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Resume of YEG, Ph.D.
Consultant

EXPERTISE AND SERVICES

Engineering Science Expert, Information Management Specialist, Signal/Image Analysis Consultant, CyberSecurity Consultant, System Health Management and Biomedical Devices Consultant, Intellectual Property and Patent Infringement Consultant, Engineering Consulting Services
Expertise in business and product development with extensive experience in the information management industry and the biomedical device industry. Background includes a track record of developing successful products/technologies in the areas of signal/image analysis and cybersecurity, system health management and biomedical devices.

This KKAI consultant possesses vision and implementation skills in areas including product development/R&D management, strategic and tactical planning, program/project management, patent/license strategies, customer focused quality, and quality assurance management.

In addition, this consultant specializes in areas related to diagnosis and prognosis of the health and behavior of complex systems through the application of signal analysis, feature extraction, classification, information fusion and knowledge management.

This consultant offers specific expertise relative to implantable defibrillator leads, advanced development, design, testing, program management and off-site manufacturing interface management, product development, quality assurance, manufacturing and patent management for site specific drug delivery products for the urological and gynecological fields, design and program management of all coronary angioplasty catheter products, R&D of pacing systems (rate responsive, dual chamber), low energy pacing leads, implantable infusion pumps, and sensors (stroke volume, pH, and glucose)

PRINCIPAL INDUSTRIES SERVED
Biomedical Devices, CyberSecurity, Health Management, Information Management, Signal/Image Analysis

EDUCATION
Ph.D., Engineering Science, Oxford University, Oxford, England
M.S., Physics/Math, Oxford University, Oxford, England
B.S., Physics/Math, Oxford University, Oxford, England

PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.

Providing expertise in engineering science, information management, signal/image analysis, cybersecurity, system health management and biomedical devices, intellectual property and patent infringement consulting, and related expertise to a wide variety of clients.

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Case Studies

Intellectual Property Manager, acute and chronic disease treatment firm, St. Paul, MN

Program Manager, NBI, Inc., St. Paul, MN

Led the key NBI program through the pre-clinical phase and planned human clinical phase. Evaluated intellectual property status, managed invention disclosures, produced due diligence IP report.

Senior Technical Manager, Integrated Security Technology, Honeywell Labs, Honeywell International, Minneapolis, MN

Was responsible for Image Analysis and CyberSecurity Technology Development. Staffed, developed and managed video capabilities in Minneapolis, Prague, Bangalore, Shanghai. Supported Business Unit Programs and Technology Development in the Services, Products and Control Divisions of the ACS Division. Provided support to classified Homeland Security programs in image analysis/cybersecurity. Achieved external US Government Contract program funding levels (DARPA, HSARPA, TSA/FAA, DOD) of $4m/annum, and Honeywell funded program levels of $2m/annum, and administered all programs. Honeywell Management Lead for Operation Secure Commerce Proposal to TSA with Black & Veatch of Kansas City targeted at Seaport and Container Security, through Long Beach-Los Angeles/Seattle-Tacoma Maritime Port Authorities. Chair of Critical Infrastructure Protection Technology Group addressing Airport, Seaport, and Container Security.

Section Head, System Health Management, Honeywell Labs, Honeywell International, Minneapolis, MN

Was responsible for the diagnosis and prognosis of the health and behavior of complex systems through the application of signal analysis, feature extraction, classification, information fusion and knowledge management. Interacted with Divisions in Air Transport, Space, Defense, Engines, Transportation, Sensors & Guidance, Homes & Buildings, to define and fund joint projects involving data acquisition and knowledge management for Health Management purposes. Honeywell Labs Leader of the Predictive Trend Monitoring (PTM) Program with ES&S, resulting in joint projects of $1.9m and $3.5m. Created and chaired the Honeywell Total Aircraft Maintenance Information group, involving representatives from Redmond, Teterborough, Albuquerque and Phoenix. Chaired an Oil Industry Consortium focusing on Corrosion and Fouling Health Management in National Institute of Standards and Technology (NIST) programs (BP-Amoco, Exxon-Mobil, Nalco-Exxon, Argonne National Labs) for 18 months.

Director of Leads Design, Sanofi-Synthelabo-ELA-Angeion Corporation, Brooklyn Park, MN

In the area of implantable defibrillator leads, was responsible for advanced development, design, testing, program management and off-site manufacturing interface management. Developed families of integrated bipolar passive and active fixation right ventricular defib leads to US and European market release. Managed Angeion activities in Congestive Heart Failure and Atrial Therapy. Developed atrial and dual chamber defib leads through concept phases. Managed two off-site Manufacturing Facilities.

Vice-President of Product Development, Iotek, Inc., Minneapolis, MN

Was responsible for product development, quality assurance, manufacturing and patent management for site specific drug delivery products for the urological and gynecological fields. Developed an iontophoretic drug delivery system for females (including stimulator and catheter), for providing local anesthesia adjunctive to collagen bulking procedures, urethral dilatation and urethrotomies, through phase 2 US and European clinicals. Developed a catheter-based iontophoretic drug delivery system for males, for providing local anesthesia adjunctive to minimally invasive surgical alternatives to transurethral resection of the prostate, through human feasibility trials.

Director of Catheter Product Development, Scimed Life Systems, Inc., Maple Grove, MN

Full responsibility for design and program management of all coronary angioplasty catheter products in a $200,000,000 business. Departmental management of the product development function, consisting of 42 engineers and technicians including planning, hiring, coaching, development of people, budgeting etc. Managed the development of 19 families of coronary angioplasty catheters, which were the basis of increases to $180m from $80m in sales, and to 40% from 20% in US market share. Co-invented the magnetic exchange system as an alternative rapid exchange system. Developed and implemented a design control system in accordance with FDA and ISO 9000 requirements.

Director of Product Development, Medtronic, Inc., Minneapolis, MN

Assumed full P/L management responsibility (with Marketing and Manufacturing) for the Pacing Leads Business ($80,000,000 annually). Was responsible for the product development and supply of all Brady Pacing lead products and Tachyarrhythmia and Defibrillator lead products. Managed a group of 65 people, consisting of the functions of Design, Reliability Assurance, Technology Development, Materials Quality Assurance, Product Support and Program Management. Developed and market released 46 Brady and Tachy pacing lead products. Increased market share to 55%, from 43%, and revenues to $80m from $60m. Was responsible for Pacemaker and External Products Mechanical Design. Chair of the Quality Steering Committee for the Pacing Business Unit. A member of the Strategic Science and Technology Committee. Manager of Material Science R&D.

Director of Research, Cardiac Pacemakers Inc., Arden Hills, MN

Was responsible for R&D of pacing systems (rate responsive, dual chamber), low energy pacing leads, implantable infusion pumps, and sensors (stroke volume, pH, and glucose). Was a pioneer in the recognition and advocacy of rate responsive pacing. Developed through clinical evaluation, the first rate responsive pacemaker by a major pacemaker manufacturer. Evaluated polyurethane for pacemaker leads, and determined it should not be used. Served as a member of the Product Evaluation Committee for Product Release Approvals and monitoring of field clinical product performance.

PROFESSIONAL REGISTRATION
ix Sigma Greenbelt Certification
Design for Six Sigma Training/Certification
Instructor, Design for Six Sigma Training

PROFESSIONAL AFFILIATIONS
Honeywell Total Aircraft Maintenance Information group
Oil Industry Consortium focusing on Corrosion and Fouling Health Management in National Institute of Standards and Technology (NIST) programs

PUBLICATIONS
Holder of numerous patents related to endocardial leads, treatment of cardiac conduction defects, magnetic medical shaft movement control apparatus and method, vaginal inserts and methods for treating urogenital disorders, a system for electrical stimulation to heart chamber, and more.

Author of numerous publications on topics related to and including deformation in spherulitic polyethylene, creep of polyethylene above room temperature, computer models of polyethylene spherulites, observations of deformation in spherulitic polyethylene, design considerations in a rolamite knee joint prosthesis, the blending and carbon black dispersing ability of transfermixes, conformal coatings for pacing applications, tissue response in the neighborhood of titanium implants, analysis of curative blending and carbon black dispersion of the transfermix, physiologic rate responsive pacing: effect on exercise tolerance and hemodynamics, a p-wave controlled rate responsive algorithm, the physiology of rate responsive pacing, ballooning arteries and the angioplasty procedure, and more.

Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.

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Case Studies

Engineering Science Expert, Information Management Specialist, Signal/Image Analysis Consultant, CyberSecurity Consultant, System Health Management and Biomedical Devices Consultant, Intellectual Property and Patent Infringement Consultant, Engineering Consulting Services
Resume of NLF product engineer, product technology manager, semiconductor engineering consultant, process architect, device engineer, test engineer, wafer fabricator consultant, engineering failure analysis, accident investigation, accident reconstruction, specialist, forensic investigator, product liability, expert witness testimony, patent infringement, expert witness testimony, engineering consulting services
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Resume of DIW design engineer, electrical engineer, biomedical engineer, medical device product developer, engineer, engineering failure analysis, accident reconstruction consultant, specialist, forensic analysis, investigation, product liability, expert witness testimony, patent infringement, expert witness testimony, engineering consulting services
Resume of NEM biomedical engineer, cardiovascular physiology specialist, biologist, physiologist, biophysicist, defibrillation expert, biomedical research consultant, fatigue failure analysis, forensic analysis, patent infringement, engineering consulting services

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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax

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