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Text: “Biodesign: the process of innovating medical technologies” By Stefanos A. Zenios, Josh Makower, Paul G. Yock

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BIOE 450W: Bioengineering Senior Design

Spring 2012

Faculty Supervisor: Maggie Slattery, Ph.D. Assistant Professor of Bioengineering 206B Hallowell Bldg. University Park PA 16802

Class Meeting Times and Location: 210 Hallowell Bldg. Tuesdays: 11:15-2:15 pm Thursdays: 1:00-2:15 pm Office Hours: Monday: 1:00 –2:00 pm Wednesday: 1:30 –3:00 pm or by appointment

[email protected] 814.865.8092 Web site for general project resources and information:

http://www.lf.psu.edu/students and ANGEL

Course Objectives: For preparation for the transition to industry, this capstone course prepares students to work together as a team and effectively communicate engineering information. This course utilizes the student's knowledge in medicine and engineering which the student has accumulated to this point. Students develop teamwork, communication and leadership skills. The course begins with the students identifying a medical device or procedure which can be improved utilizing their engineering skills. A proposal is prepared and presented for design review. Students meet with the instructor on a regular basis for progress assessment. Notebooks are carefully maintained and critiqued. At the end of the semester, students demonstrate their project in a formal presentation and prepare a written report for the class and the sponsor. Upon completion of this course, you should be able to:  Complete a design project that is interdisciplinary in nature, integrating the knowledge obtained in previous engineering classes  Communicate your project results, both in written report format and in oral presentation format  Develop budgets, schedules and deadlines  Maintain accurate engineering records  Understand the role of engineering in society, and the complexity of ethical issues Prerequisites for BIOE 450W: BIOE 403, BIOE 440, ENGL 202C Students in other majors who have been moved into BIOE 450W to complete your capstone project must meet the prerequisites as designated by your appropriate capstone course. ABET Outcomes met and documented in this course are:  An ability to design a system, component, or process to meet desired needs within realistic constraints such as economic, environmental, social, political, ethical, health and safety, manufacturability, and sustainability (Outcome 3)  An ability to function on multi-disciplinary teams. (Outcome 4)  An understanding of professional and ethical responsibility. (Outcome 6)  An ability to communicate effectively. (Outcome 7)  An ability to use the techniques, skills, and modern engineering tools necessary for engineering practice. (Outcome 11) Text: “Biodesign: the process of innovating medical technologies” By Stefanos A. Zenios, Josh Makower, Paul G. Yock Cambridge University Press (2009) - ISBN 0521517427 Grading: Your final grade will be based on the following individual and team components as well as individual writing grades. Keep in mind, your sponsor assigns a portion of your grade so it is essential you keep him/her happy. The Professor will not intervene if your sponsor is dissatisfied with your communication, progress reports, deliverables, testing and evaluation, drawings, etc. Oral presentations (6% & 6%) (team and individual portions) Written progress reports and Lab Notebook (team) In class and homework assignments (team and individual) Project Proposal/Statement of work report (team with individual writing) Design Specification Report (team with individual writing) Final Project Report (team with individual writing) Poster (team) Project Recap and Sponsor Report (team) Self-Assessment (team) Composite Writing Score (individual from SOW and DSR) Professionalism (individual and team) Peer Evaluations (3% and 7%, individual) Prototype evaluation (team) TOTAL

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12% 08% 05% 15% 12% 10% 05% 04% 02% 09% 03% 10% 05% 100%

BIOE 450W: Bioengineering Senior Design

Spring 2012

Course Policies: 

Academic Integrity: Students are expected to abide by the University and College of Engineering’s Academic Integrity policy. In this course, students are expected to work together with their team on most assignments including progress reports, written reports, and oral presentations. There are some assignments which are to be done individually, i.e., each student is required to submit his or her own original work. If you have any questions as to which assignments are to be done individually, please ask. Regardless of the nature of the assignment, plagiarism is strictly prohibited. An example of behavior that is considered plagiarism is submitting a written assignment that includes text taken directly from another source and/or text that is not properly referenced. If you have any questions as to how to properly reference material taken from another source, please ask. Senate Policy 49-20 Academic Integrity, http://www.psu.edu/ufs/policies/47-00.html#49-20 Definition and expectations: Academic integrity is the pursuit of scholarly activity in an open, honest and responsible manner. Academic integrity is a basic guiding principle for all academic activity at The Pennsylvania State University, and all members of the University community are expected to act in accordance with this principle. Consistent with this expectation, the University's Code of Conduct states that all students should act with personal integrity, respect other students' dignity, rights and property, and help create and maintain an environment in which all can succeed through the fruits of their efforts. Academic integrity includes a commitment not to engage in or tolerate acts of falsification, misrepresentation or deception. Such acts of dishonesty violate the fundamental ethical principles of the University community and compromise the worth of work completed by others. The Penn State Principles: http://www.psu.edu/ur/2001/principles.html 1. 2. 3. 4.

I will respect the dignity of all individuals within the Penn State community; I will practice academic integrity; I will demonstrate social and personal responsibility; I will be responsible for my own academic progress and agree to comply with all University policies.

Code of Conduct, http://studentaffairs.psu.edu/judicial/codeofconduct/ 

Deadlines: All reports and materials are due at the start of the class period as shown in the schedule below. Late submissions will NOT be accepted.



Grading Disputes: If a student feels that a report or homework set was graded unfairly or in error, please bring it to the instructor’s attention in writing within one week after the graded material was handed back. Scores will not be reconsidered after this time period has elapsed.



Attendance: Attendance is required at the start of each class or assigned meeting time. As a professional courtesy, please inform the instructor and your teammates prior to any anticipated legitimate absences. Two absences without a reasonable excuse is one letter grade (B to B-) reduction. All absences (including interviews –corporate, med school, or grad school) must be previously cleared with all team members and the instructor. Absence from oral presentations and/or when intensive teamwork is necessary is not permitted, so plan accordingly. See also the Faculty Senate Policy on Class Attendance (42-27; http://www.senate.psu.edu/policies/42-00.html#42-27).



Cell Phones: Turn cell phones off upon entering classroom. Texting during meetings or class is NOT acceptable.

Additional Course Requirements and Information: 

Writing Intensive course: All assignments will be graded both for quality of content as well as quality of writing. For team writing assignments such as the SOW and DSR, an additional page detailing which portions of the writing quality should be assigned to which student must be included. All students MUST contribute equally to writing and insufficient writing contributions will negatively impact your grade.

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BIOE 450W: Bioengineering Senior Design

Spring 2012



Project Notebook: One team member is responsible for organizing and maintaining a project notebook throughout the semester although the entire team shares the final grade. This notebook should be a Standard Laboratory Notebook (Lab notebook, log book, record) with numbered pages to keep track of chronological events. This permanently bound working journal will be kept with drawings, concepts, ideas, & anything discussed regarding the project with dates & initials of those present. Team information such as design sketches, hand-written meeting minutes and other similar information should be directly entered into this bound Standard Laboratory Notebook. Information typed on full-sheets should be taped directly into the lab notebook. Chronology information must include a date & time for every page; all meetings should include attendance. All communication should be documented and action items listed – especially from phone meetings which don’t have an alternate paper trail. Nevertheless some information is too difficult to paste into a laboratory notebook. This information may include two-side technical data sheets, journal papers, bills & receipts, raw testing data, computer disks, or other multi-page documentation. For these types of records you should write a reference in your Laboratory Notebook so then it can be dated and stored in the three-ring binder. The purpose of the binder is to augment information storage but not replace the purpose of the Lab Notebook. This information is also given to the sponsor so it should be clear and legible. The project notebook is a working legal document; so, neatness is not important though it must be legible and dated. The notebook may be reviewed each staff meeting.



Progress Reports: Each team must submit a weekly progress/status report, including Gantt chart with milestones, to both the project sponsor (via FAX or email) and to the instructor via ANGEL. A summary of the team’s progress and a weekly “Things-To-Do (TTD)” list with expected completion dates and responsibilities relevant to the project must be included. The TTD list will be discussed each Tuesday during the staff meetings. This list is usually a bulleted list or spreadsheet and is about one page in length. It describes the team’s accomplishments and what is planned in the immediate future. Bring a paper copy of your progress report for the instructor to review on Tuesdays. Be honest about who was in attendance, your assessment of the team’s progress, and of only what-is-fully done with no "almost complete". If it is not 100% complete then you cannot report the task as finished. There is no gray scale here. Be aware that minor delays in the beginning cause major problems at the end. It is a report to your sponsor, so make it easy to understand and extraneous information. A sample Progress Report is available to review on ANGEL. All progress reports will be graded on content, progress and quality of writing.



Labor Division: After the teams have formed, members will prepare a document showing division of labor and ground rules. This will be documented in your notebook. Effective teamwork is essential in this class. Remember that "Everyone is busy" and no person is busier than anyone else.



Resources: The Learning Factory (LF) and the basement of Hallowell have machine shops for construction. Ensure that you are certified to operate equipment in the LF prior to starting. Specialized training in machining and welding is available; see http://www.lf.psu.edu/facilities/Safety.html. Do not miss out on this wonderful opportunity even if your project does not require machining. PCs at the LF computer studio have Microsoft Project for Gantt Charts. Solidworks® for solid modeling and shop drawings can also be accessed in 315 Hammond Sunday through Wednesday evenings from 7:00PM-11:00PM. Some space, such as a large drawer for project storage, is available in 105 Hallowell (the instrumentation lab). To use the lathe or mill in the Hallowell shop you need to pass Machining I & II training classes. Additionally, the computer lab (112 Hallowell) is always available for your use.



Literature/Patent Search: This provides you with background information and a summary of what has been previously done on the topic. The engineering library is a good place to start the literature survey, while the patent search can be quickly done in the patent room in Davey Lab or the various free online sites that access USPTO, http://www.libraries.psu.edu/psul/researchguides/matbytype/patents.html . Google and USPTO offer a free patent web site at Google Patents http://www.google.com/patents. It is suggested that you first use the tutorial online at http://www.libraries.psu.edu/psul/pams/patent.html, as this tutorial will expedite your searches. The library has paper copies and discs covering patents for the last century. Note that finding patents prior to 1976 will involve a bit more work than more recent patents. Please do not think that simply searching various web sites is sufficient.



Project Proposal/Statement of Work (SOW) Report: This report is a selling document and not a highly technical document. It should include an executive summary, problem statement, literature review/patent searches, 3

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BIOE 450W: Bioengineering Senior Design

Spring 2012

project objectives, preliminary design concepts with 3 or more alternatives, budget estimates, Gantt charts, citations etc. See the course website on Angel for a template and details. You will be graded on the Title Page, Table of Contents, Executive Summary, Problem Statement, Technical Approach, Project Management, Deliverables, Budget, Communication with Sponsor, Resumes, and References. The SOW, DSR, and Final Report will also have a paragraph addressing how environmental and ethical standards were followed from the start of the project. First or third person is acceptable for the reports; however, avoid beginning paragraphs or sections with the first person (Not “We varied fluid flow rates to test the design,” but “To test the design, we varied fluid flow rates”). 

Design Specifications Report (DSR): This report should include executive summary, problem statement, quantitative design specifications, justification with concept selection matrix, engineering drawings, analysis, manufacturing process plan, evaluative test procedures, remaining work to do, updated Gantt chart, budget report, references, and appendix. See Angel site for template and details.



Oral Presentations: Presentations will be judged by the instructor and by the students on preparation, visual aids, stage presence, and overall effectiveness. Each presentation will be about 20-25 minutes including class discussion and reflection. Time allotted may vary depending upon groupings and number of groups.



Final Report: This report should include information from the DSR along with updated solid models, updated shop drawings, photographs of prototype(s), test results, final economic results, construction details, manufacturing considerations and improvements, conclusions and recommendations. See Angel site for template and details. The final report must also have an Appendix which specifically addresses how ABET outcomes #3, 4, 6, 7 and 11 were fulfilled in their project.



Self Assessment: Your end product or process will be evaluated on how effectively it satisfied all of the customer needs and design criteria. Additionally, your work should demonstrate an appreciation of any possible global and societal, safety or sustainability implications. You will be asked to rate your team on a scale of 1 to 10 in the Appendix of the Final Report on these topics. An accompanying paragraph is necessary for justification.



Homework: Homework assignments are due at the beginning of class on the assignment due date. Homework turned in after the due date will be deducted 15 points for every day it is late. Weekends count as late days! Homework can be turned in after one week (7 days) for corrections, but it will count as a zero.



Professionalism and Communication: You should conduct yourself with high professional standards and have ethical and respectful social interactions with the sponsor, team members, LF personnel and instructor. Hence, being a team player, acceptance of responsibility, and respect for others will be graded. Each absence at any out-of-class team meeting or a LF training class will be a loss of a third the professionalism grade. The sponsor evaluation at the end of the semester will also be part of this grade. Make sure that all team members meet when planned. Communication is a part of professionalism and you must stay in contact with your sponsor. Email is not the only form of communication. There is the telephone and appointments. Do not expect your sponsor to respond to repeated emails. You may leave phone messages, but you must follow up and keep trying until YOU reach your sponsor. It is not their job to find you.



Poster Presentation: There will be one poster presentation at the project showcase at the end of the semester. Use the Engineering Copy Center in the Engineering Units Building and let them know which senior design section you are in. Ensure that the text is large and uncluttered. The title, figures, text, names, and conclusions should be able to be read by someone standing 4 ft. away. Dark backgrounds are not recommended. The best two posters and prototypes in our section will be voted upon by the students. Remember to budget the cost of printing your poster. It will be approximately $60.



Project Recap and Summary for Funding Organization: The project recap is a one-page executive summary of the project that provides an overview, list of objectives, and a summary of the approach and project outcomes. One or two pictures should also be included to highlight the prototype, test results, etc. from your project. A template will be provided on ANGEL. If you signed an IP form, confidentiality may be an issue, so the sponsor should approve the Project Recap prior to submission. If your project was funded by a grant (NSF) you must also submit a 2 page summary prior to the end of the semester. List of required content and information to include in the report will be posted on ANGEL.

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BIOE 450W: Bioengineering Senior Design

Spring 2012



Safety: Start the Learning Factory training class within the first month of the semester, preferably as soon as possible. Be advised that things always take longer than expected especially if testing or machining is involved; so, please do not rush a job and cause an accident. Also never believe the results of computer simulation unless some other verification method is employed such as experimentation or back-of-the-envelope calculation.



Prototype: Working hardware is expected and will be evaluated for technical content, customer satisfaction, and intangibles.



Reimbursement: The total budget, including travel expenses, is $1000 per project with a $50/vendor/day limit. Anything over $50 requires Cindy Winkelblech to place the order. It is mandatory to have the original receipts initialed by the instructor prior to submission for reimbursement. Purchase requests should include: your name, local address, email address, team name, and sponsor name. It is highly recommended that you work with Cindy Winkelblech in 314 Leonhard Building to use the Penn State purchasing card, as it is the fastest method and least amount of paperwork for you and her. Petty cash of up to $50 can be attained weekly. If you have multiple petty cash receipts that total more than $75 for a given week, your reimbursement will be issued via check and take about two weeks to process. Meals, taxi in State College, and clothing will not be reimbursed. Postage will not be reimbursed; Cindy will mail things for you. The Bioengineering library (204 Hallowell) can also be reserved for any incoming or outgoing conference calls (see Doretta or Carol – 206 Hallowell for a reservation). PicTel conferences with the Penn State Hershey campus can also be easily arranged.

Instructor’s and Student’s Roles: The instructor is there to assist you in locating information and act as a coach and consultant on technical issues, but will not tell you which option to use in your final design. The design problems specified by your sponsor are just the tip of the iceberg. It is your responsibility to further define the problem by discussing it with your sponsor. Excellent student teamwork and communication are essential in this class!

Deliverables to the Learning Factory Office (314 Leonhard Bldg.): These requirements must be met before final funds are reimbursed. 

Intellectual Property and/or Non-Disclosure Agreement forms (if applicable with sponsored project)



A one-page Project Recap (DOC & PDF) that includes 1-2 photos/images from the project.



NSF Summary Report (format posted on ANGEL) (depending on project sponsor)



Final poster – mandatory size: 32”x40” foam board, portrait oriented. Posters from previous semesters are on display on in 105 Hallowell.



Copy of poster in PowerPoint® (PPT) & PDF formats, plus copies of SOW, DSR & Final Reports in uncompressed PDF format. Submit to the Learning Factory office on a CD the first day of finals week.

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BIOE 450W: Bioengineering Senior Design

Week

Date

1

Tue 1/10

Complete team Questionnaire in class Read project list at: http://www.lf.psu.edu/Instructors/PROJECTS.pdf Submit Project Application Form by 3:00PM;

Tue 1/17

Add/Drop Forms Team Organization and Pictures Assign Tuesday Staff Meeting times

Thu 1/19

Sign IP and NDA agreements in class Preparation for site visit Assign Statement of Work (SOW)

Team Organization/Site visit assignment (in class) READ Stage 1 (Biodesign) READ Stage 4.1 (Biodesign) IP and Confidentiality Forms to LF office (in class) READ Connecting Students with Persons with Disabilities (on ANGEL)

Tue 1/24

Site visit with sponsor if possible Staff Meetings (by appointment if no site visit)

Weekly Status Report 1 including Personal Introduction for each team member uploaded to ANGEL folder.

Thu 1/26

Global Design Process (location TBD)

LF safety training for those not already certified

Tue 1/31

Staff Meetings (according to assigned schedule)

Thu 2/2

Medical Device Regulation

Weekly Status Report 2 Team Contract due READ Stage 3 (Biodesign) Deliverables agreement to instructor for review READ Stage 4.2 (Biodesign)

Tue 2/7

Staff Meetings

Thu 2/9

Medical Research Ethics

Tue 2/14

SOW team presentations – all students must attend the entire class SOW team presentations – all students must attend the entire class

Weekly Status Report 4 SOW presentations

Tue 2/21

Staff Meetings

Thu 2/23

Intellectual Property and Patents (Rick Weyer, guest speaker)

Weekly Status Report 5 READ Taxol and other IP articles (on ANGEL) Submit revised SOW to sponsor and instructor

Tue 2/28

Staff Meetings

Weekly Status Report 6

Thu 3/1

Writing Critique Workshop

Writing Critique Assignment (in class)

1:00- 3:00 No regular class

3

4

5

6

Thu 2/16

7

8

Course Schedule and Assignments (Note: Items on the schedule are subject to change) Topic Deliverables Course Introduction and Requirements Tips for Students Overview of projects and Questionnaire Project Kickoff Q&A with project sponsors in HUB Alumni Hall Ballroom BUSINESS CASUAL DRESS REQUIRED

Thu 1/12

2

Spring 2012

Weekly Status Report 3 ISO Assignment Due (individual) Team Checkup SOW Due to instructor READ Chapters 2 and 3 Ethics for Bioengineers (ANGEL) Deliverables agreement to LF office

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BIOE 450W: Bioengineering Senior Design

Spring 2012

Tue 3/6 Thu 3/8

No Class – Spring Break No Class – Spring Break

Tue 3/13

No Class – work on DSR

Thu 3/15

Staff Meetings (alternate schedule will be set)

10

Tue 3/20 Thu 3/22

Staff Meetings Engineering Ethics

Weekly Status Report 8

11

Tue 3/27

Staff Meetings

Thu 3/29

Consultation or TBD

Weekly Status Report 9 Submit DSR to sponsor Ethics Assignment Due

12

Tue 4/3 Thu 4/5

Staff Meetings Presentation of First Prototype

Weekly Status Report 10 First Prototype due

13

Tue 4/10 Thu 4/12

Staff Meetings Consultation

Weekly Status Report 11

14

Tue 4/17

Staff Meetings

Weekly Status Report 12 Submit poster file to Engineering Copy Center

Thu 4/19

Final Report Workshop

Tue 4/24

Final Project Presentations - in the evening 5:45pm – 9:45pm 108 Wartik Lab ATTENDANCE IS MANDATORY COE Design Showcase BJC 11:00A – 12:00P setup 12:00P – 1:00P safety inspection 1:00P – 3:30P judging

Final Presentations Peer Evaluation

Final Reports Due 4:00 pm

Final Report, Project Recap, Funding Organization summary, Poster File on CD, Project Notebook

9

15

Mon 4/23 Thu 4/26

Finals Week

Mon 4/30

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Weekly Status Report 7 Peer Evaluation 2 Submit DSR to instructor by 5pm 3/16

Poster and prototype on display at Showcase Dinner at South Annex Gym (RSVP required) 5:30-8:30PM

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