Buy Now: Outsourcing Opportunities in the Medical Device
Report Description
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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Buy Now: Outsourcing Opportunities in the Medical Device
Table of contents
Executive summary
Market overview
Global services outsourcing in medical devices market Trends
Opportunities
Global services outsourcing in medical devices, by Applications
Opportunities
Global services outsourcing market in medical devices, by services
Global services outsourcing in medical devices market, geography Analysis
Global services outsourcing in medical devices market, competitive landscape
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 Life Cycle
3.3. Defining Service Outsourcing in Medical Device Market
4. Market Dynamics
4.1. Outsourcing market dynamics
4.1.1. Drivers
4.1.1.1. Increasing competition is driving the demand for outsourcing services
4.1.1.2. Growing demand for quality healthcare strengthening the service outsourcing market
4.1.1.3. Leveraging external expertise increasing
4.1.1.4. Reduced time-to-market offering competitive edge
4.1.1.5. Increased product recalls demanding better design and testing services
4.1.1.6. Growing Asian markets offer huge opportunities
4.1.2. Opportunities
4.1.2.1. Growing trend towards obtaining certification among service providers in Asian regions
4.1.2.2. Increasing Government participation to secure intellectual property rights
5. Applications market
5.1. market Overview
5.2. Drivers
5.2.1.1. Reducing product life span
5.2.1.2. Increasing demand for healthcare for low cost medical devices
5.2.1.3. Enhancement in healthcare technologies is driving the market for advanced medical devices
5.2.1.4. Threat from low cost manufacturers
5.2.1.5. Inconsistent regulations across globe increasing demand for regulatory consulting services
5.2.2. Restraints
5.2.2.1. Multiple outsourcing partners
5.2.2.2. Fear of loosing trade secrets restricting the outsourcing market growth
5.2.2.3. Lack of certified outsourcing partners
5.2.3. Opportunites
5.2.3.1. Emerging Asian markets
5.2.3.2. Growing trend towards outsourcing of IT services
5.2.4. Class III medical devices
5.2.4.1. Drivers
5.2.4.1.1. Critical devices demand more accurate and reliable design
5.2.4.1.2. Increased incidences of chronic diseases
5.3. Class II medical devices
5.3.1. Driver
5.3.1.1. Stringent government regulations
5.3.1.2. Growing complexity in design
5.4. Class I medical DEVICE
5.4.1. Driver
5.4.2. Restraint
5.4.3. Opportunity
5.5. Comparitive Analysis of Service Outsourcing medical devces
5.6. Cardiovascular devices
5.6.1. Global presence of the Key players:
5.6.1.1. Opportunities
5.6.1.1.1. Growing incidences of cardiovascular diseases:
5.6.1.1.2. Rapidly evolving technology
5.7. OrthopAedic devices
5.7.1.1. Opportunities
5.7.1.2. Consolidations in outsourcing market
5.7.1.3. Increasing product recalls
5.8. ANESTHESIOLOGY DEVICES
5.8.1. Opportunities
5.8.1.1. Increasing use of software
5.8.1.2. Changing technology
5.9. Radiology devices
5.9.1. Opportunities
5.10. Neurology
5.10.1. Opportunites
6. Services Market
6.1. Market overview
6.1.1. Drivers
6.1.1.1. Outsourcing of designing services reduce the time required to build the product
6.1.1.2. Innovation and cost reduction
6.1.1.3. Leveraging external expertise
6.1.1.4. Emergence of one stop solution providers
6.2. Product design and development services
6.2.1.Drivers
6.2.1.1. Reduced time to market and innovative product design
6.2.1.2. Huge earning opportunities through IP rights
6.2.1.3. Growing trend towards concentrating on core competencies
6.2.2. Opportunities
6.2.2.1. Entry of new players in medical device manufacturing industry
6.3. Regulatory Consulting Services
6.3.1.1. Computer system validation services (CSV)
6.3.1.2. 510(K)
6.3.1.3. PMA ( Premarket approvals)
6.3.1.4. CE Marking
6.3.2. Drivers
6.3.2.1. Reduces time to obtain approvals
6.3.2.2. Geographic expansion improving demand for regulatory consulting
6.4. Product Testing Services
6.4.1.1. Reduces chances of product recalls
6.4.1.2. Automated testing improves time to market
6.4.2. Product Implementation services
6.4.2.1. Increasing automation in medical device manufacturing companies
6.5. Product upgrade services
6.5.1. Increasing trend towards outsourcing of R&D for existing products
6.6. Product Maintenance services
7. Competitive landscape
7.1. Overview
8. Geographic Analysis
8.1. Overview
8.2. North America
8.2.1. Intense competition and rapidly changing technology
8.2.2. Highly regulated market
8.2.3. Cost containment pressure from government.
8.2.4. Increasing pressure to meet regulatory standards applicable to manufacturing processes
8.3. Europe
8.4. Asia pacific
8.4.1. Setting up of SEZs (special economic Zones).
8.4.2. Initiatives towards intellectual property rights 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
List of TableS
1. Summary Table global services outsourcing market for medical devices, By services 2007-2014 ($ Millions)
2. Major players in medical devices and their product portfolio
3. Global Services outsourcing opportunities in medical devices market, By Products 2007-2014 ($ Millions)
4. Global Services outsourcing opportunities in medical devices market, By Geography 2007-2014 ($ Millions)
5. Global services outsourcing in Class III medical devices, by Geography 2007-2014 ($ Millions)
6. Global services outsourcing opportunities in Class II medical devices market by geography by 2007-2014 ($ Millions)
7. Global services outsourcing opportunities in Class I medical devices market, by geography 2007-2014 ($ Millions)
8. Services outsourcing market in medical devices, By application 2007-2014 ($ Miilions)
9. Global presence of major cardiovascular device manufacturers
10. Global presence of key ORTHOPEDIC device manufacturers
11. Segmentation of global orthopaedic devices market
12. Service Outsouring provided by various outsourcing companies
13. Global services outsourcing opportunities in medical devices market by Services 2007-2014 ($ Millions)
14. Global services outsourcing opportunities in medical devices market, By Geography 2007-2014 ($ Millions)
15. Global Product design and development services outsourcing in medical devices, by geography 2007-2014 ($ Millions)
16. Global regulatory consulting services in medical devices market, by geography 2007-2014 ($ Millions)
17. Global product testing services outsourcing in medical devices market, by geography 2007-2014 ($ Millions)
18. Global product implementation services outsourcing in medical devices market, by geography 2007-2014 ($ millions)
19. Global Product UPGRADE services outsourcing opportunities in medical devices market, by geography 2007-2014 ($ millions)
20. Global Product maintenance services outsourcing opportunities in medical devices market, by geography 2007-2014 ($ Millions)
21. Strategic Alliance and partnerships (2007 – 2009)
22. New developments in service offering (2007-2009)
23. North American market for services outsourcing in medical devices 2007-2014
24. European market for services outsourcing in medical devices 2007-2014 ($ millions)
25. Asian Market for services outsourcing in medical devices 2007-2014 ($ Millions)
26. phthalmic Medical Device List
27. Neurology Medical Devices List
28. Radiology Device List
29. Gastroenterology – Urology Medical Devices List
30. Hematology Medical devices list
31. Dental Medical Device List
List of FIGURES
1. Participants OF OUTSOURCING market in Medical Devices manufacturing
2. Product life cycle of a medical device
3. CHALLENGE – BENEFIT ANALYSIS FOR MEDICAL DEVICE MANUFACTURING
4. Industry Life Cycle of Service Outsourcing in medical devices
5. Global market for Service Outsourcing in medical devices, by application, (2009)
6. Global Service Outsourcing Market in Medical devices, By Geography (2009)
7. Drivers impacting outsourcing in medical devices
8. Impact of Time-to-market on revenues
9. FDA classification of Medical devices
10. Global market share of top 10 medical device manufcaturers
11. Medical device approval process
12. Comparative analysis of service outsourcing in medical devices
13. Global market share of top orthopaedic device manufacturers
14. Global market share of top medical radiology device manufacturers
15. Segmentation of global medical radiology devices market
16. Major services offered by outsourcing partners and benefits to manufacturers
17. Structure of strategic partnership in the industry
18. Global services outsourcing market in medical devices
19. North American Market for service outsourcing in medical devices
20. European market for service outsourcing in medical devices
21. European medical device market
22. Asian Market for service outsourcing in medical devices
23. Asia Medical device market split
24. Requirements for ISO 13485
25. Requirements for ISO 9001:2000
26. Risk Management Process
Buy Now: Outsourcing Opportunities in the Medical Device
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.
Buy Now: Outsourcing Opportunities in the Medical Device
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