Development of FDA-Regulated Medical Products

A Translational Approach

Elaine Whitmore

• Publisher: ASQ Quality Press
• Year: 2012
• Print ISBN: 9780873898331
• eBook ISBN: 9780873892216
• Edition: 2
• Topic: Medicine
• Subtopic: Biotechnology in Medicine

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."I have been working in medical device design and design assurance for over 10 years…Elaine Whitmore really gets this right...The point is that quality regulations are not going to go away, and those responsible for healthcare product development will have to lead the charge to keep up the momentum in their organizations. I am going to have to buy several copies of this for my clients!" Joseph P. Sener, P.E.

Table of contents

• Development of FDA-Regulated Medical Products
• List of Figures and Tables
• Acronyms and Abbreviations
• Preface
• Part I: Unique Challenges in Medical Product Development
• Chapter 1: Pushing the Pipeline
• Chapter 2: Healthcare in the United States
• Chapter 3: It’s Not Your Father’s FDA
• 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
• Chapter 11: Is It Safe and Does It Work?
• Chapter 12: How Much Is the Product Really Worth?
• Part III: Product Development Planning
• Chapter 13: Models and Metaphors
• Chapter 14: Components of Product Development Planning
• Chapter 15: Components of Product Development Planning
• Chapter 16: Components of Product Development Planning
• Chapter 17: Components of Product Development Planning
• Chapter 18: Better Double-Check That
• Chapter 19: Where Do We Go From Here?
• Appendix: Resources
• Endnotes
• Glossary