Occupational and Industrial Toxicology Expert: Program Development, R&D and Product Safety Working in the Biotechnology, Medical Device and Pharmaceutical IndustriesOccupational and industrial toxicology, development programs (both preclinical and clinical) and study design.Conduct and reporting, in evaluating clinical and product safety data, in training and managing staff; in dealing with a wide range of U.S. and foreign regulatory bodies.Addressing commercial concerns, and contract research organizations in labeling and other FDA compliance issues for drugs, devices and dietary supplements.Identifying, developing and implementing new...

Medical Devices PhD Biomedical Engineer with Expertise in Cardiac Resynchronization Devices Including Both Pacemaker Devices and ICD DevicesCardiac resynchronization management therapy devices.Cardiac echocardiography.Medical device design, project management and research and development.Industrial product development in the medical industry.Heart failure studies and heart failure therapy devices.FDA device controls and regulatory issues.Expert Witness ExperienceICD device failure: Patient was subjected to unnecessary shock delivery.ICD Device failure due to lead failures.Patent Infringement case related to a heart monitoring system.Safet...

Medical Device Consultant Specializing in Materials, Design, Test Method Development, Product Development, Quality System Regulations, Process Validation, Supplier Qualification, ISO, FDA and REACH Compliance. Medical Device Process Validation Consultant, Supplier Qualification, ISO, FDA and REACH compliance.Product development from concept to market.21CFR820 (cGMP) and ISO13485 QSR.Polymers and materials for medical devices.Vascular and catheter systems.DOEs and process optimization.Process Validation (IQ, OQ, PQ).Medical device design control process.EPA, FDA, REACH and RoHS compliance regulations.Fluoropolymer and lubricious coating com...

Bioinformatics-Biomechanics Consultant; Educator, Researcher, Examiner, and Author focus on Regenerative Medicine, Immunology, and OsteoclastogenesisBioinformatics research projects, involving external collaborators with industry and core facilities.Biomechanics and design biomarker studies. Analyze and review data in drug discovery and drug development.Analyze novel signaling pathways that modulate osteoclast functions.Develop inhibitors for the treatment of autoimmune diseases.Regenerative medicine research.In-vivo research utilizing rodent models of bone disease including knock-out, transgenics, overexpression and various animal model...

Adhesives and Thin Films Consultant with expertise in Scale-Up, New Product Development, Market and AnalysisIndustrial applications development, market analysis, scale up, for thin film adhesives industry.Market analysis and development of structural adhesives.New product introduction, film adhesives: Electronics, construction, medical device, renewable energy.Six sigma and design for six sigma certified.Thin film and die cutting process web handlingThin film process development: Extrusion, UV-curing, and solvent.Reaction Injection Molding (RIM) process development: Moisture curing urethane adhesives.Expert Witness ExperienceIntellectual p...

Ph.D. Engineer Consultant Specializing in Microfluidics, Point-of-Care Diagnostics for Medical Devices for Disease Detection and Infertility DiagnosticsBiomedical engineer developing medical devices and products for early disease detection and infertility diagnostics.Develop microfluidic-based platforms from proof-of-concept through commercialization.Develop micro and nanotechnologies with application in medicine and biology.Expert in developing point-of-care biosensors for infectious diseases.Five years of experience in grant writing (NIH, NSF, DoD, Foundations) (R21, R01, SBIR, STTR).Worked with Human Leukemia, Breast, and Prostate Canc...

Dental and Technology Industry Consultant: Dental Devices, Laser, Intellectual Property, Medical Malpractice, Patent Infringements, Prior Art, and FDA WorkMedical laser technology and product development with specific focus to the Medical Infectious Disease and Dental Surgical industry.Bacterial and fungal elimination laser system.Photobiology technology in the medical and dental industry.FDA Approvals (FDA 510(k). Products: Lumenis, Contact Bone Ablation with Er:YAG lasers and OPUSDUO; OPUSDUO E; OPUSDUO EC, OPUS 20; and OPUS SPECTRUM.FDA cleared and CE Mark approved Onychomycosis Laser System selling world-wide.Dual Wavelength Infrared...

Medical Device, Medical Drug Delivery Design and Development for the Biotechnology and Pharmaceutical IndustriesAccomplished engineer/scientist with over 35 years’ experience in the design and development of drug products, pharmaceutical manufacturing processes and medical devices. Successful track record of progressing products from lab bench to commercialization. .Technical Competencies Drug product development and characterization, Process development and scale up, Project management, Identifying and managing vendors, CROs, CMOs, Tech transfer & trouble-shooting, Authoring CMC regulatory submissions, Development of micro-...

Consultant in Computational Modeling. Drug Design, Proteins, Small Molecules, Genetics, Machine Learning, Artificial Intelligence, Bioinformatics and Biomedicine, Materials Discovery, Robotics & ContrSummary  Drug discovery consulting and research and development in Biomedicine. Providing over ten years in biomolecular computational methods (small molecules and proteins, proteomics, genetics).   Drug Discovery and Biomedicine - Health  High throughput virtual screening and docking. Drug candidate identification. QSAR (Quantitative Structure Activity Relationship) and QSPR (Quantitative Structure Property...

Analysis of Soft Materials Expert Witness Reports and Mechanical Characterization of Soft Matter - Ph.D., Medical Device Expert Experienced researcher with a demonstrated history of project management in academic and industrial settings. Excellent communication and presentation skills in chemistry, materials science, data analysis, and polymers. Measurement of tensile and compressive properties of biomedical polymers and metals. Expert Witness Experience  Aided in characterization and compilation of results for hernia mesh litigation. Prepared data for thesis advisor to serve as expert witness in this litigation.