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IVD Assays and Diagnostic Tests Development
Expert's areas of expertise include the following: IVD (in vitro diagnostics) clinical laboratory regulation molecular diagnostics blood assay diagnostic instrumentation assay development CLIA-88 (Clinical Laboratory Improvement Amendments of 1988) clinical laboratory regulation quantitative risk analysis (risk assessment) laboratory management GLP…
Piezoelectric Ultrasonic Transducers and Sensors: Design, Prototyping and Measurement
He is expert in the design of ultrasonic transducers (MHz range medical/industrial, acoustic or vibration sensor/actuators). Typical applications are, medical ultrasound imaging probes, medical diagnostic sensors, medical ablation tools by high energy focused ultrasound, eye surgery sensors, eye motion sensors,…
Intellectual Property, Patents, Validity Invalidity, Infringement Noninfringement, Product Liabilty
Expert has extensive experience in product liability which include: Direct participation in more than 300 litigation cases with in-depth evaluations of multiple high-dollar claims and lawsuits. Forensic Analyses. Expert witness reports, inspections, accident reconstruction, photographs, occupant kinematics & injury causation,…
In Vitro Diagnostics Industry Including Clinical Laboratory, Immunohematology & Donor Screening
Expert's 40+ year career has spanned a variety of business disciplines and functions including information management, supply chain management, customer service, new product development, sales, and new business start-up. He began his career at Eastman Kodak Company as a Systems…
Medical Device Product Management, Product Launch, Marketing, Sales, and Sales Operations
Expert has over 30 years commercial experience in medical and diagnostic device product management and development, marketing, sales, operations, distribution and finance as an individual Contributor, Director, Vice President and CEO. Expert provides strategic advice to start-up medical device companies,…
Pressure Sensitive Adhesive Tapes, Release Coating, Laminations (Total Business)
While being a Technical Marketing Manager at Borden, Mystik tape division, and Scapa tape he visited many end use customers to discuss their applications and gained vast knowledge of applications of all different tapes. Having more than 45 years experience…
Medical Device Strategy, Up-stream Marketing and Commercialization
Expert has over 30 years marketing experience in the healthcare industry. During his career he has launched over 20 products in the USA and internationally. Products launched include electronic medical equipment, durable medical equipment, medical plastic consumables, and medical software.…
Clinical Diagnostics, Life Sciences and Medical Devices
Expert has over 30 years of experience in clinical diagnostics, life sciences, and medical devices. Expert is the President of a health care consultancy. He has experience in the identification, acquisition, and commercialization of new businesses and products in the…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Competitive Intelligence from Primary Sources in Pharmaceuticals, Diagnostics, and Medical Devices.
•Business research and development professional with a successful record targeting and developing Fortune 500 clients. •Founded pharmaceutical and information technology business intelligence firm and served as Business Development & Research Director for 15 years. •Expertise assessing the unique challenges facing…