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The original edition of this text, Clinical Evaluation of Medical Devices:
Principles and Case Studies, provided the first overview of key principles
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 innovation
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 purpose
as well as health care technology assessment methods; (2) information
on new statistical methodologies applied to medical device trials;
and (3) all new case studies, including examples of combination products,
three-phase development models (i.e., feasibility, FDA approval,
Medicare reimbursement), and novel study designs. This second edition
builds on the strength and foundation of the first, and would not have
been possible without those colleagues who graciously contributed their
expertise in the form of chapters and ideas to the final product. |
