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 Expert  726401

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


Available for your Consulting and Expert Witness Needs

New York (NY)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

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

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antimicrobial additive

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antimicrobial coating

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antimicrobial medical device

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antimicrobial preservation

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bioburden

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biocompatibility

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biocompatibility testing

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dialyzer membrane

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electron beam accelerator manufacturer

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electron-beam sterilization

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gamma radiation effect on plastic

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high-pressure sterilization

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irradiation sterilization

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medical device

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medical device irradiation sterilization

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medical device manufacturing troubleshooting

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medical device package integrity

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medical device product improvement

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medical device shelf life

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medical device sterilization

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medical elastomer

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medical instrument sterilization

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medical polymer

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medical polymer selection

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medical-grade ink

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needle

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non-food antimicrobial agent

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packaging material

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parylene coating material

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parylene conformal coating

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pharmaceutical product shelf life testing

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plastic medical device

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plastic product

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plastic stability

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polymer implantable device


Show Secondary and Basic Areas of Expertise
Localities:
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;  and Philadelphia, Pennsylvania.

Often requested
with this expert:

Biomaterials, Medical Devices, Drug Delivery,...
Medical Device Technology, Design and Manufacturing
In-Process Analytical, cGMP Auditing, Polymer...
Specialty Chemicals and Plastics, Marketing and Business...

Education:
Year   Degree   Subject   Institution   Honors
1973   PhD   Chemical Engineering, Polymer Science   City University of New york   NSF Fellowship
1967   ME   Chemical Engineering   City College of New York  
1964   BE   Chemical Engineering   City College of New York   Vice President American Rocket Society, CCNY Chapter

Work History:
Years   Employer   Department   Title   Responsibilities

2006 to

 

(Undisclosed)

 


 

Consultant

 

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.


1993 to 2006

 

Vyteris Inc.

 


 

Manager Materials Development

 

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.

1992 to 2000

 

Becton Dickinson & Co.

 

Becton Dickinson Transdermal Systems

 

Manager

 

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.


Career Accomplishments:
Associations/Societies

AIChE, ACS, AIC, AAMI

Licenses/Certifications

FAIC


Publications:
Publications and Patents Summary

He has 20 US patents and at least 10 publications.


Government Experience:
Years   Agency   Role  
1965 to   NASA   Project Director  
1967 to   NIH   Project Director  

Consulting Services:
Recent Client Requests:
  • Expert in Medtech Coatings.
  • Expert for consulting on sterilizing endovenous laser fibers for re-use.
  • Expert for consulting on Market research and applications.
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 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.
Recent Litigation Client Requests:
  • Steam turbine expert for consulting on cause of oil leak.
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  
1991 to 1992   Ireland  
2006 to   Netherlands  

Market Research:
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.

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:
Supplier and Vendor Location and 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.

Other Skills and Services

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.


 

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