SPI Infoamtion

Table of contents
1.1 List of Tables
1.2 List of Figures

2 Introduction
2.1 GlobalData Research Guidance

3 Global Medical Equipment Outsourcing
3.1 Overview
3.2 Global Medical Equipment Outsourcing Market Service Models
3.2.1 Fully Integrated Service Model
3.2.2 Functional Service Model
3.3 Global Medical Equipment Outsourcing Market Characterization
3.4 Global Medical Equipment Outsourcing Market Dynamics
3.4.1 Global Medical Equipment Outsourcing Market Drivers
3.4.2 Global Medical Equipment Outsourcing: Market Restraints

4 Global Medical Equipment Market
4.1 Global Medical Equipment Market Characterization
4.1.1 Growth in the Global Medical Equipment Market to Drive the Growth of Outsourcing Industry
4.1.2 Global Medical Equipment Market Dynamics
4.1.3 North America and European Medical Equipment Manufacturers are Expected to be Major Contributors for the Outsourcing Market
4.1.4 Top 10 Medical Companies Contributed 25% towards Global Medical Equipment Market

5 Contract Research Outsourcing (CROs)
5.1 Overview
5.2 Contract Research Organization (CRO) Market Characterization
5.2.1 Contract Research Organization (CRO), Revenue, 2009-2016
5.3 CRO Market Dynamics
5.3.1 CRO Market Drivers
5.3.2 CRO Market Restraints
5.4 Contract Research Outsourcing Services Process
5.4.1 Design and Prototype
5.4.2 Device Validation and Verification
5.4.3 Pre-Clinical Development
5.4.4 Clinical trials
5.4.5 Review and Approval from the Regulatory Agencies
5.4.6 Post-marketing Studies
5.5 Criteria for Selecting a Contract Research Organization (CRO)

6 Contract Manufacturing Outsourcing (CMOs)
6.1 Overview
6.2 Contract Manufacturing Outsourcing (CMO) Market Characterization
6.2.1 Contract Manufacturing Outsourcing (CMO), Revenue, 2009-2016
6.2.2 Strategic Advantages of CMO for Medical Equipment Companies
6.3 CMO Market Dynamics
6.3.1 CMO Market Trends
6.3.2 CMO Market Drivers
6.3.3 Global CMO Restrains
6.4 Capabilities of Contract Manufacturing Organizations (CMO)
6.4.1 Device Design and Engineering
6.4.2 Precision Component Manufacturing
6.4.3 Device Assembly & Testing
6.4.4 Electronic Manufacturing Services (EMS)
6.4.5 Supply Chain Management
6.5 CMO Manufacturing
6.5.1 Criteria for Selecting a Contract Manufacturing Organization (CMO)
6.5.2 Key Steps Involved in Executing Projects

7 Medical Equipment Outsourcing: Key Companies
7.1 Accellent
7.1.1 Company Overview
7.1.2 Customer Base
7.1.3 Financial
7.1.4 Partnership
7.1.5 Deals
7.2 Alquest, Inc.
7.2.1 Company Overview
7.3 Avail Medical Products, Inc.
7.3.1 Company Overview
7.4 Creganna Medical Devices Limited
7.4.1 Company Overview
7.4.2 Manufacturing Facilities
7.4.3 Deals
7.5 Doncasters Medical Technologies
7.5.1 Company Overview
7.6 Flextronics International
7.6.1 Company Overview
7.6.2 Deals
7.7 Fort Wayne Metals
7.7.1 Company Overview
7.8 Greatbatch, Inc.,
7.8.1 Company Overview
7.8.2 Geographic Locations
7.8.3 Financials
7.8.4 Product Offerings
7.8.5 Deals
7.9 Memry Corporation Company
7.9.1 Company Overview
7.10 NAMSA
7.10.1 Company Overview
7.11 Parexel International Corporation (Parexel)
7.12 Quintiles
7.12.1 Company Overview
7.12.2 Deals
7.13 Symmetry Medical Inc
7.13.1 Company Overview
7.13.2 Geographic Locations
7.13.3 Customer Base
7.13.4 Financials
7.13.5 Deals
7.14 TriVirix International Inc.
7.14.1 Company Overview
7.14.2 Deals
7.15 The Tech Group
7.15.1 Company Overview
7.16 Lake Region Manufacturing, Inc.
7.16.1 Company Overview
7.16.2 Deals

8 Medical Equipment Outsourcing Market: Regulatory Framework
8.1 Role of Asian Markets in the Global Medical Equipment Outsourcing Market
8.1.1 Manufacturing
8.1.2 Research and Development (R&D)
8.1.3 Clinical Trials
8.2 India
8.2.1 Overview
8.2.2 Factors Driving the Indian Outsourcing Market
8.2.3 Regulations
8.3 China
8.3.1 Overview
8.3.2 Factors Driving the China Outsourcing Market
8.3.3 Regulations
8.4 Malaysia
8.4.1 Overview
8.4.2 Factors Driving the Malaysian Outsourcing Market
8.4.3 Regulations
8.4.4 Initiatives
8.5 Singapore
8.5.1 Overview
8.5.2 Factors Driving the Singapore Outsourcing Market
8.5.3 Regulations
8.6 Latin America
8.6.1 Overview
8.6.2 Factors Driving the Outsourcing Market in Latin America
8.7 Costa Rica
8.8 US
8.8.1 Factors Driving the Outsourcing Market in the US Market
8.9 Central and Eastern Europe
8.9.1 Factors Driving the Outsourcing Market in the Central and East European Outsourcing Market
8.10 Medical Equipment Regulations in the Developed Nations
8.10.1 US
8.10.2 Japan
8.10.3 European Union
8.11 Essential Certifications for Outsourcing
8.11.1 ISO 13485
8.11.2 ISO 9001:2000
8.11.3 ISO 14971
8.11.4 FDA Title 21 CFR Parts 800-1200
8.11.5 510(k) vs. PMA

9 Global Medical Equipment Outsourcing: Mergers and Acquisitions
9.1.1 Vesta Acquires ExtruMed From Inverness Graham And Wedbush Capital in March 2009
9.1.2 Saw Mill Capital Acquires Filtrona Extrusion From Filtrona in March 2009
9.1.3 PolyMedex Discovery Group Acquires Putnam Plastics in February 2009
9.1.4 Arkema Acquires Oxford Performance Materials in February 2009
9.1.5 Innovative Medical Device Solutions (IMDS) Acquires Cencast in January 2009
9.1.6 Moog Acquires Ethox International in January 2009
9.1.7 The Riverside Company Acquires Coeur From Hammond, Kennedy, Whitney in October 2008
9.1.8 ExtruMed Acquires Innovative Extrusions in September 2008
9.1.9 Charlesbank Capital Partners Acquires Tecomet From Cardinal Health in September 2008
9.1.10 Nypro Acquires Additional 30% Stake In Nypro Precision Assemblies in August 2008
9.1.11 Theragenics Acquires NeedleTech Products in July 2008
9.1.12 SAES Getters Acquires Memry, An Orthopedic Vendor
9.1.13 Sandvik Materials Technology Acquires Eurocut in May 2008
9.1.14 Royal DSM Acquires The Polymer Technology Group in May 2008
9.1.15 Parker Hannifin Acquires Hi-Tech Group in April 2008

10 Appendix
10.1 Definitions
10.1.1 Outsourcing
10.1.2 Contract Research Organizations (CRO)
10.1.3 Contract Manufacturing Organizations (CMO)
10.2 Acronyms
10.3 Research Methodology
10.3.1 Secondary Research
10.3.2 Primary Research
10.3.3 Models
10.3.4 Forecasts
10.3.5 Expert Panels
10.4 GlobalData Consulting
10.5 Contact Us
10.6 Disclaimer

List of Figures
Figure 1: Global, Medical Device Outsourcing, Industry Structure
Figure 2: Contract Organizations, Fully Integrated Service Model
Figure 3: Medical Equipment Outsourcing, Global, Revenues ($ billion), 2009 - 2016
Figure 4: Medical Equipment Outsourcing, as percentage of Total Medical Equipment Market, 2009 - 2016
Figure 5: Medical Equipment Outsourcing, Global, Market Drivers & Restraints Analysis
Figure 6: Strategic Advantages of Outsourcing
Figure 7: Medical Equipment, Global, Revenues ($ Billions), 2009 - 2016
Figure 8: Medical Equipment, Global, Market Drivers & Restraints Analysis
Figure 9: Healthcare Expenditure as Percentage of Gross Domestic Product (GDP), Top 12 Countries, 2008
Figure 10: Medical Equipment, Global, Revenues by Geographic, %, 2008
Figure 11: Medical Equipment , Global, Company Share, %, 2008
Figure 12: Contract Research Outsourcing Market, Global, Basic Services Provided
Figure 13: Contract Research Organization (CRO), Global, Revenues ($ Billions), 2009 - 2016
Figure 14: Clinical Research Process
Figure 15: Contract Manufacturing Outsourcing (CMO), Global, Revenues ($ Billions), 2009 - 2016
Figure 16: Singapore, Medical Equipment License Application Process
Figure 17: Medical Equipment Approval Process in the US, 2008
Figure 18: Medical Equipment Approval Timeline, US, EU and Japan
Figure 19: Average Time for Total Review of a 510k and PMA Application, 2001 - 2006
Figure 20: GlobalData Methodology

List of Tables
Table 1: Medical Equipment Outsourcing, Global, Revenues ($ billion), 2009 - 2016
Table 2: Medical Equipment Outsourcing, as % of Total Medical Equipment Market, 2009 - 2016
Table 3: Medical Equipment Companies, R&D Expenditure, ($m), 2006-2008
Table 4: Medical Equipment, Global, Revenues ($ Billions), 2009 - 2016
Table 5: Healthcare Expenditure as Percentage of GDP, Top 12 Countries, 2008
Table 6: Medical Equipment, Global, Revenues by Geographic (%), 2008
Table 7: Medical Equipment, Global, Company Share, %, 2008
Table 8: Contract Research Organization (CRO), Global, Revenues ($ Billions), 2009 - 2016
Table 9: Contract Manufacturing Outsourcing (CMO), Global, Revenues ($ Billions), 2009 - 2016
Table 10: Materials Mix, Medical Equipment
Table 11: CMO, Global, Design and Engineering, Capability
Table 12: CMO, Global, Device Assembly, Capability
Table 13: CMO, Global, Supply Chain Management, Capability
Table 14: Accellent, Inc., Deals Summary
Table 15: Creganna Medical Devices Limited, Inc., Deals Summary
Table 16: Greatbatch, Inc, Deal Summary
Table 17: Symmetry Medical Inc., Deals Summary
Table 18: TriVirix International, Inc., Deals Summary
Table 19: Approval Times for Clinical Trials, India
Table 20: Cost Comparison, Clinical Trials , India
Table 21: Proposed Medical Equipment Classification in India, 2005
Table 22: Malaysian, Medical Equipment, Companies
Table 23: Medical Equipment, Supplier Base, Costa Rica
Table 24: Medical Device Classification, United States, 2008
Table 25: FDA PMA User Fees, 2007
Table 26: Device Classification in Japan
Table 27: Estimated Approval Costs, PMDA
Table 28: Device Classification in the European Union, 2008
Table 29: Comparative Overview of the Three Systems
Table 30: Global Medical Equipment Outsourcing, Key M&A Deals, 2008 - 2009