3 credits
Spring 2026 Lecture Upper Division
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.
Learning Outcomes1Assess the mechanisms of blood-surface interactions defining the biocompatibility of an extracorporeal device.
2Evaluate the influence of extracorporeal membrane structure and material on transport properties (diffusion, convection, and ultrafiltration) and the overall effect on device.
3Analyze device-related and patient-related (physiologic) parameters required for kinetic modeling of different dialysis therapies.
4Apply fundamental chemical engineering principles to provide a quantitative basis for treatments of specific clinical disorders, including end-stage renal disease (ESRD), acute kidney injury (AKI), sepsis, cardiac failure, and respiratory failure.
5Characterize the major components of a medical device company and the manner in which these different functions interact during the pre-market and post-market phases of product development.
6Apply important principles of project management, verification/validation, and lean manufacturing to medical device development.
Restrictions
made by Purdue students.