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Biomedical Sensor Packaging Failures: Regulations are not Design Standards
Keywords: FDA, Design, Standards
All medical devices involve some degree of risk and it is the role of a variety of sensor design and testing activities to manage product development risk. Some standards have emerged for process and material testing, but largely these serve consumer product and industrial process industries much better than the complex and highly interdisciplinary medical field. While designers and technicians new to medical device design might be inclined to focus exclusively on cost, speed to market, and competitive technology in the marketplace, this overlooks the role and value of regulatory agencies acting as a proxy for patients (not manufacturers) in the medical product development and launch process. Generally speaking, those closest to the product design function fail to appreciate the creation and subsequent growth in the regulatory power of the FDA throughout its brief history has frequently been a direct result of individuals harmed by mislabeled, untested, adulterated, or toxic products that were well-marketed, not well-tested. Those that see regulatory affairs as a “burden” to the product development process might be viewing a FDA regulations from the wrong perspective. Regulations are not intended to be design standards themselves or to serve industry, but rather guiding the process of assuring product safety and efficacy for the patient. Regulations are no substitute for the absence of packaging failure prediction methodologies and design standards, though they can be expected to fill the void with increasing “burden of proof” for the designer. In this presentation we examine a case study in sensor system packaging failure, comparing and contracting the various roles of regulations and design standards and what could or could not have been done to predict failure.
Colin K. Drummond, Director, Translational Research
Case Western Reserve University
Cleveland, Ohio

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