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Biomedical Engineering Expert Specializing in Bone Implants, Dental Biomaterials, and Stem Cell SeparationsSetting up research labs for residency programs.Bone implant design and testing.Dental biomaterials development and testing.Stem cell separations and testing.Bone cement based drug delivery.Undisclosed Medical Center, Director, Orthopedic Bioengineering, Lab., 2007 - PresentWork with surgeons and residents (different specialties) to develop research projects.IRB and IACUC application process.Develop bioskills cadaver laboratory s...
Medical Device, Business and Product Development Expert working in the areas of: Orthopadedics, Biomaterials, Market Analysis, and Technology AnalysisMedical device business development activities such as negotiation of term sheets, contracts and due diligence activities, and technology development from bench top to commercialization, portfolio analysis, identification of new technologies for revenue expansion.Key AreasMedical devicesBiomaterialsPatentsOrthopedicsProject managementExpert Witness ExperienceFor an orthopaedic device case: Submitted detailed analysis of technical information.
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...
Medical Device Risk Management, Quality Systems Management, Supplier Qualification and Quality Assurance: In Vitro Diagnostic Medical Devices (Class II), Biotech Manufacturing Operations, Digital Imaging Equipment, and Interventional Devices (Class III), Bio-based MaterialsMedical device and biomedical industry planning, Integration, and organizational improvements, increasing financial performances for U.S. and European businesses.Aligning technology and business strategy, medical device quality management regulations and requirements into effective and useful management systems.Remedial quality management system compliance.Pre-certifica...
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...