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 Expert  713977

Expert in Silicone Medical Devices and Implants, Product Development, Failure Analysis, etc.

Available for your Consulting and Expert Witness Needs

Michigan (MI)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert has both conducted and supervised studies of adhesion between various materials for approximately 28 years. These studies have included failure analysis and testing. They have mostly involved silicone elastomer adhering to itself, to various plastics, and to metals.

Expert has worked on artificial hearts and associated blood pumping devices for approximately 30 years. His work in this area started with cooperative efforts with Dr. Michael DeBakey in the mid 1960s. Subsequently, he has worked cooperatively with most of the leading artificial heart/blood pump/mechanical heart researchers. These include Dr. Willem Kloff, Dr. Adrian Kantrowitz, Dr. Larry Stephenson, and Dr. George Anstadt.

During his 30 years of research and development activities with materials and devices involved in biomedical applications, Expert has worked with nearly all medical specialty groups. This has included a wide range of applications and devices including dental prostheses and prosthetic material, catheters, cardiac valves, heart-lung machines, and skin substitute material. He has managed R&D programs and bioengineering for the commercialization of many medical devices, including implants and non-implants.

Expert's work over the past 30 years has involved the sciences and applications for materials in biomedical applications. A major portion of this work has been directed towards silicone elastomers and other silicones used in health care applications. These silicones include fluids, antifoams, and the like. His work has also involved some use of plastics such as polycarbonates, acrylics, polysulfones, and polyurethanes. He has done some work with metals and a lesser amount with ceramics.

Expert has conducted and managed programs and projects broadly involving elastomers, primarily silicone, in biomedical applications for approximately 30 years. These have involved syntheses of monomers and polymers, elastomer formulation and development, processing, testing, selection of elastomers for specific applications, design of elastomeric products, fabricating techniques, finished product testing, biodurability and biocompatibility studies, sterilization studies, adhesion studies between elastomers and various other substrates, and design and procurement of tooling for both laboratory prototypes and commercial production. He is Chairman of the American Society for Testing and Materials task force on standards for silicone elastomer. He recently has completed the revision and approval, via society balloting, of ASTM F 604, "Standard Specification for Silicone Elastomers Use in Medical Applications," published in the "Annual Book of ASTM Standards, Volume 13" in 1993. Expert has had some experience with thermosetting polyolefin elastomers and with thermoplastic polyurethane and silicone/polycarbonate copolymer elastomer. He is chairman of the ASTM subcommittee responsible for standards covering medical devices and implants used in plastic surgery.

Expert has managed the research and development efforts for the commercialization of a large number of silicone elastomer medical devices, including both implantable and non-implantable devices. This has included implants used in orthopaedic and reconstructive surgery, where failure modes and failure analyses are necessary and important. It has also included pre-commercialization testing of both materials and fabricated products for failure in simulated conditions of use. This work has involved laboratory studies and animal implant studies. He has investigated and tested retrieved clinical explants which have been removed for some cause. He has determined failure mode, characteristics, and the effects of implantation/clinical use on the implants.


adhesive failure


adhesive failure analysis


adhesive testing


blood pump


blood-compatible material


biomedical engineering


biomechanical engineering


biocompatible material


biocompatible polymer


bioimplantable material


elastomer processing


medical elastomer


silicone elastomer


synthetic elastomer


thermosetting elastomer


failure modes and effects analysis


medical device reliability testing

Expert's work has involved research and development activities associated with a large number of implants which have been considered and tested in most of the surgical specialties. Many of these have been commercialized for general availability. The surgical specialties which have had the greatest involvement include orthopaedic surgery, plastic surgery, neurosurgery, cardiovascular surgery, and urology.

Expert has spent six years as a hands-on research chemist. He has conducted studies in the syntheses of organosilicon chemicals, including syntheses and reactions of organofunctional silanes.

During the course of his career, Expert has supervised the development of a large number of products for use by orthopaedic surgeons. This has involved work in orthopaedic biomechanics to determine both the fit and function of implants in musculoskeletal systems. It has also involved work in orthopaedic biomechanics associated with joint and implant function. His studies have included the analysis and testing of retrieved clinical explants.


implantable device


surgical implant device


organofunctional silane




orthopedic biomechanics


silicone implant

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Detroit, Michigan;  Grand Rapids, Michigan;  Warren, Michigan;  Flint, Michigan;  Sterling Heights, Michigan;  Lansing, Michigan;  Ann Arbor, Michigan;  Livonia, Michigan;  Troy, Michigan;  and Southfield, Michigan.

Often requested
with this expert:

Biomaterials and Product Development R&D for Orthopedic,...
Silicone, RTV Rubber
Silicone/ Silicon Processing and Applications, New Process...
Web Coating Technology

Year   Degree   Subject   Institution  
1950   BS   Chemistry/Physics/Math   Central Michigan University  
1955   none   Chemistry, Physics, Math, Education   Western Michigan U. Graduate School  
1957   None   Organic Chemistry   Michigan State U. Graduate School  
1974   None   MBA Courses   Central Michigan U. Graduate School  

Work History:
Years   Employer   Department   Title   Responsibilities

1991 to 2008


Self Employed



He is an Independent Consultant


He has consulted for an array of industrial and medical businesses and legal firms on silicones. He has been an expert witness in patent cases and in litigation involving silicone implants and devices. He has conducted many forensic studies to determine causes of damage to and/or failure in silicone explants and devices.

1975 to 1991


Dow Corning Corporation


Medical Products and Dow Corning Wright


Associated Scientist


He managed development of New silicone implants and medical devices. including conceptualization, materials of construction, design, testing, manufacturing methods, tooling, standards, specifications, clinical testing, product literature, FDA approvals, post market technical service, complaint analysis, MDR's to FDA, profession relations, physician advisory panels and expert witness testimony in litigation, He also served as president of the Orthopaedic Surgery Manufacturer's Association and represented Dow Corning and chaired several subcommittees at ASTM Committee F04 (Medical Materials and Devices).

1972 to 1975


Dow Corning Corporation


Medical Products


Research Associate


He was a research associate in the Dow Corning Center For Aid To Medical Research. He provided information, technical service, samples, prototypes, advise and custom implants to Doctors and other medical researchers working with silicones in a wide array of applications..

1967 to 1972


Dow Corning Corporation


Medical Products


Pharmaceutical Products Technical and Marketing Supervisor


He was Technical and Marketing Manager for all silicone raw materials supplies to other manufacturers.

1963 to 1967


Dow Corning Corporation


Medical Products


Laboratory Supervisor


He supervised a Medical and Dental Products Development Laboratory, monitored projects with FDA, and provided technical assistance to NASA in conducting a study to determine the effect of weightlessness on humans simulated by long-term full body immersion in silicone fluid. Findings resulted in the development of space suits that help control changes in blood circulation when weightless for more than a few hours

1961 to 1963


Dow Corning Corporation


New Products Development




He Supervised a New Products Development Laboratory that did precommercialization development and technical service for a wide variety of industrial applications for silicones.

1956 to 1961


Dow Corning Corporation




Research Chemist


He identified the stable chemical fluorocarbon structure for heat and jet fuel resistant fluorosilicone elastomer as needed for the mach 3.5 B-58 bomber. He then developed the chemical processes for making the organo-fluoro compound and scaled it up for commercial production. The resulting fuel resistant fluorosilicone elastomer was used to contain jet fuel in all B-58's. .

1950 to 1956


Richland and Hasting Michigan High Schools



High School Teacher


He taught and high school chemistry, physics and math. He worked one summer for Upjohn in Kalamazoo, Michigan as a research assistant in antibiotic development.

Career Accomplishments:

Expert is a member of the American Chemical Society, the American Burn Association, the American Society for Testing and Materials, the Health Industry Manufacturers Association, the Orthopaedic Research Society, the Research Society of America, and the Society of Plastics Engineers.

Publications and Patents Summary

He is the author of more than a dozen patents and numerous technical publications.

Selected Publications and Publishers  
 - Annals of Plastic Surgery  
 - Proceedings of American College of Surgeons Instructional Course.  
 - FDA Conf. on Silicone in Medical Devices  
 - ASTM Corrosion and Degradation of Implant Materials: Second Symposium  
 - American Chemical Society (ACS) Symposium Series  

Consulting Services:
Recent Client Requests:
  • Expert in silicone for consulting on continuous silicone sponge sheet.
  • Expert for consulting on Aging of silicone tube.
  • Expert in specialty dental silicone raw materials for consulting on Dental impression silicones.
  • Expert in Silcone Device Durability.
  • Medical device expert needed for consulting regarding a silicone elastomer healing over time.
  • Expert in Electrospinning silicone for consulting on product development.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
He has testified in both Federal and State court cases involving silicone implant litigation. His forensic analysis of explants and biomechanical analysis of x-rays have resulted in many cases settling out-of-court and in favorable jury verdicts in others. He has consulted on cases of patent infringement and has done forensic analysis of subject products, has studied patent prosecution histories and has drafted declarations that were submitted to the U.S. Patent office.
Recent Litigation Client Requests:
  • Silicone medical device expert witness for consulting on faulty chest tube.
  • Chemical polyolefin foam expert for consulting on characteristics and use of polyolefin foams, especially in the field of liners prosthetic devices.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Market Research:
He is knowledgeable in silicone technology, testing and materials properties. He has many years of contact experience with Doctors and nurses and has gained an insight about factors that are important to them in selecting products for use in their professions. His extensive failure analysis experience has application in designing products that minimize potential for failure.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:

He has been an instructor in approximately 20 CME (Continuing Medical Education) courses for surgeons. He was chosen by FDA to chair the "Chemistry and Pharmacokinetics" portion of their national Silicone Conference". He has lectured to medical students and interns at many medical schools including Harvard, University of Michigan, University of Virginia, Johns Hopkins University, Michigan State University and others.

Supplier and Vendor Location and Selection

Expert knows both, most suppliers of silicone raw materials to implant and medical device manufacturers, and the implant and device manufacturers per se..

Other Skills and Services

He has taken professional training on how to testify in depositions and court trials, including practice in mock cases with a mock jury.


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