Medical Device Packaging 2009 to 2013

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Bertina Mason
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1 Medical Device Packaging 2009 to 2013 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 Global Population Table Per Capita GDP and Healthcare Spending Table 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 Copyright by Allied Development Corp. Table of Contents - 1

2 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 key concepts 1. Responsibilities 2. Scope of medical device 3. Packaging system 4. Health care facilities C. ISO 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 Allied Development Corp. Table of Contents - 2

3 Section IV: Technology 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 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 Allied Development Corp. Table of Contents - 3

4 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 Allied Development Corp. Table of Contents - 4

5 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 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 Allied Development Corp. Table of Contents - 5

6 Table to 2008 GDP and Healthcare Spending Growth 4. Global demographics and healthcare spending Table 19 Per Capita Healthcare Spending by Age Table Global Population 5. Public vs. private healthcare spending Table Global Healthcare Spending Sources 6. Summary B. Market drivers and trends 1. Healthcare spending Table 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 Allied Development Corp. Table of Contents - 6

7 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 Allied Development Corp. Table of Contents - 7

8 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 G. Primary packaging volume segmented by package type Figure 38 Primary Packaging Volume Segmented by Package Type 2. Projectiion Table 52 Packaging Consumption by Package Type H. Primary packaging value segmented by package type Figure 39 Primary Packaging Value Segmented by Package Type Table 53 Primary Packaging Value Segmented by Package Type I. Primary packaging volume segmented by material type Figure 40 Primary Packaging Volume Segmented by Materials Table 54 Primary Packaging Volume Segmented by Material J. Primary packaging value segmented by material type Figure 41 Medical Device Packaging by Packaging Materials Table 55 Primary Packaging Markets Segmented by Material Type Allied Development Corp. Table of Contents - 8

9 K. Primary packaging volume segmented by geographic region Figure 42 Primary Packaging Volume by Geographic Region Table 56 Primary Packaging Volume by Geographic Region L. Primary packaging volume segmented by sterilization method Figure 43 Primary Packaging Volume by Sterilization Process Table 57 Packaging Consumption by Sterilization Method M. Primary packaging volume segmented by level of automation Figure 44 Primary Packaging Volume by Process Automation 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 Allied Development Corp. Table of Contents - 9

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