Development of FDA-Regulated Medical Products : A Translational Approach, 2nd Edition

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.

List of Figures and Tables
Acronyms and Abbreviations
Preface

Part I : Unique Challenges in Medical Product Development
Chapter 1 : Pushing the Pipeline : Translational Research and Product Development
Chapter 2 : Healthcare in teh United States
Chapter 3 : It's Not Your Father's FDA : The "Modernization" of Medical Production Regulation
Chapter 4 : Classifying Medical Products
Chapter 5 : Product Liability and Product Development

Part II : Bringing a New Medical Product to Market
Chapter 6 : Overview of the Approval Processes for Drugs, Biologics, and Medical Devices
Chapter 7 : Quality by Design
Chapter 8 : Designing-Out Disaster : Risk Analysis
Chapter 9 : Recalls, Withdrawals, and Revocations
Chapter 10 : Human Factors and Usability Engineering : Minimizing Medical Errors
Chapter 11 : Is It Safe and Does It Work? Evaluating Safety and Efficacy in Clinical Trials
Chapter 12 : How Much Is the Product Really Worth? Outcomes Research, Pharmacoeconomics, and Manged Care

Part III : Product Development Planning
Chapter 13 : Models and Metaphors : Product Development and the Product Development Organization
Chapter 14 : Components of Product Development Planning : The Product Development Process
Chapter 15 : Components of Product Development Planning : Development Portfoliio Management
Chapter 16 : Components of Product Development Planning : Technology Assessment
Chapter 17 : Components of Product Development Planning : Technology Forecasting
Chapter 18 : Better Double-Check That : A Guide for the Risk-Averse
Chapter 19 : Where Do We Go From Here?

Appendix : Resources
Endnotes
Glossary
Index