Biomaterials - ME 765

Fall 2008:   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:  12:30 pm – 2:00 pm

 

Text:               Biomaterials:  An Introduction, 3rd Edition.  Joon Park and Roderic Lakes,   Springer, 2007.  ISBN 978-0-387-37879-4.  e-ISBN 978-0-387-37880-0.   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, copied to the student's department file, and appropriate penalties 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......................................................       55 points

(20%)

 
            Journal Club ..................................................       20 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.  Note that your final score on homework may be changed (lowered significantly or raised slightly) based on your peer review ratings.

 

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 

No late homework will be accepted.  Homework is considered late if turned in after the end of the class period on the day due.  Any special exceptions to the late homework policy will be announced in lecture.

 

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. Note that your final score on homework may be changed (lowered significantly or raised slightly) based on your final peer review ratings.  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 each worth 25 percent of the total course grade.  No written final will be given.  Instead, an oral examination/presentation of your team project will be held during the final exam period. 

 

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.  If you require additional time or special accommodations during testing, I will be most happy to help you, but you must provide documentation from the appropriate KU offices to ensure fairness to all students.  Please also see me privately in regard to this course for these needs.

 

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 and respect that I may have deadlines that preclude my discussions with you outside of the set office hours.

 

 

Descriptions of Special Projects

 

Journal Club (total 20 points):  Two "Journal Club" sessions (one after each Midterm Examination) will be held.  For Journal Club, journal article titles from the Journal of Biomedical Materials Research will be presented to the class.  Each student must choose one of the articles to read and critique.  Each article must be read independently outside of class by all students who choose that article.  The three or four 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 (5 points) and participation in class (5 points). 

 

Medical Device Analysis (total 25 points):  Each team of students will choose a 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 (total 150 points):  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 define and 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 similar to an R03 type NIH 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.  Reasonable intermediate drafts of sections of this proposal will be due before the final proposal.  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.  The point distribution associated with each draft, presentation and final proposal is listed below.  Further details on the proposal project and presentation will be given throughout the semester.

           

                               Specific Aims Draft 1:      10 Points

                      Background Draft 1:      10 Points

                                 Full Proposal Draft 1:      10 Points

                                      Final Submission:      100 Points

                   Oral/Presentation Final Exam:      20 Points

 

 

 


Course Outline

 

Lecture Period
Dates

Topic Area

Required

Reading

Assignment Status

1

08/21/08

General Discussion, Rules & Expectations; Introduction

Chapter 1

Read all chapters prior to lecture period

2

08/26/08

Basics of Ethical Analysis

Lecture notes

1st Homework assigned

Homework teams designated

3

08/28/08

Structure of Solids – Review of Basic Concepts

Chapter 2

 

4

09/02/08

Characterization of Biomaterials I – Review of Basic Concepts

Chapter 3

1st Homework due

2nd Homework assigned

5

09/04/08

Characterization of Biomaterials II – Review of Basic Concepts

Chapter 4

 

6

09/09/08

Metallic Implant Alloys

Chapter 5

 

7

09/11/08

Metallic Implant Alloys, cont.

 

2nd Homework due

8

09/16/08

Ceramic Biomaterials

Chapter 6

3rd Homework assigned

9

09/18/08

Polymeric Implant Materials

Chapter 7

 

10

09/23/08

Polymeric Implant Materials, cont.

 

 

11

09/25/08

Composite Biomaterials

Chapter 8

3rd Homework due

Journal Club I articles assigned

12

09/30/08

Catch-up, Review for Exam I

 

Medical Device Assignment

13

10/02/08

 Examination I

 

 

14

10/07/08

Journal Club I

 

Journal Club sheet due

15

10/09/08

Regulatory Issues

Review results of Exam I

Lecture Notes

4th Homework assigned

16

10/14/08

How to Write a Grant Proposal &

Review Proposal Project Guidelines

Lecture Notes

 

17

10/16/08

Considerations in Testing Biomaterials

Lecture Notes

Research Question for Proposal must be identified

18

10/21/08

No Class!  Fall Break

 

 

19

10/23/08

Structure-Property Relationship of Biological Materials

Chapter 9

4th Homework due

5th Homework assigned

20

10/28/08

Structure-Property Relationship of Biological Materials, cont.

 

 

 

21

10/30/08

Tissue Response to Implants

Chapter 10

 

 

22

11/04/08

Soft Tissue Implants I & II

Chapters

11 & 12

5th Homework due

Submit reference list in JBMR format

23

11/06/08

Hard Tissue Implants I

Chapter 13

Specific Aims Draft 1 due

24

11/11/08

Hard Tissue Implants II

Chapter 14

6th Homework assigned

25

11/13/08

Tissue Engineering Materials

Chapter 16

 

 

11/18/08

In-Class Debate

 

 

26

11/20/08

 "Catch-up", Review for Exam II

 

6th Homework due

Background Draft 1 due

27

11/25/08

Examination II

 

Journal Club II articles assigned

28

11/27/08

No class – Thanksgiving break

 

 

29

12/02/08

Journal Club II

 

Full Proposal Draft 1 due

30

12/04/08

Medical Device Discussions

Review Exam II

 

Medical Device Analysis due

31

12/09/08

Group Discussions

Review Presentation Guidelines

 

 

32

12/11/08

 

 

Final Proposal due

 

 

Final Examination – Oral Exam / Project Presentation

Wednesday, December 17, 1:30 – 4:00 pm


Course Outline – revision 1

 

Lecture Period
Dates

Topic Area

Required

Reading

Assignment Status

1

08/21/08

General Discussion, Rules & Expectations; Introduction

Chapter 1

Read all chapters prior to lecture period

2

08/26/08

Basics of Ethical Analysis

Lecture notes

1st Homework assigned

Homework teams designated

3

08/28/08

Structure of Solids – Review of Basic Concepts

Chapter 2

 

4

09/02/08

Characterization of Biomaterials I – Review of Basic Concepts

Chapter 3

1st Homework due

2nd Homework assigned

5

09/04/08

Characterization of Biomaterials II – Review of Basic Concepts

Chapter 4

 

6

09/09/08

 

 

 

7

09/11/08

Metallic Implant Alloys

Chapter 5

2nd Homework due

3rd Homework assigned

8

09/16/08

Metallic Implant Alloys, cont.

 

 

9

09/18/08

Ceramic Biomaterials

Chapter 6

 

10

09/23/08

Polymeric Implant Materials

Chapter 7

 

11

09/25/08

Polymeric Implant Materials, cont.

 

 

12

09/30/08

Composite Biomaterials

Chapter 8

 

 

13

10/02/08

Review for Exam 1

Open research discussion

 

3rd Homework due

Medical Device Assignment

Journal Club I articles assigned

14

10/07/08

Examination I

 

 

15

10/09/08

Journal Club I

 

Journal Club sheet due

16

10/14/08

Regulatory Issues

Review results of Exam I

Lecture Notes

4th Homework assigned

17

10/16/08

No Class!  Fall Break

 

 

18

10/21/08

How to Write a Grant Proposal &

Review Proposal Project Guidelines

Lecture Notes

 

19

10/23/08

Considerations in Testing Biomaterials

Lecture Notes

Research Question for Proposal must be identified

20

10/28/08

Structure-Property Relationship of Biological Materials

Chapter 9

4th Homework due

5th Homework assigned

21

10/30/08

Structure-Property Relationship of Biological Materials, cont.

 

 

 

22

11/04/08

Tissue Response to Implants

Chapter 10

 

 

23

11/06/08

Soft Tissue Implants I & II

Chapters

11 & 12

5th Homework due

Submit reference list in JBMR format

24

11/11/08

Hard Tissue Implants I

Chapter 13

Specific Aims Draft 1 due

25

11/13/08

Hard Tissue Implants II

Chapter 14

6th Homework assigned

 

11/18/08

Tissue Engineering Materials

Chapter 16

 

26

11/20/08

In-Class Debate, Review for Exam II

 

6th Homework due

Journal Club II articles assigned

27

11/25/08

 Examination II

 

Background Draft 1 due

28

11/27/08

No class – Thanksgiving break

 

 

29

12/02/08

Journal Club II

 

Full Proposal Draft 1 due

30

12/04/08

Medical Device Discussions

Review Exam II

 

Medical Device Analysis due

31

12/09/08

Group Discussions

Review Presentation Guidelines

 

 

32

12/11/08

 

 

Final Proposal due

 

Final Examination – Oral Exam / Project Presentation

Wednesday, December 17, 1:30 – 4:00 pm