Keynote:
Materials for Medical Applications: |
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| From Being Part of the Problem to Being Part of the Solution |
| Introduction by: Norbert Sparrow, Editor-in-Chief, EMDT |
| Presented by: Dr. Xiang Zhang, Division of Medical Materials and Devices, CERAM |
About the Keynote Address
Advanced materials for medical applications require a fundamental understanding of materials in use. Adverse incidents associated with medical devices and pharmaceuticals are being reported more frequently by global regulatory bodies, and their cause is often associated with the materials' properties and applications. |
| Materials science holds the key to product development, improvement and failure analysis and, consequently, failure avoidance. In theory, and in practice, materials science is a complex combination of several scientific disciplines including chemistry, physics, engineering, and various technologies. The complexity comes from the fact that materials are living matter, changing behaviour according to their properties and intended use. From a starting point of basic chemistry—imagine this as a brick, if you will—the materials morph and change until they are seen in action—a building made of bricks, in our analogy. From the material's chemical starting point to its actual materialisation and use, numerous factors come into play. Unfortunately, all of them are variables and influence each other. Hence, no single scientific discipline can manage problematic issues associated with materials. |
| The complexity of materials science means that medical device and pharmaceutical companies often are unaware of the hidden factors that cause product failures. A clear understanding of critical material characteristics and all associated factors that can affect the properties (and performance of the finished product) is essential for researchers, designers, engineers and quality managers. |
| The keynote will address materials issues associated with a range of medical devices and outline how materials will play an ever-increasing role in the development of next-generation medical devices and combination products. |
About Dr. Zhang
Dr. Zhang has combined experienced in both academia and industry. He is a materials physicist, undertaking his PhD. and postdoctoral research at Cranfield University where he studied micro-mechanics and micro-fracture mechanics of toughening plastics. After spending a further four years on |
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polymerresearch for industrial applications, he was awarded an industrial fellowship at the University of Cambridge in 1995 to carry on research in nano and micro fracture mechanics of gamma-ray-irradiated polymers and carbon-nano film. Dr. Zhang's industry experience was gained at Medisense, Abbott Laboratories, where, as Principal Scientist, his work covered almost all aspects of medical materials/devices, from R&D and manufacturing support to failure analysis and QC. Prior to joining CERAM, Xiang worked as Director of Cambridge NanoTech, in the field of nano conductive materials and diagnostic medical devices. |
Session 1:
The Building Blocks of Medical Innovation |
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| Moderated by: Yvonne Klöpping, Associate Editor, EMDT |
| Novel Approaches to Shelf-life Extension and Terminal Sterilization of Biologic-device Combination Products |
| Presented by: Dr. Wolfram Altenhofen, VP of Business Development, Leukocare AG |
| Functionalizing medical devices with biological components gives access to a broad range of next generation products with therapeutic or diagnostic impact. LEUKOCARE's platform technology serves to stabilize biologics in dehydrated conditions and to enable their terminal sterilization by irradiation or EtO. Thus it helps to increase shelf-life and to replace aseptic production resulting in a considerable reduction of production costs. |
| LEUKOCARE's technology is currently being applied in product development in the fields of dental and orthopedic implants, regenerative medicine and in vivo diagnostics e.g. for capturing circulating tumor cells. The presentation will introduce the technology and highlight application examples. |
About Dr. Altenhofen
Dr. Altenhofen is a pharmacist by training and received his PhD in Biophysics from Tübingen University. He has more than 15 years of experience in the field of computational chemistry as well as business development in biopharmaceutical, medical device, and diagnostics |
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industries and has successfully launched operations in Europe and India. |
| Ultraviolet Curing of Platinum Silicone Elastomers May Create New Opportunities for Medical Devices |
Presented by: Dr. Burkhard Ledig, Regional Marketing Manager
EMEA & India Elastomers Consumer Goods and Healthcare,
Momentive Performance Materials GmbH |
| As an example of innovative market firsts, Momentive Performance Materials introduces a new platform of Addisil* silicone elastomer products that can be cured by exposure to ultraviolet (UV) light. These products are ideal for use when there is a need for much shorter cure times at lower temperatures, while maintaining the physical properties of a typical silicone. This is particulary advantageous in the medical devices industry, where the ability to cure at low temperatures may open doors for product innovation. |
About Dr. Burkhard Ledig
Dr. Burkhard Ledig studied Organic Chemistry at the University of Marburg. He received his Ph.D. in 1993 and started his professional career as Field Sales Engineer for chemicals and polymers at SERVA Feinbiochemica GmbH, Heidelberg. In 1995 he joint the Sigma-Aldrich Cooperation |
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as Product Manager for polymer products and Sales Manager for Flavour & Fragrances. From 1997 until 2008 he worked for Trelleborg Sealing Solutions as European Technical Manager for the Chemical Processing Industry, Medical and Semiconductor Industry with global responsibilities. He joint Momentive Performance Materials (formerly GE Bayer Silicones) in 2008 as Regional Marketing Manager EMEA & India Elastomers Consumer Goods and Healthcare. |
| Resorbable Polymers: The Materials Behind Disappearing Implants With a Lasting Impact on Medicine |
| Presented by: Robert van Tuil, Marketing Director, Purac Biomaterials |
| Materials that are designed to disintegrate in the body have made a valuable contribution to advancing medicine since they were first introduced for use in wound closure more than 40 years ago. Today, resorbable medical devices are in mainstream use in all areas of healthcare, including orthopedics. And thanks to the safety and versatility of their core components, resorbable polymers, their significance in modern medicine looks set to increase even further. Resorbable polymers have properties that can be tailored to suit an increasing range of specific applications. Built upon tried and tested technology, they provide flexible yet reliable solutions that can benefit patient and physician, both now and for the future. |
About Robert van Tuil
Robert van Tuil holds a Msc in Chemical Engineering and an MSc. in Polymer Engineering and has over 15 years of experience in research, development, marketing and business development with biodegradable polymers. He joined Purac Biomaterials in 2006 in the position of |
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marketing director, having a global responsibility for marketing and new business development of resorbable polymers for medical and pharmaceutical applications. Prior to joining Purac Biomaterials he held various research, management and business development positions at a contract research organization with activities in the area of biodegradable polymers. |
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Session 2:
Emerging Technologies in
Orthopaedic Materials |
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| Moderated by: Rich Nass, Director of Content, UBM Canon Medical Device Media Group |
| Orthopaedics is one of the fastest growing sectors within the medical technology industry, accounting for approximately €28 billion in global sales, and an ageing yet restive population will continue to drive demand as far as the eye can see. Materials suppliers are exploring novel techniques to reduce wear, promote osseointegration and, perhaps, one day develop a material that will render revision surgery obsolete. The entire materials universe—plastics, metals, ceramics and even biomedical textiles—has a seat at this table. Be prepared for a spirited discussion with our panel of experts that will include taking live questions from attendees. |
| Panelists |
Patrick Peignot
Patrick Peignot is European General Manager of NuSil Technology. Patrick Peignot has a Mechanical Engineer background specific to the conception and mold designed, when he joined the plastic injection molding industry in 1984. |
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In 1986 he joined the W.H.O; (World Health Organization) as a process engineer, to work for a consortium composed of London Rubber Company, Manesty Machine and Dow Corning teams to develop and build a manufacturing molding line using silicone material to produce Drug Delivery Devices (DDS). From 1987 to 199 he worked for the European Health Care Division of Dow Corning, where he occupied different position such as Process Engineer, Manufacturing Manager to end as a Technical & Sales Engineer for Healthcare in Europe. In 1999, he joined the team of NuSil Technology Europe and has been in charge of opening a Technical Service Center for Europe when he became a Technical Sales Director in 2001. Executive MBA achieved in 2006. Since 2007, he has held the position of European General Manager. |
Virgina Read
Virgina Read isMarket Segment Manager of Industrial, DYMAX Corporation. Virginia attended the Bachelor of Science – Industrial Technology degree program at Central Connecticut State College. She |
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started her engineering, sales, and program management career in the aerospace and power generation field. Over the next twenty years, Virginia held Account Management and Engineering Management positions while earning a degree in Coating Technology.
Virginia joined the DYMAX team in August 2002. DYMAX Corporation, based in Torrington, CT, manufactures UV light-curable adhesives, sealants, coatings, and epoxy resins, as well as a complete line of compatible UV light-curing and dispensing systems. Her efforts are focused on developing global marketing programs, product line development to meet customers' needs, and training DYMAX Field Sales on the benefits of next-generation industrial products. |
Session 3:
Trends in Packaging Materials |
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Moderated by: Norbert Sparrow,
Editor-in-Chief, EMDT |
| Medical packaging materials must provide adequate protection of the contents and, depending on the product, withstand sterilisation, but it also must help manufacturers to achieve sustainability and cost-reduction goals. Panel experts will discuss recent and forthcoming innovations in medical-grade packaging materials. |
| Panelists |
Don Handrow
Don Handrow is Director of Product Development, Prent Corporation. Don Handrow graduated from the University of Wisconsin Stout with a B.S. in Industrial Design. Handrow has professionally |
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worked for Prent Corporation as a package designer, a team leader, and Director of Product Development for the past 19 years. Handrow is also a member of the IoPP, SPE and an Advisor for the University of Wisconsin Stout Packaging Department. |
John P. Merritt
John P. Merritt is President and founder of Merritt, Myers, Inc., a consultancy based in Shanghai dedicated to the medical device and pharmaceutical industries. Prior to establishing Merritt, Myers, Inc., |
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Merritt served as International Managing Director for Oliver-Tolas Healthcare. He holds an MSME, specializing in Manufacturing Engineering from Columbia University (USA), and an MBA, specializing in International Business from the University of Rhode Island (USA). He is also an IoPP Certified Packaging Professional. |
Dr. Michael H. Scholla
Dr. Michael H. Scholla is the Global Director, Regulatory and Standards for the Medical and Pharmaceutical Protection business within DuPont Protection Technologies and is located |
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in Wilmington, DE. Scholla has a diverse research background with over sixty publications and six patents. He is actively involved in numerous industry groups including of the Association for the Advancement of Medical Instrumentation (AAMI) where he serves as Co-Chair of the Sterilization Standards Committee and is a member of the Committee on Standards Strategy. He was a member of AAMI Board of Directors for ten years retiring in 2010. Scholla is also the Convener of ISO TC198 WG7 on Medical Packaging responsible for the globally harmonized standard ISO EN 11607. |
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