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BME 180/CBEMS 189: Spring Quarter Report

Due: Monday June 8th at 5 pm.

Upload to EEE dropbox.
For every 24 hours of late submission: 10% deduction from overall grade
Each team must submit a Spring Quarter Report to the class dropbox on EEE. Please write this
report such that a technically skilled reader not familiar with your project would be able to
understand the importance, design and function of your device. This report is made to stand on its
own as a permanent record of your collaborative efforts. The report will be similar to a design
project report in a real medical device company run under FDA regulations. Do not blindly cut and
paste sections of text from prior reports into this report unedited. Please focus your writing on the
process of developing your device and the end product. Discuss all of your design concepts and
justify why you chose to build your final design concept.
Group Report Total: 540pts
Individual Team Member Contribution: 50 pts
Report Formatting (20 pts)
1. Title page with a descriptive project title (i.e. not BME 180 report) and team member
2. Pages are numbered.
3. Table of contents.
4. Figures, graphs and images are numbered with a description.
5. Report is written in the third person.
6. Data presented in a logical order.

Executive Summary (30 pts)

In less than 1 page, provide a summary of your entire project. The executive summary goes at the
beginning of your report after the table of contents. This is similar to your 1 minute elevator pitch
in that if you were to hand this report to someone like an investor or research director, they would
understand the importance of your project and how your device works.

What problem are you addressing?

Why does the problem need to be addressed?
How does your device address the problem?
What makes your device novel?
How does your device work?
Why does your group feel people/companies should adopt this device?

Introduction (30 pts)


What problem are you addressing?

Why does this problem need to be addressed?
What is the current state-of-the-art for addressing your problem?
Why does it need to be improved?
How is your design an improvement? Include a market study for the current state-of-theart.
6. How do you plan on addressing the problem?

Initial Design Phase and Design Controls Regulation (70 pts)

1. Your groups proposed design. How does it work?

2. How does it address the problem? Why is it novel? Directly compare your design to current
state-of-the-art. Be sure to include any solid models, concept sketches and images.
3. What FDA class does your design fall under? Why?
4. Given the FDA class of your design, what documentation and procedures are needed to get
your design approved by the FDA?
5. What were the design criteria (ie. weight, portability, cost, accuracy, etc) and acceptance
criteria (how close does your design need to be to your design criteria to pass) for your
6. What were the software requirements for your device (if applicable)?
7. Provide your estimated project timeline.
8. Provide your estimated budget.
Project Team (Individual Team Member Contribution - 50 pts/team member)
Describe your team structure (ie. team leader, technical lead, software integration, manufacturing
lead, fabrication team member, etc) and major tasks performed (user software interface, circuit
design, part manufacturing, etc) by each team member during the course of your project.

In addition to the information provided above, each team member must provide individual
information regarding their contribution to the project. The above information is a top level
description of the major activities of each group member. This can be presented in a brief
description with a table. After the top level description, each team member will individually write
a section that contains the items below. Individual sections will follow the top level description.
1. Team member name
2. Major task assigned (for example: control system)
3. How was the major task divided into subtasks (ie: solid modeling, machining, materials
selection, circuit design, etc)?
4. How did the design requirements influence each subtask (ie. Overall device must not be
larger than 6 inches in any one direction and thus the electrical board could not exceed the
defined dimensions)?

5. How does your major task integrate into the overall design (ie. control system regulates
pressure from 0 psi to 200 psi with an accuracy of 0.1 psi)?
6. How does your major task influence the overall design (ie. control system power
requirements meant a larger battery was required which increased the overall weight of the
final design)?

Detailed Design Phase (75 pts)

1. A description of how your final design works with figures and illustrations detailing the
important parts and features of your design.
2. Why did your group select the current design versus the initial proposed design outlined in
the initial design phase?
3. If a software interface was needed for your design, how does it work?
4. If your design is part of an already existing commercial device (i.e. your device needs a
pump or power supply to operate), describe how your device integrates itself into the
current existing device. Provide documentation and specifications (i.e. data sheet) on
existing commercial devices integrated into your design.
5. What was the cost of your final design? How did it differ from the initial estimate?
6. What was the design timeline for your final design? How did it differ from the initial

Manufacturing Documentation (40 pts)

1. A bill of materials (BOM) table that includes a parts list, vendor information and associated
costs. Note any equipment that was borrowed and used in your design.
2. Describe all subassemblies. How were each manufactured? Provide drawings and build
3. Describe all higher level parts of the final design. How were higher level parts
manufactured? Provide drawings and build procedures.
4. How were subassemblies integrated into higher level parts?
5. Can your final design be readily manufactured on a large scale? If so, why? If not, what
changes do you have to make to the design to manufacture your device on a large scale?

Materials Validation (50 pts)

1. What material properties were important for your design?

2. Why did you select the materials used in your design? You must justify your selection. If a
substitute material was used due to cost limitations, you must discuss why the surrogate
material was selected and how it compares to the optimal material not used in the design.
3. What tests were conducted to validate that the materials selected are appropriate? If
material testing was not necessary, provide detailed materials specifications, properties and
data to support your materials selection.
4. If applicable, explain the details of each test and the experimental setup. How were the tests
conducted? How did your group determine variables such as duration of test, applicable
loads, temperatures, environmental conditions, etc?

5. What were the acceptance criteria for the selected materials?

6. By what margin do your materials meet the accepted criteria?

Design Validation (75 pts)

1. What were the design criteria for your prototype design?

2. Which components (i.e. hardware and/or software) needed to be validated?
3. What tests were conducted to validate that your design (hardware and/or software) meets
the design criteria?
4. Explain the details of each test and the experimental setup. How were the tests conducted?
How did your group determine variables such as duration of test, applicable loads,
pressures, voltages, etc?
5. Does the current design meet the design criteria? What parts of the design function as
intended? What parts of the design do not meet the design criteria? Your group must
present validation test data to address this question. Presented data must be accompanied
with a detailed discussion.

Failure Mode and Effect Analysis (FMEA) (30 pts)


What are the possible failure modes for your device?

What are the potential failure causes?
What are the consequences and severity of each identified failure mode?
How did your group address the potential failure modes?
If potential failure modes could not be completely addressed in your final design, what
recommendations would your group implement to mitigate the potential failure modes?
6. What failure modes remain unaddressed? Why? What impact do they have on the overall
function and lifetime of your device?

Lessons Learned Documentation (30 pts)

Lessons learned documentation is used in industry to (1) highlight major issues that were
encountered during any stage of the project, (2) provide a reason for the issue, (3) the solution that
addressed the problem and (4) give a final recommendation on how to avoid these issues in the
future. An example is given below:
Example 1: Gas was found to have leaked into the vacuum reference cavity of the designed pressure
sensor. The loss of vacuum reference lead to erroneous pressure readings due to the loss of a
calibrated reference pressure. It was found that carbon dioxide from atmospheric gases diffused
through the fluorosilicone polymer used to hermetically seal the reference cavity. To address the
issue, the cavity was hermetically sealed using a metallic fitting. It is recommended that any future
hermetic sealing make use of metallic fittings. If a polymer is absolutely required, it must be
subjected to permeability testing prior to use.
1. Identify the major issues that your group experienced and create a lessoned learned for

User Documentation and Training (20 pts)

1. User hardware interface training manual.
2. User software interface manual.
3. How is the device to be used by the user?

Functional Trials (30 pts)

1. Demonstrate the functionality of your final design with data, trial runs and images of your
2. Does your device function exactly as intended? If it does not, identify the issues.

Future Goals (20 pts)

1. If you were given unlimited resources, a $1 million R&D budget and another year to work
on your project, how would your design differ from your current design?

Works Cited (20 pts)

Cite all references using either CSE or IEEE citation style formatting.