MEDICAL DEVICE & FAILURE ANALYSIS EXPERT WITNESS

EDUCATION

2002: SolidWorks 3D Design, Orange Coast College, Costa Mesa, CA

1997: Graphics Design, University of California, Irvine, CA

1978: MA Management Peter Drucker School of Management, Claremont Graduate School, Claremont, CA

1968: MS Mechanical Engineering, (Bio-Medical Minor) University of Southern California, Los Angeles, CA

1962: BS Mechanical Engineering, (Deans List) Drexel University Philadelphia, PA

EXPERIENCE

EXPERIENCE SUMMARY

Forty years of engineering experience includes research and development, design, manufacturing and management activities in the, medical device, packaging, toy, consumer product and aerospace industries. Responsibilities have ranged from original product conception through high volume manufacturing including plastic extrusion, injection molding and decorating. I have served on several medical standards committees and worked with industry and governmental regulatory agencies. I have intimate knowledge and experience with FDA requirements and Good Manufacturing Procedures (GMP's) and in producing prototype models, performing computer aided plastic part design (SolidWorks) and failure and hazard analysis.

During the past ten years I have served as an Expert Witness working with attorneys and insurance companies in medical product, patent, packaging and product liability legal proceedings. This experience has resulted in a greater appreciation of the critical importance in developing responsible, fail-safe designs early in and throughout the product development cycle to assure the safety and well being of care givers, patients and consumers.

Product design, performance and labeling issues related to medical devices, hydroculators, moist heat pads, thermal cooling pads and cooling apparatus, laser and thermal hair removal devices, dermal abrasion equipment, luggage and costume jewelry. Patient transport gurneys, surgical staplers, surgical fluid warmers, external and implanted drug delivery devices, test and evaluation of two models of battery powered external insulin pumps, valuation of lost toy prototypes, valuation of toy packaging, smoke damage assessment of 25 different types of electronic medical devices, injury potential of chiropractic devices, dental burr and drill failures, defective counter stools, failure of pilates exercise devices, patent infringement issues relative to butane lighters, safety syringes and needles, disposable injection molded valves and medical temperature sensing devices , trade secrets relative to manufacturing processes , failure of injection molded plastic components , drug container packaging integrity , engineering contract norms.

EMPLOYMENT SUMMARY

1980- Present: President, Engineering Consulting and Design Firm

1991-1995: Vice President of Research & Development, Urohealth
Joined at company start-up and managed research and development activities and created line of patented products including incontinence pads, disposable diapers, micro-filtration fluid collection systems, urinalysis systems and ambulatory IV drug infusion devices. Designed and developed company's products, developed documentation, methods and systems to bring products into production.

1979-1989: Director of Catheter Development, Baxter Edwards Division
Managed 30 engineers, scientists and technicians engaged in the design and development of sterile disposable medical devices, including pressure monitoring, cardiac pacing, venous catheters and catheter introducers. Expert 211 managed the polymer development laboratory and the labeling and sterile packaging groups, which serviced all of the division's disposable product lines. Responsibilities included liaison with domestic and Puerto Rico facilities to transfer designs to production. New products introduced during tenure accounted for over $700,000,000 in sales.

1976-1979: New Products Engineering Manager, C. R. Bard-Inspiron Division
Managed research and development activities and developed patented line of arterial and venous catheters, respiratory care devices including, humidifiers, nebulizers, heaters and spirometers. Expert 211 developed production methods and procedures, product labeling, instructions and packaging and managed the prototype machine shop.

1969-1976: Vice President of Engineering, Automatic Helium Balloon Systems
Key player in start-up company where Expert 211 invented and developed a variety of helium balloon valves and inflation systems still being sold and was responsible for developing manufacturing methods and assembly equipment to produce company's products.

1962-1965: Design Engineer, Autonetics Div. North American Rockwell

1965-1969: Responsibilities included conceptual design, testing and development of equipment protocols for space, hospital and medical systems. Expert 211 designed mobile pharmacy equipment and a chemical agent detector system for the US Army. I helped to develop methods and equipment requirements for extricating vehicular accident victims at crash scenes.

1963-1965: 1st Lieutenant, U.S. Army Corps of Engineers. Engineering Company Commander

ACTIVITIES

Society of Plastic Engineers
Institute of Packaging Professionals
Member and former Board Member
Forensic Expert Witness Association
Former member of AAMI Standards Sub-Committees: Human Factors for Medical Devices IV Catheters, Humidifiers & Nebulizers

PATENTS

Available upon request.

KEYWORDS

Engineer Expert Witness, Mechanical Medical Device Expert Witness, Biomedical Disposable Medical Devices Expert Witness, Arterial Catheters Expert Witness, Venous Catheters Expert Witness, Syringes Expert Witness, Needle Stick Accidents Expert Witness, Toy Product Design Expert Witness, Consumer Product Design Expert Witness, Engineering Plastics Expert Witness, Labeling Issues Expert Witness, Computer Aided Plastic Part Design Expert Witness, Failure Analysis Expert Witness, Hazard Analysis Expert Witness, Plastic Extrusion Expert Witness, Injection Molding Expert Witness, Labeling of Medical Products Expert Witness, Labeling of Toy Products Expert Witness, Labeling of Consumer Products Expert Witness, Trade Secrets Relative to Manufacturing Processes Expert Witness, Safety Syringes Expert Witness, Medical Temperature Sensing Devices Expert Witness