Expert Details

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

Expert ID: 725158 California, USA

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Expert has authored and submitted 510(Experts for more than 25 IVD (In Vitro Diagnostics) products. These 510(Experts 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.

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.

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.

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.

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.

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.

Array

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.

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 - Hayward, California

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Education

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

Work History

Years Employer Title Department Responsibilities
Years: 2006 to 2007 Employer: Nanomix, Inc Title: Vice President, Product Development Department: Product Development Responsibilities: Direct and set strategy for in vitro diagnostics product development using the proprietary Nano-technology platform.
Years: 2003 to 2005 Employer: Nichols Institute Diagnostics Title: Chief Scientific Officer Department: Scientific Affairs Responsibilities: Oversee scientific and clinical matters as they relate to product applications in clinical testing laboratories.
Years: 2000 to 2003 Employer: Nichols Institute Diagnostics Title: Senior Scientific Director Department: Clinical Marketing Responsibilities: Responsible for implementing new diagnostic tests in large laboratory chains.
Years: 1992 to 2000 Employer: Nichols Institute Diagnostics Title: Scientific Director Department: R&D Responsibilities: Directed product development on automated clinical analyzers.
Years: 1990 to 1992 Employer: London Diagnostics Title: VP, R&D and Operations Department: R&D and Operations Responsibilities: Responsible IVD product development, manufacture and Quality Control.
Years: 1988 to 1990 Employer: London Diagnostics Title: Director, R&D Department: R&D Responsibilities: Technology and Product development.
Years: 1986 to 1988 Employer: London Diagnostics Title: Senior Scientist Department: Chemistry Responsibilities: Develop Chemiluminescence detection technology.

Government Experience

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

Additional Experience

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.
Vendor 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.
Marketing Experience
Having been instrumental in bringing mega-changes in testing methodologies, he has insights as to where the global diagnostic testing sector is headed to.
Other Relevant Experience
Project management,
Team building,
R&D productivity,
Work-place harmony.

Language Skills

Language Proficiency
Hindi
Malayalam
Tamil

Fields of Expertise

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