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.
USING THE CASE STUDY APPROACH, PARTICIPANTS WILL SPECIFICALLY LEARN:
- What is a design input and how do we make sure we have the right ones?
- What's the relationship between design inputs and user needs?
- How do we turn “user inputs” into a viable product and more importantly the right product!
- How do we “translate” user needs to design requirements? Can regs helps?
- How to read between the lines of user feedback, i.e., wants vs. needs?
- How do we sync design requirements and user needs?
- What are the challenges for the future?
In other words, answers are only as good as the questions we ask! i.e., what good is getting the “right” answer if we’re asking the wrong question? In this free 90 minute presentation by Michael Drues, Ph.D., participants will learn best practices to avoid timely and costly mistakes and creative ways to use the regulation to their advantage!
Who should attend?
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Medical Device Industry Executives
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Regulatory Affairs Professionals and Management
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Quality Professionals and Management
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Clinical Affairs Professionals and Management
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R&D Engineers and Management
ABOUT THE PRESENTER:
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.
