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Title
Statistical methods and analyses for medical devices / Scott A. Pardo.
ISBN
9783031261398 electronic book
3031261399 electronic book
3031261380
9783031261381
Published
Cham : Springer, 2023.
Language
English
Description
1 online resource (384 p.)
Item Number
10.1007/978-3-031-26139-8 doi
Call Number
R856.4 .P37 2023
Dewey Decimal Classification
610.284
Summary
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. There are no statistical methods specifically designed for analysis of medical device data. However, 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 knowledgeablewith 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.
Bibliography, etc. Note
Includes bibliographical references and index.
Access Note
Access limited to authorized users.
Source of Description
Online resource; title from PDF title page (SpringerLink, viewed May 8, 2023).
1. Some Fundamentals Probability
2. Some Fundamentals Estimation and Inference
3. Confidence
4. Power and Hypothesis Testing
5. Least Squares: Regression and ANOVA
6. Product Design Factorial Experiments
7. Process Control
8. Inspection and Acceptance Sampling
9. Shelf Life, Stability, Reliability, Time-to-Event
10. Diagnostics: Sensitivity and Specificity
11. Equivalence and Noninferiority
12. Nonparametrics
13. Bayesian Methods
14. Prediction, Classification, Non-Linear Modeling
15. Variance Components and Precision
16. Time Series and Dynamic Systems
17. Odds, Odds Ratios, and Comparing Proportions
18. Afterword.
