Kucklick The Medical Device R&D Handbook, Second Edition

2. Auflage 2013
ISBN: 978-1-4398-1195-5
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 510 Seiten

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.

Zielgruppe

Medical device and physician entrepreneurs, practitioners, biomedical engineers, professionals in the medical device industry or anyone interested in the medical device industry, and graduate students in medical device design/biomedical engineering.

Autoren/Hrsg.

Kucklick, Theodore R.

Fachgebiete

• Technische Wissenschaften Sonstige Technologien | Angewandte Technik Medizintechnik, Biomedizintechnik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizintechnik, Biomedizintechnik, Medizinische Werkstoffe

Inhaltsverzeichnis

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

Index

Über Autor(innen)

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.