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 67
Page 5
... testing, the agency has routinely relied on single studies evaluated for internal and across-center consistency.”6 The differences between drugs and medical devices identified by the Cooper Committee 35 years ago remain valid today, and ...
... testing, the agency has routinely relied on single studies evaluated for internal and across-center consistency.”6 The differences between drugs and medical devices identified by the Cooper Committee 35 years ago remain valid today, and ...
Page 6
... testing and animal models alone may validate new designs. Some devices are implanted. Ethical considerations may preclude comparative trials. Results from long-term clinical studies may no longer be relevant to current products and ...
... testing and animal models alone may validate new designs. Some devices are implanted. Ethical considerations may preclude comparative trials. Results from long-term clinical studies may no longer be relevant to current products and ...
Page 7
... testing and/or evaluations in animal models are often sufficient to validate the suitability of a design change without the need for controlled clinical trials. It is not uncommon for clinicians and Institutional Review Boards (IRBs) to ...
... testing and/or evaluations in animal models are often sufficient to validate the suitability of a design change without the need for controlled clinical trials. It is not uncommon for clinicians and Institutional Review Boards (IRBs) to ...
Page 8
... testing is required to develop a safe and reliable product, but practical constraints experienced by this particular segment of the health care industry are particularly influential in driving product development and testing decisions ...
... testing is required to develop a safe and reliable product, but practical constraints experienced by this particular segment of the health care industry are particularly influential in driving product development and testing decisions ...
Page 9
... testing study. 3.2. Pivotal Trials of Safety and Effectiveness A single, well-controlled clinical trial of device performance remains sufficient for FDA approval of a SR device. These prospective, analytical studies provide objective ...
... testing study. 3.2. Pivotal Trials of Safety and Effectiveness A single, well-controlled clinical trial of device performance remains sufficient for FDA approval of a SR device. These prospective, analytical studies provide objective ...
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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