LEADER 05299nam 2200649Ia 450 001 9910462130303321 005 20200520144314.0 010 $a1-283-75437-1 010 $a0-12-391943-6 035 $a(CKB)2670000000274591 035 $a(EBL)1073017 035 $a(OCoLC)819634764 035 $a(SSID)ssj0000796285 035 $a(PQKBManifestationID)12314633 035 $a(PQKBTitleCode)TC0000796285 035 $a(PQKBWorkID)10787876 035 $a(PQKB)10180644 035 $a(MiAaPQ)EBC1073017 035 $a(Au-PeEL)EBL1073017 035 $a(CaPaEBR)ebr10623058 035 $a(CaONFJC)MIL406687 035 $a(EXLCZ)992670000000274591 100 $a20121128d2013 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aMedical device design$b[electronic resource] $einnovation from concept to market /$fPeter J. Ogrodnik 205 $a1st ed. 210 $aBoston $cAcademic Press$d2013 215 $a1 online resource (369 p.) 300 $aDescription based upon print version of record. 311 $a0-12-391942-8 320 $aIncludes bibliographical references and index. 327 $aFront 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 327 $a3.2.1 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 327 $a4.5.2 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 327 $a5.3.1.2 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 327 $a5.4.8 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 327 $a7.2 Optimization 330 $aThis book provides the bridge between engineering design and medical device 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 thei 606 $aBiomedical engineering 606 $aEngineering design 608 $aElectronic books. 615 0$aBiomedical engineering. 615 0$aEngineering design. 676 $a610.28 676 $a610.284 700 $aOgrodnik$b Peter J$0865159 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910462130303321 996 $aMedical device design$91931080 997 $aUNINA