The “textbook” approach to design validation is intended to make sure we design the “right” device, i.e., the device meets user needs and intended uses. But what exactly does that mean and how do we do it? More importantly, how do we know we did it right? If we tick the validation checkbox, can we assume our validation is correct?
Validation usually involves a lot of testing. But what tests do we do? What tests do we not do? When can we use standard tests and when do we have to develop new ones? More importantly, how do we know we’re doing the right tests? If a test is “required” must we do it? In other words, how do we validate our validation? And how do we defend our validation when FDA criticizes it?
Finally, the “textbook” approach to design validation is very myopic. What else needs to be validated? human factors plan? reprocessing methods? post-market surveillance system? what else?
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, Medical Device Regulatory Affairs and Product Development, Combination Products and Pathophysiology.
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