John G. Abbott, Ph.D.5111 NE 292Nd Avenue Camas, WA 98607 Phone: +1 206 310 Esume Amplification

Resume Amplification John G. Abbott, Ph.D.

John G. Abbott, Ph.D.5111 NE 292nd Avenue Camas, WA 98607 Phone: +1 206 310 esume Amplification

Professional Experience

10/12 – Present: John Abbott Consulting, Camas WAPresident – Consulting and training services on international standards, regulatory processes, risk management, quality systems ultrasound metrology and general engineering management. Works with international regulatory agencies, government officials and industry associations to promote the use of international standards and common processes in agency regulatory systems.

1/11 – 10/12: Philips Healthcare, Bothell WADirector – Regulatory Affairs – Standards & Regulations department was integrated into an executive-level department, Global Regulations & Standards. Responsibilities of the department broadened to a more “top-down” coordination of the numerous worldwide influence management functions to ensure a “One Philips” position as perceived from the outside. Increased formal internal training responsibilities as part of the new Philips “RA University” program. Continued management of standards activities, resources and services.

1/08 – 1/11: Philips Healthcare, Bothell WADirector – Standards & Regulations – Responsibility of standards group created in 2003 expanded to include regulatory services with the addition of 4 people. Standards & Regulations (S&R) provided all of the standards services of the old SDHC while adding regulatory support services including how standards and changes in regulations affect the company’s regulatory compliance and market access. Services include maintenance of the Country Regulatory Information database, drafting of Philips policy documents, training of regulatory staff, policy proposals, interpretations, common regulatory procedures, etc. Influence of government agencies and regulatory rule makers was specifically identified as a responsibility of S&R in 2008.

3/03 – 1/08: Philips Medical Systems, Bothell WADirector – Standards Communication - created a new corporate level department responsible for oversight of the development of and training on national and international standards and regulations for all business lines and sales & service regions of Philips Medical Systems. This department, The Standards Development and Harmonization Center (SDHC), had the responsibility to track standards in development, participate in standards committees, optimize Philips medical Systems participation, coordinate Philips’ comments on drafts, influence other National Committees, develop corporate interpretations, train on new standards, and any other standards related activity of value to Philips Medical Systems.

7/93 – 3/03: Philips Medical Systems – Ultrasound, Bothell WA (previously ATL Ultrasound, Inc.) Sr. Manager, Acoustic Measurements Department - managed a team of 23 engineer/physicists, supervisors, senior acoustic measurement technicians and acoustic consultants responsible for company measurements of regulatory and acoustic output control. The department was been responsible for the design and implementation of the “Output Display Standard (ODS)” on the HDI3000, HDI5000 HDI1500, UM400c and SonoSite products. Efforts included the development of all new procedures to address the needs of the regulatory environment including those specified by the FDA, IEC and Japanese MOHW. Also responsible for directing the implementation of a major expansion, quality and automation project to increase lab throughput by a factor of greater than 30x over 7 years while reducing errors to imperceptible levels. This expansion project included the development of new measurement technologies as necessary to meet increasing regulatory requirements as well as improvements in system technology.

7/99 – 2/00: ATL Ultrasound, Inc., Bothell WADirector (acting), Ultrasound Systems Engineering Department - directed a department of 52 engineer/physicists, supervisors, senior acoustic measurement technicians, co-op students and acoustic consultants responsible for image and system design, performance, integration and quality for all ATL products. Department includes the measurements department managed independently (see above). This responsibility was assumed while the department director was on extended sabbatical 7/99 – 2/00.

5/90 - 7/93: Precision Acoustic Devices, Fremont CA (subsidiary of ATL)Engineering Manager, PAD - managed a team of 4 engineers in the design, development and manufacture of medical transducer devices for a small (30 person) subsidiary OEM manufacturer. Personal engineering responsibilities included transducer/sensor design, customer interaction, project management and contract consulting. Services at PAD included low volume medical imaging transducer design, high volume sensor design, and regulatory measurements for 510(k) submissions. As a member of the PAD management team, the company was returned to a profitable position after 2 years. In 1993, citing a desire to consolidate its core technologies, ATL chose to sell the OEM business and transfer the remainder to its main facility in Bothell WA.

2/87 - 5/90: Diasonics, Inc., Milpitas CAManager, Acoustics/Sustaining Probes Groups - managed the efforts of 4 engineer/physicists in the design and development of transducer systems, acoustics and complete probes for the Diasonics DRF-200/400™, SPA-1000™ and SPECTRA™ family of ultrasound imaging instruments. Developed relationships with numerous commercial OEM transducer manufacturers and initiated the development of a complete transducer prototype and production facility at Diasonics.

4/86 - 2/87: Diasonics, Inc., Milpitas CAEngineer V - member of the New Product Development Team involved in the acoustic design of transducers and probes for existing products and development projects. Released products under my direction for the Diasonics DRF-200/400™ and SPA-1000™ systems include, the SPA 5.0 and SPA 3.5 annular array probes, the CMS/Dplus 3.5 probe, the EndoVaginal 7.5 probes and the GP/Mplus 3.5 probes. For the SPECTRA™ system, in addition to system development, numerous annular and linear array probes were released.

2/83 - 4/86: F. Hoffmann-LaRoche & Co., Ltd., Basel SwitzerlandWobbler Probe development - designed and developed the mechanics (with the assistance of a staff mechanical engineer) and the interface drive electronics for the mechanical sector probe used with the Kontron - Sigma 1™ family of medical ultrasound imaging instruments. This development, in addition to prototyping, included the preparation of equipment and procedures for use during manufacture and test. Tissue Characterization - undertook a research program to evaluate various acoustic attenuation estimation methods in terms of accuracy and data requirements using typical commercial quality hardware and transducers obtaining acoustic data from a tissue equivalent phantom.

2/80 - 1/83: Elscint, Inc., Boston MAGroup Leader/Project Engineer - originated the startup of the Ultrasound R&D facility in the United States and was the first and only US employee for the first year. Part of the design team responsible for the Dynex 44™ diagnostic ultrasound imaging instrument. Managed and performed the development and process documentation for transducers, transducer arrays and system probes

Committees

IEC/ISO

Chairman IEC TC87: Ultrasonics. Convener IEC SC62B/MT34: Ultrasound Safety. US Head-of-Delegation IEC:SC62B: Medical Diagnostic Equipment. US expert to IEC TC76/WG4: Medical Lasers. Chairman TC87 US Mirror Committee. Convener pro tem of WG14 within TC87 1999 & 2001. Organized the IEC TC87 committee meetings in Seattle (1999) and New Orleans (2006). Authored key provisions of IEC60601-2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. Member of the Chairman’s Advisory Groups (CAG) for IEC TC62 and IEC SC62B. Member ISO TC210: Quality Management, ISO TC215: Health Infomatics, ISO TC245: Second Hand Goods. Member USNC Council.

MITA/NEMA

Managed Philips Healthcare’s participation in MITA/NEMA to ensure a One Philips position is presented to working groups and committees. Served as Ultrasound Technical Committee chairman. Served on the joint AIUM/NEMA committee for the first re-write of the AIUM/NEMA Acoustic Output Safety Standard. Served on the joint AIUM/NEMA committee for the development of the Output Display Standard. Edited the 1997 release of the FDA Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.

AIUM

Regulatory Review Scoping sub-committee chairman 2000 – 2001

Technical Standards Committee member 1993 – present, chairman 2010-2011

Bioeffects Committee member 2000 - present

Output Standards Subcommittee member 1993 – present

IEC Subcommittee chairman 2007-present

ad hoc International ODS revision 2 Working Group chairman 1997-2002

Non-Thermal Bioeffects working group member, 1998

Editor of 1998 revisions to the AIUM Acoustic Output Measurement Standard and Acoustic Output Labeling Standard

Awards

2012: Frost & Sullivan Most Valuable Thought Leader Award

in recognition of his highly valued expertise at Medical Device Mind Exchange, March 11-13, 2012 Coronado, CA.

2011: ANSI Meritorious Service Award

in recognition of many contributions to the American National Standards Institute and the voluntary standards community.

Education

Stanford University, AEA/Stanford Executive Institute
An intensive 2-week general business administration course covering all aspects of business management including Marketing, Finance, Accounting, Operations, Organizations, Negotiation, Technology Management, Corporate Strategy.

National Bureau of Standards, Washington DC
Electronic Engineer (GS-11) - a one year post-doctoral appointment awarded on a competitive basis decided by academic qualifications and a submitted short term research proposal. The research program involved the design of a unique array ultrasound imaging system for ultimate use in medical diagnosis.

Duke University, Durham NC
While in the Ph.D. program of the Biomedical Engineering Department at Duke University, I contributed to the research, design and development of improved, real-time, phased array, dynamically focused, ultrasound imaging instrumentation under the direction of F.L. Thurstone, professor. The research undertaken for the Ph.D. degree involved the investigation of techniques for reducing the granular nature of ultrasound images, a phenomenon known as acoustic speckle, using real-time spatial compounding techniques. A reprint summarizing this research is available.

Tulane University, New Orleans LA
Undergraduate Bachelor of Science degree in Engineering with an emphasis on bio-medical engineering.

Publications

Reviewed Technical Journal

Thurstone FL, Abbott JG; Actual-time scan conversion and image processing in a phased array ultrasound imaging system, in 1977 IEEE Ultrasonics Symposium Proceedings, 247 (IEEE Cat.# 77CH 1264-1SU)

Abbott JG, Thurstone FL; Multi-scan processing in a phased array imaging system, in 1978 Ultrasonics Symposium Proceedings, 220, (IEEE Cat.# 78CH 1344-1SU)

Thurstone FL, von Ramm OT, Abbott JG, Butts HB, Shattuck DP; On producing compound B-scans at high image frame rates, abstract only, 23 Annual Meeting of the American Institute of Ultrasound in Medicine, San Diego, CA (1978)

Abbott JG; Speckle Reduction Techniques in Ultrasound B-Mode Images, Dissertation for the partial fulfillment of the requirements for the degree of Doctor of Philosophy in the Department of Biomedical Engineering in the Graduate School of Arts and Sciences of Duke University (1979)

Abbott JG, Thurstone FL; Acoustic speckle: theory and experimental analysis, Ultrasonic Imaging 1, 303-324 (1979)

Abbott JG, Thomenius KE; Real-time ultrasound imaging with arrays, in Proceedings Electro-82 East Symposium, Boston MA (1982)

Abbott JG, Thomenius KE; Ultrasonics for medical diagnosis - part 10 - real-time ultrasonic imaging with arrays (professional course), Medical Electronics 14:2, 79-85 (1983)

Abbott JG; Rationale and Derivation of MI and TI – a Review, Ultrasound in Med and Biol 25:3 pp 431-441(1999)

AIUM; American Institute of Ultrasound in Medicine Mechanical Bioeffect Conference Document for 1998 Meeting in Aspen, CO, J Ultrasound Med 19:2 (2000)

O’Brien WD, Abbott JG et.al.; Acoustic Output Upper Limits Proposition. Should Upper Limits be Retained? (invited), J Ultrasound Med 21:1335-1341 (2002)

Abstracts

Abbott JG, Thurstone FL; Speckle reduction techniques in ultrasound B-mode images, abstract only, Fourth Annual International Symposium on Ultrasound Imaging and Tissue Characterization, Gaithersburg MD (1979)

Abbott JG, Bauer BJ; Cutting multi-element miniature arrays, abstract only, Fifth Annual International Symposium on Ultrasound Imaging and Tissue Characterization, Gaithersburg MD (1980)

Abbott JG; Problems in the Measurement of Acoustic Output Emissions: The Manufacturer's Perspective, panel discussion, AAPM annual meeting, San Antonio TX (1988)

Abbott JG; Safety Debate: “Sonographers Cannot be Trusted to Control Output”, con position, invited talk British Medical Ultrasound Society, Eastbourne UK (2000)

Abbott JG; Categorical course: “Should output limits be removed?”, Invited talk, AIUM, Nashville TN (2002)