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Medical Device Contract Manufacturing
Market Forecast 2016-2026
Prospects for Electronic Manufacturing Services,
Materials Processing and Finished Products

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Contents
1.1 Global Medical Device Contract Manufacturing: Market Overview
1.2 Global Medical Device Contract Manufacturing Market Segmentation
1.3 Why You Should Read This Report
1.4 How This Report Delivers
1.5 Key Questions Answered by This Analytical Report
1.6 Who Is This Report For?
1.7 Methodology
1.8 Frequently Asked Questions (FAQs)
1.9 Associated Reports
1.10 About Visiongain
2.1 What Are Medical Devices?
2.2 The Medical Device Industry: An Overview
2.3 An Introduction to Medical Device Outsourcing
2.4 Advantage of Outsourcing Medical Device Manufacturing
2.4.1 The Reasons behind Strategic Outsourcing of Medical Device Manufacturing
2.4.1.1 Outsourcing: Focusing on Core Competencies
2.4.1.2 Reducing Time-to-Market for Medical Devices
2.4.1.3 Outsourcing: A Tactical and Strategic Tool
2.4.1.4 Outsourcing: Lowering Fixed Operating Costs
2.5 Identifying Compatible CMOs
2.5.1 Building Contractual Agreements
2.5.2 Reviewing the Quality Manual: CMO-OEM Relationships
2.5.3 Audit and Site Visits
2.6 Medical Devices Classification Systems
2.6.1 The US Medical Devices Classification System
1. Report Overview
2. Medical Device Contract Manufacturing: An Introduction

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Contents
2.6.2 The EU Medical Devices Classification System
2.7 Regulation of Medical Devices
2.7.1 Regulation in the US
2.7.1.1 An Introduction to Regulatory Developments in the US
2.7.1.2 The US Approval and Regulation System
2.7.1.3 Medical Device Bans
2.7.2 The EU Approval and Regulation System
2.7.2.1 Post-Marketing Surveillance in the EU
2.7.3 Regulation in Japan
2.7.4 Regulation in China
2.7.5 Regulation in Central and South America
2.7.5.1 Regulation in Brazil
2.7.5.2 Regulation in Mexico
2.7.6 Regulation in India
2.8 Final Discussions
2.8.1 Product Requirement Specifications
2.8.2 Term Sheets and Supply Agreements
2.8.3 Project Management
2.9 Medical Device Quality Management Systems
2.10 Medical Device Outsourcing Segments
2.10.1 Design Engineering
2.10.2 Device (Contract) Manufacturing
2.10.2.1 Electronic Manufacturing Services
2.10.2.2 Material Processing
2.10.2.3 Finished Products
2.10.3 Final Goods Assembly
3.1 The Global Medical Device Market: Market Overview
3. The Medical Device Contract Manufacturing Market, 2016-2026

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Contents
3.2 The Growing Global Ageing Population
3.3 The Global Medical Device Market: Market Forecast, 2016-2026
3.4 The Global Medical Device Market: Drivers and Restraints
3.5 The Medical Device Outsourcing Market: Market Overview
3.5.1 Medical Device Outsourcing: Market Segmentation
3.5.2 Blusterous Future Growth for Design Engineering
3.5.3 Relatively High Costs of Goods Sold (COGS) for Medical Devices
3.6 Recent Trends in Medical Device Outsourcing
3.7 Estimating the Size of Outsourced Medical Device Manufacturing
4.1 Medical Device Contract Manufacturing Market: Overview of Market Segments, 2015
4.2 Medical Device Contract Manufacturing: Market Forecast 2016-2026
4.2.1 Market Sectors That Will Drive Growth in Medical Device Contract Manufacturing
4.2.2 Global Medical Device Contract Manufacturing Market - Changing Market Shares by
Sector 2016-2026
4.3 Electronic Manufacturing Services (EMS): Market Overview
4.3.1 Electronic Manufacturing Services (EMS) For Medical Devices: Market Overview, 2015
4.3.2 Leading Companies in Electronic Manufacturing Services (EMS), 2015
4.3.3 Outsourced Electronics Manufacturing: Market Forecast, 2016-2026
4.4 Materials Processing: Market Overview, 2016
4.4.1 The Materials Processing Market: Market Forecast 2016-2026
4.4.2 Medical Moulding
4.4.3 Medical Extrusion
4.5 Finished Products: Market Overview
4.5.1 Outsourced Finished Products Market Forecast 2016-2026
4. The Medical Device Contract Manufacturing Market: Submarket
Analysis and Forecast 2016-2026

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Contents
5.1 The Medical Device Contract Manufacturing Market by Region
5.1.1 The Global Distribution of Medical Device Contract Manufacturing in 2015
5.2 Leading National Markets: Market Forecast 2016-2026
5.2.1 Changing Market Shares by Region
5.3 Regional Medical Device Contract Manufacturing Markets: Analysis and Forecasts, 2016-2026
5.3.1 United States: The Largest Medical Device Contract Manufacturing Market
5.3.1.1 US Medical Device Contract Manufacturing Market: Market Forecast 2016-2026
5.3.2 The EU5 Markets: Growth Expected In Each Country
5.3.2.1 EU5 Medical Device Contract Manufacturing Market: Market Forecast 2016-2026
5.3.2.2 EU5 Medical Device Contract Manufacturing Market: CAGRs (%) by Country, 2016-
2026
5.3.2.3 EU5 Markets: Changing Market Shares by Country, 2016-2026
5.3.2.4 Germany
5.3.2.4.1 German Medical Device Contract Manufacturing Market: Market Forecast
2016-2026
5.3.2.5 UK
5.3.2.5.1 UK Medical Device Contract Manufacturing Market: Market Forecast 2016-
2026
5.3.2.6 Spain
5.3.2.6.1 Spanish Medical Device Contract Manufacturing Market: Market Forecast
2016-2026
5.3.2.7 France
5.3.2.7.1 French Medical Device Contract Manufacturing Market: Market Forecast
2016-2026
5.3.2.8 Italy
5. Leading Regional Markets for Medical Device Contract
Manufacturing, 2016-2026

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Contents
5.3.2.8.1 Italian Medical Device Contract Manufacturing Market: Market Forecast
2016-2026
5.3.3 Japan
5.3.3.1 Japanese Medical Device Contract Manufacturing Market: Market Forecast 2016-
2026
5.3.4 China
5.3.4.1 Chinese Medical Device Contract Manufacturing Market: Market Forecast 2016-
2026
5.3.5 Central America & South America
5.3.5.1 Major National Markets in the Region
5.3.5.1.1 Brazil
5.3.5.1.2 Mexico
5.3.5.2 Central America & South America Medical Device Contract Manufacturing Market:
Market Forecast 2016-2026
5.3.6 India
5.3.6.1 Indian Medical Device Contract Manufacturing Market: Market Forecast 2016-2026
5.3.7 Rest of the World
5.3.7.1 Rest of the World Medical Device Contract Manufacturing Market: Market Forecast
2016-2026
6.1 Medical Device Contract Manufacturing: A Rapidly Consolidating Market
6.2 Flextronics
6.2.1 Flextronics: Historical Financial and Performance Analysis, 2010-2015
6.2.2 Flextronics: Business Segment Revenue Analysis, 2015
6.2.3 Flextronics: Business Capabilities
6.2.4 Flextronics: Recent Developments
6.2.4.1 Business Restructuring
6. Leading Companies in Medical Device Contract Manufacturing,
2016-2026

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Contents
6.2.4.2 Flextronics’ Acquisition of RIWISA AG
6.2.4.3 Spin-Off of Supply Chain Software
6.3 Jabil Circuit
6.3.1 Jabil Circuit: Historical Financial and Performance Analysis 2010-2015
6.3.2 Jabil Circuit: Business Segment Performance Analysis, 2015
6.3.3 Jabil Circuit National Market Segmentation, 2014 and 2015
6.3.4 Jabil Circuit: Recent Acquisition and Divestiture Activities
6.3.4.1 Acquisition of Nypro
6.3.4.2 Divestment of Jabil’s Aftermarket Services Business
6.3.4.3 Acquisition of Plasticos
6.4 Benchmark Electronics
6.4.1 Benchmark Electronics: Historical Financial and Performance Analysis, 2010-2015
6.4.2 Benchmark Electronics: Business Segment Performance Analysis
6.4.3 Benchmark Electronics Regional Market Segmentation, 2014 and 2015
6.4.4 Benchmark Electronics: Recent Acquisition and Divestiture Activities
6.4.4.1 Acquisition of the EMS Sector of CTS Corporation
6.4.4.2 Acquisition of Secure Technology
6.5 Greatbatch
6.5.1 Greatbatch: Historical Financial and Performance Analysis 2010-2015
6.5.2 Greatbatch: Recent Acquisition Activities
6.5.2.1 Acquisition of Centro de Construccion de Cardioestimuladores del Uraguay (CCC)
6.5.2.2 Acquisition of NeuroNexus
6.5.2.3 Acquisition of Micro Power Electronics
6.5.2.4 Acquisition of Lake Region Medical
6.5.3 Organisational Restructuring and Investments
6.5.4 Lake Region Medical (Accellent)
6.5.4.1 Lake Region Medical: Historical Financial and Performance Analysis, 2010-2013
6.5.4.2 Lake Region Medical: Core Business Capabilities
6.5.4.3 Lake Region Medical (Accellent) Regional Market Segmentation, 2012
6.5.4.4 Lake Region Medical: Developments Prior to Acquisition by Greatbatch

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Contents
6.5.4.5 Lake Region Medical (Accellent) Site Closure
6.6 The Tech Group (West Pharmaceutical Services)
6.6.1 The Tech Group (West Pharmaceutical Services): Historical Financial and Performance
Analysis 2010-2015
6.6.2 Focusing on Research & Development
6.6.3 The Tech Group (West Pharmaceutical Services): Business Segment Performance Analysis
6.6.4 The Tech Group (West Pharmaceutical Services) Regional Market Segmentation, 2014
and 2015
6.7 Tecomet (Symmetry Medical)
6.7.1 Symmetry Medical: Historical Financial and Performance Analysis 2009-2013
6.7.2 Symmetry Medical: Business Segment Analysis, 2013 and 2014
6.7.3 Total Solutions Approach
6.7.4 Symmetry Medical Regional Market Segmentation, 2012
6.7.5 Tecomet (Symmetry Medical): Recent Acquisition Activities
6.7.5.1 Acquisition of Olsen Medical
6.7.5.2 Acquisition of Codman
6.7.5.3 Tecomet’s Acquisition of Symmetry Medical
6.8 Nortech Systems
6.8.1 Nortech Systems: Historical Financial and Performance Analysis 2010-2015
6.8.2 Nortech Systems: Business Segment Performance Analysis, 2014 and 2015
6.8.3 Acquisition of EMS Unit of Winland Electronics
6.9 TE Connectivity (Creganna Medical)
6.9.1 Acquisition of Precision Wire Components LLC
6.9.2 Creganna Medical’s Product and Services Portfolio
6.9.3 Pilot Manufacturing
6.9.4 Volume Manufacturing
6.9.5 Creganna Medical: Merger and Acquisition Activities Prior to Acquisition by TE
Connectivity
6.9.5.1 Partnership with BBA
6.9.5.2 Acquisitions of ABT Medical

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Contents
6.9.5.3 Creganna Medical’s Developments in Asia
6.10 Forefront Medical Technology
6.10.1 Forefront Medical Service Offerings
6.11 Vention Medical
6.11.1 Vention Medical: Recent Acquisition Activities
6.11.1.1 Acquisition of Ansamed
6.11.1.2 Acquisition of ATEK Medical Group
6.11.1.3 Acquisition of RiverTech Medical
6.11.1.4 Acquisition of Fast Forward Medical
6.11.1.5 Expansion of Catheter Capabilities into Costa Rica
6.12 Other Companies Operating Within the Medical Device Contract Manufacturing
7.1 Market Factors Influencing Medical Device Contract Manufacturing
7.2 SWOT Analysis of the Global Medical Device Contract Manufacturing Market, 2016-2026
7.2.1 Strengths
7.2.1.1 The Cost-Advantages of Outsourced Manufacturing
7.2.1.2 Outsourcing as a Strategy to Meet Short-term Goals
7.2.1.3 Rapidly Contracting Development Cycle and Market Entry
7.2.1.4 Increasing Focus of Medical Device Companies on Core Competencies
7.2.2 Weaknesses
7.2.2.1 Strong Dependence on the Continued Success of OEMs
7.2.2.2 The Impact of Reimbursements and Payment Approvals on Contract Manufacturing
7.2.2.3 Small Pool of Customers Accounting for a Large Proportion of CMOs’ Income
7.2.2.4 The Perception of Risk Associated with Intellectual Property Protection
7.2.2.5 Medical Device Counterfeiting – A Restraint to Growth in Emerging Markets
7.2.3 Opportunities
7.2.3.1 Intensifying Price Pressures on Medical Device Companies
7. Qualitative Analysis of the Medical Device Contract
Manufacturing Market, 2016-2026

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Contents
7.2.3.2 Globalisation as a Potential Driver of Growth
7.2.3.3 Changes to Taxation Systems May Impact upon Contract Manufacturing
7.2.3.4 Rapid Expansion in Emerging Markets
7.2.3.5 Asian Regions Offer Attractive Manufacturing Locations
7.2.4 Threats
7.2.4.1 Slower Growth Expected for Medical Devices
7.2.4.2 Changes to Reimbursement in Various Markets Globally
7.2.4.3 Manufacturing Costs on the Rise in Traditionally Low Cost Regions
7.3 Porter’s Five Force Analysis of the Global Medical Device Contract Manufacturing Market,
2016-2026
7.3.1 Rivalry among Competitors: High
7.3.2 Threat of New Entrants: Medium
7.3.3 Power of Buyers: High
7.3.4 Power of Suppliers: Medium
7.3.5 Threat of Substitutes: High
8.1 Interview with Mr. Barry Richards, EMEA Clinical Director at Ekso Bionics
8.1.1 The Key Steps to Entering the Medical Device Market
8.1.2 Growth in the Medical Device Industry in an Ageing Population
8.1.3 Growth in Emerging National Markets
9.1 Overview of Current Market Conditions and Market Forecast, 2016-2026
9.2 Leading Sectors in Medical Device Contract Manufacturing in 2015
9.3 Leading Regions in the Medical Device Contract Manufacturing Market in 2015
9.4 Future Outlook for the Various Sectors within Medical Device Contract Manufacturing, 2016-
2026
8. Expert Opinions from Our Primary Research
9. Conclusions

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Contents
9.5 Electronic Manufacturing Services Provides the Glimpse of Future Growth
9.6 Consolidation in the Contract Manufacturing Market
9.7 Concluding Remarks

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Medical Device Contract Manufacturing Market Forecast
2016-2026: Prospects for Electronic Manufacturing Services,
Materials Processing and Finished Products
2.4 Advantage of Outsourcing Medical Device Manufacturing
In addition to specialisation, outsourcing to CMOs provides unique advantages to medical device
companies, including the following:
• CMOs represent an expansion of technological resources and expertise, therefore
medical device companies save on their cost of capital by not paying for new facilities
and equipment. They will also make savings in labour costs associated with wages
and training. For this reason, more and more companies are looking to outsource to
countries like China and India to benefit from low cost of labour
• Medical device companies can take advantage of skills that they themselves may not
possess. Also, a contract manufacturer is likely to have relationships formed with raw
material suppliers or a reputable method of efficiency
• With no up-front capital investment in new technology, the medical device company
can experience improved cash flow
Figure 2.1 highlights the services currently offered by CMOs. In recent years, the demand for
CMOs’ services has grown, which has led to these companies identifying opportunities within their
own cost structures. As a result they are attempting to broaden their service offerings to include
R&D, software, education, and sales and marketing. These value added services not only exhibit a
higher margin potential for the CMO but also enable an increase in the number of entry points in
the OEM cost structure. Some leading CMOs are now competing for the opportunity to co-develop
products, patent manufacturing processes and establish distribution networks to handle finished
goods.
Figure 2.1 Services Offered by Medical Device Outsourcing Companies, 2016
Source: Visiongain 2016
Design &
Engineering
Component
Manufacturing
Device
Assembly &
Testing
Sterilisation
& Packaging
Supply
Chain
Management

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Medical Device Contract Manufacturing Market Forecast
2016-2026: Prospects for Electronic Manufacturing Services,
Materials Processing and Finished Products
Figure 3.1 World 65+ Population Forecast: Size (m) and AGR (%), 2015-2026
According to the United Nations’ Department of Economic and Social Affairs, the number of people
aged 65 and over (based on medium-fertility assumptions) is predicted to rise by 41.9% between
2013 and 2024. The Economic and Social Affairs of the UN reported that the highest levels of life
expectancy at birth in the period 2010-2015 were in China, Japan, Italy and Spain. The stage is set
for the ageing demographics to be a long-term driver for growth in the healthcare market and for
medical devices in particular.
3.3 The Global Medical Device Market: Market Forecast, 2016-2026
The global medical devices market will continue its recent trend of single digit growth, expanding
with a CAGR of 4.2% between 2015 and 2020 (Table 3.2 and Figure 3.2). As the effects of the
economic crisis of the last few years fade, growth in the medical devices market will be driven by
rapid expansion in emerging markets, allied with steady growth in more of the matured markets.
The expansion of the middle class income group in emerging economies will result in a larger
2.7
2.8
2.9
3.0
3.1
3.2
3.3
3.4
3.5
3.6
3.7
0.0
100.0
200.0
300.0
400.0
500.0
600.0
700.0
800.0
900.0
1,000.0
AGR(%)
Global65+Population(m)
Year
Global 65+ Population (m) AGR (%)
Source: Visiongain 2016; United Nations Department of Economic and Social Affairs, Population Division, 2012
and 2015.

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Medical Device Contract Manufacturing Market Forecast
2016-2026: Prospects for Electronic Manufacturing Services,
Materials Processing and Finished Products
Figure 3.6 Spending on In-house and Outsourced Device Manufacturing (%), 2015
Spending by OEMs on outsourcing is expected to increase over the coming years as OEMs have
started to face mounting pressures to reduce costs, increase margins, deliver superior products
and remain competitive in a rapidly changing marketplace. As a result, the use of outsourcing will
become a necessary strategy for OEMs. Furthermore, CMOs are starting to become more and
more diversified in their operations and have significantly expanded their capabilities. This, coupled
with the struggles faced by medical device companies, has fuelled a growing trend towards
employing third party resources to help design, engineer, package, and distribute a wide range of
medical devices.
In-house
61.5%
Outsourced
38.5%
Source: Visiongain 2016