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Medical Device R&d Handbook

ISBN-10: 143981189X
ISBN-13: 9781439811894
Edition: 2nd 2012 (Revised)
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Description: Written for medical device designers, biomedical engineering students, physician entrepreneurs, and medical device entrepreneurs, this reference provides the basics on how to prototype and develop a medical device. It gives the reader information on  More...

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Book details

Edition: 2nd
Copyright year: 2012
Publisher: CRC Press LLC
Publication date: 12/5/2012
Binding: Hardcover
Pages: 510
Size: 6.25" wide x 9.25" long x 1.00" tall
Weight: 2.244
Language: English

Written for medical device designers, biomedical engineering students, physician entrepreneurs, and medical device entrepreneurs, this reference provides the basics on how to prototype and develop a medical device. It gives the reader information on the basics of plastics, adhesives, medical needles, and rapid prototyping; as well as tips and tools to save time and money. The second to a popular first edition, this book is updated and expanded. It includes interviews from key opinion leaders and pioneers in the field, and practical advice throughout. Extensive references are included at the end of each chapter to enhance additional study.

About the Book
Preface to the Second Edition
Editor
Contributors
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

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