Expert Details
Medical Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc.
ID: 725158
California, USA
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.
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 |
|---|---|---|---|
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| Years: 1992 to 2000 | Employer: Nichols Institute Diagnostics | Title: Scientific Director | Department: R&D |
Responsibilities:Directed product development on automated clinical analyzers. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| Years: 1988 to 1990 | Employer: London Diagnostics | Title: Director, R&D | Department: R&D |
Responsibilities:Technology and Product development. |
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| Years | Employer | Title | Department |
| Years: 1986 to 1988 | Employer: London Diagnostics | Title: Senior Scientist | Department: Chemistry |
Responsibilities:Develop Chemiluminescence detection technology. |
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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
510(k) document, medical device, medical device evaluation, medical device manufacturing quality control, medical device manufacturing quality control, medical device product development, manufacturing quality control, medical diagnostic test, biomedical research and development, clinical measurement, medical device clinical research, biomedical instrumentation, biomedical product development, medical device product improvement, medical device manufacturing troubleshooting, biomedical device design review, medical device reliability testing, medical device manufacturing, biomedical diagnostic instrumentation