Transcript Concept Panel slides 2

The Idea
Karen Boezi
The Idea
• Finding Ideas
• Evaluating Ideas
• Reevaluating Ideas
Where’s the Idea?
• Start by determining market needs
– Your own clinical experience
– Interviews with physicians/researchers
– Literature review
Market Need Evaluation is Critical
• # patients
• # diagnosed
• # poorly served by existing technology
• Why poorly served?
Market Need Evaluation is Critical
• Disease severity of poorly served?
– Invasiveness supported by severity?
• Device vs. drug approach?
• Target physicians
Market Need Evaluation
Peripheral Vascular Disease Market Dynamics
U.S. Analysis
2002
10-12 mm Patients w/PVD
Symptomatic
6-7 mm patients
Not Diagnosed, Not Treated
3.0 - 3.5 mm patients
1.
2.
Currently Diagnosed
3.0 mm patients
Medical Management (2.2 mm)
- Analgesics
- Clot management
- Increase exercise
- Decrease in Lipids
Intervention (600k)
- PTA
3.
Asymptomatic
5 mm patients
Surgery (200k)
- PTA / Stent
- Cessation of smoking
Market Evaluation:
Must Have Conclusions
• Market segment worth pursuing
• Accurate problem definition
Features of ideal solution
Identifying “Ideal Solution”
Technologies
• In-licensing
– PTO/literature/database search
• Academic?
• Defunct corporation?
• Outside Area of corporate focus?
• Independent IP attorney contacts IP
attorney/tech transfer office
• Networking
Identifying “Ideal Solution”
Technologies
• De novo approach
– Clinical & technical expert partnerships
– Use of existing technology in new, nonobvious ways
– Twist on competitive approach
Evaluating Technologies
• Demonstrable Value
- Reduced cost of care?
- Improved safety?
- Improved efficacy?
Acute
Chronic
Quality of life
Evaluating Technologies:
Pre-approval considerations
• Physician controlling patient
– Skill set
– Mindset
– Integration into workflow
• Competition
– Direct and indirect
• Intellectual property
– Freedom to operate
– Barriers to entry
Evaluating Technologies:
Pre-approval considerations
• Regulatory requirements
– Pathway
– Endpoint
– Trial size to meet endpoint
– Control arm requirements/enrollment
– Follow-up requirements
Evaluating Technologies:
Post-approval considerations
• Reimbursement
– Physician (PCT)
– Facility (APC, DRG, etc.)
• COGS
– Raw material cost / availability
– Labor requirements
– Manufacturing scalability
• Distribution requirements
Evaluating the Idea
Freedom
to Operate
Reasonable
High &
Existing
Low/
No Codes
Large
High
Easy
A Few
Small
Low
Difficult
Crowded
Not novel/
Infringement
Difficult
Market
Need
Switching
Cost
Competition
Intellectual
Property
Regulatory
Market
Size
Reimbursement
Venture Investor
Return Considerations
12
120
10
12 3
10
90
Annual
IRR (%)
8
Multiple
Proceeds
/Cost
6
60
71
$200MM 5x
$100MM 2.5x
58
50
5
4
38
36
3.33
2.5
2
30
31
26
20
2
26
22
20 18
16 14
12 11
10
0
0
0
15
30
45
60
75
0 1 2 3 4 5 6 7 8 9 10
Capital Raised
Years
Assumes $200MM acquisition
25% CS/options
=$150MM to investors
Assumes $30MM
raised