rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Medical device design
    sub title: innovation from concept to market
  name:
    name part: Ogrodnik, Peter J.
    role:
      role term: creator
  name:
    name part: Knovel (Firm)
  type of resource: text
  genre: bibliography
  genre: Electronic books.
  origin info:
    place:
      place term: xx
    date issued: 2012
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource : illustrations
  abstract: 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.
  table of 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.
  table of contents: 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.
  table of contents: 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.
  table of contents: 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.
  table of contents: 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.
  note: Peter J. Ogrodnik.
  note: Electronic resource.
  note: Includes bibliographical references and index.
  subject:
    geographic code: e------
    geographic code: n-us---
  subject:
    topic: Biomedical engineering
  subject:
    topic: Engineering design
  subject:
    topic: MEDICAL
    topic: Allied Health Services
    topic: Medical Technology
  subject:
    topic: MEDICAL
    topic: Biotechnology
  subject:
    topic: MEDICAL
    topic: Family & General Practice
  subject:
    topic: MEDICAL
    topic: Lasers in Medicine
  subject:
    topic: TECHNOLOGY & ENGINEERING
    topic: Biomedical
  subject:
    topic: Biomedical engineering
  subject:
    topic: Engineering design
  subject:
    topic: Equipment Design
    topic: standards
  subject:
    topic: Equipment and Supplies
    topic: standards
  subject:
    topic: Inventions
    topic: standards
  subject:
    topic: Marketing of Health Services
    topic: methods
  subject:
    geographic: Europe
  subject:
    geographic: United States
  classification: R856 .O37 2012
  classification: 610.28
  classification: W 26
  classification: 44.31
  related item:
    title info:
      title: Medical device design
    name:
      name part: Ogrodnik, Peter J.
    origin info:
      publisher: Amsterdam ; Boston : Elsevier/Academic Press, 2013
      edition: 1st ed.
    identifier: (DLC) 2012540007
    identifier: (OCoLC)802322419
  identifier: 9780123919427
  identifier: 0123919428
  identifier: 9780123919434
  identifier: 0123919436
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: OPELS
    record creation date: 121128
    record change date: 20260609152710.8
    record identifier: in00003825848
    language of cataloging:
      language term: eng