The Medical Device R&D Handbook
Editat de Theodore R. Kucklicken Limba Engleză Hardback – 5 dec 2012
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.
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Specificații
ISBN-13: 9781439811894
ISBN-10: 143981189X
Pagini: 510
Ilustrații: 141 black & white illustrations, 15 colour illustrations, 20 black & white tables
Dimensiuni: 156 x 234 x 28 mm
Greutate: 0.86 kg
Ediția:Revizuită
Editura: CRC Press
Colecția CRC Press
ISBN-10: 143981189X
Pagini: 510
Ilustrații: 141 black & white illustrations, 15 colour illustrations, 20 black & white tables
Dimensiuni: 156 x 234 x 28 mm
Greutate: 0.86 kg
Ediția:Revizuită
Editura: CRC Press
Colecția CRC Press
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Public țintă
Academic and Professional Practice & DevelopmentCuprins
Materials for Medical Device R&D. Introduction to Medical Plastics. Getting Stuck in a Good Way: Basics of Medical Device Adhesives. Introduction to Needles and Cannulae. Assessing Biocompatibility: A Guide for Medical Device Manufacturers. Processes for Medical Device R&D. Catheter-Forming Equipment and Operations. Basics of Catheter Assembly. Rapid Prototyping for Medical Devices. Medical Applications of Rapid Technologies: Technology Update. Reverse Engineering in Medical Device Design. Prototype or Produce? How to Decide. Elements of Injection Molding Style for Medical Device R&D. Methods for Medical Device R&D. Clinical Observation: How To Be Welcome (or at Least Tolerated) in the Operating Room and Laboratory. ABCs of NDAs. Intellectual Property Strategy for Med-Tech Start-Ups. Regulatory Affairs: Medical Devices. 510(k) Reform: The Stakes Are High. Brief Introduction to Preclinical Research. Using Medical Illustration in Medical Device R&D. Case Study: The BACE™ Mitral Regurgitation Treatment, Device: Supplement to Chapter 18, Using Medical Illustration in Medical Device R&D. Interviews and Insights for the R&D Entrepreneur. Interview with Thomas Fogarty, MD. Interview with Paul Yock, MD. Interview with Dane Miller, PhD. Interview with Ingemar Lundquist. Interview with J. Casey McGlynn. Keys to Creating Value for Early Stage Medical Device Companies. Female Leadership in the Medical Device Industry. Medical Device Sales 101. Invention, Innovation, and Creativity: Or How Thomas Edison Never Changed the World by Creating the Light Bulb. How to Fail as an Entrepreneur. Raising Money for Your Medical Device Start-Up. Index.
Notă biografică
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.
Recenzii
"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
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
Descriere
Written for medical device designers, biomedical engineering students, physician entrepreneurs, and medical device entrepreneurs, this reference explains the basics on how to prototype and develop a medical device. It discusses the basics of plastics, adhesives, medical needles, and rapid prototyping as well as tips and tools to save time and money. This updated and expanded second edition includes practical advice, information on intellectual property management, and insightful interviews from key opinion leaders and pioneers in the field. Extensive references at the end of each chapter enhance additional study.