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Global Medical Device Outsourcing Industry

Rising Demand for Medical Devices Augurs Well for the Market II-8

Table 4: Global Medical Devices Market (2012): Percentage

Share Breakdown of Revenues by Industry Sector (includes

corresponding Graph/Chart) II-9

Medical Device Miniaturization Drives Demand for Outsourcing

Services II-9

Shortening Product Lifecycles, Speed to Market Will Drive

Outsourcing Trend II-10

Protection of Intellectual Property and Licensing Rights

Rises in Importance II-10

Budgetary Challenges of the Healthcare System to Benefit

Outsourcing Services II-10

Shift towards Off shoring II-11

Consolidation Continues to Mark the Industry II-11

Outsourcing of IVD Device Manufacturing Gains Momentum II-11

Emergence of Asia as a Favorable Outsourcing Destination II-12

Key Challenges II-12

Legal & Regulatory Issues II-12

Intellectual Property and Business Risks Deter OEMs to Seek

Alliances II-13

Delays In Contractual Obligations II-13

Outlook II-13



Introduction II-14

Industry Structure II-14

Advantages of Outsourcing II-14

Choosing the Right Manufacturing Partner II-15

Quality Management System II-15

Managing the Partnership II-15

Quality Remains Guiding Factor II-16

Medical Device Outsourcing Services: A Definition II-16

Product design and development services II-16

Regulatory consulting services II-16

Product testing services II-16

Product Maintenance & Upgrade Services II-16

Product Certification & Implementation services II-16

Classification of Medical Devices II-16

Class I Devices II-17

Class II Devices II-17

Class III Devices II-17

Classification of Medical Devices by Therapeutic Area II-18

Cardiology II-18

Radiology II-18

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