Outsourcing Opportunities in the Medical Device

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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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

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