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Calendar Year 2007 Presentations

Optical Cell Density Monitoring of Bioreactors
Mark Selker, PhD
Finesse LLC

Wednesday, January 17, 2007, 7:30pm
Clark Center Auditorium

Many commercially valuable proteins (industrial enzymes or therapeutic proteins) require living cells to make the end product. These cells and other microbes are typically grown in a bioreactor or fermentor where the conditions need to be monitored and controlled in order to ensure both the quality of the product, and to optimize the yield. Traditionally, the industry has only employed pH and dissolved oxygen monitors on a regular basis. Growing pressure to reduce costs and increase productivity has motivated an effort to employ better monitoring and control of the growth processes.

One tool that is gaining popularity as an aid to accomplishing this task is the optical cell density monitor. Although the devices appear quite simple, both the underlying optical physics and the design of a robust and practical instrument can be challenging. Part of this challenge arises from the limited ability to apply Beer's law to scattering systems. Further complications result from the limited selection of bio-compatible optical materials. These issues will be discussed as well as the details of the scattering theory, and the optical design which mitigate the problem.

Additionally, data from bacterial, mammalian cell, and insect cell growth runs will be examined. The data taken using optical techniques is compared to classic "grab sample" methods. The results are often surprising and reveal the pitfalls of under-sampling any system - whether it is electrical, mechanical, or biological in nature.

Mark has worked and published in various areas within the optics industry including space based and commercial lasers/nonlinear optics, analog and digital optical communication, near field optics/plasmonics and bio-optical systems. He has worked for NASA, Coherent Laser Group, Harmonic, and most recently has been a visiting scholar at Stanford University. Mark received his Sc.B. and Ph.D. in electrical engineering from Brown University in 1986 and 1990 respectively. He is currently the Chief Technical Officer for Finesse LLC, and responsible for sensor development and engineering.

It's All About The Timing... Echo Cardiogram Enhancement Through ECG/EKG Triggering
Prof. David Rivkin, PhD, PE
Professor, College of Engineering, Drexel University
IEEE Senior Member, EMBS Distinguished Lecturer
IEEE IMS TC-34 Chairman

Wednesday, February 21, 2007, 7:30pm
Clark Center Auditorium

Working with NASA scientists, GE and Philips ultrasound engineers, GCPI developed the first SystemC based ECG/EKG monitoring system on a single FPGA. The module acts as a trigger for Echo Cardiogram and other medical imaging systems to improve image quality by reducing motion between image slices. An overview of the development program, technology used and future directions will be discussed. This presentation is for engineers, physicians and engineering managers, covering technical and business processes. (Download preliminary PowerPoint slides.)

Prof. David A. Rivkin, PhD, PE is a professional scientist, engineer and organizational manager with over 20 years of high tech engineering experience and 15 years of engineering management experience leading some of the worlds top firms. Prof. Rivkin teaches at Drexel Universities College of Engineering on both engineering and management topics worldwide. David is a Distinguished Lecturer with the IEEEs Engineering in Medicine and Biology Society and a Senior Member of the IEEE. He has been a frequent guest speaker on engineering management and high-technology issues at IEEE Instrumentation and Measurement Society meetings, Chairs both the Silicon Valley Chapter of the IEEE Instrumentation and Measurement Society and the IEEE IMS Technical Committee 34 "Nanotechnology in Instrumentation and Measurement". David is the IEEE liaison to the International Standards Organizations TC-229 "Nanotechnology Standards" and many other international professional society positions including being an Executive Member of "AdvaMed" the Advanced Medical Technology Association. Dr. Rivkin holds PhDs in Applied Mathematics and Engineering Management and other graduate studies in BioPhysics, BioChemistry and Metrology. Dr. Rivkin holds several patents and has nearly 20 pending in the US and internationally. David holds a Professional Engineers License in South Africa in Electrical Engineering.

Synecor: A New Paradigm for Med Tech Development
William N. Starling
Chief Executive Officer
Synecor, LLC

Wednesday, March 21, 2007, 7:30pm
Clark Center Auditorium

Silicon Valley has produced the most successful start-up companies in the medical device field the past 25 years. Large, multinational public corporations, usually focused on near term earnings, have historically relied upon the acquisition of promising young start-up companies to fuel their growth.

The Northern California venture capital community has been primarily responsible for funding entrepreneurs and inventors for decades but today, in Synecor's opinion, there has never been a point in time in which new company founders and the venture capital community has been further apart with common goals and strategies to build companies that will last.

Synecor, LLC has developed a unique process with a uniquely qualified leadership team that has produced over $500 million in value creation in its first five years. Synecor, an "ever-greened incubator on steroids" has produced multiple new start-up companies that feature highly proprietary, disruptive technologies in multi-billion dollar medical markets.

Synecor has world class business assessment, financial, invention, engineering, pre-clinical and management capabilities and has attracted such notable corporate investors as GE Medical Systems, Guidant Corporation, Boston Scientific Corporation, Johnson & Johnson, and Abbott, Inc.

Before one dollar of risk capital is invested in a Synecor originated medical device or combination drug-device start-up company, the Synecor leadership team will have reduced the risk in the fledgling new company so that it resembles a very successful Venture Capital backed start-up company at Series B Preferred Stock Financing - thus avoiding the "Death Valley" that plagues most medical device start-up companies between the initial and second institutional rounds of financings.

William N. Starling is Chief Executive Officer of Synecor, LLC, (Synecor) a business generator of new Life Science companies based in Research Triangle Park (RTP), North Carolina, Santa Rosa, California, and Portola Valley, California. Synecor has significant academic, scientific, physician, venture capital, corporate, and investment banking partnerships and is focusing its efforts on the identification and development of proprietary, disruptive technologies with extraordinary market potential in the life sciences field.

As CEO of Synecor, Mr. Starling is a cofounder of BaroSense, Inc., Bioerodible Vascular Solutions, Inc., (acquired by Guidant/Abbott in April 2004), InnerPulse, Inc. (formerly Interventional Rhythm Management, Inc.), and TransEnterix, Inc., the initial four companies founded and incubated by Synecor. Mr. Starling currently serves as Chairman of the Board for BaroSense, Inc., a Menlo Park, CA based obesity company, InnerPulse Inc., a RTP, NC - based cardiac rhythm management company, and CEO of TransEnterix, Inc., a RTP, NC - based less invasive GI Surgery company.

William N. Starling received his BS degree from the University of North Carolina at Chapel Hill and his MBA degree from the University of Southern California. . He began his 29 year career in the medical technology device industry at American Edwards Laboratories (Edwards LifeSciences). He was subsequently part of the founding management team and Director of Marketing for Advanced Cardiovascular Systems, Inc. (acquired by Guidant/Abbott), and was a cofounder, Vice President and Board member of Ventritex, Inc. (acquired by St. Jude Medical). In 1992, Mr. Starling was a cofounder and Chairman of the Board of Directors and President/CEO of Cardiac Pathways Corporation (acquired by Boston Scientific Corporation), and was responsible for raising significant capital from the early venture capital period through an initial public offering in 1996.

Control Of Diabetes Using Continuous Glucose Monitoring
Dr. Bruce Buckingham, MD
Professor, Stanford University
Director of Pediatric Endocrinology, Santa Clara Valley Medical Center

Wednesday, April 18, 2007, 7:30pm
Clark Center Auditorium

Diabetes is a chronic disease characterized by fluctuations in blood glucose levels. Hypoglycemia can results in seizures, and hyperglycemia can result in long term complications such as visual loss and kidney failure. Current management of juvenile onset (type-1) diabetes generally relies on 4 blood glucose tests each day. These tests often miss hypoglycemia occurring overnight and hyperglycemia occurring in the initial hours following a meal. Real-time continuous glucose monitoring offers the potential to prevent nocturnal hypoglycemia by the use of real-time alarms, and prevent postprandial hyperglycemia by patients modifying their meals and insulin doses.

Dr. Buckingham has been the PI at Stanford on an NIH sponsored multicenter study to assess continuous glucose monitoring (CGM). He will discuss the use of CGM to prevent glycemic excursions, and also review some of the problems with the current technology. The future lies in the marriage of a CGM with an insulin infusion pump to create an "artificial pancreas." Current progress and obstacles to this union will also be reviewed.

Bruce Buckingham, M.D. is a Professor at Stanford University and Packard Children's Hospital. He received his MD from the University of California at San Diego, and his Pediatric Endocrinology training at the Children's Hospital of Los Angeles. He is a member of the American Diabetes Association and is currently serving on the Program Committee and is Chair of the Council on Youth. Dr. Buckingham's research interests have focused on continuous glucose monitoring in children. He is Principal Investigator at Stanford for DirecNet, an NIH sponsored multicenter study group which evaluates continuous glucose sensors in children. This group has conducted a number of studies over the last 4 years assessing the accuracy, function and utility of the Minimed CGMS sensor, the GlucoWatch, and the Therasense Navigator. He is currently co-PI on the Minimed 7-Center study to assess clinical outcomes using a real-time continuous glucose sensor. Dr. Buckingham's current work focuses on the use of continuous glucose sensors in real-time, and the development of a closed-loop for management of persons with type-1 diabetes and in pediatric intensive care units.

Intelligent Medical Vigilance System:
Detection of Physiological Signals Using a Mattress Cover
Containing Pressure Sensors for Use with Med / Surg Patients
Eben Kermit, Manager of Field Service, Hoana Medical

Wednesday, May 16, 2007, 7:30pm
Clark Center Auditorium

Med / Surg patients are at risk in hospitals due to inadequate monitoring and failure to rescue. There is a continuing trend to move patients out of ICU beds and into med/surg areas earlier than in the past. We also face a looming nursing shortage, making these busy caretakers responsible for a greater number of patients while at the same time these patients may be at an increased acuity level. Many patients will enter the hospital under increasingly challenging conditions for resources. The E.R., the O.R. and ICU all have a low staff-to-patient ratio and all routinely use physiological monitoring (ECG, NIBP, Respiratory Rate, Temperature, Pulse Oximetry, etc.) as an adjunct to clinical assessment by caregivers. These monitored parameters, also referred to as "vital signs" form a basis for both patient care and patient wellness. Physiological data are frequently used to confirm status or as an indication for clinical intervention. One significant point that differentiates these (E.R, O.R and ICU patients), is that they are mostly non-ambulatory and are confined to bed, where physiological monitoring can be done directly.

It is a rare case for a patient to be discharged directly from the ICU. In most cases, the patient is staged through a med/surg unit or step down care area prior to discharge or transfer. On the med/surg floor, the staff-to-patient ratios increase relative to the ICU. Caregivers are responsible for more patients than their colleagues in the ICU. The intervals between assessments become less frequent. Also, the level of patient activity and mobility increases, as these patients recover strength and function. The challenge for physiological assessment is make meaningful measurements that augment clinical care without restricting patients via electrodes, wires, cuffs or other sensors that "tether" them to the equipment. The LG1 (tm) system has been designed to provide basic information (heart rate and respiratory rate) from patients who are in beds with a specially equipped mattress cover.

The LG1 Intelligent Medical Vigilance (tm) System consists of two components: the Bedside Unit and the Passive Sensor Array (PSA). The Bedside unit houses the electronics, keypads and display, while the PSA consists of a mattress "coverlet" and an array of thin, flexible, sensors. These embedded sensors provide information from the patient lying in the bed without restriction. Proprietary algorithms translate the "raw" data into measured heart rate, respiratory rate, and bed exit status (in-bed sensor). The Bedside Unit displays these data and interfaces with the hospital's existing nurse call system.

Eben Kermit is a biomedical engineer and long time member of the IEEE/EMBS Santa Clara group where he has held various roles including chairman. He is the manager of field service for Hoana Medical, a medical device start-up company headquartered in Honolulu, Hawaii.

The initial concept of using pressure sensors for physiological monitoring came from the CEO and founder, Patrick Sullivan, who recognized the potential for using available technology for a novel application. Dr. Sullivan is a physicist and visionary, who has a extensive history of applied research in remote sensing and sensor technology.

Mr. Kermit joined Hoana in late 2005 and has contributed to the development and clinical evaluation of the LG1 system which is now in commercial distribution.

Mr. Kermit holds an MSEE from California State University - Sacramento

Bionic Technology for Mobility Assistance
Robert Horst, Ph.D.
Chief Technology Officer
Tibion Corporation

Wednesday, June 20, 2007, 7:30pm
Clark Center Auditorium

Powered mobility assistance devices, sometimes called active orthotics, bionics, bio-robotics, or exoskeletons, could have a tremendous impact on the quality of life for those with impaired mobility. Advances in embedded computing, lightweight batteries, and motor control electronics provide some of the needed technologies, but the field has developed slowly while waiting for a suitable actuator that meets all of the key requirements: 1) Strong enough to lift a person, 2) Small and light enough to fit under the clothing 3) Coupling/gearing to provide a range of speed/torque tradeoffs as well as free movement, and 4) Highly efficient operation to power the device for a full day with a small battery.

Tibion has been developing actuators, electronics and embedded software to address the requirements for active orthotic devices. The development has included fabrication and testing of many types of actuators to deliver the required forces while minimizing size and weight. The evolution of the design requirements and solutions will be presented through photos, video and analysis of this series of prototypes. These devices are based on new types of continuously variable transmissions (CVTs) that provide the variable impedance needed for bionic applications. The actuators deliver sufficient force to aid in rising from a chair, the ability to deliver assistance force while moving quickly, and unimpeded motion during the swing phase of the gait. The discussion will include many aspects of developing an active knee device using a CVT actuator.

Robert Horst is Chief Technology Officer at Tibion Corporation, a company he co-founded in 2002. He holds an BSEE degree from Bradley University, a MSEE from the University of Illinois at Urbana-Champaign, and a Ph.D. in computer science also from the University of Illinois. He is a Fellow of the IEEE and holds 65 US patents.

Imaging the Cancer Genome
Howard Y. Chang, M.D., Ph.D.
Stanford University

Wednesday, September 19, 2007, 7:30pm
Clark Center Auditorium

The sequencing of the human genome and development of microarray technology has allowed the activities of almost all genes in the body in normal and disease states to be observed. The extracted patterns of gene expression can be used as a signature to diagnose and to predict the likely outcomes of diseases, in particular cancer. In this talk, I will discuss the progress in predicting the course of human cancers by gene expression signatures, strategies to progress from description to causality in order to define targeted therapeutics, and new technologies to capture the information in gene signatures by non-invasive imaging.

Dr. Chang received his undergraduate degree from Harvard University, his PhD in Biology from MIT, and his MD from Harvard Medical School. He completed a residency in dermatology and a postdoctoral research fellowship at Stanford University's School of Medicine. He is currently an Assistant Professor of Dermatology at Stanford. He has contributed to more than 40 publications, holds two patents and has applied for four more. He has received research funding from the National Institutes of Health, the American Cancer Society, the Scleroderma Research Foundation and the Department of Defense, among others. Dr. Chang has received numerous prizes for excellence in research.

Surgery with the da Vinci Surgical System
Video Presentation (No speaker at this event)

Wednesday, October 17, 2007, 7:30pm
Clark Center Auditorium

Intuitive Surgical, Sunnyvale, CA, has developed a surgical system for assisting surgeons in performing complex, minimally-invasive procedures. The System provides the surgeon with a high-magnification, 3-dimensional view of the surgical site and him to precisely and rapidly control the position and orientation of the instruments with natural hand and arm motions. During this meeting we will present a video made during an actual procedure (a hysterectomy) on a real patient. The video is narrated by the surgeon and other personnel who explain the operation of the system and discuss the benefits to the patient as well as describe the procedure being performed. Although the video was made to "sell" the system to surgeons, it will interest engineers as well. The smooth movement of the instruments and the vivid imagery are particularly impressive. Although we do not expect to have a representative from Intuitive Surgical at this meeting, we have invited them to appear at a future meeting to discuss the engineering and development challenges presented by this system.

Technologies and Applications of Simulation in Healthcare
Tour of the Goodman Simulation Center (GSC) at Stanford

Wednesday, November 21, 2007, 7:30pm
Clark Center Auditorium

The last decade has seen explosive growth of technologies and applications of simulation in healthcare. This growth was based on a number of prior, often independent, developments of device and curricula. There is now a wide diversity of simulation methodologies ranging from low tech ones (verbal simulation, role-playing, using food products -- such as beef hearts -- for practice) to higher tech ones (part-task trainers, computerized mannequins) to truly high-tech ones (virtual reality). These have been linked to an equally wide diversity of applications. In fact the scope of simulation in healthcare can be described according to (at least) 11 dimensions.

This talk will provide an overview of the modalities and applications of simulation. There will be a brief review of some of the history, especially that of my own laboratory's pioneering developments dating back to 1986. Organizational aspects of the diffusion of these technologies and applications will be discussed, including why healthcare is different from the analogous industries that have been used as models of simulation (aviation, nuclear power, spaceflight, military).

There will also be a detailed tour of the new Goodman Simulation Center (GSC) at Stanford. This center is the newest of 3 dedicated simulation centers at Stanford and its associated hospitals. Stanford is one of the world leaders of all varieties of simulation in healthcare, and the GSC has many state-of-the-art (or better) characteristics. It is also the pathfinder for a 28,000 square foot Immersive Learning Center that will occupy the entire basement of the new medical education building -- the Learning and Knowledge Center -- currently in the final stages of design for construction and opening by spring 2010.

DAVID M. GABA, M.D. is Associate Dean for Immersive and Simulation-based Learning and Professor of Anesthesia (with tenure) at Stanford University School of Medicine. He is also Director of the Patient Safety Culture Institute and the Patient Simulation Center of Innovation at Veterans Affairs Palo Alto Health Care System where he is a Staff Anesthesiologist. Over the last 22 years Dr. Gaba's laboratory has worked extensively on human performance and patient safety issues. This laboratory is a pioneer in applying organizational safety theory to health care - including both Normal Accidents theory and High Reliability Organization theory. Dr. Gaba and his team is the inventor of the modern full-body patient simulator and is responsible for introducing Crew Resource Management training from aviation to healthcare, first in anesthesia and then to many other healthcare domains. He has been the principal investigator on grants from a wide variety of funders, and is currently the PI on projects concerning safety culture in hospitals and on applying simulation to address safety culture in diverse types of hospitals ranging from rural critical access hospitals to large urban academic centers. Many of Dr. Gaba's fellows, faculty collaborators, and protgs have gone on to leadership positions on human performance in healthcare, organizational safety, and simulation in healthcare throughout the world.

Dr. Gaba is an author on more than 75 original articles and editorials in a wide spectrum of journals. He is the author of 18 book chapters, and one influential book: Crisis Management in Anesthesiology (which has been translated into three other languages). He has been visiting professor at a multitude of national and international academic sites and has delivered numerous named lectures. He is the Secretary of the Anesthesia Patient Safety Foundation and a founding member of the Research Committee of the National Patient Safety. He is a current and founding board member of both the Society for Simulation in Healthcare and the Advanced Initiatives on Medical Simulation. He is a current and founding member of the Committee on Simulation of the American Society of Anesthesiologists.

Dr. Gaba served on the editorial boards of three journals: Anesthesiology, Human Factors, and Teaching and Learning in Medicine, and has been a consultant reviewer for many more. He is the current and founding Editor-in-Chief of the journal Simulation in Healthcare, the only peer-reviewed journal on simulation, published by the Society for Simulation in Healthcare. He served on the Stanford Institutional Review Board for nine years, six of which he chaired an IRB panel on medical research.

Dr. Gaba was awarded the 2003 David M. Worthen Award for Academic Excellence, a national award from the Department of Veterans Affairs as well as the 2003 Duke Award for Excellence and Innovation in Anesthesia Education from the Society for Education in Anesthesia. Dr. Gaba was one of two foreign scientists invited to address Her Majesty Queen Elizabeth II at the opening of the simulation center in Perth, Western Australia in April, 2000.

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