Expert Details

Expert in Medical Devices, Electronic Systems, Acoustics and Hearing, Intellectual Property

Expert ID: 725088 California, USA

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Because of his long-term interest in sound and hearing, Expert has been involved with many aspects of acoustic measurement. He has developed proprietary technology for sound level measurement and noise dose determination and has utilized his skills in acoustic measurement as an expert witness on several occasions, including the evaluation of sound levels and sound isolation at a crime scene, the analysis of acoustic levels produced in an automobile and the exploration of the behavior of hearing aids.

Key to the understanding of patents is claim construction and due to his work as an expert in patent-related matters, Expert has a deep understanding of issues of claim construction. He has opined on matters of claim construction and applied agreed-upon claim construction to validity and infringement issues on behalf of both plaintiffs and defendants; and he successfully argued obviousness in a landmark case based on a recent ruling by the Supreme Court. He has also applied his expertise regarding issues of claim construction to device patenting and patent strategy issues. Further, Expert has worked on claim construction issues having to do with European Patent Office.

Expert holds seven patents of his own with five pending. He has been involved with patent strategy questions both in his own businesses as well as for various employers and clients. He has served as an expert on a variety of patent matters, having testified at deposition and at trial for both defendants and plaintiffs. His in depth analysis of patent validity and infringement issues as an expert along with his own experience as an inventor allows Expert to view issues of device patenting from a broad perspective.

Data acquisition and digital signal processing have been incorporated into the majority of Expert’s research, product development and consulting efforts. Signal processing is a technology equally important to medical, acoustic and scientific instrumentation, all of which Expert has had extensive experience. Expert has extensively applied digital filtering, digital signal analysis and synthesis, and other forms of digital signal manipulation in his R&D and consulting efforts. In addition, signal processing has been involved in many of cases for which he has served as an expert.

Patent litigation invariably involves the evaluation of infringement issues related to the alleged infringing devices or methods. Expert’s facilities includes a laboratory where can evaluate devices and thus he can opine on infringement based on his own independent measurements and analyses as well as his review of design documentation and data. Due to his knowledge of analog and digital circuits, audio and RF and microwave technologies, and both hardware and software issues, Expert can opine on infringement regarding a wide a variety of electronic systems including medical instruments, communications systems, scientific instruments, and audio / consumer products.

Expert has worked on a variety of projects involving electroacoustics: sound measurement, hearing aids, assistive listening devices, noise dose measurement and audiometric test equipment. His interest in sound, hearing, and music developed early and is reflected in his academic work at MIT and in his many R&D and consulting efforts. He researched novel acoustic techniques as applicable toward various sorts of medical devices, both therapeutic and diagnostic, while employed in the Research Department of a medical instrument manufacturer.

Electronic system design has been Expert’s focus for his entire career. His hobby as an amateur radio operator since age 11, his education, and all of his work experience have involved electronic design. Expert has diverse R&D experience, having successfully developed systems combining a wide variety of technologies including acoustical, optical, radio frequency, and microwave components and sensors, as well as data acquisition, embedded firmware and microprocessor-based control and measurement technologies. His multidisciplinary approach to design has combined analog and digital circuitry and signal processing with various sensors resulting in unique and proprietary designs for medical devices, applications involving sound and hearing, and a variety of scientific instruments.

Expert has design, manufacturing and expert witness experience in infusion pump projects and worked for a major manufacturer of infusion pumps and vital signs measurement equipment for ten years. He has served as an expert witness in patent litigation, product failure and liability cases involving infusion and fluid delivery; and has experience with pumps for hospital use as well as pumps for personal use. Expert has worked in many specific technology areas relevant to infusion pumps, including: motor control, air-in-line detection, flow rate measurement, data communications, pressure measurement, and sensor signal processing.

Expert’s professional experience includes the development of many types of medical instrumentation. Projects have involved clinical thermometry, pulse oximetry, blood pressure measurement, infusion pumps for hospital and personal use, a system with implantable markers to aid surgeons in the treatment of cancer, instruments to assist in the fitting of hearing aids, measurement of noise exposure, tissue ablation and aspiration, and the determination of farm animal fertility. As an expert witness, Expert has opined on the design and use of various medical instruments, most notably infusion pumps, and has also opined regarding intellectual property matters associated with medical equipment. Having worked in the medical device industry, Expert has had experience with the FDA-regulated manufacturing and development environment and has also presented data to the FDA as part of a product recall.

Array

Product development and consulting: noise dose measurement system; miniature sound level meter; communication system for hard of hearing; occlusion effect meter.Research and prototype development: solar-powered system for insect abatement.Product research and development, manufacturing process development: system which aids surgeon, including miniature human implantable devices and extensive signal processing. Technology involves electromagnetic sensing Expert Witness regarding patent infringement related to medical instrument design; on behalf of defendant. Technology involves pulse oximetry. Expert Witness regarding patent infringement related to radio frequency communications devices on behalf of plaintiff in a declaratory action and counter-defendant.

Expert may consult nationally and internationally, and is also local to the following cities: Los Angeles, California - San Diego, California - Long Beach, California - Santa Ana, California - Anaheim, California - Riverside, California - Glendale, California - Huntington Beach, California - San Bernardino, California - Chula Vista, California

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Education

Year Degree Subject Institution
Year: 1973 Degree: BS Subject: Electrical Engineering & Computer Science Institution: MIT
Year: 1978 Degree: MS Subject: Electrical Eng & Computer Science Institution: MIT

Work History

Years Employer Title Department Responsibilities
Years: 1995 to Present Employer: Undisclosed Title: President / owner Department: Responsibilities: President of contract engineering and consulting business specializing in the area of electrotechnology and focusing on medical instrumentation, sensors, control, measurement, audio, acoustics, RF technology, and signal processing,. Consulting efforts have included: expert witness work related to intellectual property, product liability, sound and hearing, as well as research and development for various audio, scientific and medical instrument manufacturers. R&D projects have included: sound measurement and processing systems; the design and production of miniature human implantable devices and associated sensing means; optical system for analysis of farm animal biomaterials; headworn ultrasonic sensing system with auditory display for the blind; motor control system for use in eye surgery, radio frequency communication device for the hard of hearing; and acoustical apparatus to assist in the fitting of hearing aids. Personally responsible for design of analog and digital circuitry, signal processing and control algorithms, acoustical planning and analysis, testing and evaluation, and software/firmware development. Experienced with embedded firmware programming (C and Assembly languages), LabView, database, MatLab, and Visual Basic. Staff and associates include electrical, software, mechanical, industrial and bioengineers, technicians, and assemblers.
Years: 2003 to 2012 Employer: Hearing Enhancement Group Title: Chief Technical Officer Department: Responsibilities: Chief Technical Officer of business involved with the development and marketing of listening devices and other products related to hearing. Technology focus is in the areas of acoustics, signal processing, and control. Responsibilities include development of acoustical design, hardware and software, intellectual property strategy, management of all aspects of product development, including test, and technical interface with overseas factory. Developed proprietary position-sensing system for determining whether or not a headworn device is in place on a user’s head.
Years: 1992 to 1995 Employer: IVAC Corporation, San Diego, CA Title: Engineering Manager Department: Vital Signs Division Responsibilities: Directed entire staff of 24 in Business Unit of hospital equipment manufacturer. Technical and managerial contributor to three Product Development programs. Managed Operations Engineering efforts for existing line of products, with emphasis on cost and quality improvements, automation, regulatory issues, and customer complaints. Lead member of team tasked with Product Recall effort and associated response to FDA. Formulated long-term strategy for business unit and sought both technical and marketing partnerships. Created systems to streamline and better control existing business practices to ensure timely introduction of new products and responsiveness to ongoing production issues. Products included infrared and conventional clinical thermometers, and blood pressure measurement systems.
Years: 1984 to 1992 Employer: IVAC Corporation, San Diego, CA Title: Principal Engineer / Project Leader Department: Research and Advanced Product Development Responsibilities: Performed research and developed proprietary technology in support of fluid delivery systems product line, including flow and pressure measurement subsystems and sensors for detection of air in fluid path. Conceptualized new products, recommended patent strategy, and evaluated business and technical proposals from outside organizations. Led teams for review of technologies for parent corporation, Eli Lilly, including flow measurement of fluids by means of thermal markers, microwave sensing of fluid composition, catheter-based RF tissue ablation, and non-invasive measurement of blood glucose. Set up microelectronics prototype lab. Prepared clinical protocols and regulatory submittals. Served as technical leader in development of new clinical thermometer and devised unique calibration method.
Years: 1983 to 1984 Employer: Dyn-Aura Engineering Laboratories, San Diego, CA Title: Chief Engineer Department: Responsibilities: Managed design, production, and test engineering functions for manufacturer of hearing aids, hearing test equipment and associated components. Designed analog circuitry and acoustic subassemblies, and improved assembly and test procedures. Supervised microelectronics assembly line, significantly increasing production yield. Implemented documentation standards and inventory control system. Conducted training seminars and product presentations, and contributed to company marketing plans.
Years: 1979 to 1983 Employer: Steinbrecher Corporation, Woburn, MA Title: Project Leader Department: Responsibilities: Led product development teams for manufacturer of scientific instruments. Projects included a navigation system based on GPS satellite signal reception, a sonar signal filtering subsystem, and a moisture measurement system employing microwave technology. Designed control algorithms, data acquisition subsystems, and software for data analysis and information display. Analyzed communications systems for various military and commercial clients. Wrote technical operation and service manuals for products. Company was acquired by Tellabs, Inc. in 1996.
Years: 1978 to 1979 Employer: Mech-El Industries, Woburn, MA Title: Manager of Electrical Design Department: Responsibilities: Managed engineering group for supplier of equipment used in semiconductor manufacturing.
Years: 1973 to 1978 Employer: Grason Stadler, Inc., Concord, MA Title: Engineer Department: Responsibilities: Product development for manufacturer of hearing test and acoustic measurement equipment.

International Experience

Years Country / Region Summary
Years: 2007 to Present Country / Region: Shenzhen region, China Summary: managed process of setting up production of consumer electronic product in China
Years: 2000 to Present Country / Region: Moscow / Minsk / Belarus Summary: Involvement with child relief program in areas affected by Chernobyl nuclear power plant accident. Work with Belorussian officials to bring children to US for health respite.

Career Accomplishments

Associations / Societies
Senior Member, Institute of Electrical and Electronics Engineers Medicine and Biology, Signal Processing
Member, Acoustical Society of America
Member, American Auditory Society
Organizing Committee Member, MIT Enterprise Forum -- 1986-1991
Amateur Radio Extra Class license holder: W6JZ
Professional Appointments
Treasurer, Children of Chernobyl Foundation (a CA not-for-profit)
Publications and Patents Summary
Expert has several patients. Presentations include meetings of the Acoustical Society of America and of the American Auditory Society.

Additional Experience

Expert Witness Experience
Served as an expert in intellectual property, product liability, trade secret matters and in cases involving medical instruments, audio measurement and analysis, and communication systems. Experience includes trial testimony on behalf of both plaintiffs and defendants in medical and RF patent cases, including a landmark patent case concerning obviousness, and trial testimony related to criminal eyewitness. Six depositions, four in IP-related matters. Testified in court four times, three in IP-related cases and once in a criminal case.
Training / Seminars
2006 American Board of Trial Advocates, Orange County, CA
Masters in Trial ( Expert presentation at mock trial)
Vendor Selection
Worked with Chinese factory to start up production of consumer audio product
Marketing Experience
Knowledgeable in areas related to Intellectual Property strategy and trends as well as recent changes in IP law.
Other Relevant Experience
Detailed knowledge includes control systems, embedded hardware and software, digital and analog circuits and systems, infusion pumps, medical vital signs measurement, signal processing, acoustical design and measurements, hearing, and RF and microwave. Skilled at embedded firmware design, assembly language programming, C programming and LabView. Experience in printed circuit board design, wire-bonding and electronics manufacturing.

Language Skills

Language Proficiency
Russian Fair proficiency in Russian language. Studied in high school and still using today due to involvement with not-for-profit involved with helping children in areas affected by Chernobyl power plant accident.

Fields of Expertise

acoustic measurement, patent claim construction, device patenting, digital signal processing, direct infringement, electroacoustics, assistive technology, electronic system design, infusion pump, medical instrument, medical device patent, control system analysis, control system design, electronic communication equipment, biomedical instrumentation, electronics, digital-to-analog converter, control system performance evaluation, electronics design engineering, electronics research and development, device product development, digital filtering, acoustic transducer, digital signal, design for manufacturability, electronic equipment, electronics engineering, electronic device design, new product development, control-system modeling, electronic medical device design, electronic circuit design, medical device manufacturing, digital-to-analog conversion, electronic product development, energy-efficient control system, control process, engineering acoustics, new product development management, design process, digital control system, legal patenting, electronic medical device, innovation, biomedical instrument, servomechanism, numerical control, medical pump, medical device, firmware, electronics manufacturing, electromechanical control, digital integrated circuit, control system, biomedical sensor, bioinstrumentation, audio acoustics, acoustic signal processing, acoustic analysis, software intellectual property, intellectual property strategy, sound level, infringement, patent claim chart, patent claim construction brief, claim (patent), acoustical instrumentation, new consumer product development, electronic design automation, blood flow meter, clinical measurement, electromagnetic acoustic transducer, analog output, electronic breadboard, linear system, hospital equipment, engineering project management, acoustics, electronics test equipment, feedback control system, 510(k) document, control-system direct-current motor, acoustic sensor, control system resolution, digital recording process, electronic equipment design, digital signal acquisition, design for cost, electromechanical control system, engineering control computer system

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