We did the surgery perfectly, yet the patient died anyway… we designed the medical device perfectly, yet the patient died anyway… we followed the regulation perfectly, yet the patient died anyway.
All are iterations on the same theme, i.e., all have the same root cause: answers are only as good as the questions we ask!
Or put another way: what good is designing the right medical device if we are solving the wrong problem?
Is regulatory and quality simply about making sure your design inputs match your user needs, i.e., ticking the boxes? What if your user needs are wrong? Do we need regulation to require us to make sure we are solving the right problems? asking the right questions?
Regulation is all about the interpretation of words and your ability to defend your interpretation.
Medical Device Industry Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
Michael Drues, Ph.D., is President of Vascular Sciences, a consulting and training 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.
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.
Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, Dr. Drues teaches 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 onground & on-line.
Michael Drues, Ph.D.
President
Vascular Sciences
Jon Speer
Founder & VP QA/RA
Greenlight Guru
Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS,
Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our home page to learn more.
Valscular Sciences is a consulting and training 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. For additional information, contact Dr. Drues at (508) 887-9486, e-mail mdrues @ vascularsci.com or via LinkedIn.