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 companies—both what works and what doesn’t 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.
Table of Contents
Materials for Medical Device R&D
Introduction to Medical Plastics, Theodore R. Kucklick
Getting Stuck in a Good Way: Basics of Medical Device Adhesives, Theodore R. Kucklick
Introduction to Needles and Cannulae, Theodore R. Kucklick
Assessing Biocompatibility: A Guide for Medical Device Manufacturers, Tom Spalding
Processes for Medical Device R&D
Catheter-Forming Equipment and Operations, Theodore R. Kucklick
Basics of Catheter Assembly, Theodore R. Kucklick
Rapid Prototyping for Medical Devices, Theodore R. Kucklick
Medical Applications of Rapid Technologies: Technology Update, Theodore R. Kucklick
Reverse Engineering in Medical Device Design, Theodore R. Kucklick
Prototype or Produce? How to Decide, Theodore R. Kucklick
Elements of Injection Molding Style for Medical Device R&D, Theodore R. Kucklick
Methods for Medical Device R&D
Clinical Observation: How To Be Welcome (or at Least Tolerated) in the Operating Room and Laboratory, Theodore R. Kucklick
ABCs of NDAs, Theodore R. Kucklick
Intellectual Property Strategy for Med-Tech Start-Ups, Ryan H. Flax
Regulatory Affairs: Medical Devices, Thom Wehman
510(k) Reform: The Stakes Are High, Sherrie Conroy
Brief Introduction to Preclinical Research, James Swick
Using Medical Illustration in Medical Device R&D, Theodore R. Kucklick
Case Study: The BACE™ Mitral Regurgitation Treatment, Device: Supplement to Chapter 18, Using Medical llustration in Medical Device R&D, Theodore R. Kucklick
Interviews and Insights for the R&D Entrepreneur
Interview with Thomas Fogarty, MD, Theodore R. Kucklick
Interview with Paul Yock, MD, Theodore R. Kucklick
Interview with Dane Miller, PhD, Theodore R. Kucklick
Interview with Ingemar Lundquist, Theodore R. Kucklick
Interview with J. Casey McGlynn, Theodore R. Kucklick
Keys to Creating Value for Early Stage Medical Device Companies, Richard Ferrari
Female Leadership in the Medical Device Industry, France Helfer
Medical Device Sales 101, Devin Hughes
Invention, Innovation, and Creativity: Or How Thomas Edison Never Changed the World by Creating the Light Bulb, Theodore R. Kucklick
How to Fail as an Entrepreneur, Theodore R. Kucklick
Raising Money for Your Medical Device Start-Up, Theodore R. Kucklick
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.
"This is a handbook in the classic sense of the word. It is a concise guide that is directed for those who want to develop products for the marketplace. …. I would say this would serve any professional well, and also be an excellent guide for senior design projects by those students studying biomedical engineering. The information in this book is priceless and represents an immense accumulation of practical knowledge. There is no other text like it.
This is a must read for anyone entering the medical device industry. If you want to make a product— particularly a therapeutic device—you will find no better resource than this text. It should be on the bookshelf of each and every biomedical engineer"
—Brian Wong M.D., Ph.D., University of California–Irvine, USA
"I think this book is a must-have for any engineer involved in medical device design, but also for medical doctors focused on inventing innovative devices to address their needs. A book like this is inspiring for an undergraduate or a graduate student that is planning a career in medical device design. It can be an invaluable source for answers for the full lifecycle of a medical device.
It covers the conception and nurturing of a new idea, how to develop a reliable prototype, how to bring it into production, and, last but not least, addresses the fundamental issues of intellectual property protection. Interviews of big names in medical device design are the grand finale of the book. It is so inspiring to read about success stories in the field of medical devices. There is such a need for innovation in healthcare and this book is a perfect how-to manual to guide inventors of all ages through the full process of medical device design."
—Pietro Valdastri, Vanderbilt University, Nashville, Tennessee, USA
"With all your academic training in biomedical engineering, I hope you will agree you have not been taught how to develop a practical medical device. Ted Kucklick wrote this book just for you. He assumes that you are well schooled in the basic concepts, and he recognizes that what you need is a tutorial on how to apply your knowledge to develop medical devices. He covers broad areas of design and early prototyping of disposable medical devices, with how-to instructions for many fabrications, and links to helpful outside industrial resources. This is a book you will want to keep handy on your bookshelf and find a valuable reference."
—Frank Ingle, Ph.D., PE, CEO, and CTO, Instruments for Science and Medicine, Inc., Palo Alto, California, USA
"The Medical Device Handbook is a must for any company engaged in the increasingly complex world of medical device development. Author Kucklick has updated his ‘one-stop’ handbook, covering the essentials of medical device development from design to manufacturing scale-up. This is a practical reference book that will have a broad audience in any medical device company—from start-up to multinational."
—Thomas Loarie, Mercator MedSystems, Inc., Danville, California
Praise for the First Edition:
"This is the first in its class of multidisciplinary books for medical device innovators, reaching across several disciplines to capture what innovators need."
—Michael Gertner, MD, Co-Director, Surgical Innovation Program at Stanford University
"This is a resource that will help medical device innovators develop better products, and more focused companies, more quickly."
—Randy Williams, Founder, The Keiretsu Forum
"Finally, a real manual that for the first time supports efficient medical device development."
—Peter H. Muller, President, Interform Product Development