Expert Details

Expert in Hydrogel Science and Technology for Drug Delivery, Medical Devices and Consumer Products

Expert ID: 726401 New York, USA

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Expert’s major contributions are in microbial control of wide range of medical devices and pharmaceuticals. He has a background in chemical engineering and polymer science. He has decades of experience from numerous companies- large device and pharmaceutical companies to startups developing medical devices and drug delivery systems. He has taken products from the laboratory to full commercial release. In developing these products there are regulatory needs, depending on the product, for low bioburden to full sterilization, 10^-6 sterility assurance levels (SAL). He has worked with a diverse range of materials from liquids, hydrogels, and plastics to structural metals and combinations thereof. He is an expert in the use of antimicrobials, determination of bioburden and all means of sterilization, including electron beam, gamma ray, ethylene oxide and thermal. With products developed, he has worked on long term stability at a range of temperatures. This includes selection of packaging materials and testing of the package with the product.

Expert’s [particular] expertise comes from background in materials science and extensive experience in all major sterilization processes. He therefore knows the changes in properties of a device, including package, due to sterilization and shelf life. A good example of this is Expert’s extensive experience in developing hydrogels from formulation to process and product. As use of hydrogel in a sterile product, it must overcome the issues of being a growth medium by choice of using antimicrobials. As hydrogels have high water content, the choice of the package is crucial. The interaction the sterilization process has upon the hydrogel has to be considered and operating conditions have to be established. The sterilization dose may not be high enough to achieve the required SAL but if too high may over cure or degrade the product. Another product area where he has made significant contributions is dialyzers. These devices are made of many different polymeric materials, therefore choosing effective materials including the membrane, that will be functional and not be damaged by sterilization is crucial.

Expert may consult nationally and internationally, and is also local to the following cities: New York, New York - Yonkers, New York - Newark, New Jersey - Jersey City, New Jersey - Paterson, New Jersey - Elizabeth, New Jersey - Bridgeport, Connecticut - New Haven, Connecticut - Hartford, Connecticut - Philadelphia, Pennsylvania

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Education

Year Degree Subject Institution
Year: 1973 Degree: PhD Subject: Chemical Engineering, Polymer Science Institution: City University of New york
Year: 1967 Degree: ME Subject: Chemical Engineering Institution: City College of New York
Year: 1964 Degree: BE Subject: Chemical Engineering Institution: City College of New York

Work History

Years Employer Title Department Responsibilities
Years: 2006 to Present Employer: Undisclosed Title: Consultant Department: Responsibilities: He is an established expert technical consultant in product and process development for medical device companies. He specializes in drug delivery, OTC topicals, wound dressings, medical electrodes, and medical devices. He is expert in advanced development of materials: membranes, hydrogels, super-absorbents and other materials for medical or cosmetic use. He has developed hydrogels businesses(s) from formulation to manufacturing. He has experience and expertise in packaging, sterilization, toxicology, and stability studies. He invented products. He has assisted attorneys in filings and office actions and advised on patentability to avoid litigation.

Years: 1993 to 2006 Employer: Vyteris Inc. Title: Manager Materials Development Department: Responsibilities: He was lead inventor responsible for directing research and development of novel hydrogel reservoirs as major component of iontophoretic drug-delivery system. He oversaw all phases of product scale-up from bench to commercial manufacturing. He administered budgets and managed technologists and laboratory staff. He developed and executed all specifications for component reservoirs. He interacted effectively with other disciplines including medical professionals, attorneys, QA, QC, manufacturing, contractors, consultants, and vendors. He coordinated Intellectual Property issues with company executives and attorneys. He write and submitted patent applications and position papers. He served as technical lead in opposition suits against competitors.
Years: 1992 to 2000 Employer: Becton Dickinson & Co. Title: Manager Department: Becton Dickinson Transdermal Systems Responsibilities: He began work as a consultant. He was offered a position in BDTS. He trasferred to Vyteris when division was bought by investors in 2000. His work responsibilities were the same as those stated for Vyteris Inc.

Government Experience

Years Agency Role Description
Years: 1965 to Present Agency: NASA Role: Project Director Description:
Years: 1967 to Present Agency: NIH Role: Project Director Description:

International Experience

Years Country / Region Summary
Years: 1991 to 1992 Country / Region: Ireland Summary:
Years: 2006 to Present Country / Region: Netherlands Summary:

Career Accomplishments

Associations / Societies
AIChE, ACS, AIC, AAMI
Licenses / Certifications
FAIC
Publications and Patents Summary
He has 20 US patents and at least 10 publications.

Additional Experience

Expert Witness Experience
He supports clients and law firms by formulating technical arguments in patent litigations and serving as expert witness in federal court. He had taken the lead in eight EP patent oppositions by formulating theories, supplied evidence and chose witnesses. All opositions were won in EU court.
Vendor Selection
He sources, locates and sets specifications with suppliers and vendors in his areas of expertise. He has with extensive experience has inside information on many vendors and their products or services.
Marketing Experience
He has developed materials used in medical devices and drug delivery systems that led to multiple commercial products. He has set standards that have been approved by FDA. Many materials developed by him have been used in medical and consumer products for decades.
Other Relevant Experience
He is creative and effective problem solver. He has based upon his experience and expertise in many fields been able to determine outcome of issue quickly and ultimately correctly saving clients both time and resources.

Fields of Expertise

antimicrobial additive, antimicrobial coating, antimicrobial medical device, antimicrobial preservation, bioburden, biocompatibility, biocompatibility testing, dialyzer membrane, electron beam accelerator manufacturer, electron-beam sterilization, gamma radiation effect on plastic, high-pressure sterilization, irradiation sterilization, medical device, medical device irradiation sterilization, medical device manufacturing troubleshooting, medical device package integrity, medical device product improvement, medical device shelf life, medical device sterilization, medical elastomer, medical instrument sterilization, medical polymer, medical polymer selection, medical-grade ink, needle, non-food antimicrobial agent, packaging material, parylene coating material, parylene conformal coating, pharmaceutical product shelf life testing, plastic medical device, plastic product, plastic stability, polymer implantable device, medical packaging, medical device evaluation, polyvinyl chloride quality control, medical polymer molding, medical polymer extrusion, mechanical integrity, medical seal, Food and Drug Administration compliance, medical device coating material, medical instrument cleaning, Current Good Manufacturing Practice, transcutaneous electrical nerve stimulator, cannula, medical pressure-sensitive adhesive, medical product manufacturing, medical protocol, medical filter, medical device safety, medical device testing, medical device manufacture clean room, medical device premarket approval, medical device package testing, medical package testing, medical package strength, medical package, 510(k) document, therapeutic device, Food and Drug Administration chemical registration, medical adhesive tape, disposable medical device, medical device manufacturing, Food and Drug Administration, accelerated aging, medical product, microwave sterilization, autoclave, color additive, surgical instrument, new drug application, implantable device, Good Manufacturing Practice, Good Laboratory Practice, catheter, bandage

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