BMEN 5601 -- New Course

Fri Apr 15 10:21:46 2016

Approvals Received:
on 04-14-16
by Rachel Jorgenson
Approvals Pending: College/Dean  > Provost > Catalog > PeopleSoft Manual Entry
Effective Status: Active
Effective Term: 1163 - Spring 2016
Course: BMEN 5601
UMNTC - Twin Cities/Rochester
UMNTC - Twin Cities
Career: UGRD
College: TIOT - College of Science and Engineering
Department: 11143 - Biomedical Engineerng, Dept of
Course Title Short: Cardiovascular Devices
Course Title Long: Cardiovascular Devices
Max-Min Credits
for Course:
1.0 to 1.0 credit(s)
Design of cardiovascular devices with experts from local medtech companies. Discussion of clinical need, the generic design (emphasizing use of engineering principles), typical testing and validation methods, and major limitations of the available devices. Design, analysis, and testing of these and related devices.

prereq: BMEN 3011, 3111, 3211, or equivalents with instr consent; or CSE grad student
Print in Catalog?: Yes
CCE Catalog
<no text provided>
Grading Basis: A-F or Aud
Topics Course: No
Honors Course: No
Online Course: No
Contact Hours:
1.0 hours per week
Course Typically Offered: Every Spring
Component 1 : LEC (no final exam)
Progress Units:
Not allowed to bypass limits.
1.0 credit(s)
Financial Aid
Progress Units:
Not allowed to bypass limits.
1.0 credit(s)
Repetition of
Repetition not allowed.
for Catalog:
BMEN 3011, 3111, 3211, or equivalents with instr consent
No course equivalencies
Add Consent
No required consent
Drop Consent
No required consent
(course-based or
BMEn upper div or CSE grad student
Editor Comments: <no text provided>
Proposal Changes: This course was offered in Spring 2015 and Spring 2016 as a Special Topics course, BMEn 5920. We wish to turn it into a permanent course effective Spring 2017 and beyond.
History Information: 12/29/15: Returned to dept for more information, per CCC request. -RLR

04/14/16: Resubmitted by dept with updated syllabus. -RJJ
Sponsor Name:
Sponsor E-mail Address:
Student Learning Outcomes
Student Learning Outcomes: * Student in the course:

- Can identify, define, and solve problems

Please explain briefly how this outcome will be addressed in the course. Give brief examples of class work related to the outcome.

This course will expose students to the design of cardiovascular devices by experts from local medical technology companies. Lectures will be structured so students understand the clinical need, the generic design (emphasizing use of engineering principles), typical testing and validation methods, and major limitations of the available devices (to stimulate thought on research opportunities) on a different cardiovascular device each week. Upon completion of this course, students should be able to understand the design, analysis, and testing of these and related devices. They will have opportunities to apply and reinforce engineering principles learned in prior courses. In particular, students will be required to complete a report on the design and testing of a cardiovascular device.

How will you assess the students' learning related to this outcome? Give brief examples of how class work related to the outcome will be evaluated.

Students will be required to complete a written report on the design and testing of a cardiovascular device, worth 70% of the overall course grade.

Liberal Education
this course fulfills:
Other requirement
this course fulfills:
Criteria for
Core Courses:
Describe how the course meets the specific bullet points for the proposed core requirement. Give concrete and detailed examples for the course syllabus, detailed outline, laboratory material, student projects, or other instructional materials or method.

Core courses must meet the following requirements:

  • They explicitly help students understand what liberal education is, how the content and the substance of this course enhance a liberal education, and what this means for them as students and as citizens.
  • They employ teaching and learning strategies that engage students with doing the work of the field, not just reading about it.
  • They include small group experiences (such as discussion sections or labs) and use writing as appropriate to the discipline to help students learn and reflect on their learning.
  • They do not (except in rare and clearly justified cases) have prerequisites beyond the University's entrance requirements.
  • They are offered on a regular schedule.
  • They are taught by regular faculty or under exceptional circumstances by instructors on continuing appointments. Departments proposing instructors other than regular faculty must provide documentation of how such instructors will be trained and supervised to ensure consistency and continuity in courses.

<no text provided>
Criteria for
Theme Courses:
Describe how the course meets the specific bullet points for the proposed theme requirement. Give concrete and detailed examples for the course syllabus, detailed outline, laboratory material, student projects, or other instructional materials or methods.

Theme courses have the common goal of cultivating in students a number of habits of mind:
  • thinking ethically about important challenges facing our society and world;
  • reflecting on the shared sense of responsibility required to build and maintain community;
  • connecting knowledge and practice;
  • fostering a stronger sense of our roles as historical agents.

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LE Recertification-Reflection Statement:
(for LE courses being re-certified only)
<no text provided>
Statement of Certification: This course is certified for a Core, effective as of 
This course is certified for a Theme, effective as of 
Writing Intensive
Propose this course
as Writing Intensive
Question 1 (see CWB Requirement 1): How do writing assignments and writing instruction further the learning objectives of this course and how is writing integrated into the course? Note that the syllabus must reflect the critical role that writing plays in the course.

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Question 2 (see CWB Requirement 2): What types of writing (e.g., research papers, problem sets, presentations, technical documents, lab reports, essays, journaling etc.) will be assigned? Explain how these assignments meet the requirement that writing be a significant part of the course work, including details about multi-authored assignments, if any. Include the required length for each writing assignment and demonstrate how the minimum word count (or its equivalent) for finished writing will be met.

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Question 3 (see CWB Requirement 3): How will students' final course grade depend on their writing performance? What percentage of the course grade will depend on the quality and level of the student's writing compared to the percentage of the grade that depends on the course content? Note that this information must also be on the syllabus.

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Question 4 (see CWB Requirement 4): Indicate which assignment(s) students will be required to revise and resubmit after feedback from the instructor. Indicate who will be providing the feedback. Include an example of the assignment instructions you are likely to use for this assignment or assignments.

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Question 5 (see CWB Requirement 5): What types of writing instruction will be experienced by students? How much class time will be devoted to explicit writing instruction and at what points in the semester? What types of writing support and resources will be provided to students?

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Question 6 (see CWB Requirement 6): If teaching assistants will participate in writing assessment and writing instruction, explain how will they be trained (e.g. in how to review, grade and respond to student writing) and how will they be supervised. If the course is taught in multiple sections with multiple faculty (e.g. a capstone directed studies course), explain how every faculty mentor will ensure that their students will receive a writing intensive experience.

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Statement of Certification: This course is certified as Writing Internsive effective  as of 
Course Syllabus
Course Syllabus: For new courses and courses in which changes in content and/or description and/or credits are proposed, please provide a syllabus that includes the following information: course goals and description; format;structure of the course (proposed number of instructor contact hours per week, student workload effort per week, etc.); topics to be covered; scope and nature of assigned readings (text, authors, frequency, amount per week); required course assignments; nature of any student projects; and how students will be evaluated. The University "Syllabi Policy" can be found here

The University policy on credits is found under Section 4A of "Standards for Semester Conversion" found here. Course syllabus information will be retained in this system until new syllabus information is entered with the next major course modification. This course syllabus information may not correspond to the course as offered in a particular semester.

(Please limit text to about 12 pages. Text copied and pasted from other sources will not retain formatting and special characters might not copy properly.)

(Pdf also sent to Tom Shield 4/14/16)

Prerequisites:  BMEn 3011, 3111, 3211, or equivalents with department consent

Other Suggested Prerequisites:  None

Brief Description:  In this seminar, weekly guest speakers from local medical device industry will present students with an overview of current and emerging technologies in the field of devices for the treatment of cardiovascular diseases, while providing industry perspective on the process, considerations and challenges of bringing these technologies to market.  Speakers will deliver an overview of clinical need and market analysis, generic design, relevant engineering principles, typical testing and validation methods as well as comment on the limitations of the devices and possibly future directions.  As a whole, the series of lectures will provide a picture of the current landscape of cardiovascular devices, the companies in the industry, as well as the engineering roles involved in medical device development.  At the end of each session, time will be provided for students to ask questions.  

Instructor:  Prof. Bruce H. KenKnight, PhD     E-mail:

Grading Assistant: Jared Hierman  E-mail:

Course Format:  1 lecture per week  

Course Credit:  1 Credit

ABET Students Outcomes: You should develop (g) an ability to communicate effectively (from writing your report) and (j) a knowledge of contemporary issues (from our speakers).

Important Dates:
Apr 7: Prospectus Draft Submission Due Date
Apr 28: Report Submission Due Date

Course Grading (A through F):
•        Participation (30%)
•        Report on design and testing of a cardiovascular device (70%)
• Attendance Policy:100% attendance is required for a passing grade, as documented by sign-in each week, except for excused absence due to documented medical reasons, personal emergency, or extraordinary circumstances approved by the instructor. Unexcused absences include not signing-in even if you were present. As a courtesy to our invited speakers, you must be seated by 2:30 and stay with rapt attention until the instructor adjourns the class - students who arrive after 2:30, or leave the classroom before the end of the end of class without pre-approval by the instructor, or do something besides listen to the speaker (texting, doing homework, reading the Daily, etc.) may have their attendance credit cancelled.  An I (Incomplete) is assigned if 100% attendance (including make-ups) is not attained by the end of classes; when make-ups for all remaining unexcused absences are completed, the I will be converted to the report grade.  Note that by University policy, an I converts to an F automatically one year of the last day of final examinations of the term in which the I was given.  
• Attendance Records: Our records are posted on UMN Moodle 2.0 – consult the Instructor about any discrepancies. You can access the Moodle site from http://www.myu.umn.eduunder the My Courses tab. • Class Make-up Procedure:  Unexcused absences can be made up by attending a BMEN 8602 Graduate Seminar (held 3:30-4:30 Mondays and some Wednesdays in 2-101 NHH – check the schedule at, writing 1 page describing what you thought was the most interesting technical aspect of the presentation, and why (don’t write a summary!), and emailing it to the Instructor by the class meeting of 5920 that follows the date of the seminar or it will not be accepted (note: you do not need to attend the first 8602 seminar that takes place after the missed class!).
• Extra Credit Policy: To encourage your participation, the Instructor will have the prerogative to select one or more particularly insightful questions related to design considerations or testing for their device as “extra credit” – those students will have their report grade increased by one increment (e.g. B+ to A-); a student can earn more than one increment during the semester.  Submit your question by email ( within 24 hours following the class session.
• Class will be adjourned when the speaker has been thanked – please remain seated until class has been formally adjourned by TA or Course Coordinator.
• Grade Basis: Passing grades will be decided entirely upon a report.  The report must be on a specific, high impact biomedical device different from what you reported on in BMEn 1601 or 1602, if you have already taken these courses.
• Report Format/Requirements:
-        Exactly 4-5 pages (11 pt Times font, 1.5 line spacing, 1” margins, not including references and figures; note you may simply reference figures in the key reference attached to your report)
-        About 2 pages should be used to describe the device, and 2 pages to explain what you consider to be the key technical design consideration – make sure you explicitly describe this point.
-        The report should demonstrate understanding of the device, it’s technical aspects and clinical evidence supporting safety and efficacy.  Please use your best writing skills; poor writing style, including misspelling, will adversely affect the grade; use resources like as necessary.
-        Cite at least 4 references, 3 of which are journal publications, 1 of which (the key reference), must be attached to your prospectus.  Note: not all references are “high quality references.”  Be mindful of the significance of various journals by investigating their Impact Factor.
-        You must highlight the text in your key reference, when you reference it in your report, so it will be obvious why it is your key reference (i.e. highlighting will show us where and why you made reference to it).
-        The approved prospectus (see below) must be bound to your report if you pick it up after its review and approval, using a binder clip to secure it to your report.
• Key Reference:
It must be a technical, not a “clinical study”, original research article published in a peer-reviewed journal. A technical research article reports a study performed in a controlled setting, usually in an animal model or some sort of laboratory setting, generally not in human patients. Clinical studies take a device or therapy that as already been developed and reports its safety and efficacy in human patients.  
It should be obvious when an article presents original research results.  Note that if your reference is classified as a "Review" article, then it is definitely not an original research report.   
• Plagiarism: You should make explicit use of your references in the text, wherever appropriate, so there is no chance that your report would be cited for plagiarism, which will result in an F for the course. For example: “Providing directional information to regenerating axons should be a powerful strategy for improving peripheral nerve regeneration (Dubey et al, 1999).”  See and / or if you have any questions about what constitutes plagiarism and how to ensure you avoid it. While sparing use of ver batim text (i.e. cut and paste) if quotations are used and with citation is acceptable, excessive use (more than 5% of your text) will reduce the grade assigned (even though appropriately referenced) -- you should synthesize your sources into your own original exposition (which will also generally require frequent citations!).  Minor editing of cut and pasted text from multiple sources that is strung together might be determined as plagiarism and at best will result in a lower grade for not should synthesizing your sources into your own original exposition.  Plagiarism will result in an F for the report grade and F for the course grade, and reporting to the Office of Student Conduct and Academic Integrity.  Obviously, your report must contain at least one reference to your key reference that makes it crystal clear why you chose it as the key reference.
• Report Topic Advice: Select a cardiovascular device that was not presented by a speaker during the course lectures.  Ideas for topics may be generated from perusing,, medical device company websites, and/or journals (e.g. Journal of Medical Devices, Medical Devices & Surgical Technology Week) via the MEDLINE (OVID) database accessible via or a similar search engine. Downloadable PDFs of many recent journal publications (as well as on-line access to many journals) can be had via You may use any resource (e.g. Google Scholar: to identify journal references.
• Prospectus Definition and Due Date: A 100 word prospectus of the report (from prospectus is “something, such as a statement or situation, that forecasts the course or nature of something”; in our case, how it will meet the report requirements regarding impact and technical aspects as supported by the key reference) along with the at least 4 references listed, a copy of the key journal paper, and a printout from the journal website showing it is a peer-reviewed journal, bound together with a binder clip, is due in class on April 7.  (These will be reviewed for suitability with students being promptly notified of any problems via email (please include your email in prospectus) if submitted before the deadline or via the Moodle site for those submitting on the deadline.)
• Report Submission and Due Date:
-        The report is due at the start of class on Apr 28th, including your complete prospectus if you picked it up following its review/approval.  Late reports will not be accepted without a documented medical reason, personal emergency or extraordinary circumstance approved by the instructor.
-        Electronic submission on the due date will also be required.  Details will be sent via email just prior to the due date. Late e-submissions will not be accepted.

Schedule (subject to change)
Date        Name        Topic        Suggested Reading
21-Jan        Quan Ni        Neuromodulation for obstructive sleep apnea       
Ramirez, J.-M. et al. Central and Peripheral factors contributing to Obstructive Sleep Apneas. Respiratory physiology & neurobiology 189, 344–353 (2013).

28-Jan        Curt Deno        Mapping of cardiac arrhythmias       
Willems, S. et al. Mapping and ablation of ventricular fibrillation—how and for whom? Journal of Interventional Cardiac Electrophysiology 40, 229–235 (2014).

4-Feb        Mark Wisniewski        Left atrial appendage occlusion device       
Alli, O. & Holmes, D. Left atrial appendage occlusion. Heart 101, 834–841 (2015).

11-Feb        Eric Lovett        Baroreceptor activation therapy       
Shen, M. J. & Zipes, D. P. Interventional and Device-Based Autonomic Modulation in Heart Failure. Heart Failure Clinics 11, 337–348 (2015).

18-Feb        Jim Georgakopoulos        LV assist via Counterpulsation       
Capoccia, M., Bowles, C. T., Pepper, J. R., Banner, N. R. & Simon, A. R. Evidence of clinical efficacy of counterpulsation therapy methods. Heart Failure Reviews 20, 323–335 (2014).

25-Feb        Eddy Warman        Atrial therapies in pacemakers and ICDs       
Yap, Y. G. & Camm, J. in Essentials of Atrial Fibrillation (eds. Yap, G. Y. & Camm, J. A.) 21–36 (Springer Healthcare Ltd., 2014).

3-Mar        Paul Krause        Implantable cardiac monitors       
Fung, E. et al. Electrocardiographic patch devices and contemporary wireless cardiac monitoring. Frontiers in Physiology 6, 149 (2015).

10-Mar        Aparna Bhave        Cardiac stent design       
Sigwart, U. Living history of medicine: vascular scaffolding, from dream to reality. European Heart Journal (2016). doi:10.1093/eurheartj/ehv656

24-Mar        Paul Robinson        Transcatheter cardiac valves       
Zeeshan, A., Tuzcu, E. M., Krishnaswamy, A., Kapadia, S. & Mick, S. Transcatheter aortic valve replacement: History and current indications. Cleveland Clinic journal of medicine 82, S6–S10 (2015).

31-Mar        Mark Brown        ICD sensing        TBA
7-Apr        Dawn Bardot        Computational models        TBA
14-Apr        Bruce Jones        Rate responsive pacing (flex dates)        TBA
21-Apr        Cassie Morris        Renal denervation       
Iliescu, R., Lohmeier, T. E., Tudorancea, I., Laffin, L. & Bakris, G. L. Renal denervation for the treatment of resistant hypertension: review and clinical perspective. American Journal of Physiology - Renal Physiology 309, F583–F594 (2015).

28-Apr        Stephen Hahn        S-ICD       
De Maria, E., Olaru, A. & Cappelli, S. The entirely subcutaneous defibrillator (S-Icd): state of the art and selection of the ideal candidate. Current cardiology reviews 11, 180–186 (2015).

5-May        Jeffrey Vogel        Self-expanding vascular stent        TBA
Strategic Objectives & Consultation
Name of Department Chair
Bob Tranquillo
Strategic Objectives -
Curricular Objectives:
How does adding this course improve the overall curricular objectives ofthe unit?

This unique course, because of the expert speakers from local companies, connects principles to devices and better prepares our students for employment in the medtech industry.
Strategic Objectives - Core
Does the unit consider this course to be part of its core curriculum?

Strategic Objectives -
Consultation with Other
In order to prevent course overlap and to inform other departments of new curriculum, circulate proposal to chairs in relevant units and follow-up with direct consultation. Please summarize response from units consulted and include correspondence. By consultation with other units, the information about a new course is more widely disseminated and can have a positive impact on enrollments. The consultation can be as simple as an email to the department chair informing them of the course and asking for any feedback from the faculty.

See below for email consultations with (1) Will Durfee in Mechanical Engineering (CSE); and (2) Michael O'Connor and Melissa Gardner in  Genetics, Cell Biology and Development (CBS):


(1) - Will Durfee, CSE


This is an excellent course. It does not overlap with any course in Mechanical Engineering, with any course in CSE, and as far as I know, with any other course at the University. The only related course, which does not represent an overlap, is the week-long cardiovascular physiology course directed by Paul Iaizzo and held in January. Your course is a great complement to that one, and vice-versa.

I hope that your course will be publicized within CSE as there are Mechanical Engineering graduate and undergraduate students who would be interested and who would have the equivalents to the listed pre-reqs.


William Durfee
Professor and Director of Design Education
Department of Mechanical Engineering
University of Minnesota
111 Church St SE, Minneapolis, MN 55455


(2) - Michael O'Connor and Melissa Gardner, CBS

Hello Rachel,

Both Melissa and i looked over the syllabus for BME 5920 and we see no overlap with present GCD courses.

Mike O'Connor

Michael B. O'Connor
Ordway Professor of Developmental Biology
Head, Department of Genetics, Cell Biology and Development
University of Minnesota
Minneapolis, MN 55455
Tel: 612-626-0642