Entrepreneurship in BME - Session 2

Entrepreneurship in
Biomedical Engineering
Session 2 | Entrepreneurship for Medical Devices
Reliance Restricted
Sep 2021 | Version 2.0

Overview of the lecture
An Overview of the Lecture
Introduction to Entrepreneurship for Medical Devices
What is Entrepreneurship?
► The activity of setting up a business
Commercialization Process ► And, taking on financial risks in the hope of
► Bringing new products to markets profit
1
6
► Financial and Business Model
► Fund raising and Strategic partners
Entrepreneurship in Biomedical
Engineering Program
2 ► Get knowledge from education
Entrepreneurship in Medical Devices ► Foundation to conduct research
► Quality Management Principles: customer ► Deliver new device/technology to end
►
focus, leadership, relationship management,
etc.
Quality Management System ISO 13485
5 users
3 Biomedical Engineering Curriculum

► Common courses required
4
► Technical electives courses are necessary
► Pre-Thesis
Academic Prototype vs Consumer Product
► Academic prototype is a tool to help you validate a specific
assumption
► Consumer product contract manufacturing services, include
accounting, packing, consulting, shipping, tagging, etc.
Page 3
1
6
Engineering Program
►
etc.
5 users

4
► Pre-Thesis
assumption
Page 4
What is an Entrepreneurship?
The activity of setting up a business
And, taking on financial risks in the hope of profit
What Is an Entrepreneur?
► Someone who creates and runs a business is called an entrepreneur
Why Be an Entrepreneur?
► The personal satisfaction that comes from having the freedom to make your own business decisions and then act on them
► Doing Work You Enjoy
► Creating Greater Wealth
► Helping Your Community
Risks of Being an Entrepreneur Entrepreneurship in History
► Potential Business Failure
► Unexpected Obstacles
► Financial Insecurity
► Long Hours and Hard Work
Page 5
What is an Entrepreneurship?
The activity of setting up a business
And, taking on financial risks in the hope of profit
WhyStudy Entrepreneurship?
► Knowledge of process of starting a business
► Basic principles applicable to any business environment
► Learn to think like an entrepreneur and develop a vision for our
life
Page 6
1
6
Engineering Program
►
etc.
5 users

4
► Pre-Thesis
assumption
Page 7
Entrepreneurship in Biomedical Engineering Program
Get knowledge from education - Foundation to conduct research
Deliver new device/technology to end users – Get feedback
Why do we have Entrepreneurship in BME program?
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Page 8
1
6
Engineering Program
►
etc.
5 users

4
► Pre-Thesis
assumption
Page 9
Biomedical Engineering Curriculum
Common courses required
Technical electives courses are necessary , Pre-Thesis
Page 10
1
6
Engineering Program
►
etc.
5 users

4
► Pre-Thesis
assumption
Page 11
Academic prototype is a tool to validate a specific assumption
Consumer product contract manufacturing services
Page 12
Page 13
Page 14
1
6
Engineering Program
►
etc.
5 users

4
► Pre-Thesis
assumption
Page 15
Entrepreneurship in Medical Devices
Quality Management Principles: customer focus, leadership, CRM, etc.
Page 16
1
6
Engineering Program
►
etc.
5 users

4
► Pre-Thesis
assumption
Page 17
Commercialization Process
Beginning new products to markets
Financial and Business Model
Fund raising and Strategic partners
Financial plan
► Estimate the venture potential
► A set of assumptions on sales revenues and costs
► Based on best available information & intuition
► Better assumptions à better projection à better preparation à higher chance for success
FORECAST YEAR 1 YEAR 2 YEAR 3 YEAR 4 YEAR 5
Revenues 0 50 100 200 400
Costs 100 110 120 130 140

CASH FLOW POSITIVE
Profits -100 -60 -20 70 260
Cumulative -100 -160 -180 -110 150
BREAK-EVEN POINT
Page 18
Commercialization Process
Beginning new products to markets
Financial and Business Model
Fund raising and Strategic partners
1 2 … 11 12 Year Total
Production cost (#units*unit cost)

- Materials
- Manufacturing Manufacture capacity & sale
- Packaging ability
- Shipping
- Servicing
Rentals (factory, office)
Physical assets (equipment, computers, furniture, etc.)
Salaries (all paid positions)

Other benefits (% of salaries)
Legal/other professional assistance
Marketing & selling
Utilities, supplies, travel, communication,...
Interest (from bank loan)
Page 19
What will students actually do in this course?
Experience some processes in developing a startup (by a team of 5-6

students) for a biomedical product or service:
► Identify an opportunity – develop startup’s idea
► Develop a business model
► Validate your business model with key stakeholders
► Make a final pitch to sell your idea
Page 20
Group’s Assigned Topic
The Assignment's topic for each group is as follow:

Group 1: Commercialize a medical device, e.g: a Tele - Blood Pressure
Group 2: Commercialize an online platform that connecting doctors and patients together
Group 3: Commercialize a Gel hand wash with Silver ion (Ag+)
Group 4: Commercialize an App using Artificial-Intelligence technology and cellphone's camera
for Acne diagnosis, then give recommendations to the users
Group 5: Commercialize a medical online platform connecting all the medical products or
business together, i.e, a supper platform where people can use blood pressure devices, can ask
doctor's opinions, can buy medical products, etc.
Page 21
Course assessment
Assignment: 30% - individual assessment

► Contribution to team work: 30%
► Peer evaluation: 10% - team members evaluate each other at the end of the
course
► Instructor evaluation: 30% - contribution of each member to team presentation
and defense
► Contribution to in-class discussion: 30%
► Max 3 points each time giving comments & questions to the presenting team.
Maximum 15 pts for each student
Midterm: 35%
► The average points of Presentation P1-P6 50%
Final: 35% - team assessment
► The average points of Presentation P6-P11 50%
Page 22
Presentations for upcoming weeks
Class Date Topics Assignment
1 Week 2 - Execution summary P0: Received Group’s Assigned Topic,
23
- Opportunity Ask and Comment (if any)
- Solution
- Market Analysis summary:
- Data/User’s needs/
trends/Key customer/Key
players/Your advantages
2 Week 3 - Business model canvas. P1: Each Group prepare a 15-minute

presentation (15MP) your startup idea
3 Week 4 - Execution: P2: 7MP – Present your business

- Marketing plan model canvas
- Technology
4 Week 5 - Prototype releasing P3: 15MP – Present your Marketing
- Landing Page plan and Technology
- App demo
5 Week 6 - Financial Modelling P4: 10MP – Present your Prototype
Page 23
Presentations
► 12 presentations in total
► Grading of each presentation includes:
§ Presentation quality: 60 pts
§ Defense quality: 40 pts
► Each time the team presents, each member will be given points for:
§ Delivering the presentation: 50
§ Defending/Answering other teams’ comments & questions: 30
§ Contributing to the discussion of the team: 20
► Final score is the average of all times
Page 24
The commercialization process
Source: Allen, K. R. (2010). Entrepreneurship for Scientists and Engineers (1st ed). Pearson
Rework concept
Opportunity Feasibility
Discovery Recognition
Technology feasibility
Invention Invention disclosure
Market feasibility
Innovation Concept
development Initial financials
Refine, redesign
Prototype development Market/Customer Test
Intellectual Platform Field test
Property & Applications Applications
Regulatory Testing Testing
Pre-clinical Clinical trials
Business plan
Launch strategy Execution strategy
License
Start a business
Develop operation/marketing
plan
Secure needed management
Launch
Sell or joint venture Identify funding needs &
sources
Page 25
Opportunity Identification & Evaluation
Opportunity Identification & Evaluation
Drew Houston, a CS student Founder of an online backup &

repeatedly forgot his USB storage service
Page 27
Opportunity identification
Pain Pain killer
Need Innovation
A process of realizing a particular need that exists in the marketplace and recognizing
an innovative solution
Page 28
Linking technologies & markets
► Technological fungibility:
a technology could be applied to multiple markets à might have multiple market
opportunities
Page 29
Linking technologies & markets
¨ Innovators often link their technology with a specific market application

à delink to understand the technology leveraging potential
¨ Combine & recombine technologies in different ways à different kinds of
products
¨ Learn to “fail fast”
Page 30
Analyze your opportunity
► How large is the market?

► How competitive is the market?
► Which market is most fertile?
► Does it match my growth ambitions?
► What does it mean for my organizational identity? For my venture’s relationships?
à go through all areas to find the best place to put the technology
Page 31
Assess your opportunities
► Customer perspective
► Exploitation perspective
Market perspective
Venture development
Economic perspective perspective
Page 32
Customer perspective
► The purpose of a company is not to create a product but to create a market

(Peter Drucker – the founder of modern management)
► How strong is the customer pain?
§ How strong is the need for your product?
§ A may-have, should-have, or must-have?
► Try to quantify the benefit that your solution can offer relative to existing
solutions
§ Time, labor, cost, health outcome, information, etc.
§ Ex: it saves the customer $10
Page 33
Market perspective
► Market: aggregation of all customers
► What is the market size?
► Max out the number of people who potentially buy the product or the
number of transactions
► How strongly does the market grow over time?
► Growing or declining market segment
Page 34
Economic perspective
► Project the costs: supplies, production, distribution, overhead, etc.
► Include your own labor cost!
► Where/How can you get funding to cover the costs?
► What if you need more?
Page 35
Economic perspective
► Pricing
► Frequent approaches (but problematic)
► Cost + x
► Price of competitors – x
► Very timid (low) pricing
► Understand the value you create to customers
► Growth of sales
► What is the speed of revenue generation?
► Does the price that is likely to be attainable cover the costs?
Page 36
Exploitation perspective
► Do you have the competencies to produce and commercialize the
product?
► Network resources – What is the level of support you can get/will need
from external partners?
§ Knowledge, experience, financial, etc.
► What are the chances of winning this market?

§ Any ruthless competitor? Lower the price below reasonable value to
keep you out
Page 37
Venture development perspective
► Is the window of opportunity open?
§ Is it actually a market that I can enter now?
§ Whether the customers are ready to buy my product? Or is this a market that
might take time to develop and unfold?
§ Seize the window of opportunity: timing is critical
§ A study on 250 high-tech firms: premature entry à failure in 40% cases
► Based on this opportunity, can you leverage into new segments?
► Can you defend your position over time?
§ Project the product life cycle
§ Short cycle: invest a lot, frequently update capabilities, update products
§ Example?
Page 38
References
► Lee, J. (2014). Biomedical Engineering Entrepreneurship. River Edge, SG: World Scientific.
► Allen, K. R. (2010). Entrepreneurship for Scientists and Engineers (1st ed). Pearson.
► Byers, T. H., Dorf, R. C., & Nelson, A. J. (2011). Technology Ventures From Idea to Enterprise (3rd
ed.). Mc Graw Hill.
► Kuratko, D. F. (n.d.). Entrepreneurship Theory Process Practice (8th ed.). South-Western Cengage
Learning.
► Stevenson, H. H., & Jarillo, J. C. (1990). A Paradigm of Entrepreneurship: Entrepreneurial
Management.
► Tucci, C. L., & Gruber, M. (n.d.). Launching New Venture.
Page 39
Presentations for upcoming weeks
Class Date Topics Assignment
1 Week 2 - Execution summary P0: Received Group’s Assigned Topic,
40
- Opportunity Ask and Comment (if any)
- Solution
- Market Analysis summary:
- Data/User’s needs/
trends/Key customer/Key
players/Your advantages
2 Week 3 - Business model canvas. P1: Each Group prepare a 15-minute

presentation (15MP) your startup idea
3 Week 4 - Execution: P2: 7MP – Present your business

- Marketing plan model canvas
- Technology
4 Week 5 - Prototype releasing P3: 15MP – Present your Marketing
- Landing Page plan and Technology
- App demo
5 Week 6 - Financial Modelling P4: 10MP – Present your Prototype
Page 40
ThankYou
Dr. Phan Gia Hoang
+84 90 368 4780
giahoang108@gmail.com
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Entrepreneurship in

Sep 2021 | Version 2.0

3 Biomedical Engineering Curriculum

3 Biomedical Engineering Curriculum

► Doing Work You Enjoy

► Creating Greater Wealth

► Helping Your Community

Risks of Being an Entrepreneur Entrepreneurship in History

► Potential Business Failure

► Long Hours and Hard Work

3 Biomedical Engineering Curriculum

Why do we have Entrepreneurship in BME program?

3 Biomedical Engineering Curriculum

3 Biomedical Engineering Curriculum

3 Biomedical Engineering Curriculum

3 Biomedical Engineering Curriculum

► A set of assumptions on sales revenues and costs

► Based on best available information & intuition

FORECAST YEAR 1 YEAR 2 YEAR 3 YEAR 4 YEAR 5

Revenues 0 50 100 200 400

Costs 100 110 120 130 140

Cumulative -100 -160 -180 -110 150

Production cost (#units*unit cost)

Physical assets (equipment, computers, furniture, etc.)

Salaries (all paid positions)

Utilities, supplies, travel, communication,...

Interest (from bank loan)

Experience some processes in developing a startup (by a team of 5-6

The Assignment's topic for each group is as follow:

Assignment: 30% - individual assessment

2 Week 3 - Business model canvas. P1: Each Group prepare a 15-minute

3 Week 4 - Execution: P2: 7MP – Present your business

§ Defense quality: 40 pts

§ Defending/Answering other teams’ comments & questions: 30

§ Contributing to the discussion of the team: 20

► Final score is the average of all times

Drew Houston, a CS student Founder of an online backup &

Pain Pain killer

¨ Innovators often link their technology with a specific market application

► How large is the market?

► Which market is most fertile?

► Does it match my growth ambitions?

► What does it mean for my organizational identity? For my venture’s relationships?

► The purpose of a company is not to create a product but to create a market

§ A may-have, should-have, or must-have?

§ Ex: it saves the customer $10

► What are the chances of winning this market?

2 Week 3 - Business model canvas. P1: Each Group prepare a 15-minute

3 Week 4 - Execution: P2: 7MP – Present your business

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