Table of Content



Chapter 1 Methodology and Scope
1.1 Market Segmentation & Scope
1.1.1 Service
1.1.2 Application
1.2 Research Methodology
1.3 Information Procurement
1.3.1 Purchased Database
1.3.2 GVR’s Internal Database
1.3.3 Secondary Sources
1.3.4 Primary Research
1.3.5 Details of Primary Research
1.3.5.1 Data for primary interviews in the U.S.
1.4 Information or Data Analysis
1.4.1 Data Analysis Models
1.5 Market Formulation & Validation
1.5.1 Model Details
1.5.2 Commodity Flow Analysis (Model 1)
1.5.2.1 Approach 1: Commodity Flow Approach
1.5.3 Volume Price Analysis (Model 2)
1.5.3.1 Approach 2: Volume Price Analysis
1.6 List of Secondary Sources
1.7 Objectives
1.7.1 Objective 1:
1.7.2 Objective 2:
1.7.3 Objective - 3:
1.7.4 Objective - 4:
Chapter 2 Executive Summary
2.1 Market Outlook
Chapter 3 Market Variables, Trends & Scope
3.1 Market Dynamic
3.1.1 Market Driver Analysis
3.1.1.1 Changing Regulatory Landscape
3.1.1.2 Rising Demand for the Advanced Products
3.1.1.3 Implementation of the International Standards by the Contract Manufacturers
3.1.1.4 Rising Price Competition and the Requirement to Reduce Cost
3.1.1.5 Increasing Complexity with Respect to Product Design and Engineering
3.1.2 Market Restraint Analysis
3.1.2.1 Compliance Issues While Outsourcing
3.1.2.2 Contractual Obligation
3.1.3 Industry Challenges
3.1.3.1 Managing Relationships
3.1.4 Impact of Covid-19 Pandemic
3.1.4.1 Impact on the U.S. medical device outsourcing market
3.1.4.2 Impact on Supply Chain
3.1.4.3 After effect of the pandemic
3.1.4.4 Impact Analysis
3.2 U.S. Medical Devices Outsourcing Market Analysis Tools
3.2.1 Industry Analysis - Porter’s
3.2.2 PESTEL Analysis
Chapter 4 U.S. Medical Device Outsourcing Market: Segment Analysis, By Service, 2016 - 2028 (USD Million)
4.1 Definitions and Scope
4.2 Service Market Share Analysis
4.3 Segment Dashboard
4.4 Quality Assurance Services
4.4.1 Quality Assurance Services Market Estimates and Forecast, 2016 - 2028
4.5 Regulatory Consulting Services
4.5.1 Regulatory Consulting Services Market, 2016 - 2028 (USD Million)
4.5.2 Clinical Trial Application and Product Registration
4.5.2.1 Clinical Trial Application and Product Registration Market, 2016 - 2028 (USD Million)
4.5.3 Regulatory Writing and Publishing
4.5.3.1 Regulatory Writing and Publishing Market, 2016 - 2028 (USD Million)
4.5.4 Legal Representation
4.5.4.1 Legal Representation Market, 2016 - 2028 (USD Million)
4.5.5 Other Regulatory Affairs Services
4.5.5.1 Other Regulatory Affairs Service Market, 2016 - 2028 (USD Million)
4.6 Product Design and Development
4.6.1 Product Design and Development Services Market, 2016 - 2028 (USD Million)
4.6.2 Designing and Engineering
4.6.2.1 Designing and Engineering Market, 2016 - 2028 (USD Million)
4.6.3 Machining
4.6.3.1 Machining Market, 2016 - 2028 (USD Million)
4.6.4 Molding
4.6.4.1 Molding Market, 2016 - 2028 (USD Million)
4.6.5 Packaging
4.6.5.1 Packaging Market, 2016 - 2028 (USD Million)
4.7 Product Testing And Sterilization
4.7.1 Product Testing And Sterilization Market, 2016 - 2028 (USD Million)
4.8 Product Implementation
4.8.1 Product Implementation Market, 2016 - 2028 (USD Million)
4.9 Product Upgrade
4.9.1 Product Upgrade Market, 2016 - 2028 (USD Million)
4.10 Product Maintenance
4.10.1 Product Maintenance Market, 2016 - 2028 (USD Million)
4.11 Contract Manufacturing
4.11.1 Contract Manufacturing Market, 2016 - 2028 (USD Million)
4.11.2 Accessories Manufacturing
4.11.2.1 Accessories Manufacturing Market, 2016 - 2028 (USD Million)
4.11.3 Assembly Manufacturing
4.11.3.1 Assembly Manufacturing Market, 2016 - 2028 (USD Million)
4.11.4 Component Manufacturing
4.11.4.1 Component Manufacturing Market, 2016 - 2028 (USD Million)
4.11.5 Device Manufacturing
4.11.5.1 Device Manufacturing Market, 2016 - 2028 (USD Million)
Chapter 5 U.S. Medical Device Outsourcing Market: Segment Analysis, By Application, 2016 - 2028 (USD Million)
5.1 Definitions and Scope
5.2 Application Market Share Analysis
5.3 Segment Dashboard
5.4 Class I
5.4.1 Class I Market Estimates and Forecast, 2016 - 2028 (USD Million)
5.5 Class II
5.5.1 Class II Market Estimates and Forecast, 2016 - 2028 (USD Million)
5.6 Class III
5.6.1 CLASS III Market Estimates and Forecast, 2016 - 2028 (USD Million)
Chapter 6 Competitive Landscape
6.1 Key Company Profiles
6.1.1 Integer Holdings Corporation
6.1.1.1 Company overview
6.1.1.2 Financial performance
6.1.1.3 Product benchmarking
6.1.1.4 Strategic initiatives
6.1.2 Avail Medical Products, Inc.
6.1.2.1 Company overview
6.1.2.2 Product benchmarking
6.1.2.3 strategic Initiatives
6.1.3 Active Implants
6.1.3.1 Product benchmarking
6.1.3.2 strategic Initiatives
6.1.4 Omnica Corporation
6.1.4.1 Product Benchmarking
6.1.5 Teleflex Incorporated
6.1.5.1 Company overview
6.1.5.2 financial performance
6.1.5.3 Product benchmarking
6.1.5.4 Strategic initiatives
6.1.6 Kinetic Climax Inc.
6.1.6.1 Company overview
6.1.6.2 Product benchmarking
6.1.6.3 Strategic initiatives
6.1.7 Cantel Medical Corp.
6.1.7.1 Company Overview
6.1.7.2 Financial Performance
6.1.7.3 Product Benchmarking
6.1.7.4 Strategic Initiatives



List of Figures

List of Figures

Fig. 1 Market research process
Fig. 2 Data triangulation technique
Fig. 3 Primary research pattern
Fig. 4 Primary interviews in the U.S.
Fig. 5 Market research approaches
Fig. 6 QFD modeling for market share assessment
Fig. 7 U.S. medical devices outsourcing market: Market outlook (2020)
Fig. 8 U.S. medical devices outsourcing market Driver impact
Fig. 9 Current shared services and outsourcing usage levels
Fig. 10 U.S. Medical devices outsourcing market Restraint Impact
Fig. 11 Porter’s five forces analysis
Fig. 12 SWOT analysis, by factor (political & legal, economic and technological)
Fig. 13 U.S. medical devices outsourcing market: Service movement analysis
Fig. 14 U.S. medical devices outsourcing market: Service outlook and key takeaways
Fig. 15 Quality assurance services market estimates and forecast, 2016 - 2028
Fig. 16 Regulatory affairs services market, 2016 - 2028 (USD Million)
Fig. 17 Stages of review of PMA devices
Fig. 18 Clinical trial application and product registration market, 2016 - 2028 (USD Million)
Fig. 19 Regulatory writing and publishing market, 2016 - 2028 (USD Million)
Fig. 20 Legal representation market, 2016 - 2028 (USD Million)
Fig. 21 Others market, 2016 - 2028 (USD Million)
Fig. 22 Product design and development services market, 2016 - 2028 (USD Million)
Fig. 23 Designing and engineering market, 2016 - 2028 (USD Million)
Fig. 24 Machining market, 2016 - 2028 (USD Million)
Fig. 25 Molding market, 2016 - 2028 (USD Million)
Fig. 26 Packaging market, 2016 - 2028 (USD Million)
Fig. 27 Product testing and sterilization market, 2016 - 2028 (USD Million)
Fig. 28 Product implementation market, 2016 - 2028 (USD Million)
Fig. 29 Product upgrade market, 2016 - 2028 (USD Million)
Fig. 30 Product maintenance market, 2016 - 2028 (USD Million)
Fig. 31 Contract manufacturing market, 2016 - 2028 (USD Million)
Fig. 32 Accessories manufacturing market, 2016 - 2028 (USD Million)
Fig. 33 Accessories manufacturing market, 2016 - 2028 (USD Million)
Fig. 34 Component manufacturing market, 2016 - 2028 (USD Million)
Fig. 35 Device manufacturing market, 2016 - 2028 (USD Million)
Fig. 36 Class I medical device outsourcing market, 2016 - 2028 (USD Million)
Fig. 37 Class II medical device outsourcing market, 2016 - 2028 (USD Million)
Fig. 38 Class III medical device outsourcing market, 2016 - 2028 (USD Million)

List of Tables

List of Tables

Table 1 List of secondary sources
Table 2 List of Abbreviation