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 59
Page 4
... established business goals. The Food and Drug Administration (FDA) is concerned with the safety and efficacy of a product, whereas health care providers and payors are interested in comparative performance, superiority or product ...
... established business goals. The Food and Drug Administration (FDA) is concerned with the safety and efficacy of a product, whereas health care providers and payors are interested in comparative performance, superiority or product ...
Page 9
... establish “reasonable evidence” of safety and effectiveness. When direct comparisons are made to alternative treatment options, effectiveness of the new device is expected to be not worse than that of other available devices or ...
... establish “reasonable evidence” of safety and effectiveness. When direct comparisons are made to alternative treatment options, effectiveness of the new device is expected to be not worse than that of other available devices or ...
Page 15
... establishing the reimbursement strategy. Data on safety and adverse events associated with the studied intervention should be collected as broadly as possible. Previous clinical experience with the device and/or data from nonclinical ...
... establishing the reimbursement strategy. Data on safety and adverse events associated with the studied intervention should be collected as broadly as possible. Previous clinical experience with the device and/or data from nonclinical ...
Page 17
... establish a Data Safety Monitoring Board comprised of experts who continually evaluate the safety data accrued in a study. This is most common for early clinical experience with an investigational device or studies in which significant ...
... establish a Data Safety Monitoring Board comprised of experts who continually evaluate the safety data accrued in a study. This is most common for early clinical experience with an investigational device or studies in which significant ...
Page 23
... established in 21 C.F.R. Part 812 and refrain from engaging in promotional activities and the other prohibited activities enumerated in 21 C.F.R. §812.7 (e.g., commercializing an investigational device).19 FDA regularly issues warning ...
... established in 21 C.F.R. Part 812 and refrain from engaging in promotional activities and the other prohibited activities enumerated in 21 C.F.R. §812.7 (e.g., commercializing an investigational device).19 FDA regularly issues warning ...
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
addition analysis application appropriate approval assessment associated authorization Bayesian benefit cardiac Center changes claims clinical trial codes component conducted considered costs coverage covered criteria decision defined determine disease distribution drug effect entity established evaluation example failure filed Food function heart hospital human identify implanted important improvement imputation individual initial invention investigational issues lead limited manufacturer measures mechanism medical devices Medicare meet ment methods missing multiple necessary observed obtain outcome patients payment performance potential present primary prior procedures protection rail randomized reasonable received regulations regulatory reimbursement request risk Rule safety significant specific sponsor standard stent studies subjects testing therapy tion tray treatment typically values valve