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CerviCare
Providing automated cervical cancer diagnostics for accurate, rapid testing of low-income populations
Team
Jahrane Dale
Olachi Oleru
Ritish Patnaik
Stephanie Yang
Advisor: Dr. Aaron Kyle
Interviews
Last 24 hours: 15
Total: 53
Day 1 - What We Thought
Good Need +
Good Product =
Great Business
Opportunity
Plan to build up
the company over
the span of
multiple years
Talk primarily to
our “end users”
(gynecologists)
Build up business
model over the
next month
Begin talks with
VCs and angels in
Mid-February
Day 1 - Canvas
6. Key Partners
Key Partners:
International Health
Groups (WHO); NGOs;
Key Suppliers:
Manufacturers; Columbia
Tech Ventures (CTV);
International Health
Groups; NGOs
Getting: Access to
customers & device
manufacturing
Giving: CerviCare
Diagnostic System
7. Key Activities
9. Cost Structure 5. Revenue Streams
Per device sold to the international health organization and non-profit
organizations (NGOs)
Estimated $50 per CerviCare system
1. Value Propositions 4. Customer Relationships
Get Customers:
partnerships with health
organizations
Keep and Grow: ease of
use and quality service
2. Customer Segments
Most Important
Customers: Patients: get
care; Gynecologists:
provide care; Low-Cost
Clinics: venue for care;
International Health
Organizations (NGOs):
provide medical devices
What they want: low-cost,
rapid and more accurate
cervical cancer diagnostics
8. Key Resources 3. Channels
Day 2 - What We Learned
don’t make their hotlines
bling (cold calling doesn’t go
over well)
Total Available
Market (2020)
Served Available
Market
Target
Market
$22B
$18B
$3B
Day 2 - Canvas
6. Key Partners 7. Key Activities
9. Cost Structure 5. Revenue Streams
1. Value Propositions 4. Customer Relationships 2. Customer Segments
8. Key Resources 3. Channels
Day 3 - What We Learned
EARLYJANUARY
CTV evaluation of IP rights
Preparation of provisional patent
Consultation with CTV and
external IP lawyer
Prototype iteration(s)
Field testing
Prototype reiteration
US Patent & Trademark Office
Monopoly for up to 20 years
~90% of issued patent documents
$3-5k
$30-50k
→ Final Design
Reimbursement Officer
Invention Report
Provisional Patent
Money
Claims
Pays membership
Coverage
Out-of-pocket fees
LATEJANUARY
Utility Patent
FEBRUARY2017
Medical Services
CerviCare
Insurance
Patients
Healthcare
Providers
(i.e hospitals and
physicians)
$0
Day 3 - Canvas
6. Key Partners 7. Key Activities
Development of automated
software; customer
management; hardware
development; regulatory
process; filing patents;
organize government-
supported training;
fundraising efforts
9. Cost Structure 5. Revenue Streams
1. Value Propositions
Current Problems:
Low sensitivity and specificity;
hard to get complete acetic
acid coverage; subjectively
classify cancerous lesions;
requires hours of lesion ID
training
Product Features:
Automated and objective
diagnostic; reduced required
operational training; complete
acetic acid coverage; low-
cost;
data is sent to referral
hospitals
4. Customer Relationships
Get Customers: design
competitions; get attention of
opinion leaders & prominent
health advocates; research
publications; referrals
Keep and Grow: ease of use
and quality service
2. Customer Segments
Most Important Customers
(Domestic & in
Uganda/India):
Patients: get care;
Healthcare workers:
provide/influence care;
Low-Cost Clinics: venue for
care;
International Health
Organizations (Uganda) &
NGOs (both): provide medical
devices
What they want:
low-cost, accessible, rapid
and more accurate cervical
cancer diagnostics
8. Key Resources
3. Channels
Day 4 - What We Learned
Cost of Goods
(Supply Chain)
$25
R&D + SG&A + Profits
$135
EU
Discounts
$20
$200 EU
price
Cost of Goods
(Supply Chain)
$0.05
R&D + SG&A + Profits
$0.35
EU
Discounts
$0.05
$0.50 EU
price
Disposable Sleeve
CerviCare System
Reseller
$0.05
Reseller
$20
Day 4 - Canvas
6. Key Partners
NGOs
7. Key Activities
9. Cost Structure 5. Revenue Streams
1. Value Propositions
Addressed Problems:
~75% sensitivity and ~80%
specificity; subjective cancer
lesion identification; 5-10
days of lesion ID training
Funding bodies: ~$0.50 per
test; ~$22B total market size;
matches grant requirements
Clinics/Hospitals: 1-2 days
of healthcare worker training,
visual referral data & images;
12 patients per hour & nurse
Physicians: ~95% sensitivity
& ~95% specificity; reduced
required training & treatment;
12 patients per hour & nurse
4. Customer Relationships 2. Customer Segments
Funding Bodies (Global
Health Organizations
8. Key Resources 3. Channels
Day 5 - What We Learned
510(k), Class II Approval
Predicate (DySIS) Screening
Approval for Use in Uganda
510(k) Review
FDA (USA)
NDA (Uganda)
REGULATORY PATHWAYKEY ACTIVITIES, PARTNERS & RESOURCES
Grants &
Angels
Advisory
Board
Manufacturing
Facilities &
Device
Materials
Provisional
and Utility
Patent
Device
Design &
Development
Fundraising
Clinical Trials
& Regulatory
Approval
Manufacturing
Freedom to
Operate
Medit;Analog
Devices; Rex
Plastics
WHO; Gates
Foundation;
World Bank
Low-Income
NGOs and
Governments
USAID, ADF,
IMF, AfDB,
DFID
Columbia
Technology
Ventures
Resources
ActivitiesPartners
6. Key Partners 7. Key Activities
9. Cost Structure 5. Revenue Streams
1. Value Propositions
Addressed Problems:
~75% sensitivity and ~80%
specificity; subjective cancer
lesion identification; 5-10
days of lesion ID training
Funding bodies: ~$0.50 per
test; ~$22B total market size;
matches grant requirements
Clinics/Hospitals: 1-2 days
of healthcare worker training,
visual referral data & images;
12 patients per hour & nurse
Physicians: ~95% sensitivity
& ~95% specificity; reduced
required training & treatment;
12 patients per hour & nurse
4. Customer Relationships 2. Customer Segments
Funding Bodies (Global
Health Organizations
8. Key Resources 3. Channels
Day 5 - Canvas
Conclusions
Good Need +
Good Product =
Great Business
Opportunity
Plan to build up
the company over
the span of
multiple years
Talk primarily to
our “end users”
(gynecologists)
Game Plan:
Build up business
model over the
next month
Begin talks with
VCs and angels in
Mid-February
WHAT WE THOUGHT
WHERE WE ENDED
Need to
consider other
aspects: archetypes,
IP, regulatory,
revenue model,
etc.
Need to talk
to all customer
segments and key
partners, not just
“end users”
Gain funding
through both
competitions and
grants before
talks
Game Plan:
Prototyping and
continue iterating
business model
hypotheses
Acquisition or
licensing
Future Plans
DEVELOPMENT
IP &
FUNDING
FIELD
TESTING
DEVELOPMENT
FEBRUARY 1, 2016
Finish prototyping
and produce a MVP
Continue customer
discovery process
for India & USA
IP & FUNDING
FEBRUARY 15, 2016
Obtain a provisional
patent on our device
Apply for incubators,
design competitions,
& health/aid grants
FIELD TESTING
SUMMER 2016
Conduct field tests in
Mulago Hospital via
Columbia partnership
Pitch to angels & VCs
CLINICAL TRIALS
DECEMBER 2016
Begin Phase I clinical
trials (FDA approval)
CLINICAL
TRIALS

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CerviCare Columbia

  • 1. CerviCare Providing automated cervical cancer diagnostics for accurate, rapid testing of low-income populations Team Jahrane Dale Olachi Oleru Ritish Patnaik Stephanie Yang Advisor: Dr. Aaron Kyle Interviews Last 24 hours: 15 Total: 53
  • 2. Day 1 - What We Thought Good Need + Good Product = Great Business Opportunity Plan to build up the company over the span of multiple years Talk primarily to our “end users” (gynecologists) Build up business model over the next month Begin talks with VCs and angels in Mid-February
  • 3. Day 1 - Canvas 6. Key Partners Key Partners: International Health Groups (WHO); NGOs; Key Suppliers: Manufacturers; Columbia Tech Ventures (CTV); International Health Groups; NGOs Getting: Access to customers & device manufacturing Giving: CerviCare Diagnostic System 7. Key Activities 9. Cost Structure 5. Revenue Streams Per device sold to the international health organization and non-profit organizations (NGOs) Estimated $50 per CerviCare system 1. Value Propositions 4. Customer Relationships Get Customers: partnerships with health organizations Keep and Grow: ease of use and quality service 2. Customer Segments Most Important Customers: Patients: get care; Gynecologists: provide care; Low-Cost Clinics: venue for care; International Health Organizations (NGOs): provide medical devices What they want: low-cost, rapid and more accurate cervical cancer diagnostics 8. Key Resources 3. Channels
  • 4. Day 2 - What We Learned don’t make their hotlines bling (cold calling doesn’t go over well) Total Available Market (2020) Served Available Market Target Market $22B $18B $3B
  • 5. Day 2 - Canvas 6. Key Partners 7. Key Activities 9. Cost Structure 5. Revenue Streams 1. Value Propositions 4. Customer Relationships 2. Customer Segments 8. Key Resources 3. Channels
  • 6. Day 3 - What We Learned EARLYJANUARY CTV evaluation of IP rights Preparation of provisional patent Consultation with CTV and external IP lawyer Prototype iteration(s) Field testing Prototype reiteration US Patent & Trademark Office Monopoly for up to 20 years ~90% of issued patent documents $3-5k $30-50k → Final Design Reimbursement Officer Invention Report Provisional Patent Money Claims Pays membership Coverage Out-of-pocket fees LATEJANUARY Utility Patent FEBRUARY2017 Medical Services CerviCare Insurance Patients Healthcare Providers (i.e hospitals and physicians) $0
  • 7. Day 3 - Canvas 6. Key Partners 7. Key Activities Development of automated software; customer management; hardware development; regulatory process; filing patents; organize government- supported training; fundraising efforts 9. Cost Structure 5. Revenue Streams 1. Value Propositions Current Problems: Low sensitivity and specificity; hard to get complete acetic acid coverage; subjectively classify cancerous lesions; requires hours of lesion ID training Product Features: Automated and objective diagnostic; reduced required operational training; complete acetic acid coverage; low- cost; data is sent to referral hospitals 4. Customer Relationships Get Customers: design competitions; get attention of opinion leaders & prominent health advocates; research publications; referrals Keep and Grow: ease of use and quality service 2. Customer Segments Most Important Customers (Domestic & in Uganda/India): Patients: get care; Healthcare workers: provide/influence care; Low-Cost Clinics: venue for care; International Health Organizations (Uganda) & NGOs (both): provide medical devices What they want: low-cost, accessible, rapid and more accurate cervical cancer diagnostics 8. Key Resources 3. Channels
  • 8. Day 4 - What We Learned Cost of Goods (Supply Chain) $25 R&D + SG&A + Profits $135 EU Discounts $20 $200 EU price Cost of Goods (Supply Chain) $0.05 R&D + SG&A + Profits $0.35 EU Discounts $0.05 $0.50 EU price Disposable Sleeve CerviCare System Reseller $0.05 Reseller $20
  • 9. Day 4 - Canvas 6. Key Partners NGOs 7. Key Activities 9. Cost Structure 5. Revenue Streams 1. Value Propositions Addressed Problems: ~75% sensitivity and ~80% specificity; subjective cancer lesion identification; 5-10 days of lesion ID training Funding bodies: ~$0.50 per test; ~$22B total market size; matches grant requirements Clinics/Hospitals: 1-2 days of healthcare worker training, visual referral data & images; 12 patients per hour & nurse Physicians: ~95% sensitivity & ~95% specificity; reduced required training & treatment; 12 patients per hour & nurse 4. Customer Relationships 2. Customer Segments Funding Bodies (Global Health Organizations 8. Key Resources 3. Channels
  • 10. Day 5 - What We Learned 510(k), Class II Approval Predicate (DySIS) Screening Approval for Use in Uganda 510(k) Review FDA (USA) NDA (Uganda) REGULATORY PATHWAYKEY ACTIVITIES, PARTNERS & RESOURCES Grants & Angels Advisory Board Manufacturing Facilities & Device Materials Provisional and Utility Patent Device Design & Development Fundraising Clinical Trials & Regulatory Approval Manufacturing Freedom to Operate Medit;Analog Devices; Rex Plastics WHO; Gates Foundation; World Bank Low-Income NGOs and Governments USAID, ADF, IMF, AfDB, DFID Columbia Technology Ventures Resources ActivitiesPartners
  • 11. 6. Key Partners 7. Key Activities 9. Cost Structure 5. Revenue Streams 1. Value Propositions Addressed Problems: ~75% sensitivity and ~80% specificity; subjective cancer lesion identification; 5-10 days of lesion ID training Funding bodies: ~$0.50 per test; ~$22B total market size; matches grant requirements Clinics/Hospitals: 1-2 days of healthcare worker training, visual referral data & images; 12 patients per hour & nurse Physicians: ~95% sensitivity & ~95% specificity; reduced required training & treatment; 12 patients per hour & nurse 4. Customer Relationships 2. Customer Segments Funding Bodies (Global Health Organizations 8. Key Resources 3. Channels Day 5 - Canvas
  • 12. Conclusions Good Need + Good Product = Great Business Opportunity Plan to build up the company over the span of multiple years Talk primarily to our “end users” (gynecologists) Game Plan: Build up business model over the next month Begin talks with VCs and angels in Mid-February WHAT WE THOUGHT WHERE WE ENDED Need to consider other aspects: archetypes, IP, regulatory, revenue model, etc. Need to talk to all customer segments and key partners, not just “end users” Gain funding through both competitions and grants before talks Game Plan: Prototyping and continue iterating business model hypotheses Acquisition or licensing
  • 13. Future Plans DEVELOPMENT IP & FUNDING FIELD TESTING DEVELOPMENT FEBRUARY 1, 2016 Finish prototyping and produce a MVP Continue customer discovery process for India & USA IP & FUNDING FEBRUARY 15, 2016 Obtain a provisional patent on our device Apply for incubators, design competitions, & health/aid grants FIELD TESTING SUMMER 2016 Conduct field tests in Mulago Hospital via Columbia partnership Pitch to angels & VCs CLINICAL TRIALS DECEMBER 2016 Begin Phase I clinical trials (FDA approval) CLINICAL TRIALS