EML 4585 DESIGN OF BIOMEDICAL SYSTEMS AND DEVICES
Summer 2004
INSTRUCTOR: Richard T. Schoephoerster
OFFICE: EAS 2600 PHONE: 348-3722
EMAIL: Richard.Schoephoerster@fiu.edu
Class Description: This course will cover the engineering design of the human body and of the devices used for artificial replacement of organs or systems. The class will not follow any particular text, but material will be covered from a variety of references listed below as well as current journal articles. The material covered can be divided into three parts:
1) Concepts of Engineering Design
2) Concepts of Biomedical Engineering Design
3) Application of design principles to human and artificial systems:
a) skeletal and muscular
b) circulatory
c) respiratory
d) renal
Course Objectives: This course is designed to provide the student with an introduction to systems and devices used in the biomedical industry and the basic principles of their design. It is meant to offer the students an application in the biomedical area to the basic theory developed in the lower level course work, as well as an opportunity to learn basic steps and processes involved in engineering design as it specifically applies to biomedical problems.
By the end of this course, students should be able to:
1. Apply the principles of engineering design from recognition of need to a fully-tested product.
2. Organize and manage a design project and work effectively in a team to complete the project.
3. Incorporate biocompatibility, regulatory issues, and other considerations and constraints pertinent to medical devices, into the design process.
4. Apply knowledge of natural physiological systems to the design of their replacements, and to devise means to overcome constraints in doing so.
5. Communicate items 1 through 4 in written, oral, and graphical form.
POINTS DISTRIBUTION: Class Participation 10%
Interim Assignments 10%
Design Project Proposal and Presentation 20%
Design Project Final Report and Presentation 40%
Final Exam 20%
TENTATIVE COURSE OUTLINE
TOPICS
1 Engineering Design
2 Recognition of Need
3 Introduction to QSR and Design Controls – Design Input
4 Creativity and Innovation
5 Feasibility Assessment
6 Project Management – Organization/Work Breakdown Structure
7 Biocompatibility
8 Natural Design of the human skeletal and muscular systems
9 Joint and bone implants - fixation devices, hip and knee joints
10 Natural Design of the human circulatory system
11 Cardiovascular hemodynamics
12 Cardiovascular implants and devices
13 Natural Design of the human respiratory system
14 Oxygenators
15 Natural Design of the human renal system
16 Hemodialyzers
References
Black Biological Performance of Materials
Marcel Dekker
Chandran Cardiovascular Biomechanics
NYU Press
Cooney Biomedical Engineering Principles: An Introduction to
Fluid, Heat, and Mass Transport Processes
Marcel - Dekker
Ertas and Jones The Engineering Design Process
Wiley
Guyton Textbook of Medical Physiology
W.B. Saunders
Hastings Cardiovascular Biomaterials
Springer - Verlag
Hwang and Norman Cardiovascular Flow Dynamics and Measurements
University Park Press
Milnor Hemodynamics
Williams and Wilkins
Nichols and O'Rourke McDonald's Blood Flow in Arteries
Lea & Febiger
Park Biomaterials: An Introduction
Plenum Press
Webster Medical Instrumentation: Application and Design
Houghton - Mifflin
Winter Biomechanics of Motor Control and Human Movement
Wiley
FDA Center for Devices and Radiological Health
Medical Device Quality Systems Manual (FDA 97-4179)
Design Control Guidance for Medical Device Manufacturers (for FDA 21 CFR 820.30)