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Santa Clara Valley Chapter

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JANUARY 21, 1998

A Short history of Medical Device Quackery

Monroe Postman

Charms and fetishes were devised thousands of years ago to ward off evil spirits and cure disease. These beginnings of device quackery seem pretty tame as compared to some of today's medical quack devices. A formal history of device quackery in America might begin in 1796 when Dr. Elisha Perkins patented and sold his "Metallic Tractors", a pair of dissimilar rods which he claimed would "pull out the ailment" when applied to the body.

As legitimate science progressed over the next two centuries, and various means of generating and controlling electric current were made available, the medical quacks quickly sold a host of cure-alls. They preyed on the public's fascination with the emerging sciences and their fear of the many diseases which were not curable at the time.

As vacuum tube (and later solid state) technology became available, a new crop of "Radio" diagnostic and treatment machines appeared. These employed impressive control panels with lights, dials, and meters. A present-day device, under review by the FDA, utilizes flashing LEDs and a hypnotic audio tape to "Energize your mind and body...".

Many of these devices will be described and a number of items, which have been on display at a local museum, will be available for inspection.

Monroe Postman has a Bachelor's Degree in Electrical Engineering from the Polytechnic Institute of Brooklyn. His professional career includes the design of computer interfaces, "skunk works" management, and over five years as Science Advisor to the City of San Jose. He is presently a volunteer on the technical staff of the Museum of American Heritage in Palo Alto. He is a Life Member of the IEEE.

FEBRUARY 18, 1998

Anatomy of a Medical Device Startup

Stuart D. Edwards
Somnus Medical Corporation

Somnus Medical Technologies was founded in January 1996. In the following 23 months it developed a novel system for surgical treatment of upper airway disorders, conducted clinical trials, obtained clearance from the FDA, ramped up manufacturing, and introduced the product with nationwide media coverage. Along the way, Somnus raised over 17 million dollars in startup capital and executed an initial public offering raising over $45 million. Stuart D. Edwards, the inventor, founder and CEO of Somnus, will present the company as a case study in taking a medical device company from the initial idea through the IPO and beyond.

Stuart D. Edwards is an accomplished and prolific medical device inventor and has started several companies to develop and market his products. He holds an Advanced Certificate in Mechanical and Electrical Engineering from the U.K. and is named inventor on close to two hundred patents. He was most recently President, Chairman, and CEO of VidaMed, a publicly-held medical startup he founded to develop minimally invasive surgical systems. Previously he was Chief Technical Officer and Corporate Vice President of EP Technologies, a company involved in the development and manufacture of intracardiac catheters for use by cardiac electrphysiologists. He serves on the board of RITAmedical and as a consultant to Oratec, two privately-held medical device companies which he founded.

MARCH 18, 1998

Rehabilitation Robotics
Assistance, Assessment and Therapy

H. F. Machiel Van der Loos

In rehabilitation, robots have the same strengths of quality control, consistency and low failure rate as in industrial applications, and combine a few more. Compared to an attendant, a robot as an assistive device under the control of a person with a physical disability is always on call and provides privacy to its operator. In the clinic as an assistant to a therapist, a robot provides customization of exercise programs, quantification of performance, and monitoring of progress. These are important factors in the currently changing health care landscape that focuses on cost-effectiveness and functional outcome measures. The promise of robotics has always been evident; the implementation continues to provide challenges.

The VA Palo Alto Rehabilitation R&D Center, in collaboration with Stanford University's Dept. of Mechanical Engineering, has a 16 year history of developing robots for personal assistance, concentrating on voice controlled desktop systems for individuals with high level spinal cord injury. DeVAR, the latest prototype, has been extensively tested in the clinic, in the field, and in the classroom. Past projects include a mobile robot (MoVAR), an instructable, natural language interface and gripper designs. Videotapes of these robots will be shown and concepts from our current development project, proVAR, will be discussed. A more recent research direction of our Center is the use of robots as a therapist assistant for early intervention, upper-extremity stroke rehabilitation. Two projects are exploring therapies in which both arms are engaged in a functional task, with the strong arm of a person with hemiplegia guiding (through robot-assisted mirroring) the motions of the weaker arm. Preliminary results will be presented.

Machiel Van der Loos received the Ingnieur Mcanicien degree from the Swiss Federal Institute of Technology in Lausanne in 1979, and as Engineer's degree (1984) and Ph.D. (1992) from Stanford in Mechanical Engineering, all in robotics. He has been involved in the VA/Stanford Rehabilitation Robotics Program since 1979 in various roles from graduate student to project director. He is presently co-Principal Investigator on several federally funded robotics and information technology projects and Consulting Assistant Professor with the Dept. of Functional Restoration at Stanford. He has a special interest in the use of mechatronics in rehabilitation, human-machine interface design and assistive device assessment for the clinic. He has numerous professional affiliations, conference publications and journal articles, and will be hosting the next International Conference on Rehabilitation Robotics (CORR) at Stanford University in 1999.

APRIL 15, 1998

A Low-Cost System for Painless Self-Monitoring of Blood Glucose

Joel Douglas
Mercury Diagnostics, Inc.
Palo Alto, CA

This presentation will provide a discussion on the design and development of low-cost electronics for medical devices. In the majority of cases, devices currently on the market do not take advantage of the latest technology to reduce costs. This is apparently due to the following factors:
  • FDA requirements (or "regulatory stagnation") mandating that manufacturers get approval for medical device modifications.
  • Developers' lack of knowledge, or "skill gap" because companies focus engineering effort on design documentation and validation.
  • Developers' focus on the cost of the associated disposables rather the cost of the electronic device.
The speaker will discuss how his company reduced the cost of a medical device for self-monitoring of blood glucose while improving reliability and user convenience. Careful cost analysis was applied together with the most appropriate electronics technology.

Joel Douglas, a native of Connecticut, graduated from the University of Connecticut with a degree in Engineering and from the University of New Haven with an MS in Computer Science. He is currently Chief Technology Officer of Mercury Diagnostics, Inc., a new company developing a painless device for blood glucose monitoring. Previously, he was Senior Project Manager with LifeScan, Inc. working on new product development. Prior to LifeScan, he worked at Komag, a manufacturer of thin film disks.

MAY 20, 1998

Human Genome Project

Mark Schena, Ph.D.
Stanford University

The Human Genome Project endeavors to determine the precise sequence of the three billion bases that comprise the human genome. With sequence in hand, it will be possible to determine the function of all 100,000 human genes within ten years. At the heart of so-called "functional genomics" is the emerging microarray or biochip industry. Microarrays or "chips" contain microscopic nucleic acid features that allow hybridization-based gene analysis on a genomic scale. Continued advances in microarray technology (biochemistry, chemistry, engineering and physics) will soon permit the analysis if all 100,000 human genes in a single experiment. Data mining of the information contained on the chips will provide genetic databases of extraordinary value. Biochips will accelerate drug discovery and disease diagnosis and provide clues to the genetic and environmental determinants of health, aging, and human behavior. Concomitant political and social advances will ensure the constructive use of human genomic information.

Mark Schena is a postdoctoral fellow in the Department of Biochemistry at the Beckman Center at Stanford University. He has been a pioneer in developing methods, applications and enabling technologies for the microarray field. A manuscript published in Science magazine by Dr. Schena and his colleagues from Stanford (Science 270, 467-470, 1995) is regarded as an important force in promoting biochip technology. Dr. Schena's undergraduate work in Biochemistry was carried out at UC Berkeley, and he earned his Ph.D. from the Biochemistry Department at UCSF in 1990. In the course if his research on bacteria, yeast, plants and mammalian systems, Dr. Schena has authored more than twenty scientific papers and has become an internationally recognized scientist, lecturer, consultant, teacher and writer. Concurrent with his academic post at Stanford, he is President of Mark Schena Inc., which provides consulting and mentoring services to academic and commercial communities. In this capacity, he has worked with a host of private sector organizations.

JUNE 10, 1998

High Tech Meets Medicine: the Virtual Hospital and the Electronic Housecall

Muriel Ross
NASA Ames Research Center

The ability to produce interactive high fidelity 3-D images from patient scans is a reality using high-end workstations and virtual environment technologies. We have now also been able to visualize complex images, such as breast tumors and heart, in 3-D using an inexpensive computer and shutter glasses. Sharing of and interacting with 3-D images between remote sites, using virtual environment technologies and a variety of computers, will shape the future of medicine into the next century. The advent of low Earth satellites, high bandwidth internet capability, and transportable medical imaging equipment will herald the return of the housecall, this time electronically. These advances in technology will help equalize health care around the globe.

Muriel Ross is a neuroscientist who has focused her basic research on the ultrastructural organization of mammalian gravity sensors and on adaptive changes (neural plasticity) in the sensors under conditions of altered gravity. She left the University of Michigan in 1986 to join NASA's Ames Research Center in Mountain View to apply computer-based technologies to her studies. At Ames, she founded the Biocomputation Center, which she directs. At the Center, she facilitated the development of a method of semiautomatic 3-D reconstruction from serial thin sections and a dynamic, finite volume simulation of vestibular afferent activity. More recently, this work has led to applications in virtual environment for scientific and medical simulations and training. She directed the development of software for high fidelity imaging from CT and MRI scans. A result of all these efforts is the establishment of a National Center for Biocomputation at Stanford University Medical School through a cooperative agreement with NASA Ames Research Center.

SEPTEMBER 16, 1998

Hybrid Biosensors: Harnessing Living Tissues for Toxin Detection and Drug Discovery

Gregory T. A. Kovacs
Stanford University

For many years, researchers have been able to grow living tissues on integrated circuit substrates. A wide variety of anchorage-dependent primary and immortalized cells can be used to form sensors in this way, assessing cellular state using action potentials (in the case of electrically active cells), transmembrane impedance, or cell motility. Complete sensor systems can be built that include full microenvironments for the cells and are fieldable. These sensors can be applied to the detection of chemical and biological warfare agents. In addition, bench-top instruments can be used for drug discovery. A variety of recent results will be presented, including simple but powerful methods for signal analysis.

Gregory T. A. Kovacs received the B.A.Sc. degree in Electrical Engineering from the University of British Columbia, the M.S. degree in Bioengineering from UC Berkeley, and the Ph.D. degree in Electrical Engineering and M.D. degrees from Stanford University .His industry experience includes the design of high-speed data acquisition systems, the design of instruments for GaAs device fabrication, commercial and consumer product design, extensive patent law consulting, and the co-founding of several companies, most recently Cepheid, Inc., in Sunnyvale, CA.

In 1991, he joined Stanford University and is currently an Associate Professor of Electrical Engineering. He teaches courses in electronic circuits and micromachined transducers. He held the Robert N. Noyce Family Faculty Scholar Chair in 1992 - 94, received an NSF Young Investigator Award in 1993, was appointed a Terman Fellow in 1994, and was appointed a University Fellow in 1996. His present research areas include solid-state sensors and actuators, micromachining, neural/electronic interfaces, integrated circuit fabrication, medical instruments, and biotechnology, all with emphasis on solving practical problems.

OCTOBER 21, 1998

Signal Processing, Auditory Perception, and Hearing Aid Design

Brent Edwards
ReSound Corporation

In 1989, the sophistication of signal processing in hearing aids increased dramatically with the introduction of multiband fast-acting compression on small, low-power analog chips. For the next several years, technical advances were incremental at best, primarily due to the severe chip design constraints for practical application in commercially successful hearing aids. In 1995, two companies introduced hearing aids that processed sound on DSP chips, taking the next step necessary for dramatic improvements in how hearing aids can compensate for sensorineural hearing loss. This talk will discuss the current state of the art with respect to sound processing in hearing aids from the perspective of both hearing loss compensation and improvements to the intelligibility of speech in noise. Psychoacoustic and speech perception research will be discussed with respect to their relevance to hearing aid design.

Brent Edwards is the Director of Research at ReSound Corporation, a hearing aid manufacturer in Redwood City. Dr. Edwards completed his Ph.D. in Electrical Engineering in 1992 at the University of Michigan where he investigated the application of signal processing to the human auditory system. He followed this with a postdoctoral fellowship in Psychology at the University of Minnesota where he studied human psychoacoustics, specializing in modulation perception and intensity coding. In 1995 he joined ReSound Corporation as a Research Engineer, became Director of Research in 1996 and added Clinical Audiology to his directorship in 1997.

NOVEMBER 18, 1998

The Promise of MRI for Guiding Minimally Invasive Therapy

Bruce L. Daniel, MD
Assistant Professor of Radiology
Stanford University

Over the past 15 years, dramatic improvements in Magnetic Resonance Imaging Techniques have lead to exquisite ability to depict the extent of localized diseases in the body. This has raised the interesting prospect that Magnetic Resonance Imaging might be able to guide minimally invasive therapy for tumors and other localized disease processes.

A number of technical challenges must be surmounted before interventional MRI can fulfill its potential to replace open surgical procedures, or non-targeted systemic therapies. New scanning systems are in development which provide unparalleled access to patients undergoing minimally invasive therapy. Minimally invasive therapeutic devices are being engineered that function in concert with the MRI environment. Finally, MRI techniques that not only provide visualization of the target lesion, but of the progress of a therapeutic process are being developed which will enable true interactive control during minimally invasive iMRI procedures.

This talk will highlight these developments, as well as some of the remaining challenges. A variety of iMRI approaches to the treatment of liver metastases, breast cancer, prostate cancer, cirrhosis, incontinence, and other diseases will be reviewed.

Dr. Bruce Daniel received his BA degree in Physics from Williams College and his MD from Harvard Medical School. He completed his Residency in Diagnostic Radiology at the University of Michigan in 1995, and held a Cancer Imaging Fellowship at Stanford University from 1995 to 1997. He is currently Assistant Professor of Radiology at Stanford. His research interests are interventional MRI, breast MRI and prostate MRI.

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