Michael Drues

Michael Drues

Vascular Sciences

Michael Drues, Ph.D., is a regulatory strategy consultant specializing in designing novel regulatory strategies to bring new and innovative medical products to market and in developing effective communication strategies between companies and regulatory agencies to minimize time to market and avoid delays.

Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University. He works 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, Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services and other regulatory and governmental agencies around the world.

Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and
regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology
companies, the FDA, Health Canada, the US and European Patent Offices, CMS and other regulatory and governmental
agencies around the world.

Finally, Dr. Drues is an Adjunct Professor of Regulatory Affairs, Medicine and Biomedical Engineering at several
universities and medical schools. He regularly teaches graduate courses in Regulatory Affairs and Clinical Trials, Clinical
Trial Design, Medical Device Regulatory Affairs and Product Development, Combination Products and Pathophysiology.

For a comprehensive list of columns, webinar, podcasts, etc., visit, Global Medical Device Podcast (GreenLight.Guru) here, Mike on MedTech (Medical Product Outsourcing) here, Medical Design and Outsourcing here, Guerilla Regulatory Strategy (MED Device Online) here and Healthcare Packaging here, LinkedIn here.