Development of FDA-Regulated Medical Products: A Translational Approach, Second Edition
| Author | : | |
| Rating | : | 4.84 (625 Votes) |
| Asin | : | 0873898338 |
| Format Type | : | paperback |
| Number of Pages | : | 256 Pages |
| Publish Date | : | 2014-07-26 |
| Language | : | English |
DESCRIPTION:
Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution from bench to bedside has become known as translational research and development, and this approach is what this book illuminates.. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. The years since the publication of the previous
Finally, Someone gets it right! I have been working in medical device design and design assurance for over 10 years. I have been having the fight and argument with management that "of course it is harder to do it right than not but your current approach has really not worked so well!!!Elaine Whitmore really gets this right. The one paragraph that really got me ranting is on page 80: "A significant challenge for anyone working in product development in the healthcare field, especially with medical devices where. "Essential guide for medical product management, investors, scientists and engineers" according to David M. Wiseman. Dr. Whitmore exposes a raw nerve too long protected by the bubble that has been the biotech boom of the last 20 or so years. In her opening salvo she observes "there is no lack of innovation or shortage of important scientific discoveries in this country, but our ability to transform scientific advances into new and effective medical products has been disappointing."In attempting to pinpoint the reason for the gap between expectations and actual productivity, Dr. Whitmore rounds. "A Must Read for any Healthcare Professional" according to Tyler. The updated version of this book provides new insight into the development of medical products in changing times, where regulation now takes longer to pass through than development. This is really a beginners overview of the process, so if you work in the industry some of the chapters may seem a bit simple and lacking in content. Overall it is a great read for anyone (especially healthcare providers) that want to know more about how medical devices are regulated.