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Medical Device Packaging 2017 to 2021

"Medical Device Packaging 2017-2021" is a global study that connects trends in global macroeconomics, demographics, healthcare spending, and spending on medical devices to spending on medical device packaging. With global healthcare spending of $10.7 trillion and global spending on medical devices of $512 billion, the medical device packaging market will reach $5.4 billion by 2021. 

In addition to value, Medical Device Packaging provides a complete analysis of volume measured in area for a full compliment of market segmentations. It outlines fast growing market end-use segments such as catheters and orthopedics. It explains the trends and provides a quantitative forecast for all of the sterilization techniques used for medical devices, and it examines the corresponding packaging implications. In addition to end-use segments and sterilization methods, the study breaks down the global industry by geographic region, materials, package type, level of automation, and other characteristics. 

The Profiles section includes analyses of the key packaging producers, paper and non-woven suppliers, and equipment suppliers. 


Section I: Introduction
A. Medical device packaging defined
B. Medical device packaging defined
1. Medical devices defined
2. Combination devices
3. Medical device packaging
4. Sterile barrier
5. Sterile field
6. Sterility acceptable limits
C. Study organization
D. Study methodology
E. Geographic regions
F. Conventions
Section II: 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 the package
4. Final package
D. Packaging development process
1. Material selection
2. Package design
3. Design the manufacturing process
4. ISO 11607 in practice
5. Conclusion
E. Approval submissions and response times
1. Classes of medical devices
2. Approval options
3. Device approval process and timeline
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 III: Technology
A. Technology drivers and trends
1. Product safety
2. Labeling
3. In-package sterilization
4. Sterility procedures
5. Packaging cost
6. Product and package integrity
7. Easy-open feature
8. Combinations devices
9. Transparency
10. Packaging process automation
11. Environmental factors
12. In-line thermoforming
13. Seal validation
B. UDIS and labeling
1. Uniform device identification system (UDIS)
2. Bar codes
3. Label space
4. Anti-counterfeiting
C. Sterilization technology
1. Heat sterilization
2. Ethylene oxide (EtO) gas sterilization
3. Gamma radiation sterilization
4. Electron beam radiation sterilization
5. Other sterilization methods
6. Other sterilization technologies (emerging)
7. Sterility assurance limits
8. Contract sterilization
D. Packaging materials
1. Non-wovens and paper
2. Papers for medical device packaging
E. Packaging structures
1. Papers and non-wovens
2. High-barrier materials
3. Film and sheet
F. Finished packaging
1. Finished package types
2. Unique medical device package types
3. Suppliers
G. Medical device packaging equipment
1. Automated packaging equipment
2. Pouch and bag machines
3. Tray formers
4. Thermoform/fill/seal
5. Tray sealers
6. Sealers
7. Horizontal wrappers
8. Four-side-seal
9. Other packaging equipment
10. In-line printing
11. In-line sterilization
12. Machine vision quality systems
H. Environmental considerations
1. Source reduction
2. Raw material selection
3. Package recycling
I. Cost reduction trends
1. Reduced thickness
2. Package size
3. Rigid trays to semi-rigid trays
4. In-house thermoforming
5. Flow packaging
6. Non-woven vents on lids
7. Peelable heat-seal films
8. Non-wovens
J. Catheter segment
K. Drapes
1. Drapes
L. Electro-mechanical devices
1. High-value electro-mechanical devices
2. Commodity electro-mechanical devices
M. Gloves
N. Injection Systems
O. Minimally-invasive devices
P. Orthopedic devices
Q. Other (includes kits)
R. Sutures
S. Tubing
T. Wound care
U. In-hospital packaging
1. Sterilization wraps
2. Sterilization cases
3. Pouches and bags
4. Sterilization methods
V. Summary
Section IV: Market Trends and Projections
A. Global healthcare industry
1. Global healthcare spending
2. Population and GDP factors
3. Healthcare and GDP considerations
4. Sources of healthcare spending
5. Disparity of healthcare spending
6. Demographics and healthcare spending
7. Summary
B. Medical device drivers and trends
1. Global medical device revenue
2. Device export activity
3. Demographics
4. Competing drug delivery methods
5. Medical tourism
6. Disposable versus reusable devices
C. Packaging drivers and trends
1. Medical device demand
2. Export activity 3. Sterilization method
4. Types of users
5. Packaging automation
6. Rigid versus flexible
7. Downgauging
8. Non-woven versus paper (porous packaging)
9. Patch film rollstock
10. Direct seal films
11. Barrier packaging
12. Custom kits
13. Insert packaging
14. Clean room package production
15. Qualification process
16. Security
17. Printing and labeling
18. Globalization and ISO standardization
D. Primary packaging volume segmented by end-use
1. Catheters
2. Drapes
3. Electro-mechanical devices
4. Gloves
5. Injection systems
6. Minimally-invasive devices
7. Orthopedic devices
8. Sutures
9. Tubing
10. Wound care
11. Other (kits)
12. In-hospital
13. Summary
E. Primary packaging value segmented by end-use
1. Primary packaging value segmented by end-use
F. Primary packaging purchases
1. Catheters
2. Drapes
3. Electro-mechanical devices
4. Gloves
5. Injections systems
6. Minimally-invasive devices
7. Orthopedic devices
8. Sutures
9. Tubing
10. Wound care
11. Other and kits
12. In-hospital
13. Summary
G. Primary packaging volume segmented by package type
1. Pouches and bags
2. Header bags
3. Lidding
4. Bottom web
5. Rigid trays
6. Other
H. Primary packaging value segmented by package type
1. Pouches and bags
2. Header bags
3. Lidding
4. Bottom webs
5. Rigid trays
I. Primary packaging volume segmented by material type
1. Paper
2. Non-woven
3. Polymer
4. High-barrier
5. Other
J. Primary packaging value segmented by material type
1. Polymer
2. High-barrier
3. Non-woven
4. Paper
K. Primary packaging volume segmented by geographic region
1. Europe
2. North America
3. Japan
4. China
5. Asia
6. ROW
L. Medical device volume segmented by sterilization method
1. EtO
2. Gamma
3. Electron beam
4. Heat
5. Other
M. Medical device volume segmented by level of automation
1. Manual and semi-automated
2. Automated
N. Insert, secondary, and tertiary packaging volume and value
1. Insert packaging volume by material type
2. Insert packaging value by material type
3. Secondary packaging volume by package type
4. Secondary packaging value by package type
5. Tertiary packaging volume segmented by package type
6. Tertiary packaging value by package type
Section V: Packaging Producer Profiles
Section VI: Paper/Nonwoven Supplier Profiles
Section VII: Equipment Supplier Profiles
Section VIII: Glossary
Figures: 20
Tables: 58

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