I am President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including (but not limited to): stimulating & innovative educational programing, brain-storming sessions, prototype design, product development, benchtop & animal testing , regulatory strategy & clinical trial design, FDA presentation preparation & defense, reimbursement, clinical acceptance, business development & technology assessment.I received my B.S., M.S., & Ph.D. degrees in Biomedical Engineering from Iowa State University. I have worked for & consulted with leading medical device, pharmaceutical & biotechnology companies ranging in size from start-ups to Fortune 100 companies. I also work on a regular basis for the U.S. Food & Drug Administration (FDA), Health Canada, the US & European Patent Offices, the Centers for Medicare & Medicaid Services (CMS) & other regulatory & governmental agencies around the world.As an internationally recognized expert & featured keynote speaker, I present frequently on cutting-edge medical technologies & regulatory affairs. I conduct seminars & short-courses for medical device, pharmaceutical & biotechnology companies, FDA, Health Canada, US & European Patent Offices, CMS & other regulatory & governmental agencies around the world.Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, I regularly teach graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination Products, Pathophysiology, Medical Technology & Biotechnology at several universities & medical schools on-ground & on-line.Specialties:Combination Products, Medical Devices, Biotechnology, Pharmaceuticals, Animal Studies, Pathophysiology, Clinical Trial Design, Regulatory Strategy, Pharmacogenomics/Personalized Medicine, R&D, Testing & Evaluation and Bus. Dev.