Medical Devices: Dev and Clin App
Start Date:June 28, 2021
- Assess the mechanisms of blood-surface interactions defining the biocompatibility of an extracorporeal device
- Evaluate the influence of extracorporeal membrane structure and material on transport properties (diffusion, convection, and ultrafiltration) and the overall effect on device performance
- Explain the implications of different blood flow regimes (laminar versus turbulent) on both the removal properties of membrane-based devices and the function of different vascular access devices
- Analyze device-related and patient-related (physiologic) parameters required for kinetic modeling of different dialysis therapies
- Apply 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
- Characterize 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
- Understand the regulatory expectations for objective evidence in support of medical device approval, including concepts as part of the Quality System, Risk Management, and Design Controls
- Recognize engineering roles in manufacturing considerations of a medical device, including concepts in lean manufacturing and process validation
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.
While the above information will be presented didactically in online lecture format, deeper assessments of key aspects will be assigned on a regular basis for applied learning. In this regard, oral and written reports on a topic of each student's choosing (in lieu of examinations) are an important component of the class. An additional way in which students will gain practical knowledge is through a series of case studies over the course of the semester.
In addition to this class, students interested in healthcare technology are also likely to find two other classes offered by Purdue Engineering Online (PEO) to be useful: Analytical Approach to Healthcare Delivery (also offered in the Summer 2021 session) and Medical Technology Development in the COVID-19 Era (to be offered in Fall 2021). Steps are being taken now to bundle these three courses into a Healthcare Technology certificate and concentration for students enrolled in PEO programs (https://www.purdue.edu/newsroom/releases/2020/Q2/purdue-offers-new-series-of-online-courses-in-health-care-technology.html).
Summer 2021 Syllabus
Prerequisites:Prior biology, physics (mechanics) and calculus classes (or permission from the instructor)
Applied / Theory:75 / 25
Homework:Homework (4): Each worth 75 points (total of 300)
Projects:A student may assess a medical device-based therapy from a suggested list prepared by Professor Clark or choose one on his/her own. In either case, students should plan to meet with Professor Clark before beginning work on the project to set expectations. The assessment will include the disease state(s) for which the technology is used, its historical development and evolution, the engineering principles underlying its use, the clinical challenges associated with the device, and the potentially improved designs for the future. Requirements for the presentations during the semester and the final written report will be provided early in the semester.
By the end of week 5, students will have chosen a high-impact clinical condition to study for the class project. Each student will submit a short PowerPoint slide deck (10 slides or less) at the end of week 4 (Presentation 1) and week 6 (presentation 2) to serve as progress reports for the project. All students will make a 15 minute online summary presentation during the final regular week of class (week 8) and submit a 15-20 page written summary at the end of that week.
Textbooks:Recommended (not required):
- Guyton and Hall Textbook of Medical Physiology, Edited by John E. Hall, Elsevier, 2016, ISBN: 978-1-4557-7005-2
- Medical Device Development, Edited by Jonathan S. Kahan, Barnett International, 2009, ISBN: 1-882615-92-1
- Biomaterials Science: An Introduction to Materials in Medicine, Edited by Buddy Ratner, Allan Hoffman, Frederick Schoen, Jack Lemons, Elsevier, 2012, ISBN: 978-0-12-374626-99