Biomaterials - ME 765

Fall 2007:   Tuesday/Thursday  4:00 pm – 5:15 pm

 

Instructor:   Lisa Friis, Ph.D., Associate Professor, Mechanical Engineering

                  Room 3134, Learned Hall

                  Office phone:  864-2104

                  Email:  lfriis@ku.edu

                  Office Hours:    Tuesday: 12:30 pm – 2:00 pm

                                                      Thursday:  9:00 am – 10:30 am

 

Text:           Biomaterials Science:  An Introduction to Materials in Medicine, 2nd Edition.  Edited by Ratner, Hoffman, Schoen, and Lemons.  Elsevier Academic Press, 2004.  ISBN 0-12-582463-7.  Required text.

 

Course Objectives:  By the end of this course, students should be able to:

-      explain to a high school student what a biomaterial and how and why they are used in different sites in the body.

-      choose an appropriate biomaterial for a given implant design.

-      define biocompatibility of a biomaterial for a given implant design and use.

-      decide what is the best test protocol to use in characterizing a biomaterial.

-      determine what FDA classification a given device design would be assigned, why that assignment would be given, and what steps might be taken to avoid a PMA route.

-      apply the biomaterials principles discussed in the design of medical devices.

-      critically review biomaterials research studies and new technology.

 

Course Policy on Academic Dishonesty: 

Academic dishonesty (cheating) will not be tolerated in the KU School of Engineering.  In this course, cheating will be defined as sharing information during Examinations, direct copying of homework assignments, allowing others to do the majority of the work for your projects, and plagiarism on the reports, homework assignments, papers or projects. (For an excellent definition of plagiarism with examples, see http://www.ehhs.cmich.edu/~mspears/plagiarism.html).  In this course it is okay to ask each other questions on the homework assignments (but not on Take-Home Exams).  This implies that each student has individual active input on every problem or assignment.  Tag teams efforts on homework assignments are not allowed and submission of identical homework is not permitted.  Cheating in class is inconsistent with professional engineering ethics and is a serious violation.  If any student is found cheating, he/she will be dealt with in a forthright and no nonsense manner.  The instance will be reported with documentation to the Associate Dean and appropriate penalties will be invoked. 

 

Course Grading Structure

KU Grading System  (adapted from the University Senate Rules and Regulations "Article II, Section 2:  The Grading System", http://www.ku.edu/~unigov/usrr.html#art2sect2)

 

The letters A, B, C, D shall be used to indicate passing work.

-      The grade of A will be reported for achievement of outstanding quality.

-      The grade of B will be reported for achievement of high quality.

-      The grade of C will be reported for achievement of acceptable quality.

-      The grade of D will be reported for achievement that is minimally passing, but at less than acceptable quality.

The letter F shall indicate that the quality of work was such that, to obtain credit, the student must repeat the regular work of the course, or that the student's work was not of passing quality at the time of disenrollment from the course.

 

Breakdown of total points available:

         Examination I...................................      125 points (25%)

         Examination II..................................      125 points (25%)

         Final Exam.......................................      None

         Homework.......................................      60 points

(20%)

 
         Journal Club ...................................      15 points

         Medical Device Analysis ....................      25 points

         Research Proposal and Presentation...      150 points (30%)

 

In general, reported earned grades will follow these general guidelines:

Outstanding quality ( A ) equates to 90 – 100% of the total available points.

High quality ( B) equates to 80 – 90% of the total available points.

Acceptable quality ( C ) equates to 70 – 80% of the total available points.

Minimally passing quality ( D ) equates to 60 – 70% of the total available points.

Not passing quality ( F ) equates to less than 60% of the total available points.

 

*****  Borderline scores will be affected by class attendance and participation.  *****

 

Notice:  I do not curve grades in this course.  It is theoretically possible for everyone in the class to get an A (or an F).  Your performance depends only on how you do, not on how everyone else in the class does.  It is therefore in your best interest to help your classmates in every legal and ethical way possible.

 

Gray areas between guaranteed letter grades

There will be a "gray area" of several points below the specified numerical cutoff grades, within a system will be used.  Two people getting the same weighted average grade (say, 89%) might therefore get different course grades (A or B).  If you are in one of these gray areas, whether you get the higher or lower grade depends on whether your test performance has been improving (your grade goes up) or declining (it goes down), and whether you participation in group work has been good (up) or inadequate (down).

 

Homework

Completed assignments should be turned in by the beginning of class on the due date in class.  Unless the assignment specified otherwise, you must work in teams of two or three, handing in one team solution per assignment.  It is strongly suggested that each team member should set up each problem individually (read in advance, define the unknowns, outline the solution procedure), then get together to work out the details.  On some assignments, this procedure will be required and your instructor will ask for the individual outlines to be signed and turned in.

 

Team roles for homework

On each group assignment, you and your homework partner must designate

-      a coordinator to organize work sessions, make sure you agree on where and when to meet, and understands who is supposed to be doing what.

-      a recorder to prepare and turn in the final solution set and

-      a checker (who is the same person as the coordinator in a group of two) to check the solutions for correctness and verify that you both understand both the solutions and the strategies used to obtain them.

The team roles must rotate on every assignment – once a team member has carried out a role, he/she may not do it again until everyone else on the team has done it.

 

Homework format

If a student's name appears on a solution set, it certifies that he/she participated in solving the problems.  To present the problem solution, start with restating (preferably in your own words) what was given in the problem, what you are to find, and then provide your solution as such:

Given:

Find:

Solution:

The final answer to the problem (if numerical) should be encompassed by a line box or indicated by an arrow (if written).  This format is intended to help students organize a problem and make grading of the homework more straight-forward.  However, some problems are not amenable to using this format.  Use your own discretion in following this specific format. 

 

Late Homework 

Homework is considered late if turned in after the end of the class period on the day due.  Late homework will be accepted, but penalties will also be imposed as follows:

One (1) day late:  50% deduction from total score.  

Two (2) days late:  75% deduction from total score. 

Three (3) or more days late:  100% deduction (no credit). 

Special exceptions to the late homework policy will be announced in lecture in the case of homework due the class period before an examination.

 

Individual effort assessments for team homework and projects

All students will periodically be asked to submit evaluations of how well they and their teammate performed as team members.  These evaluations will be incorporated into the assignment of homework grades.  If repeated efforts to improve team functioning (including faculty intervention) fail, a non-participant member may be fired by the other team member(s).  Similarly, a team member doing essentially all the work may quit.  Individuals who quit or are fired must find a team of two unanimously willing to accept them; otherwise they will receive zeros for the remainder of the homework. 

Tests

There will be two midterm exams.  The point layout of these exams is given on a previous page.

Disability Services

The staff of Services for Students with Disabilities (SSD), 135 Strong, 785-864-2620 (v/tty), coordinates accommodations and services for KU courses.  If you have a disability for which you may request accommodation in KU classes and have not contacted them, please do as soon as possible.  Please also see me privately in regard to this course.

 

Consulting with faculty

I strongly encourage you to discuss academic or personal questions about this course with your course instructor during my office hours or by email.  Office hours are set for you -- I welcome questions and interaction with you.  Since this is a small class, I also welcome you to come in to talk about the course or the field at other times.  Please understand, however, if I have deadlines that preclude my discussions with you outside of the set office hours.

 

 

Descriptions of Special Projects

 

Journal Club:  Three Journal Club sessions (one after each Midterm Examination and one at the end of the semester) will be held.  For Journal Club, journal article titles will be presented to the class.  Each student must choose one of the articles to read and critique.  Each article will be read by all students who choose that article independently outside of class.  The two or three students who choose an article form a group – this group may be different from the teams that work together on homework.  Before the article is discussed in class, each student will individually prepare an individual written review of the article (format to be distributed later).  During the Journal Club class session, each group will then discuss the article first within their group and prepare an informal presentation and critique of the article to the rest of the class.  The purpose of this exercise is to learn more about current technology in the field of biomaterials and to develop skills in critical review of research.  Journal Club points are earned by completing the individual written review and participation in class.

 

 

Medical Device Analysis:  Each team of students will choose a real medical device from our KU supply to analyze.  A variety of different devices are available.  Students must carefully "dissect" the product, making note of how it was packaged, how/why it was labeled, what materials were used in packaging, sterilization concerns, what materials were used in the device, how the device functions, etc.  Each team will prepare a report on these issues to submit to the instructor.  Teams will then given an informal presentation of their analysis to the class in a group discussion format.  More details on this analysis will be given during the semester.

 

 

Biomaterials Research Project Development and Presentation:  A "library research" and proposal preparation project topic will be either assigned to or chosen by each team.  Teams will be the same as those for the homework assignments.  Teams should consist of at least three students unless class numbers prohibit this arrangement.  In this project, each team will explore a research question in the biomaterials field.  The team will explore the biomaterials research question through a review of the literature on the subject matter, come up with a reasonable method to study the research question, determine the budget, equipment and personnel expertise required to study the project, and present this information in the form of an NIH style proposal format using forms for PHS 398.  Proposals are typically in the Phase I SBIR line or the R03 track.  Examples of topics are the use a biomedical material in a specific implant or device, processing concerns with a specific biomaterial leading to use in the specific design, or special problems associated with a specific biomaterial.  Please discuss your topic choice with the instructor before doing extensive background work.  Each team member will be assigned a role on the project and will represent an area of expertise on the study.  Students will be required to write the specific aims, background and literature, and research design sections according to NIH guidelines.  The team must then present their proposed research question, literature review, budget and study design to the class for review and critique.  Two drafts of this proposal will be due before the final draft.  Please review your specific aims and proposed research plan with your instructor in person after each draft submission.  A representative of the team must come in to talk with the instructor after each draft submission to review the specific aims and proposal development.  Twenty-five percent of the final project score will be based on submission of a reasonable effort on these drafts.  Further details on the proposal project and presentation will be given throughout the semester.

 

 


Course Outline – subject to revision!

 

Week
Dates

Topic Area

Required

Reading

Assignment Status

1

08/16/07

-      General Discussion, Rules & Expectations

-      Basics of Ethical Analysis

 

 

 

08/21/07

-      Ethics, Cont.

-      Introduction; Structure of Solids – Review of Basic Concepts

Chapter 1

1st Homework assigned

Homework teams designated

2

08/23/07

-      Characterization of Biomaterials

 

 

 

08/28/07

-      Characterization of Biomaterials, cont.

 

1st Homework due

 

3

08/30/07

-      Metallic Implant Alloys

Chapter 2: section 2.9, Chapter 6: section 6.3

2nd Homework assigned

 

 

09/04/07

-      Metallic Implant Alloys, Cont.

 

 

4

09/06/07

-      Ceramic Biomaterials

 

2nd Homework due

 

09/11/07

-      Polymeric Implant Materials

 

3rd Homework assigned

5

09/13/07

-      Polymeric Implant Materials, cont.

Chapter 2: sections 2.10-2.11

 

Medical Device Assignment

 

 

09/18/07

-      Composite Biomaterials

Chapter 3:  sections 3.2 – 3.8, 3.12

 

6

09/20/07

-      "Catch-up", Review for Exam I

 

3rd Homework due

Journal Club I articles assigned

 

09/25/07

Examination I

 

 

7

09/27/07

-       Journal Club I

 

 

 

 

 

10/02/07

-      Regulatory Issues

-      Review results of Exam I

Lecture notes

4th Homework assigned

Research Question for Proposal Project must be selected and teams identified

8

10/04/07

-      Structure-Property Relationship of Biological Materials

Chapter 10

 

 

10/09/07

Guest Lecture: Characterization at the Interface

 

4th Homework due

9

10/11/07

No Class!  Fall Break

 

 

 

10/16/07

-      Tissue Response to Implants

-      Soft Tissue Implants

 

5th Homework assigned

References for Proposal Project identified – submit reference list in JBMR format

10

10/18/07

-      Blood Interfacing Implants

-      Review Proposal Project Guidelines – Group discussions

Chapter 4: sections 4.1–4.3

Chapter 7: sections 7.1-7.4, 7.6, 7.10-7.13

 

 

 

10/23/07

-      Orthopaedic and Dental Implants

 

5th Homework due

6th Homework assigned

Outline for Proposal Project due

11

10/25/07

-      Considerations in Testing Biomaterials

Chapter 7, sections 7.7-7.9

 

 

 

10/30/07

-      Guest Lecture:  How to Write a Winning Grant Proposal

 

 

12

11/01/07

-      Intro to Tissue Engineering

-      In-Class Debate

Chapter 8 Chapter 9, lecture notes

 

Draft 1 Proposal Project due

 

11/06/07

"Catch-up", Review for Exam II

 

6th Homework due

Journal Club II articles assigned

13

11/08/07

Examination II

 

 

 

11/13/07

Journal Club II

 

Medical Device Analysis due

14

11/15/07

Medical Device Discussions

Review Exam II

 

Draft 2 Proposal Project due

 

11/20/07

Group Discussions

Review Presentation Guidelines

 

 

15

11/22/07

No class – Thanksgiving break

 

 

 

11/27/07

Group Discussions

 

 

16

11/29/07

Proposal Project Presentations

 

Final Proposal Project due

 

12/04/07

Proposal Project Presentations

 

 

 

No Final Examination