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

2. 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

3. The Design Innovation Process (sections refer to Biodesign book)

4. 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

5. 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

6. 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?

7. 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 !

8. 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

9. Expect to be prodded, criticized, questioned, and praised Everyone will be a judge in this class.

10. There is no crying or whining in senior design! Senior Design

11. This is all part of the process known as Due Diligence Be prepared to answer tough questions !

13. 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.

14. 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.

15. 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.

16. Project Selection Getting 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

17. 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

18. 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

19. 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

20. Hermann Brain Dominance Model

21. 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

22. 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

24. 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

25. 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

26. Managers do things right, leaders do the right things.

28. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. Brainstorming Ideas What to do with this box? http://candyaddict.com/blog/ 2005/11/02/things-to-do- with-altoids-tins/http://candyaddict.com/blog/ 2005/11/02/things-to-do- with-altoids-tins/ Generate 5 ideas for how you could use this altoid tin

36. 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?

37. 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

38. QFD Matrix Customer Voice Design Requirements Represent how the company will respond to the customer’s wants and needs, i.e. the functions that the device must have Attributes or qualities of what the customer expects Intersection records the presence and the strength of relationships that exist between the voice and the design requirements

39. The “functions” of marriage The “qualities” of your desired marriage partner Possible marriage partners Correlation between “qualities” & “functions”, ie. Is marriage a fit for these qualities? Interaction between functions Weight given to each “quality” The score Scoring of each potential partner

41. Evaluation Charts Used to screen opportunities, to compare alternative designs and design options etc.