Outsourcing Opportunities in the Medical Device (2009 - 2014)
Medical devices form one of the largest industries in healthcare sector with an estimated size of $250 billion in 2009 and a growth rate of 6%-8%. The industry has been outsourcing medical device manufacturing services for almost a decade now. This trend has brought about huge profit margins, which has attracted many new players. Outsourcing has helped medical device manufacturers reduce product development cost by 10% to 30%. The services outsourcing industry has also gained from the entry of new medical device manufacturing companies, as these players lack experience in the field.
Orthopedic devices hold the largest market share and cardiology devices have the highest growth rate in the medical device manufacturing industry. The increasing regulations for class 2 and class 3 devices have increased the demand for regulatory consulting services. Growing complexities in supply chain and the need for efficient management of client accounts have increased the scope of product lifecycle management solution providers in the medical devices industry. Firms offering chip designing services have also benefitted from the increasing incidence of chronic diseases and the growing use of electronic and embedded systems in cardiovascular and neurology devices.
The report analyzes the outsourcing opportunities in cardiovascular, ophthalmic, oncology, dental, and neurology devices, along with a study of various tools used for developing, testing and simulation tools used for medical devices. The report categorizes the service outsourcing in medical device market as follows:
Services Market: Product design and development services, product testing and certification services, product implementation services, product maintenance services, product upgrade services and Regulatory consulting services for medical devices.
Applications Market: Class I Devices, Class II Devices and Class III Devices.
STAKEHOLDERS
The intended audience includes:
Service outsourcing companies
Medical devices manufacturers
Consulting companies
Financial institutions
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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
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 ($Millions)
Table 3 Global Services outsourcing market for medical devices,By Geography2007-2014 ($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 geography2007-2014 ($Millions)
Table 7 medical device Services outsourcing market, By application 2007-2014 ($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 ($Millions)
Table 16 Global regulatory consulting services market for medical devices, by geography2007-2014 ($Millions)
Table 17 Global services outsourcing market for medical device testing, by geography 2007-2014 ($Millions)
Table 18 Global services outsourcing market for medical device implementation, by geography2007-2014 ($millions)
Table 19 Global services outsourcing market for medical device UPGRADEs, by geography2007-2014 ($millions)
Table 20 Global services outsourcing market for medical device maintenance, by geography2007-2014 ($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 devices2007-2014 ($millions)
Table 24 European services outsourcing marketfor medical devices 2007 – 2014 ($millions)
Table 25 Asian services outsourcing Market for medical devices 2007-2014 ($Millions)
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
