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MEDICAL DEVICE MANUFACTURING & TECHNOLOGY 2005 - MAY 2005


Business Briefing: Medical Device Manufacturing & Technology 2005 will serve as an indispensable source of information to manufacturers of finished medical devices, IVD manufacturers and outsourcing service manufacturers, enabling them to keep abreast of the latest technologies, materials and services in order to maintain and develop leading-edge medical device applications.
Contents:

Contents
Advisory Panel
Foreword
Industry Overview
Regulations & Legislations
Design
Materials/Biomaterials
Expert Perspective
Cardiovascular Devices
Wireless Devices
In Vitro Diagnostics
Device Testing
Reference Section
Technology & Services Section


Contents

Contents

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Advisory Panel

Advisory Panel

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Foreword

Foreword
Neil R Armstrong
Chair, Medical Device Quality Group, Institute of Quality Assurance (IQA) and Chief Executive Officer, MeddiQuest

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Industry Overview

A New Culture of Dialogue for a Future-oriented Health Economy in Germany
Joachim M Schmitt
Director General, German Medical Technology Association (BVMed)

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UK Government and Medical Technology Sector Join Forces in Landmark
John Wilkinson
Director General, Association of British Healthcare Industries (ABHI)

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Regulations & Legislations

Challenges Facing the Medical Device Standards System
Charles Sidebottom
Director, Corporate Standards, Medtronic, Inc. and Secretary,
International Electrotechnical Commission (IEC) Subcommittee (SC) 62A

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ISO 11137 – Requirements for the Validation and Routine Control of Radiation Sterilization of Healthcare Products – A Discussion of Current Revisions
John Harries
UK Expert to WG2 and WG8, International Organization for Standardization (ISO)

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ISO 13485:2003 – A Quality Management Standard for Medical Devices
ISO
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Electromagnetic Compatibility for Functional Safety
EurIng Keith Armstrong
Chairman, Working Group on ‘EMC and Functional Safety’, Institution of Electrical Engineers (IEE)

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The Status of ISO/EN DIS 11607-1 and -2
Dr Michael H Scholla
Industry Vice Chair, Association for the Advancement of Medical Instrumentation (AAMI)

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Design

Using Computational Fluid Dynamics to Examine the Haemodynamics of Artificial Heart Valves
Ajit Yoganathan 1,3 and Fotis Sotiropoulos 2,3
1. Wallace H Coulter Department of Biomedical Engineering,
2. School of Civil and Environmental Engineering and
3. Georgia Institute of Technology

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Materials/Biomaterials

Bioresorbable Polymers in Orthopaedics
David Farrar
Technology Manager for Biomaterials, Smith & Nephew Research Centre

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Metallocene Polypropylene Used in the Pharmaceutical and Medical Sector
Bernd Schütz and Rainer Konrad
Member, Verein Deutscher Ingenieure VDI (The Association of German Engineers) and Product Manager, Ultrapolymers Deutschland GmbH

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Expert Perspective

Expert Perspective
Dr James Barry  Corporate Vice President of R&D, Boston Scientific Corp.
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Cardiovascular Devices

Investigating the Interaction of Coronary Fibroatheromas and Stents
Christopher Feezor
Senior Research and Development Engineer, Vascular Intervention, Guidant Corporation

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Addressing Unmet Clinical Needs in the Catheterisation Laboratory – The Future Role of Device-based Coronary Interventions
Drs Deborah L Kilpatrick and Jeffrey T Ellis
Director, Research and Technology, Vascular Intervention Division and Research Advisor,
Vulnerable Plaque Program, Guidant Corporation

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Safety of Implantable Pacemakers and Cardioverter Defibrillators in the MRI Environment
Dr J Rod Gimbel and Ted McKenna
Parkwest Hospital, Knoxville, Tennessee, and Medtronic

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Trends and Developments in Self-expanding Nitinol Stents
Philippe Poncet
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Wireless Devices

Wireless Healthcare – Bluetooth® and Beyond
Dr Masako Miyazaki
Associate Professor, Faculty of Rehabilitation Medicine, University of Alberta

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In Vitro Diagnostics

In Vitro Diagnosis – A Universe of Information Captured in Three Words
Christine Tarrajat
Director General, European Diagnostics Manufacturers Association (EDMA)

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Optimal Sensitivity of Pregnancy Tests
Drs Ulf-Håkan Stenman and Henrik Alfthan
Department of Clinical Chemistry, Biomedicum Helsinki University Central Hospital

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Device Testing

Testing Implantable Electronic Medical Devices
J Max Cortner
Director of Test Engineering, Guidant Corporation

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Evolving Approaches to Medical Care Require Changes to the Design of Products and Their Packaging
Dr Laura Bix, Javier de la Fuente and Jane E Severin
Assistant Professor, Research Assistant and PhD student, School of Packaging, Michigan State University (MSU)

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Reference Section

Testing Implantable Electronic Medical Devices
J Max Cortner
Director of Test Engineering, Guidant Corporation

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Bioresorbable Polymers in Orthopaedics
David Farrar
Technology Manager for Biomaterials, Smith & Nephew Research Centre

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Investigating the Interaction of Coronary Fibroatheromas and Stents
Christopher Feezor
Senior Research and Development Engineer, Vascular Intervention, Guidant Corporation

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Safety of Implantable Pacemakers and Cardioverter Defibrillators in the MRI Environment
Dr J Rod Gimbel and Ted McKenna
Parkwest Hospital, Knoxville, Tennessee, and Medtronic

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A New Culture of Dialogue for a Future-oriented Health Economy in Germany
Joachim M Schmitt
Director General and Member of the Board, BVMed – German Medical Technology Association

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Using Computational Fluid Dynamics to Examine the Haemodynamics of Artificial Heart Valves
Ajit Yoganathan 1,3 and Fotis Sotiropoulos 2,3
1. Wallace H Coulter Department of Biomedical Engineering, 2. School of Civil and Environmental Engineering and 3. Georgia Institute of Technology

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Technology & Services Section

Corporate Report
Alden Translations
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Current Trends in Durability Testing of Vascular Stents
Bose Corporation – EnduraTEC Systems Group
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Strategic use of Scrapie-free Donor Animals in an International Regulatory Environment Concerned with the Control of Transmissible Spongioform Encephalopathies (TSE)
Capralogics, Inc.
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Medical Device Packaging Printing. In-line, On Demand, Flexible and Cost Effective to the Max.
Amaco Ing. Vonach GMBH
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Avery Dennison at a Glance
Avery Dennison Medical
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Metocene – Metallocene Polypropylene Used in the Pharmaceutical and Medical Sector
Basell Polyolefine GmbH
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A Profile of Biocompatibles International plc – Proprietary Technology Platforms for Drug Delivery and Biocompatibility
Biocompatibles International plc
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A New Class of Drug-delivery Coatings – Porous Carbon–Carbon Composites
Blue Membranes GmbH
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Bluetooth and Medical Technology
Brainboxes
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British Standards Institution – The Certification Process
British Standards Institution
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The Status of ISO/EN DIS 11607-1 and -2
DuPont Medical Packaging
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The Single Market and Patient Mobility
Eucomed
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Corporate Report
Fluent Europe Limited
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Stent Crimping Equipment – Meeting the Varied Customer Requirements
Machine Solutions Inc.
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SKF Actuation Solutions Improve Hospital Economy
Magnetic Elektromotoren AG
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Supplying Materials for High-performance Healthcare Products
GE Advanced Materials
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ISO 11137 – Requirements for the Validation and Routine Control of Radiation Sterilization of Healthcare Products – A Discussion of Current Revisions
Isoton Plc
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Contractual Obligations of Outsourcing Companies in the EU Regulatory Environment
mdi Europa GmbH
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How to Pass FDA Factory Inspections
Medical Device Consultancy
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Facilitating the FDA Bioresearch Monitoring Inspection for Sponsor/monitors
Promedica International
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Aligning Quality and Business Objectives for Success
QMS Consulting, Inc.
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Process Signature Verification in Medical Device Manufacturing
Sciemetric Instruments Inc.
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Woven Filter Solutions for Medical Devices
Sefar
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Optics and Photonics in the Medical Devices Industry in Europe – Framework Seven and its Implications
SPIE – International Society for Optical Engineering
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Medical Device and Pharmaceutical Packaging
Wipak Medical
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Corporate Report
TÜV Product Service GmbH
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