Medical Device Packaging - Global Technologies, Markets, and Opportunities - 2009 to 2013

Table of Contents

Section I:

• Introduction
• A. Study purpose
• B. Medical devices defined
• C. Medical device packaging defined
• D. Study organization
• E. Geographic regions
• F. Study methodology
• G. Conventions

Section II:

• Executive Summary

• A. Regulations and standards
  • 1. Regulation sources
  • 2. Globalization

• B. Technology
  • 1. Sterilization
    • Figure 1 - Sterilization Processes
  • 2. Materials
  • 3. Structures
  • 4. Packaging automation
  • 5. Package formats

• C. Medical device market
  • 1. Drivers and trends
    • Table 1 - 2008 Global Population
    • Table 2 - 2008 Per Capita GDP and Healthcare Spending
    • Table 3 - 2008 Global Healthcare and Device Spending
    • Table 4 - Global Healthcare Spending
  • 2. Market projections
    • Figure 2 - Packaged Units of Medical Devices
    • Figure 3 - Medical Device Growth Rates

• D. Medical device packaging
  • 1. Drivers and trends
  • 2. Total market segmentation
    • Figure 4 - Packaging Volume - All Categories of Packaging
    • Figure 5 - Packaging Value - All Categories of Packaging
  • 3. Categories of packaging
    • Figure 6 - Packaging Volume Segmented by Category
    • Figure 7 - Packaging Value Segmented by Category
  • 4. Primary packaging consumption segmented by end-use
    • Figure 8 - Primary Packaging Consumption Segmented by End-use
  • 5. Primary packaging buyers segmentation
    • Table 5 - Global Packaging Purchases - All Categories
  • 6. Primary packaging segmented by package type
    • Figure 9 - Primary Packaging Consumption by Package Type
    • Figure 10 - Primary Packaging Value Segmented by Package Type
    • Figure 11 - Packaging Growth Rates by Packaging Format
  • 7. Geographic region segmentation
    • Figure 12 - Packaging Consumption by Geographic Region
    • Figure 13 - Packaging Growth Rates by Geographic Region

Section III:

• Regulations and Standards

• A. Regulations and standards
  • 1. Global device and packaging regulations
  • 2. Testing standards
  • 3. Additional concepts

• B. ISO 11607 key concepts
  • 1. Responsibilities
  • 2. Scope of medical device
  • 3. Packaging system
  • 4. Health care facilities

• C. ISO 11607 review
  • 1. General requirements
  • 2. Materials
  • 3. Forming and sealing process
  • 4. Final package

• D. Packaging development process
  • Figure: 14 - Medical Device Package Development Process
  • 1. Material selection
  • 2. Package design
  • 3. Design the manufacturing process
  • 4. Conclusion

• E. Submissions and approval times
  • 1. Approval options
  • 2. Classes of medical devices
    • Figure 15 - Medical Device Classification by FDA in United States
  • 3. Device approval process

• F. Marketing considerations
  • 1. Packaging producers
  • 2. Equipment suppliers
  • 3. ISO quality systems
  • 4. Clean room production
  • 5. Material and process changes

• G. Labeling

• H. Combination healthcare products

Section IV:

• Technology

• A. Technology trends and drivers
  • 1. Regulations
  • 2. Labelling
  • 3. In-package sterilization
  • 4. Sterility procedures
    • Figure 16 - Sterile Presentation of Suture
  • 5. Packaging cost
  • 6. Product and package integrity
  • 7. Easy-open feature
  • 8. Transparency
  • 9. Packaging process automation
  • 10. Environmental factors
  • 11. User perceptions

• B. Sterilization technology
  • Figure 17 - Trends of Sterilization Methods
  • 1. Heat sterilization
  • 2. Ethylene oxide (EtO) gas sterilization
  • 3. Radiation sterilization
  • 4. Emerging sterilization processes
  • 5. Sterility assurance limits
  • 6. Summary

• C. Packaging materials
  • 1. Non-wovens for medical device packaging
    • Table 6 - Comparison of Tyvek Non-Woven Grades Table 7 - Medical Grade Non-woven Suppliers
  • 2. Papers for medical device packaging
    • Table 8 - Medical Grade Paper Producers
  • 3. High-barrier materials
  • 4. Film and sheet

• D. Packaging structures
  • 1. Coated papers and non-wovens
  • 2. High-barrier materials
  • 3. Film and sheet
  • 4. Other materials
    • Figure 18 - Vent System

• E. Package types
  • Figure 19 - Header Bag
  • Table 9 - Package and Film Producers

• F. Medical device packaging equipment
  • 1. Automated packaging equipment
  • 2. Pouch and bag machines
  • 3. Tray formers
  • 4. Thermoform/fill/seal
    • Table 10 - Thermoform/fill/seal Equipment Suppliers
    • Figure 20 - Thermoform/Fill/Seal Process
    • Figure 21 - Chain Drive System
    • Figure 22 - Gripper Design
  • 5. Tray sealers
    • Table 11 - Tray Sealing Equipment Suppliers
    • Figure 23 - Tray Sealer
  • 6. Sealers
    • Figure 24 - Band Sealer
    • Table 12 - Pouch Sealing Equipment Suppliers
  • 7. Horizontal wrappers
  • 8. In-line printing
  • 9. In-line sterilization
  • 10. Packaging materials for high speed packaging
  • 11. Continuous monitoring
  • 12. Packaging equipment suppliers126
    • Table 13 - Packaging Speeds in Select Markets

• G. Environmental considerations
  • 1. Waste reduction
  • 2. Recycling
  • 3. Homogeneous packaging

• H. Cost reduction trends
  • 1. Reduced thickness
  • 2. Use of non-woven vents on lids
  • 3. Peelable films - use of uncoated non-wovens
  • 4. Peelable films - use of uncoated paper
  • 5. Rigid trays to semi-rigid trays
  • 6. New resin formulations for forming web materials

• I. Catheter segment
  • Figure 25 - Foley Catheter and Catheter Packaging
  • Figure 26 -
  • Stent and Guidewire

• J. Drapes
  • 1. Drapes
    • Figure 27 - Drapes and Drape Packaging
  • 2. Sterilization wraps
    • Figure 28 - Sterilization Wrap

• K. Electro-mechanical devices
  • 1. High-value electro-mechanical devices
  • 2. Commodity electro-mechanical devices
    • Figure 29 - Electrosurgical Pencil

• L. Gloves
  • Figure 30 - Glove and Glove Packaging

• M. Injection Systems
  • Figure 31 - Injection Systems and Injection Systems Packaging

• N. Non-invasive devices
  • Figure 32 - Non-invasive Device and Non-invasive Device Packaging

• O. Orthopedic devices
  • Figure 33 - Orthopedic Dental Implant Packaging

• P. Other (includes kits)
  • Figure 34 - Other Packaging Including Kits

• Q. Sutures
  • Figure 35 - Sutures and Suture Packaging

• R. Tubing
  • Figure 36 - Tubing and Tubing Packaging

• S. Wound care
  • Figure 37 - Wound Care and Wound Care Packaging

• T. Summary
  • Table 14 - Popular Packaging Formats in Use Today by Application

Section V:

• Market Trends/Projections

• A. Global healthcare industry
  • Table 15 - Global Healthcare Spending
  • 1. GDP and healthcare spending
    • Table 16 - 2008 Per Capita GDP and Healthcare Spending
  • 2. Global disparity of healthcare spending
    • Table 17 - CAGR of Per Capita GDP by Geographic Region
  • 3. GDP vs. healthcare spending growth
    • Table 18 - 2003 to 2008 GDP and Healthcare Spending Growth
  • 4. Global demographics and healthcare spending
    • Table 19 - Per Capita Healthcare Spending by Age
    • Table 20 - 2008 Global Population
  • 5. Public vs. private healthcare spending
    • Table 21 - 2008 Global Healthcare Spending Sources
  • 6. Summary

• B. Market drivers and trends
  • 1. Healthcare spending
    • Table 22 - 2008 Global Healthcare and Device Spending
  • 2. Demographics
  • 3. Universal healthcare spending
  • 4. Price controls and regulations
  • 5. Device inflation
    • Table 23 - Catheter/Stent Costs
  • 6. Private healthcare spending
  • 7. Standards and regulations
  • 8. Globalization of the healthcare industry
  • 9. Medical tourism
  • 10. Disposable versus reusable devices
  • 11. Technology and device innovation
  • 12. Home healthcare
  • 13. Contract manufacturing
  • 14. Mergers and acquisitions

• C. Packaging drivers and trends
  • 1. Medical device demand
  • 2. Types of users
  • 3. Custom kits
  • 4. Reusable vs. disposable devices
  • 5. Sterilization method
  • 6. Mounting cards
  • 7. Custom devices
  • 8. Packaging cost compared to cost of the device
  • 9. Clean room package production
  • 10. Contract packaging and sterilization
  • 11. Packaging automation
  • 12. Globalization and ISO standardization
  • 13. Rigid versus flexible
  • 14. Downgauging
  • 15. Non-woven versus paper
  • 16. Coated versus uncoated
  • 17. Standard versus reinforced paper
  • 18. Demand for transparent packaging
  • 19. Security
  • 20. Printing and labeling
  • 21. Home healthcare
  • 22. Mergers and acquisitions
  • 23. Environmental

• D. Primary packaging volume segmented by end-use
  • Table 24 - Device Category
  • 1. Catheters
    • Table 25 - Catheters Packaging
  • 2. Drapes
    • Table 26 - Drapes Packaging
  • 3. Electro-mechanical devices
    • Table 27 - Electro-mechanical Device Packaging
  • 4. Gloves
    • Table 28 - Sterilized Gloves Packaging
  • 5. Injection systems
    • Table 29 - Injection Systems Packaging
  • 6. Non-invasive devices
    • Table 30 - Non-invasive Devices Packaging
  • 7. Orthopedic devices
    • Table 31 - Orthopedic Devices Packaging
  • 8. Sutures
    • Table 32 - Sutures Packaging
  • 9. Tubing
    • Table 33 - Tubing Packaging
  • 10. Wound care
    • Table 34 - Wound Care Packaging
  • 11. Other (including kits)
    • Table 35 - Other and Kits Packaging
  • 12. In-hospital
    • Table 36 - In-hospital Packaging
  • 13. Summary
    • Table 37 - Total End-use Packaging
    • Table 38 - Primary Packaging Volume by End-use

• E. Primary packaging value segmented by end-use
  • 1. Primary packaging value segmented by end-use
    • Table 39 - Primary Packaging Value by End-use

• F. Primary packaging purchases
  • 1. Catheters
    • Table 40 - Global Packaging Purchases - Catheters
  • 2. Drapes
    • Table 41 - Global Packaging Purchases - Drapes
  • 3. Electro-mechanical devices
    • Table 42 - Global Packaging Purchases - Electro-mechanical
  • 4. Gloves
    • Table 43 - Global Packaging Purchases - Gloves
  • 5. Injections systems
    • Table 44 - Global Packaging Purchases - Injection Systems
  • 6. Non-invasive devices
    • Table 45 - Global Packaging Purchases - Non-invasive Devices
  • 7. Orthopedic devices
    • Table 46 - Global Packaging Purchases - Orthopedic Devices
  • 8. Sutures
    • Table 47 - Global Packaging Purchases - Sutures
  • 9. Tubing
    • Table 48 - Global Packaging Purchases - Tubing
  • 10. Wound care
    • Table 49 - Global Packaging Purchases - Wound Care
  • 11. Other and kits
    • Table 50 - Global Packaging Purchases - Other and Kits
  • 12. In-hospital
  • 13. Summary
    • Table 51 - Global Packaging Purchases - All Categories
• Primary packaging volume segmented by package type
  • 1. Market
    • Figure 38 - Primary Packaging Volume Segmented by Package Type
  • 2. Projectiion
    • Table 52 - Packaging Consumption by Package Type
• Primary packaging value segmented by package type
  • 1. Market
    • Figure 39 - Primary Packaging Value Segmented by Package Type
  • 2. Projection
    • Table 53 - Primary Packaging Value Segmented by Package Type
• Primary packaging volume segmented by material type
  • 1. Market
    • Figure 40 - Primary Packaging Volume Segmented by Materials
  • 2. Projection
    • Table 54 - Primary Packaging Volume Segmented by Material
• Primary packaging value segmented by material type
  • 1. Market
    • Figure 41 - Medical Device Packaging by Packaging Materials
  • 2. Projection
    • Table 55 - Primary Packaging Markets Segmented by Material Type

• K. Primary packaging volume segmented by geographic region
  • 1. Market
    • Figure 42 - Primary Packaging Volume by Geographic Region
  • 2. Projection
    • Table 56 - Primary Packaging Volume by Geographic Region

• L. Primary packaging volume segmented by sterilization method
  • 1. Market
    • Figure 43 - Primary Packaging Volume by Sterilization Process
  • 2. Projection
    • Table 57 - Packaging Consumption by Sterilization Method

• M. Primary packaging volume segmented by level of automation
  • 1. Market
    • Figure 44 - Primary Packaging Volume by Process Automation
  • 2. Projection
    • Table 58 - Primary Packaging Volume by Process Automation

• N. Insert, secondary, and tertiary packaging - volume and value
  • 1. Insert packaging
    • Table 59 - Insert Packaging Volume by Package Type
    • Table 60 - Insert Packaging Value by Package Type
  • 2. Secondary packaging
    • Table 61 - Secondary Packaging Volume by Package Type
    • Table 62 - Secondary Packaging Value by Package Type
  • 3. Tertiary Packaging
    • Table 63 - Tertiary Packaging Volume by Package Type
    • Table 64 - Tertiary Packaging Value by Package Type

Section VI:

• Packaging Producer Profiles

Section VII:

• Paper/Nonwoven Supplier Profiles

Section VIII:

• Equipment Supplier Profiles

Section IX:

• Glossary