Medical Device Failure Analysis Expert Witness

Expert Witness No.211

Southern California

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

Engineering Experience Summary

Expert 211 is considered to be a creative and effective individual who applies a pragmatic approach to the conception, design, development and commercialization of new products. I am the inventor or co-inventor of 30 U.S. Patents.

Expert 211, 40 years of engineering, management and expert witness experience includes research and development, design, and manufacturing 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, assembly, decorating, labeling and packaging.  I have served on several medical standards committees and interacted with industry and governmental regulatory agencies. I have intimate knowledge and experience with FDA requirements and Good Manufacturing Procedures (GMP’s), producing prototype models, performing computer aided plastic part design (SolidWorks) and failure and hazard analysis including Failure Mode Effects Analysis (FMEA).

Expert Witness Experience Summary

During the past 10 years Expert 211 has 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. In March, 2006 was invited to be the “Expert for the Plaintiff” at the annual Mock Trial sponsored by the California Chapter of the American Board of Trial Advocates.

Below is a representative listing of “Areas of Expertise” for which Expert 211 has been retained.

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 beds,  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, child’s training device • trade secrets relative to manufacturing processes • failure of injection molded plastic components • drug container packaging integrity • defibrillator mechanical design issues • surgical laser power cord design reliability •  gel ball patent infringement • gel cushioning patent infringement •shipping carton package integrity • engineering contract norms.

Below is a summary of industry positions held and areas of experience.

1980 to Present
Engineering Consulting and Design Firm - President
Clients have included the following: Gary Frugard & Assoc. ,Thermometrics, Inc. , ENSOL, Inc., Dr. John Stevenson, Merlin Technologies, AccuLase, Inc., Intern’l Diversified Prod., Optical Radiation Corp., Luther Medical Partners, X-Technologies, Inc, TherOx, Inc.     Abbott Laboratories, LifePoint, Inc., Sutura, Inc., Servall Industries, Luther Medical Prod., Baxter Healthcare, Venetec, Inc. & N, Gortz Co., Intertherapy, Inc.

2000 to Present
Engineering Consulting and Design Firm - Vice President of Engineering
Joined company as consultant in 2000 and became a partner in 2003. Developed and patented product line of male urinary management devices (Winner of 2008 Medical Design Excellence Awards). Company has begun nation-wide sales of products which have received FDA approval and earned Medicare reimbursement approval.

1991 to 1995
UROHEALTH - Vice President of Research & Development
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 collectionsystems, programmed centrifuge, 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 to 1989
Baxter-Edwards Division - Director of Catheter Development
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. I 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 to 1979
C. R. Bard-Inspiron Division - New Products Engineering Manager
Managed research and development activities and developed patented line of arterial and venous catheters, respiratory care devices including, humidifiers, nebulizers, heaters and spirometers. I developed production methods and procedures, product labeling, instructions and packaging and managed the prototype machine shop.

1969 to 1976
Automatic Helium Balloon Systems - Vice President of Engineering
Key player in start-up company where I 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 to  1965
Autonetics Div. North American Rockwell - Design Engineer

1965 to 1969
Responsibilities included conceptual design, testing and development of equipment protocols for space, hospital and medical systems. I 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. 

Military Service

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

Organizations

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

U. S. Patents Earned To Date