Bioengineering Senior Design Project I Dr. Ron Fournier August 22, 2011 Welcome to.

Bioengineering Senior Design Project I

Dr. Ron Fournier

August 22, 2011

Welcome to

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

– 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– Sales and marketing Business Plan

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 designsDetailed analyses and calculations to define profitability and expected costsPrototype testing

• Firm or final designsComplete design/specifications for all components of the productAccurate costs based on quotesReady 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 12, 19

– Proposal presentations• November 14, 21, 28

– Design proposal• Due October 31, or October 3 if in the biz plan competition

– 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 !

Project SelectionGetting 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 SelectionGetting 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 SelectionGetting 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 SelectionGetting from and Idea to an Opportunity

• Option 4: Make contact with other people to see if they have projects available.– friends – family – roommates– other companies

UT Has Rights to Your Inventions

• UT Policy and Procedure Manual 3364-70-04

• 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– 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– 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– 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

Our design groups will have 2 or 3 and not more than 4 members

Let’s form our design groups

Brainstorming Ideas

What to do with this box?

• http://candyaddict.com/blog/2005/11/02/things-to-do-with-altoids-tins/

• Generate 5 ideas for how you could use this altoid tin

Product Definition• 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

• 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

CustomerVoice

DesignRequirements

Represent how the company willrespond to the customer’s wants and needs, i.e.the functions that the device must have

Attributes orqualitiesof what thecustomer expects

Intersection records the presence and the strength of relationships that exist betweenthe voice and the design requirements

The “functions” of marriageThe “qualities” of yourdesired marriage partner

Possible marriage partners

Correlation between“qualities” & “functions”,ie. Is marriage a fit forthese qualities?

Interaction between functions

Weight given to each “quality”

The score

Scoring of eachpotential partner

Evaluation Charts

Used to screen opportunities, to compare alternative designsand design options etc.