Dr. Vinny Sastri President, WINOVIA ® LLC www.winovia.com

1. 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

2. AGENDA • Introduction • Methodology • Results • Conclusion

3. 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. 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. SURVEY - RESPONDENTS BREAKDOWN Breakdown by Device Class Breakdown by Plastic Type Use (Preliminary Results) Breakdown by Company Size

6. 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

7. VALUE CHAIN FINISHED DEVICE MANUFACTURER ASSEMBLER PROCESSOR DESIGN SUPPLIER

8. 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. 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. STERILIZATION AND CLEANLINESS STERILIZATION • Gamma used the most, followed by EtO and Autoclave • Higher temperature materials at lower cost for autoclaving • Need for more radiation stable grades (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)

11. 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

12. 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. ISO 10993 STANDARDS

14. 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. 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. QUALITY SYSTEMS – AN ENTERPRISE APPROACH

17. ESSENTIAL COMPONENTS AND PROCESS PARAMETERS

18. 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. 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. 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 VSastri@winovia.com +1 518-436-8110