| Conference — Tuesday, February 9
9:00 AM - 4:00 PM (Lunch 12:00 PM - 1:00 PM)
ABOUT THE CHAIR Joseph A. Chinn, Ph.D., Owner, J Chinn LLC and Past President, Surfaces in Biomaterials Foundation Joe has 20 years experience in applied research and product development in the medical device industry. His tenures on both the device manufacturer and technology supplier sides of the industry give him a valuable perspective on the critical factors that determine project success or failure. His is currently a consultant to the medical device industry, primarily in the areas of product research and development, and intellectual property and technology assessment. His clientele include both technology vendors and device manufacturers ranging in size from start-ups to multinational Fortune 500 companies. As Past President of the Surfaces in Biomaterials Foundation, Joe also serves as the Program Chair of the 2010 BioInterface Workshop and Symposium. Bioabsorbable Polymers for Medical Devices ABSTRACT This presentation will focus on bioabsorbable polymers for medical devices. The use of bioabsorbable polymers for medical devices dates back to the introduction of bioabsorbable filaments used for wound closure over 40 years ago. Since that time, several new polymer families have surfaced and are undergoing various levels of investigation. However, the most widely researched and utilized class of bioabsorbable polymers continues to be the polyesters. The most commonly used bioabsorbable polyesters include polyglycolide, poly(l,d, and dl-lactide), polydioxanone, and polycaprolactone. Each of these polymers possess differences in properties that make them excellent building blocks for customizing copolymers or terpolymers with finely tuned strength, modulus, and absorption profiles. Likewise, as homopolymers, they afford a wide array of the same properties. ABOUT THE SPEAKER Bruce Anneaux, Ph.D., Corporate Manager, Research and Development, Zeus, Inc. Dr. Anneaux holds undergraduate degrees in Electrical Engineering (Clemson University) and Extracorporeal Life Support Systems (Medical University of South Carolina) and Master and Doctoral degrees in BioEngineering (Clemson University). He has extensive experience in durable and absorbable polymer synthesis and processing and the design and development of novel load bearing and active medical devices. His experience and training in the arena of Absorbable Polymers was garnered during 8 years as the Medical Device and Product Development Manager for one of the world's leaders in this field. Dr. Anneaux has been very active in Biomaterial Research and Development through research partnerships and collaborations as well as private efforts. His development experience has included every aspect from initial design conception to in-vivo protocol development and implementation, and regulatory documentation support under ISO9001 and ISO13485 quality systems. Receiving Product Approval: an FDA Perspective ABSTRACT Ms. Goode will present on the type of information necessary for device applications where new materials are incorporated into the final product. ABOUT THE SPEAKER Jennifer Goode, Scientific Reviewer, FDA Office of Device Evaluation Jennifer Goode, B.S., is a senior reviewer in the FDA Office of Device Evaluation, where she is responsible for reviewing peripheral vascular and interventional cardiology devices in the Division of Cardiovascular Devices, and coordinates the scientific review of peripheral drug-eluting stents. During her career at the FDA, Ms. Goode has also been responsible for the review of obstetrics/gynecology, neurology, cardiac ablation, and cardiac pacing devices. In addition, she provides consulting reviews in the area of material biocompatibility for various products throughout the Office of Device Evaluation. Ms. Goode received a Bachelor of Science degree in Biomedical Engineering from Boston University. Coatings ABSTRACT Coatings on Medical Devices have become commonplace over the past two decades. Technology ranging from hydrophilic, lubricious, hemo/biocompatible, anti-microbial, pro-healing, and drug delivery coatings have been developed and incorporated into Medical Devices to enhance or enable device functionality. Selecting the right technology can depend on a number of crucial factors such as Regulatory History, Device Geometry, Material Compatibility, Throughput Requirements, Performance Requirements and Cost/Benefit Analysis. Medical Device coatings continue to advance and expand the capabilities and benefits of medical device applications. ABOUT THE SPEAKER Sean Stucke, Director, Cardiovasular Business Unit, SurModics Currently Oversees Commercial Development with Hydrophilic, Hemocompatible, and Biocompatible Coatings in the Cardiovascular Business Unit at SurModics. Has over 12 years experience developing coating formulations, coating processes, and leading commercial development projects for medical device applications. Surface Characterization of Materials for Medical Devices ABSTRACT The characterization of materials is important for meeting the technical challenges encountered at all stages in the life-cycle of a medical device: in the selection of materials; in the monitoring of manufacturing and processing steps; and in trouble-shooting device failures in the field. The successful resolution of a materials issue requires the use of appropriate analytical techniques. This presentation will describe the analytical techniques which are most useful for addressing commonly-encountered medical device materials problems, with a particular focus on issues pertaining to the surfaces of materials. ABOUT THE SPEAKER Angela Y. Craig, Manager, FTIR, Raman, and GC-MS Services, Evans Analytical Group, LLC Angela Craig is a Manager of FTIR, Raman, and GCMS Services at Evans Analytical Group, a commercial analytical service company in Sunnyvale, CA. She obtained her Ph.D. in organic chemistry from UCLA. Her previous responsibilities at EAG was in the XPS/ESCA Services group. Currently, her work involves the characterization of a wide range of materials for commercial applications in various industries, including the biomedical industry. Nitinol ABSTRACT In recent decades, many minimally invasive procedures and transluminal medical interventions have been revolutionized by superelastic Nitinol. The enormous elasticity and kink-resistance allow a Nitinol device to be deployed through a small incision and while reaching the intended anatomic site the device can be released to regain a shape close to the original dimension. The stress plateau developed during the deformation of superelastic Nitinol also provides a well-controlled contact stress between tissues and the device. Well known dental and medical applications include orthodontic appliances, medical guidewires, minimally invasive surgical instruments, orthopedic components, stents, transcatheter heart valves and thin-film mini-pumps for drug delivery. The presentation will review alloy properties, processing methods and the design principles of various exemplary applications. It is anticipated that Nitinol will continue to drive medical device innovations in minimally invasive surgeries and transluminal intervention procedures in the near future. ABOUT THE SPEAKER Ming H. Wu., Ph.D., Vice President Engineering, Advanced Materials Technology, Edwards Lifesciences Dr. Wu is Vice President Engineering at Edwards LifeSciences LLC in Irvine, Califronia, a leading company in heart valve and hemodynamic monitoring technologies. Before joining Edwards in 2006, Dr. Wu had more than twenty years of experience at Memry Corporation, a Nitinol development and manufacturing company in Bethel, Connecticut. During his career at Memry, he held a variety of technical and senior level management positions including Chief Metallurgist, Director of Engineering, Vice President General Manager, and Vice President Technology. Challenges and Experiences in Using New Materials ABOUT THE PANEL Robert Ward, President and CEO, DSM PTG, Part of DSM Biomedical Bob Ward is a chemical engineer and President/CEO of The Polymer Technology Group (PTG) in Berkeley, California, a company he founded in 1989. He is also Chairman and CEO of Emergence LLC a Life Science Incubator. PTG’s business includes custom synthesis, and the R&D/manufacturing of biomaterials, specialty polymers and medical devices. PTG uses a unique vertically-integrated approach ranging from molecular design to the clean room manufacturing of device components. Henry Klyce, Spartek Medical Information to come. Janine Robinson, VP, Research and Development, Articulinx, Inc. Ms. Robinson brings more than 20 years experience in medical device development and engineering. Before Articulinx, Ms. Robinson was Vice President of Engineering at Spinal Kinetics, a company developing total artificial disc technology. Previously she was Vice President of Engineering with Cardeon Corporation. Other companies include GSI, Unisurge and Advanced Cardiovascular Systems (Guidant). Ms. Robinson also conducted NIH-funded research. She holds BS and MS degrees in Mechanical Engineering from The University of Michigan, Ann Arbor. Ming H. Wu., Ph.D., Vice President Engineering, Advanced Materials Technology, Edwards Lifesciences Dr. Wu is Vice President Engineering at Edwards LifeSciences LLC in Irvine, Califronia, a leading company in heart valve and hemodynamic monitoring technologies. Before joining Edwards in 2006, Dr. Wu had more than twenty years of experience at Memry Corporation, a Nitinol development and manufacturing company in Bethel, Connecticut. During his career at Memry, he held a variety of technical and senior level management positions including Chief Metallurgist, Director of Engineering, Vice President General Manager, and Vice President Technology. Joseph A. Chinn, Ph.D., Owner, J Chinn LLC and Past President, Surfaces in Biomaterials Foundation Joe has 20 years experience in applied research and product development in the medical device industry. His tenures on both the device manufacturer and technology supplier sides of the industry give him a valuable perspective on the critical factors that determine project success or failure. His is currently a consultant to the medical device industry, primarily in the areas of product research and development, and intellectual property and technology assessment. His clientele include both technology vendors and device manufacturers ranging in size from start-ups to multinational Fortune 500 companies. As Past President of the Surfaces in Biomaterials Foundation, Joe also serves as the Program Chair of the 2010 BioInterface Workshop and Symposium. Jennifer A. Neff, PhD, CEO, CTO, Allvivo Vascular, Inc. Dr. Neff graduated Cum Laude in Materials Science and Engineering and earned a Ph.D. in Bioengineering from the University of Utah. While completing her undergraduate degree, she was an engineer at Terra Tek, where she developed new mycotoxin test kits, taking the products from an early development stage through manufacturing and commercialization. After completing her PhD, she worked as a Post Doctoral Fellow in Pharmacology and Toxicology at the Center for Human Toxicology in Salt Lake City, Utah where she studied the pharmacokinetics and drug-drug interactions associated with the use of acetylmethadol for treatment of opiate addiction. Before joining Allvivo Vascular, she was a founder and the Director of Research for Allvivo, Inc, with responsibility for bringing nine new life science products to market. Dr. Neff currently acts as the CEO for Allvivo Vascular, a company developing biomimetic surface coatings for medical devices and combination products. Risk Management and Assessment in Sourcing and Working with New Materials ABSTRACT Information to come. ABOUT THE SPEAKER Jennifer A. Neff, PhD, CEO, CTO, Allvivo Vascular, Inc. Dr. Neff graduated Cum Laude in Materials Science and Engineering and earned a Ph.D. in Bioengineering from the University of Utah. While completing her undergraduate degree, she was an engineer at Terra Tek, where she developed new mycotoxin test kits, taking the products from an early development stage through manufacturing and commercialization. After completing her PhD, she worked as a Post Doctoral Fellow in Pharmacology and Toxicology at the Center for Human Toxicology in Salt Lake City, Utah where she studied the pharmacokinetics and drug-drug interactions associated with the use of acetylmethadol for treatment of opiate addiction. Before joining Allvivo Vascular, she was a founder and the Director of Research for Allvivo, Inc, with responsibility for bringing nine new life science products to market. Dr. Neff currently acts as the CEO for Allvivo Vascular, a company developing biomimetic surface coatings for medical devices and combination products. Next Generation Medical Devices ABSTRACT Over the past several decades, considerable research has focused on the development of biocompatible medical devices such as implantable blood gas sensors, stents, and vascular grafts. However, infection, blood clots, and tissue growth around these implanted devices can still pose serious risks to patients. Synthetic drug-based therapies that attempt to alleviate these problems have their own risks to patients and have thus struggled to gain and maintain FDA approval for clinical use. To reduce these risks, research has focused more closely on biomimetic routes for designing implantable medical devices in order to cause platelet passivation and overcome restenosis and infection. If a lesson is to be taken from nature, the question must be asked how does normal endothelium prevent thrombus formation and tissue disruption yet simultaneously maintain hemostasis within the body? In this presentation, the design, development, and in vivo evaluation of biomimetic materials that provide the most efficacious and safe route towards medical device coatings will be discussed. ABOUT THE SPEAKER Melissa M. Reynolds, Assistant Professor of Chemistry, Colorado State University Dr. Reynolds received her Ph.D. in chemistry from the University of Michigan in Dr. Mark E. Meyerhoff's laboratory where she developed new methods for synthesizing and characterizing nitric oxide releasing polymeric materials. Following graduate school she was hired to initiate a new interdisciplinary program at a medical device development company that aimed to create polymeric materials for use as implant coatings. During her tenure, she designed and implemented both synthesis and analytical testing programs, was awarded over $5 million dollars in NIH funding, formed both industrial and academic materials development partnerships, was an inventor on more than 10 patents and/or applications, and created a comprehensive IP portfolio through licensing and internal research. In addition, she coordinated cross-organizational studies for new product development and translated bench experiments from basic research, to engineering processes and ultimately to in vivo evaluation in multiple animal models. Her endeavors resulted in the formation of a spin-off company supported by venture capitalist groups. She has authored over 25 papers/presentations on nitric oxide materials for improving the biocompatibility of devices and was awarded a Science Award from the National Institutes of Health for her work. She is considered an expert in the area of nitric oxide materials research, has been invited to serve as a reviewer on NIH special emphasis panels, and has experience in directing research in both industrial and academic settings. She is currently a faculty member in the Department of Chemistry and holds a joint appointment in the School of Biomedical Engineering at Colorado State University. |
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Physical properties