The document discusses the importance of engineering students understanding basic legal principles and business concepts. It covers topics around laws, legislation, standards, entrepreneurship, and the various career paths and legal knowledge needed for biomedical engineers. The course aims to provide knowledge on legal topics affecting engineers, contracts, intellectual property, and entrepreneurship steps from identifying opportunities to business plans.

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‫مواصفات‬ ‫و‬ ‫تشريعات‬ ‫و‬ ‫قانون‬
Laws, Legislation
and Standards
Humanities Elective Course SBE 494
Actually the course will cover
Laws, Entrepreneurship
and Standards
Humanities Elective Course

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The Legal Framework
Should Engineering Students Really Care
About Law?
Yes or No ?
If you say no, your professional career is headed towards
disaster.
Engineers should have an understanding of basic legal
principles and broad guidelines of law.
Also knowing the basics of business accounting, contracts, and
legal implications will help the young engineer practice
engineering more appropriately.

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Stanford University Joint Degree
Students who pursue a joint degree in law and bioengineering will find many
exciting career opportunities with law firms, medical device makers, biotech
companies, venture capital firms, government regulators, and other institutions.
Before we answer the question of WHY we need to address this basic
question:
What is Law??
• Jungle law, Family law (customs, traditions) religious law etc in every
aspect of our lives.
• Plus the formal legal (‫قانونية‬) system
• And if we don’t have actual legal laws and constraints we need to have
our own professional ethics (‫المهنة‬ ‫أخالقيات‬) .

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Biomedical
Engineer
Employee Entrepreneur Other career paths
How many of you want to be in each?
Why do YOU need to know about law?
To answer this question, assume a hypothetical career path
What legal knowledge do you need?
If you are an Employee:
• Your contract (benefits, compensation, constraints after leaving)
• If you are buying equipment for a hospital you need to know about
tender documents, standards, Service contracts etc.
• If you are dealing with suppliers and managing contracts on a regular
basis, it's important for you to be able to make informed decisions
without waiting to consult with legal specialists.
• Legal Aspects of Software Development (do you own the software or
does the company own it?)

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What legal knowledge do you need?
If you are an Entrepreneur:
•Types of companies legal structure, Business Structures
• Intellectual property rights: either to protect your invention or if
you want to use another’s invention (patents, copyrights,
trademarks, trade secrets)
•Standards for medical devices that you have to abide by if you
make a new invention
•Product Liability (Breach, Negligence, Fraud)
•Dispute Resolution
What other knowledge do you need if you
want to start your own business??
Examples:
• How to find a good Opportunity (the idea)
• Market survey
• How to write a Business Plan/Model
• Basic Accounting and Finance
• Marketing and Sales
• http://how-to-start-a-business-guide.com/

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Course Structure
• Lectures
• Guest lectures from experts in the field
• Readings
• Research assignments/plus project
• Class presentations and discussions
ILO’s
 Gain knowledge of legal topics that commonly affect engineers in their
careers.
 Gain basic knowledge of contracts, intellectual property law, and
employment law.
 Understand entrepreneurship and steps to a successful startup
Opportunity/Idea, business model/plan
 Gain basic knowledge of sales, marketing and accounting.
 Sources of funding
 Medical Device standards
 Ethics

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Lecture 1
Entrepreneurship
Books

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Overview
• What is entrepreneurship?
• Characteristics & Skills of an entrepreneur
• Steps to start your own business “startup”
• First Step: Finding the right “opportunity”
What is
Entrepreneurship?

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What is Entrepreneurship?
• Academic Definition (Stevenson & Jarillo)
• Entrepreneurship is the process by which individuals
pursue opportunities without regard to resources they
currently control
• Venture Capitalist (Fred Wilson)
• Entrepreneurship is the art of turning an idea into a
business
1-17
Types of Entrepreneurship
• Business Entrepreneurship
• Social Entrepreneurship
• Corporate Entrepreneurs
1-18

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Entrepreneurship Cycle
1-19
Observing
Problem/
Market
Opportunity
Assessing
Market/
Industry
Defining
Customer
Value
Proposition
Developing
and Testing
Solution
Early
Launch
Investors
Pitch/Raising
Fund
Expand or Exit
Business
Venture Team /Organization Creation
Entrepreneurship is the future?
Career choices have changed over history
What is the next phase?
It’s the startup companies.
It’s those willing to take larger risks for larger rewards.
“By being more innovative and creating more value in the marketplace,
startups will lead the future”

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Global Entrepreneurship Egypt Report
"Entrepreneurship is a key driver of economic growth for
Egypt and around the world”
Egypt Small and Medium Enterprise (SME)
Distribution by sales

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Egypt Small and Medium Enterprise (SME)
Comparison with other countries : % share of exports
But Why Become an Entrepreneur? And take
the risk?
Poll: Have a secure job or take the risk?
1. Right after graduation?
2. Five years after?
3. Ten years after?

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Sum-up: Why Become an Entrepreneur?
Primary reasons that people become entrepreneurs
Freedom/Be their own Boss
Financial rewards
Desire to pursue their
own ideas
1-25
Social Impact
Common Myths About Entrepreneurs
1-26
Entrepreneurs Are Born, Not Made
Entrepreneurs Are Gamblers
Entrepreneurs Are Motivated Only by Money
Entrepreneurs Should Be Young and Energetic

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So: What is an Entrepreneur?
An entrepreneur is an individual ‘alert’ to opportunities.
“An entrepreneur is someone who perceives an opportunity and
creates an organization to pursue it.“
Entrepreneur: A person who organizes and manages an enterprise,
especially a business, usually with considerable initiative and risk.
• Initiative: Readiness and ability in initiating action.
• Risk: The hazard or chance of loss.
opportunities
Twelve Characteristics of Successful Entrepreneurs
28
persistent
creative
Take responsibility for their actions
Leadership
*goal-oriented
optimistic
self-demanding
*self-confident
risk-taking
Have vision
action-oriented
enthusiastic

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Ten Essential Entrepreneurial Skills
29
basic business skills
math
problem-solving
technology and computer
decision-making
organizing and planning
teamwork
Interpersonal skills
Basic law
*Maintain social network
Examples:
Confidence
• Self-confidence is an important tool within entrepreneurial behavior.
A high degree of personal confidence is required to be innovative.
• Your confidence is critical to influencing others to participate in your
startup as an investor, employee, partner, or customer. You need a
high level of confidence
• when talking with investors,
• For recruiting prospective partners or co-founders,
• for bringing employees on board,
• for communicating your product’s benefits to customers.

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Social Capital
• Are you rich in social capital?
• Social capital is incredibly valuable. It gives you tremendous access
and tremendous relationships that either can’t be bought, or would
be expensive to buy or attain over time.
• Activity: List up to five individuals per group among three different
groups:
Your most trusted friends.
Your coworkers
Your social circle
Goal Oriented
• Do you have personal goals?
• Are they written?
• Are they specific and challenging and relevant?
• Putting a timeline to your goals improves your likelihood of actually
getting there.
• Do you mentally rehearse or forecast or think about future events?
• Do you anticipate obstacles?
• Do you develop alternative solutions?

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How do you start?
Many different books, Websites, Lectures etc.
These are examples of basic steps from several sources
Please read https://www.entrepreneur.com/article/245880
Steps to start your business
Simplistic steps#1:
• Evaluate your business skills, knowledge and goals.
• Find the business idea (opportunity) that suits you best.
• Research your competitors (and prepare to crush them).
• Make a business plan.
GO AHEAD…

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Steps to start your business
Simplistic steps#2
• Find a product/service (opportunity)
• Think about WHO is going to want your product/service,
• What they will PAY for it,
• What you will NEED to carry it off,
• and How you will MAKE MONEY someday.
• That is, make a PLAN.
Steps to start your business
Simplistic steps#3
• Define a real problem,
• Design a competitive solution and build your advantage
• Form the right team.
Real means there are enough customers
that really care about the problem that
you aim to solve?

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Opportunity identification
Opportunity identification is a critical first step to
success as an entrepreneur.
Success of your startup
Once you have identified your opportunity you can develop
it, implement it, and build a successful business
Success is measured by:
1. positive cash flow,
2. growth,
3. value creation
value

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Value Creation
A successful business is one that
delivers value to its customers and
creates value for its owners.
Value to the economy (the country)
Value Creation for Customers
Value is delivered to your customers when you do something for
them
• Better (service, social image, easier to use ..)
• Cheaper
• Faster
• Different
However, it is likely that none of these will work for long, so continuous
improvement and innovation are essential.

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Opportunity identification
What’s A Good Opportunity?

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Types of Opportunities
Discovering a need Creating a need
The majority of new products or services
are the consequence of the acquisition of
market information which identifies either
customer dissatisfaction or the emergence
of an unfulfilled need.
Research and new technology
leading to the development of a
radically new product or service
Demand driven Technology driven
Types of Opportunities
Discovering a need Creating a need
Steve Jobs ‘ The job is to figure what customers are
going to want before they do … People don’t know
what they want until you show it to them. Our task is
to read things that are not yet on the page.’
Schumpeter: “the most successful form of innovation is
technology driven, entrepreneurship is not a demand-driven
process. Entrepreneurs launch new products and believe that
significant market demand will eventually develop for them.

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Types of Opportunities
New applications of existing technology
Example: Laser
When the laser was invented, initially scientists had no idea to what
practical use it could be put. Since that time, however, understanding
of the technology’s attributes has produced numerous entrepreneurial
applications in areas such as medical, cutting, repairing and
measurement, so that the laser has come to be seen as an important
technological breakthrough

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Types of Opportunities
Discovering a need Creating a need
Discovery Creation
Creative destruction
Leading to the disappearance of
existing product or technology
Creative destruction
Example: KODAK

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Three stages of opportunity identification
1. Collect as many ideas as you can
3. Final group for detailed study
i.e. business plan etc. to be
discussed
2. First level of evaluation and elimination
We will discuss elimination criteria
1. Collecting ideas (how do you find them?)
•The world is full of problems that need to be
solved. Notice trends and ask people what their
problems are. Each is a potential opportunity.
Think of ways to solve them.
• Be creative

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Creativity: new ideas
Fist man try to fly Da Vinci’s Design of flying Machine
-
Not necessarily inventing something new. Developing an existing idea
or product is also creativity. SCAMPER
Substitute
Combine
Adapt
Modify
Put to another use
Eliminate
Reverse/rearrange
Creativity: SCAMPER

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Collecting ideas
•Think creatively: look at situations from unusual
angles
•Challenge the usual: Ask a lot of “why” and “what
if” questions
•Understand the needs and wants of people
•Identify gaps between supply and demand
•Technology ideas: can be new technology or new
uses of old technology
•Connect unrelated ideas
Collecting ideas
•Think about product substitution
•Study current entrepreneurial trends
•Notice culture shifts for example the global
increase in consumers concern about their heath.
•Look at markets and ideas outside Egypt
•Read Read Read, keep up with new technology,
scan the internet
Keep a list of all your opportunities.

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Example: Technological Trends
Mobile and internet penetration in Egypt
Does this
give you any
ideas??
Examples: Solving large scale problems
The need for sustainable energy The need for pure water for the poor

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Examples of entrepreneurship trends
Internet
businesses
home-based
businesses
service
businesses
outsourcing Mobile apps
Social
entrepreneurship
is hiring people and other companies to handle tasks
that a business can not do or chooses not to do itself.
Example: Freelance online
• New online communities
• Businesses can contract out jobs to freelancers online to deliver
work.
• Cumulative transactions for these online communities are in
excess of a billion dollars.
• Examples: Upwork (oDesk & Elance), Freelancer, 99 designs
• If you pay a $300 fee to oDesk—to have a logo designed, for example—10% of that will stay
with oDesk, and that’s essentially their management fee. The remaining 90% goes to the
individual who’s actually designing that logo. This often exceeds their compensation for
completing a similar project as an employee of a large company

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Example : Online retailing
Class discussion:
• Think of challenges:
Problems when it was a new trend
Problems now
• Think of advantages (for the entrepreneur NOT the customer)
• Think of ideas to gain market share now
Case Study: AMAZON
• http://www.cbsnews.com/videos/the-jeff-bezos-of-1999-nerd-of-the-
amazon/
• In 1994, Amazon set out to sell books on the Internet at an affordable price
and with a selection of titles as vast as the Amazon rainforest.
• 10 years later, Amazon was a leader in printed books and CD-based music.
• Product choice: books and music.. Advantage no need for size, colour,
quality etc..
• No need to brand and market
• Today, 43% of their sales are from media and digital goods, (change with
technology, market needs, competition)
• Added more products. Trying to lead the change even if it kills the initial
products..

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Ideas to gain market share now
• Customer tracking
• Product partners
• Technology partners
• International sites / languages
• Customer interaction – chat
• Product comparisons
• Innovative new products: Amazon web services
Three stages of opportunity identification
1. Collect as many ideas as you can
3. Final group for detailed study
i.e. business plan etc. to be
discussed
2. Initial evaluation and elimination
We will discuss elimination criteria

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2. Initial evaluation/screening and elimination
So now you have many ideas..
Which one should you choose?
Answer these basic questions:
•Is it suitable for your characteristics and skills?
•Does it satisfy your goals?
•How much is the initial investment? Do you have it?
Can you get it?
•Are you passionate about it?

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Why Passion?
• If you are solving a problem you are passionate about and/or
serving a customer segment you care about, your overall quality
of life will be higher, and you will be more successful.
• In starting a company, you inevitably have to ask a lot of people
for help. For example, big things like introductions to key people,
or for small things like to share your site with their friends. You
have to be proud of your business and passionate about it to be
motivated.
• Many businesses require spending a lot of time with customers,
so you want to enjoy that time.
Initial Market and Customer evaluation
• How will your product or service benefit customers?
• Think about value creation: Value creation is a measure of
success
• What is the potential size of the market?
• Are potential customers aware of their need for the product, or is
this a created need? (Think why you need to answer this
question)

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Initial Market and customer evaluation
• Who exactly are the potential customers? Can you name them?
Can you describe them? If you cannot perhaps your business
opportunity is strictly theoretical.
• Is another product or service from competitors available? How
does your product compare?
• What is the degree of your advantage? Are there better features
that you can bring to the market? If a competing product has five features, it
doesn’t necessarily mean that you need those five features plus several more. Instead,
focus on delivering the right set of features. maybe there are one or two features that
customers don’t really value. You can remove those and reinvest your resources into the
features most desirable by customers.
Initial Market and customer evaluation
• What are the strengths and weaknesses of the main competitors?
• Are the barriers to market entry high or low? Low barriers to
entry usually means that it is quite easy to enter the market,
resulting in an increasing number of competitors, which means
lower profit margins. However, if entry barriers are high, how will
you surmount them?
• What is the single worst thing that a competitor could do to your
business prospects? How would you respond?

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Final Opportunity identification
Once you have finished the first elimination stage you will now have 1
or 2 ideas remaining for more rigorous evaluation
(To be discussed later)
Startup Analysis Tools
1. SWOT Analysis
2. Industry and Competition Analysis
3. Business Model and BM Canvas

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1. SWOT Analysis
• Make a list in each box
• Brainstorm with team
SWOT Analysis
Can be applied
• For yourself
• For an existing company
• For a startup
• For making specific decisions for a company

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SWOT Analysis
Benefit is to find:
1. Ways to use each strength or make each one stronger;
2. Ideas to diminish each weakness, or even convert it into a strength;
3. Ways to get benefit from each opportunity;
4. Solutions to face each threat.
Generally, a SWOT analysis serves to uncover the optimal match
between environmental trends (opportunities and threats) and the
internal strengths of a given entity.
SWOT general example
Strengths
patents; price/cost
advantages; exclusivity;
speed of new product
development;
Opportunities
space for innovation;
additional markets
Weakness
shortage of cash for stock;
unreliable supplies of raw
material; inexperienced
staff; high cost structure;
Threats
competitors; low cost
imports; interest rates;
new regulations;

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SWOT decision making example
Industry and Competition Analysis
• Assess Industry Attractiveness for your new venture
• Assess Competition landscape and position of your
startup within competitors

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What is an industry?
Industry
An industry is a group of firms producing a similar product or
service, such as airlines, fitness drinks, furniture, or electronic
games.
Techniques to assess Industry Attractiveness
Study Environmental
and Business Trends
Competitive
Forces Model

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Business Trends
In which business would you invest?
Business Trends
0
1,000
2,000
3,000
4,000
5,000
6,000
7,000
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
# Public Village Hospitals and Rural Units in Egypt
Average Growth Rate of Health units  6%
Source: Espicom 2008

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Key Question about Industry
Trend/Growth?
Avoid declining industry, watch out from mature stage
industries, and target growing and emerging
At which stage is your industry and what is it growth
rate?
 Emerging (very new, young industry, growing <5%/yr) –>
opportunity for early movers
 Growth Stage growing >5% per/yr
 Matured – growth slowed <5%/yr
 Declining – negative growth
Industry Attractiveness:
5 Competitive Forces Model

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Power of Suppliers
Suppliers are the companies who sell product to a final consumer or sell
intermediate material or product to another company
Markets where there are few suppliers means the suppliers retain the power
and control the industry
Examine how many suppliers are in the market?
Are there a few who control prices?
Or many so prices are lower?
Do your suppliers hold the power?
How easy is it to switch to new supplier, what’s the cost?
Example: Intel and AMD
control the market of
Processors
Power of Customers/Buyers
Where there are fewer buyers, they often control the market. Questions here
include:
How powerful are the buyers?
How many are there?
Can the buyers get costs down?
Do they have the power to dictate terms?
Example: Hypermarkets
influences the prices of
their suppliers, as they
are few, and order big
volume from suppliers

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Threat of Substitution
If there are available alternatives then the threat of substitution increases.
How easy is it to find an alternative to this product or service?
Threat of new Entrants
If a new businesses can be easily started up in your sector without substantial
investment - then this is a threat. The Internet has made this a reality in many
sectors, especially publishing! So ask yourself the questions:
What’s the threat of new businesses starting in this sector?
How easy is it to start up in this business?
What are the rules and regulations?
What finance would be needed to start-up?
Are there barriers to entry which give you greater power?
Industries not easy
to enter are
dominated by big
players unless you
have innovation
out of the box

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Competitive Rivalry
Markets where there are few competitors are attractive but can be short-lived.
There are highly competitive markets with many companies chasing the same
work reduce your power in the market.
 What’s the level of competition in this sector?
 What’s the competitor situation? Many competitors and you’re all in a commodity
situation or a few?
Although industries with fewer competitors are attractive, industries with many
competitors also could be attractive….. Example food sector, lot of competition but still
lot of demand… no dominate players
Competitor Analysis

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Competitor Analysis
• A competitor analysis is a detailed analysis of a firm’s
competition.
• It helps a firm understand the positions of its major
competitors and the opportunities that are available.
• A competitive analysis grid is a tool for organizing the
information a firm collects about its competitors.
5-89
Identifying Competitors
Types of Competitors New Ventures Face
5-90

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Competitive Analysis Steps
5-91
 Map existing competitors within you industry
 Classify their type (direct, indirect..etc)
Understand their product offering, pricing, geographic
spread and product features
Understand current competitors market share and
position
Develop competitor grid for comparing between different
potential competitors
Competitors Grid Template
5-92
Company A Company B Company C
Product Features
Pricing
Brand Name
Recognition
Current Market
Share
Quality of Customer
Support

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Competition Related Concepts
5-93
 Competitive Barriers
 Competitive Position
 Competitive Advantage
 Angles of Competition
>>>>> What a systems does (verb) vs. what a system is (noun)
3. The Concept of a Business Model
A Business Model is not a business plan.
It addresses the basic question:
“How do you plan to make money?”

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Examples of successful business models:
 Traditional physical stores
 Online stores
 Razor blade model
 Lease to buy model
 SAAS model
 Freemium Model