Welcome to
Bioengineering Senior Design
Project I
Dr. Ron Fournier
August 20, 2012
Textbook
• Required, Biodesign, by Zenios, Makower
and Yock
• Readings from this book will guide and
supplement our classroom discussions and
the activities of your design team
• Other required books are Brave New World
and Innovation and Entrepreneurship
The Design Innovation Process
(sections refer to Biodesign book)
What is Design?
• Some definitions
– The engineering design process is a step by step method
to produce a device, structure, or system that satisfies a
need
• A carefully balanced combination of theory, practice,
originality, experimentation, and common sense
– Research can be a factor, but research itself is not design, design
is product and market oriented
• Involves assumptions, approximations, detailed analyses,
experiments
• Considers customer needs and demands
• Considers economic conditions and limitations
• profitable
What is design?
• The engineering design process
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Customer need or opportunity
Problem definition/specifications
Data and information collection
FDA regulations
Development of design alternatives
Evaluation of alternative designs
Selection and specification of optimal design
Implementation of optimal design
Economic analysis
Business Plan
Sales and marketing
What is design?
• Design process is a continuum of activities
somewhat classified into the following
• Preliminary or quick-estimate designs
Decide whether work should even be done, rule out alternatives,
approximate methods, rough economic analyses
• Detailed designs
Detailed analyses and calculations to define profitability and
expected costs
Prototype testing
• Firm or final designs
Complete design/specifications for all components of the product
Accurate costs based on quotes
Ready to manufacture and market
• Where does senior design fall?
What is design?
• Your project must have a significant design
component
– Clearly identify the engineering design principles and
the methodologies to be used
– Must propose to make something, eg. a medical device,
new software, not just research
– Demonstration of design can be by an actual prototype
or through detailed engineering analysis and/or
computer analysis
– Just doing research in the lab on a phenomena or
something is not design
– Must have the potential for a profitable outcome, write
a business plan, be entrepreneurial !
Reporting Progress
• You will report your progress periodically
– Idea presentations
• September 17, 24
– Proposal presentations
• November 19, 26, December 3
– Design proposal
• Due October 29
– Progress presentations
– Progress reports
– Business plan
• key deliverable at end of this semester
– Final presentation, Design History File, and final
report
• key deliverable at the end of the next semester
Expect to be prodded, criticized, questioned, and praised
Everyone will be a judge in this class.
There is no crying or whining in senior design!
Senior Design
This is all part of the process known as Due Diligence
Be prepared to answer tough questions !
You are entering the Shark Tank!
http://www.youtube.com/watch?v=
GYQ8dY_khXk&feature=related
Project Selection
Getting from an Idea to an Opportunity
In all cases discuss your ideas with me!!!
• Option 1: Talk to your co-op employer to see if
perhaps a project you have been working on for
your co-op can be extended as a senior design
project.
– Your current or past assignment on co-op cannot count
as your design project.
– It has to be something new or a further extension of the
work.
– Any patent rights will need to be worked out between
you, the University, and the company.
– The work needs to be done here with your team.
Project Selection
Getting from and Idea to an Opportunity
• Option 2: Talk to a faculty member of the
Department of Bioengineering and see if
they have an idea for a senior design project
for you.
– If you know of other faculty outside the
department talk to them as well.
Project Selection
Getting from and Idea to an Opportunity
• Option 3: Develop your own ideas. To
facilitate this,
– review the bioengineering literature
– look for patents (www.uspto.gov)
– or search the web for ideas or extensions of
work that has been presented.
– Use techniques for generating ideas such as
brainstorming.
Project Selection
Getting from and Idea to an Opportunity
• Option 4: Make contact with other people to
see if they have projects available.
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friends
family
roommates
other companies
UT Has Rights to Your
Inventions
• UT Policy and Procedure Manual 3364-7004
• In accordance with State of Ohio Section
3345.14 Ohio Revised Code
• File an invention disclosure with the UT
Office of Research and Innovation
– Usually they will give you the patent rights
The Opportunity: Creating, Shaping,
Recognizing, Seizing
• “I was seldom able to see an opportunity, until it
ceased to be one” Mark Twain
• Ralph Waldo Emerson “If a man can make a
better mouse trap than his neighbor, though he
builds his house in the woods, the world will make
a beaten path to his door”
– ideas are inert and worthless
– problem is attachment to the product and not the
business, need to translate idea to the market
– focusing on making it better may not lead to profits
– being first is no guarantee either, may prove to the
competition that the market exists
Pattern Recognition
• “If I had asked my customers what they wanted,
they would have said a faster horse,” Henry Ford
• Recognizing patterns is a creative process that is
not logical, linear, or additive
– 10 yrs to get the 50,000 chunks of experience
• recognizing opportunities stems from the capacity
to see what others do not
• creativity peaks in 1st grade, rest of education is
rigid and structured, usually destroying creativity
• dual brain model, Hermann Brain Dominance the
Creative Brain
– The idea of a team is to have a complete brain
Hermann Brain Dominance Model
Opportunity driven
• A good idea is not necessarily a good opportunity
– the more imperfect the market, the greater the
opportunity, a perfect market means everyone knows
everything about everything
– only 1, 2, or 3 out of a 100 business plans ever get
venture funding
– it may take 58 initial ideas to get a commercially
successful new product to market
So what is an opportunity?
• Has the qualities of being attractive, durable, and
timely, and is anchored in a product or service
which creates or adds value for its buyer or end
user
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has a window of opportunity
market entry is feasible and team can do it
venture has a competitive advantage
economics are rewarding and forgiving with good profit
and growth potential
Team and leader are passionate
So… What is Entrepreneurship?
• Is a way of thinking, reasoning, and acting that is
opportunity obsessed, holistic in approach, and
leadership balanced
– results in the creation, enhancement, realization, and
renewal of value, not just for owners, but for all
participants and stakeholders
– the heart is creation and/or recognition of opportunities
– the will and initiative to seize these opportunities
– willingness to take risks in a calculated fashion to shift
the odds to your favor, balance risk with reward
Drucker Says of Entrepreneurs
• French economist named JB Say around
1800 coined the word entrepreneur
• Shifts economic resources out of an area of
lower into an area of higher productivity
and greater yield
• The essence of economic activity is the
commitment of present resources to future
expectations
• Decisions have to be made, and the essence
of any decision is uncertainty
Managers do things right, leaders do the right things.
Entrepreneurship not just in
startups
• Includes companies, institutions, and
organizations of all types
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new firms and old
small firms and large
fast and slow growing firms
private, not for profit, public sectors
any location
regardless of politics
The Team
• A team is small number of people with
complementary skills that are committed to
a common purpose, performance goals, and
approach for which they hold themselves
mutually accountable
Entrepreneurial team
• The team is the key ingredient in a high
potential venture
• investors are captivated by the leader and
bet on the track records of the team
• prefer a grade A entrepreneur and team with
a grade B idea over a grade B team and a
grade A idea
• if you can find good people, they can
always change the product, most folks pick
the wrong people, not the wrong idea
The Design Team
• Core product team
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Marketing
Engineering
Electrical
Mechanical
Biomedical
Chemical
Software
Reliability engineering
Safety engineering
Service
Regulatory
Quality assurance
finance
• Working design team
– Primarily engineers, take the
product specifications and develop
the detailed design specifications
– Develop the detailed design from
these specifications and verify
their designs thru testing
– Validate and verify the design
The Team Leader
• Think of appointing a leader for your team
– Keeps the purpose, goals, and approach relevant and
meaningful
– Builds commitment and confidence
– Strengthens the mix and level of skills
– Monitors timing and schedules for planned activities
– Manages relationships with outsiders including removal of
obstacles
– Creates opportunities for others
– Does real work too
The Team Success
• Team success factors include
– Multifunctional involvement of the stakeholders
• Customers, suppliers, marketing, lawyers, manufacturing, engineers, managers
– Simultaneous full-time involvement
• cannot chase two rabbits at the same time
– Co-location
• Team members need to be close together
– Communication
• Stay in touch; phones, emails, regular meetings
– Shared resources
• Need commitment of resources to the team, sharing with others is not good
– Outside involvement
• Suppliers, distributors, and final customers
With 46 students we will have
about 12 teams
Let’s form our design groups
Brainstorming Ideas
What to do with this box?
• http://candyaddict.com/blog/
2005/11/02/things-to-dowith-altoids-tins/
• Generate 5 ideas for how
you could use this altoid tin
Product Definition
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The product definition process
– Where are we in the market now?
• What is the relevant market?
• Where is the product in its life cycle?
• What are the key competitive factors in the industry?
– Competitor strengths/weaknesses, competitor resources, market shares of
the players
– Where do we want to go?
– How big is the potential market?
– What does the customer really want?
• Demands vs. wishes
• Customers want the “benefits” of the “features”
– For example, patient wants to extend their life (benefit), whereas
the pacemaker design reduces arrhythmias (feature)
– How feasible is the technical development?
– How do we get to where we want to go?
– What are the chances of success?
Quality Function Deployment (QFD)
also referred to as 6 sigma
www.isixsigma.com
• Based on the “voice of the customer”
– 4 phase process involving
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Planning
Design
Manufacture
Consistency
• QFD process begins with the wants of the customer
– Product features based on customer needs, not defined based on
the developers of the product
– Get in touch with the customer and satisfy their needs
QFD Matrix
Design
Requirements
Customer
Voice
Attributes or
qualities
of what the
customer
expects
Represent how the company will
respond to the customer’s wants and needs, i.e.
the functions that the device must have
Intersection records the presence and the
strength of relationships that exist between
the voice and the design requirements
Interaction between functions
The “qualities” of your
desired marriage partner
The “functions” of marriage
Weight given to each “quality”
The score
Scoring of each
potential partner
Possible marriage partners
Correlation between
“qualities” & “functions”
ie. Is marriage a fit for
these qualities?
Evaluation Charts
Used to screen opportunities, to compare alternative designs
and design options etc.