Clinical Evaluation of Medical Devices: Principles and Case StudiesKaren M. Becker, John J. Whyte The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs. |
From inside the book
Results 1-5 of 54
Page 3
... typically a health care professional but may be the patient. The impact of this third parameter—the medical device user—is a variable unique to medical device studies and can be responsible for the greatest degree of variability in the ...
... typically a health care professional but may be the patient. The impact of this third parameter—the medical device user—is a variable unique to medical device studies and can be responsible for the greatest degree of variability in the ...
Page 4
... typically considered in the design of well-controlled studies, such as the choice of a control group, the need to reduce bias, and the need to control for confounders, are common to both drug and device trials; however, the nature of ...
... typically considered in the design of well-controlled studies, such as the choice of a control group, the need to reduce bias, and the need to control for confounders, are common to both drug and device trials; however, the nature of ...
Page 5
... typical pharmaceutical product on a per product basis. Relying on the Cooper Committee's recommendations and subsequent testimony, Congress developed legislation incorporating a regulatory pathway for medical devices based on the ...
... typical pharmaceutical product on a per product basis. Relying on the Cooper Committee's recommendations and subsequent testimony, Congress developed legislation incorporating a regulatory pathway for medical devices based on the ...
Page 6
... typically a health care professional. Thus, the clinical outcomes measured in the study of a medical device's safety and effectiveness are a function of the user's skill as well as the interaction between the device and the patient. The ...
... typically a health care professional. Thus, the clinical outcomes measured in the study of a medical device's safety and effectiveness are a function of the user's skill as well as the interaction between the device and the patient. The ...
Page 7
... typically called the learning curve. Training in the use of a device is a key part of the investigation of its clinical performance and eventual marketing. If the variability in the user's proficiency is not accurately assessed or ...
... typically called the learning curve. Training in the use of a device is a key part of the investigation of its clinical performance and eventual marketing. If the variability in the user's proficiency is not accurately assessed or ...
Contents
21 | |
Requirements for Medicare Coverage | 59 |
Postmarket Requirements for Significant Risk Devices 81 Suzan Onel | 99 |
Intellectual Property Protection for Medical Devices | 117 |
HIPAA Compliance in Clinical Research 141 Peter M Kazon and Sharon D Brooks | 153 |
Developing DrugDevice Combination Products | 161 |
Wall Streets Perspective on Medical Device | 187 |
Left Ventricular Assist Device | 199 |
A Randomized ShamProcedure | 217 |
Use of Multiple Imputation Models | 251 |
Case Studies on the Local Coverage Process 253 Mitchell I Burken | 269 |
Role of Device Retrieval and Analysis | 305 |
Other editions - View all
Clinical Evaluation of Medical Devices: Principles and Case Studies Karen M. Becker,John J. Whyte No preview available - 2007 |
Clinical Evaluation of Medical Devices: Principles and Case Studies Karen M. Becker,John J. Whyte No preview available - 2010 |
Clinical Evaluation of Medical Devices: Principles and Case Studies Karen M. Becker,John J. Whyte No preview available - 2005 |
Common terms and phrases
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