CHE 59700: Chemical Engineering Applications in Medical Devices

 

 

A. Instructors: William Clark, M.D. and Michelle Chutka

 

B. Course Description. This course provides a unique perspective 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 (with emphasis on fundamental chemical engineering principles) but also the forces that have shaped its development into a market generating annual revenue of nearly $100 billion on a global basis. The third segment of the course addresses industry-focused concepts pertaining to medical device development, including the role of the chemical engineer in design verification and validation activities, process validations including IQ/OQ/PQ, risk analysis, lean manufacturing concepts, and project management in an increasingly complex regulatory environment. Providing a real-world perspective based on over 15 years of experience in the medical device field, Ms. Michelle Chutka (President, Symbiosis Consulting LLC; Continuing Lecturer, Davidson School of Chemical Engineering, Purdue University) will lead this third part of the course.

 

C. Instructor Biographical Information: Dr. Clark is a nephrologist (kidney specialist) and chemical engineer by training. He received his M.D. degree along with specialty and sub-specialty training in internal medicine and nephrology, respectively, at Indiana University School of Medicine. In addition, he received both his B.S and M.S. degrees in chemical engineering from Purdue University, at which he is now Professor of Engineering Practice in the Davidson School of Chemical Engineering. Before joining the Purdue faculty, Dr. Clark worked in the medical device (dialysis) industry for more than 20 years in a variety of positions. During this time, he applied engineering principles to gain expertise in two broad areas, namely extracorporeal membrane structure/function and solute kinetics during dialysis. Dr. Clark continues to serve as a consultant in the dialysis industry.

 

Professor Chutka has been an active contributor to the Davidson School of Chemical Engineering since 2019. During her time, she has served as a Continuing Lecturer for courses supporting the Professional Master’s Program. Professor Chutka is a chemical engineer by training with both B.S and M.S degrees from the University of Michigan. Following her 19-year career in new product development for medical devices at Cook Biotech (now Evergen), Michelle has recently founded Symbiosis Consulting LLC and is actively supporting medical device companies and other industries, in areas of new product development, manufacturing, and continuous improvement. Outside of medical device experience, Ms. Chutka has also worked in the pharmaceutical industry and abroad within the automotive industry.

 

D. Prerequisites. CHE 37700 (or equivalent) and BIOL 23000 (or BCHM 30700). These are not strict requirements - interested students should contact Dr. Clark with inquiries.

 

E. Recommended (NOT REQUIRED) Texts.

F. Course Learning Outcomes

G.Course Meeting Schedule

Lectures: Tues/Thurs 3:00-4:15 PM

Homework 1: due February 10

Homework 2: due March 3

Homework 3: due April 7

Homework 4: due April 28

Presentation 1: Feb 27 (8-10 PM)

Presentation 2: April 15 (8-10 PM)

Final Report due: May 2

 

Early in the semester, students will assemble into groups of 3 and choose a medical device-based clinical therapy to study. Each group will provide two progress updates (Presentations 1 and 2) during the course of the semester in lieu of formal examinations. A complete written summary of each group’s assessment (Final Report) will be due at semester’s end in lieu of a final examination.

 

H. Instructor Contact Information.

Professor William R. Clark – Email: [email protected], Telephone: (765) 496-8647 (office); (317) 691-1438 (cell); office: FRNY 1055

Professor Michelle Chutka - Email: [email protected]

Office Hours: by appointment

 

I. Assessment of Course Outcomes. A weighted average grade will be calculated as follows.

Homework (4): 5% each = 20% total

Presentations (2): 20% each = 40% total

Final report: 40%

 

The grading scale will be as follows.

A: 100 – 85% of the weighted points

B: 84.9 – 75% of the weighted points

C: 74.9 – 65% of the weighted points

D: 64.9 – 55% of the weighted points

F: Less than 55% of the weighted points

 

Note that students with grades within 3 weighted percentage points of either the upper or lower bounds of a grade range listed above will receive a “plus” or “minus” mark, respectively, after his/her score (e.g., scores between 75% and 78% of the total weighted points would earn an B–). Marks of an A– will not be given.

 

Group projects

Student groups may assess a medical device-based therapy from a suggested list prepared by Professor Clark or choose one on their own. In either case, each group 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 potentially improved designs for the future. Requirements for the presentations during the semester and the final written summary will be provided early in the semester.

 

J. Class Schedule.

*: guest lecture