Medical Wearable Electronic Devices FDA Expert Witness

SUMMARY

• Award winning, Oxford Educated scientist whose areas of expertise include imaging, electronics, semiconductors, MEMS, medical engineering, sensors, signal processing and              image processing.
• Experience in industries/applications including medical devices, imaging, consumer electronics, biometric security, and electrical power delivery.
• Extensive Intellectual Property experience including patent development, analysis, licensing, and strategy. Serial inventor holding 26 U.S. Patents.
• Diverse technical consulting experience includes multinationals such as GE, Medtronic, Fujifilm, Samsung, Siemens, and many start-ups.
• Well-published in peer-reviewed scientific journals.
• Winner of grants from National Institute of Health (NIH) and DARPA. Extensive international consulting experience.
• Three years at University of Illinois teaching electrical and computer engineering.
• IEEE Senior Member since 2004.

EDUCATION

• D. Phil. (equal to Ph.D.) in Materials Science, Oxford University, UK, 1987. Thesis title: Acoustic microscopy of biological tissue.
• M.A. in Physics, Oxford University, UK, 1985.
• B.A. in Physics with 1st class honors, Oxford University, UK, 1984.

HIGHLIGHTS OF RECENT WORK

• Deposition and trial testimony experience, mostly in patent litigation (PTAB and ITC) and trade secret matters.
• Deposition and trial testimony experience in the Superior Court of California, and US District Courts.
• Chief Technology Officer of a neurotech startup.
• System design for a wearable cancer monitoring device.
• Portable point-of-care imaging (research supported by a grant to River Sonic Solutions from the National Institutes of Health).
• Design of beam formation and image reconstruction techniques for transcranial imaging and treatment (with the University of Arizona).
• Acoustics and transducer design for medical and industrial applications.
• Design of MEMS (micro-electro-mechanical systems) transducers, signal processing and front-end electronics for pediatric otitis diagnosis.

EXPERT WITNESS EDUCATION

• Expert Witnessing seminars attended (each course is 14 hours, on-site):
• How to Start, Build, and Run a Successful Expert Witness Practice
• How to be an Effective Expert Witness
• How to Excel at Your Expert Witness Deposition
• Advanced Testifying Skills for Experts
• How to Write a Bulletproof Expert Witness Report
• How to Excel and Succeed as an Expert Witness in Patent Cases: Special Techniques

Expert Witness Conferences attended:

• Forensic Expert Witness Association National Conference, San Francisco, CA, 2016
• National Expert Witness Conference, Clearwater, FL, 2017

VOLUNTEER WORK

• Member of the Board of Directors, IEEE-CNSV (Consultants’ Network of Silicon Valley), 2017-2019. IEEE-CNSV is the Silicon Valley chapter of the IEEE-USA Consultants’ Network. It brings together consultants, clients, and other interested parties to exchange ideas about electrical, electronic and software engineering. I served as the Secretary of this organization for two years.
•  Project Manager, Keizai Silicon Valley, 2013-2021. KSV is a non-profit business and professional networking organization. It provides a venue for showcasing specialists with expertise on issues critical to the success of entrepreneurs and companies doing business with Japan and the U.S.
• Member of Technical Program Committee, IEEE International Ultrasonics Symposium. This committee is responsible for the technical content of the IEEE International Ultrasonics Symposium.

ISSUED PATENTS

1. Receive-side beam forming for an ultrasonic image sensor: European Patent EP3353708B1
2. Methods, devices and systems for inducing collagen regeneration: United States Patent 11,172,978
3. Receive-side beam forming for an ultrasonic image sensor: United States Patent 10,067,229
4. Ultrasonic device and operation method therefor: European Patent EP3311752B1
5. Piezoelectric transducer device for configuring a sequence of operational modes: United States Patent 10,022,751
6. Redistribution layer in an ultrasound diagnostic imaging transducer: United States Patent 9,274,088
7. Switch for aperture control in medical diagnostic ultrasound imaging: United States Patent 8,795,182
8. Volume mechanical transducer for medical diagnostic ultrasound: United States Patent 8,647,279
9. Aperture synthesis using cMUTs: United States Patent 8,641,628
10. Multi-dimensional CMUT array with integrated beam formation: United States Patent 8,465,431
11. Piezoelectric and CMUT layered ultrasound transducer array: United States Patent 8,277,380
12. Ultrasound imaging transducer array for synthetic aperture: United States Patent 7,963,919
13. Apparatus for two-dimensional transducers used in three-dimensional ultrasonic imaging: United States Patent 7,824,338
14. Method and apparatus for improving the performance of capacitive acoustic transducers using bias polarity control and multiple firings: United States Patent 7,780,597
15. Apparatus for two-dimensional transducer used in three-dimensional ultrasonic imaging: United States Patents 7,719,166 & 7,679,263
16. Electric circuit for tuning a capacitive electrostatic transducer: United States Patent 7,670,290
17. Microfabricated ultrasonic transducer array for 3-D imaging and method of operating the same: United States Patent 7,618,373
18. Apparatus for two-dimensional transducers used in three-dimensional ultrasonic imaging: United States Patent 7,508,113
19. Microfabricated ultrasonic transducers with bias polarity beam profile control and method of operating the same: United States Patent 7,087,023
20. System and method for statistical design of ultrasound probe and imaging system: United States Patent 7,006,955
21. Method and system for conducting medical imaging transactions: United States Patent 6,931,270
22. Ultrasound imaging system having post-beamformer signal processing using deconvolution algorithm: United States Patent 6,245,016
23. Ultrasound imaging system with dynamic window function generator: United States Patent 5,817,023
24. Focused ultrasound surgery system guided by ultrasound imaging: United States Patent 5,769,790
25. Method for adaptively filtering doppler signals using a complex time domain filter: United States Patent 5,445,156
26. Color flow imaging system utilizing a time domain adaptive wall filter: United States Patent 5,349,524
27. Ultrasound imaging system with dynamic window function: United States Patent 5,345,939

PENDING PATENT APPLICATIONS

1. US 63/435,158 – Image guided therapeutic
2. US 63/516,463 – Physiological measurement
3. US 63/516,465 – EEG shielding
4. US 63/516,469 – EEG design
5. US 63/580,071 – Ultrasound aberration correction
6. US 63/589,928 – Treatment system
7. US 63/590,716 – Ultrasonic device
8. US 63/601,577 – Wearable device
9. US 63/607,032 – Acoustic coupling device
10. US 63/617,605 – Treatment safety method
11. US 63/554,004 – AI guided therapeutic
12. US 63/599,816 – Blockchain protected therapeutic
13. US 63/567,382 – AI centric treatment
14. US 63/582,162 – Closed loop treatment
15. US 63/586,735 – Stroke treatment
16. US 63/572,577 – Transcranial parameters

PROFESSIONAL MEMBERSHIPS

• IEEE Consultants Network of Silicon Valley: member from 2012 to Present.
• IEEE Senior Member: September 1987 to Present. The Institute of Electrical and Electronic Engineers is the world’s largest professional association dedicated to advancing                   technological innovation and excellence for the benefit of humanity.

EMPLOYMENT EXPERIENCE

SANMAI TECHNOLOGIES, PBC (2020 – present)

Chief Technology Officer

Responsible for technology at Public Benefit Corporation aimed at non-pharmaceutical treatment of mental illness.

RIVER SONIC SOLUTIONS, LLC (2012 – present)

Principal

Technical Consulting and Expert witness practice in: Imaging, especially Medical Imaging; Patents; Ultrasound; Electronics; Transducers; Application Specific Integrated Circuits (ASIC); Micro-electro-mechanical systems (MEMS); FDA approval of medical devices; Signal Processing; Design for Six-Sigma (DFSS); Semiconductors/ICs; Biometric security; Surgical Tissue Ablation; Tomography; Parallel Computing; Minimally Invasive Surgical Guidance; Wearables and Hearables.

CEPHASONICS, INC. (previously Samplify)

Chief Scientist, Santa Clara, CA: 2011-2013

• Responsible for technical direction of a start-up seeking to commoditize front- end and beam formation electronics.
• Advised CEO on all technical matters; also deeply involved in angel and VC fund- raising.
• Extensive customer interaction: marketed products to imaging and non- traditional customers.

SIEMENS HEALTHCARE, ULTRASOUND DIVISION

Senior Manager, Engineering, Mountain View, CA: 2005-2011

• Delivered 3 ASICs on tight schedule to support new Silicon Ultrasound product line.
• Managed team of eight engineers to design, test and manufacture all electronics needed for introduction of Silicon Ultrasound transducers.
• Technology evangelist presenting weekly to customers at Siemens’ Innovation Center.

SENSANT CORPORATION

Manager, Research and Development, San Leandro, CA: 2003-2005

• Managed group which created electronics for first 2D and 3D images using silicon ultrasound transducer.
• Co-authored successful grant proposal to DARPA on battlefield ultrasound imaging and surgery. $7.5 M was awarded to Sensant and its collaborator.
Senior Staff Engineer, San Leandro, CA: 2000-2003

• Design of new types of imaging systems using capacitive micro-fabricated ultrasound transducers (cMUTs, also known as Silicon Ultrasound.)
• Co-authored several successful SBIR grant proposals.

GENERAL ELECTRIC COMPANY

Physicist, Corporate R&D, Niskayuna, NY: 1990-2000

• Designed algorithms for IC implementation; resulting beamforming IC was the heart of GE’s successful entry into the premium ultrasound market.
• Developed statistical methods (now patented) for robust simultaneous design of transducer and imaging system to six-sigma quality standards.
• Much transducer design, acoustic field simulation and measurement.
• Research in signal processing for improved image quality and blood flow estimation. Several of these signal processing innovations are used in current GE products.

UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN

Assistant Professor of Electrical and Computer Engineering, Urbana, IL: 1987-1990

• Research in scanning laser acoustic microscopy to characterize tissue, and applications of neural networks to ultrasonic imaging.
• Taught undergraduate courses in circuit theory, medical imaging, and acoustics.
• Thesis Advisor for Masters’ students and undergraduate senior projects.

TESTIMONY EXPERIENCE: Available upon request.

HONORS AND AWARDS: Available upon request.

ACADEMIC PUBLICATIONS: Available upon request.