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Contract Manufacturing in Medical Devices (Materials, Processing, Electronics, Finished Products)

Medical device manufacturers are under pressure to reduce costs and improve margins and outsourcing at least some operations is increasingly a tactic for the top original equipment manufacturers (OEMs). There are hundreds of firms who specialize in device making operations and many more companies that do some medical device work.

Kalorama's Contract Manufacturing in Medical Devices (Materials, Processing, Electronics, Finished Products) is a complete study of the market and opportunity for outsourcing finished medical devices or a part of a medical device. It looks at the OEM contract manufacturing market revenues by therapeutic area (cardiology, respiratory, etc.), as well as by segment of device manufacturing (chemicals, implantable devices, semiconductors, metal molding, etc.) This allows those looking at this growing market to get a complete picture of the OEM market.

In this one volume, device companies will find Kalorama's estimate of outsourcing market sizes for Raw Materials & Material Processing, as well as for Finished Clinical Products for the following therapeutic areas:

  • Cardiovascular
  • General Surgery
  • Imaging
  • I.V. Diagnostics
  • Ophthalmology
  • Orthopedics
  • Respiratory
  • Neurology
  • Urology
Market size and forecast to 2015 is also estimated for the following CM service categories:
  • Material Handling and Packaging
  • Materials, Chemicals and Adhesives
  • Metal Fabrication and Injection Molding
  • Plastic Extrusions
  • Plastic Moldings
  • Flow Control and Fluid Transfer
  • Fluid Power Components
  • Sterilization
  • Network and Communication Equipment
  • Optical Components and Optics
  • Semiconductors
  • Data Acquisition and Signal Conditioning
  • Electrical and Electronic Components
  • Sensors Transducers and Detectors
  • Test and Measurement Equipment
  • Imaging and Video Equipment
  • Industrial Medical Software
  • Industrial Computers and Embedded Systems
  • Finished Medical Device Implantable Products
  • Finished Surgical Instruments
  • Finished Patient Monitoring Products
  • Finished Diagnostic Laboratory Equipment
  • Finished Imaging Products
  • Finished Networking, IT technology and Telemetry Products
  • Consulting Services
In addition this exhaustive market analysis, Kalorama Information study includes snapshots of top Original Equipment Manufacturing Companies (OEMs) and representative CM companies, provides overview of the general medical device market, and looks at issues and trends in CM for medical devices.

A truly worldwide study, current revenues and forecasts in all therapeutic areas are provided for:

  • U.S.
  • Europe
  • Asia
  • ROW

The report covers the following trends

  • HCR Device ‘tax’ - Pressure on Costs?
  • Bypassing US Market?
  • Recession Overcoming Conservatism About Outsourcing
  • Following the Customer
  • Three Key Device Areas Dominate Market
  • Patient Monitoring A Critical Need
  • Partnerships
  • Aging Population
All market numbers are estimated by Kalorama analysts using secondary and primary research. This Kalorama Information report is compiled from various data sources including government reports, trade publications and company annual reports and previous Kalorama Information reports on the medical device industry. Secondary research and primary interviews were used to make forecast estimates. Market data and analytics are derived from primary and secondary research. Sales of this report are 'as is' and the publisher cannot answer questions outside of report specific scope or compare Kalorama Information's data to third party research. Company profiles are extracted from URL research and reported select online sources.

Originally published February 2011, this report was revised April 2011 revised to reflect the recent industry expert opinion, the current economy, increased fuel costs, tax trends and new trends in offshoring to Asian and ROW, as well as published company revenues not available earlier in the year.

All Kalorama reports advertise the single user price. Use is limited to one user. We also feature department and global pricing for reports that we be utilized by more than one user at your company. Please consult ask your sales representative or select the correct license on our website.

For Kalorama's take on the healthcare news of the week, based on our analysis of healthcare markets, follow Kalorama Information's Key Point Blog at http://kaloramakeypoint.blogspot.com/


HCR DEVICE ‘TAX’ - PRESSURE ON COSTS? In order to partially subsidize healthcare financing and reduce the cost of the recent federal healthcare reform legislation (PAPPA), tax was included in the core bill and the America’s Healthy Future Act.

The law includes new tax provisions intended to help fund healthcare reform, which require device manufacturers to pay a 2.3% excise tax on “taxable medical device” sales beginning January 1, 2013. The tax applies to medical devices intended for human use, but exempts eyeglasses, contact lenses, and hearing aids, as well as devices that are “generally purchased by the general public for retail or individual use,” as determined by the Secretary of the Treasury.

Because the excise tax does not include a blanket exemption for Class I devices, the large category of non-retail Class I products, including low-risk hospital and physician office supplies, will be subject to the new tax. Further, while the text of the new law states that as the excise tax is applicable to the “sale” of medical devices, device leases also will be considered taxable events.

The Medical Device Manufacturers Association (MDMA) and other groups successfully fought to reduce the target size of the tax as well as the rate. The group is currently working to repeal or change the provision in the Healthcare Reform bill.

Although the tax will not be a reality of device manufacturing until 2013, it is a consideration now and will be for the next few years for many in the industry as they await any further action on healthcare reform.

Kalorama Information feels that any pressure on profits will get manufacturers thinking about costs. This is particularly true in the case of a tax that goes on revenues of the device rather than profits. Long term, it is probable that this tax will drive outsourcing decisions at major companies who have not yet outsourced operations as early as late 2011 as they prepare to meet the challenge of earning profit with the tax placed on the device.

At least one CM is using the new tax in its own ad campaign. Lake Region Medical, says “The pressure on major MD companies from the new taxes introduced in healthcare reform presents a growing opportunity to further serve the industry.”

  • Executive Summary
    • THREE SECTORS OF CONTRACT MANFUCTURING
    • REACHING CRITICAL MASS
    • SIZE AND GROWTH OF MARKET
      • Table Global Device Market and Contract Manufacturing Market 2010-2015
    • TRENDS DISCUSSED
    • SCOPE AND METHODOLOGY
  • Introduction
    • OUTSOURCING PARTNERSHIPS
      • Agreement Necessities
    • CLASSIFICATION OF MEDICAL DEVICES
    • CATEGORIZATION OF MEDICAL DEVICES
      • Table Products and Key Manufacturers
    • OVERALL MEDICAL DEVICE MARKET
      • Hospital Profits
      • Aging Population
    • DECISION TO OUTSOURCE
  • Materials and Material Processing
    • SEGMENTS
      • Material Handling and Packaging Equipment
      • Materials, Chemicals and Adhesives
      • Adhesives
      • Metal Fabrication and Metal Injection Molding
      • Plastics Extrusions
      • Plastics Moldings
      • Flow Control and Fluid Transfer
      • Fluid Power Components
      • Sterilization
    • REVENUE ESTIMATES AND FORECASTS
      • Table Total Market Contract Manufacturing in Medical Devices Market 2010-2015
      • Table Material Handling and Processing Revenues by Category, Cardiology
      • Table Material Handling and Processing Revenues by Category, General Surgery
      • Table Material Handling and Processing Revenues by Category, Imaging
      • Table Material Handling and Processing Revenues by Category, IV Diagnostics
      • Table Material Handling and Processing Revenues by Category, Orthopedics
      • Table Material Handling and Processing Revenues by Category, Respiratory
      • Table Material Handling and Processing Revenues by Category, Ophthalmology
      • Table Material Handling and Processing Revenues by Category, Neurology
      • Table Material Handling and Processing Revenues by Category, Urology
  • Electronic and Advanced Components
    • NETWORKING AND COMMUNICATION EQUIPMENT
      • Networking Equipment
      • Communication Devices
    • OPTICAL COMPONENTS AND OPTICS
      • Optical Components
      • Optics
    • SEMICONDUCTORS
    • DATA ACQUISITION AND SIGNAL CONDITIONING
    • MANUFACTURING SOFTWARE
    • SENSORS, TRANSDUCERS AND DETECTORS
    • MEDICAL SOFTWARE
    • INDUSTRIAL COMPUTERS AND EMBEDDED SYSTEMS
      • Industrial Computers
      • Embedded Systems
    • TEST AND MEASUREMENT EQUIPMENT
      • Measurement Equipment
    • IMAGING AND VIDEO EQUIPMENT
      • Video Equipment
    • REVENUE ESTIMATES AND FORECASTS
      • Table Electronic and Advanced Components, Cardiovascular 2010-2015
      • Table Electronic and Advanced Components, General Surgery 2010-2015
      • Table Electronic and Advanced Components, Imaging 2010-2015
      • Table Electronic and Advanced Components, IV Diagnostics 2010-2015
      • Table Electronic and Advanced Components, Orthopedics 2010-2015
      • Table Electronic and Advanced Components, Respiratory 2010-2015
      • Table Electronic and Advanced Components, Ophthalmology, 2010- 2015
      • Table Electronic and Advanced Components, Neurology 2010-2015
      • Table Electronic and Advanced Components, Urology, 2010-2015
  • Finished Products
    • TYPES OF FINISHED PRODUCTS
    • FINISHED PRODUCT REVENUE ESTIMATES AND FORECASTS
      • Table Finished Clinical Products, Cardiology, 2010-2015
      • Table Finished Clinical Products, General Surgery, 2010-2015
      • Table Finished Clinical Products, Imaging, 2010-2015
      • Table Finished Clinical Products, IV Diagnostics, 2010-2015
      • Table Finished Clinical Products, Orthopedics, 2010-2015
      • Table Finished Clinical Products, Respiratory, 2010-2015
      • Table Finished Clinical Products, Ophthalmology, 2010-2015
      • Table Finished Clinical Products, Neurology, 2010-2015
      • Table Finished Clinical Products, Urology, 2010-2015
  • Regional Markets
    • Table Contract Manufacturing Revenues, US (Materials & Mat. Process., Electronics, Finished)
    • Table Contract Manufacturing Revenues, Europe (Materials & Mat. Process., Electronics, Finished)
    • Table Contract Manufacturing Revenues, Asia (Materials & Mat. Process., Electronics, Finished)
    • Table Contract Manufacturing Revenues, Rest of World (Materials & Mat. Process., Electronics, Finished)
  • Trends
    • HCR DEVICE `TAX' - PRESSURE ON COSTS?
    • BYPASSING US MARKET?
    • RECESSION OVERCOMING CONSERVATISM ABOUT OUTSOURCING
    • FOLLOWING THE CUSTOMER
    • THREE KEY DEVICE AREAS DOMINATE MARKET
    • PATIENT MONITORING A CRITICAL NEED
    • PARTNERSHIPS
    • MERGERS AND ACQUISITIONS
    • AGING POPULATION
      • Table Percent Population Over 65 by Year and Region
  • Company Briefs: OEMs and CMs
    • JOHNSON & JOHNSON
    • GE HEALTHCARE
    • SIEMENS HEALTHCARE
    • CAREFUSION
    • MEDTRONIC
    • BAXTER INTERNATIONAL
    • PHILIPS HEALTHCARE
    • COVIDIEN
    • ABBOTT LABORATORIES
    • BECTON DICKINSON & CO.
    • STRYKER
    • B. BRAUN
    • ST. JUDE MEDICAL
    • 3M HEALTH CARE
    • TOSHIBA
    • ZIMMER
    • SMITH & NEPHEW
    • HOSPIRA
    • DANAHER
    • SYNTHES
    • BECKMAN COULTER
    • TERUMO
    • ALCON
    • FRESENIUS MEDICAL
    • BOSTON SCIENTIFIC
    • CR BARD
    • ACCELLENT
    • BRENTWOOD INDUSTRIES.
    • SYMMETRY MEDICAL
    • LAKE REGION MEDICAL
    • FORT WAYNE METALS
    • HERAEUS MEDICAL
    • TECH GROUP (WEST)
    • FLEXTRONICS (AVAIL)
    • WILSON GREATPATCH
    • MEDICCONCEPTS LIMITED
    • TEGRA MEDICAL
    • HELIX MEDICAL
    • MILLER TECHNICAL SERVICES
    • GEMCITY ENGINEERING COMPANY
    • IMDS
    • WAUKESHA METAL
    • CREGANNA-TACTX MEDICAL
    • PHASE 2 MEDICAL
    • AUTOCAM MEDICAL
    • AMETEK

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