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IDENTIFYING A REAL UNMET CLINICAL NEED
Martina Mariano
Spark Co-Lab Actuator Series
19th July 2018
martina.mariano@biacor.com.au
Need Screening – Disease State
Epidemiology
Disease Anatomy
and Physiology
Pathophysiology
Clinical
Presentation
Clinical
Outcomes
Economic Impact
Geographic setting
Human aspect
Need Screening – Existing Solutions
Ø insights into existing and emerging solutions and services for diagnosis, treating and managing the
condition;
Ø opportunity to understand clinical, patient-related, and economic requirements that any new
solution must meet to be considered equivalent or superior to the existing alternatives.
Overview of
Solution
Options
Clinical
Solution
Profile
Economic
Solution
Profile
Utilization
Solution
Profile
Emerging
Solution
Profile
Summary of
the Solution
Landscape
Need Screening – Existing Solutions
GAP ANALYSIS
Questionnaires
Home Devices
Telemonitorning
surgery
GAP
Cost $
Efficacy
$50 $400 $60,000
Ø analysis of direct and indirect interactions of all parties involved in financing and delivering care to patients
Ø opportunity to understand their perspectives, evaluate how they are affected by the need and determine they
requirements in order to anticipate resistance and prioritize requirements.
Cycle of Care Flow of Money
How patients interact with the medical
system during diagnosis and treatment
Identify SKs who directly or
indirectly finance the cycle of care
Need Screening – Stakeholder Analysis
Need Screening – Stakeholder Analysis
Ø Output of the analysis is a summary of the
stakeholder environment which identify
decision makers, primary benefits and costs
and assess the net impact of an eventual
technology for each group.
Need Screening – Market analysis
Ø allows to understand which of the needs are associated with a commercially viable market based on the total size, the
range of existing solutions, competitors, gaps, market segments which can be targeted;
Ø opportunity to draw a value estimate of a potential solution which may address that need.
Market
Landscape
Market
Segmentation
Target
Market
evaluation of the total
market and how existing
solutions are currently
addressing the problem
identification of key factors
to divide the total market
of all potential customers
into segments
Assessment of the market
segments to identify the
subpopulation that would
gain more value
- Gaps
- Size and Growth
- Size and
Growth
- Competitive
dynamics
- Segment
Needs
- Willingness to
pay
Need Selection
Ø identify a small subset of needs amongst
the initial list
Ø process founded on the information
gathered so far and finalized to the
identification of the most compelling need
for which significant risks can be most
effectively mitigated
Need Specification
SKs and
market
analysis
solution
landscape
disease
state
Need Selection process
Select factors to evaluate
Rate each factors for each need
Produce a final score and rank the
needs
select a smaller set of needs and
perform additional research
validate the needs with key SKs and
KOLs
Need Scoping
Testing and refining the need statements through
further exploration of the problem, population and
outcome.
Disease State
Event 1
Event 2
“prevent atrial fibrillation”
“prevent clot from forming”
“prevent clot from leaving the heart”Likelihood of an
innovation to be
superseded by
another one
addressing a more
fundamental problem
high
low
Need Scoping
ü Can the problem be
broadened?
ü Is the issue affecting a
larger population than the
one described?
ü Is this need the most
relevant a smaller subset
of the population?
ü Is the outcome the most
essential one?
ü Is the need aligned with
the team’s strategic focus?
Need Generation & Scoping: Pitfalls
1. Having a solution-embedded need
2. Sticking too close to the current
medical practice
3. Formulating a negatively-framed need
The aim is to unlock creativity!
Need Categorization
Incremental
Innovation
Blue sky
Innovation
MIXED
level of
improvement of the
current practice
Game changer for
the market/industry
Early validation of the need
Talking with potential:
- users
- customers
- stakeholders
Researching around
your problem
Need Criteria
“MUST –
HAVES”
“NICE-TO-
HAVE”
“a way to reduce the
incidence of urinary tract
infections in ICU patients
to reduce hospital stay”
Need Specification
Need
statement
• may be
refined
progressively
Data Collected
• quantitative
information
Need Criteria
• specific and
measurable
Ø Succinct and detailed document which provide a summary of the most important and relevant information
gathered in support of the need.
IDENTIFY INVENT IMPLEMENT
Take the first step…
“a well characterized need is the
DNA of a good invention…”
[PaulYock]
Waste
Of
Money
Brain
And
Time
LUCK IS WHAT HAPPENS
WHEN PREPARATION MEETS OPPORTUNITY…
[Seneca]
Questions?
martina.mariano@biacor.com.au
www.linkedin.com/in/martinamariano

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SPARK Co-Lab Actuator Series: Identifying an Unmet Clinical Need

  • 1. IDENTIFYING A REAL UNMET CLINICAL NEED Martina Mariano Spark Co-Lab Actuator Series 19th July 2018 martina.mariano@biacor.com.au
  • 2. Need Screening – Disease State Epidemiology Disease Anatomy and Physiology Pathophysiology Clinical Presentation Clinical Outcomes Economic Impact Geographic setting Human aspect
  • 3. Need Screening – Existing Solutions Ø insights into existing and emerging solutions and services for diagnosis, treating and managing the condition; Ø opportunity to understand clinical, patient-related, and economic requirements that any new solution must meet to be considered equivalent or superior to the existing alternatives. Overview of Solution Options Clinical Solution Profile Economic Solution Profile Utilization Solution Profile Emerging Solution Profile Summary of the Solution Landscape
  • 4. Need Screening – Existing Solutions GAP ANALYSIS Questionnaires Home Devices Telemonitorning surgery GAP Cost $ Efficacy $50 $400 $60,000
  • 5. Ø analysis of direct and indirect interactions of all parties involved in financing and delivering care to patients Ø opportunity to understand their perspectives, evaluate how they are affected by the need and determine they requirements in order to anticipate resistance and prioritize requirements. Cycle of Care Flow of Money How patients interact with the medical system during diagnosis and treatment Identify SKs who directly or indirectly finance the cycle of care Need Screening – Stakeholder Analysis
  • 6. Need Screening – Stakeholder Analysis Ø Output of the analysis is a summary of the stakeholder environment which identify decision makers, primary benefits and costs and assess the net impact of an eventual technology for each group.
  • 7. Need Screening – Market analysis Ø allows to understand which of the needs are associated with a commercially viable market based on the total size, the range of existing solutions, competitors, gaps, market segments which can be targeted; Ø opportunity to draw a value estimate of a potential solution which may address that need. Market Landscape Market Segmentation Target Market evaluation of the total market and how existing solutions are currently addressing the problem identification of key factors to divide the total market of all potential customers into segments Assessment of the market segments to identify the subpopulation that would gain more value - Gaps - Size and Growth - Size and Growth - Competitive dynamics - Segment Needs - Willingness to pay
  • 8. Need Selection Ø identify a small subset of needs amongst the initial list Ø process founded on the information gathered so far and finalized to the identification of the most compelling need for which significant risks can be most effectively mitigated Need Specification SKs and market analysis solution landscape disease state
  • 9. Need Selection process Select factors to evaluate Rate each factors for each need Produce a final score and rank the needs select a smaller set of needs and perform additional research validate the needs with key SKs and KOLs
  • 10. Need Scoping Testing and refining the need statements through further exploration of the problem, population and outcome. Disease State Event 1 Event 2 “prevent atrial fibrillation” “prevent clot from forming” “prevent clot from leaving the heart”Likelihood of an innovation to be superseded by another one addressing a more fundamental problem high low
  • 11. Need Scoping ü Can the problem be broadened? ü Is the issue affecting a larger population than the one described? ü Is this need the most relevant a smaller subset of the population? ü Is the outcome the most essential one? ü Is the need aligned with the team’s strategic focus?
  • 12. Need Generation & Scoping: Pitfalls 1. Having a solution-embedded need 2. Sticking too close to the current medical practice 3. Formulating a negatively-framed need The aim is to unlock creativity!
  • 13. Need Categorization Incremental Innovation Blue sky Innovation MIXED level of improvement of the current practice Game changer for the market/industry
  • 14. Early validation of the need Talking with potential: - users - customers - stakeholders Researching around your problem
  • 15. Need Criteria “MUST – HAVES” “NICE-TO- HAVE” “a way to reduce the incidence of urinary tract infections in ICU patients to reduce hospital stay”
  • 16. Need Specification Need statement • may be refined progressively Data Collected • quantitative information Need Criteria • specific and measurable Ø Succinct and detailed document which provide a summary of the most important and relevant information gathered in support of the need.
  • 17. IDENTIFY INVENT IMPLEMENT Take the first step… “a well characterized need is the DNA of a good invention…” [PaulYock] Waste Of Money Brain And Time
  • 18. LUCK IS WHAT HAPPENS WHEN PREPARATION MEETS OPPORTUNITY… [Seneca] Questions? martina.mariano@biacor.com.au www.linkedin.com/in/martinamariano