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1All rights reserved - WINOVIA® LLC 2009
Dr. Vinny SastriPresident, WINOVIA® LLC
www.winovia.com
Product Development and Quality Management Consulting
Medical Plastics – Future Needs from the Perspective of the Medical
Device Manufacturer
Medical Plastics – Future Needs from the Perspective of the Medical
Device Manufacturer
Indian Medical Devices & Plastics Disposables Industry 2009Ahmedabad, India
February 27-28, 2009
2All rights reserved - WINOVIA® LLC 2009
AGENDA
• Introduction
• Methodology
• Results
• Conclusion
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SURVEY
Purpose:- Understand the trends and needs of medical
plastics from the perspective of the device manufacturer.
- To hear the voice of the device manufacturer.
• Regulations• Performance• Quality• Buyer-supplier interaction and relationships
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METHODOLOGY
• Live one-on-one, interactive interviews
• Follow-up questions
• Anonymous
• Small, medium and large companies
• Those involved in the selection and use of plastics -Product design and development, manufacturing, quality etc.
• All functional levels - vice presidents, owners, directors, managers, engineers, scientists
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SURVEY - RESPONDENTS BREAKDOWN
Breakdown by Device Class Breakdown by Plastic Type Use
Breakdown by Company Size(Preliminary Results)
Class III17% Class I
32%
Class II51%
Engineering53%
Commodity28%
High Performance Engineering
19%
Medium46%
Small13%
Large41%
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MATERIAL SUPPLIERS & THE QUALITY SYSTEMS REGULATIONS
FDA – 21 CFR Parts 820 Quality Systems Regulation
ISO 13485:2003 Medical devices – Quality management
systems – Requirements for regulatory purposes
Purchasing Controls Purchasing
Raw material specifications, acceptance criteriaIdentification and traceability
Supplier audits and qualification
Finished Device Manufacturers Finished Device Manufacturers
Raw Material and Component Suppliers
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VALUE CHAIN
FINISHED DEVICE MANUFACTURER
DESIGN
PROCESSOR
SUPPLIER
ASSEMBLER
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TRENDS
• Cost reduction• Increased substitution of plastic for metals and glass• Single use devices replacing reusable devices• Cleanliness• Coatings for surface modification and property enhancement• Globalization – products and raw material supply
• Smaller• Lighter• Stronger• More performance features
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PERFORMANCE
• Light weight• High strength• Impact strength• Dimensional stability• Finishes and colors• Wear resistance• Abrasion resistance• Fatigue• Aesthetics (colors, finishes)• Flow
• Electrostatic dissipative (ESD) and electro conductive materials• Electromagnetic Interference (EMI) /Radiofrequency Interference (RFI) shielding
– inherent in the plastic or with secondary spraying or shielding operations• Antistatic materials• Thermal management• Impregnated with drugs, antibacterial drugs, anti-thrombosis drugs (controlled
release)
“We need polyolefins that act as polyurethanes”
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STERILIZATION AND CLEANLINESS
• Gamma used the most, followed by EtO and Autoclave
• Higher temperature materials at lower cost for autoclaving
• Need for more radiation stable grades
STERILIZATION
CLEANLINESS
• Increased demand for material cleanliness, purity
• No contamination
• No discoloration
• Follow current Good Manufacturing Practices (cGMP)
(Does not add up to 100 as companies may use more than one method of sterilization)
0
5
10
15
20
25
30
35
40
45
50
Gamma EtO Autoclave None eBeam
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CHEMICAL RESISTANCE AND DURABILITY
• Cleaning solutions
• Solvents
• Ointments (as in catheter tips)
• IPA, alcohols for cleaning
• Long term ageing and shelf life studies based on product life cycle and intended use
• Long term durability
• Durability in different environments and climates
CHEMICAL RESISTANCE
DURABILITY
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BIOCOMPATIBILITY – BIOSTABILITY
• USP Class VI• Biocompatibile materials that do not degrade over time• Biocompatibility (from months to 5 – 10 years…) – Biostability• Non-leachables• Education and understanding of how raw materials affect biocompatibility
Biological effects include:• Cytotoxicity• Sensitization• Irritation/Intracutaneous• Systemic Toxicity• Subchronic Toxicity• Genotoxicity• Implantation• Hemocompatibility• Carcinogenesis• Reproductive• Biodegradation
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ISO 10993 STANDARDSStandard Description
ISO 10993-1:2003 Evaluation and testing
ISO 10993-2:2006 Animal welfare requirements
ISO 10993-3:2003 Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2002 Amd 1:2006 Selection of tests for interactions with blood
ISO 10993-5:1999 Tests for in vitro cytotoxicity
ISO 10993-6:2007 Tests for local effects after implantation
ISO 10993-7:1995 Ethylene oxide sterilization residuals
ISO 10993-8:2000 Selection and qualification of reference materials for biological tests
ISO 10993-9:1999 Framework for identification and quantification of potential degradation products
ISO 10993-10:2002 Amd 1:2006 Tests for irritation and delayed-type hypersensitivity
ISO 10993-11:2006 Tests for systemic toxicity
ISO 10993-12:2007 Sample preparation and reference materials
ISO 10993-13:1998 Identification and quantification of degradation products from polymeric medical devices
ISO 10993-14:2001 Identification and quantification of degradation products from ceramics
ISO 10993-15:2000 Identification and quantification of degradation products from metals and alloys
ISO 10993-16:1997 Toxicokinetic study design for degradation products and leachables
ISO 10993-17:2002 Establishment of allowable limits for leachable substances
ISO 10993-18:2005 Chemical characterization of materials
ISO/TS 10993-19: 2006 Physico-chemical, morphological and topographical characterization of materials
ISO/TS 10993-20:2006 Principles and methods for immunotoxicology testing of medical devices
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NEEDS
•PartneringTechnical expertise not salesMaterials expertiseProcessing expertiseApplications expertiseProblem solving
•Breadth of material portfolio
•Meet performance criteria and specifications
•Responsiveness (CAPAs, NCMRs…etc)
•Master Files
“Listen to some of our ideas”
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NEEDS
•New technologies•New materials•Customization•Assurance of supply•No formulation changes
•Giving market analysis, pricing trends•Communication (technologies, pricing)•Building confidence and trust in quality and supply
“Learn the medical device business and regulations”
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QUALITY SYSTEMS – AN ENTERPRISE APPROACH
Design & Development
ProductionTest and Release
Post-production Monitoring
Customer Needs Customer Satisfaction
Quality Systems – A Total Systems Approach
Design & Development
ProductionTest and Release
Post-production Monitoring
Customer Needs Customer Satisfaction
Quality Systems – A Total Systems Approach
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ESSENTIAL COMPONENTS AND PROCESS PARAMETERS
Component 1
Component 2
Component 3
Incoming inspection
and testing of critical
components / raw materials
Production, labeling,
packaging, sterilization, inspection,
test and release
Safe, Effective, Consistent Finished
Device/Product
Process Parameter 1
Process Parameter 2
Process Parameter 3
Control of critical
process parameters
Components
Process Parameters
Consistency Process validation
Purchasing controlsTraceability
Component 1
Component 2
Component 3
Incoming inspection
and testing of critical
components / raw materials
Production, labeling,
packaging, sterilization, inspection,
test and release
Safe, Effective, Consistent Finished
Device/Product
Process Parameter 1
Process Parameter 2
Process Parameter 3
Control of critical
process parameters
Components
Process Parameters
Consistency Process validation
Purchasing controlsTraceability
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PROCESSING
• Flow• Low flash• Consistency • Robustness during processing• Thermal stability• Meet performance criteria and specifications
• Effects of processing on:SterilizationChemical resistanceLeachables and extractablesBiocompatibility
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CONCLUSION
• Cost reduction pressures• High performance materials at lower costs• Customized formulations• New technologies and materials• Breadth of product portfolio• Partnering• Data and information sharing• Responsiveness• Quality and consistency• Use of current Good Manufacturing Practices
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Thank you !Questions ?
Dr. Vinny SastriWINOVIA® LLC
136 Chestnut Street, Albany, NY 12210www.winovia.com
[email protected]+1 518-436-8110
WINOVIA® LLC is a consulting company that provides customized, sustainable solutions and strategies in new product development, quality management and high performance materials. WINOVIA® LLC provides consulting and training in:
FDA and ISO Quality Systems Regulations for Medical DevicesDesign ControlsProcess ValidationDesign for Six Sigma and New Product DevelopmentSix Sigma and Total Quality ManagementStrategic Technology RoadmapsMaterials Expertise and Material Selection
WINOVIA® LLC is a consulting company that provides customized, sustainable solutions and strategies in new product development, quality management and high performance materials. WINOVIA® LLC provides consulting and training in:
FDA and ISO Quality Systems Regulations for Medical DevicesDesign ControlsProcess ValidationDesign for Six Sigma and New Product DevelopmentSix Sigma and Total Quality ManagementStrategic Technology RoadmapsMaterials Expertise and Material Selection
Product Development and Quality Management Consulting