ConferenceThursday, June 5, 2008
Maureen Reitman, Principal Engineer, Exponent Abstract Established techniques and emerging technologies related to creating and delivering multiphase materials are driving improvements in the medical device industry. This introductory talks provides some basic definitions and introduces key technologies, materials and applications that will be further discussed in presentations throughout the day. About the Instructor Maureen Reitman, Principal Engineer, Exponent Dr. Maureen Reitman is a Principal Engineer in the Mechanics and Materials Practice at Exponent Failure Analysis Associates. She provides product development, failure analysis, intellectual property analysis and consulting support on technical issues related to plastics, rubbers, adhesives, fibers and coatings as well as additives such as nano-sized materials. Dr. Reitman earned both her SB and ScD at MIT and held a number of research and management positions at 3M before joining Exponent in 2002. She holds two US Patents, regularly publishes peer-reviewed technical articles, is an active member of two Underwriters Laboratory Standards Panels and is the current Chairman of the Medical Plastics Division of the Society of Plastics Engineers. Dr. Reitman is based in Exponent's Bowie MD office, located near Washington, DC.
Absorbable Molecular, Micro, & Macro Composites Scott Taylor, PhD., Manager, Medical Device Engineering & Design, Poly-Med, Inc. Abstract This presentation will cover:
Development of composite materials allows for modulating properties most pertinent to their application. These include breaking strength retention and mass loss profiles. This presentation deals with the design and application of molecular, micro-, and macro-scale composite materials. Specifically, this will include discussion of segmented copolymers and their use as monofilament and braided sutures, as well as non-woven microfibrous fabrics. About the Instructor Dr. M. Scott Taylor is manager of Medical Device Engineering & Design at Poly-Med, Inc., Anderson, SC. He holds B.S. degrees in Physics and Mechanical Engineering from Furman and Clemson Universities, respectively, and a Ph.D. in Bioengineering from Clemson University. In his 7-year tenure at Poly-Med, Inc., Scott has performed an integral role in increasing intellectual property, as well as assisted in the development of a number of medical devices from initial concept to final products. Engineered Polyurethanes for Medical Devices Tony Walder, Sr. R&D Associate, Thermedics Polymer Products Abstract Polyurethanes are a very important group of materials used in a variety of medical applications. Although most of the pounds polyurethanes produced in the world are use as foams, this presentation is interested in the smaller segment of polyurethanes called, Thermoplastic Polyurethanes (TPU). TPU achieve material requirements through the versatility of the chemistries available to design the material and the methods to form a component or device. Selection of the class of TPU is very important for the device performance required by the device manufacturer or OEM. A material selected for an application outside the body may be different from selecting a material that will be implanted. Selecting a material implanted for 2 days may be different from those implanted 30-days or those implanted life-of-patient. The versatility of the TPU and associated properties will be discussed. About the Instructor Tony Walder, Sr. R&D Associate, Thermedics Polymer Products Anthony Walder has worked almost 20 years developing thermoplastic polyurethanes for medical and specialty non-medical applications. Areas of interest include water absorbing, implantable, high modulus, soft, processing temperature modified, surface energy modified as well as other specific modified TPU for medical applications. He received a B.S. in Chemistry from the University of Wisconsin-Stevens Point in 1983 and in 1989 he received a Ph.D. from the University of Tennessee-Knoxville in the area of polymer chemistry. Work history includes 1988 to 1994 at Becton, Dickinson and Company developing novel polyurethanes and devices for medical application. Since 1994, he has worked for ThermedicsT Polymer Products developing new polyurethanes and technology/customer support. He is presently a Sr. R&D Associate at Lubrizol Advanced Materials (ThermedicsT Polymer Products). Critical Material Considerations and the Effects of Processing for Device Applications Vinny Sastri, President, Winovia, LLC Abstract This presentation will cover:
About the Instructor Vinny Sastri, President, Winovia LLC Vinny Sastri, Ph.D., is the President of WINOVIA LLC. His firm provides customized, sustainable solutions, strategies and training in new product development, quality management and high performance materials for medical device companies. His areas of expertise include design controls, process validation, and FDA and ISO Quality Systems for Medical devices, quality systems and Design for Six Sigma. He consults with medical device companies in designing, developing and manufacturing innovative new products with validated processes and in the implementation of effective quality systems. Prior to starting his own consulting firm, Dr. Sastri has held positions in technology, quality, manufacturing and marketing in companies like BASF, AlliedSignal and General Electric Plastics. Dr. Sastri earned a Ph.D. from Rutgers University, and completed post-doctoral work at Brooklyn Polytechnic Institute. He was also an Adjunct Professor at Virginia Commonwealth University in Richmond, Virginia. He has published articles in the Medical Device and Diagnostic Industry trade journal, and has given workshops and training on the integration of product development, Design for Six Sigma and the FDA Quality System Regulation in the United States, Europe and Asia. Applications Stephen P. McCarthy, Professor, Massachusetts Medical Device Development Center Abstract This presentation will cover:
About the Instructor Stephen P. McCarthy, Professor, Massachusetts Medical Device Development Center Professor McCarthy is a Full Professor in the Plastics Engineering Department at the University of Massachusetts Lowell. He is currently the Director of the Biodegradable Polymer Research Center where he is conducting research into Biodegradable Polymers and Blends and Co-director of the Massachusetts Medical Device Development Center (M2D2)at U. Mass. Lowell. He is currently the Editor for the Journal of Polymers and the Environment. He received his Masters in Chemical Engineering from Princeton University, and a Ph.D. in Macromolecular Science from Case Western. Multiphase Polymer Systems – Opportunities and Considerations for Medical Devices Lecon Woo, PhD, Baxter Distinguished Scientist Emeritus Abstract As the discovery of "totally new" polymers slowed, the industry has turned increasingly toward combination of polymers, or manipulation of a single monomer through different micro-phase domains and at times combining with a third phase to achieve properties impossible previously. For example, via minor incorporation of high aspect ratio inorganic ingredients, remarkable improvements in modulus, gas barrier and heat distortion were achieved, thus launching the nano-material era. Recently, devices utilizing the technology begin to appear. Through the combination of a crystalline polypropylene phase which confers high temperature resistance with low glass transition olefinic elastomers, high performance large volume parenteral delivery systems were produced. For polymers commonly thought as a single material, many important properties are derived from micro domains at times smaller than the wavelength of light. Thus the understanding and control of the domains and their interfaces are key to performance innovation for medical devices. In this presentation, most recent developments and successful case histories will be discussed to foster innovation and competitive products serving our customers.
About the Instructor Lecon Woo, PhD, Baxter Distinguished Scientist Emeritus Dr. Lecon ( Lee ) Woo was trained in chemical physics from the University of Chicago. To date, he has been named inventor or co-inventor in 51 patents on medical devices, materials, and processes while contributing more than 150 technical articles and 12 book chapters to his professional societies. He is a fellow of the Society of Plastics Engineers, member of American Chemical Society, American Institute of Physics, AAAS, and Sigma Xi.
Functionalized Polymers for Medical Applications Patricia Hubbard, Director of Technology, Engineered Materials Group, PolyOne Corporation Abstract
About the Instructor Patricia Hubbard, Director of Technology, Engineered Materials Group, PolyOne Corporation Dr. Hubbard is Director of Technology for the Specialty Engineered Materials business at PolyOne. She earned her B.S. in Chemistry at Case Western Reserve University and her Ph.D. in Polymer Science from the University of Akron. Her 19-year career spans a variety of materials covering coatings, silicones, and ceramics, and is now focused on high-performance engineered polymers for both medical and non-medical applications.
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