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About the Book | |
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Preface to the Second Edition | |
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Editor | |
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Contributors | |
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Materials for Medical Device R&D | |
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Introduction to Medical Plastics | |
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Getting Stuck in a Good Way: Basics of Medical Device Adhesives | |
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Introduction to Needles and Cannulae | |
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Assessing Biocompatibility: A Guide for Medical Device Manufacturers | |
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Processes for Medical Device R&D | |
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Catheter-Forming Equipment and Operations | |
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Basics of Catheter Assembly | |
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Rapid Prototyping for Medical Devices | |
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Medical Applications of Rapid Technologies: Technology Update | |
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Reverse Engineering in Medical Device Design | |
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Prototype or Produce? How to Decide | |
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Elements of Injection Molding Style for Medical Device R&D | |
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Methods for Medical Device R&D | |
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Clinical Observation: How to Be Welcome (or at Least Tolerated) in the Operating Room and Laboratory | |
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ABCs of NDAs | |
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Intellectual Property Strategy for Med-Tech Start-Ups | |
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Regulatory Affairs: Medical Devices | |
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510(k) Reform: The Stakes Are High | |
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Brief Introduction to Preclinical Research | |
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Using Medical Illustration in Medical Device R&D | |
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Case Study: The BACE™ Mitral Regurgitation Treatment Device: Supplement to Chapter 18, Using Medical Illustration in Medical Device R&D | |
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Interviews and Insights for the R&D Entrepreneur | |
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Interview with Thomas Fogarty, MD | |
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Interview with Paul Yock, MD | |
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Interview with Dane Miller, PhD | |
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Interview with Ingemar Lundquist | |
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Interview with J. Casey McGlynn | |
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Keys to Creating Value for Early Stage Medical Device Companies | |
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Female Leadership in the Medical Device Industry | |
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Medical Device Sales 101 | |
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Invention, Innovation, and Creativity: Or How Thomas Edison Never Changed the World by Creating the Light Bulb | |
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How to Fail as an Entrepreneur | |
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Raising Money for Your Medical Device Start-Up | |
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Index | |