Medical Device Packaging - 2009 to 2013 - TOC - TOC

Table of Contents

Section I: Introduction
1. A. Study purpose
2. B. Medical devices defined
3. C. Medical device packaging defined
4. D. Study organization
5. E. Geographic regions
6. F. Study methodology
7. G. Conventions
Section II: Executive Summary
1. A. Regulations and standards
  1. 1. Regulation sources
  2. 2. Globalization
2. B. Technology
  1. 1. Sterilization
    1. Figure 1 – Sterilization Processes
  2. 2. Materials
  3. 3. Structures
  4. 4. Packaging automation
  5. 5. Package formats
3. C. Medical device market
  1. 1. Drivers and trends
    1. Table 1 – 2008 Global Population
    2. Table 2 – 2008 Per Capita GDP and Healthcare Spending
    3. Table 3 – 2008 Global Healthcare and Device Spending
    4. Table 4 – Global Healthcare Spending
  2. 2. Market projections
    1. Figure 2 – Packaged Units of Medical Devices
    2. Figure 3 – Medical Device Growth Rates
4. D. Medical device packaging
  1. 1. Drivers and trends
  2. 2. Total market segmentation
    1. Figure 4 – Packaging Volume – All Categories of Packaging
    2. Figure 5 – Packaging Value – All Categories of Packaging
  3. 3. Categories of packaging
    1. Figure 6 – Packaging Volume Segmented by Category
    2. Figure 7 – Packaging Value Segmented by Category
  4. 4. Primary packaging consumption segmented by end-use
    1. Figure 8 – Primary Packaging Consumption Segmented by End-use
  5. 5. Primary packaging buyers segmentation
    1. Table 5 – Global Packaging Purchases – All Categories
  6. 6. Primary packaging segmented by package type
    1. Figure 9 – Primary Packaging Consumption by Package Type
    2. Figure 10 – Primary Packaging Value Segmented by Package Type
    3. Figure 11 – Packaging Growth Rates by Packaging Format
  7. 7. Geographic region segmentation
    1. Figure 12 – Packaging Consumption by Geographic Region
    2. Figure 13 – Packaging Growth Rates by Geographic Region
Section III: Regulations and Standards
1. A. Regulations and standards
  1. 1. Global device and packaging regulations
  2. 2. Testing standards
  3. 3. Additional concepts
2. B. ISO 11607 key concepts
  1. 1. Responsibilities
  2. 2. Scope of medical device
  3. 3. Packaging system
  4. 4. Health care facilities
3. C. ISO 11607 review
  1. 1. General requirements
  2. 2. Materials
  3. 3. Forming and sealing process
  4. 4. Final package
4. D. Packaging development process
  1. Figure: 14 – Medical Device Package Development Process
  2. 1. Material selection
  3. 2. Package design
  4. 3. Design the manufacturing process
  5. 4. Conclusion
5. E. Submissions and approval times
  1. 1. Approval options
  2. 2. Classes of medical devices
    1. Figure 15 – Medical Device Classification by FDA in United States
  3. 3. Device approval process
6. F. Marketing considerations
  1. 1. Packaging producers
  2. 2. Equipment suppliers
  3. 3. ISO quality systems
  4. 4. Clean room production
  5. 5. Material and process changes
7. G. Labeling
8. H. Combination healthcare products
Section IV: Technology
1. A. Technology trends and drivers
  1. 1. Regulations
  2. 2. Labelling
  3. 3. In-package sterilization
  4. 4. Sterility procedures
    1. Figure 16 – Sterile Presentation of Suture
  5. 5. Packaging cost
  6. 6. Product and package integrity
  7. 7. Easy-open feature
  8. 8. Transparency
  9. 9. Packaging process automation
  10. 10. Environmental factors
  11. 11. User perceptions
2. B. Sterilization technology
  1. Figure 17 – Trends of Sterilization Methods
  2. 1. Heat sterilization
  3. 2. Ethylene oxide (EtO) gas sterilization
  4. 3. Radiation sterilization
  5. 4. Emerging sterilization processes
  6. 5. Sterility assurance limits
  7. 6. Summary
3. C. Packaging materials
  1. 1. Non-wovens for medical device packaging
    1. Table 6 – Comparison of Tyvek Non-Woven Grades
    2. Table 7 – Medical Grade Non-woven Suppliers
  2. 2. Papers for medical device packaging
    1. Table 8 – Medical Grade Paper Producers
  3. 3. High-barrier materials
  4. 4. Film and sheet
4. D. Packaging structures
  1. Figure: 14 – Medical Device Package Development Process
  2. 1. Coated papers and non-wovens
  3. 2. High-barrier materials
  4. 3. Film and sheet
  5. 4. Other materials
    1. Figure 18 – Vent System
5. E. Package types
  1. Figure 19 – Header Bag
  2. Table 9 – Package and Film Producers
6. F. Medical device packaging equipment
  1. 1. Automated packaging equipment
  2. 2. Pouch and bag machines
  3. 3. Tray formers
  4. 4. Thermoform/fill/seal
    1. Table 10 – Thermoform/fill/seal Equipment Suppliers
    2. Figure 20 – Thermoform/Fill/Seal Process
    3. Figure 21 – Chain Drive System
    4. Figure 22 – Gripper Design
  5. 5. Tray sealers
    1. Table 11 – Tray Sealing Equipment Suppliers
    2. Figure 23 – Tray Sealer
  6. 6. Sealers
    1. Figure 24 – Band Sealer
    2. Table 12 – Pouch Sealing Equipment Suppliers
  7. 7. Horizontal wrappers
  8. 8. In-line printing
  9. 9. In-line sterilization
  10. 10. Packaging materials for high speed packaging
  11. 11. Continuous monitoring
  12. 12. Packaging equipment suppliers126
    1. Table 13 – Packaging Speeds in Select Markets
7. G. Environmental considerations
  1. 1. Waste reduction
  2. 2. Recycling
  3. 3. Homogeneous packaging
8. H. Cost reduction trends
  1. 1. Reduced thickness
  2. 2. Use of non-woven vents on lids
  3. 3. Peelable films – use of uncoated non-wovens
  4. 4. Peelable films – use of uncoated paper
  5. 5. Rigid trays to semi-rigid trays
  6. 6. New resin formulations for forming web materials
9. I. Catheter segment
  1. Figure 25 – Foley Catheter and Catheter Packaging
  2. Figure 26 – Stent and Guidewire
10. J. Drapes
  1. 1. Drapes
    1. Figure 27 – Drapes and Drape Packaging
  2. 2. Sterilization wraps
    1. Figure 28 – Sterilization Wrap
11. K. Electro-mechanical devices
  1. 1. High-value electro-mechanical devices
  2. 2. Commodity electro-mechanical devices
    1. Figure 29 – Electrosurgical Pencil
12. L. Gloves
  1. Figure 30 – Glove and Glove Packaging
13. M. Injection Systems
  1. Figure 31 – Injection Systems and Injection Systems Packaging
14. N. Non-invasive devices
  1. Figure 32 – Non-invasive Device and Non-invasive Device Packaging
15. O. Orthopedic devices
  1. Figure 33 – Orthopedic Dental Implant Packaging
16. P. Other (includes kits)
  1. Figure 34 – Other Packaging Including Kits
17. Q. Sutures
  1. Figure 35 – Sutures and Suture Packaging
18. R. Tubing
  1. Figure 36 – Tubing and Tubing Packaging
19. S. Wound care
  1. Figure 37 – Wound Care and Wound Care Packaging
20. T. Summary
  1. Table 14 – Popular Packaging Formats in Use Today by Application
Section V: Market Trends/Projections
1. A. Global healthcare industry
  1. Table 15 – Global Healthcare Spending
  2. 1. GDP and healthcare spending
    1. Table 16 – 2008 Per Capita GDP and Healthcare Spending
  3. 2. Global disparity of healthcare spending
    1. Table 17 – CAGR of Per Capita GDP by Geographic Region
  4. 3. GDP vs. healthcare spending growth
    1. Table 18 – 2003 to 2008 GDP and Healthcare Spending Growth
  5. 4. Global demographics and healthcare spending
    1. Table 19 – Per Capita Healthcare Spending by Age
    2. Table 20 – 2008 Global Population
  6. 5. Public vs. private healthcare spending
    1. Table 21 – 2008 Global Healthcare Spending Sources
  7. 6. Summary
2. B. Market drivers and trends
  1. 1. Healthcare spending
    1. Table 22 – 2008 Global Healthcare and Device Spending
  2. 2. Demographics
  3. 3. Universal healthcare spending
  4. 4. Price controls and regulations
  5. 5. Device inflation
    1. Table 23 – Catheter/Stent Costs
  6. 6. Private healthcare spending
  7. 7. Standards and regulations
  8. 8. Globalization of the healthcare industry
  9. 9. Medical tourism
  10. 10. Disposable versus reusable devices
  11. 11. Technology and device innovation
  12. 12. Home healthcare
  13. 13. Contract manufacturing
  14. 14. Mergers and acquisitions
3. C. Packaging materials
  1. 1. Medical device demand
  2. 2. Types of users
  3. 3. Custom kits
  4. 4. Reusable vs. disposable devices
  5. 5. Sterilization method
  6. 6. Mounting cards
  7. 7. Custom devices
  8. 8. Packaging cost compared to cost of the device
  9. 9. Clean room package production
  10. 10. Contract packaging and sterilization
  11. 11. Packaging automation
  12. 12. Globalization and ISO standardization
  13. 13. Rigid versus flexible
  14. 14. Downgauging
  15. 15. Non-woven versus paper
  16. 16. Coated versus uncoated
  17. 17. Standard versus reinforced paper
  18. 18. Demand for transparent packaging
  19. 19. Security
  20. 20. Printing and labeling
  21. 21. Home healthcare
  22. 22. Mergers and acquisitions
  23. 23. Environmental
4. D. Primary packaging volume segmented by end-use
  1. Table 24 –Device Category
  2. 1. Catheters
    1. Table 25 – Catheters Packaging
  3. 2. Drapes
    1. Table 26 – Drapes Packaging
  4. 3. Electro-mechanical devices
    1. Table 27 – Electro-mechanical Device Packaging
  5. 4. Gloves
    1. Table 28 – Sterilized Gloves Packaging
  6. 5. Injection systems
    1. Table 29 – Injection Systems Packaging
  7. 6. Non-invasive devices
    1. Table 30 –Non-invasive Devices Packaging
  8. 7. Orthopedic devices
    1. Table 31 – Orthopedic Devices Packaging
  9. 8. Sutures
    1. Table 32 – Sutures Packaging
  10. 9. Tubing
    1. Table 33 – Tubing Packaging
  11. 10. Wound care
    1. Table 34 – Wound Care Packaging
  12. 11. Other (including kits)
    1. Table 35 – Other and Kits Packaging
  13. 12. In-hospital
    1. Table 36 – In-hospital Packaging
  14. 13. Summary
    1. Table 37 – Total End-use Packaging
    2. Table 38 – Primary Packaging Volume by End-use
5. E. Primary packaging value segmented by end-use
  1. 1. Primary packaging value segmented by end-use
    1. Table 39 – Primary Packaging Value by End-use
6. F. Primary packaging purchases
  1. 1. Catheters
    1. Table 40 – Global Packaging Purchases – Catheters
  2. 2. Drapes
    1. Table 41 – Global Packaging Purchases – Drapes
  3. 3. Electro-mechanical devices
    1. Table 42 – Global Packaging Purchases – Electro-mechanical
  4. 4. Gloves
    1. Table 43 – Global Packaging Purchases – Gloves
  5. 5. Injection systems
    1. Table 44 – Global Packaging Purchases – Injection Systems
  6. 6. Non-invasive devices
    1. Table 45 – Global Packaging Purchases – Non-invasive Devices
  7. 7. Orthopedic devices
    1. Table 46 – Global Packaging Purchases – Orthopedic Devices
  8. 8. Sutures
    1. Table 47 – Global Packaging Purchases – Sutures
  9. 9. Tubing
    1. Table 48 – Global Packaging Purchases – Tubing
  10. 10. Wound care
    1. Table 49 – Global Packaging Purchases – Wound Care
  11. 11. Other (including kits)
    1. Table 50 – Global Packaging Purchases – Other and Kits
  12. 12. In-hospital
  13. 13. Summary
    1. Table 51 – Global Packaging Purchases – All Categories
7. G. Primary packaging volume segmented by package type
  1. 1. Market
    1. Figure 38 – Primary Packaging Volume Segmented by Package Type
  2. 2. Projectiion
    1. Table 52 – Packaging Consumption by Package Type
8. H. Primary packaging value segmented by package type
  1. 1. Market
    1. Figure 39 – Primary Packaging Value Segmented by Package Type
  2. 2. Projectiion
    1. Table 53 – Primary Packaging Value Segmented by Package Type
9. I. Primary packaging volume segmented by material type
  1. 1. Market
    1. Figure 40 – Primary Packaging Volume Segmented by Materials
  2. 2. Projectiion
    1. Table 54 – Primary Packaging Volume Segmented by Material
10. J. Primary packaging value segmented by material type
  1. 1. Market
    1. Figure 41 – Medical Device Packaging by Packaging Materials
  2. 2. Projectiion
    1. Table 55 – Primary Packaging Markets Segmented by Material Type
11. K. Primary packaging volume segmented by geographic region
  1. 1. Market
    1. Figure 42 – Primary Packaging Volume by Geographic Region
  2. 2. Projectiion
    1. Table 56 – Primary Packaging Volume by Geographic Region
12. L. Primary packaging volume segmented by sterilization method
  1. 1. Market
    1. Figure 43 – Primary Packaging Volume by Sterilization Process
  2. 2. Projectiion
    1. Table 57 – Packaging Consumption by Sterilization Method
13. M. Primary packaging volume segmented by level of automation
  1. 1. Market
    1. Figure 44 – Primary Packaging Volume by Process Automation
  2. 2. Projectiion
    1. Table 58 – Primary Packaging Volume by Process Automation
14. N. Insert, secondary, and tertiary packaging – volume and value
  1. 1. Insert packaging
    1. Table 59 – Insert Packaging Volume by Package Type
    2. Table 60 – Insert Packaging Value by Package Type
  2. 2. Secondary packaging
    1. Table 61 – Secondary Packaging Volume by Package Type
    2. Table 62 – Secondary Packaging Value by Package Type
  3. 3. Tertiary Packaging
    1. Table 63 – Tertiary Packaging Volume by Package Type
    2. 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