2. MammOptics
The Team
Pedro Hernandez Emma Medjuck
BS Chemical Eng., Stanford U. BComm Business/Math, McGill U.
MS Chemical Eng. (candidate) MS MS&E (candidate)
Mayfield Fellow 2010
Brings experience of internship at Pacific Previous experience with customer
Biosciences. Numerous courses in discovery and customer activities.
entrepreneurship.
Josef Miler Ramin Miri
BS Mechanical Eng, MIT BS Electrical Eng., Sharif U.
MS Mechanical Eng., Stanford U. MS Electrical Eng., Stanford U.
PhD Mechanical Eng. (candidate) MS MS&E, Stanford U.
PhD, Electrical Eng. (candidate)
Technical consulting for start-ups. Expert PhD research in optical spectroscopy signal
witness in medtech IP case. Background in IP. processing. Numerous courses in
entrepreneurship.
3. Project overview
Initial hypotheses
Canvas #1: Finding the right customer
Testing value proposition
Purchasing decision tree
Canvas #2: Getting to the customer
Medical marketing
Medical sales
Canvas #3: Building the company
Clinical trials
Reimbursement
Financing the company
Company timeline
Reflection on the company
Reflection on the medtech industry
Key industry requirements
Lessons learned
Appendix
Financial calculations
Business model canvas weeks 1-10
5. 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
- Non-invasive
6. MammOptics
Technology Comparison
False False Time
Risk Invasiveness Resolution Device Cost
Pos. Neg. Required
MammOptics Very Low Very Low <.1 I.I.T.Y.I.W.H.T.K.Y
cm <15% 5% 15-20k 10 min.
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.
7. 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 Expertise hospitals
Product Development
Clinical trials
Capital equipment sales
Operating Costs
and disposable item
8. 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
Test: Non-invasive hospitals
er segment
Distributors
Custom
e proposition to
IP
Leading doctors Valu Direct sales
Technical Expertise hospitals
Product Development
Clinical trials
Capital equipment sales
Operating Costs
and disposable item
10. MammOptics
Excursions into hospitals
Debra Ikeda
Leading doctors Jason Davies
Jafi Alissa Lipson
Sunita Pal
6 women >40
Patients
8 women <40
Alicia X-ray
Technicians
mammography
Hospital Paul Billings
Managers Holly V. Gautier
14. MammOptics
Private practice purchasing decision tree
Private practice
✔ Faster adoption rate
e value proposition
Attractiv
15. MammOptics
Business Model Canvas 2 of 4
Product Doctors: Strong clinical
Development Earlier detection data
Hospitals (Capital IP Price Training
Spending Clinical trials Accuracy Maintenance Pioneering
Committee) FDA Doctors
Leading doctors Patients: Hospitals
3rd party Radiation Free OB/GYNs
manufacturers Non-Invasive PCPs
Distributors Direct Sales to
IP
Research Hospitals doctors
Leading doctors
Technical Expertise
Product Development
Clinical trials Capital Equipment Sales and
Operating Costs disposable item
16. MammOptics
Business Model Canvas 2 of 4
Product Doctors: Strong clinical
Development Earlier detection data
Hospitals (Capital IP Price Training
Spending Clinical trials Accuracy Maintenance Pioneering
Committee) FDA Doctors
Leading doctors Patients: Hospitals
ur customer?
3rd party Radiation Free OB/GYNs
do we get to o Direct Salescity
manufacturers Non-Invasive PCPs
How
y and specifi to
Distributors
Research Hospitals
Leading doctorsnsitivi
IP
se
eedExpertise t doctors
N
Technical
Product Development
Clinical trials Capital Equipment Sales and
Operating Costs disposable item
17. Getting to our customer
The world of direct sales and medical marketing
18. 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
19. 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
20. MammOptics
Marketing
Strong influence on doctors via
ACOG Standard of Care Key
Opinion
Leaders
(KOLs)
Strongly influenced
American College
of Obstetricians by KOLs
Medical Journals
and Gynecologists
(ACOG)
Access to ACOG by Market
former member Adoption
American College
of Obstetricians Continuing
and Gynecologists Medical Education
(ACOG)
Conferences
21. MammOptics
Marketing
Researchers Researchers with
conducting important strong peer
clinical trials Key
Opinion
recommendations
Leaders
(KOLs)
American College
Researchers with
of Obstetricians Outsourced survey
numerous Medical Journals
and Gynecologists research
publications
(ACOG)
Market
Adoption
American College
of Obstetricians Continuing
and Gynecologists Medical Education
(ACOG)
Conferences
22. MammOptics
Marketing
Focus on prominent
Key
Opinion
journals
Leaders
(KOLs)
Need two big
publications
American College
of Obstetricians
Medical Journals
and Gynecologists
(ACOG)
Market Choose KOL as Principal
Adoption Investigators (PI)
American College
of Obstetricians Continuing
and Gynecologists Medical Education
(ACOG)
Conferences
23. MammOptics
Marketing
Key
Opinion
Leaders
(KOLs)
American College
of Obstetricians
Medical Journals
and Gynecologists
(ACOG)
Market Effective method for
educating doctors
Adoption
American College
of Obstetricians Workshop must be Continuing
and Gynecologists approved by ACOG Medical Education
(ACOG)
Doctors required to
Conferences
attend workshops Taught by objective
medical experts
24. MammOptics
Marketing
Key
Opinion
Leaders
(KOLs)
American College
of Obstetricians
Medical Journals
and Gynecologists
(ACOG)
Market
Adoption
American College
of Obstetricians Continuing
and Gynecologists Medical Education
(ACOG) ACOG Annual
Opportunity for Clinical Meeting
feedback from Conferences
doctors
Miami Breast Cancer
Conference
25. MammOptics
Marketing
Key
Opinion
Leaders
(KOLs)
American College
of Obstetricians
Medical Journals
and Gynecologists
(ACOG)
Trusted information source Market
for patients Adoption
Breast Cancer Continuing
Advocacy Groups Medical Education
Access to media
outlets
Conferences
Critical opinion leader
for technology adoption
26. MammOptics
Channel Strategies and Costs
High value medical Direct Sales Individual
Individual
products Doctors
Doctors
(e.g. cardiovascular
stents) • Doctor education
• Direct feedback from doctors
• Very expensive
Commodity medical Purchasing
Purchasing
Distributors Administrators
Administrators
products
(e.g. latex gloves) • No doctor education
• No customer feedback
• Inexpensive
27. 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 Use women’s healthcare
with established equipment distributor
relationships
Already established
Early adopter feedback network of customers
28. MammOptics
Pricing Strategy
Equipment Lease model Per-use model Consumable
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
29. MammOptics
mers
Pricing Strategy db y custo
Approve vestors
and in
Equipment Lease model Per-use model Consumable
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
30. MammOptics
Customer Workflow
Insurance
Current market
Mammography Radiologist
Technician Hospital
Administration
ACOG Doctor specialty
ACS committee
31. MammOptics
Customer Workflow
Insurance
Current market
But what would
happen if we replace
Mammography Radiologist
mammography?
Technician Hospital
Administration
ACOG Doctor specialty
ACS committee
32. MammOptics
Customer Workflow
Insurance
Mammography Radiologist
Breast Radiologists Technicians Hospitals
Loss of jobs Eliminates loss leader
Loss of jobs Puts emphasis on biopsies
Technician Hospital
Administration
ACOG Doctor specialty
ACS committee
39. MammOptics
Business Model Canvas 3 of 4
Product Strong clinical
Development Doctors: data
IP Earlier detection Training
Clinical trials Price Maintenance
Leading doctors FDA Conferences
Key Opinion Leaders Accuracy OB/GYNs
Publishing CME courses PCPs
3rd party
manufacturers Patients:
Distributors Radiation Free
Breast Cancer Non-Invasive
Foundations Direct Sales to
IP
ACOG hospitals
Leading doctors
ACS Distributor
Technical Expertise
Product Development
Clinical trials Capital Equipment Sales and
Operating Costs disposable item
Marketing Costs Per use fees
40. MammOptics
Business Model Canvas 3 of 4
Product Strong clinical
Development Doctors: data
IP Earlier detection Training
Clinical trials Price Maintenance
Leading doctors FDA Conferences
Key Opinion Leaders Accuracy OB/GYNs
Reimbursement CME courses PCPs
3rd party Publishing
manufacturers Patients:
e customer
Distributors Radiation Free
h
ow to reach t
Breast Cancer Non-Invasive
Learned h Direct Sales d on
seto this?
a company ba
Foundations
IP
do we build
ACOG hospitals
Leading doctors
ACS How Distributor
Technical Expertise
Product Development
Clinical trials Capital Equipment Sales and
Operating Costs disposable item
Marketing Costs Per use fees
42. MammOptics
Interviews
Stanford Statistics
FDA Clinical Trials Steve 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
Michael J. Nohr
56. 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
Series C
Cash Reserve
$30M
$30.5 MM $35 MM
$20M
$15M
Series B $9
MM
$10M
Series A
$5M $3.5 MM
Initialize
Financial Regulatory / Clinical Launch
Proof of Marketable
timeline
Milestones
Beta Prototype Second Release
Concept Product
Design
Beta- 1st
Laboratory 2nd Release Test
Version Release
Prototype Testing Test
Publication
Publication
Milestones
Clinical
Pilot Clinical Post-Market Clinical
US Interim Trials US Pivotal Clinical Results Studies
Studies
Trials
Non-Specific Codes
Provisional
Regulatory/ IP
Patent
IRB / Cat III FDA – Class II – 510 (k) with Specific Codes
Milestones
IDE CPT Clinical Trials (Cat. I CPT / APC)
IC and Application Initial
Processing and System Product
Technology Patents Patents Launch
Licensing 56 12/4/2009
59. 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
Regulatory / Clinical
Marketable
Milestones
Beta Prototype
Product
Design
Laboratory Beta-
Version
Prototype Testing
Milestones
Clinical
Pilot
Studies
Regulatory/ IP
IRB /
Milestones
IDE
IC and Application
Processing and System
Patents Patents
59 12/4/2009
60. 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 C
Cash Reserve
$30M
$20M
$30.5 MM
$15M
Series B $9
MM
$10M
$5M
Regulatory / Clinical
Milestones
Second Release
Design
1st
Release
Test
Publication
Milestones
Clinical
Pilot
US Interim Trials US Pivotal Clinical
Studies
Trials
Regulatory/ IP
IRB / Cat III
Milestones
IDE CPT
IC and Application
Processing and System
Patents Patents
60
61. 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 C Series D
Cash Reserve
$30M
$30.5 MM $35 MM
$20M
$15M
$10M
$5M
Regulatory / Clinical Launch
Milestones
Second Release
Design
2nd Release Test
Publication
Publication
Milestones
Clinical
Clinical
US Interim Trials US Pivotal Clinical Results
Trials
Non-Specific Codes
Regulatory/ IP
FDA – Class II – 510 (k) with
Milestones
Clinical Trials
Initial
Product
Launch
61 12/4/2009
62. 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
Publication
Milestones
Clinical
Clinical Post-Market Clinical
Results Studies
Non-Specific Codes
Regulatory/ IP
FDA – Class II – 510 (k) with Specific Codes
Milestones
Clinical Trials (Cat. I CPT / APC)
Initial
Product
Launch
12/4/2009
63. 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
Series C
Cash Reserve
$30M
$30.5 MM $35 MM
$20M
$15M
Series B $9
MM
$10M
Series A
$5M $3.5 MM
Initialize Regulatory / Clinical Launch
Proof of Marketable
Milestones
Beta Prototype Second Release
Concept Product
Design
Beta- 1st
Laboratory 2nd Release Test
Version Release
Prototype Testing Test
Publication
Publication
Milestones
Clinical
Pilot Clinical Post-Market Clinical
US Interim Trials US Pivotal Clinical Results Studies
Studies
Trials
Non-Specific Codes
Provisional
Regulatory/ IP
Patent
IRB / Cat III FDA – Class II – 510 (k) with Specific Codes
Milestones
IDE CPT Clinical Trials (Cat. I CPT / APC)
IC and Application Initial
Processing and System Product
Technology Patents Patents Launch
Licensing 63 12/4/2009
64. MammOptics
Business Model Canvas 4 of 4
Product Strong clinical
Development Doctors: data
IP Earlier detection Training
Clinical trials Price Maintenance
KOLs FDA Conferences
3rd party Accuracy OB/GYNs
Reimbursement Immediate CME courses PCPs
manufacturers Publishing
Distributors Results
Breast Cancer
Foundations Patients:
ACOG Radiation Free
IP Non-Invasive Direct Sales to
ACS hospitals
Leading doctors
Clinical trial designer Distributor
Technical Expertise
Online
Product Development
Clinical trials Per use fees
Operating Costs
Marketing Costs
65. MammOptics
Business Model Canvas 4 of 4
Product Strong clinical
Development data
IP Training
Clinical trials Maintenance
KOLs FDA Conferences
3rd party Earlier detection OB/GYNs
Reimbursement Non invasive CME courses PCPs
manufacturers Publishing
Breast Cancer Price
iness model
Foundations Accuracy
ion of our bus
ACOG Immediate Results
Final iterat Direct Sales to ic tu
b ig p re…
nk about the
ACS
IP
i
… need to th
Clinical trial designer hospitals
Leading doctors
But Distributor
Technical Expertise
Online
Product Development
Clinical trials Per use fees
Operating Costs
Marketing Costs
66. Reflection on the Company
Lessons learned from the medical device industry
67. MammOptics
Fundamental Challenges of a Medtech Startup
Reimbursement
FDA approval
Medical
technology
Intellectual
Property
68. MammOptics
Fundamental Challenges of a Medtech Startup
Reimbursement
Capital intensive
Long time to
market
FDA approval
Medical
technology
Profitability
networks
Dependence
Intellectual on KOLs
Property
69. MammOptics
Fundamental Challenges of a Medtech Startup
Reimbursement
Capital intensive
Long time to
market
FDA approval
Medical
technology
Profitability
networks
Dependence
Intellectual on KOLs
Property
71. Near 50 interviews
Around 50 hrs/week
Special thanks to our mentors
Rowan Chapman Thank you…
Steve Turner Business Model Recap
Jason Davies
72. 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 and
Operating Costs disposable item
73. 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 Hospitals IP Direct Sales to
Leading doctors hospitals
Technical Expertise
Product Development
Clinical trials Capital Equipment Sales and
Operating Costs disposable item
74. MammOptics
Business Model Canvas 3
Product Doctors: Strong clinical
Development Earlier detection data
Hospitals (Capital IP Price Training
Spending Clinical trials Accuracy Maintenance Pioneering
Committee) FDA Doctors
Leading doctors Patients: Hospitals
3rd party Radiation Free
manufacturers Non-Invasive
Distributors Direct Sales to
IP
Research Hospitals hospitals
Leading doctors
Technical Expertise
Product Development
Clinical trials Capital Equipment Sales and
Operating Costs disposable item
75. MammOptics
Business Model Canvas 4
Product Doctors: Strong clinical
Development Earlier detection data
Hospitals (Capital IP Price Training
Spending Clinical trials Accuracy Maintenance Pioneering
Committee) FDA Immediate Doctors
Leading doctors Results Hospitals
3rd party OB/GYNs
manufacturers Patients: PCPs
Distributors Radiation Free
IP Non-Invasive Direct Sales to
Research Hospitals hospitals
Leading doctors
Breast Cancer
Technical Expertise
Foundations
Product Development
Clinical trials Capital Equipment Sales and
Operating Costs disposable item
76. MammOptics
Business Model Canvas 5
Product Strong clinical
Development Doctors: data
IP Earlier detection Training
Clinical trials Price Maintenance
Leading doctors FDA Conferences
Key Opinion Leaders Accuracy OB/GYNs
Reimbursement CME courses PCPs
3rd party Publishing
manufacturers Patients:
Distributors Radiation Free
Breast Cancer Non-Invasive
Foundations Direct Sales to
IP
ACOG hospitals
Leading doctors
ACS Distributor
Technical Expertise
Product Development
Clinical trials Capital Equipment Sales and
Operating Costs disposable item
Marketing Costs
77. MammOptics
Business Model Canvas 6
Product Strong clinical
Development Doctors: data
IP Earlier detection Training
Clinical trials Price Maintenance
KOLs FDA Conferences
3rd party Accuracy OB/GYNs
Reimbursement Immediate CME courses PCPs
manufacturers Publishing
Distributors Results
Breast Cancer
Foundations Patients:
ACOG Radiation Free
IP Non-Invasive Direct Sales to
ACS hospitals
Leading doctors
Technical Expertise Distributor
Product Development
Clinical trials Capital Equipment Sales and
Operating Costs disposable item
Marketing Costs Per use fees
78. MammOptics
Business Model Canvas 7
Product Strong clinical
Development Doctors: data
IP Earlier detection Training
Clinical trials Price Maintenance
KOLs FDA Conferences
3rd party Accuracy OB/GYNs
Reimbursement Immediate CME courses PCPs
manufacturers Publishing
Distributors Results
Breast Cancer
Foundations Patients:
ACOG Radiation Free
IP Non-Invasive Direct Sales to
ACS hospitals
Leading doctors
Clinical trial designer Distributor
Technical Expertise
Product Development
Clinical trials Per use fees
Operating Costs
Marketing Costs
79. MammOptics
Business Model Canvas 8
Product Strong clinical
Development Doctors: data
IP Earlier detection Training
Clinical trials Price Maintenance
KOLs FDA Conferences
3rd party Accuracy OB/GYNs
Reimbursement Immediate CME courses PCPs
manufacturers Publishing
(local) Results
Breast Cancer
Foundations Patients:
ACOG Radiation Free
IP Non-Invasive Direct Sales to
ACS hospitals
Leading doctors
Clinical trial designer Distributor
Technical Expertise
Product Development
Clinical trials Per use fees
Operating Costs
Marketing Costs
80. MammOptics
Business Model Canvas 9
Product Strong clinical
Development Doctors: data
IP Earlier detection Training
Clinical trials Price Maintenance
KOLs FDA Conferences
3rd party Accuracy OB/GYNs
Reimbursement Immediate CME courses PCPs
manufacturers Publishing
(local) Results
Breast Cancer
Foundations Patients:
ACOG Radiation Free
IP Non-Invasive Direct Sales to
ACS hospitals
Leading doctors
Clinical trial designer Distributor
Technical Expertise
Product Development
Clinical trials Per use fees
Operating Costs
Marketing Costs