| Conference
Thursday, January 31, 2008 - 9 a.m. to 4 p.m.
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 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. Exponent is an engineering and scientific consulting firm that leverages multidisciplinary teams of scientists, physicians, engineers, and business consultants to solve complex problems. The staff includes more than 800 degreed technical professionals, more than 280 of whom have earned an M.D. or Ph.D. Exponent operates 18 regional offices and 3 international locations, and is publicly traded on the NASDAQ exchange under the symbol EXPO. More information can be found at www.exponent.com.
Engineered Polymer Systems including Self Assembling Monolayer Endgroups Abstract This presentation will cover:
About the Instructor The selection of polymers for medical devices requires consideration of bulk physical properties and processability, together with surface properties. Most so-called medical-grade polymers are developed by their manufacturer to provide specific bulk mechanical properties and to satisfy processing requirements, but little consideration is given to the biological response of their surfaces. Consequently a myriad of surface coatings, plasma treatments and grafting methods are used to obtain the surface properties needed for safe and effective implants. Most require a post-fabrication treatment of the polymer component or finished device, which adds expense to device manufacturing. The use of molecular self assembly to create well-defined surfaces has become an important research method in nano-technology. A reactive group binds to the surface, spacer chains then line up perpendicular to the surface to position a ‘head group' in the outermost molecular layer. Head groups can be chosen from a wide range of passive, reactive, or biologically-active groups to obtain a variety of surface properties. New biomaterials that can be processed by high-volume methods favored in device manufacturing consist of well-known polymers with new self-assembling end groups. These specially-designed end groups are chemically bonded to the biomaterial by the polymer manufacturer during production synthesis of thermoplastic pellets, two-component liquids, or solutions. Device manufacturers use these raw materials to fabricate device components by extrusion and molding, RIM, dipping and casting, etc. In polymers with self-assembling monomer end groups (SAME™) every polymer molecule contains end groups capable of migrating to the surface of a device and spontaneously assembling there. For this reason the surfaces can be self healing: if for any reason polymer is lost from the outer monolayer, more end groups are available below the surface to fill in the gap. An added advantage of polymers with SAME technology is that the desired surface modification can be achieved without the need for post-fabrication coatings or surface treatments. The potential uses for SAME-modified polymers in medical products are numerous and include diagnostics, disposable and implantable devices, and many therapeutic and prosthetic uses of biomedical polymers. Potential property enhancements include biostability, abrasion resistance, passive thrombo-resistance, anti-microbial activity, reduced protein adsorption, additive-free processing, surface lubricity, and anti-coagulant activity.
Engineered Polyurethanes for Medical Devices 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 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).
A New Look at BioPolymers - The Emergence of Starch Based Polymer Systems Abstract Cereplast Hybrid ResinsTM, also known as BIOPOLYOLEFINST, are bio-based plastic resins, replacing 50 percent or more of the petroleum content in traditional plastic products with renewable source materials such as starches from corn, tapioca, wheat, and potatoes. The addition of Cereplast Hybrid ResinsTM to the existing line of Compostable ResinsTM further establishes Cereplast as the leading solutions provider in environmental and sustainable plastics. The first product from the Cereplast Hybrid ResinsTM family is BiopropyleneTM, a 50 percent bio-based resin that can replace traditional polypropylene in many applications. Cereplast Hybrid ResinsTM can be processed at the same cycle time as traditional plastics on conventional equipment, but requires less energy in the production process by using significantly lower processing temperatures. In addition, Cereplast Hybrid ResinsTM meet the requirements for toxicity set by ASTM D 6400-04 specifications , making Cereplast Hybrid ResinsTM safe for all applications. This paper further discusses mechanical properties and potential applications of BiopropyleneTM.
About the Instructor Dr. Bagrodia, Senior Vice President Research and Development at Cereplast leads all R&D functions including Intellectual Capital Management. Shriram brings more than 30 years of experience in the field of Polymers/Materials research. Prior to joining Cereplast, Shriram was at Eastman Chemical Company, where he was responsible for developing new products, processes, and applications. Shriram is co-inventor of 50+ US Patents. Dr. Bagrodia is a "Fellow" member of the Society of Plastics Engineers (SPE). He received SPE 2005 Fred O. Conley, Engineering/Technology award. Dr. Bagrodia holds a Ph.D. from Virginia Tech, M.S. from Princeton University, and B.S. from IIT, Kanpur, India, all in Chemical Engineering.
Critical Material Considerations and the Effects of Processing for Device Applications Abstract This presentation will describe the requirements of raw material suppliers for medical device applications as required by the FDA and ISO Quality Systems Regulations for Medical Devices. Requirements like material characterization, sterilization, chemical resistance, biocompatibility and ageing will be discussed. The effects of processing on these requirements will also be elaborated. About the Instructor Dr. Vinny Sastri, President of WINOVIA ® LLC, and has over 20 years experience in new product development and quality improvement with a strong track record in the healthcare, medical device, electronics and consumer goods industries. Winovia LLC is a consulting company that provides sustainable solutions in new product development, quality improvement and high performance materials with the goal of strategic market penetration, improving the quality and efficiencies of products and processes, streamlining business processes, reducing operational costs, improving margins and increasing revenues and profits for its clients.
Applications Abstract This presentation will cover:
About the Instructor 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 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.
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