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Demolishing the Status Quo in
 Entrepreneurial Education
I Write a Blog
www.steveblank.com
This Talk is Based On
  Business Model Generation
  Four Steps to the Epiphany
       The Lean Startup
This Talk
•   What’s a Startup?
•   Search versus Execution
•   Entrepreneurship As a Mgmt Science
•   B-Schools = Large company mgmt
•   Incubators = the transition
•   E-School = the conclusion
First -
What’s A Startup?

 Six Types of Startups
Lifestyle Startups
               Work to Live their Passion




     Startup




• Serve known customer with
  known product
• Pay for their passion
Small Business Startups
               Work to Feed the Family



                                          Small
     Startup
                                         Business



• Serve known customer with
  known product
• Feed the family
Small Business Startups
                    Work to Feed the Family



                                                 Small
      Startup
                                                Business


                       Exit Criteria
• known customer       - Business Model found
  known product
                       - Profitable business
• Feed the family
                       - Existing team
                       < €100K in revenue
Small Business Startups



                                                   Small
    Startup
                                                  Business


                     - Business Model found
                     - Profitable business
                     - Existing team
                     < $10M in revenue



• 5.7 million small businesses in the U.S. <500 employees
• 99.7% of all companies
• ~ 50% of total U.S. workers
                                                     http://www.sba.gov/advo/stats/sbfaq.pdf
Scalable Startup

    Search

    Scalable                        Large
    Startup                       Company



Goal is to solve for:
 unknown customer and
 unknown features
Scalable Startup
                Born to Be Big

Search                                    Execute

Scalable                                    Large
Startup                                   Company


       Exit Criteria
       - Business model found
       - Total Available Market > €300m
       - Can grow to €50/year
Scalable Startup

     Search                                           Execute

     Scalable                                           Large
     Startup                                          Company

                - Total Available Market > $500m
                - Company can grow to $100m/year
                - Business model found
                - Focused on execution and process
                - Typically requires “risk capital”


• In contrast a scalable startup is designed to grow big
• Typically needs risk capital
• What Silicon Valley means when they say “Startup”
The Transition – Founders Leave


  Scalable                              Large
                 Transition
  Startup                             Company


 Search           Build               Execute

             Founders depart
             - Operating executives
             - Professional Mgmt
             - Process
             - Beginning of scale
Buyable Startup
                    Born to Be Big

    Search                              Sell
     Scalable                        €3 to 30M
     Startup                         Acquisition




Goal is to solve for:
 Internet, Mobile, Gaming Apps
Buyable Startup

     Search                               Sell
     Scalable                          €3 to e0M
     Startup                           Acquisition




Goal is to solve for:           Sell to larger company
 Internet and Mobile Apps
What’s A Startup?
      Search                             Execute

     Scalable                            Large
     Startup                            Company


   -Business Model found
   - i.e. Product/Market fit
   - Repeatable sales model
   - Managers hired


A Startup is a temporary organization used to search
   for a repeatable and scalable business model
Large Company Sustaining Innovation
            Innovate or Evaporate

                             Sustaining Innovation
 Scalable                             Large
                Transition
 Startup                            Company




                   • Existing Market / Known customer
                   •Known product feature needs
Large Company Disruptive Innovation




     New                                   Large
                       Transition
    Division                             Company


                 Disruptive Innovation
•New Market
•New tech, customers, channels
Large Company Disruptive Innovation


    New                                  Large
                     Transition
   Division                            Company


               Disruptive Innovation
  •Build
  •Acquire
      - IP
  - Talent
      - Product
      - Customers
      - Business
Social Entrepreneurship Startups



      Social                            Large
     Startup                          Non-Profit



• Solve pressing social problems
• Social Enterprise: Profitable
• Social Innovation: New Strategies
Each of these startups
  require different skills

They Can Not Be Taught the Same Way
Search Versus Execution

Why Accountants Don’t Run Startups
Startups Search and Pivot


The Search for the Business Model

     Scalable                                 Large
                         Transition
     Startup                                Company



   Business Model found
  - customer needs/product features found
    i.e. Product/Market fit
  -Found by founders, not employees
  - Repeatable sales model
  - Managers hired
Startups Search, Companies Execute

The Search for the Business Model       The Execution of the Business Model


        Scalable                                           Large
                                    Transition
        Startup                                          Company


         -Business Model found              - Cash-flow breakeven
         - Product/Market fit               - Profitable
         - Repeatable sales model
         - Managers hired
                                            - Rapid scale
                                            - New Senior Mgmt
                                            ~ 150 people
Metrics Versus Accounting


              The Execution of the Business Model


Scalable                           Large
            Transition
Startup                          Company



                         Traditional Accounting
                         -Balance Sheet
                         - Cash Flow Statement
                         - Income Statement
Metrics Versus Accounting


The Search for the Business Model      The Execution of the Business Model



      Scalable                                      Large
                          Transition
      Startup                                     Company


Startup Metrics
- Customer Acquisition Cost                Traditional Accounting
                                          - Balance Sheet
- Viral coefficient                       - Cash Flow Statement
- Customer Lifetime Value                 - Income Statement
- Average Selling Price/Order Size
- Monthly burn rate
- etc.
Customer Validation Versus Sales


              The Execution of the Business Model


  Scalable                           Large
             Transition
  Startup                          Company



                          Sales
                          -Sales Organization
                          - Scalable
                          - Price List/Data Sheets
                          - Revenue Plan
Customer Validation Versus Sales


The Search for the Business Model         The Execution of the Business Model



       Scalable                                            Large
                             Transition
       Startup                                           Company


Customer Validation
- Early Adopters                                  Sales
                                                  - Sales Organization
- Pricing/Feature unstable                        - Scalable
- Not yet repeatable                              - Price List/Data Sheets
-“One-off’s”                                      - Revenue Plan
- Done by founders
Customer Development Versus
    Product Management


              The Execution of the Business Model



Scalable                         Large
           Transition
Startup                        Company


                          Product Management
                         - Delivers MRD’s
                         - Feature Spec’s
                         - Competitive Analysis
                         - Prod Mgmt driven
Customer Development Versus
           Product Management


The Search for the Business Model       The Execution of the Business Model



      Scalable                                         Large
                           Transition
      Startup                                        Company



 Customer Development                             Product Management
                                                 - Delivers MRD’s
 - Hypothesis Testing                            - Feature Spec’s
 - Minimum Feature Set                           - Competitive Analysis
 - Pivots
 - Founder-driven
Engineering Versus
           Agile Development


                   The Execution of the Business Model


Scalable                               Large
                Transition
Startup                              Company



                              Engineering
                              - Requirements Docs.
                              - Waterfall Development
                              - QA
                              - Tech Pubs
Engineering Versus
                Agile Development

The Search for the Business Model      The Execution of the Business Model



     Scalable                                       Large
                          Transition
     Startup                                      Company



Agile Development                             Engineering
                                              - Requirements Docs.
- Continuous Deployment                       - Waterfall Development
- Continuous Learning                         - QA
- Self Organizing Teams                       - Tech Pubs
- Minimum Feature Set
- Pivots
Startups Model, Companies Plan

             The Execution of the Business Model


Scalable                         Large
           Transition
Startup                        Company


              Business Plan
              -Plan describes “knowns”
              - Known features for line extensions
              - Known customers/markets
              - Known business model
Startups Model, Companies Plan


 The Search for the Business Model         The Execution of the Business Model


       Scalable                                               Large
                              Transition
       Startup                                              Company



Business Model                                 -Plan describes “knowns”
                                               - Known features for line extensions
- Unknown customer needs                       - Known customers/markets
- Unknown feature set                          - Known business model
- Unknown business model
- Model found by iteration
Startups Are Not Small Versions of
        Large Companies


   Scalable                           Large
                   Transition
   Startup                          Company


  Search            Build           Execute




    Yet our curriculums assume they are –
we teach that the knowledge is interchangeable
Entrepreneurship as a
Management Science
E-School instead of B-School
Business as a Management Science


• 1601 East India Company

• 300 years of companies
  without MBA credentials

•1908 Harvard first MBA
Business School Topics


                          Business School

Scalable                        Large
             Transition
Startup                       Company


                           -Execution
                           - Strategy
                           - Accounting
                           - Products
                           - Engineering
                           - Management
                           -Administration
Business School Courses


                                  Business School

Scalable                                Large
             Transition
Startup                               Company


                          Courses
                          -Managerial Finance/Accounting
                          - Managing Groups and Teams
                          - Financial Accounting
                          - Operations
                          - Modeling for Optimization
                          - Global Value Chain Strategies
B-School Results?


• U.S. corporations went from local to national
  then international

•Cadre of experienced managers to match

• Experts on finance and growth (Dupont/GM)

       B-Schools made the 20th Century
        the American business century
Business School Focus on
Large Company Strategies

 Execution versus Search
Business School Limitations


•Most Professors consult for large corporations

• Most believe startups are just smaller versions of
  large companies
• Most B-school entrepreneurship programs are
  side-shows
Irony:
21st Century Job Growth will Come
        from New Ventures
Incubators
       a Reaction to the lack of Practical
          University Entrepreneurship

• 1959 Josephy Mancuso - Batavia Industrial Ctr.

• 1996 IdeaLab

•2005 Y-Combinator

•2011 100+ Incubators world-wide
Startup Incubators


•Hands-on (experience vs. theory)

• Goal: create a company and jobs

• Full-time residential, stipend-based program

• Curriculum: product development + best practices
What’s Missing?

A Repeatable Methodology
   Not Just War Stories
Startups Are Not Smaller Versions
       of Large Companies

    Large Companies Execute Known
            Business Models
Startups Are Not Smaller Versions
       of Large Companies

     Startups Search for Unknown
           Business Models
E-School

•Complete curriculum with Hands-on emphasis
• Goal: methodology for startup creation
• Can be taught anywhere
  - University
  - Incubator
  - Remotely

• Curriculum: about the search for a business model
The Business Model:
Any company can be described in
       9 building blocks
CUSTOMER SEGMENTS




which customers and users are you serving?
which jobs do they really want to get done?
VALUE PROPOSITIONS




 what are you offering them? what is that
  getting done for them? do they care?
CHANNELS




how does each customer segment want to be
 reached? through which interaction points?
CUSTOMER RELATIONSHIPS




   what relationships are you establishing with each
segment? personal? automated? acquisitive? retentive?
REVENUE STREAMS




   what are customers really willing to pay for? how?
are you generating transactional or recurring revenues?
KEY RESOURCES




which resources underpin your business model?
          which assets are essential?
KEY ACTIVITIES




which activities do you need to perform well in
   your business model? what is crucial?
                                                  57
KEY PARTNERS




which partners and suppliers leverage your model?
           who do you need to rely on?
COST STRUCTURE




what is the resulting cost structure?
which key elements drive your costs?
key       value         customer
            activities   proposition      relationships




     key                                            customer
partners                                            segments




     cost                                           revenue
structure         key                               streams
            resources                  channels
                                                          60
                                                    images by JAM
sketch out your
business model
sketch out your
business models
But,
Realize They’re Hypotheses
9 Guesses


                              Guess
Guess     Guess
                                        Guess

                    Guess
        Guess                 Guess



        Guess                   Guess
Customer Development
The founders
     ^Get   Out of the Building
Customer Development
The Search For the Business Model



Customer            Customer     Customer   Company
Discovery           Validation   Creation   Building



            Pivot
Customer Discovery


    Customer      Customer     Customer   Company
    Discovery     Validation   Creation   Building




•   Stop selling, start listening
•   Test your hypotheses
•   Continuous Discovery
•   Done by founders
Turning Hypotheses to Facts



         Test Hypotheses:
             •Product
          • Market Type
          • Competition
Test
Hypotheses:
 •Problem
• Customer
   • User
  • Payer
Test Hypotheses:
    •Channel
Test
                                       Hypotheses    Test
                            Test           :      Hypothese
   Test                  Hypotheses:    •Demand       s:
Hypothese                 •Product      Creation •Problem
    s:                    • Market                     •
 •Channel                   Type                  Customer
    •                         •           Test      • User
(Customer                Competitive   Hypotheses: • Payer
     )                                  •Channel
    •     Test Hypotheses:             Test Hypotheses:
(Problem)      •Size of                •Pricing Model /
       Opportunity/Market                   Pricing
Test
               Agile                 Hypotheses    Test
                          Test           :      Hypothese
   Test      Developme
                       Hypotheses:    •Demand       s:
                 nt
Hypothese               •Product      Creation •Problem
    s:                  • Market                     •
 •Channel     Customer    Type                  Customer
    •        Developme      •           Test      • User
(Customer     nt Team Competitive    Hypotheses: • Payer
     )                                •Channel
    •     Test Hypotheses:           Test Hypotheses:
(Problem)      •Size of              •Pricing Model /
       Opportunity/Market                 Pricing
The Minimum Viable Product (MVP)




    • Smallest feature set that gets you the most …
          - orders, learning, feedback, failure…
The Pivot




•The heart of Customer Development
      •Iteration without crisis
   •Fast, agile and opportunistic
Pivot Cycle Time Matters




  •Speed of cycle minimizes cash needs
•Minimum feature set speeds up cycle time
 • Near instantaneous customer feedback
             drives feature set
The Pivot



A Pivot is the change of one or more
Business Model Canvas Components
The Pivot

                      Product                          Strong clinical
                   Development          Doctors:            data
                         IP              Earlier          Training
Leading doctors   A Pivot is the change of one or more
                   Clinical trials
                        FDA
                                        detection       Maintenance
                                                        Conferences
  Key Opinion                             Price        OB/GYNs
    Leaders
                  Business Model Canvas Components PCPs
                    Publishing          Accuracy       CME courses
    3rd party
 manufacturers                          Patients:
  Distributors                        Radiation Free
 Breast Cancer                        Non-Invasive
                        IP                             Direct Sales to
  Foundations                                             hospitals
                  Leading doctors
     ACOG                                                Distributor
                     Technical
      ACS
                     Expertise


           Product Development
               Clinical trials                         Capital Equipment Sales
             Operating Costs                             and disposable item
             Marketing Costs                                 Per use fees
How Does This Really Work?

Stanford Lean LaunchPad Class
How Does This Really Work?

Stanford Lean LaunchPad Class
  8 Weeks From an Idea to a Business
Pivot Example
    Robotic Weeding
Talked 75 Customers in 8 Weeks
Our initial plan
20 interviews, 6 site visits…
                            We got OUR Boots dirty
                                  Weeding
        Visited two farms in Salinas Valley to better understand problem

                             Interviewed:
         • Bolthouse Farms, Large Agri-Industry in Bakersfield
           • White Farms, Large Peanut farmer in Georgia
             • REFCO Farms, large grower in Salinas Valley
             • Rincon Farms, large grower in Salinas Valley
             • Small Organic Corn/Soy grower in Nebraska
    •    Heirloom Organics, small owner/operator, Santa Cruz Mts
            • Two small organic farmers at farmers market
              • Ag Services of Salinas, Fertilizer applicator

                                 Mowing
                               Interviewed:
                       • Golf: Stanford Golf course
•       Parks: Stanford Grounds Supervisor, head of maintenance and
                         lead operator (has crew of 6)
                • Toro dealer (large mower manufacturer)
                   • User of back-yard mowing system
               • Maintenance Services for City of Los Altos
          • Colony Landscaping (Mowing service for stadiums)
Business Plan
     Autonomous Vehicles for Mowing & Weeding


                     - Innovation                            Dealers sell,           Mowing
    - Dealers         - Customer          We reduce          installs and          - Owners of
  (Mowing and         Education         operating cost    supports customer          public or
       Ag)        - Dealer training   - Labor reduction                          commercially
- Vehicle OEMs                              - Better      Co. trains dealers,       used green
  (John Deere,                           utilization of    supports dealers     spaces (e.g. golf
Toro, Jacobsen,                       assets (eg mow or                              courses)
       etc)                             weed at nights)                          - Landscaping
                   Engineers on           - Improved           - Mowing
                                                                                service provider
- Research labs     Autonomous        performance (less         Dealers
                   vehicles, GPS,        rework, food        - Ag Dealers           Weeding
                   path-planning             safety)                            - Farmers with
                                                                                manual weeding
                                                                                   operations


            Dealer discount                                      Asset sale
    COGS seek a 50-60% Gross Margin              Our revenue stream derives from selling the
        Heavy R&D investment                                     equipment
Found weeding in organic crops is HUGE
      problem; 50 - 75% of costs

                        Crews of 100s-1000

                        Back-breaking task

                        (Ilegal) labor harder to get

                        1-5 weedings per year/field

                        $250-3,500 per acre and
                        increasing

                        Food contamination risk
Decision to make – mowing vs weeding



Application     If ROI is < 1   Labor costs      Autonomous            TAM
                yr they will    significant?     would solve
                    buy                           problem?

Mowing of           Yes.            Yes              Yes          Adjusted up to
               Professionally                                          xxx
large fields        run
               organizations
Weeding in     Agri Industry:      YES! for                       TAM increased
                    YES!        organic crops   Not necessarily   to $2.6 B (Total
Agriculture                                                           organic)
                  Large           They are       Key need is
               Growers: Yes       spending      weed vs. crop     Target Market
                                  $500/ac!      differentiation      (organic
                  Small                                             specialty)
               Growers: No                                          162 M/yr
                                                                  18%/yr growth
Autonomous vehiclesWEEDING

                     - Innovation                            Dealers sell,       - Low density
 - Ag Dealers         - Customer          We reduce          installs and           vegetable
 - Ag Service         Education         operating cost    supports customer          growers
   providers      - Dealer training   - Labor reduction                         - High density
                                          (100 to 1)      Co. trains dealers,       vegetable
- Research labs                       - Reduced risk of    supports dealers          growers
                                        contamination                              - Thinning
                                       - Mitigate labor                            operations
                   Engineers on          availability        - Ag Dealers
                                                                                - Conventional
                  Machine Vision          concerns           - Ag Service
                                                                                   vegetables
                  Two problems:                                providers
                  - Identification
                   - Elimination



            Dealer discount                                      Asset sale
    COGS seek a 50-60% Gross Margin              Our revenue stream derives from selling the
        Heavy R&D investment                                     equipment
1 Week – 1 CarrotBot
CARROTBOT

   Machine Vision data
    collection platform
     Monochrome   & Color
      Cameras
     Laser-line sweep
      (depth measurement)
     Encoders               CarrotBot 1.0
      (position/velocity)
     Onboard data
      acquisition & power
The Business Plan Canvas Updated

                  •Technology                               •Farming
                     Design                               conventions.
                   •Marketing                            •Demo, demo,
                   •Demo and                               and demo!!
                    customer               •Cost          •Proximity is          •Organic
•Research Labs      feedback                               paramount             Farmers
                                         Reduction
   •Equipment                                                                   •Weeding
                                      •Remove labor
 Manufacturers                                                                    Service
                                        force pains
  •Distribution                                                                 Providers
                                      •Eliminate bio-
     Network                                                                  •Conventional
                                      waste hazards
     •Service      •IP – Patents                                                 Farmers
    Providers          •Video                               •Dealers
                  Classifier Files                       •Direct Service
                      •Robust                           •Indirect Service
                    Technology                          • … then Dealers


                                                                     •Asset Sale
                       Value-Driven                              •Direct Service with
                                                                  equipment rental
                                                                 •… then Asset Sale
Visit Highlights




    Above: Organic Carrots, 7wks.
    Top right: Conventional carrots
Bottom Right: Very weedy. Will require
    multiple passes of hand weeding
Visit Highlights




                       Carrot vs. Weeds
Due to small root systems, carrots have no chance against weeds
Visit Highlights




Organic Broccoli, closely
cultivated. Weeds close
  to plants are hand-
Visit Highlights




State of the Art in Weeding Technology
Customer Hypothesis
Pre-                                          Large
Test                                         Growers
            Us            Dealer
                                            Industrial
                                             Growers


                          Industrial          Hypothesis Confirmed
                                       • Growers interested in own equipment
                           Growers           • Industrial (10,000s of acres)
Post-                                           • Large (1,000s of acres)
                            Large            • Willing to pay $100k for one
Test                       Growers                         unit
       Us        Dealer
                           Service       • Smaller growers (100s of acres)
                          Providers    usually subcontract the labor services
                                                 or rent equipment
                          Equipment
                            Rental      • All purchases through local dealers
                                               •Customer service is essential
Customer Map #1 – Industrial Growers
 Example: Bolthouse Farms – Large Industrial Carrot
              Producer – 8K acres/yr
  End User    • Equipment
                Operator

  Influencer   • Local Farm Mgr
                  • Cliff Kirkpatrick,
                          visited


 Recommender     • Director, Ag            Equipment
                  Technology                Operator
                    • Justin Grove,
                      interviewed
   Decision
    Maker       • VP, Growing
                  Operations

   Approver    • CFO, CEO (Jeff
                    Dunn)
                                         Cliff, Farm Mgr
Customer Map #2 – Service Providers
   Example: Ag Services – Service Provider, Salinas
                      Valley
  End User     • Equipment
                 Operator


  Influencer         • Grower



Recommender      • Service Mgr
                              Me (left), Marty (middle, Service
                               Mgr), Doug (right, Grower)
Decision Maker
 & Approver
                 • ?? (service mgr’s
                         boss)
The Business Plan Canvas Updated

                   •Technology                               •Farming
                      Design                               conventions.
                    •Marketing                            •Demo, demo,          •Mid/Large
                    •Demo and                               and demo!!       Organic Farmers
                     customer               •Cost          •Proximity is       •Agricultural
•Research Labs       feedback                               paramount
                                          Reduction                            corporations
   •Equipment
                                       •Remove labor                         •Weeding Service
 Manufacturers
                                         force pains                             Providers
  •Distribution
                                       •Eliminate bio-
     Network
     •Service      •IP – Patents
                                       waste hazards                            •Mid/Large
    Providers          •Video                             •Direct Service      Conventional
                  Classifier Files                       •Indirect Service       Farmers
                      •Robust                            • … then Dealers
                    Technology

                                                                  •Direct Service with
                                                                    equipment rental
                        Value-Driven                              •($1,500/d; 120d/yr )
                                                                •Low density: $1,500/d
                                                                •High density: $6,000/d
World Ag Expo interviews:
the need is real and wide spread

                 • 10+ interviews at show
                    – Everyone confirmed the need
                    – Robocrop, UK based, crude
                      competitor sells for $171 K


                 • Revenue Stream
                    – Mid to small growers prefer a
                      service
                    – Large growers prefer to buy, but
                      OK with service until technology
                      is proven
                    – Charging for labor cost saved is
                      OK, as we provide other benefits
                      (food safety, labor availability)
The Business Plan Canvas Updated

                   •Technology                                  •Farming
                      Design                                  conventions.
                    •Marketing                               •Demo, demo,          •Mid/Large
•Research Labs      •Demo and                                  and demo!!       Organic Farmers
   •Equipment        customer                  •Cost          •Proximity is       •Agricultural
 Manufacturer        feedback                Reduction         paramount          corporations
  •Distribution                           •Remove labor                         •Weeding Service
     Network                                force pains                             Providers
      •Service                            •Eliminate bio-
     Providers
                   •IP – Patents
                                          waste hazards                            •Mid/Large
    •2 or 3 Key
                       •Video                                •Direct Service      Conventional
       Farms
                  Classifier Files                          •Indirect Service       Farmers
                      •Robust                               • … then Dealers
                    Technology

                       Value-Driven                                  •Direct Service with
                            • R&D                                     equipment rental
                    • Bill of Materials                            •Low density: $1,500/d
                  • Training & Service                             •High density: $6,000/d
                           • Sales
Autonomous weeding - Final


                       - Innovation                              Direct            - Low density
  - Ag Service          - Customer          We reduce        - Provide high           vegetable
    providers           Education         operating cost    quality service at         growers
                    - Dealer training   - Labor reduction   competitive price     - High density
   - Research                               (100 to 1)                                vegetable
Institutes (eg UC                       - Reduced risk of                              growers
  Davis, Laser                            contamination                              - Thinning
    Zentrum                              - Mitigate labor                            operations
   Hannover)         Engineers on          availability            Direct
                                                                                  - Conventional
                    Machine Vision          concerns          - Alliance with
                                                                                     vegetables
- 3-4 key farms     Two problems:                           service providers
                    - Identification                         - Eventually sell
                     - Elimination                           through dealers



        Costs for service provision                              Service provision
     COGS seek a 50-60% Gross Margin              - Charge by the acre with modifier according to
         Heavy R&D investment                                      weed density
                                                          - Eventually move to asset sale
MammOptics
Final project presentation for E 245 Winter 2011
MammOptics
   Initial Idea

          Breast cancer                    Mammography
  Leading cause of cancer in women 15%-25% false negatives rate
   190,000 diagnosis every year US   25% false positives rate
     41,000 deaths every year US     Requires X-ray radiation
      Increasing diagnosis rates         Low resolution



                          MammOptics
                    Novel technology based on
                      RF-modulated optical
                           spectroscopy
                            - Earlier
                           detection
                             - Non-
                           radiative
MammOptics
    Technology Comparison

                           Invasivenes                False   False   Device     Time
                 Risk                    Resolution
                           s                          Pos.    Neg.    Cost     Required

 MammOptics                                I.I.T.Y.I.W.H.T.K.Y

 Mammography      High        High         .6 cm      25%     30%     20-50k   20 min.



     MRI        Medium       Medium        .1 cm      70%      5%     1000k    45 min.



  Ultra-Sound   Very Low    Very Low       >.6 cm     >30%    >40%    5-15k    20 min.
MammOptics
   Business Model Canvas 1 of 4


                       Product                            Strong clinical
                    Development                                data
                          IP                                 Training
    Hospitals
                    Clinical trials                        Maintenance
 Leading doctors                                                              Pioneering
                         FDA           Radiation-free
     3rd party                                                              radiologists in
                                      Earlier detection
  manufacturers                                                                hospitals
                                       Non-invasive
   Distributors

                         IP
                   Leading doctors                        Direct sales to
                      Technical                              hospitals
                      Expertise


          Product Development
              Clinical trials
                                                              Capital equipment sales
            Operating Costs
                                                               and disposable item
MammOptics
 Business Model Canvas 1 1 of 4
  Business Model Canvas of 4


                       Product                            Strong clinical
                    Development                                data
                          IP                                 Training
    Hospitals
                    Clinical trials                        Maintenance
 Leading doctors                                                              Pioneering
                         FDA           Radiation-free
     3rd party                                                              radiologists in
                                      Earlier detection
  manufacturers                                                                hospitals
                                       Non-invasive
   Distributors

                         IP
                   Leading doctors                        Direct sales to
                      Technical                              hospitals
                      Expertise


          Product Development
              Clinical trials
                                                              Capital equipment sales
            Operating Costs
                                                               and disposable item
Finding the right customer
     From radiologists to gynecologists
MammOptics
  Excursions into hospitals

                        Debra Ikeda
        Leading        Jason Davies
        doctors      Jafi Alissa Lipson
                         Sunita Pal

                       6 women >40
        Patients
                       8 women <40


                       Alicia X-ray
       Technicians
                      mammography


        Hospital       Paul Billings
        Managers      Holly V. Gautier
MammOptics
  Hospital purchasing decision tree
MammOptics
  Hospital purchasing decision tree
MammOptics
 Private practice purchasing decision tree
MammOptics
 Private practice purchasing decision tree
MammOptics
 Business Model Canvas 2 of 4


                         Product          Doctors:       Strong clinical
                      Development          Earlier            data
Hospitals (Capital          IP            detection         Training
   Spending           Clinical trials       Price         Maintenance       Pioneering
  Committee)               FDA            Accuracy                           Doctors
Leading doctors                                                             Hospitals
    3rd party                             Patients:                         OB/GYNs
 manufacturers                          Radiation Free                         PCPs
  Distributors                          Non-Invasive
                           IP                            Direct Sales to
   Research                                                 doctors
                     Leading doctors
   Hospitals
                        Technical
                        Expertise


            Product Development
                Clinical trials                          Capital Equipment Sales
              Operating Costs                              and disposable item
MammOptics
 Business Model Canvas 2 of 4


                         Product          Doctors:       Strong clinical
                      Development          Earlier            data
Hospitals (Capital          IP            detection         Training
   Spending           Clinical trials       Price         Maintenance       Pioneering
  Committee)               FDA            Accuracy                           Doctors
Leading doctors                                                             Hospitals
    3rd party                             Patients:                         OB/GYNs
 manufacturers                          Radiation Free                         PCPs
  Distributors                          Non-Invasive
                           IP                            Direct Sales to
   Research                                                 doctors
                     Leading doctors
   Hospitals
                        Technical
                        Expertise


            Product Development
                Clinical trials                          Capital Equipment Sales
              Operating Costs                              and disposable item
Getting to our customer
he world of direct sales and medical marketing
MammOptics
   Interviews


      Breast Cancer  Be Bright Pink
     Advocacy Groups Jennifer Glover

                       Dr. Cindy Woo
        OB/GYNs       Dr. Jags Powers
                          Dr. Aaron
                          Shuvkan
                        Katrina Bell
      Medical Sales   Tanay Dudhela
                         Jed Hwang

       FDA/Clinical   Phyllis Whitely
         Trials       Carl Simpson
MammOptics
   Marketing
                        Key Opinion
                       Leaders (KOLs)

   American College
    of Obstetricians
                                          Medical Journals
   and Gynecologists
        (ACOG)


                        Market
                       Adoption

     Breast Cancer                         Continuing
    Advocacy Groups                     Medical Education


                        Conferences
MammOptics
    Marketing
Strong influence on
 doctors via ACOG            Key Opinion Leaders
 Standard of Care Strongly (KOLs)
    American College  influenced by
     of Obstetricians
    and Gynecologists      KOLs                      Medical Journals
         (ACOG)

  Access to
  ACOG by                         Market
   former                        Adoption
   member
     American College
      of Obstetricians                                Continuing
     and Gynecologists                             Medical Education
          (ACOG)

                                   Conferences
MammOptics
   Marketing                                         Researchers
     Researchers                                      with strong
          conducting                                     peer
           important          Key Opinion Leaders
                                                    recommendati
         clinical trials            (KOLs)
               Researchers                                ons
   American College                                 Outsourced
    of Obstetricians with                              survey Journals
                                                            Medical
                 numerous
   and Gynecologists
        (ACOG)                                        research
               publications
                                Market
                               Adoption

   American College
    of Obstetricians                                        Continuing
   and Gynecologists                                     Medical Education
        (ACOG)

                                Conferences
MammOptics
   Marketing
                                                     Focus on
                        Key Opinion Leaders          prominent
                              (KOLs) Needtwo big
                                                      journals
                                    publications
   American College
    of Obstetricians
                                                 Medical Journals
   and Gynecologists
        (ACOG)


                          Market               Choose KOL as
                         Adoption                 Principal
                                              Investigators (PI)
    American College
     of Obstetricians                             Continuing
    and Gynecologists                          Medical Education
         (ACOG)

                          Conferences
MammOptics
   Marketing
                        Key Opinion Leaders
                              (KOLs)

   American College
    of Obstetricians
                                                Medical Journals
   and Gynecologists
        (ACOG)
                                                Effective
                          Market               method for
                         Adoption              educating
                                                doctors
    American College
     of Obstetricians   Workshop must            Continuing
    and Gynecologists                         Medical Education
         (ACOG)         be approved by
                             ACOG
                                 Doctors
                         Conferences
                               required to          Taught by
                                  attend            objective
                               workshops             medical
MammOptics
   Marketing
                         Key Opinion Leaders
                               (KOLs)

   American College
    of Obstetricians
                                                    Medical Journals
   and Gynecologists
        (ACOG)


                           Market
                          Adoption

    American College
     of Obstetricians                                 Continuing
                                                ACOG Education
    and Gynecologists                              Medical
         (ACOG)                                 Annual
           Opportunity                          Clinical
          for feedback     Conferences         Meeting
          from doctors                         Miami Breast
                                                  Cancer
                                               Conference
MammOptics
   Marketing
                             Key Opinion Leaders
                                   (KOLs)

   American College
    of Obstetricians
                                                     Medical Journals
   and Gynecologists
        (ACOG)

    Trusted
  information                  Market
   source for                 Adoption
    patients
     Breast Cancer                                    Continuing
    Advocacy Groups    Access to                   Medical Education
                        media
 Critical opinion       outlets
                              Conferences
    leader for
   technology
     adoption
MammOptics
 Channel Strategies and Costs

    High value             Direct Sales             Individual
                                                     Individual
  medical products                                    Doctors
                                                     Doctors
  (e.g. cardiovascular
         stents)           • Doctor education
                         • Direct feedback from
                                  doctors
                            • Very expensive

   Commodity                                        Purchasing
                                                    Purchasing
                           Distributors           Administrators
                                                   Administrators
 medical products
  (e.g. latex gloves)
                           • No doctor
                             education
                         • No customer
                              feedback
                          • Inexpensive
MammOptics
 Channel Strategies and Costs


                 Sales strategy 1       Sales strategy 2


             5 dedicated sales people   Continue with core
                $150,000 each/year        group of sales
                                              people
         Hire nurses or technicians
              with established             Use women’s
                relationships               healthcare
                                            equipment
             Early adopter feedback         distributor

                                        Already established
                                             network of
                                             customers
MammOptics
   Pricing Strategy

               Equipment   Lease model   Per-use   Consumable
                                          model
 Cost of the
                $50,000      $5,000      $5,000      $25,000
   device

Service per     $3,000       $10,000       0           0
   year

Per-use fee        0            0         $50          0


Consumable         0            0          0          $20
MammOptics
   Pricing Strategy

               Equipment   Lease model   Per-use   Consumable
                                          model
 Cost of the
                $50,000      $5,000      $5,000      $25,000
   device

Service per     $3,000       $10,000       0           0
   year

Per-use fee        0            0         $50          0


Consumable         0            0          0          $20
MammOptics
  Customer Workflow

        Current market      Insurance




                          Mammography          Radiologist




                     Technician            Hospital
                                         Administration



                                  ACOG       Doctor
                                   ACS      specialty
                                           committee
MammOptics
  Customer Workflow

        Current market      Insurance



       But what would
        happen if we
                          Mammography         Radiologist
           replace
       mammography?

                     Technician            Hospital
                                         Administration



                                  ACOG       Doctor
                                   ACS      specialty
                                           committee
MammOptics
  Customer Workflow

                            Insurance




                          Mammography              Radiologis
       Breast           Technicians           Hospitals
                                                      t
     Radiologists        Loss of jobs    Eliminates loss leader
      Loss of jobs                         Puts emphasis on
                                                biopsies
                     Technician                   Hospital
                                               Administration



                                  ACOG            Doctor
                                   ACS           specialty
                                                committee
MammOptics
  Customer Workflow

                       Insurance




                      Mammography        Radiologist




                Technician            Hospital
                                    Administration



                             ACOG       Doctor
                              ACS      specialty
                                      committee
MammOptics
  Customer Workflow

                                    Insurance




                                  Mammography        Radiologis
             Insurance                      ACOG/ACS     t
      Same cost as mammography                Improved healthcare
                 ($140)                   (mammography weak technique)
      Reduced number of biopsies
                ($1000)      Technician                     Hospital
                                                          Administration



                                          ACOG                Doctor
                                           ACS               specialty
                                                            committee
MammOptics
  Customer Workflow

                       Insurance




                      Mammography      Radiologist




                Technician            Hospital
                                    Administration



                             ACOG       Doctor
                              ACS      specialty
                                      committee
MammOptics
  Customer Workflow

                              Insurance




   Patient      PCP         Mammography       Radiologist
               OB/GY
                 N

                       Technician            Hospital
  MammOptics                               Administration



                                    ACOG       Doctor
                                     ACS      specialty
                                             committee
MammOptics
  Customer Workflow

                                       Insurance




   Patient           PCP             Mammography          Radiologis
       PCP OB/GYNs  OB/GY            Patient          MammOptics
                                                            t
                       N
       Increased revenue        Improved healthcare     Revenue
   More complete patient care        Comfort
                                Technician              Hospital
   MammOptic                                          Administration
      s

                                             ACOG         Doctor
                                              ACS        specialty
                                                        committee
MammOptics
  Customer Workflow

                              Insurance




  Patient       PCP         Mammography        Radiologist
               OB/GY
                 N

                       Technician            Hospital
  MammOptics                               Administration



                                    ACOG       Doctor
                                     ACS      specialty
                                             committee
MammOptics
    Business Model Canvas 3 of 4

                       Product                         Strong clinical
                    Development         Doctors:            data
                          IP             Earlier          Training
                    Clinical trials     detection       Maintenance
 Leading doctors         FDA                            Conferences
   Key Opinion                            Price                            OB/GYNs
                     Publishing         Accuracy       CME courses          PCPs
     Leaders
     3rd party
  manufacturers                         Patients:
   Distributors                       Radiation Free
  Breast Cancer                       Non-Invasive
                         IP                            Direct Sales to
   Foundations                                            hospitals
                   Leading doctors
      ACOG                                               Distributor
                      Technical
       ACS
                      Expertise


            Product Development
                Clinical trials                        Capital Equipment Sales
              Operating Costs                            and disposable item
              Marketing Costs                                Per use fees
MammOptics
    Business Model Canvas 3 of 4

                      Product                         Strong clinical
                   Development         Doctors:            data
                         IP             Earlier          Training
                   Clinical trials     detection       Maintenance
 Leading doctors        FDA                            Conferences
   Key Opinion                           Price                            OB/GYNs
                   Reimburseme         Accuracy       CME courses          PCPs
     Leaders       ntPublishing
     3rd party
  manufacturers                        Patients:
   Distributors                      Radiation Free
  Breast Cancer                      Non-Invasive
                         IP                           Direct Sales to
   Foundations                                           hospitals
                   Leading doctors
      ACOG                                              Distributor
                      Technical
       ACS
                      Expertise


            Product Development
                Clinical trials                       Capital Equipment Sales
              Operating Costs                           and disposable item
              Marketing Costs                               Per use fees
Building the company
The backstage of a medical device company
MammOptics
   Interviews
                              Stanford
     FDA Clinical Trials   StatisticsSteve
                              Axelrod
                           Marga Ortigas-
                             Wedekind
      Manufacturing        Nick Mourlas
                                 Don
                            Archambault
                       Shannon Bergstedt
     Reimbursement
                           Ali Habib


         Venture
                            Dana Mead
        Capitalists
                            Bill Starling

      Doctors/Sales         Dr. Aron
                            Shuftan
                           Jed Hwang
MammOptics
   Partners

 Manufacturing


                     Choose
                 manufacturing
                 facility close to
                       home
MammOptics
   Partners

 Manufacturing                      Reimbursement



                 Difficult to get
                 coverage for
                 new product.
MammOptics
   Reimbursement Partners

                            Insurances




 CPT Codes
  $75-$150
MammOptics
   Partners

 Manufacturing                    Reimbursement


                 510K vs. PMA
                  Largest cost
                    Biggest
                 financial risk



                                   FDA Clinical
                                     Trials
MammOptics
  Clinical Trials




    Stage 1          Feasibility
   Pilot trials     Comparison
   50 patients         with
     $600K          mammograph
                         y

    6 months


                                   12/4/2009
MammOptics
  Clinical Trials


                   Stage 2
                  Interim trials   Prove superior
                                   safety-efficacy
    Stage 1       500 patients      & sensitivity
   Pilot trials      $7.2M




    6 months 15 months


                                                     12/4/2009
MammOptics
  Clinical Trials


                   Stage 2
                  Interim trials
    Stage 1                          Stage 3        FDA class II,
   Pilot trials                     FDA pivotal    510(K) w/ trials
                                       trials        Focus on
                                   1500 patients    superiority &
                                      $20.5M       economic end-
                                                       points
    6 months 15 months              24 months


                                                            12/4/2009
MammOptics
  Clinical Trials

                                                    Stage 4
                                                   Post-market
                   Stage 2
                                                     studies
                  Interim trials                  2000 patients
    Stage 1                         Stage 3          $26.8M
   Pilot trials                    FDA pivotal
                                     trials       Specific Cat III
                                                 CPT/ACP Codes
                                                 Market traction


    6 months 15 months             24 months         24 months


                                                            12/4/2009
MammOptics
  Clinical Trials

                                                  Stage 4
                                                 Post-market
                   Stage 2
                                                   studies
                  Interim trials
                                                   $26.8M
    Stage 1          $7.2M          Stage 3
   Pilot trials                    FDA pivotal
                                     trials
     $600K
                                     $20.5M


    6 months 15 months             24 months      24 months


                                                        12/4/2009
MammOptics
  Clinical Trials




                    12/4/2009
MammOptics
   Partners

 Manufacturing               Reimbursement



                 Financial
                 timeline


    Funding                    FDA Clinical
                                 Trials
MammOptics
                      Financial / Operations Timeline
                                   2012                    2013             2014                2015               2016                  2017              2018
                             Q1 Q2    Q3 Q4       Q1 Q2      Q3 Q4    Q1    Q2   Q3 Q4   Q1    Q2   Q3   Q4 Q1   Q2      Q3    Q4   Q1   Q2   Q3 Q4    Q1 Q2/ IPO
                                                                                                                                                       M&A Q3
                      $40M
                                                                                                                                Series D                  $50 MM
       Cash Reserve




                      $30M                                                         Series C
                                                                                   $30.5 MM                                     $35 MM
                      $20M

                      $15M
                                                     Series B
                                                      $9 MM
                      $10M
                             Series A
                      $5M    $3.5 MM

                      Initialize         System
                                                                               Financial Regulatory / Clinical                                   Launch

                       Proof of        Beta            Marketable
Milestones




                                                                               timeline
                                                                                    Second Release
 Design




                       Concept       Prototype          Product
                                                  Beta-
                             Laborator            Versio         1st                                       2nd Release
                                 y                  n          Release                                         Test
                             Prototype            Testin        Test                                                     Publicatio
                                                    g                                 Publicatio                             n
Milestones




                                                                                          n
 Clinical




                                                   Pilot                                                            Clinical                  Post-Market Clinical
                                                  Studie            US Interim Trials      US Pivotal Clinical      Results                         Studies
                                                     s                                           Trials
                                                                                                                              Non-Specific Codes
Regulatory/ IP




                        Provision
                                                       IRB /      Cat III                                FDA – Class II – 510 (k)               Specific Codes
 Milestones




                        al Patent
                                                        IDE       CPT                                      with Clinical Trials                (Cat. I CPT / APC)
                                                                  Applicatio
                                                    IC and                                                                                 Initial
                                                                    n and
                       Technolog                  Processin                                                                               Product
                                                                   System
                           y                      g Patents                                                                               Launch
                                                                   Patents
                       Licensing                                                         151                                                         12/4/2009
MammOptics
                       Financial / Operations Timeline
                                    2012         2013              2014                2015           2016              2017              2018
                              Q1 Q2   Q3 Q4   Q1 Q2   Q3 Q4   Q1   Q2   Q3 Q4   Q1    Q2   Q3 Q4 Q1   Q2   Q3 Q4   Q1   Q2   Q3 Q4   Q1   Q2   Q3
                       $40M
        Cash Reserve




                       $30M

                       $20M

                       $15M

                       $10M

                       $5M




                       Initialize

                        Proof of
 Milestones
  Design




                        Concept
 Milestones
  Clinical




Provision
 Regulatory/ IP
  Milestones




al Patent




Technolog
    y
Licensing                                                                       152                                              12/4/2009
MammOptics
                      Financial / Operations Timeline
                                   2012                    2013           2014                2015           2016              2017              2018
                             Q1 Q2    Q3 Q4       Q1 Q2      Q3 Q4   Q1   Q2   Q3 Q4   Q1    Q2   Q3 Q4 Q1   Q2   Q3 Q4   Q1   Q2   Q3 Q4   Q1   Q2   Q3
                      $40M
       Cash Reserve




                      $30M

                      $20M

                      $15M

                      $10M
                             Series A
                      $5M    $3.5 MM

                      Initialize         System

                       Proof of        Beta
Milestones
 Design




                       Concept       Prototype
                                                  Beta-
                             Laborator            Versio
                                 y                  n
                             Prototype            Testin
                                                    g
Milestones
 Clinical




                                                   Pilot
                                                  Studie
                                                     s
Regulatory/ IP




                       Provision
 Milestones




                       al Patent



                       Technolog
                           y
                       Licensing
                                                                                       153                                              12/4/2009
MammOptics
                      Financial / Operations Timeline
                                 2012                      2013            2014                2015             2016              2017              2018
                             Q1 Q2    Q3 Q4       Q1 Q2      Q3 Q4    Q1   Q2   Q3 Q4   Q1    Q2   Q3 Q4 Q1     Q2   Q3 Q4   Q1   Q2   Q3 Q4   Q1   Q2   Q3
                      $40M
       Cash Reserve




                      $30M

                      $20M

                      $15M
                                                     Series B
                                                      $9 MM
                      $10M
                             Series A
                      $5M    $3.5 MM

                                         System                                         Regulatory / Clinical

                                       Beta            Marketable
Milestones
 Design




                                     Prototype          Product
                                                  Beta-
                             Laborator            Versio
                                 y                  n
                             Prototype            Testin
                                                    g
Milestones
 Clinical




                                                   Pilot
                                                  Studie
                                                     s
Regulatory/ IP




                                                       IRB /
 Milestones




                                                        IDE
                                                                  Applicatio
                                                    IC and
                                                                    n and
                                                  Processin
                                                                   System
                                                  g Patents
                                                                   Patents
                                                                                        154                                                12/4/2009
MammOptics
                      Financial / Operations Timeline
                                 2012               2013                2014                2015             2016              2017              2018
                             Q1 Q2   Q3 Q4     Q1 Q2    Q3 Q4     Q1    Q2   Q3 Q4   Q1    Q2   Q3 Q4 Q1     Q2   Q3 Q4   Q1   Q2   Q3 Q4   Q1   Q2   Q3
                      $40M
       Cash Reserve




                      $30M                                                     Series C
                      $20M
                                                                               $30.5 MM
                      $15M
                                                  Series B
                                                   $9 MM
                      $10M

                      $5M




                                      System                                         Regulatory / Clinical
Milestones




                                                                                Second Release
 Design




                                                              1st
                                                            Release
                                                             Test
                                                                                 Publicatio
Milestones




                                                                                     n
 Clinical




                                                Pilot
                                               Studie          US Interim Trials      US Pivotal Clinical
                                                  s                                         Trials
Regulatory/ IP




                                                    IRB /     Cat III
 Milestones




                                                     IDE      CPT
                                                              Applicatio
                                                 IC and
                                                                n and
                                               Processin
                                                               System
                                               g Patents
                                                               Patents
                                                                                     155
MammOptics
                      Financial / Operations Timeline
                                 2012           2013              2014                2015                2016               2017               2018
                             Q1 Q2   Q3 Q4   Q1 Q2   Q3 Q4   Q1   Q2   Q3 Q4   Q1    Q2   Q3 Q4 Q1      Q2      Q3 Q4   Q1   Q2   Q3 Q4    Q1   Q2   Q3
                      $40M
                                                                                                                      Series D
       Cash Reserve




                      $30M                                               Series C
                                                                         $30.5 MM                                     $35 MM
                      $20M

                      $15M

                      $10M

                      $5M




                                                                               Regulatory / Clinical                                Launch
Milestones




                                                                          Second Release
 Design




                                                                                                  2nd Release
                                                                                                      Test
                                                                                                                Publicatio
                                                                           Publicatio                               n
Milestones




                                                                               n
 Clinical




                                                                                                           Clinical
                                                         US Interim Trials      US Pivotal Clinical        Results
                                                                                      Trials
                                                                                                                 Non-Specific Codes
Regulatory/ IP




                                                                                                FDA – Class II – 510 (k)
 Milestones




                                                                                                  with Clinical Trials

                                                                                                                               Initial
                                                                                                                              Product
                                                                                                                              Launch
                                                                               156                                                       12/4/2009
MammOptics
                      Financial / Operations Timeline
                                 2012           2013              2014                2015                2016               2017              2018
                             Q1 Q2   Q3 Q4   Q1 Q2   Q3 Q4   Q1   Q2   Q3 Q4   Q1    Q2   Q3 Q4 Q1      Q2   Q3 Q4      Q1   Q2   Q3 Q4    Q1 Q2/ IPO
                                                                                                                                           M&A Q3
                      $40M
                                                                                                                      Series D                $50 MM
       Cash Reserve




                      $30M
                                                                                                                      $35 MM
                      $20M

                      $15M

                      $10M

                      $5M




                                                                               Regulatory / Clinical                                 Launch
Milestones
 Design




                                                                                                              Publicatio
                                                                                                                  n
Milestones
 Clinical




                                                                                                           Clinical               Post-Market Clinical
                                                                                                           Results                      Studies

                                                                                                                Non-Specific Codes
Regulatory/ IP




                                                                                                FDA – Class II – 510 (k)            Specific Codes
 Milestones




                                                                                                  with Clinical Trials             (Cat. I CPT / APC)

                                                                                                                               Initial
                                                                                                                              Product
                                                                                                                              Launch
                                                                                                                                         12/4/2009
MammOptics
                      Financial / Operations Timeline
                                   2012                    2013             2014                2015                2016               2017              2018
                             Q1 Q2    Q3 Q4       Q1 Q2      Q3 Q4    Q1    Q2   Q3 Q4   Q1    Q2   Q3 Q4 Q1      Q2      Q3 Q4   Q1   Q2   Q3 Q4    Q1 Q2/ IPO
                                                                                                                                                     M&A Q3
                      $40M
                                                                                                                                Series D                $50 MM
       Cash Reserve




                      $30M                                                         Series C
                                                                                   $30.5 MM                                     $35 MM
                      $20M

                      $15M
                                                     Series B
                                                      $9 MM
                      $10M
                             Series A
                      $5M    $3.5 MM

                      Initialize         System                                          Regulatory / Clinical                                 Launch

                       Proof of        Beta            Marketable
Milestones




                                                                                    Second Release
 Design




                       Concept       Prototype          Product
                                                  Beta-
                             Laborator            Versio         1st                                        2nd Release
                                 y                  n          Release                                          Test
                             Prototype            Testin        Test                                                      Publicatio
                                                    g                                 Publicatio                              n
Milestones




                                                                                          n
 Clinical




                                                   Pilot                                                             Clinical               Post-Market Clinical
                                                  Studie            US Interim Trials      US Pivotal Clinical       Results                      Studies
                                                     s                                           Trials
                                                                                                                           Non-Specific Codes
Regulatory/ IP




                        Provision
                                                       IRB /      Cat III                                 FDA – Class II – 510 (k)            Specific Codes
 Milestones




                        al Patent
                                                        IDE       CPT                                       with Clinical Trials             (Cat. I CPT / APC)
                                                                  Applicatio
                                                    IC and                                                                               Initial
                                                                    n and
                       Technolog                  Processin                                                                             Product
                                                                   System
                           y                      g Patents                                                                             Launch
                                                                   Patents
                       Licensing                                                         158                                                       12/4/2009
MammOptics
    Business Model Canvas 4 of 4

                      Product                         Strong clinical
                   Development         Doctors:            data
                         IP             Earlier          Training
                   Clinical trials     detection       Maintenance
     KOLs               FDA                            Conferences
    3rdparty                             Price                             OB/GYNs
                   Reimburseme         Accuracy       CME courses           PCPs
 manufacturers     nt Publishing
  Distributors                        Immediate
 Breast Cancer                          Results
  Foundations
     ACOG                              Patients:
                         IP          Radiation Free   Direct Sales to
      ACS                                                hospitals
                   Leading doctors   Non-Invasive
  Clinical trial                                        Distributor
                      Technical
   designer                                               Online
                      Expertise


            Product Development
                Clinical trials                             Per use fees
              Operating Costs
              Marketing Costs
MammOptics
 Business Model Canvas 4 of 4

                      Product                             Strong clinical
                   Development                                 data
                         IP                                  Training
                   Clinical trials                         Maintenance
     KOLs               FDA                                Conferences
    3rdparty                          Earlier detection                        OB/GYNs
                   Reimburseme         Non invasive       CME courses           PCPs
 manufacturers     nt Publishing
 Breast Cancer                              Price
  Foundations                            Accuracy
     ACOG                            Immediate Results
      ACS                                                 Direct Sales to
                         IP
  Clinical trial                                             hospitals
                   Leading doctors
   designer                                                 Distributor
                      Technical
                      Expertise                               Online


            Product Development
                Clinical trials                                 Per use fees
              Operating Costs
              Marketing Costs
MammOptics
   Business Model Canvas 1


                       Product                            Strong clinical
                    Development                                data
                          IP                                 Training
    Hospitals
                    Clinical trials    Radiation-free      Maintenance       Pioneering
 Leading doctors
                         FDA          Earlier detection                       Doctors
     3rd party
                                       Non invasive                          Hospitals
  manufacturers
   Distributors

                         IP                               Direct Sales to
                   Leading doctors                           hospitals
                      Technical
                      Expertise


          Product Development
              Clinical trials                             Capital Equipment Sales
            Operating Costs                                 and disposable item
MammOptics
    Business Model Canvas 2


                       Product                            Strong clinical
                    Development                                data
                          IP                                 Training
                    Clinical trials    Radiation-free      Maintenance       Pioneering
    Hospitals
                         FDA          Earlier detection                       Doctors
 Leading doctors
                                       Non invasive                          Hospitals
     3rd party
  manufacturers
   Distributors
    Research             IP                               Direct Sales to
    Hospitals      Leading doctors                           hospitals
                      Technical
                      Expertise


            Product Development
                Clinical trials                           Capital Equipment Sales
              Operating Costs                               and disposable item
MammOptics
     Business Model Canvas 3


                         Product          Doctors:       Strong clinical
                      Development          Earlier            data
Hospitals (Capital          IP            detection         Training
   Spending           Clinical trials       Price         Maintenance       Pioneering
  Committee)               FDA            Accuracy                           Doctors
Leading doctors                                                             Hospitals
    3rd party                             Patients:
 manufacturers                          Radiation Free
  Distributors                          Non-Invasive
                           IP                            Direct Sales to
   Research                                                 hospitals
                     Leading doctors
   Hospitals
                        Technical
                        Expertise


            Product Development
                Clinical trials                          Capital Equipment Sales
              Operating Costs                              and disposable item
MammOptics
    Business Model Canvas 4


                         Product          Doctors:       Strong clinical
                      Development          Earlier            data
Hospitals (Capital          IP            detection         Training
   Spending           Clinical trials       Price         Maintenance       Pioneering
  Committee)               FDA            Accuracy                           Doctors
Leading doctors                          Immediate                          Hospitals
    3rd party                              Results                          OB/GYNs
 manufacturers                                                                 PCPs
  Distributors                            Patients:
                           IP           Radiation Free   Direct Sales to
   Research                                                 hospitals
                     Leading doctors    Non-Invasive
   Hospitals
                        Technical
 Breast Cancer
                        Expertise
  Foundations


            Product Development
                Clinical trials                          Capital Equipment Sales
              Operating Costs                              and disposable item
MammOptics
    Business Model Canvas 5

                      Product                         Strong clinical
                   Development         Doctors:            data
                         IP             Earlier          Training
                   Clinical trials     detection       Maintenance
 Leading doctors        FDA                            Conferences
   Key Opinion                           Price                            OB/GYNs
                   Reimburseme         Accuracy       CME courses          PCPs
     Leaders       ntPublishing
     3rd party
  manufacturers                        Patients:
   Distributors                      Radiation Free
  Breast Cancer                      Non-Invasive
                         IP                           Direct Sales to
   Foundations                                           hospitals
                   Leading doctors
      ACOG                                              Distributor
                      Technical
       ACS
                      Expertise


            Product Development
                Clinical trials                       Capital Equipment Sales
              Operating Costs                           and disposable item
              Marketing Costs
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
Steve Blank "Entrepreneurial education"
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Steve Blank "Entrepreneurial education"

  • 1. Demolishing the Status Quo in Entrepreneurial Education
  • 2. I Write a Blog www.steveblank.com
  • 3. This Talk is Based On Business Model Generation Four Steps to the Epiphany The Lean Startup
  • 4. This Talk • What’s a Startup? • Search versus Execution • Entrepreneurship As a Mgmt Science • B-Schools = Large company mgmt • Incubators = the transition • E-School = the conclusion
  • 5. First - What’s A Startup? Six Types of Startups
  • 6. Lifestyle Startups Work to Live their Passion Startup • Serve known customer with known product • Pay for their passion
  • 7. Small Business Startups Work to Feed the Family Small Startup Business • Serve known customer with known product • Feed the family
  • 8. Small Business Startups Work to Feed the Family Small Startup Business Exit Criteria • known customer - Business Model found known product - Profitable business • Feed the family - Existing team < €100K in revenue
  • 9. Small Business Startups Small Startup Business - Business Model found - Profitable business - Existing team < $10M in revenue • 5.7 million small businesses in the U.S. <500 employees • 99.7% of all companies • ~ 50% of total U.S. workers http://www.sba.gov/advo/stats/sbfaq.pdf
  • 10. Scalable Startup Search Scalable Large Startup Company Goal is to solve for: unknown customer and unknown features
  • 11. Scalable Startup Born to Be Big Search Execute Scalable Large Startup Company Exit Criteria - Business model found - Total Available Market > €300m - Can grow to €50/year
  • 12. Scalable Startup Search Execute Scalable Large Startup Company - Total Available Market > $500m - Company can grow to $100m/year - Business model found - Focused on execution and process - Typically requires “risk capital” • In contrast a scalable startup is designed to grow big • Typically needs risk capital • What Silicon Valley means when they say “Startup”
  • 13. The Transition – Founders Leave Scalable Large Transition Startup Company Search Build Execute Founders depart - Operating executives - Professional Mgmt - Process - Beginning of scale
  • 14. Buyable Startup Born to Be Big Search Sell Scalable €3 to 30M Startup Acquisition Goal is to solve for: Internet, Mobile, Gaming Apps
  • 15. Buyable Startup Search Sell Scalable €3 to e0M Startup Acquisition Goal is to solve for: Sell to larger company Internet and Mobile Apps
  • 16. What’s A Startup? Search Execute Scalable Large Startup Company -Business Model found - i.e. Product/Market fit - Repeatable sales model - Managers hired A Startup is a temporary organization used to search for a repeatable and scalable business model
  • 17. Large Company Sustaining Innovation Innovate or Evaporate Sustaining Innovation Scalable Large Transition Startup Company • Existing Market / Known customer •Known product feature needs
  • 18. Large Company Disruptive Innovation New Large Transition Division Company Disruptive Innovation •New Market •New tech, customers, channels
  • 19. Large Company Disruptive Innovation New Large Transition Division Company Disruptive Innovation •Build •Acquire - IP - Talent - Product - Customers - Business
  • 20. Social Entrepreneurship Startups Social Large Startup Non-Profit • Solve pressing social problems • Social Enterprise: Profitable • Social Innovation: New Strategies
  • 21. Each of these startups require different skills They Can Not Be Taught the Same Way
  • 22. Search Versus Execution Why Accountants Don’t Run Startups
  • 23. Startups Search and Pivot The Search for the Business Model Scalable Large Transition Startup Company Business Model found - customer needs/product features found i.e. Product/Market fit -Found by founders, not employees - Repeatable sales model - Managers hired
  • 24. Startups Search, Companies Execute The Search for the Business Model The Execution of the Business Model Scalable Large Transition Startup Company -Business Model found - Cash-flow breakeven - Product/Market fit - Profitable - Repeatable sales model - Managers hired - Rapid scale - New Senior Mgmt ~ 150 people
  • 25. Metrics Versus Accounting The Execution of the Business Model Scalable Large Transition Startup Company Traditional Accounting -Balance Sheet - Cash Flow Statement - Income Statement
  • 26. Metrics Versus Accounting The Search for the Business Model The Execution of the Business Model Scalable Large Transition Startup Company Startup Metrics - Customer Acquisition Cost Traditional Accounting - Balance Sheet - Viral coefficient - Cash Flow Statement - Customer Lifetime Value - Income Statement - Average Selling Price/Order Size - Monthly burn rate - etc.
  • 27. Customer Validation Versus Sales The Execution of the Business Model Scalable Large Transition Startup Company Sales -Sales Organization - Scalable - Price List/Data Sheets - Revenue Plan
  • 28. Customer Validation Versus Sales The Search for the Business Model The Execution of the Business Model Scalable Large Transition Startup Company Customer Validation - Early Adopters Sales - Sales Organization - Pricing/Feature unstable - Scalable - Not yet repeatable - Price List/Data Sheets -“One-off’s” - Revenue Plan - Done by founders
  • 29. Customer Development Versus Product Management The Execution of the Business Model Scalable Large Transition Startup Company Product Management - Delivers MRD’s - Feature Spec’s - Competitive Analysis - Prod Mgmt driven
  • 30. Customer Development Versus Product Management The Search for the Business Model The Execution of the Business Model Scalable Large Transition Startup Company Customer Development Product Management - Delivers MRD’s - Hypothesis Testing - Feature Spec’s - Minimum Feature Set - Competitive Analysis - Pivots - Founder-driven
  • 31. Engineering Versus Agile Development The Execution of the Business Model Scalable Large Transition Startup Company Engineering - Requirements Docs. - Waterfall Development - QA - Tech Pubs
  • 32. Engineering Versus Agile Development The Search for the Business Model The Execution of the Business Model Scalable Large Transition Startup Company Agile Development Engineering - Requirements Docs. - Continuous Deployment - Waterfall Development - Continuous Learning - QA - Self Organizing Teams - Tech Pubs - Minimum Feature Set - Pivots
  • 33. Startups Model, Companies Plan The Execution of the Business Model Scalable Large Transition Startup Company Business Plan -Plan describes “knowns” - Known features for line extensions - Known customers/markets - Known business model
  • 34. Startups Model, Companies Plan The Search for the Business Model The Execution of the Business Model Scalable Large Transition Startup Company Business Model -Plan describes “knowns” - Known features for line extensions - Unknown customer needs - Known customers/markets - Unknown feature set - Known business model - Unknown business model - Model found by iteration
  • 35. Startups Are Not Small Versions of Large Companies Scalable Large Transition Startup Company Search Build Execute Yet our curriculums assume they are – we teach that the knowledge is interchangeable
  • 36. Entrepreneurship as a Management Science E-School instead of B-School
  • 37. Business as a Management Science • 1601 East India Company • 300 years of companies without MBA credentials •1908 Harvard first MBA
  • 38. Business School Topics Business School Scalable Large Transition Startup Company -Execution - Strategy - Accounting - Products - Engineering - Management -Administration
  • 39. Business School Courses Business School Scalable Large Transition Startup Company Courses -Managerial Finance/Accounting - Managing Groups and Teams - Financial Accounting - Operations - Modeling for Optimization - Global Value Chain Strategies
  • 40. B-School Results? • U.S. corporations went from local to national then international •Cadre of experienced managers to match • Experts on finance and growth (Dupont/GM) B-Schools made the 20th Century the American business century
  • 41. Business School Focus on Large Company Strategies Execution versus Search
  • 42. Business School Limitations •Most Professors consult for large corporations • Most believe startups are just smaller versions of large companies • Most B-school entrepreneurship programs are side-shows
  • 43. Irony: 21st Century Job Growth will Come from New Ventures
  • 44. Incubators a Reaction to the lack of Practical University Entrepreneurship • 1959 Josephy Mancuso - Batavia Industrial Ctr. • 1996 IdeaLab •2005 Y-Combinator •2011 100+ Incubators world-wide
  • 45. Startup Incubators •Hands-on (experience vs. theory) • Goal: create a company and jobs • Full-time residential, stipend-based program • Curriculum: product development + best practices
  • 46. What’s Missing? A Repeatable Methodology Not Just War Stories
  • 47. Startups Are Not Smaller Versions of Large Companies Large Companies Execute Known Business Models
  • 48. Startups Are Not Smaller Versions of Large Companies Startups Search for Unknown Business Models
  • 49. E-School •Complete curriculum with Hands-on emphasis • Goal: methodology for startup creation • Can be taught anywhere - University - Incubator - Remotely • Curriculum: about the search for a business model
  • 50. The Business Model: Any company can be described in 9 building blocks
  • 51. CUSTOMER SEGMENTS which customers and users are you serving? which jobs do they really want to get done?
  • 52. VALUE PROPOSITIONS what are you offering them? what is that getting done for them? do they care?
  • 53. CHANNELS how does each customer segment want to be reached? through which interaction points?
  • 54. CUSTOMER RELATIONSHIPS what relationships are you establishing with each segment? personal? automated? acquisitive? retentive?
  • 55. REVENUE STREAMS what are customers really willing to pay for? how? are you generating transactional or recurring revenues?
  • 56. KEY RESOURCES which resources underpin your business model? which assets are essential?
  • 57. KEY ACTIVITIES which activities do you need to perform well in your business model? what is crucial? 57
  • 58. KEY PARTNERS which partners and suppliers leverage your model? who do you need to rely on?
  • 59. COST STRUCTURE what is the resulting cost structure? which key elements drive your costs?
  • 60. key value customer activities proposition relationships key customer partners segments cost revenue structure key streams resources channels 60 images by JAM
  • 64. 9 Guesses Guess Guess Guess Guess Guess Guess Guess Guess Guess
  • 65. Customer Development The founders ^Get Out of the Building
  • 66. Customer Development The Search For the Business Model Customer Customer Customer Company Discovery Validation Creation Building Pivot
  • 67. Customer Discovery Customer Customer Customer Company Discovery Validation Creation Building • Stop selling, start listening • Test your hypotheses • Continuous Discovery • Done by founders
  • 68. Turning Hypotheses to Facts Test Hypotheses: •Product • Market Type • Competition
  • 70. Test Hypotheses: •Channel
  • 71. Test Hypotheses Test Test : Hypothese Test Hypotheses: •Demand s: Hypothese •Product Creation •Problem s: • Market • •Channel Type Customer • • Test • User (Customer Competitive Hypotheses: • Payer ) •Channel • Test Hypotheses: Test Hypotheses: (Problem) •Size of •Pricing Model / Opportunity/Market Pricing
  • 72. Test Agile Hypotheses Test Test : Hypothese Test Developme Hypotheses: •Demand s: nt Hypothese •Product Creation •Problem s: • Market • •Channel Customer Type Customer • Developme • Test • User (Customer nt Team Competitive Hypotheses: • Payer ) •Channel • Test Hypotheses: Test Hypotheses: (Problem) •Size of •Pricing Model / Opportunity/Market Pricing
  • 73. The Minimum Viable Product (MVP) • Smallest feature set that gets you the most … - orders, learning, feedback, failure…
  • 74. The Pivot •The heart of Customer Development •Iteration without crisis •Fast, agile and opportunistic
  • 75. Pivot Cycle Time Matters •Speed of cycle minimizes cash needs •Minimum feature set speeds up cycle time • Near instantaneous customer feedback drives feature set
  • 76. The Pivot A Pivot is the change of one or more Business Model Canvas Components
  • 77. The Pivot Product Strong clinical Development Doctors: data IP Earlier Training Leading doctors A Pivot is the change of one or more Clinical trials FDA detection Maintenance Conferences Key Opinion Price OB/GYNs Leaders Business Model Canvas Components PCPs Publishing Accuracy CME courses 3rd party manufacturers Patients: Distributors Radiation Free Breast Cancer Non-Invasive IP Direct Sales to Foundations hospitals Leading doctors ACOG Distributor Technical ACS Expertise Product Development Clinical trials Capital Equipment Sales Operating Costs and disposable item Marketing Costs Per use fees
  • 78. How Does This Really Work? Stanford Lean LaunchPad Class
  • 79. How Does This Really Work? Stanford Lean LaunchPad Class 8 Weeks From an Idea to a Business
  • 80. Pivot Example Robotic Weeding Talked 75 Customers in 8 Weeks
  • 82. 20 interviews, 6 site visits… We got OUR Boots dirty Weeding Visited two farms in Salinas Valley to better understand problem Interviewed: • Bolthouse Farms, Large Agri-Industry in Bakersfield • White Farms, Large Peanut farmer in Georgia • REFCO Farms, large grower in Salinas Valley • Rincon Farms, large grower in Salinas Valley • Small Organic Corn/Soy grower in Nebraska • Heirloom Organics, small owner/operator, Santa Cruz Mts • Two small organic farmers at farmers market • Ag Services of Salinas, Fertilizer applicator Mowing Interviewed: • Golf: Stanford Golf course • Parks: Stanford Grounds Supervisor, head of maintenance and lead operator (has crew of 6) • Toro dealer (large mower manufacturer) • User of back-yard mowing system • Maintenance Services for City of Los Altos • Colony Landscaping (Mowing service for stadiums)
  • 83. Business Plan Autonomous Vehicles for Mowing & Weeding - Innovation Dealers sell, Mowing - Dealers - Customer We reduce installs and - Owners of (Mowing and Education operating cost supports customer public or Ag) - Dealer training - Labor reduction commercially - Vehicle OEMs - Better Co. trains dealers, used green (John Deere, utilization of supports dealers spaces (e.g. golf Toro, Jacobsen, assets (eg mow or courses) etc) weed at nights) - Landscaping Engineers on - Improved - Mowing service provider - Research labs Autonomous performance (less Dealers vehicles, GPS, rework, food - Ag Dealers Weeding path-planning safety) - Farmers with manual weeding operations Dealer discount Asset sale COGS seek a 50-60% Gross Margin Our revenue stream derives from selling the Heavy R&D investment equipment
  • 84. Found weeding in organic crops is HUGE problem; 50 - 75% of costs Crews of 100s-1000 Back-breaking task (Ilegal) labor harder to get 1-5 weedings per year/field $250-3,500 per acre and increasing Food contamination risk
  • 85. Decision to make – mowing vs weeding Application If ROI is < 1 Labor costs Autonomous TAM yr they will significant? would solve buy problem? Mowing of Yes. Yes Yes Adjusted up to Professionally xxx large fields run organizations Weeding in Agri Industry: YES! for TAM increased YES! organic crops Not necessarily to $2.6 B (Total Agriculture organic) Large They are Key need is Growers: Yes spending weed vs. crop Target Market $500/ac! differentiation (organic Small specialty) Growers: No 162 M/yr 18%/yr growth
  • 86. Autonomous vehiclesWEEDING - Innovation Dealers sell, - Low density - Ag Dealers - Customer We reduce installs and vegetable - Ag Service Education operating cost supports customer growers providers - Dealer training - Labor reduction - High density (100 to 1) Co. trains dealers, vegetable - Research labs - Reduced risk of supports dealers growers contamination - Thinning - Mitigate labor operations Engineers on availability - Ag Dealers - Conventional Machine Vision concerns - Ag Service vegetables Two problems: providers - Identification - Elimination Dealer discount Asset sale COGS seek a 50-60% Gross Margin Our revenue stream derives from selling the Heavy R&D investment equipment
  • 87. 1 Week – 1 CarrotBot
  • 88. CARROTBOT  Machine Vision data collection platform  Monochrome & Color Cameras  Laser-line sweep (depth measurement)  Encoders CarrotBot 1.0 (position/velocity)  Onboard data acquisition & power
  • 89. The Business Plan Canvas Updated •Technology •Farming Design conventions. •Marketing •Demo, demo, •Demo and and demo!! customer •Cost •Proximity is •Organic •Research Labs feedback paramount Farmers Reduction •Equipment •Weeding •Remove labor Manufacturers Service force pains •Distribution Providers •Eliminate bio- Network •Conventional waste hazards •Service •IP – Patents Farmers Providers •Video •Dealers Classifier Files •Direct Service •Robust •Indirect Service Technology • … then Dealers •Asset Sale Value-Driven •Direct Service with equipment rental •… then Asset Sale
  • 90. Visit Highlights Above: Organic Carrots, 7wks. Top right: Conventional carrots Bottom Right: Very weedy. Will require multiple passes of hand weeding
  • 91. Visit Highlights Carrot vs. Weeds Due to small root systems, carrots have no chance against weeds
  • 92. Visit Highlights Organic Broccoli, closely cultivated. Weeds close to plants are hand-
  • 93. Visit Highlights State of the Art in Weeding Technology
  • 94. Customer Hypothesis Pre- Large Test Growers Us Dealer Industrial Growers Industrial Hypothesis Confirmed • Growers interested in own equipment Growers • Industrial (10,000s of acres) Post- • Large (1,000s of acres) Large • Willing to pay $100k for one Test Growers unit Us Dealer Service • Smaller growers (100s of acres) Providers usually subcontract the labor services or rent equipment Equipment Rental • All purchases through local dealers •Customer service is essential
  • 95. Customer Map #1 – Industrial Growers Example: Bolthouse Farms – Large Industrial Carrot Producer – 8K acres/yr End User • Equipment Operator Influencer • Local Farm Mgr • Cliff Kirkpatrick, visited Recommender • Director, Ag Equipment Technology Operator • Justin Grove, interviewed Decision Maker • VP, Growing Operations Approver • CFO, CEO (Jeff Dunn) Cliff, Farm Mgr
  • 96. Customer Map #2 – Service Providers Example: Ag Services – Service Provider, Salinas Valley End User • Equipment Operator Influencer • Grower Recommender • Service Mgr Me (left), Marty (middle, Service Mgr), Doug (right, Grower) Decision Maker & Approver • ?? (service mgr’s boss)
  • 97. The Business Plan Canvas Updated •Technology •Farming Design conventions. •Marketing •Demo, demo, •Mid/Large •Demo and and demo!! Organic Farmers customer •Cost •Proximity is •Agricultural •Research Labs feedback paramount Reduction corporations •Equipment •Remove labor •Weeding Service Manufacturers force pains Providers •Distribution •Eliminate bio- Network •Service •IP – Patents waste hazards •Mid/Large Providers •Video •Direct Service Conventional Classifier Files •Indirect Service Farmers •Robust • … then Dealers Technology •Direct Service with equipment rental Value-Driven •($1,500/d; 120d/yr ) •Low density: $1,500/d •High density: $6,000/d
  • 98. World Ag Expo interviews: the need is real and wide spread • 10+ interviews at show – Everyone confirmed the need – Robocrop, UK based, crude competitor sells for $171 K • Revenue Stream – Mid to small growers prefer a service – Large growers prefer to buy, but OK with service until technology is proven – Charging for labor cost saved is OK, as we provide other benefits (food safety, labor availability)
  • 99. The Business Plan Canvas Updated •Technology •Farming Design conventions. •Marketing •Demo, demo, •Mid/Large •Research Labs •Demo and and demo!! Organic Farmers •Equipment customer •Cost •Proximity is •Agricultural Manufacturer feedback Reduction paramount corporations •Distribution •Remove labor •Weeding Service Network force pains Providers •Service •Eliminate bio- Providers •IP – Patents waste hazards •Mid/Large •2 or 3 Key •Video •Direct Service Conventional Farms Classifier Files •Indirect Service Farmers •Robust • … then Dealers Technology Value-Driven •Direct Service with • R&D equipment rental • Bill of Materials •Low density: $1,500/d • Training & Service •High density: $6,000/d • Sales
  • 100. Autonomous weeding - Final - Innovation Direct - Low density - Ag Service - Customer We reduce - Provide high vegetable providers Education operating cost quality service at growers - Dealer training - Labor reduction competitive price - High density - Research (100 to 1) vegetable Institutes (eg UC - Reduced risk of growers Davis, Laser contamination - Thinning Zentrum - Mitigate labor operations Hannover) Engineers on availability Direct - Conventional Machine Vision concerns - Alliance with vegetables - 3-4 key farms Two problems: service providers - Identification - Eventually sell - Elimination through dealers Costs for service provision Service provision COGS seek a 50-60% Gross Margin - Charge by the acre with modifier according to Heavy R&D investment weed density - Eventually move to asset sale
  • 101. MammOptics Final project presentation for E 245 Winter 2011
  • 102. MammOptics Initial Idea Breast cancer Mammography Leading cause of cancer in women 15%-25% false negatives rate 190,000 diagnosis every year US 25% false positives rate 41,000 deaths every year US Requires X-ray radiation Increasing diagnosis rates Low resolution MammOptics Novel technology based on RF-modulated optical spectroscopy - Earlier detection - Non- radiative
  • 103. MammOptics Technology Comparison Invasivenes False False Device Time Risk Resolution s Pos. Neg. Cost Required MammOptics I.I.T.Y.I.W.H.T.K.Y Mammography High High .6 cm 25% 30% 20-50k 20 min. MRI Medium Medium .1 cm 70% 5% 1000k 45 min. Ultra-Sound Very Low Very Low >.6 cm >30% >40% 5-15k 20 min.
  • 104. MammOptics Business Model Canvas 1 of 4 Product Strong clinical Development data IP Training Hospitals Clinical trials Maintenance Leading doctors Pioneering FDA Radiation-free 3rd party radiologists in Earlier detection manufacturers hospitals Non-invasive Distributors IP Leading doctors Direct sales to Technical hospitals Expertise Product Development Clinical trials Capital equipment sales Operating Costs and disposable item
  • 105. MammOptics Business Model Canvas 1 1 of 4 Business Model Canvas of 4 Product Strong clinical Development data IP Training Hospitals Clinical trials Maintenance Leading doctors Pioneering FDA Radiation-free 3rd party radiologists in Earlier detection manufacturers hospitals Non-invasive Distributors IP Leading doctors Direct sales to Technical hospitals Expertise Product Development Clinical trials Capital equipment sales Operating Costs and disposable item
  • 106. Finding the right customer From radiologists to gynecologists
  • 107. MammOptics Excursions into hospitals Debra Ikeda Leading Jason Davies doctors Jafi Alissa Lipson Sunita Pal 6 women >40 Patients 8 women <40 Alicia X-ray Technicians mammography Hospital Paul Billings Managers Holly V. Gautier
  • 108. MammOptics Hospital purchasing decision tree
  • 109. MammOptics Hospital purchasing decision tree
  • 110. MammOptics Private practice purchasing decision tree
  • 111. MammOptics Private practice purchasing decision tree
  • 112. MammOptics Business Model Canvas 2 of 4 Product Doctors: Strong clinical Development Earlier data Hospitals (Capital IP detection Training Spending Clinical trials Price Maintenance Pioneering Committee) FDA Accuracy Doctors Leading doctors Hospitals 3rd party Patients: OB/GYNs manufacturers Radiation Free PCPs Distributors Non-Invasive IP Direct Sales to Research doctors Leading doctors Hospitals Technical Expertise Product Development Clinical trials Capital Equipment Sales Operating Costs and disposable item
  • 113. MammOptics Business Model Canvas 2 of 4 Product Doctors: Strong clinical Development Earlier data Hospitals (Capital IP detection Training Spending Clinical trials Price Maintenance Pioneering Committee) FDA Accuracy Doctors Leading doctors Hospitals 3rd party Patients: OB/GYNs manufacturers Radiation Free PCPs Distributors Non-Invasive IP Direct Sales to Research doctors Leading doctors Hospitals Technical Expertise Product Development Clinical trials Capital Equipment Sales Operating Costs and disposable item
  • 114. Getting to our customer he world of direct sales and medical marketing
  • 115. MammOptics Interviews Breast Cancer Be Bright Pink Advocacy Groups Jennifer Glover Dr. Cindy Woo OB/GYNs Dr. Jags Powers Dr. Aaron Shuvkan Katrina Bell Medical Sales Tanay Dudhela Jed Hwang FDA/Clinical Phyllis Whitely Trials Carl Simpson
  • 116. MammOptics Marketing Key Opinion Leaders (KOLs) American College of Obstetricians Medical Journals and Gynecologists (ACOG) Market Adoption Breast Cancer Continuing Advocacy Groups Medical Education Conferences
  • 117. MammOptics Marketing Strong influence on doctors via ACOG Key Opinion Leaders Standard of Care Strongly (KOLs) American College influenced by of Obstetricians and Gynecologists KOLs Medical Journals (ACOG) Access to ACOG by Market former Adoption member American College of Obstetricians Continuing and Gynecologists Medical Education (ACOG) Conferences
  • 118. MammOptics Marketing Researchers Researchers with strong conducting peer important Key Opinion Leaders recommendati clinical trials (KOLs) Researchers ons American College Outsourced of Obstetricians with survey Journals Medical numerous and Gynecologists (ACOG) research publications Market Adoption American College of Obstetricians Continuing and Gynecologists Medical Education (ACOG) Conferences
  • 119. MammOptics Marketing Focus on Key Opinion Leaders prominent (KOLs) Needtwo big journals publications American College of Obstetricians Medical Journals and Gynecologists (ACOG) Market Choose KOL as Adoption Principal Investigators (PI) American College of Obstetricians Continuing and Gynecologists Medical Education (ACOG) Conferences
  • 120. MammOptics Marketing Key Opinion Leaders (KOLs) American College of Obstetricians Medical Journals and Gynecologists (ACOG) Effective Market method for Adoption educating doctors American College of Obstetricians Workshop must Continuing and Gynecologists Medical Education (ACOG) be approved by ACOG Doctors Conferences required to Taught by attend objective workshops medical
  • 121. MammOptics Marketing Key Opinion Leaders (KOLs) American College of Obstetricians Medical Journals and Gynecologists (ACOG) Market Adoption American College of Obstetricians Continuing ACOG Education and Gynecologists Medical (ACOG) Annual Opportunity Clinical for feedback Conferences Meeting from doctors Miami Breast Cancer Conference
  • 122. MammOptics Marketing Key Opinion Leaders (KOLs) American College of Obstetricians Medical Journals and Gynecologists (ACOG) Trusted information Market source for Adoption patients Breast Cancer Continuing Advocacy Groups Access to Medical Education media Critical opinion outlets Conferences leader for technology adoption
  • 123. MammOptics Channel Strategies and Costs High value Direct Sales Individual Individual medical products Doctors Doctors (e.g. cardiovascular stents) • Doctor education • Direct feedback from doctors • Very expensive Commodity Purchasing Purchasing Distributors Administrators Administrators medical products (e.g. latex gloves) • No doctor education • No customer feedback • Inexpensive
  • 124. MammOptics Channel Strategies and Costs Sales strategy 1 Sales strategy 2 5 dedicated sales people Continue with core $150,000 each/year group of sales people Hire nurses or technicians with established Use women’s relationships healthcare equipment Early adopter feedback distributor Already established network of customers
  • 125. MammOptics Pricing Strategy Equipment Lease model Per-use Consumable model Cost of the $50,000 $5,000 $5,000 $25,000 device Service per $3,000 $10,000 0 0 year Per-use fee 0 0 $50 0 Consumable 0 0 0 $20
  • 126. MammOptics Pricing Strategy Equipment Lease model Per-use Consumable model Cost of the $50,000 $5,000 $5,000 $25,000 device Service per $3,000 $10,000 0 0 year Per-use fee 0 0 $50 0 Consumable 0 0 0 $20
  • 127. MammOptics Customer Workflow Current market Insurance Mammography Radiologist Technician Hospital Administration ACOG Doctor ACS specialty committee
  • 128. MammOptics Customer Workflow Current market Insurance But what would happen if we Mammography Radiologist replace mammography? Technician Hospital Administration ACOG Doctor ACS specialty committee
  • 129. MammOptics Customer Workflow Insurance Mammography Radiologis Breast Technicians Hospitals t Radiologists Loss of jobs Eliminates loss leader Loss of jobs Puts emphasis on biopsies Technician Hospital Administration ACOG Doctor ACS specialty committee
  • 130. MammOptics Customer Workflow Insurance Mammography Radiologist Technician Hospital Administration ACOG Doctor ACS specialty committee
  • 131. MammOptics Customer Workflow Insurance Mammography Radiologis Insurance ACOG/ACS t Same cost as mammography Improved healthcare ($140) (mammography weak technique) Reduced number of biopsies ($1000) Technician Hospital Administration ACOG Doctor ACS specialty committee
  • 132. MammOptics Customer Workflow Insurance Mammography Radiologist Technician Hospital Administration ACOG Doctor ACS specialty committee
  • 133. MammOptics Customer Workflow Insurance Patient PCP Mammography Radiologist OB/GY N Technician Hospital MammOptics Administration ACOG Doctor ACS specialty committee
  • 134. MammOptics Customer Workflow Insurance Patient PCP Mammography Radiologis PCP OB/GYNs OB/GY Patient MammOptics t N Increased revenue Improved healthcare Revenue More complete patient care Comfort Technician Hospital MammOptic Administration s ACOG Doctor ACS specialty committee
  • 135. MammOptics Customer Workflow Insurance Patient PCP Mammography Radiologist OB/GY N Technician Hospital MammOptics Administration ACOG Doctor ACS specialty committee
  • 136. MammOptics Business Model Canvas 3 of 4 Product Strong clinical Development Doctors: data IP Earlier Training Clinical trials detection Maintenance Leading doctors FDA Conferences Key Opinion Price OB/GYNs Publishing Accuracy CME courses PCPs Leaders 3rd party manufacturers Patients: Distributors Radiation Free Breast Cancer Non-Invasive IP Direct Sales to Foundations hospitals Leading doctors ACOG Distributor Technical ACS Expertise Product Development Clinical trials Capital Equipment Sales Operating Costs and disposable item Marketing Costs Per use fees
  • 137. MammOptics Business Model Canvas 3 of 4 Product Strong clinical Development Doctors: data IP Earlier Training Clinical trials detection Maintenance Leading doctors FDA Conferences Key Opinion Price OB/GYNs Reimburseme Accuracy CME courses PCPs Leaders ntPublishing 3rd party manufacturers Patients: Distributors Radiation Free Breast Cancer Non-Invasive IP Direct Sales to Foundations hospitals Leading doctors ACOG Distributor Technical ACS Expertise Product Development Clinical trials Capital Equipment Sales Operating Costs and disposable item Marketing Costs Per use fees
  • 138. Building the company The backstage of a medical device company
  • 139. MammOptics Interviews Stanford FDA Clinical Trials StatisticsSteve Axelrod Marga Ortigas- Wedekind Manufacturing Nick Mourlas Don Archambault Shannon Bergstedt Reimbursement Ali Habib Venture Dana Mead Capitalists Bill Starling Doctors/Sales Dr. Aron Shuftan Jed Hwang
  • 140. MammOptics Partners Manufacturing Choose manufacturing facility close to home
  • 141. MammOptics Partners Manufacturing Reimbursement Difficult to get coverage for new product.
  • 142. MammOptics Reimbursement Partners Insurances CPT Codes $75-$150
  • 143. MammOptics Partners Manufacturing Reimbursement 510K vs. PMA Largest cost Biggest financial risk FDA Clinical Trials
  • 144. MammOptics Clinical Trials Stage 1 Feasibility Pilot trials Comparison 50 patients with $600K mammograph y 6 months 12/4/2009
  • 145. MammOptics Clinical Trials Stage 2 Interim trials Prove superior safety-efficacy Stage 1 500 patients & sensitivity Pilot trials $7.2M 6 months 15 months 12/4/2009
  • 146. MammOptics Clinical Trials Stage 2 Interim trials Stage 1 Stage 3 FDA class II, Pilot trials FDA pivotal 510(K) w/ trials trials Focus on 1500 patients superiority & $20.5M economic end- points 6 months 15 months 24 months 12/4/2009
  • 147. MammOptics Clinical Trials Stage 4 Post-market Stage 2 studies Interim trials 2000 patients Stage 1 Stage 3 $26.8M Pilot trials FDA pivotal trials Specific Cat III CPT/ACP Codes Market traction 6 months 15 months 24 months 24 months 12/4/2009
  • 148. MammOptics Clinical Trials Stage 4 Post-market Stage 2 studies Interim trials $26.8M Stage 1 $7.2M Stage 3 Pilot trials FDA pivotal trials $600K $20.5M 6 months 15 months 24 months 24 months 12/4/2009
  • 149. MammOptics Clinical Trials 12/4/2009
  • 150. MammOptics Partners Manufacturing Reimbursement Financial timeline Funding FDA Clinical Trials
  • 151. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2/ IPO M&A Q3 $40M Series D $50 MM Cash Reserve $30M Series C $30.5 MM $35 MM $20M $15M Series B $9 MM $10M Series A $5M $3.5 MM Initialize System Financial Regulatory / Clinical Launch Proof of Beta Marketable Milestones timeline Second Release Design Concept Prototype Product Beta- Laborator Versio 1st 2nd Release y n Release Test Prototype Testin Test Publicatio g Publicatio n Milestones n Clinical Pilot Clinical Post-Market Clinical Studie US Interim Trials US Pivotal Clinical Results Studies s Trials Non-Specific Codes Regulatory/ IP Provision IRB / Cat III FDA – Class II – 510 (k) Specific Codes Milestones al Patent IDE CPT with Clinical Trials (Cat. I CPT / APC) Applicatio IC and Initial n and Technolog Processin Product System y g Patents Launch Patents Licensing 151 12/4/2009
  • 152. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 $40M Cash Reserve $30M $20M $15M $10M $5M Initialize Proof of Milestones Design Concept Milestones Clinical Provision Regulatory/ IP Milestones al Patent Technolog y Licensing 152 12/4/2009
  • 153. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 $40M Cash Reserve $30M $20M $15M $10M Series A $5M $3.5 MM Initialize System Proof of Beta Milestones Design Concept Prototype Beta- Laborator Versio y n Prototype Testin g Milestones Clinical Pilot Studie s Regulatory/ IP Provision Milestones al Patent Technolog y Licensing 153 12/4/2009
  • 154. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 $40M Cash Reserve $30M $20M $15M Series B $9 MM $10M Series A $5M $3.5 MM System Regulatory / Clinical Beta Marketable Milestones Design Prototype Product Beta- Laborator Versio y n Prototype Testin g Milestones Clinical Pilot Studie s Regulatory/ IP IRB / Milestones IDE Applicatio IC and n and Processin System g Patents Patents 154 12/4/2009
  • 155. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 $40M Cash Reserve $30M Series C $20M $30.5 MM $15M Series B $9 MM $10M $5M System Regulatory / Clinical Milestones Second Release Design 1st Release Test Publicatio Milestones n Clinical Pilot Studie US Interim Trials US Pivotal Clinical s Trials Regulatory/ IP IRB / Cat III Milestones IDE CPT Applicatio IC and n and Processin System g Patents Patents 155
  • 156. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 $40M Series D Cash Reserve $30M Series C $30.5 MM $35 MM $20M $15M $10M $5M Regulatory / Clinical Launch Milestones Second Release Design 2nd Release Test Publicatio Publicatio n Milestones n Clinical Clinical US Interim Trials US Pivotal Clinical Results Trials Non-Specific Codes Regulatory/ IP FDA – Class II – 510 (k) Milestones with Clinical Trials Initial Product Launch 156 12/4/2009
  • 157. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2/ IPO M&A Q3 $40M Series D $50 MM Cash Reserve $30M $35 MM $20M $15M $10M $5M Regulatory / Clinical Launch Milestones Design Publicatio n Milestones Clinical Clinical Post-Market Clinical Results Studies Non-Specific Codes Regulatory/ IP FDA – Class II – 510 (k) Specific Codes Milestones with Clinical Trials (Cat. I CPT / APC) Initial Product Launch 12/4/2009
  • 158. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2/ IPO M&A Q3 $40M Series D $50 MM Cash Reserve $30M Series C $30.5 MM $35 MM $20M $15M Series B $9 MM $10M Series A $5M $3.5 MM Initialize System Regulatory / Clinical Launch Proof of Beta Marketable Milestones Second Release Design Concept Prototype Product Beta- Laborator Versio 1st 2nd Release y n Release Test Prototype Testin Test Publicatio g Publicatio n Milestones n Clinical Pilot Clinical Post-Market Clinical Studie US Interim Trials US Pivotal Clinical Results Studies s Trials Non-Specific Codes Regulatory/ IP Provision IRB / Cat III FDA – Class II – 510 (k) Specific Codes Milestones al Patent IDE CPT with Clinical Trials (Cat. I CPT / APC) Applicatio IC and Initial n and Technolog Processin Product System y g Patents Launch Patents Licensing 158 12/4/2009
  • 159. MammOptics Business Model Canvas 4 of 4 Product Strong clinical Development Doctors: data IP Earlier Training Clinical trials detection Maintenance KOLs FDA Conferences 3rdparty Price OB/GYNs Reimburseme Accuracy CME courses PCPs manufacturers nt Publishing Distributors Immediate Breast Cancer Results Foundations ACOG Patients: IP Radiation Free Direct Sales to ACS hospitals Leading doctors Non-Invasive Clinical trial Distributor Technical designer Online Expertise Product Development Clinical trials Per use fees Operating Costs Marketing Costs
  • 160. MammOptics Business Model Canvas 4 of 4 Product Strong clinical Development data IP Training Clinical trials Maintenance KOLs FDA Conferences 3rdparty Earlier detection OB/GYNs Reimburseme Non invasive CME courses PCPs manufacturers nt Publishing Breast Cancer Price Foundations Accuracy ACOG Immediate Results ACS Direct Sales to IP Clinical trial hospitals Leading doctors designer Distributor Technical Expertise Online Product Development Clinical trials Per use fees Operating Costs Marketing Costs
  • 161. MammOptics Business Model Canvas 1 Product Strong clinical Development data IP Training Hospitals Clinical trials Radiation-free Maintenance Pioneering Leading doctors FDA Earlier detection Doctors 3rd party Non invasive Hospitals manufacturers Distributors IP Direct Sales to Leading doctors hospitals Technical Expertise Product Development Clinical trials Capital Equipment Sales Operating Costs and disposable item
  • 162. MammOptics Business Model Canvas 2 Product Strong clinical Development data IP Training Clinical trials Radiation-free Maintenance Pioneering Hospitals FDA Earlier detection Doctors Leading doctors Non invasive Hospitals 3rd party manufacturers Distributors Research IP Direct Sales to Hospitals Leading doctors hospitals Technical Expertise Product Development Clinical trials Capital Equipment Sales Operating Costs and disposable item
  • 163. MammOptics Business Model Canvas 3 Product Doctors: Strong clinical Development Earlier data Hospitals (Capital IP detection Training Spending Clinical trials Price Maintenance Pioneering Committee) FDA Accuracy Doctors Leading doctors Hospitals 3rd party Patients: manufacturers Radiation Free Distributors Non-Invasive IP Direct Sales to Research hospitals Leading doctors Hospitals Technical Expertise Product Development Clinical trials Capital Equipment Sales Operating Costs and disposable item
  • 164. MammOptics Business Model Canvas 4 Product Doctors: Strong clinical Development Earlier data Hospitals (Capital IP detection Training Spending Clinical trials Price Maintenance Pioneering Committee) FDA Accuracy Doctors Leading doctors Immediate Hospitals 3rd party Results OB/GYNs manufacturers PCPs Distributors Patients: IP Radiation Free Direct Sales to Research hospitals Leading doctors Non-Invasive Hospitals Technical Breast Cancer Expertise Foundations Product Development Clinical trials Capital Equipment Sales Operating Costs and disposable item
  • 165. MammOptics Business Model Canvas 5 Product Strong clinical Development Doctors: data IP Earlier Training Clinical trials detection Maintenance Leading doctors FDA Conferences Key Opinion Price OB/GYNs Reimburseme Accuracy CME courses PCPs Leaders ntPublishing 3rd party manufacturers Patients: Distributors Radiation Free Breast Cancer Non-Invasive IP Direct Sales to Foundations hospitals Leading doctors ACOG Distributor Technical ACS Expertise Product Development Clinical trials Capital Equipment Sales Operating Costs and disposable item Marketing Costs