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Tuesday, September 13, 2011
|
Applying New Materials to Enable Innovative Devices |
2:00 – 4:00 |
Part II: Materials and Electronics |
Materials that House Electronics: Jason Clevenger, Ph.D., Principal Scientist, Exponent
The choice of biocompatible material for the encapsulation of implantable electronics is a significant one for device designers. Many current packaging materials first found use in the electronics industry and have been adapted to meet the challenges of maintaining a hermetic microenvironment in a highly corrosive biological matrix. With the development of microscale biosensors, drug delivery systems and other novel devices, conventional implantable packaging approaches need to be reexamined. This presentation will survey recent advances in next-generation packaging materials and discuss design rules for material selection.
• The challenge of packaging
Developing Body-powered Devices for Intelligent Medicine: Hooman Hafezi, Pharma Products R&D Manager, Proteus Biomedical, Inc.
Effective management of many disease conditions requires an accurate assessment of a patient's adherence and response to prescribed pharmacotherapy. The Proteus Raisin(TM) System provides a platform for (i) collecting and integrating adherence data, physiological metrics and consumer input, (ii) allowing patients to access and share data with physicians, family members and/or caregivers, and (iii) enabling targeted feedback and tailored management for wellness promotion. This data-enriched, networked approach to healthcare - Intelligent Medicine - is designed to enhance patient experience and clinical outcomes in therapeutic areas such as transplant, mental health, heart failure, diabetes, and infectious disease.
At the heart of the Raisin(TM) System is the Raisin(TM) Ingestible Event Marker, a micro-fabricated device that can be integrated into any pharmaceutical tablet or capsule to allow real-time detection of pill ingestion and authentication of drug dosage and identity. This presentation will review the key technical features of the RaisinTM Ingestible Event Marker such as material selection, power generation, and communication mode. The RaisinTM system performance will be discussed, including strategies for meeting the technical, safety, and manufacturing requirements critical to the product's success.
• Material Selection • Power Generation • Communication • Performance • Safety • Manufacturability
Testing for MRI Compatibility: Joseph McGowan, Ph.D., PE Exponent
There is an increasing emphasis on testing of medical devices for compatibility with Magnetic Resonance Imaging (MRI). Four ASTM standards form the basis for test protocols covering a variety of implantable and non-implantable devices. These standards address the principal known hazards associated with the presence of metallic devices in the MRI environment. This presentation will include an update of risks associated with scanning of metallic devices and will outline testing approaches to quantify and mitigate those risks. The role of numerical modeling and simulation in the design of a comprehensive investigation of the safety of a family of devices will be addressed.
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
Jason Clevenger, Ph.D., Principal Scientist, Exponent
Jason Clevenger is a Senior Managing Scientist at Exponent. Dr. Clevenger's expertise focuses on materials characterization and process engineering for specialty manufacturing. Dr. Clevenger's medical device experience includes materials selection and qualification, method development for regulatory submissions, product development and manufacturing support, quality assurance, recall guidance, and technology due diligence assessment. He has led a series of root cause investigations for transdermal, solid-oral, and extended release pharmaceutical formulations as well as a diverse array of Class III medical devices at the pre- and post-approval stages, focusing on uncovering key quality and process attributes of raw materials and intermediates. Dr. Clevenger's clients range from virtual startups with no internal manufacturing capabilities to established multinational corporations, some of whom were involved in significant FDA enforcement activity. Dr. Clevenger is a former technologist at Applied Materials, and holds a Ph.D. in Physical Chemistry from MIT.
Hooman Hafezi, Pharma Products R&D Manager, Proteus Biomedical, Inc.
Hooman Hafezi is the Pharma Products R&D Manager at Proteus Biomedical, where he has been responsible for developing new biomedical technologies. Dr. Hafezi has been with Proteus since 2006 and is a co-inventor of the Raisin(TM) System. Prior to joining Proteus, he held positions in R&D and engineering at Applied Materials and Intel Corporation. His primary areas of expertise are applications of electrochemical engineering and polymer coatings. Dr. Hafezi holds a B.S. and Ph.D. in Chemical Engineering from the University of California, Berkeley, and is a former chair of the Electrochemical Society, San Francisco Bay Area Section.
Joseph McGowan, Ph.D., PE Exponent
Dr. McGowan obtained his PhD in Bioengineering from the University of Pennsylvania, where he served on the faculty of Radiology. During this time he was active in MRI research including the study of brain disorders and brain trauma with quantitative imaging. Following that he joined the faculty of Electrical Engineering at the United States Naval Academy as both a professor and an officer in the United States Navy. He retired from the Navy in 2006 and joined Exponent, Inc, where he leads efforts in MRI compatibility testing. Currently, he serves on the ASTM committee charged with developing standards for MRI safety testing and also as a member of the Editorial Board of the American Journal of Neuroradiology.
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