Dr. Vinny Sastri President, WINOVIA ® LLC

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

Indian Medical Devices & Plastics Disposables Industry 2009Ahmedabad, India

February 27-28, 2009


AGENDA

• Introduction

• Methodology

• Results

• Conclusion


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


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


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%


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


VALUE CHAIN

FINISHED DEVICE MANUFACTURER

DESIGN

PROCESSOR

SUPPLIER

ASSEMBLER


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


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”


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


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


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


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


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”


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”


QUALITY SYSTEMS – AN ENTERPRISE APPROACH

Design & Development Production Test and

Release

Post-production Monitoring

Customer Needs Customer Satisfaction

Quality Systems – A Total Systems Approach

Design & Development Production Test and

Release

Post-production Monitoring

Customer Needs Customer Satisfaction

Quality Systems – A Total Systems Approach


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


PROCESSING

• Flow• Low flash• Consistency • Robustness during processing• Thermal stability• Meet performance criteria and specifications

• Effects of processing on:SterilizationChemical resistanceLeachables and extractablesBiocompatibility


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


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

Product Development and Quality Management Consulting

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Dr. Vinny Sastri President, WINOVIA ® LLC