Fundability Criteria Worksheet_MediCoventures_v3.1

Fundability Criteria Worksheet v3.1
This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved
Proprietary and Confidential 6/24/15- 1 -
Fundability Criteria Worksheet
Using this worksheet:
The following worksheet is intended to aid medical device entrepreneurs in evaluating various key
criteria necessary to reach fundability. Adequately addressing these criteria is the first step in
appropriately evaluating a company or technology not only for fundability but also to validate whether
founders’ time or money should be spent on the effort. This worksheet becomes the basis for the
company’s business strategy including determining the next de-risking activities that should be
accomplished and will aid with developing the appropriate business model, business plan and investor
documentations moving forward.
Current Status
Describe the current status and value
proposition in regards to the company or
technology today
Fundability Criteria
Perform an in-depth evaluation of the
fundability criteria
Criteria Scoring
Quantitatively score the criteria
1
2
3

Company Name
Founder(s) name(s) and contact
information
Corporate status
(LLC or C Corp? State of Incorporation)
Existing shareholders and equity held
Total capital raised and spent to date
THE PROBLEM
What problem does your company/product address?
VALUE PROPOSITION
How are you going to convince someone they should pay cash for your product? Define the core value
proposition(s) that you plan to offer with your product. (This should not be a list of features)
MILESTONES
List any successes achieved to date and list all upcoming milestones including funding needs.
1 Current Status

The following provides a general outline of key criteria needing to be evaluated in order to begin to determine if
your idea/company can become fundable. References should be documented for all data/information gathered.
1. CUSTOMER VALIDATION 4
2. MARKET SIZE 5
3. COMPETITION 6
4. IP POSITION 7
5. TECHNICAL FEASIBILITY 8
6. REGULATORY PATHWAY 9
7. CLINICAL FEASIBILITY 10
8. REIMBURSEMENT 11
2 Fundability Criteria

1. CUSTOMER VALIDATION
Speak with and list as many relevant customers’ feedback as possible from each customer segment.
http://steveblank.com/category/life-sciences/
1.1
Patients
(end users or direct beneficiaries
of thetechnology)
1.2
Physicians
(the medical professional closest
to theproblem)
1.3 Providers
(surgery centers, hospitals…etc.)
1.4
Payers
(health insurancepayers,
ACOs…etc.)
1.5
Purchasers
(thestrategic companies who
could potentially acquirethe
technology)
1.6 Customer adoption risks

2. MARKET SIZE
Determine how large the problem is and how much is being spent on a solution currently.
2.1
Patients and/or
procedures annually
(global and in theUS specifically)
2.2 Anticipated average sale
price (ASP)
2.3
Annual market size
(number of procedures x ASP
(current or anticipated))
2.4
Annual market growth rate
(is your product goingto growthe
market morequickly?)
2.5
Revenues at 1% market
penetration
2.6 Market risks

3. COMPETITION
List and describe who is addressing or trying to address the same problem.
Competitor 1
3.1 Description/Image
3.2 Advantages
3.3 Disadvantages/limitations
3.4
Traction to date
(funding, clinical data, sales, market
share…etc.)
3.5
ASP, and Sales Model
(bundled, discounted on volume,
capital equipment…etc.)
3.6 Marketing, branding,
positioning
3.7 FDA indications
3.8 IP status
3.9 Other/Notes
Competitor 2
3.1 Description/Image
3.2 Advantages
3.3 Disadvantages/limitations
3.4
Traction to date
(funding, clinical data, sales, market
share…etc.)
3.5
ASP, and Sales Model
(bundled, discounted on volume,
capital equipment…etc.)
3.6
Marketing, branding,
positioning
3.7 FDA indications
3.8 IP status
3.9 Other/Notes

4. IP POSITION
List and describe the patent landscape and patent status. Will you own the space? Are there blocking
patents you may end up infringing on?
4.1 Patent Landscape
4.2 IP Risks
List relevant,andpotentiallycompeting,patentsorotherdisclosures.
Number/
Assignee
Title Summary Image Filing date/
Status

5. TECHNICAL FEASIBILITY
Describe the technical feasibility of the technology. This is from the engineers’ and manufacturers’
perspective.
5.1 Why it will work
technically
5.2 Technical Risks

6. REGULATORY PATHWAY
Determine the regulatory pathway strategy and potential risks associated with it.
6.1 FDA Classification
(class I, II or III?)
6.2
Predicate devices
(look at competitivedevices that
haveindications you will mimic)
6.3 Product classification
6.4
Is your product GMP
exempt?
6.5
If 510k, is clinical data
required?
(Why, what typeand how much?)
6.6
If PMA, is a De Novo
possible?
6.7
What are the regulatory
risks?

7. CLINICAL FEASIBILITY
Describe the evidence that suggests the technology could be clinically feasible. (e.g. site journals, clinical
studies, clinical experiences)
7.1
Physician workflow
(Describethecurrent workflow
and how your technology
integrates or disrupts thatflow)
7.2 Why it will work clinically?
7.3 What are the clinical risks?

8. REIMBURSEMENT
List relevantreimbursementcodesandcostsummaries basedonCMSorotherdata regarding CPTs, APCs,
DRGs…etc. Existence of reimbursement codes does not guarantee coverage or sufficient payment. If cash
paying, delve into data regarding payment behaviors and pricing for the consumer.
8.1 List reimbursement codes
8.2
What are the coverage policies
associated with this
treatment? (e.g. Blue Cross)
8.3 What is the payment allowed
under these codes?
8.4 What are the reimbursement
risks?
8.5 Notes

Score Criteria 0 1 2 3
1. Customervalidation No customer excitement to
purchase
Hesitant interest to purchase
or
Not enough customer feedback
to-date
Masses haveexpressed interest
to purchase
Significant customers have
agreed to purchase and/or are
willing to invest
2. Market size (US only) Less than 80M 80M-200M 200M -500M Over 500M
3. Competition
Single dominant competitor
or
Value proposition insufficient to
compete
Crowded market space
Differentiation will be difficult
Competitors exist but clinical
improvements are still being
sought
Value proposition will easily
displace any competition
4. IP Position
No patentability
or
Freedom to operate
No or weak patent applications
or
Provisionals only
Non-provisional(s) filed and
pending
or
Issued patents, but weak
Strong, issued patents
5. Technical Feasibility Physics would have to be bent
Will require large
investments/research,
Development will be cost
prohibitive
Some challenges but will be
overcomewithtimeandwithin a
reasonable cost
Simple and straight forward
design with known materials and
methods
6. Regulatory Pathway Unclear regulatory pathway PMA
510k -clinical data needed
or
De Novo
510k - no clinical data needed
Exempt
7. Clinical feasibility Clinical success unlikely
Others have tried and failed
Clinical success is unclear. Large
patient volumes or long time-
frame trials required
Clinical success is likely but will
require special expertise and/or
research
Clear path to clinical success
Others have been clearly
successful
8. Reimbursement
Reimbursement unlikely
no cash paying incentives
New application to CMS
necessary priorto any payments
being issued
Reimbursement could fall under
an existing codebut a new code
will eventually need to be filed
Reimbursement readilyaccepted
or patients are very incentivized
to pay cash
TOTAL (product)
3 Criteria Scoring

Fundability Criteria Worksheet_MediCoventures_v3.1

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