Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving.
The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. The text also contains interviews with leaders in the industry who offer their vast experience and insights on how to start and grow successful companiesboth what works and what doesnt work. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development.
| About the Book |
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ix | |
| Preface to the Second Edition |
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xiii | |
| Editor |
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xvii | |
| Contributors |
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xix | |
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Section I Materials for Medical Device R&D |
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Chapter 1 Introduction to Medical Plastics |
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3 | (26) |
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Chapter 2 Getting Stuck in a Good Way: Basics of Medical Device Adhesives |
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29 | (14) |
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Chapter 3 Introduction to Needles and Cannulae |
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43 | (22) |
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Chapter 4 Assessing Biocompatibility: A Guide for Medical Device Manufacturers |
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65 | (28) |
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Section II Processes for Medical Device R&D |
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Chapter 5 Catheter-Forming Equipment and Operations |
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93 | (14) |
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Chapter 6 Basics of Catheter Assembly |
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107 | (20) |
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Chapter 7 Rapid Prototyping for Medical Devices |
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127 | (40) |
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Chapter 8 Medical Applications of Rapid Technologies: Technology Update |
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167 | (16) |
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Chapter 9 Reverse Engineering in Medical Device Design |
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183 | (28) |
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Chapter 10 Prototype or Produce? How to Decide |
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211 | (6) |
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Chapter 11 Elements of Injection Molding Style for Medical Device R&D |
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217 | (26) |
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Section III Methods for Medical Device R&D |
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Chapter 12 Clinical Observation: How to Be Welcome (or at Least Tolerated) in the Operating Room and Laboratory |
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243 | (8) |
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251 | (12) |
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Chapter 14 Intellectual Property Strategy for Med-Tech Start-Ups |
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263 | (32) |
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Chapter 15 Regulatory Affairs: Medical Devices |
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295 | (38) |
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Chapter 16 510(k) Reform: The Stakes Are High |
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333 | (14) |
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Chapter 17 Brief Introduction to Preclinical Research |
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347 | (4) |
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Chapter 18 Using Medical Illustration in Medical Device R&D |
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351 | (22) |
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Chapter 19 Case Study: The BACE™ Mitral Regurgitation Treatment Device: Supplement to
Chapter 18, Using Medical Illustration in Medical Device R&D |
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373 | (6) |
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Section IV Interviews and Insights for the R&D Entrepreneur |
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Chapter 20 Interview with Thomas Fogarty, MD |
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379 | (8) |
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Chapter 21 Interview with Paul Yock, MD |
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387 | (6) |
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Chapter 22 Interview with Dane Miller, PhD |
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393 | (6) |
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Chapter 23 Interview with Ingemar Lundquist |
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399 | (2) |
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Chapter 24 Interview with J. Casey McGlynn |
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401 | (12) |
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Chapter 25 Keys to Creating Value for Early Stage Medical Device Companies |
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413 | (10) |
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Chapter 26 Female Leadership in the Medical Device Industry |
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423 | (6) |
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Chapter 27 Medical Device Sales 101 |
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429 | (4) |
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Chapter 28 Invention, Innovation, and Creativity: Or How Thomas Edison Never Changed the World by Creating the Light Bulb |
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433 | (14) |
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Chapter 29 How to Fail as an Entrepreneur |
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447 | (12) |
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Chapter 30 Raising Money for Your Medical Device Start-Up |
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459 | (8) |
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| Index |
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467 | |
Theodore R. Kucklick has extensive experience in the hands-on design and commercial development of medical devices, including radio frequency ablation devices, microwave catheters for minimally invasive therapy, in-home diagnostics devices, surgical closure devices, battery-powered devices, disposables, and general surgery tools. Ted is currently the cofounder, CEO, and CTO for Cannuflow, Inc., an arthroscopic instrument start-up company, and design director for TRKD Medical Device R&D, a medical device design and development company. Ted is the inventor of more than 40 U.S. and international patents, and he is a member of the IEEE/Engineering in Medicine and Biology Society, the Industrial Designers Society of America, and the Association of Medical Illustrators.
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