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 49
Page 5
... sponsors must provide valid scientific evidence of safety and efficacy. Unlike requirements for drug approvals, this evidence can come from sources other than well-controlled clinical investigations, such as “partially controlled ...
... sponsors must provide valid scientific evidence of safety and efficacy. Unlike requirements for drug approvals, this evidence can come from sources other than well-controlled clinical investigations, such as “partially controlled ...
Page 9
... sponsor to collect data on a series of patient outcomes that may be related to device performance, thereby contributing to the identification and selection of clinically significant measures for use as effectiveness endpoints in a ...
... sponsor to collect data on a series of patient outcomes that may be related to device performance, thereby contributing to the identification and selection of clinically significant measures for use as effectiveness endpoints in a ...
Page 10
... sponsors of Class III devices to conduct a postapproval clinical study as a mandatory condition of PMA approval. These ... sponsor-initiated or required by a regulatory agency in response to a perceived safety concern. The federal Safe ...
... sponsors of Class III devices to conduct a postapproval clinical study as a mandatory condition of PMA approval. These ... sponsor-initiated or required by a regulatory agency in response to a perceived safety concern. The federal Safe ...
Page 11
... Sponsors are also beginning to use observational studies effectively for retrospective studies of clinical experience, especially when the goal is to gather data on patient- or device-specific factors that may contribute to longterm ...
... Sponsors are also beginning to use observational studies effectively for retrospective studies of clinical experience, especially when the goal is to gather data on patient- or device-specific factors that may contribute to longterm ...
Page 17
... sponsor will elect to 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 ...
... sponsor will elect to 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 ...
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