1. 1All rights reserved - WINOVIA ® LLC 2009 Dr. Vinny Sastri President, WINOVIA ® LLC www.winovia.com 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

2. 2All rights reserved - WINOVIA ® LLC 2009 AGENDA Introduction Methodology Results Conclusion

3. 3All rights reserved - WINOVIA ® LLC 2009 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

4. 4All rights reserved - WINOVIA ® LLC 2009 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

5. 5All rights reserved - WINOVIA ® LLC 2009 SURVEY - RESPONDENTS BREAKDOWN Breakdown by Device ClassBreakdown by Plastic Type Use Breakdown by Company Size (Preliminary Results)

6. 6All rights reserved - WINOVIA ® LLC 2009 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 ControlsPurchasing Raw material specifications, acceptance criteria Identification and traceability Supplier audits and qualification Finished Device Manufacturers Raw Material and Component Suppliers

7. 7All rights reserved - WINOVIA ® LLC 2009 VALUE CHAIN FINISHED DEVICE MANUFACTURER DESIGN PROCESSOR SUPPLIER ASSEMBLER

8. 8All rights reserved - WINOVIA ® LLC 2009 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

9. 9All rights reserved - WINOVIA ® LLC 2009 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”

10. 10All rights reserved - WINOVIA ® LLC 2009 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)

11. 11All rights reserved - WINOVIA ® LLC 2009 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

12. 12All rights reserved - WINOVIA ® LLC 2009 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

13. 13All rights reserved - WINOVIA ® LLC 2009 ISO 10993 STANDARDS StandardDescription ISO 10993-1:2003Evaluation and testing ISO 10993-2:2006Animal welfare requirements ISO 10993-3:2003Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-4:2002 Amd 1:2006Selection of tests for interactions with blood ISO 10993-5:1999Tests for in vitro cytotoxicity ISO 10993-6:2007Tests for local effects after implantation ISO 10993-7:1995Ethylene oxide sterilization residuals ISO 10993-8:2000Selection and qualification of reference materials for biological tests ISO 10993-9:1999Framework for identification and quantification of potential degradation products ISO 10993-10:2002 Amd 1:2006Tests for irritation and delayed-type hypersensitivity ISO 10993-11:2006Tests for systemic toxicity ISO 10993-12:2007Sample preparation and reference materials ISO 10993-13:1998Identification and quantification of degradation products from polymeric medical devices ISO 10993-14:2001Identification and quantification of degradation products from ceramics ISO 10993-15:2000Identification and quantification of degradation products from metals and alloys ISO 10993-16:1997Toxicokinetic study design for degradation products and leachables ISO 10993-17:2002Establishment of allowable limits for leachable substances ISO 10993-18:2005Chemical characterization of materials ISO/TS 10993-19: 2006Physico-chemical, morphological and topographical characterization of materials ISO/TS 10993-20:2006Principles and methods for immunotoxicology testing of medical devices

14. 14All rights reserved - WINOVIA ® LLC 2009 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”

15. 15All rights reserved - WINOVIA ® LLC 2009 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”

16. 16All rights reserved - WINOVIA ® LLC 2009 QUALITY SYSTEMS – AN ENTERPRISE APPROACH

17. 17All rights reserved - WINOVIA ® LLC 2009 ESSENTIAL COMPONENTS AND PROCESS PARAMETERS

18. 18All rights reserved - WINOVIA ® LLC 2009 PROCESSING 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

19. 19All rights reserved - WINOVIA ® LLC 2009 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

20. 20All rights reserved - WINOVIA ® LLC 2009 Thank you ! Questions ? Dr. Vinny Sastri WINOVIA ® LLC 136 Chestnut Street, Albany, NY 12210 www.winovia.com VSastri@winovia.com +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 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 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 Product Development and Quality Management Consulting