Statistical Procedures for the Medical Device Industry PDF Download

Author: Wayne A. Taylor
Publisher:
ISBN: 9780963512291
Category :
Languages : en
Pages : 0

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Author: Scott A. Pardo
Publisher: Springer Nature
ISBN: 3031261399
Category : Mathematics
Languages : en
Pages : 384

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Book Description
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. 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.

Author: David J. Smith
Publisher: CRC Press
ISBN: 1000469581
Category : Business & Economics
Languages : en
Pages : 91

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Book Description
We are bombarded with statistical data each and every day, and healthcare professionals are no exception. All sectors of healthcare rely on data provided by insurance companies, consultants, research firms, and government to help them make a host of decisions regarding the delivery of medical services. But while these health professionals rely on data, do they really make the best use of the information? Not if they fail to understand whether the assumptions behind the formulas generating the numbers make sense. Not if they don’t understand that the world of healthcare is flooded with inaccurate, misleading, and even dangerous statistics. The purpose of this book is to provide members of medical and other professions, including scientists and engineers, with a basic understanding of statistics and probability together with an explanation and worked examples of the techniques. It does not seek to confuse the reader with in-depth mathematics but provides basic methods for interpreting data and making inferences. The worked examples are medically based, but the principles apply to the analysis of any numerical data.

Author: Frederick Faltin
Publisher: Wiley
ISBN: 9780470670156
Category : Medical
Languages : en
Pages : 520

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Book Description
In recent years the number of innovative medicinal products and devices submitted and approved by regulatory bodies has declined dramatically. The medical product development process is no longer able to keep pace with increasing technologies, science and innovations and the goal is to develop new scientific and technical tools and to make product development processes more efficient and effective. Statistical Methods in Healthcare focuses on the application of statistical methodologies to evaluate promising alternatives and to optimize the performance and demonstrate the effectiveness of those that warrant pursuit is critical to success. Statistical methods used in planning, delivering and monitoring health care, as well as selected statistical aspects of the development and/or production of pharmaceuticals and medical devices are also addressed. With a focus on finding solutions to these challenges, this book: Provides a comprehensive, in-depth treatment of statistical methods in healthcare, along with a reference source for practitioners and specialists in health care and drug development. Offers a broad coverage of standards and established methods through leading edge techniques. Uses an integrated, case-study based approach, with focus on applications. Looks at the use of analytical and monitoring schemes to evaluate therapeutic performance. Features the application of modern quality management systems to clinical practice, and to pharmaceutical development and production processes. Addresses the use of modern Statistical methods such as Adaptive Design, Seamless Design, Data Mining, Bayesian networks and Bootstrapping that can be applied to support the challenging new vision. Practitioners in healthcare-related professions, ranging from clinical trials to care delivery to medical device design, as well as statistical researchers in the field, will benefit from this book.

Author: Manuel E. Pena-Rodriguez
Publisher: Quality Press
ISBN: 0873898524
Category : Business & Economics
Languages : en
Pages : 205

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Book Description
The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Although the examples and case studies presented throughout the book are based on situations found in an organization regulated by FDA, the book can also be used to understand the application of those tools in any type of industry. Readers will obtain a better understanding of some of the statistical tools available to control their processes and be encouraged to study, with a greater level of detail, each of the statistical tools presented throughout the book. The content of this book is the result of the author’s almost 20 years of experience in the application of statistics in various industries, and his combined educational background of engineering and law that he has used to provide consulting services to dozens of FDA-regulated organizations.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442

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Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Author: Jeffrey C. Bauer
Publisher: CRC Press
ISBN: 9781439800775
Category : Business & Economics
Languages : en
Pages : 160

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Book Description
Americans are bombarded with statistical data each and every day, and healthcare professionals are no exception. All segments of healthcare rely on data provided by insurance companies, consultants, research firms, and the federal government to help them make a host of decisions regarding the delivery of medical services. But while these health professionals rely on data, do they really make the best use of the information? Not if they fail to understand whether the assumptions behind the formulas generating the numbers make sense. Not if they don’t understand that the world of healthcare is flooded with inaccurate, misleading, and even dangerous statistics. Statistical Analysis for Decision Makers in Healthcare: Understanding and Evaluating Critical Information in a Competitive Market, Second Edition explains the fundamental concepts of statistics, as well as their common uses and misuses. Without jargon or mathematical formulas, nationally renowned healthcare expert and author, Jeff Bauer, presents a clear verbal and visual explanation of what statistics really do. He provides a practical discussion of scientific methods and data to show why statistics should never be allowed to compensate for bad science or bad data. Relying on real-world examples, Dr. Bauer stresses a conceptual understanding that empowers readers to apply a scientifically rigorous approach to the evaluation of data. With the tools he supplies, you will learn how to dismantle statistical evidence that goes against common sense. Easy to understand, practical, and even entertaining, this is the book you wish you had when you took statistics in college — and the one you are now glad to have to defend yourself against the abundance of bad studies and misinformation that might otherwise corrupt your decisions.

Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54

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Book Description
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241564040
Category : Medical
Languages : en
Pages : 147

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Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212456
Category : Medical
Languages : en
Pages : 318

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Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.