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The Idea

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

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The Idea

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  1. The Idea Karen Boezi

  2. The Idea • Finding Ideas • Evaluating Ideas • Reevaluating Ideas

  3. Where’s the Idea? • Start by determining market needs • Your own clinical experience • Interviews with physicians/researchers • Literature review

  4. Market Need Evaluation is Critical • # patients • # diagnosed • # poorly served by existing technology • Why poorly served?

  5. Market Need Evaluation is Critical • Disease severity of poorly served? • Invasiveness supported by severity? • Device vs. drug approach? • Target physicians

  6. Market Need Evaluation 2002 • Medical Management (2.2 mm) • - Analgesics - Clot management - Cessation of smoking • - Increase exercise - Decrease in Lipids • Intervention (600k) • - PTA - PTA / Stent • 3. Surgery (200k)

  7. Market Evaluation: Must Have Conclusions • Market segment worth pursuing • Accurate problem definition Features of ideal solution

  8. 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

  9. Identifying “Ideal Solution” Technologies • De novo approach • Clinical & technical expert partnerships • Use of existing technology in new, non-obvious ways • Twist on competitive approach

  10. Evaluating Technologies • Demonstrable Value - Reduced cost of care? - Improved safety? - Improved efficacy? Acute Chronic Quality of life

  11. 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

  12. Evaluating Technologies: Pre-approval considerations • Regulatory requirements • Pathway • Endpoint • Trial size to meet endpoint • Control arm requirements/enrollment • Follow-up requirements

  13. Evaluating Technologies: Post-approval considerations • Reimbursement • Physician (PCT) • Facility (APC, DRG, etc.) • COGS • Raw material cost / availability • Labor requirements • Manufacturing scalability • Distribution requirements

  14. Evaluating the Idea Freedom to Operate Reason-able High & Existing Large High Easy A Few Small Low Difficult Crowded Difficult Not novel/ Infringement Low/ No Codes Competition Regulatory MarketSize MarketNeed SwitchingCost IntellectualProperty Reimburse-ment

  15. Venture Investor Return Considerations Annual IRR (%) MultipleProceeds/Cost 36 31 Capital Raised Years Assumes $30MM raised Assumes $200MM acquisition25% CS/options=$150MM to investors

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