Expert Details

Expert in Sterilization, Biomaterials, Tissue Banking, Medical Product Development, Polymer Toxicology

Expert ID: 717866 Virginia, USA

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Expert K. Expert has spent 30 years in the medical products business, in which he developed sterilization processes such as ethylene oxide, gamma radiation, vapor phase hydrogen peroxide, plasma sterilization, aseptic processing, disinfection with formaldehyde, glutaraldehyde, and steam sterilization. Novel sterilization processes involving high pressure hydrostatic cycles, and vapor phase-plasma combinations are presently under research.

Expert has spent four years developing unique osteoconductive and osteoinductive allografts for use in orthopedic and neurosurgery. He has had three patents issued on the processing of tissue, and the sterilization of dead tissue.

Expert has spent 30 years in the management of technical teams who carry out product development for healthcare companies. Technology companies in which he has operated are: absorbable polymers for sutures and drug release, orthop

Expert has ten years of experience in the toxicology of biomaterials used in medical products, devices, and drug containers. He has experience in the preparation of experimental protocols for both in vivo and in vitro toxicity testing. He has also carried out acute, sub-acute, and chronic toxicity tests.

For four years, Expert was the head of Osteotech, Inc.'s research in developing osteoinductive allografts and surgical bone pastes, liquids, and methods of sterilizing tissue products.

Expert's academic training in polymer toxicology and his industrial career in the health care industry caused him to be exposed to a large number of candidate polymers for use in contact with living cells and tissues. He was deeply involved with testing methods for safety tests and

During his four years at Ethicon, Expert studied the rates of absorption and tensile strength loss for absorbable polymers such as Lactide Glycolide copolymers, catgut, and drug release polymers such as monoglycerides.

Throughout his entire career in healthcare products, Expert has been researching the uses of cobalt 60 irradiation, E-beam, steam, and ethylene oxide disinfectants. He is currently researching the use of high-pressure sterilization for those products and materials which cannot have the residuals of a sterilant but must be sterilized.

Expert has used cobalt 60 and electron-beam (E-beam) sterilization in his product development activities since 1962.

Expert is experienced with tissue cultures. He has used USP cytotoxicity testing for biomaterials.

Expert is an expert in toxicity testing including pathology and histochemistry techniques. He has experience in carrying out protocols for wound healing methods such as those described by Dr. Thomas Hunt at the University of California at San Francisco. He also has extensive experience in suture models for wound healing.

In his three years researching and formulating plasticizers for PVC, Expert has had a special focus on the use of non-toxic citric acid esters for medical devices. He also worked with the phthalate esters.


Lifenet Tissue Bank- Virginia Beach, VA:
sterlization, debridement, and demineralization of human tissue processingBob has worked with many confidential law firm motions, depositions and court trialsBob has had many Intota Consulting requests from 1982 to date

Expert may consult nationally and internationally, and is also local to the following cities: Virginia Beach, Virginia - Norfolk, Virginia - Chesapeake, Virginia - Richmond, Virginia - Newport News, Virginia - Hampton, Virginia - Alexandria, Virginia - Portsmouth, Virginia - Suffolk, Virginia - Bowie, Maryland

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Year Degree Subject Institution
Year: 1969 Degree: PhD Subject: Institution: Biomaterial Science & Toxicology - University of Texas
Year: 1966 Degree: MS Subject: Institution: Biomaterial Science & Toxicology - University of Texas
Year: 1962 Degree: BS Subject: Institution: Chemistry - University of Notre Dame

Work History

Years Employer Title Department Responsibilities
Years: 1997 to Present Employer: Undisclosed Title: Department: Responsibilities:
Years: 1993 to 1997 Employer: Becton-Dickinson Title: Vice President Department: Research and Development Responsibilities:
Years: 1989 to 1993 Employer: Osteotech, Inc . Title: Executive Vice President Department: Responsibilities:
Years: 1988 to 1989 Employer: Trans/Scitech, Incorporated Title: President Department: Responsibilities:
Years: 1979 to 1988 Employer: American Sterilizer Co . Title: Director Department: Research & Technology Responsibilities:
Years: 1977 to 1979 Employer: Baxter Travenol Labs, Incorporated Title: Director of Product Development Department: Artificial Organs Division Responsibilities:
Years: 1972 to 1977 Employer: Ethicon Title: Director Department: Patient CareDivision, Research & Product Development Responsibilities:

International Experience

Years Country / Region Summary
Years: 1982 to 1988 Country / Region: Saudi Arabia Summary: Consulting on the subject of introducing sterilization science into the hospitals
Years: 1979 to 1984 Country / Region: Telgte, Germany Summary: Develop a hollow fiber processing capability for a hollow fiber Kidney Dialzyers facility for Baxter Travenol.
Years: 1989 to 1993 Country / Region: Leiden, Netherlands Summary: Establish tissue processing capabilities in concert with university polymer science cell substrates
Years: 1994 to 1997 Country / Region: Southern France Summary: Worked on a radiation process for etching polymers upon which cells would grow

Career Accomplishments

Professional Appointments
Johnson & Johnson's Patient Care Division's Board of Directors;
Osteotech's Board Of Directors;
Co-owner of AMSCO - Leverage Buy Out
Awards / Recognition
He received the Thomas Edison Award from the State of New Jersey for his invention which was the first osteinductive bone healing paste ever invented
Publications and Patents Summary
He has 40 patents in medical and agricultural inventions and human tissue science

Additional Experience

Expert Witness Experience
Expert has experience with Personal Injury;
Human Tissue Multiple District Litigation;
Medical Device Failure;
Osteotech Patent Infringement Litigation
Root Cause Analysis
Training / Seminars
Technologogy Forecast;
Product Development PACE;
Management Training/MBO/
Management Grid
Marketing Experience
Board Member Osteotech;
Divisional Board Member Johnson & Johnson;
Leverage Buy Out Owner -ESOP AMSCO
Other Relevant Experience
Artificial Organs Development;
Sterilization Science;
Allograft Product Development;

Fields of Expertise

biologic sterilization, cobalt-60, electron-beam sterilization, medical device sterilization, sterilant, cold gaseous sterilant, cold sterilization, food sterilization, high-pressure sterilization, medical instrument sterilization, microwave sterilization, allograft development, allograft processing, procurement of allograft, medical device product development, new product development, testing, biomaterial toxicology, toxicity testing, human tissue transplantation, biocompatible polymer, polymer biocompatibility, biodegradable plastic, irradiation sterilization, medical device irradiation sterilization, medical polymer sterilization, medical sterilization, sterilization, sterilization processing technology, sterilizer, polymeric material sterilization, steam sterilization, sterile processing, terminal sterilization, hydrogen peroxide, hydrogen peroxide environmental effect, industrial sterilization, tissue culture, wound healing, bone healing, suturing, wound care, di-n-butylphthalate, tissue banking, neurosurgical device, wound care product, subacute care, bone morphogenetic protein, gamma radiation effect on plastic, plastic irradiation, in vivo biodegradable polymer, biologic (product), drug container, cytotoxicity testing, cobalt-60 sterilization, patient monitoring sensor, vapor phase hydrogen peroxide sterilization, xenograft, Band-Aid, startup, orthopedics, bioburden, bacterial spore, gamma-ray sterilization, histological tissue engineering, wound, non-ionizing radiation sterilization, blood oxygenation, ethylene oxide sterilization, technology planning, management, electrically conductive polymer, personal care product, medical product packaging process, medical device manufacturing, technology forecasting, polymer toxicology, strategic planning, allograft, microwave frequency, toxicity, legal patenting, vinyl compound, vinyl polymerization, vapor phase, urethane polymerization, ultrapure water, ultrafiltration, toxicology, synthetic organic polymer, surgical transplantation, sensor, prosthesis, polyvinyl chloride, plasticizer, microbiology, medical polymer, medical device, hollow fiber technology, formaldehyde, formaldehyde environmental effect, flexible polyvinyl chloride, ethylene oxide, endoscope, electron beam, cobalt, biomedical sensor, bacillus, aseptic packaging process, artificial organ, artificial artery modeling

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