Statistical Procedures for the Medical Device Industry PDF Download
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Author: Wayne A. Taylor
Publisher:
ISBN: 9780963512291
Category :
Languages : en
Pages : 0
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Book Description
Author: Wayne A. Taylor
Publisher:
ISBN: 9780963512291
Category :
Languages : en
Pages : 0
Get Book Here
Book Description
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: Alex Bottle
Publisher: CRC Press
ISBN: 1482246104
Category : Mathematics
Languages : en
Pages : 292
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Book Description
Healthcare is important to everyone, yet large variations in its quality have been well documented both between and within many countries. With demand and expenditure rising, it’s more crucial than ever to know how well the healthcare system and all its components – from staff member to regional network – are performing. This requires data, which inevitably differ in form and quality. It also requires statistical methods, the output of which needs to be presented so that it can be understood by whoever needs it to make decisions. Statistical Methods for Healthcare Performance Monitoring covers measuring quality, types of data, risk adjustment, defining good and bad performance, statistical monitoring, presenting the results to different audiences and evaluating the monitoring system itself. Using examples from around the world, it brings all the issues and perspectives together in a largely non-technical way for clinicians, managers and methodologists. Statistical Methods for Healthcare Performance Monitoring is aimed at statisticians and researchers who need to know how to measure and compare performance, health service regulators, health service managers with responsibilities for monitoring performance, and quality improvement scientists, including those involved in clinical audits.
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
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: 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: Kwanchai A. Gomez
Publisher: John Wiley & Sons
ISBN: 9780471870920
Category : Technology & Engineering
Languages : en
Pages : 698
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Book Description
Here in one easy-to-understand volume are the statistical procedures and techniques the agricultural researcher needs to know in order to design, implement, analyze, and interpret the results of most experiments with crops. Designed specifically for the non-statistician, this valuable guide focuses on the practical problems of the field researcher. Throughout, it emphasizes the use of statistics as a tool of research—one that will help pinpoint research problems and select remedial measures. Whenever possible, mathematical formulations and statistical jargon are avoided. Originally published by the International Rice Research Institute, this widely respected guide has been totally updated and much expanded in this Second Edition. It now features new chapters on the analysis of multi-observation data and experiments conducted over time and space. Also included is a chapter on experiments in farmers' fields, a subject of major concern in developing countries where agricultural research is commonly conducted outside experiment stations. Statistical Procedures for Agricultural Research, Second Edition will prove equally useful to students and professional researchers in all agricultural and biological disciplines. A wealth of examples of actual experiments help readers to choose the statistical method best suited for their needs, and enable even the most complicated procedures to be easily understood and directly applied. An International Rice Research Institute Book
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309042860
Category : Medical
Languages : en
Pages : 241
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Book Description
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author: Manuel E. Pena-Rodriguez
Publisher: Quality Press
ISBN: 1953079806
Category : Technology & Engineering
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: 0309212421
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.
