Global Services Outsourcing Opportunities in Medical Devices
The medical device industry is one of the largest healthcare segments, generating an estimated $250 billion in 2009. The industry has been outsourcing medical device manufacturing services for about a decade. Outsourcing has helped medical device manufacturers to cut product development costs by 10% to 30%. The huge profit margins of the industry have attracted many new players, increasing the industry’s competitiveness. The entry of new medical devices manufacturers has also increased the demand for outsourcing services, as these players lack experience in the field. Firms have also begun offering chip designing services, following the increasing incidence of chronic diseases and of the growing use of electronics and embedded systems in medical devices.
The medical device service outsourcing market is categorized into the applications and services submarkets. The services market covers designing, prototyping, validation and verification and regulatory consulting; while the applications market covers Class I, II, and III medical devices as per FDA norms. The report also analyzes outsourcing opportunities in cardiovascular, ophthalmic, oncology, dental and neurology devices. It also studies the markets for various testing and simulation tools used for medical devices. Orthopedic devices hold the largest market share in medical device manufacturing industry and cardiology market is expected to be the fastest growing market.
Scope of the report
The report categorizes the service outsourcing in medical device market as follows:
- Applications Market: Class I devices, Class II devices, and Class III devices.
- Services Market: Product design and development, testing and certification, implementation and maintenance, upgrade and regulatory consulting for medical devices.
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Table of contents
Trends in Global services outsourcing market for medical devices
Global services outsourcing market for medical devices, by Applications
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
1.1. KEY TAKE-AWAYS
1.2. Report description
1.4. Research Methodology
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
188.8.131.52. Growing demand for quality healthcare
184.108.40.206. Increasing competition in medical device manufacturing is driving the demand for outsourcing services
220.127.116.11. Leveraging external expertise
18.104.22.168. Reduced time-to-market
22.214.171.124. Increased product recalls
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
126.96.36.199. Reducing new product roll out time
188.8.131.52. Increasing demand to lower healthcare costs
184.108.40.206. Advancements in healthcare technologies
220.127.116.11. Threat from low-cost device manufacturers
18.104.22.168. Differences in regulations across the globe
22.214.171.124. Multiple outsourcing partners
126.96.36.199. Data security issues
188.8.131.52. Lack of certified outsourcing partners
184.108.40.206. Growing Asian medical device markets offers opportunities for region specific outsourcing
220.127.116.11. Increasing trend towards outsourcing of IT services
5.2. Class III medical devices
18.104.22.168. Life-critical devices offering greater scope for inclusion of IT based solutions
5.3. Class II medical devices
22.214.171.124. Stringent government regulations
126.96.36.199. 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
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
188.8.131.52. Reduction in costs & time-to-market
184.108.40.206. Huge earning opportunities through IP rights
220.127.116.11. Entry of new players in medical device industry
6.3. Regulatory Consulting Services
6.3.1. Computer system validation services
18.104.22.168. PMA (Premarket approvals)
22.214.171.124. CE Mark
126.96.36.199. Reduces time to obtain approvals
188.8.131.52. 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
8 Geographic Analysis
8.2. North America
8.2.1. market trends
184.108.40.206. Intense competition and need for cost containment
220.127.116.11. Highly regulated market
8.4. Asia Pacific
8.4.1. market trends
18.104.22.168. Setting up of SEZs
22.214.171.124. Initiatives towards IPR protection
9 Essential Certifications for Outsourcing
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
10.2. Avail Medical Product Inc.
10.3. Benchmark Electronics, Inc.
10.5. Code Refinery
10.6. Epic System
10.10. Intertech Engineering Associates Inc.
10.11. Lake Region Medical Ltd.
10.14. MedTech Development
10.15. Medtech Group
10.17. Patni Computer Systems Ltd.
10.18. Persistent Systems
10.19. Pilgrim Software Inc.
10.22. Sterling Tech Software
10.23. Toltec International
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
Service Outsourcing Opportunities in the Medical Device Market
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.
The medical device outsourcing market is classified into the applications and services submarkets. Applications market covers outsourcing in class1, class2 and class 3 medical devices; while the services market covers designing, prototyping, validation and verification, and regulatory consulting services. The report also 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.
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 global services outsourcing market in medical devices is expected to be worth $26,770 million by 2014, growing at a CAGR of 13.9% from 2009 to 2014. Regulatory consulting and other services forms the fastest growing market with a CAGR of 15.1% from 2009 to 2014.