Michael Drues, Ph.D., is President of Vascular Sciences (www.vascularsci.com) in Grafton, Massachusetts. Vascular Sciences offers a full range of consulting services to medical device, pharmaceutical and biotechnology companies including: prototype design, product development, testing and evaluation, animal and clinical trials, business development, strategic planning, technology assessment and regulatory affairs. Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA). Dr. Drues is an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology at several universities including Northeastern University (Boston), Steven’s Institute of Technology (Hoboken), Boston College (Boston), University of Wisconsin (Madison), Drexel Medical School (Philadelphia), Regis College (Boston) and University of California (Irvine). He regularly teaches both undergraduate and graduate courses in pathophysiology, biotechnology, regulatory affairs and clinical trials. Dr. Drues conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the European Patent Office and the FDA. Current offerings include: Designing Cardiovascular, Peripheral Vascular and Neurovascular Devices, Designing Gastrointestinal and Urinary Devices, Designing Better Medical Devices: Begin with the body in Mind, Minimally Invasive Technologies, Combination Products: Medical Devices Meet Drugs, Biologics & Beyond™, Overview of Biotechnology, Emerging Trends in the Medical Device Industry™, Big Picture Issues in Clinical Trials™ and Regulatory Affairs for Non-Regulatory Professionals.