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 Expert  717866

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

Available for your Consulting and Expert Witness Needs

Virginia (VA)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
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.

biologic sterilization




electron-beam sterilization


medical device sterilization




cold gaseous sterilant


cold sterilization


food sterilization


high-pressure sterilization


medical instrument sterilization


microwave sterilization

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.

allograft development


allograft processing


procurement of allograft

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

medical device product development


new product development



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.

biomaterial toxicology


toxicity testing

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.

human tissue transplantation

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

biocompatible polymer


polymer biocompatibility

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.

biodegradable plastic

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.

irradiation sterilization


medical device irradiation sterilization


medical polymer sterilization


medical sterilization




sterilization processing technology




polymeric material sterilization


steam sterilization


sterile processing


terminal sterilization

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

hydrogen peroxide


hydrogen peroxide environmental effect


industrial sterilization

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

tissue culture

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.

wound healing


bone healing




wound care

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.



tissue banking

Show Only Primary Areas of Expert Consulting

Secondary Expertise
allograft, artificial artery modeling, artificial organ, aseptic packaging process, bacillus, bacterial spore, Band-Aid, bioburden, biologic (product), biomedical sensor, blood oxygenation, bone morphogenetic protein, cobalt, cobalt-60 sterilization, cytotoxicity testing, drug container, electrically conductive polymer, electron beam, endoscope, ethylene oxide, ethylene oxide sterilization, flexible polyvinyl chloride, formaldehyde, formaldehyde environmental effect, gamma radiation effect on plastic, gamma-ray sterilization, histological tissue engineering, hollow fiber technology, in vivo biodegradable polymer, legal patenting, management, medical device, medical device manufacturing, medical polymer, medical product packaging process, microbiology, microwave frequency, neurosurgical device, non-ionizing radiation sterilization, orthopedics, patient monitoring sensor, personal care product, plastic irradiation, plasticizer, polymer toxicology, polyvinyl chloride, prosthesis, sensor, startup, strategic planning, subacute care, surgical transplantation, synthetic organic polymer, technology forecasting, technology planning, toxicity, toxicology, ultrafiltration, ultrapure water, urethane polymerization, vapor phase, vapor phase hydrogen peroxide sterilization, vinyl compound, vinyl polymerization, wound, wound care product, xenograft

Basic Expertise
absorption, acid, animal, bioimplantable material, blood, bone, chemistry, cold liquid sterilant, combination, copolymer, culture, cytotoxicity, demineralization, dialysis, dialysis machine, differential-scanning calorimetry, disinfectant, disinfection, drug, drug release polymer, drug toxicology, efficacy, ester, ethylene, facility, formulation, gamma radiation, gel, glutaraldehyde, glycolide, growth factor, hard-face, health, histochemistry, hydrogen peroxide stabilization, hydrostatic pressure, hydrostatics, industrial process, irradiation, lactide, measurement process, membrane, monitoring, monoglyceride, neurosurgical procedure, oxide, oxygen, paste, pathology, peroxide, phthalate ester, polymer, protein, protocol, rapid method, renal dialysis, safety, safety testing, screening, specific material property, steam, surgical adhesive, temperature, tendon, test procedure, thermal detection, training, transplantation, vapor, water
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;  and Bowie, Maryland.

Often requested
with this expert:

Medical Device Sterilization - Ops, QA/ RA, R&D, Packaging,...
Validation of Sterilization Processes and USP/ AAMI...
Human Toxicant Effects
Wound Healing, Combat Casualty Care, Hemostasis, Collagen,...

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

Work History:
Years   Employer   Department   Title  

1997 to






1993 to 1997




Research and Development


Vice President


1989 to 1993


Osteotech, Inc .



Executive Vice President


1988 to 1989


Trans/Scitech, Incorporated





1979 to 1988


American Sterilizer Co .


Research & Technology




1977 to 1979


Baxter Travenol Labs, Incorporated


Artificial Organs Division


Director of Product Development


1972 to 1977




Patient CareDivision, Research & Product Development




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


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 30 patents in medical and agricultural inventions

Consulting Services:
Selected Consulting Examples:
  • Lifenet Tissue Bank- Virginia Beach, VA:sterlization, debridement, and demineralization of human tissue processing
  • Expert has worked with many confidential law firm motions, depositions and court trials
  • Expert has had many Intota Consulting requests from 1982 to date
Recent Client Requests:
  • Expert in Class room training 1 day - bandages and wound dressing products.
  • Expert in Gamma and Ethylene Oxide Sterilization.
  • Expert for consulting on Consultation on Biomaterials.
  • Expert for consulting on sterilization methods.
  • Steam sterilization expert for consulting on Steam Sterilization Validation per ANSI/AAMI ST 79.
  • Wound management expert for consulting on wound treatmentand risk assessment.
  • Expert in microwave sterilization of powdered chemicals.
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:
Expert has experience with Personal Injury; Human Tissue Multiple District Litigation; Medical Device Failure; Osteotech Patent Infringement Litigation
Recent Litigation Client Requests:
  • Hydrogen peroxide expert for consulting on peracetic acid.
  • Valve replacement expert for consulting on pericardial prosthesis.
  • Expert for consulting on soft tissue allografts - patent litigation.
  • Expert for consulting on allograft trade secret misappropriation.
  • Medical packaging expert for consulting on bottle design and sterility.
  • Expert in contracts in the chemical industry for consulting on chemical industry contract dispute.
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.

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

Market Research:
Board Member Osteotech; Divisional Board Member Johnson & Johnson; Leverage Buy Out Owner -ESOP AMSCO

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:

Technologogy Forecast; Product Development PACE; Management Training/MBO/ Management Grid

Other Skills and Services

Artificial Organs Development; Sterilization Science; Allograft Product Development; Toxicology


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