BMEN 3151 -- Proposed New Course

Thu Feb 8 10:08:29 2018



Approvals Received:
Department
on 2/8/18
by Ashlee Haluptzok
(ahaluptz@umn.edu)
Approvals Pending: College/Dean  > Provost > Catalog > PeopleSoft Manual Entry
Effective Status:
Active
Effective Term:
1185 - Summer 2018
Course:
BMEN 3151
Institution:
UMNTC - Twin Cities/Rochester
Campus:
UMNTC - Twin Cities
Career:
UGRD
College:
TIOT - College of Science and Engineering
Department:
11143 - Biomedical Engineerng, Dept of

General

Course Title Short:
Medical Device Practicum
Course Title Long:
Medical Device Practicum
Max-Min Credits for Course:
1.0 to 1.0 credit(s)
Catalog Description:
BMEN 3151 "Medical Device Practicum" allows students to use the skills they learned in BMEN 2151 "Introductory Medical Device Prototyping" for making an actual medical device prototype. Weekly seminars introduce advanced medical device topics that will be fundamental to senior design. Students will become acquainted with the following topics: Design opportunities in medicine, conceiving and vetting a medical device, FDA regulations and guidance, intellectual property, commercialization ? licensing and entrepreneurship, and building a medical device prototype.
Print in Catalog?:
Yes
CCE Catalog Description:
false
Grading Basis:
A-F
Topics Course:
No
Honors Course:
No
Online Course:
No
Freshman Seminar:
No
Is any portion of this course taught outside of the United States?:
No
Community Engaged Learning (CEL):
New: None
Old:
Instructor Contact Hours:
1.0 hours per week
Course Typically Offered:
Every Summer
Component 1:
LEC
Auto Enroll Course:
No
Graded Component:
LEC
Academic Progress Units:
1.0 credit(s) (Not allowed to bypass limits.)
Financial Aid Progress Units:
1.0 credit(s) (Not allowed to bypass limits.)
Repetition of Course:
Repetition not allowed.
Course Prerequisites for Catalog:
<No Text Provided>
Course Equivalency:
<No text provided>
Cross-listings: No cross-listings
Add Consent Requirement:
No required consent
Drop Consent Requirement:
No required consent
Enforced Prerequisites: (course-based or non-course-based):
BMEN 2151
Editor Comments:
<No text provided>
Proposal Changes:
<No text provided>
History Information:
<No text provided>
Faculty Sponsor Name:
<No text provided>
Faculty Sponsor E-mail Address:
<No text provided>

Student Learning Outcomes

Student Learning Outcomes

* Students in this course:

- Can identify, define, and solve problems

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.

The purpose of this team-based course is to train junior undergraduate students in the skills necessary for conceiving, designing and fabricating medical devices. BMEN 3151 Medical Device Practicum (May Session, 1 cr.) is meant to refine and implement skills learned by students in the prerequisite course, BMEN 2151 Introductory Medical De-vice Prototyping (Spring Semester, 3 cr.). The later course develops skills in engineer-ing drawing, rapid prototyping, machining, electronics, material science, biocompatibil-ity, microcontroller hardware and software, and interfacing of various sensors and ac-tuators. The Practicum provides a venue for designing, building and testing a medical device. In addition, seminar topics include physician led discussion of design opportunities, con-ceiving and vetting a concept, regulatory matters, ethics and responsible conduct of re-search, intellectual property, entrepreneurship, and other pathways to commercialization. The content of this course has come from recommendations from our medical device industry advisors and student feedback.

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

Assessment of learning will be accomplished by grading of a team project.

- Can locate and critically evaluate information

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.

This course utilizes a number of resources, including the Earl E. Bakken Medical De-vices Center, Anderson Student Labs and ME Student Machine Shop. In addition, students will interact with engineers, physicians and with students from oth-er departments. The use of team conference rooms assists in the process of accessing relevant information, discussion, and assistance in critically evaluating new ideas.

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

Assessment of learning will be accomplished by grading of a team project.

- Have mastered a body of knowledge and a mode of inquiry

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.

The Practicum serves as a prelude to senior design, a two semester course in which student teams are provided a clinical experience, and have both an industry and clinical advisor assigned to them. Therein, emphasis is on deliverables, vetting a concept, forming a needs statement, building a prototype, and presenting their work in a show-case environment. By virtue of mastering the topics of this course, students will more effectively partici-pate in senior design, be more competitive when making applications for internships, and ultimately will be more desirable in the job market. This course will also stimulate the subset of students inclined to full-time employment in the medical device industry.

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

Assessment of learning will be accomplished by grading of a team project and its presentation.

Liberal Education

Requirement this course fulfills:
<no text provided>
Other requirement this course fulfills:
<no text provided>
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.

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.

LE Recertification-Reflection Statement (for LE courses being re-certified only):
<No text provided>
Statement of Certification:
This course is certified for a Core (blank) as of
This course is certified for a Theme (blank) as of

Writing Intensive

Propose this course as Writing Intensive curriculum:
No
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? Also, describe where in the syllabus there are statements about the critical role writing plays in the course.

<No text provided>
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 2,500 minimum word count (or its equivalent) for finished writing will be met.

<No text provided>
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.

<No text provided>
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.

<No text provided>
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?

<No text provided>
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.

<No text provided>
Statement of Certification:
This course is certified for a Theme (blank) as of

Course Syllabus

Course Syllabus:
BMEn 3151 "Medical Device Practicum" Department of Biomedical Engineering, University of Minnesota Syllabus - May Session 2018 Instructor: Prof. Steven Saliterman Website: http://saliterman.umn.edu/ Office: Department of Biomedical Engineering University of Minnesota Nils Hasselmo Hall Suite 7-105 312 Church Street S.E. Minneapolis, MN 55455-0215 Tel (eve.): 952-935-2771 Cell: 612-910-8771 E-mail: drsteve@umn.edu Office Hours: Email me Location: Medical Devices Center TA: TBD Office Hours: TBD Location: TBD Phone: TBD E-mail: TBD Overview: This course allows students to use the skills they learned in BMEN 2151 "Introductory Medical Device Prototyping" for making an actual medical device prototype. Weekly seminars introduce advanced medical device topics that will be fundamental to senior design. The class size will be 21 students. Schedule: Seminars are in the Earl Bakken Medical Devices Center?s ?Brainstorming Room.? The Anderson Student Innovation Labs and ME Student Machine Shop will also be used for independent projects. ?May Session? runs from 5/21 to 6/8/2018. Mondays 9:30 ? 10:30 a.m. Wednesdays 9:30 ? 11:30 a.m. Fridays 9:30 ? 11:30 a.m. Credits: 1 Prerequisites: BMEN 2151 ?Introductory Medical Device Prototyping? Course Goals and Objectives Students will become acquainted with the following topics: Design opportunities in medicine, conceiving and vetting a medical device, FDA regulations & guidance, intellectual property, commercialization ? licensing and entrepreneurship, and building a medical device prototype Required Books: None Required Software (Windows computer required ? software does not run on an Apple): Arduino (free download) SolidWorks (free from the University ? download as soon as you register for the class) Multisim and Ultiboard (free student evaluation period, then $39.95 to purchase) Reference Books: (Most are available on reserve from Prof. Saliterman in the EBMDC) Design, Quality, Testing & Validation: Gad, S. Biomaterials, Medical Devices, and Combination Products, CRC Press (2015) Geckler, V. Design Controls, Risk Management & Process Validation for Medical Device Profes- sionals, Wasatch Consulting Resources LLC; 1st edition (2017) King, P.H., Design of Biomedical Devices and Systems, Third Edition (2014) Kucklick, T.R., The Medical Device R&D Handbook, Second Edition (2012) Rodriguez-Perez, J. Quality Risk Management in the FDA-Regulated Industry, Quality Press; 2nd ed. (2017) Yock, P., Biodesign, 2nd ed. (2015) Intellectual Property & Law: Kane, S.D., Trademark Law ? A Practitioner?s Guide, Practicing law Institute (2005). Mehta, S.S., Commercializing Successful Biomedical Technologies, Cambridge University Press, New York (2008). Poltorak, A. and P. J. Lerner, Essentials of Intellectual Property, Wiley, New York, (2002). Razgaitus, R., Valuation and Pricing of Technology-Based Intellectual Property, Wiley, New Jer- sey (2003). Stim, R., Patent, Copyright & Trademark, 8th ed., Nolo (2006). Wellons, H.B. and E.S. Ewing, Biotechnology and the Law, ABA Publishing, (2007). Examinations: None Homework: Additional time and activities may be required depending on the nature and complexity of the project chosen. Class Time: About 20% lecture, 20% discussion and 60% independent project time. Grading Participation 20% Presentation 20% Project 60% If you are having difficulties with the material please let Prof. Saliterman or the TA know. We will meet with you and set up whatever is necessary for you to improve. Course Conflicts: Please notify Prof. Saliterman if you have a course or final examination conflict. University Policies Administrative Policy for Legitimate Absences Students may be absent absence during the semester due to unavoidable or legitimate circumstances. Such circumstances include illness of the student or his or her dependent, participation in intercollegiate athletic events. For other University of Minnesota policies regarding absences and makeup work, please see: http://policy.umn.edu/Policies/Education/Education/MAKEUPWORK.html Board of Regents Policy on Academic Freedom Please read this important information on the University of Minnesota?s Board of Regents Policy on Academic Freedom and Responsibility http://regents.umn.edu/sites/default/files/policies/Academic_Freedom.pdf Board of Regents and Administrative Policy on Conduct, Teaching, and Learning Please familiarize yourself with the Student Conduct Code and Administrative Policy on Teaching and Learning: http://policy.umn.edu/Policies/Education/Education/STUDENTRESP.html http://regents.umn.edu/sites/default/files/policies/Student_Conduct_Code.pdf Board of Regents Policy on Equity, Diversity, Equal Employment Opportunity, and Affirmative Action Please see this important information on the University of Minnesota?s Board of Regents Policy on Equity, Diversity, Equal Employment Opportunity, and Affirmative Action: http://regents.umn.edu/sites/default/files/policies/Equity_Diversity_EO_AA.pdf Board of Regents Policy on Sexual Harassment Please see this important information on the University of Minnesota?s Policy on Sexual Harass- ment: http://regents.umn.edu/sites/default/files/policies/SexHarassment.pdf Disability The University of Minnesota is committed to providing equitable access to learning opportunities for all students. Disability Services (DS) is the campus office that collaborates with students who have disabilities to provide and/or arrange reasonable accommodations. If you have, or think you may have, a disability (e.g., mental health, attentional, learning, chronic health, sensory, or physical), please contact DS at 612-626-1333 to arrange a confidential discussion regarding equitable access and reasonable accommodations. If you are registered with DS and have a current letter requesting reasonable accommodations, I encourage you to contact me early in the semester to review how the accommodations will be applied in the course. Grade Definitions The University of Minnesota?s ?Grading and Transcripts? policy can be reviewed here: http://policy.umn.edu/Policies/Education/Education/GRADINGTRANSCRIPTS.html Mental Health and Stress Management Services As a student you may experience a range of issues that can cause barriers to learning, such as strained relationships, increased anxiety, alcohol/drug problems, feeling down, difficulty concentrating, and/or lack of motivation. These mental health concerns or stressful events may lead to diminished academic performance or reduce your ability to participate in daily activities. University of Minnesota services are available to assist you with addressing these and other concerns you may be experiencing. You can learn more about the broad range of confidential mental health services available on campus via www.mentalhealth.umn.edu. Please visit http://mentalhealth.umn.edu/ for several resources for students, their parents, faculty, and staff. Student Conduct Code The University of Minnesota?s Student Conduct Code can be reviewed here: http://regents.umn.edu/sites/default/files/policies/Student_Conduct_Code.pdf

Strategic Objectives & Consultation

Name of Department Chair Approver:
Robert Tranquillo
Strategic Objectives - Curricular Objectives:

How does adding this course improve the overall curricular objectives of the unit?

This course allows students to use the skills they learned in BMEN 2151 ?Introductory Medical Device Prototyping? for making an actual medical device prototype. Weekly seminars also introduce advanced medical device topics that will be fundamental to senior design.
Strategic Objectives - Core Curriculum:

Does the unit consider this course to be part of its core curriculum?

No
Strategic Objectives - Consultation with Other Units:

Before submitting a new course proposal in ECAS, circulate the proposed syllabus to department chairs in relevant units and copy affiliated associate dean(s). Consultation prevents course overlap and informs other departments of new course offerings. If you determine that consultation with units in external college(s) is unnecessary, include a description of the steps taken to reach that conclusion (e.g., catalog key word search, conversation with collegiate curriculum committee, knowledge of current curriculum in related units, etc.). Include documentation of all consultation here, to be referenced during CCC review. If email correspondence is too long to fit in the space provided, paraphrase it here and send the full transcript to the CCC staff person. Please also send a Word or PDF version of the proposed syllabus to the CCC staff person.

We have reached out to both the ECE and ME departments to obtain feedback from them which we hope to have available for the CC meeting on Friday. In the meantime, below you will find the feedback we received for BMEn 2151, the prerequisite to this course. Because BMEn 3151 is a continuation of BMEn 2151, we feel that this feedback could suffice. Summary of consultation with Barry Kudrowitz, Assistant Professor, College of Design: Prof. Kudrowitz indicates that his college offers two product design courses, PDES 3704 Innovative Computer Modeling and PDES 3706 Designing for Manufacture, that have some overlap with a few of the topics covered in BMEn 2151, but the overlap is minimal enough that he is supportive of the proposed course. Summary of consultation with Thomas Smith, Research Associate and Course Instructor, School of Kinesiology: Prof. Smith teaches a human factors/ergonomics class and a human-centered design class, both offered through Kinesiology. He confirmed that the proposed course does not overlap with either of these courses. Full text of the correspondence with these faculty will be available upon request from bmedus@umn.edu if necessary - it far exceeded the character limit for this field.