5. Value Propositions are NOT complex
•
•
•
•
•
More accurate results, faster!
Higher sensitivity with less sample volume
Accurate ranking of treatment options
Easy-to-use cosmic ray gun
Portable nuclear warhead
But the environment is…
•
VP maps onto CS
•
• No Value Proposition, no Customer Segment
• Too many value propositions, not a Customer Segment
VPs for each ‘customer’ in the ecosystem, to the extent possible
5
6. How we will fit DX into the BMC
CLINICAL
TRIALS
REGULATION
IP
REIMBURSEMENT
6
7. Who is a Customer?
•
•
•
•
Someone who has a NEED which can be satisfied by your VPs
Someone who has a WANT which can be satisfied
Someone who can be IDENTIFIED
Someone who can be DIFFERENTIATED
9. Customer Archetype:
Joe “Dude” Marrama
• Loves to ski, surf, rock climb
• Salary ~100K/year
• Looking for something to do
when the surf’s blown out
• Intimidated by cost and learning
curve of kiting
“Companies need to offer more entry level
packages."
Matt Sexton
Founder Collegiate Kiteboarding Association
10. Results:
Our Customers
• Professional Kite Surfers
• Solely concerned with performance
• Average Kite Surfer
• Performance and cost sensitive
• “One less thing to carry” effect
• Prospective Kite Surfer
• Cost sensitive
• Learning barrier
11. Meet Xing Xie
International Graduate Student at Stanford
• Engineering graduate student
Xing
Art
– Receives financial package to cover tuition,
fees, insurance and living expenses
• Chinese 4-2-1 family
– No siblings, spoiled by parents
– High disposable income
• 1st time to America
– No credit score, SSN, or US address
– Strong ties to his community in China
• Academically responsible
– Completes all homework on time
• Financially responsible
– Pays all bills on time and in full
• Social network is similarly responsible
12. Customer Segments?
•
•
•
•
•
•
x
Kids
Boys
Adults
Kids under 10 with disposable
income (and who are thirsty)
Boys who like to watch machines
working, like the juicer machine
Dads and Moms who are walking
past our stand in the afternoon
Consider ‘Un-customer segments’
12
14. Definitions: Four Types of Markets
Existing
Market
Resegmented
Market
New
Market
• Existing Market
– Faster/Better = High end
• Resegmented Market
– Niche = marketing/branding driven
– Cheaper = low end
• New Market
– Cheaper/good enough can create a new class of
product/customer
– Innovative/never existed before
• Clone Market
• Local adaptation
Clone
Market
16. Because you are special…
hypothesize now
CLINICAL
TRIALS
IP
REGULATION
REIMBURSEMENT
16
17. Know your regulator
• Food and Drug Administration (FDA)
– Center for Devices and Radiological Health
•
•
•
•
•
USDA
European agencies (EMEA, national level)
Japanese Ministry of Health and Welfare
Chinese (SFDA)
Health Canada
18. Regulation
•
Invitro diagnostic products (IVD) are those reagents, instruments, and systems
intended for use in diagnosis of disease or other conditions, including a
determination of the state of health, in order to cure, mitigate, treat, or prevent
disease or its sequelae. Such products are intended for use in the collection,
preparation, and examination of specimens taken from the human body. [21 CFR
809.3]
•
IVDs are medical devices as defined in section 210(h) of the Federal Food, Drug,
and Cosmetic Act, and may also be biological products subject to section 351 of
the Public Health Service Act. Like other medical devices, IVDs are subject to
premarket and postmarket controls. IVDs are also subject to the Clinical Laboratory
Improvement Amendments (CLIA '88) of 1988.
•
What isn’t an IVD?
–
–
In vivo
Treatments
19. Regulatory classes for diagnostics
•
Class I (low to moderate risk): general controls
•
Class II (moderate to high risk): general controls and Special Controls (510(k)) aka PMN
–
–
–
–
–
•
Performance standards
Postmarket surveillance
Patient registries
Special labeling requirements
Premarket data requirements
Class III (high risk): general controls and Premarket Approval (PMA)
–
–
Under federal law, class III devices are subject to approval of a Premarket Approval Application
(PMA).
Devices that are not within a type marketed before the date of the Medical Device Amendments of
1976 – referred to preamendments devices – are classified into class III automatically under federal
law.. In addition, the FDA classifies into class III devices intended to be used in supporting or
sustaining human life or preventing impairment of human health, or that may present a potential
unreasonable risk of illness or injury for which general controls and special controls are insufficient to
provide reasonable assurance of the safety and effectiveness of a device, or for which there is
insufficient information to make such a determination.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm2005378.htm#class_1
20. Believe it or not…
Regulators are part of your
customer set
1. Find out which regulator
and sub-agency is likely to
be yours
2. Find out the process for
regulation and validation
3. Map them into your
ecosystem
22. What is Reimbursement?
•
Reimbursement for procedures and
services performed by providers is made
by commercial payers or federal
intermediaries acting on behalf of a halfdozen programs. Reimbursement is
based on claims and documentation
filed by providers using medical
diagnosis and procedure codes.
•
Commercial payers must use standards
defined by the U.S. Department of
Health and Human Services (HHS) but
are largely regulated state-by-state. Save
for specific national mandates such as
reimbursement for childbirth,
commercial payers determine their own
rules of medical necessity or payment
and reimbursement fee schedules.
Federal intermediaries are regulated as
contractors by the Centers for Medicare
& Medicaid Services (CMS).
•
The Current Procedural
Terminology (CPT) code set is a medical
code set maintained by the American
Medical Association. The CPT code set
(copyright protected by the AMA)
describes medical, surgical, and
diagnostic services and is designed to
communicate uniform information
about medical services and procedures
among physicians, coders, patients,
accreditation organizations, and payers
for administrative, financial, and
analytical purposes
23. Like it or not…
Reimbursers and code
allocators are part of your
customer set
1. Find out which code groups
you may fit into
2. Find out the value for them
3. Find out the process for
assignment and approval
4. Map them into your
ecosystem
24. Next week
• Standard slides as per the syllabus
• Plus
– Ecosystem overview
– Regulation overview
– Reimbursement overview
Editor's Notes
Generally impacts some part of your business model diagram (usually NOT the product component)
