Table of contents Executive summary Market overview Trends in Global services outsourcing market for medical devices Opportunities Global services outsourcing market for medical devices, by Applications Opportunities Global services outsourcing market for medical devices Geographic Analysis of Global services outsourcing market for medical devices competitive landscape of Global services outsourcing market for medical devices 1 Introduction 1.1. KEY TAKE-AWAYS 1.2. Report description 1.3. STAKEHOLDERS 1.4. Research Methodology 2 Summary 3 Market overview 3.1. Market overview 3.2. Industry Lifecycle 3.3. Defining Service Outsourcing Market FOR Medical DeviceS 4 Market Dynamics 4.1. Outsourcing market dynamics 4.1.1. Drivers 4.1.1.1. Growing demand for quality healthcare 4.1.1.2. Increasing competition in medical device manufacturing is driving the demand for outsourcing services 4.1.1.3. Leveraging external expertise 4.1.1.4. Reduced time-to-market 4.1.1.5. Increased product recalls 4.2. Opportunities 4.2.1. Government support to secure IP property rights 4.2.2. Asian service providers obtaining certification 5 Applications market 5.1. market Overview 5.1.1. Drivers 5.1.1.1. Reducing new product roll out time 5.1.1.2. Increasing demand to lower healthcare costs 5.1.1.3. Advancements in healthcare technologies 5.1.1.4. Threat from low-cost device manufacturers 5.1.1.5. Differences in regulations across the globe 5.1.2. Restraints 5.1.2.1. Multiple outsourcing partners 5.1.2.2. Data security issues 5.1.2.3. Lack of certified outsourcing partners 5.1.3. Opportunities 5.1.3.1. Growing Asian medical device markets offers opportunities for region specific outsourcing 5.1.3.2. Increasing trend towards outsourcing of IT services 5.2. Class III medical devices 5.2.1. Drivers 5.2.1.1. Life-critical devices offering greater scope for inclusion of IT based solutions 5.3. Class II medical devices 5.3.1. Drivers 5.3.1.1. Stringent government regulations 5.3.1.2. Growing complexity in design 5.4. Class I medical DEVICEs 5.4.1. Drivers & Restraints 5.5. Comparative Analysis of Service Outsourcing submarkets for medical devices 5.6. Cardiovascular devices 5.7. Orthopedic devices 5.8. Radiology devices 5.9. ANESTHESIOLOGY DEVICES 5.10. Neurology 6 Services Market 6.1. Market overview 6.1.1. Market trend: Emergence of end-to-end solution providers 6.2. Product design and development services 6.2.1. Drivers & Opportunities 6.2.1.1. Reduction in costs & time-to-market 6.2.1.2. Huge earning opportunities through IP rights 6.2.1.3. Entry of new players in medical device industry 6.3. Regulatory Consulting Services 6.3.1. Computer system validation services 6.3.1.1. 510(K) 6.3.1.2. PMA (Premarket approvals) 6.3.1.3. CE Mark 6.3.2. Drivers 6.3.2.1. Reduces time to obtain approvals 6.3.2.2. Facilitates entry into new geographies 6.4. Product Testing Services 6.4.1. Reduces chances of product recalls 6.5. Product Implementation services 6.6. Product upgrade services 6.7. Product Maintenance services 7 Competitive landscape 7.1. Overview 8 Geographic Analysis 8.1. Overview 8.2. North America 8.2.1. market trends 8.2.1.1. Intense competition and need for cost containment 8.2.1.2. Highly regulated market 8.3. Europe 8.4. Asia Pacific 8.4.1. market trends 8.4.1.1. Setting up of SEZs 8.4.1.2. Initiatives towards IPR protection 9 Essential Certifications for Outsourcing 9.1. Overview 9.1.1. ISO 13485:2003 9.1.2. ISO 9001:2000 9.1.3. ISO 14971 9.1.4. FDA 21 CFR PART 820: 10 company profiles 10.1. Accellent 10.2. Avail Medical Product Inc. 10.3. Benchmark Electronics, Inc. 10.4. Claricode 10.5. Code Refinery 10.6. Epic System 10.7. Etq 10.8. Infosys 10.9. HCL 10.10. Intertech Engineering Associates Inc. 10.11. Lake Region Medical Ltd. 10.12. Lynuxworks 10.13. MDCI 10.14. MedTech Development 10.15. Medtech Group 10.16. Oracle 10.17. Patni Computer Systems Ltd. 10.18. Persistent Systems 10.19. Pilgrim Software Inc. 10.20. PTC 10.21. RTEmd 10.22. Sterling Tech Software 10.23. Toltec International 10.24. Wipro Appendix 1 Ophthalmic Medical Devices 2 ORTHOPEDIC Medical Devices 3 Neurology Medical Devices 4 Radiology Devices 5 Gastroenterology – Urology Medical Devices 6 Hematology Medical devices list 7 Dental Medical Devices List of TableS Summary Table global services outsourcing market for medical devices 2007-2014 ($Millions) Table 1 Major players in medical devices market and their product portfolio Table 2 Global Services outsourcing market for medical devices, By Applications 2007-2014 ($Millions) Table 3 Global Services outsourcing market for medical devices,By Geography 2007-2014 ($Millions) Table 4 Global services outsourcing market for Class III medical devices, by Geography 2007-2014 ($Millions) Table 5 Global services outsourcing market for Class II medical devices, by geography 2007-2014 ($Millions) Table 6 Global services outsourcing market for Class I medical devices, by geography 2007-2014 ($Millions) Table 7 medical device Services outsourcing market, By application 2007-2014 ($MILLIONS) Table 8 Global presence of key cardiovascular device manufacturers Table 9 Segmentation of global orthopedic devices market Table 10 Global presence of key ORTHOPEDIC device manufacturers Table 11 Segmentation of global medical radiology devices market Table 12 Outsourcing Services provided by various companies Table 13 Global service outsourcing market IN medical devices,2007-2014 ($Millions) Table 14 Global services outsourcing market for medical devices, By Geography 2007-2014 ($Millions) Table 15 Global services outsourcing market for medical device design and development, by geography 2007 2014 ($Millions) Table 16 Global regulatory consulting services market for medical devices, by geography 2007-2014 ($Millions) Table 17 Global services outsourcing market for medical device testing, by geography 2007-2014 ($Millions) Table 18 Global services outsourcing market for medical device implementation, by geography 2007-2014 ($millions) Table 19 Global services outsourcing market for medical device UPGRADEs, by geography 2007-2014 ($millions) Table 20 Global services outsourcing market for medical device maintenance, by geography 2007-2014 ($Millions) Table 21 Alliances, acquisitions and partnerships in the services outsourcing market for medical DEVICES (2007 – 2009) Table 22 New developments in the service outsourcing market for medical devices (2007-2009) Table 23 North American services outsourcing market for medical devices 2007-2014 ($millions) Table 24 European services outsourcing market for medical devices 2007 – 2014 ($millions) Table 25 Asian services outsourcing Market for medical devices 2007-2014 ($Millions) List of FIGURES Figure 1 Market Participants in OUTSOURCed Medical Device manufacturing industry Figure 2 Product lifecycle of medical devices Figure 3 Industry Lifecycle of Service Outsourcing for medical devices FIGURE 4 CHALLENGE – BENEFIT ANALYSIS FOR MEDICAL DEVICE MANUFACTURING Figure 5 Global Service Outsourcing market for medical devices,by applications (2009) Figure 6 Global Service Outsourcing Market for medical devices,By Geography (2009) Figure 7 Factors impacting outsourcing in medical devices Figure 8 Impact of Time-to-market on revenues Figure 9 FDA classification of Medical devices Figure 10 Global market share of top 10 medical device MANUFACTURERS Figure 11 Medical device approval process Figure 12 Comparative analysis of service outsourcing markets for medical devices Figure 13 Global market shares of key orthopedic device manufacturers* Figure 14 Global market shares of key medical radiology device manufacturers Figure 15 outsourced services & benefits to manufacturers Figure 16 Structure of strategic AlLiances in the industry Figure 17 Global services outsourcing market for medical devices Figure 18 North American service outsourcing Market for medical devices Figure 19 European service outsourcing market for medical devices Figure 20 European medical device market Figure 21 Asian service outsourcing Market for medical devices Figure 22 Asia Medical device market split Figure 23 Requirements for ISO 13485 Figure 24 Requirements for ISO 9001:2000 Figure 25 Risk Management Process