Find an Expert
Medical Device Research and Development
Expert has over 30 years experience in medical device design dealing with all phases of design -- brainstorming, concept design, proof of concept testing, prototyping, cost / task estimating, project planning, project management, detailed design, bench testing, troubleshooting, design verification…
Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization
His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition…
Nanotechnology, Biomaterials, Sol-gel Sciences, Optics, Biotechnology, Glass, Ceramics, Spectroscopy
Expert is a specialist of sol-gel chemistry. He developed a new non-aqueous method for sol-gel glass coating to obtain transparent films for integrated optics and photonics using polysiloxane materials. The aim was to obtain low-softening temperature glasses to permit facile…
Biomedical Engineering, Patents, Medical Device Design, Product Development, Eye Activity Devices
He has served as a consultant as well as trained and led numbers of team consultants in application software development projects for over 20 years. Masters Degree specializes in optics and diagnostic/remediative processes and devices based on eye activity. PhD…
Total Quality, Supply Chain, Industrial Engineering, Lean Six Sigma, Baldrige, Project Management
Expert has taught Engineering Economics at Oregon State University. He has applied Engineering Economics to drive strategic decision-making in client companies, partnering with Stanford faculty to apply economic analysis in the design of Supply Chain networks in Pharmaceutical and Electronics…
Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
Medical Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc.
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…
Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of…
Development and Assurance of High-Assurance / Safety-Critical Software & Embedded Systems
Expert has substantial experience with software safety and reliability. Most of his career has been spent working with high-assurance systems and safety-critical software. He has developed software for commercial aviation systems, for medical devices, and for industrial controls and safety…
Human Factors: Human Error and Accident Reduction, Performance and Safety into Complex Systems, etc.
Involved in accident analysis from the point of view of human error as a causal or contributory factor in the accident. Led the investigation for the Nuclear Regulatory Commission into the extent to which human error and training played a…