ME 760 Biomedical Product Development

Spring 2008:  Monday/Wednesday   9:00 am – 9:50 am

Third meeting time: Monday 5:00 pm – 5:50 pm


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

                        Room 3134, Learned Hall

                        Office phone:  864-2104


                        Office Hours:  Monday: 10:00 am – 11:00 am

                                                Tuesday: 9:00 – 10:00 am

                                                Wednesday: 10:00 am – 11:00 am

                                                Please email to confirm other meeting times


                        Nathan Dormer, Graduate Teaching Assistant,


Text:               New Venture Creation:  Entrepreneurship for the 21st Century, 7th Ed.  Timmons and Spinelli, McGraw-Hill Irwin, New York, NY

                        ISBN-13: 978-0-07-310279-5  or ISBN-10: 0-07-310279-2


                        Supplement on reserve in the Spahr Engineering Library:: 

                        Product Design and Development, 3rd Edition, by Karl T. Ulrich and Steven D. Eppinger.  ISBN 0-07-247146-8 (hardcover -- also available in paperback)


                        Supplement on reserve in the Spahr Engineering Library:

                        Design of Biomedical Devices and Systems, by Paul H. King and Richard C. Fries.  ISBN 0-8247-0889-X


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

-      explain to a high school student the basic steps in analyzing the potential of a biomedical invention concept to be successful in the marketplace.

-      prepare a business feasibility plan for a small company based around any product.

-      apply principles of product development in any field.

-      enter into any industry quality system environment with a basic understanding of quality system requirements and approaches.

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

-      apply biomechanics and biomaterials principles to the development of medical devices.

-      begin to understand how to critically review product ideas in any new biotechnology field.


Course Policy on Academic Dishonesty: 

Academic dishonesty (cheating) will not be tolerated in the School of Engineering.  In this course, cheating will be defined as sharing information during Examinations or Quizzes, direct copying of homework assignments or laboratory reports, 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  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",


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.



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 professional behavior of the student, such as class attendance, consistent submission of homework, peer ratings and participation.  *****


Notice:  I do not curve grades in this course.  It is 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.


Individual effort assessments for teamwork and team projects and the peer rating adjustment factor

All students will periodically be asked to submit evaluations of how well they and their teammate performed as team members.  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 team earned scores.  Quitting or firing should not be undertaken without extensive instructor consultation.  The final peer team evaluation will be incorporated into an individual adjustment of team earned scores.  At the end of the semester, a peer performance rating adjustment factor (that is derived from the final team peer evaluation) will be applied to the total teamwork score earned in order to account for individual team member performance.  The adjustment factor will either add up to 5 percent of the team earned score, or subtract up to 100% of the team earned score to calculate your individual score, based on adequately justified ratings on team participation and effort given to you by your team. 


Gray areas between guaranteed letter grades

In determining final letter grades, a "gray area" system of up to several percentage points below the specified numerical cutoff grades will be used.  For example, 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 the gray areas, whether you get the higher or lower grade depends on whether your homework and 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), as well as your overall professional attitude in the course.



Homework in this course will be nontraditional, with most assignments having open-ended problems in which many answers could be correct, based on the justification of the answer.  Complete answers with justification are thus required.  Nearly all of the homework assignments will be completed by the team.  In this case, only one copy of the homework is required for the team.  When submitting completed homework, please staple the pages and fold them vertically when you hand them in, putting the names of the participating group members and the problem set number and date on the outside.  If a student's name appears on a solution set, it certifies that he/she participated in solving the problems.


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:  030% 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 the examination.



There will be one midterm exam.  The final exam will be the VC pitch.


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 course instructor and GTA

I strongly encourage you to discuss academic or personal questions about this course with me, preferably during my office hours or by email.    Please do not hesitate to email at any time.  Office hours are set for you -- I welcome questions and interaction with you.  Unfortunately, I may have to cancel my office hours from time-to-time.  If my office hours do not fit with your schedule, please come in at other times, but understand that I may not be able to talk at that time due to other my work and deadlines.




Project description

Each team will be assigned a project that will be their focus for the second half of this course.  The project will be analysis of the commercialization potential and pathway for a real medical product concept.  The medical product concept may be in various levels of initial development, ranging from concept only to prototype available.  Consideration of this variance of initial product level will be taken into account in the final deliverables, so that each team will have nearly equal work load.  Remember, one desired outcome of this course is for students to earn the skill of looking forward into possible development of a product, no matter what the starting point. 


Project Document Deliverables at End of Course

-      Design/Development History File (partial) [~30% of Project grade]

       quality control documents – ISO 13485 (limited)

-      Design Input Requirements

-      Design Risk Analysis with Failure Modes and Effects Analysis (FMEA)

-      Design Verification

       each student's development notebook

-      Business feasibility plan for small company (real or fictional startup) that will commercialize invention  [~15% of Project grade]

-      Write a "Mock" NIH SBIR Fast Track proposal to develop your biomedical product [~45% of Project grade]

       Limited literature review around the invention concept

       Research plan (Phase I and Phase II) of research needed to bring invention to near commercialization or Phase III

       Commercialization Plan (similar to business feasibility plan)

-      Venture Capitalist panel "pitch" (10 minute presentation) of development plan [~10% of Project grade]


Tentative Course Outline (subject to change): 


Week /           Day

Topic Area

Venture Workbook

Assignment Status

1           M


MLK Holiday – No Class





Syllabus, Survey, Introduction, DISC








2           M


What is Product Development





SBIR/STTR Introduction








3           M


Ethics of Product Development


HW 1 due



Regulatory Aspects and Standards








4           M


Market Validation





Identifying Customer Needs and Product Specifications


HW 2 due Project Assigned






5           M


Design History Files


HW 3 due











6           M


Biomaterials Basics


HW 4 due



Biomedical Product Characterization








7           M


Design of Biomedical Products





Product Development Research Protocols


HW 5 due






8           M


Human Factors and Industrial Design





Technology Entrepreneurship


HW 6 due






9           M


Spring Break





Spring Break








10          M


Catch up and review for Midterm





Midterm Exam






11          M


The VC Pitch – Selling yourself and your product













12          M


Initial Proposal – Oral Presentations


1st draft project documents due



Team meetings








13          M


Team meetings





Team meetings








14          M


Team meetings





Progress Report - Oral Presentations


2nd draft project documents due






15          M


Team meetings





Team meetings








16          M


VC Panel Practice Presentations





Team meetings


Final project documents due








Oral exam:  VC Pitch during final exam time




Final Examination = Oral Exam (VC Pitch) – Exam time Tuesday, May 13, 7:30 am – 10:00 am                                                                                                                          *Required Reading