Development of FDA-Regulated Medical Products: A Translational Approach
Development of FDA-Regulated Medical Products: A Translational Approach
Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia regardless of functional specialty, workplace, or seniority who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. 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. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. 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. ASIN: 0873898338 VSKU: PKV.0873898338.G Condition: Good Author/Artist:Whitmore, Elaine Binding: Hardcover Note: Any images shown are stock photographs and product may differ from what is shown. Condition Notes: A well-loved companion. Corners and cover might show a little wear, and you could find some notes or highlights. The dust jacket might be MIA, it might have been a library book and extras aren't guaranteed—but the story's all there!
$30.62
Development of FDA-Regulated Medical Products: A Translational Approach—
$30.62
Product Information
Shipping & Returns
Description
Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia regardless of functional specialty, workplace, or seniority who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. 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. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. 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. ASIN: 0873898338 VSKU: PKV.0873898338.G Condition: Good Author/Artist:Whitmore, Elaine Binding: Hardcover Note: Any images shown are stock photographs and product may differ from what is shown. Condition Notes: A well-loved companion. Corners and cover might show a little wear, and you could find some notes or highlights. The dust jacket might be MIA, it might have been a library book and extras aren't guaranteed—but the story's all there!
You may also like
-70%NEW
Building an Elite Organization: The Blueprint to Scaling a High-Growth, High-Profit Business
$2.60
$0.78
-70%NEW
Liar's Poker (Norton Paperback)
$2.52
$0.76
-70%NEW
The 5 Essential People Skills: How to Assert Yourself, Listen to Others, and Resolve Conflicts (Dale Carnegie Books)
$2.44
$0.73
-70%NEW
The Blueprints to Your Business: A Guide to Managing Your Roofing Business
$8.85
$2.65
-70%NEW
Stocks for the Long Run 5/E: The Definitive Guide to Financial Market Returns & Long-Term Investment Strategies
$2.92
$0.88
-70%NEW
Naked Economics: Undressing the Dismal Science
$2.52
$0.76
-70%NEW
The Iso 14000 Handbook
$14.74
$4.42
-70%NEW
Jack Welch & The G.E. Way: Management Insights and Leadership Secrets of the Legendary CEO
$2.76
$0.83
-70%NEW
Leadership and Self Deception: Getting Out of the Box
$2.44
$0.73
-70%NEW
The ONE Thing: The Surprisingly Simple Truth About Extraordinary Results
$2.67
$0.80
-70%NEW
The Extraordinary Coach: How the Best Leaders Help Others Grow
$2.67
$0.80
-70%NEW
Change Your Habits, Change Your Life: Strategies that Transformed 177 Average People into Self-Made Millionaires
$2.44
$0.73
$30.62
Development of FDA-Regulated Medical Products: A Translational Approach—