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Tuesday, September 13, 2011
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Implantable Device Design |
2:00 – 4:00 |
Part II: Beyond ISO: Material Testing at You Should Do but Probably Don't |
Bulk Materials Characterization: David Albert, Ph.D., Senior Scientist and Chief Chemist, NAMSA
Toxicological hazard is a property of the chemical constituents of the materials from which a medical device is made and should be considered in relation to the assurance of biological safety. Therefore, for a biological safety assessment, the first step comprises chemical characterization of materials using the principles set forth in ISO 10993 Part 1 and Part 18.
Toxicological hazards can be identified from knowledge of the toxicity of materials or extracted chemicals. The manufacturer, analytical chemists, and toxicological risk assessor, must all have input and be significant contributors to the assessment process. This type of collaborative approach will be described in this presentation along with defining the role of materials characterization and toxicological risk assessment in a risk management process.
•What polymer characteristics do I evaluate? •How do changes to ISO 10993-1 affect materials characterization? •How to use ISO 10993-18 to make the right choice. •Is my polymer compatible and suited for my medical device application?
Surface and Other Analytical Characterization: John Newman, Director of Analytical Services MN, Evans Analytical
The ultimate success of many of today's implantable biomedical devices is often associated with the surface properties of the materials used in the device. This is because the surface is the interface between the body and the device and its chemistry directly affects how the two interact. Therefore, characterizing and understanding the nature of the device surface is critical in both the development and production stages of the product. Material characterization has also received increased emphasis from biomaterial regulatory agencies such as the FDA. This presentation will discuss some of the more advanced surfaced analysis techniques available to truly understand the surface of implantable devices and show examples of their applicability.
• Dozens of different analytical tools are available to characterize biomedical device materials, each with their own advantages and limitations.
Materials Packaging for Implantables—Working within a challenging environment: Jan Gates, Principal Packaging Engineer, Abbott
Packaging for Implantable Medical Devices is a heavily documented regime that may cause a professional to miss the obvious while meeting regulatory requirements. Traceability, testing, and distribution system familiarity could overwhelm the practical requirement to deliver a sterile and protected product for use. The speaker will discuss a systematic approach for packaging system evaluation and product protection during the packaging validation process while meeting regulatory requirements.
• Packaging Materials
Panel discussion |
Admission to the Conference is complimentary for employees of qualifying implantable device manufacturers.
For all others, a registration fee will apply. Your colleagues can register online at MEDeviceForum.com.
ABOUT THE SPEAKERS
Chair: Trevor D. Johnson, M.S., Director of Operations and Image Analysis, Flagship Biosciences LLC
Trevor Johnson is the director of operations and image analysis at Flagship Biosciences. Trevor has spent several years working in all aspects of image analysis for pharmaceutical and medical device applications. He has developed quantitative algorithms and high throughput workflow solutions for tissue analysis in several disease areas using multiple imaging modalities. He has a M.S. in Engineering from UCLA and has experience working with several medical device companies including Aperio and QinetiQ North America.
David Albert, Ph.D., Senior Scientist and Chief Chemist, NAMSA
Dr. David Albert, Senior Scientist at NAMSA has over 27 years of medical device related experience. Dave has been at NAMSA for 12 years. During this time, he has served as a Corporate Staff Chemist, Manager of the Chemistry Department and most recently as a Senior Scientist. Prior to joining NAMSA, he served as a Senior Scientist at Anatrace, Inc. where he supervised research and developed projects involving new and existing medical devices. His primary expertise is in the areas of pharmacology and biochemistry. Dave has been a faculty member in the Department of Chemistry at Lourdes College for over 10 years and an adjunct professor in the College of Pharmacy at the University of Toledo. He holds several degress: a B.S. in Pharmaceutical Sciences, an M.S. with an emphasis in Endocrinology and Biochemistry, a Ph.D. in Chemistry and a Doctorate in Podiatric Medicine. He has presented and published numerous papers. He is currently a member of the American Association for Clinic al Chemistry (AACC), the American Chemical Society (ACS), American Association of Pharmaceutical Scientists(AAPS), Association for the Advancement of Medical Instrumentation (AAMI), Parenteral rug Association (PDA) and the Ohio Academy of Science.
John Newman, Director of Analytical Services MN, Evans Analytical
John G. Newman completed his BS degree in chemistry at Gustavus Adolphus College in 1980 and his MS degree in analytical chemistry at the University of Minnesota in 1984. John joined the Analytical Lab at Physical Electronics in 1983 where he specialized in Secondary Ion Mass Spectrometry (SIMS) and its application to both semiconductors (Dynamic SIMS) and organic materials (Static SIMS). In 1990 John left Physical Electronics and became co-founder and Director of Analytical Services at Evans Central, a laboratory that specialized in materials characterization and problem solving using surface analysis instrumentation. In 1995 John returned to the Analytical Lab at Physical Electronics (later to become the Evans Analytical Group - MN Lab) where he was involved with Scanning X-ray Photoelectron Spectroscopy (XPS) and is currently Director of Analytical Services.
John authored or co-authored multiple publications in peer-reviewed journals covering topics including plasma etching of polymers, Secondary Ion Mass Spectrometry, and X-ray Photoelectron Spectroscopy. He is the primary author of the Static SIMS Handbook of Polymer Analysis (Physical Electronics, 1991).
Jan Gates, Principal Packaging Engineer, Abbott
Jan Gates is a Principal Packaging Engineer for Abbott Vascular, formerly Guidant. She has over 30 years package engineering experience in food, pharmaceutical, detergent and medical device industries. She has focused on optimizing companies' packaging systems by starting at the user end and working back for new or existing products. Her work has included cold chain shipping, several types of sterilization methods, production line efficiency increases, packaging system validations, as well as documentation procedures and policies with multiple types of packaging materials and production lines. For the last 15 years she has worked in the medical device industry for EU/FDA/Japanese and other countries requirements. She is, also, an active member on the ASTM D10 and F2 (rigid and flexible packaging) groups developing industry standard test methods and guides, the AAMI TIR 22 revision group and the IoPP Southern California chapter revitalization group.
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