CHE 50100 - Medical Devices - Development And Clinical Application

Credit Hours: 3.00. This course is an introduction to the medical device field, with emphasis on the ways in which chemical engineering processes provide the foundation for many device-related therapies. The course involves the application of several fundamental chemical engineering principles, including those related to mass transfer, separations, and fluid flow, to devices used for extracorporeal therapies and other treatments. The first part of the course addresses the relevant physiology and pathophysiology serving as a foundation for subsequent clinical material. With the focus on extracorporeal devices, the interactions between blood and biomaterials in a general sense are also explored. The second part of the course assesses the extracorporeal treatment of kidney failure by dialysis, which is highlighted as the only long-term, device-based replacement therapy for terminal organ failure (end-stage renal disease). This analysis will not only consider the evolution of dialysis therapy from a technology perspective but also the forces that have shaped its development into a market generating annual revenue of nearly $100 billion on a global basis. In addition, extracorporeal support therapies used clinically not only for failure of other organs (namely the heart, liver, and lungs) but also systemic inflammation secondary to severe infection (sepsis) will be presented. The third segment of the course addresses industry-focused concepts pertaining to medical device development, including verification/validation, lean manufacturing, project management, and regulatory issues. Providing a real-world perspective based on broad experience in the medical device field, Ms. Michelle Chutka (see below) will lead this third part of the course. Permission of instructor required.Credits: 3.00

CHE 50100 - Medical Devices - Development And Clinical Application

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