BME 498Y: Biomedical Engineering Capstone Design Fall 2020 & Winter 2021

Guidelines for Project Requirements

Overview
This project requirements document has two main goals:
1) Draft a clear needs statement that includes a problem, population, and outcome
2) List the criteria and constraints of your design project

A good understanding of your design requirements takes time to develop and involves the entire team, the
supervisor, and your potential clinical partners. In practice, this process can take much longer than the
timespan given to your team to complete this task and therefore you should continually update the
requirements as you progress. The major reason for producing this document now is to allow your team to
receive feedback and improve/iterate your project requirements before the project proposal is due at the
end of the fall term. A popular misconception is that ‘all this writing’ takes one away from the ‘real’
design. In truth, producing this document will force you to work on your ‘real’ design all along, only at
the most abstract, system level which is quite new and unfamiliar for most students and new engineers.
Get as much help as you can from your project supervisor in team meetings, the course coordinator, and
the clinical partners you have observed or interviewed. It may be helpful to think of your team as a
consulting firm with your interview subjects as the ‘experts’ who have a good understanding of the
problem.

Formatting
• 12-point Times New Roman font; minimum 0.7” margins; 1.5-line-spacing for all body text.
• There is no page limit and figures that are necessary to improve understanding should be
embedded in the main body of text. Clear and succinct writing is valued highly and verbose
writing is discouraged.
• If you put material in an appendix, ensure that you label your figures and tables and make proper
reference to them in the proposal. For grading purposes, the appendices will not be reviewed in
detail other than to read references, tables, charts, figures and photographs (i.e., the proposal
should not depend on extra written content that may appear in an appendix).
BME 498Y: Biomedical Engineering Capstone Design Fall 2020 & Winter 2021
Project Requirements Template
Your project requirements should contain the following sections, in the following order:
Cover Page
Executive Summary (1-page Max)
Table of Contents
Introduction
Project Goal
Project Requirements
Appendices
Bibliography
Interview Transcripts
Needs Statement Database
Report Attribution Table

Cover Page
Include the following information centered on the first page of your submission: Title of your project and
names of each individual team member

Executive Summary (1-page Max)

This section must allow the reader to understand the whole report. To achieve this understanding, you
must summarize the overall project and provide highlights from each section of the document concisely
and professionally. It must be an independent document and therefore should not make any reference to
other parts of the report. For example: instead of writing “A preliminary budget is included in the report.”,
you should write “The estimated budget for this project is $300.”

Table of Contents (1-page)

List all the sections (Do not include the Table of Contents or cover pages in this listing!) and their
corresponding page numbers, including sub-sections when appropriate.

Introduction
This section is aimed at demonstrating your understanding of a healthcare-related need and the topic, in
general, that your team is motivated to address. Provide background (in the form of research, interviews,
and observations), context, and motivation behind your project and communicate what the implications
may be if you solved a specific problem. Give a sense of the current state-of-the-art by answering the
following: What exists currently and how could it be improved? Why is the project important? What
benefits could your work be to the field or to society? Is there a market for your ideas? Benefits and
valuable outcomes could arise in many forms, such as: greater reliability, lower cost, greater ease of use,
treating more patients, etc.

You should summarize the key findings of your user interviews or observations. Include extra
information, such as transcripts (from interviews) or notes (from observations) in appendices. You should
make contact with at least one stakeholder who would welcome your solution to a problem they have. To
identify these stakeholders, think of users of a potential medical device (e.g., if the device goes inside a
BME 498Y: Biomedical Engineering Capstone Design Fall 2020 & Winter 2021
person’s body, then the user is usually a surgeon rather than the patient). In the case of investigating a
novel medical device, consider asking some of the following questions (not word for word):

• What do you like about your device? Why did you choose it? How often do you use it?
Approximately how much did you pay for it?
• What don’t you like about your device? Why?
• If you could have a completely new design of your device, what would it look like or what would
it do? Why? Would you use it more often if it had these features?
• Approximately how much more would you be willing to pay for these extra features? Do you
think other people would be willing to pay for these extra features as well?
• Observe the user using the device. If possible, try it yourself. For more information on observation
go to Section 1.2: Needs Exploration on www.ebiodesign.org (watch videos on observation and
read information on getting started section)

You do not necessarily need to design a device based on what the potential user immediately tells you
they need. It may be that you notice a problem as a user is using an existing device that they have not
noticed themselves (or why a non-user may be choosing not to use an existing device). In this case, ask
them whether or not they consider this to be a problem and whether or not they would pay more for a
device that solves it (or pay less while giving up on some other features). This may result in a bigger
“leap” from the current device compared to simply getting ideas from the user. Many of the most
successful products identify latent needs. Nonetheless, you need to know that what you see as a problem
is something multiple stakeholders see as a problem.

Understanding the problem in the context of the bigger picture requires that you do a literature or market
research search and you should be prepared to put in enough time to build your case. Provide relevant
references to original sources of information. References to webpages (like Wikipedia) are inadequate.
Proper research will reference original sources such as journals, books, and technical standards, and
provide complete information in a standard format. Consider connecting with your resource librarian to
help access patent databases, market research reports, or industry standards documents.

In summary, this section should cover:

1. Background
2. Motivation
3. Interview or observation highlights (transcript can be in appendix)

Project Goal
The project goal is a statement that outlines the scope of your project by identifying the problem that
your client has, the population or group of people you are targeting, and a measurable overall outcome
that you can use to determine if you have provided a successful solution. A well-crafted “need statement”
should be generated from conversations with experts you interview and observe. It can be general and
non-technical but should give direction to the entire project. You may need a few attempts to reach a clear
project goal, and your goal may also change as your project develops.

Design projects can take many forms. There are those that have hard functional goals but the details of the
methodology are left undefined. Another type, common to research-oriented projects, is a feasibility study
or experiment where the result of the study is not known; however, the design (or setup) of the study is a
hard functional goal. Such projects may be somewhat harder to define but must meet the same
requirements for verifiable project goals. One aid in these cases is to think of what has to be specified to
guarantee that another team could exactly duplicate the experiment.
BME 498Y: Biomedical Engineering Capstone Design Fall 2020 & Winter 2021

One of the major challenges when setting the project goal and requirements in the early stages of a project
is in establishing an appropriate scope for the project. A common mistake is to be too ambitious and to set
a scope that is too broad initially, and to be forced to repeatedly redefine the project until the final result
has only a small resemblance to the initial proposal. On the other hand, setting a scope that is too limited
will affect your evaluation if the project is considered too easy or trivial (e.g. setting up a simple web
site). You are expected to create a database with all of the different need statements that result from your
scoping exercises and include this in an appendix (N.B., provide a simple numbered list). The database
must also include a column that categorizes each entry as either: incremental, mixed, or blue sky. All this
information is necessary to judge how much effort your team has dedicated to exploring your area of need
and support the examples you provide in this report of scoping.

In summary, this section should cover:

1. Goals
2. Need Statement
3. Scoping highlights (needs list should be in appendix)

Project Requirements
Provide a list of target project requirements which will be used to evaluate whether your design meets the
needs of your client and to measure the success of your project. (For more basic information see McCahan
et al.(1) or for additional information on how to use advanced product definition tools (i.e., quality
function deployment) see Ullman(2)). Every one of the following project requirement elements should
include supporting documentation (e.g., analysis of assumptions, or user feedback)

In general, project requirements include:

• Criteria (what the design should be)
• Constraints (what the design must be)

Criteria and constraints should be stated in clear, understandable terms. Criteria may be thought of as
objectives that are “measures of effectiveness” that allow different solutions to be ranked or evaluated.
Constraints are absolute limits (i.e., if a potential solution violates a constraint, it must be discarded) that
are set by the client that may be based on safety, ethical, societal, or functional reasons. The number of
requirements depends largely on the project, but at this early stage, the list should not be very long, but
enough to capture the essence of your project. The point is to be complete, but not to constrain your
design unnecessarily. In terms of recognizing the functional requirements you will probably start by think
of performance (i.e., how fast, how slow, how often, loads, stresses, tolerances, etc.) but other elements
may include the: environment (e.g., temperature range, vibration, etc.), service life, environmental
sustainability, maintenance, target product cost, competition, shipping, packing, quantity produced,
manufacturing, size, weight, aesthetics (also appearance and finish), materials, product life span,
standards & specifications, ergonomics, customer satisfaction, quality & reliability, shelf life/storage,
testing, safety, course constraints, and other factors.(3)

Notes on requirements:
• Criteria must be presented in a way that is measurable and in most cases have an objective
goal/target that can be verified with at least one type of test
GOOD: ‘Criteria: The case has a wide variety of colors; Target: At least 100 different colour
options are available to users’
BAD: ‘Criteria: The case should be pleasing aesthetically’
BME 498Y: Biomedical Engineering Capstone Design Fall 2020 & Winter 2021
• Requirements should be free of implementation details.
GOOD: ‘The unit shall determine the highest frequency component in the signal; Sampling rate is
greater than 1 kHz’
BAD: ‘The unit shall have an A/D converter and microcontroller, which determines the highest
frequency component in the signal.’
• Constraints must be presented in a way that can be verified (i.e., quantitative)
GOOD: ‘it must weigh less than 1.5 kg’, ‘it must have a resolution of 2 pN’
BAD: ‘it must be light weight’
• The reasons for including each requirement should be documented. For example, how does each
engineering specification (i.e., how will client requirements be met?) link to customer needs (i.e.,
what does a client want?).
• Any objective goal or target should be supported with evidence (rough calculations, engineering
standards, literature research, etc.).

In Summary, this section should provide the following information to understand your requirements:
1. Criteria
2. Constraints

Appendices
Appendix A: Bibliography
Good references are an important part of documenting your work. Use original sources such as books,
journals, and standards publications wherever possible. Minimize your use of web references, which are
generally unreliable. You must use one style consistently and have references listed in the order they
appear in the text.

Appendix B: Interview Transcripts

Provide full transcriptions or notes of interviews or in-person observations

Appendix C: Need Statement Database

Provide a numbered list (or spreadsheet) of each need statement your team has created. Categorize each
according to incremental, mixed, or blue sky.

Appendix D: Report Attribution Table

The report attribution table summarizes the contribution of each team member to the project requirements
document. Complete the table, showing the initials of each team member in a separate column, and using
the abbreviations shown. This sheet must be signed by all group members.

Team Team Team Team Team

Component
Member 1 Member 2 Member 3 Member 4 Member 5
Section 1 X A
Section 2 X A
Report Attribution Table Template

Notes: While your whole team will be involved in most aspects of your project and help draft this
document, you must note who the principle contributor is for each section of the proposal. Mark the
principle contributor with an ‘X’ and if necessary note who else contributed in a less but substantial way
with an ‘A’.
BME 498Y: Biomedical Engineering Capstone Design Fall 2020 & Winter 2021

References
1. McCahan S, Woodhoue KA, Weiss PE, Kortschot M, Anderson P. Designing Engineers: An
Introductory Text. Wiley; 2015. 610 p.
2. Ullman DG. The mechanical design process [Internet]. McGraw-Hill Education; 2016 [cited 2017
Aug 3]. 480 p. Available from: http://www.davidullman.com/
3. Pugh S. Total design : integrated methods for successful product engineering [Internet]. Addison-
Wesley Pub. Co; 1990 [cited 2017 Aug 8]. 278 p. Available from:
http://search.library.utoronto.ca/details?7358467
BME 498Y: Biomedical Engineering Capstone Design
Project Proposal Evaluation Rubric
See rubric below to understand what the expectations are for each section of this report.
Section Fails
Executive  Length is greater than 1/2-page
Summary and/or
 Does not summarize the
document
Background  No introduction or introduction
does not orient the reader to the
subject of the document
 Lacks supporting background
information or lacks appropriate
range
Motivation  Does not identify or identifies
irrelevant concerns and/or excludes
essentials (e.g. safety, cost)
 Descriptions are erroneous or not
provided
Interviews or  Sources are inappropriate or not
Observations provided
 Information is presented
separately/unconnected or not
integrated
 Misunderstandings or unidentified
gaps in knowledge will prevent
successful problem framing
Fall 2020 & Winter 2021
Below Expectations
 Summary is weak or poorly
formulated and/or
 Minimally summarizes the key
points of the document
 Introduction minimally orients the
reader to the subject of the document
 Minimal background information
 Critical gaps in design priorities or
concerns indicate an underestimation
of the project's impact
 Descriptions are superficial and
not specific to the engineering design
problem
 Sources are minimally appropriate
 Some additional information is
integrated (addresses some gaps in
problem statement)
 Understanding is insufficient and
will limit problem framing
Meets Expectations
 Summary is clear and concise and
 Summarizes the key points of the
document
 Introduction orients the reader to
the subject of the document
 Background information provides
understanding of proposed research
 Identifies expected engineering
design priorities or concerns
 Descriptions relate to the specific
engineering design problem
 Sources are appropriate (reliable,
diverse, credible)
 Information is integrated with
existing knowledge of problem and
stakeholder interests/ concerns
 Understanding of the problem is
enhanced sufficiently for problem
framing
Exceeds Expectations
Meets +
 Summary is engaging and provides
a clear context that impressively
situates the key point of the
document
 Introduction orients the reader to
the subject of the document in a
succinct and complete manner
 Background synthesizes previous
research and knowledge in the field
 Identifies both expected elements
of engineering design and specific,
novel elements that suit the problem
 Descriptions are insightful
 Meets+ e.g.
 Evaluates and synthesizes
information from a variety of
authoritative sources
 Resolves discrepancies between
new information and stakeholder
interests/concerns
 Understanding is greatly enhanced,
enabling informed problem framing
BME 498Y: Biomedical Engineering Capstone Design
Section Fails
Goals Goals are:
 Not provided
 Not apparent
 Not manageable
Need Statement  Need statement or problem is not
appropriate or not identified for a
biomedical engineering design project
(e.g., due to the misconception of
engineering design as a well-defined
problem with one correct answer)
Scoping  Defines an inappropriate (e.g.
trivial or infeasible) project scope or
no definition provided
 Justification is inappropriate (e.g.
misuse of evidence) or no
justification given
Requirements  Documents inappropriate
requirements (e.g. will not help
distinguish between alternatives)
 Requirements are not measurable
(i.e. subjective) or undefined
 Erroneous explanations of
uncertainty (i.e. complete problem
miscomprehension) or does not
acknowledge uncertainty
 Makes illogical or unreasonable
assumptions or does not make
explicit assumptions
Fall 2020 & Winter 2021
Below Expectations
Goals are:
 Somewhat apparent
 Too broad and difficult to manage
 Need statement or problem is
minimally appropriate for a
biomedical engineering design project
(i.e., evidence of some understanding
of the nature of a healthcare-related
needs or engineering design activities)
 Scope is minimally appropriate
 Justification is incomplete or
vague (unconvincing)
 Defines some appropriate
requirements
 Requirements are somewhat
measurable (may not be feasible or
reliable)
 Explanations of uncertainty
contain minimal errors
 Makes simplistic assumptions
and/or assumptions are unsupported
Meets Expectations
Goals are:
 Apparent
 Generally manageable
 Need statement or problem is
appropriate for a biomedical
engineering design project
 Defines an appropriate project
scope
 Justifies scoping decisions (e.g.
prioritization of design concerns
reflects project and designers)
 Defines appropriate requirements
for the engineering design problem
 Requirements are expressed in
measurable terms
 Explains uncertainty in
requirements
 Makes logical assumptions
supported with evidence as needed
Exceeds Expectations
Goals are:
 Very clear
 Very manageable
 Need statement or problem is
unique and ideal for a biomedical
engineering design project (e.g.,
industry is “ripe for disruption”,
problem is challenging but feasible
for student design team)
 Meets+ e.g.
 Mature and realistic project scope
 Demonstrates insightful
understanding of problem
 Skillfully integrates information to
document comprehensive
requirements (e.g., by using QFD)
 Requirements are precise,
measurable, orthogonal, universal,
discriminatory, and external
promoting objective judgement of
solutions
 Explanations of uncertainty
demonstrate deep insight into the
problem
 Makes elegant assumptions
justified with convincing, credible
arguments
BME 498Y: Biomedical Engineering Capstone Design
Section Fails
Presentation  Paragraphs have multiple
and Readability inconsistent claims or focus areas
 Problems in grammar and
sentence structure hinder
 Formatting is not appropriate for
purpose, audience and genre
understanding of the document
 Visuals are disconnected from the
key points
Organization  Structure is confusing to navigate
 No or unclear relationship among
sections and main point
 Document lacks context and detail
and/or details presented before or
without any context
References  Lacks sources or lacks appropriate
range
 Information collected is not at all
credible
 Reference style not followed
Fall 2020 & Winter 2021
Below Expectations
 Paragraph focus/claim is vague or
unclear; requires some effort to
understand
 Some problems in grammar and
sentence structure hinder readability
of prose but not understanding of the
document
 Formatting presents some
inconsistencies with purpose,
audience and genre
 Visuals are not clearly related to
the key points
 Structure requires effort to
navigate (e.g., by not using the
template given)
 Inadequate relationship among
sections and main point
 Document inconsistently provides
context before detail or does not
have a coherent thread
 Evidence is from a minimal range
of sources
 Information collected covers some
important concepts and relevant
prior work in research area
 Information collected is somewhat
credible
 Reference style is not completely
adequate and not in correct order
Meets Expectations
 Paragraphs have a clear focus or
claim usually signaled by a topic
sentence
 Grammar and sentence structure
are mostly accurate and clear
throughout the document
 Formatting is appropriate for
purpose, audience and genre
 Visuals support and clarify key
points
 Structure directs the audience (e.g.,
by using the template given)
 Clear relationship among sections
and main point
 Sentences and paragraphs build
logically by providing context before
detail
 Evidence is from an appropriate
range of sources
 Information collected covers most
important concepts and relevant
prior work in research area
 Information collected is mostly
credible
 Reference style is correct and in
proper order
Exceeds Expectations
 Paragraphs sustain focus
throughout and signaled by a topic
sentence where appropriate and
supported with explanation, evidence
and/or sufficient detail
 Grammar and sentence structure
are accurate and coherent, and clearly
communicate complex topics in well-
designed paragraphs and sentences
 Formatting is highly effective for
the purpose, audience and genre
 Visuals simplify explanations and
deepen understanding of text
 Structure makes it easy to navigate
the material in multiple ways
 Clear relationship and support
between sections and the main point,
making it easy to follow
 Presentation of detail emerges
naturally from context and helps
build a convincing argument
 Evidence is from a wide range of
sources that demonstrates extensive
research that goes beyond standard
or typical sources
 Information collected covers all
important concepts and relevant
prior work in research area
 Information collected is entirely
credible
 Reference style is correct and in
proper order