Michael Drues, Ph.D.

Biography

Michael Drues, Ph.D., is a professional biomedical engineer and independent regulatory and quality consultant who has worked in the medical technology industry for more than 30 years. He is president of Vascular Sciences, a consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense, educational programming, brain-storming, prototype design, product development, benchtop & animal testing, clinical trial design, reimbursement, clinical acceptance, business development & technology assessment.

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), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) 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 U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.

As an Adjunct Professor of Regulatory Science, Medicine and Biomedical Engineering, Dr. Drues teaches graduate-level courses in Medical Device Regulatory Affairs & Clinical Trials, Combination Products and Pathophysiology at several universities & medical schools including Cornell University Graduate Dept. of Biomedical Engineering on-ground & on-line.

Dr. Drues is a contributing editor to several of the largest medical technology and regulatory publications in the world and has a combined readership/listenership averaging 4000+ people per month. For a comprehensive list of columns, webinar, podcasts, etc., visit, Global Medical Device Podcast (GreenLight.Guru), Mike on MedTech (Medical Product Outsourcing), Medical Design and Outsourcing, Guerilla Regulatory Strategy (MED Device Online), Healthcare Packaging and LinkedIn.

Dr. Drues was named one of the 24 Medtech Voices to Follow in 2024 by Medical Device and Diagnostic Industry (MDDI) Magazine in December, 2023.