The medical device R&D handbook
著者
書誌事項
The medical device R&D handbook
CRC press, Taylor & Francis, c2013
2nd ed
- : hardback
大学図書館所蔵 全2件
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
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.
目次
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 (TM) 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.
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