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Santa Clara Valley Chapter

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Calendar Year 2009 Presentations

Wednesday, January 21, 2009, 7:30pm
Clark Center auditorium, Stanford University

Optional Dinner, Nexus cafeteria in the Clark Center, 6:15 pm (no host, no reservations)

Title: smartMOVE Technology: A New Disruptive Actuator Technology
Marcus Rosenthal
Artificial Muscle, Inc.

Artificial Muscle, Inc. (AMI) is pursuing the commercialization of its artificial muscle technology and SmartMOVET actuators through innovative designs and fabrication processes and by focusing on performance, reliability and manufacturability across a wide variety of applications. Scalable solutions developed by AMI include pumps, valves, linear motion controllers, and vibration actuators for haptics, fluid mixing, and other applications. Innovative device designs demonstrating the ability to meet the specifications of demanding applications and combining practical levels of power densities and actuation lifetimes will be discussed. Integrated electronic control modules allow the freedom to design actuators directly into new or existing product lines while effectively managing the transition from conventional technologies. Simple modular designs, coupled with low cost industrial materials and flexible automated manufacturing processes, provide a cost effective solution for products serving such diverse industries as consumer electronics and medical devices. Several case examples are presented to illustrate the commercial viability of SmartMOVE-based devices.

Marcus Rosenthal is a Co-Founder of Artificial Muscle, Inc. (AMI) was formed as a spin-off of SRI International in March 2004 in order to commercialize smartMOVE technology. At AMI, Marcus has contributed in a large number of areas including technology development, product line development, manufacturing process development, and materials development. Marcus is currently the Program Manager for the smartTOUCH product line which is AMI's product for haptic feedback. Prior to working at AMI, Marcus was a Research Engineer at SRI International from 2001-2004. Marcus was part of the Active Transducer Program at SRI where smartMOVE technology was one of the key developments. Marcus Rosenthal graduated with a B.S. in Mechanical Engineering from UC Berkeley in 2002.

Wednesday, February 18, 2009, 7:30 pm
Clark Center auditorium, Stanford University
Optional Dinner, NEW LOCATION: Nexus Cafeteria in the Clark Center, 6:15 pm (no host, no reservations)

State of the Heart: Development of the Levacor Ventricular Assist Device

Phillip Miller
World Heart Inc

World Heart is a pioneer in the development of Ventricular Assist Devices (VADs) – implantable pumps that take over the workload of the diseased heart of patients in end-stage heart failure. The Novacor® Left Ventricular Assist System was used in the world’s first bridge to transplant with an implanted electromechanical device, at Stanford University Medical Center in 1984. This first-generation VAD was subsequently implanted in over 1800 patients world-wide, for both bridge to transplant and destination therapy, with support durations of up to five years. WorldHeart is currently developing the Levacor™ VAD, a fourth-generation centrifugal pump with a magnetically levitated rotor. Using a unique combination of permanent and electromagnets, the levitation system requires just one active control axis. The bearingless maglev design eliminates any wearing mechanical elements, while facilitating optimization of the flow path through the pump. Development of this pump will be discussed, along with some of the history of the VAD field.

Phillip Miller has over 30 years of experience in the development of cardiac assist devices. One of the original designers of the Novacor LVAS, he was involved in the development of the Novacor's pulsed-solenoid drive system, as well as assessment of system performance and animal implant evaluation. Subsequently, as Director of Biomedical Engineering, he was responsible for all technical aspects of the clinical program, including engineering supervision and support, staff training at clinical centers and field service and coordinating technical inputs to regulatory submissions. Currently his efforts are focused on system R & D, including development of the Levacor VAD. Mr. Miller was appointed Vice President, Research and Development, in 2004. Mr. Miller holds a BS in Mechanical Engineering from MIT and an MS in Mechanical Engineering from UC Berkeley.

Wednesday, March 18, 2009, 7:30 pm
Clark Center auditorium, Stanford University
Optional Dinner, NEW LOCATION: Nexus Cafeteria in the Clark Center, 6:15 pm (no host, no reservations)


Lex Bayer
VP of Product Development, Avantis Medical Systems

Colorectal cancer is the second leading cause of cancer death in the United States. Adults 50 years of age and older are advised to routinely undergo colorectal cancer screening as a preventative measure. Much literature has been published demonstrating that the traditional colonoscopy procedure misses a significant percentage of lesions and cancers.

The Avantis Medical Systems 3rd eye Retroscope was developed as an adjunct product designed to improve the diagnostic yield of colonoscopy procedures. The device is a miniature disposable imaging device that illuminates and delivers a continuous retrograde view of the colon. It allows the physician to look behind the folds and flexures in the colon to find lesions that might otherwise be hidden. A second video processor ties in with the main colonoscope camera system to provide a split screen showing a simultaneous forward and rear views to create a 360 degree view of the colon. The device employs novel techniques in the field of image sensors, optics, image processing, and catheter design. Research and development of the Third Eye Retroscope and published clinical results will be presented. In addition, an overview of recent technological advancements in the field of colonoscopy will be discussed.

Lex joined Avantis Medical in 2005 where he has led the development of catheter-based endoscopic devices for the detection and treatment of cancers and other abnormalities of the gastrointestinal (GI) tract. Previously, at Gyration, he directed the creation of a low-cost 2-axis micro gyroscope for use in pointing devices, remote controls and game controllers (a precursor to the Nintendo Wii remote). His core technical expertise is in the field of sensor development and device miniaturization.

Lex earned his M.S. in Mechanical Engineering in the Smart Products Program at Stanford University, where he also received his B.S. degree in Mechanical Engineering.

Wednesday April 15, 2009, 7:30 pm
Clark Center Auditorium
Optional dinner, new location: Nexus Cafeteria in the Clark Center, 6:15 pm (no host, no reservations)

How to maximize the success factor for new medical company start-ups
Fred Seddiqui
CEO, Axis Surgical

As an entrepreneur, company founder, CEO and Corporate Chairman, Fred Seddiqui brings many years of experience to this months presentation on how to start-up a successful medical company.Mr. Seddiqui will discuss the following points in his talk:
Decision points for pursuing a medical start-up company; obtaining seed money;
when to submit a business plan to venture people, how to obtain venture money;
who to hire; how to apply seed and venture money to the business; how to track start-up progress;
what not to do in a start-up business plus many other items that are critical to a start-up companies success.

Fred Seddiqui is currently CEO of Axis Surgical Technologies, a company founded to develop surgical instruments. He is also currently serving as Chairman of the Board of Avantis Medical Systems; a company founded to develop and manufacture catheter-based endoscopic devices He has over 20 years of executive management experience in emerging companies in the high tech and life sciences industries. Fred was a Principal of Silicon Valley Venture Partners since 1998, where he primarily invested in private emerging companies.

Fred received an honorary doctorate degree of Business Psychology from Pacific Graduate School of Psychology. He is a graduate of the Stanford University Executive Management Program, Stanford Business School. Fred also holds an M.B.A. from Golden Gate University, as well as a B.S. and M.S. in Engineering, both from Fairleigh Dickinson University.

Fred is past chairman of ASME/American Society of Mechanical Engineering, Santa Clara Valley Section. He currently serves on the Boards of Directors of several private companies and non-profit agencies. Since 2002 he has served as Chairman of the APL Foundation.

Fred has authored a book titled Engineering Functions Concerning Industry, published by Vantage Press, New York.

Wednesday, May 20, 2009, at 7:30 PM.
Room M-114, Stanford University Medical School
Optional dinner location: Nexus Cafeteria in the Clark Center, 6:15 pm (no host, no reservations)

How the CyberKnife utilizes robotics and image guidance to annihilate cancer.
Michael Saracen

Robots are commonplace in many industries today demonstrating the benefits reliability, precision and accuracy have to offer. Medicine is entering a new age where it is starting to embrace technology, realizing some tasks are performed better and in some cases better performed by a machine. One area which has greatly benefited from this marriage of technology and medicine is Radiation Oncology. Targeting tumors inside the body with high precision and accuracy throughout a treatment is challenging, often requiring immobilization devices to prevent the patient from moving. The problem becomes significantly more difficult when treating tumors that move with respiration like those found in the lung, liver or pancreas. One system has successfully integrated robotics into patient setup and delivery of radiation, making treatments safer and more precise. Leveraging fully integrated image guidance capabilities, the system automatically adapts to movements and changes in the patient’s breathing patterns without user input. Robotics has a place in medicine, the question is, does it improve patient care and can it reduce he cost of healthcare in the long run.

Michael Saracen is an independent contractor with over 15 years experience creating, patenting, developing and launching new products and services into the medical device industry. Most recently Michael worked at Accuray Inc. as director of business development focusing on licensing, strategic partnerships, mergers & acquisitions and developing new business opportunities. Prior to his role in business development, Michael was director of product management and product marketing departments overseeing all aspects of the product lifecycle. Before Accuray, Michael worked in three different medical device companies overseeing their Image Guided Surgery product lines. He has extensive experience in robotics, biomaterials, radiation delivery and medical software systems. Michael received his Masters from Brown University in Biomaterials and Artificial Organs. Prior to getting his masters he worked in protein biochemistry research in the Orthopedic Department at Rhode Island Hospital.

While at Accuray Michael was a lead inventor on the RoboCouch, a fully robotic patient positioner, and took the product from concept to prototype in 6 months and received FDA clearance within 9 months. Michael has 7 issued and 12 pending patents covering robotics, quality assurance, tracking & vision systems and treatment planning software.

Wednesday, June 17, 2009, 7:30 pm
New location: Room M-114, Stanford University Medical School
Optional dinner, new location: Nexus Cafeteria in the Clark Center, 6:15 pm (no host, no reservations)

Miniaturized Confocal Microscope for Early Detection of Cancer
Christopher H. Contag
Stanford University

The earliest malignant lesions are microscopic in size and may be characterized abnormal cell surface markers and disrupted microanatomy. The challenge for early detection of cancer is localizing and characterizing these lesions, and in cancers of the gastrointestinal (GI) tract there are some predisposing conditions that indicate when microscopic analyses is justified. Similarly the residual cells that remain after surgical resection of a tumor will have similar characteristics, and in brain cancer removal of these cells, without damage to the normal tissue, remains a significant treatment challenge. To address these needs we have developed a miniaturized confocal microscope that is based on a dual axes architecture. The dual axes design enables the use of lens with low numerical apertures and a folded light path that is amenable to a small form factor. The design features of this microscope included axial and transverse resolutions comparable to that used by pathologists, a 0.5 x 0.5 x 0.5 mm 3D field of view, and an external diameter that was compatible with use in an endoscope for GI cancer. The first dual axes confocal (DAC) microscope that has been used in a clinical study for GI cancer with these capabilities has a 5 mm external diameter and an excitation wavelength of 780 nm. The earlier design had a 10 mm external diameter and this instrument has been fit with a GRIN lens to create a hand held microscope that can be used to examine tumor margins during surgical resection of brain cancers. With contrast dyes these microscopes can be used to visualize microanatomic changes that are characteristic of cancer, and we are developing molecular probes that will enable visualization of cell surface markers that are indicative of malignant transformation. The co-development of molecular probes and new instruments to visualize cancer will improve detection of cancer by providing image guidance for biopsies and resections, and can be used to assess therapeutic outcome.

Dr. Contag is an Associate Professor of Pediatrics and member of the BioX faculty at Stanford University. He is the Director of the Stanford Infrared Optical Science and Photomedicine Program, director of Stanford's Center for Innovation in Imaging and co-director of the Molecular Imaging Program at Stanford (MIPS). Dr. Contag received his B.S. in Biology from the University of Minnesota, St. Paul in 1982; and earned his Ph.D. in Microbiology from the University of Minnesota, Minneapolis in 1988. He was a postdoctoral fellow at Stanford University from 1990-1994, and joined the faculty in Pediatrics at Stanford in 1995 with a joint appointment in Microbiology and Immunology and a courtesy appointment in Radiology. Dr. Contag is a pioneer in the emerging field of molecular imaging and is developing imaging approaches aimed at revealing molecular processes in living subjects and advancing therapeutic strategies through imaging. His laboratory develops macroscopic and microscopic optical imaging tools and uses imaging to assess tissue responses to stress, reveal immune cell migration patterns, understand stem cell biology and advance biological therapies. He is a founding member, and a recent past president, of the Society for Molecular Imaging, and for his fundamental contributions in imaging, is a recipient of the Achievement Award from the Society for Molecular Imaging. Dr. Contag chairs the steering committee for the Network in Translational Research (NCI) and is on the editorial boards for Molecular Imaging¯ Disease Models and Mechanisms¯, BMC Medical Physics¯ and Cancer Biology and Therapy¯ and a member of the Medical Imaging (MEDI) study section for the NIH. He is a scientific founder of Xenogen Corp., now Caliper Life Sciences. He is also a founder of ConcentRx Corp.

Wednesday, September 16, 2009, 7:30 pm
New location: Room M-114, Stanford University Medical School
Optional dinner, new location: Nexus Cafeteria in the Clark Center, 6:15 pm (no host, no reservations)

Using light to measure blood alcohol and glucose non-invasively
Kate Bechtel
Triple Ring Technologies

The ability to measure blood analytes through tissue without the need for drawing blood or sample preparation would revolutionize the health care industry. With the growing rate of diabetes in developed countries and the possibility of creating a closed-loop artifical pancreas, glucose has been the primary target analyte for this quest. However, despite many researchers, numerous start-up companies, and millions of dollars, there is still not a clinically approved device to accurately measure blood glucose non-invasively. Why is this problem so difficult? This talk will introduce the concept of using light in the form of absorption and Raman spectroscopy to quantitatively measure blood analytes non-invasively. Glucose and alcohol will be discussed as example analytes. I will present basic principles of the techniques involved and the key challenges that must be overcome for a device to be successful.

Dr. Kate Bechtel is a Senior Scientist at Triple Ring Technologies, a contract engineering firm that specializes in medical devices. She has over 10 years of experience in researching and developing optic-based instruments for analytical and medical applications. She has worked on numerous devices including non-invasive glucose sensing using Raman spectroscopy; the detection of early stage breast cancer using Raman, diffuse reflectance, and fluorescence; optical coherence tomography for deep tissue imaging; and time-domain oximetry measurements. Dr. Bechtel received her Ph.D. in Analytical/Physical Chemistry from Stanford University and was a postdoctoral researcher at the Massachusetts Institute of Technology in the Spectroscopy Laboratory.

Wednesday, October 21, 2009, 7:30 pm
New location: Room M-114, Stanford University Medical School
Optional dinner, new location: Nexus Cafeteria in the Clark Center, 6:15 pm (no host, no reservations)

The Application of Photocoagulation Technology to the Treatment of Ocular Disease

Steve Hanlon
VP for Research and Development, OptiMedica Corp.

OptiMedica Corporation was founded in January 2004 to develop a radically new technology for the treatment of ocular disease. Initially developed at Stanford University, and exclusively licensed to the OptiMedica Corporation, the PASCALĀ® Method of Photocoagulation is used to treat a variety of retinal conditions including diabetic retinopathy, age-related macular degeneration, and retinal vascular occlusive disease. The PASCAL Photocoagulator provides significantly improved performance for the physician and an enhanced therapeutic experience for the patient. The company received FDA clearance for its PASCAL Photocoagulator device in 2005 and secured funding from Kleiner, Perkins,Caufield & Byers and Alloy Venture Partners in the same year.

The talk will include a discussion of the technology behind the PASCAL Photocoagulator and the application of the technology to retinal eye diseases. In addition, the growth of OptiMedica and the challenges of product development in an early stage company will be discussed.

Stephen P. Hanlon has more than twenty-five years of leadership experience in medical technology research and development, with areas of focus including stereotactic radiosurgery, image-guided surgery, implantable devices, electrosurgery and dialysis products. He is currently Vice President,Research & Development for OptiMedica Corporation in Santa Clara,California.

Prior to joining OptiMedica, Mr. Hanlon was vice president of research and development for Boston Scientific's Neurovascular Division, where he oversaw a 100-person multi-disciplinary department and numerous successful product launches. He also previously served as vice president of operations for Photoelectron Corp. as well as vice president and general manager of the Radionics division of Tyco Healthcare. Mr. Hanlon received a B.S. in electrical engineering from the University of Wyoming, an M.S. in electrical engineering from Arizona State University and an M.B.A. from the University of Colorado.

Wednesday, November 18, 2009, 7:30 pm
New Location: Room M-114, Stanford University Medical School
Optional dinner, new location: Nexus Cafeteria in the Clark Center, 6:15 pm(no host, no reservations)

The development of the LATITUDE Patient Management System

Ken Hoyme
Sr. Fellow – Systems Engineering
Boston Scientific – Cardiac Rhythm Management

Patients who have implantable cardiac therapy devices (pacemakers and defibrillators) are required to make regular visits to a cardiac device specialist to ensure that the device is working properly, and optimized for that person’s specific needs. These visits can be a burden, both for the patient as well as their device physician, and the frequency of these visits are a balance between that burden and the benefit if a condition is detected that needs attention. More recently, cardiac resynchronization therapy has been shown to benefit patients suffering from heart failure, a disease that requires frequent monitoring to avoid recurring hospitalization. In-home remote patient monitoring systems have become the solution to these needs.

The LATITUDE Patient Management System® was developed to address these needs for patients implanted with Boston Scientific’s implantable cardiac devices. This system has well over 100,000 active patients. This talk will focus on some of the key technical challenges in creating this system, including power management, safety, security and making this work within the workflow of a monitoring clinic.

Ken Hoyme has over 25 year experience working in the systems engineering of complex, safety critical systems. His is currently Senior Fellow within the Cardiac Device Telematics group, responsible for defining the company’s future directions in patient management. He was the technical leader for the development of the LATITUDE Patient Management System. Prior to coming to Boston Scientific, Mr. Hoyme was a Senior Fellow at Honeywell’s corporate research center, where his research focused on safety critical control systems for commercial aircraft.

Mr.Hoyme received his BS and MS in Electrical Engineering from the University of Minnesota. He is a member of the IEEE and is a Certified Systems Engineering Professional (CSEP) from INCOSE.

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