View
473
Download
1
Embed Size (px)
DESCRIPTION
Part of 2013 Q2 Lean Launch Pad Presentations 0a-Introduction.2013.Q2.pptx 1a-Three_Types_Of_Startup.2013.Q2.pptx 1b-Customer Discovery (problem hypothesis).2013.Q2.pptx 2a-Customer Discovery ( canvas and story ).2013.Q2.pptx 2b-Value_Chain (team specific).2013.Q2.pptx 3a-Customer_Validation.2013.Q2.pptx 3b-GKG-CustomerRelationships.2013.Q2.pptx 4a-EndGame.2013.Q2.pptx
Citation preview
1
Customer DiscoveryClass # 2a
Iain Verigin
Today
• Majority of Time : Review an example – “what exactly does this work looks like”
• Timeline– Quickly Recap “Customer Discovery Planning”– Example – MammOptics – LeanLaunch Pad project
3
CustomerDiscovery
CustomerValidation
CustomerCreation
ScaleCompany
Customer Discovery
• Stop selling, start listening– There are no facts inside your building, so get outside
• Test your hypotheses – Two are fundamental: problem and product concept
4
Discovery Phase = Hypothesis Testing
• What is the Hypothesis? • Where does the Hypothesis come from? • Why Test them? • How do you test them?
5
Customer Discovery: Rules
• Rule 1: Facts are outside the building, opinions are inside.
• Rule 2: Solve a problem that customers say is important and valuable
• Rule 3: Does the product concept solve that problem?
6
Customer Discovery: Exit Criteria
• What are your customers top problems?– How much will they pay to solve them
• Does your product concept solve them?– Do customers agree? – How much will they pay?
• Can you draw a day-in-the-life of a customer– before & after your product
• Can you draw the org chart of users & buyers
7
Customer Dev’t ProcessTime Frames
CustomerDiscovery
CustomerValidation
CustomerCreation
ScaleCompany
Existing Market: 1 Months - 1 Year
Resegmenting a Market: 6 Months - 3 Years
New Market: 1 - 3 Years
8
Customer DiscoveryTime Frames
CustomerDiscovery
CustomerValidation
CustomerCreation
ScaleCompany
Existing: 1 - 6 Months
Resegmenting: 3 - 12 Months
New: 12 - 24 Months
9
Customer Discovery
In Detail
10
Methodology
• Customer Development can take months, or years • Each Step has a set of phases • Plan what you need to learn in writing
… so that everyone knows: – what they should be doing – when they should do it – If they succeeded – If they need to do more
• These are checklists, not “Inviolable Commandments”
11
State Your Hypothesis
• One-time writing exercise • All other time is spent in front of customers • Assumes you’re smart
– ( but guessing )
building blocks 9
TEAM NAME HERE
Who are our most important
customers?
What are their archetypes?
What Job do they want us to get done for them?
What Key Activities do we
require?Manufacturing?
Software? Supply chain?
Which of our customer’s
problems are we helping to solve?
Which customer needs are we
satisfying
What are the Key Features of our
product that match customers
problem/need?
Who are our Key Partners?
Who are our key suppliers?
What are we getting from
them? Giving them?
What are the most important costs inherent in our business model? Fixed? Variable? How do we make money? What’s the revenue
model? Pricing tactics?
Through which Channels do our
Customer Segments want to be reached?
What Key Resources we
require?Financial,
physical, IP, HR?
FILL OUT ALL 9 BOXES OF THE CANVAS IN ORDER 1 THUR 9
1
3
4 2How will we Get, Keep and Grow
Customers?
5
6 7
8
9
CUSTOMER SEGMENTS
images by JAM
VALUE PROPOSITIONS
images by JAM
16
Product (Solution) Hypothesis
• Features• Benefits • Product Delivery Schedule• Intellectual Property • Total Cost of Ownership• Dependency Analysis
– What is out of our control?
17
Customer/Problem Hypotheses
• Types of Customers • Magnitude of the problem • Visionaries • A Day in the Life of a customer
( Service Journey) • Organizational impact • ROI Justification • Problem Recognition • Minimum Feature Set
18
Competition Hypotheses
• Who is out there? • Why are they important? • How do customers use them today? • What don’t customers like about them?
CHANNELS
images by JAM
20
Distribution/ Pricing Hypotheses
• Distribution Model • Distribution Diagram • Sales Cycle/Ramp • Channel strategy • Pricing (ASP, LTV)
– Actual Selling Price, Life Time Value
• Customer Organization Map • Demand Creation
CUSTOMER RELATIONSHIPS
images by JAM
22
Demand Creation Hypotheses• How do competitors create demand? • How will you?
– Viral – Advertising – PR – Trade shows
• Who are influencers/recommendors? • Key trade shows? • Key trends? • Start assembling advisory board
Get keep grow
23
Get keep grow
24
25
Type of Market Hypotheses
• Positioning and Differentiation
– Existing Market • The product is the basis of competition
– New Market • Creating the market is the basis of competition
– Resegment - Redefine Existing Market • New segment of the existing market is the basis of competition
• :Think: What does my playing field look like?
REVENUE STREAMS
images by JAM
Market/Opportunity Analysis
How Big is It?: Market/Opportunity Analysis– Identify a Customer and Market Need– Size the Market– Competitors– Growth Potential
How Big is the Pie?Total Available Market
Total Available Market
• How many people would want/need
the product?
• How large is the market be (in $’s) if they all bought?
• How many units would that be?
How Do I Find Out?
• Industry Analysts – Gartner, Forrester
• Wall Street Analysts – Goldman, Morgan
How Big is My Slice?Served Available Market
• How many people need/can use product?
• How many people have the money to buy the product
• How large would the market be (in $’s) if they all bought?
• How many units would that be?
How Do I Find Out?• Talk to potential customers
Served Available
Market
TotalAvailableMarket
How Much Can I Eat?Target Market
• Who am I going to sell to in year 1, 2 & 3?
• How many customers is that?
• How large is the market be (in $’s) if they all bought?
• How many units would that be?
How Do I Find Out?• Talk to potential customers
• Identify and talk to channel partners
• Identify and talk to competitors
TotalAvailableMarket Target
Market
ServedAvailableMarket
Market Size: Summary• Market Size Questions:
– How big can this market be? – How much of it can we get?– Market growth rate– Market structure (Mature or in flux?)
• Most important: Talk to Customers and Sales Channel• Next important: Market size by competitive approximation
– Wall Street analyst reports are great• And : Market research firms Like Forester, Gartner
KEY RESOURCES
images by JAM
KEY ACTIVITIES
images by JAM
KEY PARTNERS
images by JAM
COST STRUCTURE
images by JAM
images by JAM
customer segments
key partners
cost structure
revenue streams
channels
customer relationships
key activities
key resources
value proposition
test
37
:Score Card: ( Hypothesis Summary)
Guess GuessGuess Guess Guess
GuessGuess
Guess Guess
WHAT DOES THIS “REALLY” LOOK LIKE?
38
40
?
? ?
?
?
??
?
?
possible alternatives
42
radiation-freedetection of breast cancer
hospitals
43
proprietary IP medical device manufacturers
44
?
? ?
?
?
??
?
?
But,Realize They’re Hypotheses
9 Guesses
Guess Guess
Guess
Guess
GuessGuess
Guess
GuessGuess
How Does This Really Work?
Stanford Lean LaunchPad Class
8 Weeks From an Idea to a Business
The Final Presentation
MammOpticsFinal project presentation for E 245 Winter 2011
MammOpticsInitial Idea
Breast cancer
Leading cause of cancer in women190,000 diagnosis every year US41,000 deaths every year USIncreasing diagnosis rates
Mammography
15%-25% false negatives rate25% false positives rateRequires X-ray radiationLow resolution
Novel technology based on RF-modulated optical spectroscopy
MammOptics
- Earlier detection- Non-radiative- Non-invasive
MammOpticsTechnology Comparison
RiskInvasiveness
Resolution
False Pos.
False Neg.
Device Cost
Time Require
d
MammOptics
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.
I.I.T.Y.I.W.H.T.K.Y
MammOpticsBusiness Model Canvas 1 of 4
Radiation-freeEarlier detectionNon-invasive
Pioneering radiologists inhospitals
Direct sales to hospitals
Strong clinical dataTrainingMaintenance
Product DevelopmentClinical trialsOperating Costs Capital equipment
sales and disposable item
Product DevelopmentIPClinical trialsFDA
IP Leading doctorsTechnical Expertise
HospitalsLeading doctors3rd party manufacturersDistributors
MammOpticsBusiness Model Canvas 1 of 4
Radiation-freeEarlier detectionNon-invasive
Pioneering radiologists inhospitals
Direct sales to hospitals
Strong clinical dataTrainingMaintenance
Product DevelopmentClinical trialsOperating Costs Capital equipment
sales and disposable item
Product DevelopmentIPClinical trialsFDA
IP Leading doctorsTechnical Expertise
HospitalsLeading doctors3rd party manufacturersDistributors
Initi
al guess
Initi
al guess
Initi
al guess
Initi
al guess
MammOpticsBusiness Model Canvas 1 of 4
Test:Customer segment
Value proposition
Finding the right customerFrom radiologists to gynecologists
MammOpticsExcursions into hospitals
Leading doctors
Patients
Hospital Managers
Technicians
Debra Ikeda Jason Davies
Jafi Alissa LipsonSunita Pal
6 women >40 8 women <40
Alicia X-ray mammography
Paul BillingsHolly V. Gautier
MammOpticsHospital purchasing decision tree
MammOpticsHospital purchasing decision tree
Hospitals
Complex purchasing decision
tree. Several saboteours
MammOpticsPrivate practice purchasing decision tree
MammOpticsPrivate practice purchasing decision tree
Private practice
Faster adoption rate
Attractive value proposition✔
Pioneering DoctorsHospitalsOB/GYNsPCPs
Direct Sales to doctors
Strong clinical dataTrainingMaintenance
Product DevelopmentClinical trialsOperating Costs
Capital Equipment Sales and disposable item
Product DevelopmentIPClinical trialsFDA
IP Leading doctorsTechnical Expertise
Hospitals (Capital Spending Committee)Leading doctors3rd party manufacturersDistributorsResearch Hospitals
Doctors:Earlier detectionPriceAccuracy
Patients:Radiation FreeNon-Invasive
MammOpticsBusiness Model Canvas 2 of 4
Pioneering DoctorsHospitalsOB/GYNsPCPs
Direct Sales to doctors
Strong clinical dataTrainingMaintenance
Product DevelopmentClinical trialsOperating Costs
Capital Equipment Sales and disposable item
Product DevelopmentIPClinical trialsFDA
IP Leading doctorsTechnical Expertise
Hospitals (Capital Spending Committee)Leading doctors3rd party manufacturersDistributorsResearch Hospitals
Doctors:Earlier detectionPriceAccuracy
Patients:Radiation FreeNon-Invasive
MammOpticsBusiness Model Canvas 2 of 4
How do we get to our customer?
Need sensitivity and specificity
Getting to our customerThe world of direct sales and medical marketing
MammOpticsInterviews
Breast Cancer Advocacy Groups
OB/GYNs
FDA/Clinical Trials
Medical Sales
Be Bright PinkJennifer Glover
Dr. Cindy WooDr. Jags Powers
Dr. Aaron Shuvkan
Katrina BellTanay Dudhela
Jed Hwang
Phyllis WhitelyCarl Simpson
MammOpticsMarketing
Access to ACOG by former member
Strong influence on doctors via ACOG Standard of Care
Strongly influenced by
KOLs
MammOpticsMarketing
Researchers conducting
important clinical trials
Researchers with numerous
publications
Outsourced survey research
Researchers with strong peer
recommendations
MammOpticsMarketing
Focus on prominent journals Need two big
publications
Choose KOL as Principal Investigators (PI)
MammOpticsMarketing
Effective method for educating doctors
Doctors required to attend workshops
Workshop must be approved by ACOG
Taught by objective medical experts
MammOpticsMarketing
ACOG Annual Clinical Meeting
Miami Breast Cancer Conference
Opportunity for feedback from
doctors
MammOpticsMarketing
Trusted information source for patients
Critical opinion leader for technology adoption
Access to media outlets
MammOpticsMarketing
IndividualDoctors
Purchasing Administrato
rs
High value medical products
(e.g. cardiovascular stents)
Commodity medical products
(e.g. latex gloves)
• Doctor education• Direct feedback from doctors• Very expensive
• No doctor education• No customer feedback• Inexpensive
Direct Sales
Distributors
MammOpticsChannel Strategies and Costs
Individual Doctors
Purchasing Administrato
rs
Channel Strategies and CostsMammOptics
5 dedicated sales people$150,000 each/year
Hire nurses or technicianswith establishedrelationships
Early adopter feedback
Continue with core group of sales people
Use women’s healthcare equipment distributor
Already established network of customers
Sales strategy 1 Sales strategy 2
MammOpticsPricing Strategy
Equipment Lease model
Per-use model
Consumable
Cost of the device
Service per year
Per-use fee
Consumable
$50,000
$3,000
0
0
$5,000
$10,000
0
0
$5,000
0
$50
0
$25,000
0
0
$20
MammOpticsPricing Strategy
Equipment Lease model
Per-use model
Consumable
Cost of the device
Service per year
Per-use fee
Consumable
$50,000
$3,000
0
0
$5,000
$10,000
0
0
$5,000
0
$50
0
$25,000
0
0
$20
Approved by
customers and
investors
ACOGACS
Doctor specialty
committee
Hospital Administrati
on
Technician
RadiologistMammography
MammOpticsCustomer Workflow
Current market Insurance
ACOGACS
Doctor specialty
committee
Hospital Administrati
on
Technician
RadiologistMammography
MammOpticsCustomer Workflow
Current market
But what would happen if we replace mammography?
Insurance
ACOGACS
Doctor specialty
committee
Hospital Administrati
on
Technician
Radiologist
Mammography
MammOpticsCustomer Workflow
Breast Radiologists
Technicians Hospitals
Loss of jobs
Loss of jobs Eliminates loss leaderPuts emphasis on
biopsies
Insurance
ACOGACS
Doctor specialty
committee
Hospital Administrati
on
Technician
Radiologist
Mammography
MammOpticsCustomer Workflow
Insurance
ACOGACS
Doctor specialty
committee
Hospital Administrati
on
Technician
Radiologist
Mammography
MammOpticsCustomer Workflow
InsuranceSame cost as mammography
($140)Reduced number of biopsies
($1000)
ACOG/ACSImproved healthcare(mammography weak
technique)
Insurance
ACOGACS
Doctor specialty
committee
Hospital Administrati
on
Technician
Insurance
Radiologist
Mammography
MammOpticsCustomer Workflow
Insurance
Doctor specialty
committee
Hospital Administrati
on
Technician
RadiologistMammography
MammOpticsCustomer Workflow
ACOGACS
MammOptics
Patient
PCPOB/GYN
Insurance
Doctor specialty
committee
Hospital Administrati
on
Technician
Radiologist
Mammography
MammOpticsCustomer Workflow
ACOGACS
MammOptics
Patient
PCPOB/GYN
Hospital Administrati
on
Technician
Radiologist
Mammography
MammOptics
Patient
PCPOB/GYN
PCP OB/GYNsIncreased revenue
More complete patient care
PatientImproved healthcare
Comfort
MammOpticsRevenue
ACOGACS
Doctor specialty
committee
Hospital Administrati
on
Technician
Insurance
Radiologist
Mammography
MammOpticsCustomer Workflow
MammOptics
Patient
PCPOB/GYN
OB/GYNsPCPs
Direct Sales to hospitalsDistributor
Strong clinical dataTrainingMaintenanceConferencesCME courses
Product DevelopmentClinical trialsOperating CostsMarketing Costs
Capital Equipment Sales and disposable itemPer use fees
Product DevelopmentIPClinical trialsFDAPublishing
IP Leading doctorsTechnical Expertise
Leading doctorsKey Opinion Leaders3rd party manufacturersDistributorsBreast Cancer FoundationsACOGACS
Doctors:Earlier detectionPriceAccuracy
Patients:Radiation FreeNon-Invasive
MammOpticsBusiness Model Canvas 3 of 4
OB/GYNsPCPs
Direct Sales to hospitalsDistributor
Strong clinical dataTrainingMaintenanceConferencesCME courses
Product DevelopmentClinical trialsOperating CostsMarketing Costs
Capital Equipment Sales and disposable itemPer use fees
Product DevelopmentIPClinical trialsFDAReimbursementPublishing
IP Leading doctorsTechnical Expertise
Leading doctorsKey Opinion Leaders3rd party manufacturersDistributorsBreast Cancer FoundationsACOGACS
Doctors:Earlier detectionPriceAccuracy
Patients:Radiation FreeNon-Invasive
MammOpticsBusiness Model Canvas 3 of 4
Learned how to reach the customer
How do we build a company based on this?
Building the companyThe backstage of a medical device company
MammOpticsInterviews
FDA Clinical Trials
Manufacturing
Venture Capitalists
Reimbursement
Stanford Statistics Steve AxelrodMarga Ortigas-
Wedekind
Nick MourlasDon
Archambault
Shannon BergstedtAli Habib
Dana MeadBill Starling
Doctors/Sales
Dr. Aron Shuftan
Jed HwangMichael J. Nohr
Manufacturing
MammOpticsPartners
Choose manufacturing facility close to
home
Manufacturing Reimbursement
MammOpticsPartners
Difficult to get coverage for new product.
Manufacturing
MammOpticsPartners
Reimbursement PartnersMammOptics
Insurances
CPT Codes$75-$150
MammOpticsPartners
Manufacturing
FDA Clinical Trials
Reimbursement
510K vs. PMALargest cost
Biggest financial risk
Clinical Trials
12/4/2009
Stage 1Pilot trials
50 patients$600K
MammOptics
6 months
FeasibilityComparison
with mammograph
y
Clinical Trials
12/4/2009
MammOptics
6 months 15 months
Stage 1Pilot trials
Stage 2Interim trials
500 patients$7.2M
Prove superior safety-
efficacy & sensitivity
Clinical Trials
12/4/2009
MammOptics
6 months 15 months
Stage 1Pilot trials
Stage 2Interim trials
24 months
Stage 3FDA
pivotal trials1500
patients$20.5M
FDA class II, 510(K) w/ trials
Focus on superiority &
economic end-points
Clinical Trials
12/4/2009
MammOptics
6 months 15 months
Stage 1Pilot trials
Stage 2Interim trials
Stage 3FDA
pivotal trials
Stage 4Post-
market studies2000 patients$26.8M
Specific Cat III CPT/ACP CodesMarket traction
24 months24 months
Clinical Trials
12/4/2009
MammOptics
6 months 15 months
Stage 1Pilot trials
Stage 2Interim trials
Stage 3FDA
pivotal trials$600K
$7.2M
$20.5M
$26.8M
Stage 4Post-
market studies
24 months 24 months
MammOpticsPartners
MammOpticsPartners
Manufacturing
FDA Clinical Trials
Reimbursement
Financial timeline
Funding
$10M
$15M
2012
Series A $3.5 MM
Cash
Rese
rve
Clin
ical
Mile
stones
$5M
Initialize
Desi
gn
Mile
stones
Reg
ula
tory
/ IP
M
ilest
ones
Q1 Q2 Q3 Q4
2013Q1 Q2 Q3 Q4
2014Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016
Series B $9 MM
System
2017Q1 Q2Q1 Q2 Q3 Q4
2018Q3
Launch
Series C $30.5 MM
$30M
$20M
Regulatory / Clinical
Series D $35
MM
M&A / IPO $50 MM
$40M
98 12/4/2009
Proof of Concep
t
Pilot Studie
s
IC and Processing Patents
Marketable Product
Provisional Patent
Beta-Versio
n Testin
g
Application and
System Patents
IRB / IDE
Clinical Results
Second Release
Initial Product Launch
Specific Codes (Cat. I CPT / APC)
Non-Specific Codes
1st Release
Test
2nd Release Test
Publication
Post-Market Clinical Studies
Beta Prototype
US Interim Trials
FDA – Class II – 510 (k) with Clinical Trials
Publication
Financial / Operations Timeline
Cat III
CPT
US Pivotal Clinical Trials
Laboratory
Prototype
Technology
Licensing
MammOpticsMammOptics
Financial timeline
$10M
$15M
2012
Cash
Rese
rve
Clin
ical
Mile
stones
$5M
Initialize
Desi
gn
Mile
stones
Reg
ula
tory
/ IP
M
ilest
ones
Q1 Q2 Q3 Q4
2013Q1 Q2 Q3 Q4
2014Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016 2017Q1 Q2Q1 Q2 Q3 Q4
2018Q3
$30M
$20M
$40M
99 12/4/2009
Proof of Concep
t
Provisional Patent
Financial / Operations Timeline
Technology
Licensing
MammOpticsMammOptics
$10M
$15M
2012
Series A $3.5 MM
Cash
Rese
rve
Clin
ical
Mile
stones
$5M
Initialize
Desi
gn
Mile
stones
Reg
ula
tory
/ IP
M
ilest
ones
Q1 Q2 Q3 Q4
2013Q1 Q2 Q3 Q4
2014Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016
System
2017Q1 Q2Q1 Q2 Q3 Q4
2018Q3
$30M
$20M
$40M
100 12/4/2009
Proof of Concep
t
Provisional Patent
Beta-Versio
n Testin
g
Laboratory
Prototype
Beta Prototype
Technology
Licensing
Financial / Operations Timeline
Pilot Studie
s
MammOpticsMammOptics
$10M
$15M
2012
Series A $3.5 MM
Cash
Rese
rve
Clin
ical
Mile
stones
$5M
Desi
gn
Mile
stones
Reg
ula
tory
/ IP
M
ilest
ones
Q1 Q2 Q3 Q4
2013Q1 Q2 Q3 Q4
2014Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016
Series B $9 MM
System
2017Q1 Q2Q1 Q2 Q3 Q4
2018Q3
$30M
$20M
$40M
101 12/4/2009
IC and Processing Patents
Marketable Product
Beta-Versio
n Testin
g
Application and
System Patents
IRB / IDE
Beta Prototype
Financial / Operations Timeline
Pilot Studie
s
Regulatory / Clinical
Laboratory
Prototype
MammOpticsMammOptics
$10M
$15M
2012
Cash
Rese
rve
Clin
ical
Mile
stones
$5M
Desi
gn
Mile
stones
Reg
ula
tory
/ IP
M
ilest
ones
Q1 Q2 Q3 Q4
2013Q1 Q2 Q3 Q4
2014Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016
Series B $9 MM
System
2017Q1 Q2Q1 Q2 Q3 Q4
2018Q3
Series C $30.5 MM
$30M
$20M
Regulatory / Clinical
$40M
102
IC and Processing Patents
Application and
System Patents
IRB / IDE
Cat III
CPT
Second Release
1st Release
Test
US Interim Trials US Pivotal Clinical Trials
Publication
Financial / Operations Timeline
Pilot Studie
s
MammOpticsMammOptics
$10M
$15M
2012
Cash
Rese
rve
Clin
ical
Mile
stones
$5M
Desi
gn
Mile
stones
Reg
ula
tory
/ IP
M
ilest
ones
Q1 Q2 Q3 Q4
2013Q1 Q2 Q3 Q4
2014Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016 2017Q1 Q2Q1 Q2 Q3 Q4
2018Q3
Launch
Series C $30.5 MM
$30M
$20M
Regulatory / Clinical
Series D $35
MM
$40M
103 12/4/2009
Clinical Results
Second Release
Initial Product Launch
Non-Specific Codes
2nd Release Test
Publication
US Interim Trials
FDA – Class II – 510 (k) with Clinical Trials
Publication
Financial / Operations Timeline
US Pivotal Clinical Trials
MammOpticsMammOptics
$10M
$15M
2012
Cash
Rese
rve
Clin
ical
Mile
stones
$5M
Desi
gn
Mile
stones
Reg
ula
tory
/ IP
M
ilest
ones
Q1 Q2 Q3 Q4
2013Q1 Q2 Q3 Q4
2014Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016 2017Q1 Q2Q1 Q2 Q3 Q4
2018Q3
Launch
$30M
$20M
Regulatory / Clinical
Series D $35
MM
M&A / IPO $50 MM
$40M
12/4/2009
Clinical Results
Initial Product Launch
Specific Codes (Cat. I CPT / APC)
Non-Specific Codes
Publication
Post-Market Clinical Studies
FDA – Class II – 510 (k) with Clinical Trials
Financial / Operations TimelineMammOpticsMammOptics
$10M
$15M
2012
Series A $3.5 MM
Cash
Rese
rve
Clin
ical
Mile
stones
$5M
Initialize
Desi
gn
Mile
stones
Reg
ula
tory
/ IP
M
ilest
ones
Q1 Q2 Q3 Q4
2013Q1 Q2 Q3 Q4
2014Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016
Series B $9 MM
System
2017Q1 Q2Q1 Q2 Q3 Q4
2018Q3
Launch
Series C $30.5 MM
$30M
$20M
Regulatory / Clinical
Series D $35
MM
M&A / IPO $50 MM
$40M
105 12/4/2009
Proof of Concep
t
Pilot Studie
s
IC and Processing Patents
Marketable Product
Provisional Patent
Beta-Versio
n Testin
g
Application and
System Patents
IRB / IDE
Clinical Results
Second Release
Initial Product Launch
Specific Codes (Cat. I CPT / APC)
Non-Specific Codes
1st Release
Test
2nd Release Test
Publication
Post-Market Clinical Studies
Beta Prototype
US Interim Trials
FDA – Class II – 510 (k) with Clinical Trials
Publication
Financial / Operations Timeline
Cat III
CPT
US Pivotal Clinical Trials
Laboratory
Prototype
Technology
Licensing
MammOpticsMammOptics
Radiation-freeEarlier detectionNon invasive
Pioneering DoctorsHospitals
Direct Sales to hospitals
Strong clinical dataTrainingMaintenance
Product DevelopmentClinical trialsOperating Costs
Capital Equipment Sales and disposable item
Product DevelopmentIPClinical trialsFDA
IP Leading doctorsTechnical Expertise
HospitalsLeading doctors3rd party manufacturersDistributors
MammOpticsBusiness Model Canvas 1
Radiation-freeEarlier detectionNon invasive
Pioneering DoctorsHospitals
Direct Sales to hospitals
Strong clinical dataTrainingMaintenance
Product DevelopmentClinical trialsOperating Costs
Capital Equipment Sales and disposable item
Product DevelopmentIPClinical trialsFDA
IP Leading doctorsTechnical Expertise
HospitalsLeading doctors3rd party manufacturersDistributorsResearch Hospitals
MammOpticsBusiness Model Canvas 2
Pioneering DoctorsHospitals
Direct Sales to hospitals
Strong clinical dataTrainingMaintenance
Product DevelopmentClinical trialsOperating Costs
Capital Equipment Sales and disposable item
Product DevelopmentIPClinical trialsFDA
IP Leading doctorsTechnical Expertise
Hospitals (Capital Spending Committee)Leading doctors3rd party manufacturersDistributorsResearch Hospitals
Doctors:Earlier detectionPriceAccuracy
Patients:Radiation FreeNon-Invasive
MammOpticsBusiness Model Canvas 3
Pioneering DoctorsHospitalsOB/GYNsPCPs
Direct Sales to hospitals
Strong clinical dataTrainingMaintenance
Product DevelopmentClinical trialsOperating Costs
Capital Equipment Sales and disposable item
Product DevelopmentIPClinical trialsFDA
IP Leading doctorsTechnical Expertise
Hospitals (Capital Spending Committee)Leading doctors3rd party manufacturersDistributorsResearch HospitalsBreast Cancer Foundations
Doctors:Earlier detectionPriceAccuracyImmediate Results
Patients:Radiation FreeNon-Invasive
MammOpticsBusiness Model Canvas 4
OB/GYNsPCPs
Direct Sales to hospitalsDistributor
Strong clinical dataTrainingMaintenanceConferencesCME courses
Product DevelopmentClinical trialsOperating CostsMarketing Costs
Capital Equipment Sales and disposable item
Product DevelopmentIPClinical trialsFDAReimbursementPublishing
IP Leading doctorsTechnical Expertise
Leading doctorsKey Opinion Leaders3rd party manufacturersDistributorsBreast Cancer FoundationsACOGACS
Doctors:Earlier detectionPriceAccuracy
Patients:Radiation FreeNon-Invasive
MammOpticsBusiness Model Canvas 5
OB/GYNsPCPs
Direct Sales to hospitalsDistributor
Strong clinical dataTrainingMaintenanceConferencesCME courses
Product DevelopmentClinical trialsOperating CostsMarketing Costs
Capital Equipment Sales and disposable itemPer use fees
Product DevelopmentIPClinical trialsFDAReimbursement Publishing
IP Leading doctorsTechnical Expertise
KOLs3rd party manufacturersDistributorsBreast Cancer FoundationsACOGACS
Doctors:Earlier detectionPriceAccuracyImmediate Results
Patients:Radiation FreeNon-Invasive
MammOpticsBusiness Model Canvas 6
OB/GYNsPCPs
Direct Sales to hospitalsDistributor
Strong clinical dataTrainingMaintenanceConferencesCME courses
Product DevelopmentClinical trialsOperating CostsMarketing Costs
Per use fees
Product DevelopmentIPClinical trialsFDAReimbursement Publishing
IP Leading doctorsTechnical Expertise
KOLs3rd party manufacturersDistributorsBreast Cancer FoundationsACOGACSClinical trial designer
Doctors:Earlier detectionPriceAccuracyImmediate Results
Patients:Radiation FreeNon-Invasive
MammOpticsBusiness Model Canvas 7
OB/GYNsPCPs
Direct Sales to hospitalsDistributor
Strong clinical dataTrainingMaintenanceConferencesCME courses
Product DevelopmentClinical trialsOperating CostsMarketing Costs
Per use fees
Product DevelopmentIPClinical trialsFDAReimbursement Publishing
IP Leading doctorsTechnical Expertise
KOLs3rd party manufacturers(local)Breast Cancer FoundationsACOGACSClinical trial designer
Doctors:Earlier detectionPriceAccuracyImmediate Results
Patients:Radiation FreeNon-Invasive
MammOpticsBusiness Model Canvas 8
OB/GYNsPCPs
Direct Sales to hospitalsDistributor
Strong clinical dataTrainingMaintenanceConferencesCME courses
Product DevelopmentClinical trialsOperating CostsMarketing Costs
Per use fees
Product DevelopmentIPClinical trialsFDAReimbursement Publishing
IP Leading doctorsTechnical Expertise
KOLs3rd party manufacturers(local)Breast Cancer FoundationsACOGACSClinical trial designer
Doctors:Earlier detectionPriceAccuracyImmediate Results
Patients:Radiation FreeNon-Invasive
MammOpticsBusiness Model Canvas 9
WHAT ARE YOU “REALLY”THINKING?
115
116
! Holy Cow !
! I don’t know any of this stuff !
? How deep do I need to go ?
:HELP:
117
:Think:
• In practice I call “Version 1.0” a “Splat”– I find it sets the tone/expectation much better– Nb. expectation is that this phase requires 2 to 3 passes
( or iterations ) before its done.• Keys
– You want to figure out what you know and don’t know. • :Issue: A lot of people are afraid to “write down” what they don’t
know, or accept that they don’t know.– The real work is “Outside” the building to fill in the blanks
& convert assumptions into facts
118
Before You Start
• Board and Management Buy-In – “Learning & discovery” not execution
• Customer Development Team – Not traditional hires
• Sufficient funding for 2-3 passes
:Aside:
119
! Titles Matter !“Traditional organizations & titles fail”
• People equate their titles with their functions– Standard titles describe execution functions
• We need new titles consistent with “learning & discovery” functions
CEO
VP Eng VP Mkt VP Sales VP Biz Dev
:Aside:
120
In Front of Customer Positions
Customer Development Team“Tasks”
CEO
VP Product Dev
Technical Visionary
Business Visionary
Business Execution
Nb. This doesn’t mean “VP, Product Dev” doesn’t visit customers
:Aside:
Documenting
• “Not too much and not to little”
• Get to know yourself– Basic Rule of Thumb
• Marketers like to analyse and plan – Ie lotsa documentation
• Sales likes to live in the field– Ie none
121
122
Design The Tests
• These can be simple.
• Q. How Accurate is our Service Journey Sketch?
• Action: Review our “Service Journey Sketch” with Emergency Staff at “n” hospitals.
123