1 Table of contents
1 Table of contents 2
1.1 List of Tables 5
1.2 List of Figures 5
2 Introduction 6
2.1 Research Guidance 6
3 Global Medical Equipment Outsourcing 7
3.1 Overview 7
3.2 Global Medical Equipment Outsourcing Market Service Models 8
3.2.1 Fully Integrated Service Model 8
3.2.2 Functional Service Model 9
3.3 Global Medical Equipment Outsourcing Market Characterization 9
3.4 Global Medical Equipment Outsourcing Market Dynamics 11
3.4.1 Global Medical Equipment Outsourcing Market Drivers 11
3.4.2 Global Medical Equipment Outsourcing: Market Restraints 14
4 Global Medical Equipment Market 15
4.1 Global Medical Equipment Market Characterization 15
4.1.1 Growth in the Global Medical Equipment Market to Drive the Growth of Outsourcing Industry 15
4.1.2 Global Medical Equipment Market Dynamics 16
4.1.3 North America and European Medical Equipment Manufacturers are Expected to be Major Contributors for the Outsourcing Market 19
4.1.4 Top 10 Medical Companies Contributed 25% towards Global Medical Equipment Market 20
5 Contract Research Outsourcing (CROs) 21
5.1 Overview 21
5.2 Contract Research Organization (CRO) Market Characterization 21
5.2.1 Contract Research Organization (CRO), Revenue, 2009-2016 21
5.3 CRO Market Dynamics 22
5.3.1 CRO Market Drivers 22
5.3.2 CRO Market Restraints 22
5.4 Contract Research Outsourcing Services Process 22
5.4.1 Design and Prototype 23
5.4.2 Device Validation and Verification 23
5.4.3 Pre-Clinical Development 23
5.4.4 Clinical trials 24
5.4.5 Review and Approval from the Regulatory Agencies 24
5.4.6 Post-marketing Studies 24
5.5 Criteria for Selecting a Contract Research Organization (CRO) 25
6 Contract Manufacturing Outsourcing (CMOs) 26
6.1 Overview 26
6.2 Contract Manufacturing Outsourcing (CMO) Market Characterization 26
6.2.1 Contract Manufacturing Outsourcing (CMO), Revenue, 2009-2016 26
6.2.2 Strategic Advantages of CMO for Medical Equipment Companies 26
6.3 CMO Market Dynamics 27
6.3.1 CMO Market Trends 27
6.3.2 CMO Market Drivers 27
6.3.3 Global CMO Restrains 27
6.4 Capabilities of Contract Manufacturing Organizations (CMO) 28
6.4.1 Device Design and Engineering 28
6.4.2 Precision Component Manufacturing 29
6.4.3 Device Assembly & Testing 29
6.4.4 Electronic Manufacturing Services (EMS) 30
6.4.5 Supply Chain Management 30
6.5 CMO Manufacturing 30
6.5.1 Criteria for Selecting a Contract Manufacturing Organization (CMO) 31
6.5.2 Key Steps Involved in Executing Projects 31
7 Medical Equipment Outsourcing: Key Companies 34
7.1 Accellent 34
7.1.1 Company Overview 34
7.1.2 Customer Base 34
7.1.3 Financial 34
7.1.4 Partnership 35
7.1.5 Deals 35
7.2 Alquest, Inc. 36
7.2.1 Company Overview 36
7.3 Avail Medical Products, Inc. 36
7.3.1 Company Overview 36
7.4 Creganna Medical Devices Limited 36
7.4.1 Company Overview 36
7.4.2 Manufacturing Facilities 37
7.4.3 Deals 37
7.5 Doncasters Medical Technologies 38
7.5.1 Company Overview 38
7.6 Flextronics International 38
7.6.1 Company Overview 38
7.6.2 Deals 38
7.7 Fort Wayne Metals 39
7.7.1 Company Overview 39
7.8 Greatbatch, Inc., 39
7.8.1 Company Overview 39
7.8.2 Geographic Locations 39
7.8.3 Financials 39
7.8.4 Product Offerings 39
7.8.5 Deals 40
7.9 Memry Corporation Company 40
7.9.1 Company Overview 40
7.10 NAMSA 41
7.10.1 Company Overview 41
7.11 Parexel International Corporation (Parexel) 41
7.12 Quintiles 41
7.12.1 Company Overview 41
7.12.2 Deals 42
7.13 Symmetry Medical Inc 42
7.13.1 Company Overview 42
7.13.2 Geographic Locations 42
7.13.3 Customer Base 42
7.13.4 Financials 42
7.13.5 Deals 43
7.14 TriVirix International Inc. 43
7.14.1 Company Overview 43
7.14.2 Deals 44
7.15 The Tech Group 44
7.15.1 Company Overview 44
7.16 Lake Region Manufacturing, Inc. 45
7.16.1 Company Overview 45
7.16.2 Deals 45
8 Medical Equipment Outsourcing Market: Regulatory Framework 46
8.1 Role of Asian Markets in the Global Medical Equipment Outsourcing Market 46
8.1.1 Manufacturing 46
8.1.2 Research and Development (R&D) 46
8.1.3 Clinical Trials 46
8.2 India 46
8.2.1 Overview 46
8.2.2 Factors Driving the Indian Outsourcing Market 48
8.2.3 Regulations 48
8.3 China 52
8.3.1 Overview 52
8.3.2 Factors Driving the China Outsourcing Market 52
8.3.3 Regulations 52
8.4 Malaysia 56
8.4.1 Overview 56
8.4.2 Factors Driving the Malaysian Outsourcing Market 57
8.4.3 Regulations 57
8.4.4 Initiatives 57
8.5 Singapore 57
8.5.1 Overview 57
8.5.2 Factors Driving the Singapore Outsourcing Market 58
8.5.3 Regulations 58
8.6 Latin America 59
8.6.1 Overview 59
8.6.2 Factors Driving the Outsourcing Market in Latin America 59
8.7 Costa Rica 60
8.8 US 61
8.8.1 Factors Driving the Outsourcing Market in the US Market 62
8.9 Central and Eastern Europe 62
8.9.1 Factors Driving the Outsourcing Market in the Central and East European Outsourcing Market 62
8.10 Medical Equipment Regulations in the Developed Nations 62
8.10.1 US 63
8.10.2 Japan 65
8.10.3 European Union 66
8.11 Essential Certifications for Outsourcing 68
8.11.1 ISO 13485 69
8.11.2 ISO 9001:2000 69
8.11.3 ISO 14971 69
8.11.4 FDA Title 21 CFR Parts 800-1200 69
8.11.5 510(k) vs. PMA 69
9 Global Medical Equipment Outsourcing: Mergers and Acquisitions 71
9.1.1 Vesta Acquires ExtruMed From Inverness Graham And Wedbush Capital in March 2009 71
9.1.2 Saw Mill Capital Acquires Filtrona Extrusion From Filtrona in March 2009 72
9.1.3 PolyMedex Discovery Group Acquires Putnam Plastics in February 2009 72
9.1.4 Arkema Acquires Oxford Performance Materials in February 2009 72
9.1.5 Innovative Medical Device Solutions (IMDS) Acquires Cencast in January 2009 72
9.1.6 Moog Acquires Ethox International in January 2009 72
9.1.7 The Riverside Company Acquires Coeur From Hammond, Kennedy, Whitney in October 2008 73
9.1.8 ExtruMed Acquires Innovative Extrusions in September 2008 73
9.1.9 Charlesbank Capital Partners Acquires Tecomet From Cardinal Health in September 2008 73
9.1.10 Nypro Acquires Additional 30% Stake In Nypro Precision Assemblies in August 2008 73
9.1.11 Theragenics Acquires NeedleTech Products in July 2008 73
9.1.12 SAES Getters Acquires Memry, An Orthopedic Vendor 74
9.1.13 Sandvik Materials Technology Acquires Eurocut in May 2008 74
9.1.14 Royal DSM Acquires The Polymer Technology Group in May 2008 74
9.1.15 Parker Hannifin Acquires Hi-Tech Group in April 2008 74
10 Appendix 75
10.1 Definitions 75
10.1.1 Outsourcing 75
10.1.2 Contract Research Organizations (CRO) 75
10.1.3 Contract Manufacturing Organizations (CMO) 75
10.2 Acronyms 75
10.3 Research Methodology 77
10.3.1 Secondary Research 78
10.3.2 Primary Research 78
10.3.3 Models 78
10.3.4 Forecasts 79
10.3.5 Expert Panels 79
10.4 Consulting 79
10.5 Contact Us 79
10.6 Disclaimer 791.1 List of Tables
Table 1: Medical Equipment Outsourcing, Global, Revenues ($ billion), 2009 – 2016 9
Table 2: Medical Equipment Outsourcing, as % of Total Medical Equipment Market, 2009 – 2016 10
Table 3: Medical Equipment Companies, R&D Expenditure, ($m), 2006-2008 12
Table 4: Medical Equipment, Global, Revenues ($ Billions), 2009 – 2016 15
Table 5: Healthcare Expenditure as Percentage of GDP, Top 12 Countries, 2008 17
Table 6: Medical Equipment, Global, Revenues by Geographic (%), 2008 19
Table 7: Medical Equipment, Global, Company Share, %, 2008 20
Table 8: Contract Research Organization (CRO), Global, Revenues ($ Billions), 2009 – 2016 22
Table 9: Contract Manufacturing Outsourcing (CMO), Global, Revenues ($ Billions), 2009 – 2016 26
Table 10: Materials Mix, Medical Equipment 28
Table 11: CMO, Global, Design and Engineering, Capability 29
Table 12: CMO, Global, Device Assembly, Capability 29
Table 13: CMO, Global, Supply Chain Management, Capability 30
Table 14: Accellent, Inc., Deals Summary 35
Table 15: Creganna Medical Devices Limited, Inc., Deals Summary 37
Table 16: Greatbatch, Inc, Deal Summary 40
Table 17: Symmetry Medical Inc., Deals Summary 43
Table 18: TriVirix International, Inc., Deals Summary 44
Table 19: Approval Times for Clinical Trials, India 47
Table 20: Cost Comparison, Clinical Trials , India 47
Table 21: Proposed Medical Equipment Classification in India, 2005 50
Table 22: Malaysian, Medical Equipment, Companies 56
Table 23: Medical Equipment, Supplier Base, Costa Rica 61
Table 24: Medical Device Classification, United States, 2008 63
Table 25: FDA PMA User Fees, 2007 65
Table 26: Device Classification in Japan 65
Table 27: Estimated Approval Costs, PMDA 66
Table 28: Device Classification in the European Union, 2008 67
Table 29: Comparative Overview of the Three Systems 68
Table 30: Global Medical Equipment Outsourcing, Key M&A Deals, 2008 – 2009 711.2 List of Figures
Figure 1: Global, Medical Device Outsourcing, Industry Structure 7
Figure 2: Contract Organizations, Fully Integrated Service Model 8
Figure 3: Medical Equipment Outsourcing, Global, Revenues ($ billion), 2009 – 2016 9
Figure 4: Medical Equipment Outsourcing, as percentage of Total Medical Equipment Market,
2009 – 2016 10
Figure 5: Medical Equipment Outsourcing, Global, Market Drivers & Restraints Analysis 11
Figure 6: Strategic Advantages of Outsourcing 11
Figure 7: Medical Equipment, Global, Revenues ($ Billions), 2009 – 2016 15
Figure 8: Medical Equipment, Global, Market Drivers & Restraints Analysis 16
Figure 9: Healthcare Expenditure as Percentage of Gross Domestic Product (GDP), Top 12 Countries, 2008 17
Figure 10: Medical Equipment, Global, Revenues by Geographic, %, 2008 19
Figure 11: Medical Equipment , Global, Company Share, %, 2008 20
Figure 12: Contract Research Outsourcing Market, Global, Basic Services Provided 21
Figure 13: Contract Research Organization (CRO), Global, Revenues ($ Billions), 2009 – 2016 21
Figure 14: Clinical Research Process 23
Figure 15: Contract Manufacturing Outsourcing (CMO), Global, Revenues ($ Billions), 2009 – 2016 26
Figure 16: Singapore, Medical Equipment License Application Process 59
Figure 17: Medical Equipment Approval Process in the US, 2008 64
Figure 18: Medical Equipment Approval Timeline, US, EU and Japan 67
Figure 19: Average Time for Total Review of a 510k and PMA Application, 2001 – 2006 70
Figure 20: Methodology 77
