March 3, 2020

New graduate-level CHE elective for Fall 2020 (CHE 597 Medical Device)

CHE 59700: Medical Devices: Development and Clinical Application (Fall 2020)

Instructor. William R. Clark, M.D.

Course Description. 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 transport phenomena, separations, and fluid flow, to devices used for extracorporeal therapies and other treatments. Several clinical conditions in which these considerations are relevant are discussed, using the treatment of renal failure by dialysis as a large, representative medical device sector. In addition to a focus on extracorporeal therapeutic devices, the concepts of verification/validation, lean manufacturing, and project management as they relate to medical device development are presented. A final consideration is the evolving area of drug/device combinations, with focus on drug delivery systems for biologic pharmaceutical products.

Prerequisites. CHE 37700 and BIOL 23000 (or BCHM 30700); or permission from the instructor.

Recommended (NOT REQUIRED) texts.

  • 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

Course Learning Outcomes.

  • 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

Course Meeting Schedule.

  • Lectures:                  Tuesday/Thursday  10:30-11:45 AM
  • Presentation 1:        TBD
  • Presentation 2:        TBD
  • Final Report due:     December 11

At the approximate mid-point of the semester, students will assemble into groups of four 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.

Instructor Contact Information.

Professor William R. Clark – Email: clarkw@purdue.edu, Telephone: (765) 496-8647 (office); (317) 691-1438 (cell); office: FRNY 2158
Office Hours: TBD
 

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

Homework (2): 10% each = 20% total
Presentations: 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.
 
Lecture Topics.
Class #1: Introduction
Class #2: Overview of the medical device industry
Class #3: Physiology overview (I)
Class #4: Physiology overview (II)
Class #5: Physiology overview (III)
Class #6: Interactions of blood with biomaterials (I)
Class #7: Interactions of blood with biomaterials (II)
Class #8: Normal kidney function
Class #9: Chronic kidney disease (CKD) and end-stage renal disease (ESRD)
Class #10: Hemodialysis and related therapies (I)
Class #11: Hemodialysis and related therapies (II)
Class #12: Kinetic modeling
Class #13: Acute kidney injury (AKI)/sepsis
Class #14: New device approaches for ESRD and AKI
Class #15: Vascular access for dialysis (I)
Class #16: Vascular access for dialysis (II)
Class #17: Medical device product development: Design verification/validation (I)
Class #18: Medical device product development: Design verification/validation (II)
Class #19: Medical device product development: Project management (I)
Class #20: Medical device product development: Project management (II)
Class #21: Lean manufacturing in the medical device industry (I)
Class #22: Lean manufacturing in the medical device industry (II)
Class #23: Drug/device combination products
Class #24: Regulation of medical devices (I)
Class #25: Regulation of medical devices (II)
Class #26: Medical device clinical trials
Class #27: Evolution of a medical device market: chronic dialysis case study
Class #28: Challenges/opportunities in the medical device industry; wrap-up
 

 

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