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The Resource Medical device design : innovation from concept to market, Peter J. Ogrodnik

Medical device design : innovation from concept to market, Peter J. Ogrodnik

Label
Medical device design : innovation from concept to market
Title
Medical device design
Title remainder
innovation from concept to market
Statement of responsibility
Peter J. Ogrodnik
Creator
Subject
Language
eng
Summary
This book provides the bridge between engineering design and medical devices development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices regulatory (FDA and EU) requirements: some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products' commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context, based on the authors' years of experience in academia (R & D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the market place rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpels, stents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how. Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand. Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products
Cataloging source
OPELS
Illustrations
illustrations
Index
index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Series statement
Engineering professional collection
Medical device design : innovation from concept to market, Peter J. Ogrodnik
Label
Medical device design : innovation from concept to market, Peter J. Ogrodnik
Link
Publication
Related Contributor
Related Location
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Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • Front Cover; Medical Device Design; Copyright Page; Contents; Preface; Acknowledgements; 1 Introduction; 1.1 What Is Design?; 1.2 The Design Life Cycle; 1.3 Medical Devices Definitions; 1.4 Summary; References; 2 Classifying Medical Devices; 2.1 Introduction: Why Classify?; 2.2 Classification Rules; 2.3 Classification Case Study; 2.3.1 EU Classification; 2.3.2 USA Classification; 2.3.3 Special Cases; 2.4 Classification Models; 2.5 Classification and the Design Process; 2.6 Summary; References; 3 The Design Process; 3.1 Design Process versus Design Control; 3.2 Design Models
  • 3.2.1 Pahl and Beitz, and Pugh3.2.2 Divergent-Convergent Model; 3.3 Managing Design; 3.3.1 Common Design Management Models; 3.3.1.1 Serial Design; 3.3.1.2 Ad Hoc Feedback; 3.3.1.3 Concurrent Design/Concurrent Engineering; 3.3.1.4 Collaborative Models; 3.3.1.5 Holistic Models; 3.3.1.6 Which Model Is Best for Me?; 3.4 Cross-Reference with Regulatory Requirements; 3.5 Summary; Tasks; References; Further Reading; 4 Implementing Design Procedures; 4.1 Introduction; 4.2 Review of Guidelines; 4.3 Overall Procedure; 4.4 Audit /Review Procedure; 4.5 The Design Process; 4.5.1 New Product Procedure
  • 4.5.2 Clarification/Product Specification Procedure4.5.3 Detailed Design Procedure; 4.5.4 Design Verification/Validation/Evaluation Procedure; 4.5.5 Design Changes; 4.5.6 Control of Documents; 4.5.7 Risk Assessment Procedure; 4.6 Implementing a Procedure; 4.7 Summary; References; 5 Developing Your Product Design Specification; 5.1 Introduction; 5.2 Developing the Statement of Need (or Brief); 5.2.1 Identifying the "One Thing"; 5.2.2 Formalizing the Statement of Need; 5.3 The Product Design Specification (PDS); 5.3.1 Essential Elements of a PDS; 5.3.1.1 Customer
  • 5.3.1.2 Regulatory and Statutory5.3.1.3 Technical; 5.3.1.4 Performance; 5.3.1.4.1 Biomechanics; 5.3.1.5 Sales; 5.3.1.6 Manufacturing; 5.3.1.7 Packaging and Transportation; 5.3.1.8 Environmental; 5.3.1.9 Summary; 5.4 Finding, Extracting, and Analyzing the Content; 5.4.1 Focus Groups; 5.4.2 Regulatory Bodies; 5.4.3 Immersion; 5.4.4 Libraries; 5.4.4.1 Standards; 5.4.4.2 Journals and Learned Publications; 5.4.4.3 Books; 5.4.4.4 Librarians; 5.4.5 Technical Literature; 5.4.5.1 General Trade Magazines; 5.4.5.2 Catalogs, Fliers, and Trade Literature; 5.4.6 The Internet; 5.4.7 Conferences and Symposia
  • 5.4.8 Others5.5 Summary; References; 6 Generating Ideas and Concepts; 6.1 Introduction; 6.2 The "Engineer's Notebook"; 6.3 Creative Space; 6.3.1 The White Room; 6.3.2 Personal Space; 6.4 Generating Concepts/Ideas; 6.4.1 Radial Thinking; 6.4.2 Inversion (or Word Association); 6.4.3 Analogue; 6.4.4 Brainstorming; 6.4.5 Discretizing; 6.4.6 Morphological Analysis; 6.4.7 Research; 6.4.8 We Have Ideas!; 6.5 Selecting Concepts and Ideas; 6.5.1 Morphological Analysis; 6.5.2 Criteria Assessment; 6.5.3 Weighted Criteria Assessment; 6.6 Summary; References; 7 Quality in Design; 7.1 Introduction
http://library.link/vocab/cover_art
https://contentcafe2.btol.com/ContentCafe/Jacket.aspx?Return=1&Type=S&Value=9780123919427&userID=ebsco-test&password=ebsco-test
Dimensions
unknown
http://library.link/vocab/discovery_link
{'f': 'http://opac.lib.rpi.edu/record=b3647478'}
Extent
1 online resource
File format
unknown
Form of item
online
Isbn
9780123919427
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote

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