Transcript Medical Plastics Engineering Resins

Product Development and Quality Management Consulting
Medical Plastics – Future Needs
from the Perspective of the Medical
Device Manufacturer
Indian Medical Devices & Plastics Disposables Industry 2009
Ahmedabad, India
February 27-28, 2009
Dr. Vinny Sastri
President, WINOVIA® LLC
www.winovia.com
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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
Class III
17%
Class I
32%
High
Performance
Engineering
19%
Commodity
28%
Engineering
53%
Class II
51%
Breakdown by Device Class
Breakdown by Plastic Type Use
Small
13%
Large
41%
Medium
46%
Breakdown by Company Size
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(Preliminary Results)
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MATERIAL SUPPLIERS & THE QUALITY
SYSTEMS REGULATIONS
Finished Device Manufacturers
Finished Device Manufacturers
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 and Component Suppliers
Raw material specifications, acceptance criteria
Identification and traceability
Supplier audits and qualification
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VALUE CHAIN
FINISHED DEVICE MANUFACTURER
ASSEMBLER
PROCESSOR
DESIGN
SUPPLIER
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TRENDS
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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
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Smaller
Lighter
Stronger
More performance features
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PERFORMANCE
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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
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STERILIZATION
• Gamma used the most, followed by
EtO and Autoclave
• Higher temperature materials at lower
cost for autoclaving
45
40
35
30
25
20
15
10
5
• Need for more radiation stable grades
0
Gamma
EtO
Autoclave
None
eBeam
(Does not add up to 100 as companies may use more than one
method of sterilization)
CLEANLINESS
• Increased demand for material cleanliness, purity
• No contamination
• No discoloration
• Follow current Good Manufacturing Practices (cGMP)
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CHEMICAL RESISTANCE AND DURABILITY
CHEMICAL RESISTANCE
• Cleaning solutions
• Solvents
• Ointments (as in catheter tips)
• IPA, alcohols for cleaning
DURABILITY
• Long term ageing and shelf life studies based on product life cycle
and intended use
• Long term durability
• Durability in different environments and climates
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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 STANDARDS
Standard
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
•Partnering
Technical expertise not sales
Materials expertise
Processing expertise
Applications expertise
Problem 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
Customer Needs
Customer Satisfaction
Post-production
Monitoring
Design &
Development
Production
Test and
Release
Quality Systems – A Total Systems Approach
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ESSENTIAL COMPONENTS AND PROCESS
PARAMETERS
Components
Component 1
Incoming
inspection
and testing of
critical
components /
raw materials
Component 2
Component 3
Process
Parameters
Process Parameter 1
Control of
critical
process
parameters
Process Parameter 2
Process Parameter 3
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Production,
labeling,
packaging,
sterilization,
inspection,
test and
release
Safe, Effective,
Consistent
Finished
Device/Product
Consistency
Process validation
Purchasing controls
Traceability
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PROCESSING
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Flow
Low flash
Consistency
Robustness during processing
Thermal stability
Meet performance criteria and specifications
• Effects of processing on:
Sterilization
Chemical resistance
Leachables and extractables
Biocompatibility
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CONCLUSION
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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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Product Development and Quality Management Consulting
Thank you !
Questions ?
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 Devices
Design Controls
Process Validation
Design for Six Sigma and New Product Development
Six Sigma and Total Quality Management
Strategic Technology Roadmaps
Materials Expertise and Material Selection
Dr. Vinny Sastri
WINOVIA® LLC
136 Chestnut Street, Albany, NY 12210
www.winovia.com
[email protected]
+1 518-436-8110
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