence testing, and experimental design, for example.
This book is for those with no statistical experience, as well as those with statistical knowledgeable—with the hope to provide some insight into what methods are likely to help provide rationale for choices relating to data gathering and analysis activities for medical devices.
Authors and Affiliations
About the author
Bibliographic Information
Book Title: Statistical Methods and Analyses for Medical Devices
Authors: Scott A. Pardo
DOI: https://doi.org/10.1007/978-3-031-26139-8
Publisher: Springer Cham
eBook Packages: Mathematics and Statistics, Mathematics and Statistics (R0)
Copyright Information: The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2023
Hardcover ISBN: 978-3-031-26138-1Published: 25 April 2023
Softcover ISBN: 978-3-031-26141-1Published: 26 April 2024
eBook ISBN: 978-3-031-26139-8Published: 24 April 2023
Edition Number: 1
Number of Pages: XIII, 384
Number of Illustrations: 153 b/w illustrations
Topics: Statistics, general, Biostatistics, Statistics and Computing/Statistics Programs