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 Expert  725158

Expert in Medical Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc.


Available for your Consulting and Expert Witness Needs

California (CA)
USA
Education Work HistoryPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert has authored and submitted 510(k)s for more than 25 IVD (In Vitro Diagnostics) products. These 510(k)s encompass a variety of IVD products from manual, semi-automated to fully automated non-isotopic diagnostic tests including point-of-care devices. Expert has the expertise to prepare the 510(k) for successful and timely acceptance by FDA.
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510(k) document

He is a consummate In Vitro Diagnostics (IVD) device development expert with more than 40 non-isotopic chemiluminescence tests which he designed, developed and launched successfully under his direct supervision. Many of these products were specialty products having to meet unique and challenging specifications.
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medical device

He has conducted and directly supervised many test method comparisons and new product evaluations. He has successfully implemented new methods in national laboratory chains meeting stringent evaluation criteria.

He was the prime mover in bringing a paradigm shift in parathyroid hormone (PTH) testing methodology by head-on evaluations with current methods.

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medical device evaluation

He has transferred more than 40 products to manufacturing floor with scale-up process and material control details.

He has directly supervised start-to-finish production and packaging of non-isotopic IVD products.

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medical device manufacturing quality control

He has implemented Quality Control procedures and specifications to meet GMP and FDA requirements for many IVD products. He is an expert in application of statistics to IVD product quality control. He has offered exhaustive presentations on 'Six Sigma' quality initiatives.
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medical device manufacturing quality control

He, apart from having developed many IVD products, is also an expert in effortlessly trouble-shooting the complex immunodiagnostic test kits.

He has a superb command over a broad range of disciplines from Organic chemistry, Biochemistry, Pharmaceutical chemistry, Immunochemistry, Antibody/antigen interactions and Chemiluminescence.

He is also well versed in clinical applications of IVD products. Therefore, his expertise in designing and developing the IVD products, consistent with clinical requirements is versatile.

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medical device product development

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manufacturing quality control


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California;  San Francisco, California;  Sacramento, California;  Oakland, California;  Stockton, California;  Fremont, California;  Modesto, California;  Salinas, California;  Santa Rosa, California;  and Hayward, California.

Education:
Year   Degree   Subject   Institution  
1981   PhD   Medicinal Chemistry   University of Minnesota  
1975   MS   Pharmaceutical Chemistry   Bombay University  
1972   BS   Pharmacy   Bombay University  

Work History:
Years   Employer   Department   Title   Responsibilities

2006 to 2007

 

Nanomix, Inc

 

Product Development

 

Vice President, Product Development

 

Direct and set strategy for in vitro diagnostics product development using the proprietary Nano-technology platform.

2003 to 2005

 

Nichols Institute Diagnostics

 

Scientific Affairs

 

Chief Scientific Officer

 

Oversee scientific and clinical matters as they relate to product applications in clinical testing laboratories.

2000 to 2003

 

Nichols Institute Diagnostics

 

Clinical Marketing

 

Senior Scientific Director

 

Responsible for implementing new diagnostic tests in large laboratory chains.

1992 to 2000

 

Nichols Institute Diagnostics

 

R&D

 

Scientific Director

 

Directed product development on automated clinical analyzers.

1990 to 1992

 

London Diagnostics

 

R&D and Operations

 

VP, R&D and Operations

 

Responsible IVD product development, manufacture and Quality Control.

1988 to 1990

 

London Diagnostics

 

R&D

 

Director, R&D

 

Technology and Product development.

1986 to 1988

 

London Diagnostics

 

Chemistry

 

Senior Scientist

 

Develop Chemiluminescence detection technology.


Publications:
Publications and Patents Summary

Two single author dominant patents in chemiluminescence. Publications in PTH measurements in RENAL CARE.

Selected Publications and Publishers  
 - International Society of Nephrology  

Government Experience:
Agency   Role   Description
FDA   Liaison   IVD 510(k) submissions, product applications, clinical and use validations, site audits.

Consulting Services:
Selected Consulting Examples:
  • QA/QC department from a major pharmaceutical research company in California was provided with extensive consulting services spanning about 4-5 months (2007-2008) on validation of certain diagnostic tests for their clinical studies.
Recent Client Requests:
  • Expert in medical device manufacturing for consulting on medical device manufacturing trouble shooting.
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:
Recent Litigation Client Requests:
  • Expert in 510(k) Program Development for consulting on FDA issues.
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.

Language Skills:
Foreign Language  
Hindi  
Malayalam  
Tamil  

Market Research:
Having been instrumental in bringing mega-changes in testing methodologies, he has insights as to where the global diagnostic testing sector is headed to.

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:
Training/Seminars

He has given several talks to technicians, laboratorians and clinicians on applications of specialty diagnostic products.

Has trained scientists on Six Sigma Quality initiatives.

Supplier and Vendor Location and Selection

During the long tenure in product development, he has come across many instances of deciding on appropriate choices for materials and resources.

IVD expertise in efficient and accelerated product development. Product improvement and comprehensive product problem-solving. Product design to generate flag-ship products.

Other Skills and Services

Project management, Team building, R&D productivity, Work-place harmony.


 

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