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Medical Entrepreneurship Rami Katz,  MBA & Attorney (IL) Director of Tech Commercialization High Tech Rochester Commercializing  Medical Innovations
Discussion Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Discussion Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What is Tech Commercialization? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What is Tech Commercialization? ,[object Object],Big Corporation University Tech Inventor / Spin-out Room for thought:  Is the iPod Technology Commercialization?
Discussion Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Sources of Technology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Commercialization Lead Time ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
TRL Definitions
What makes a good opportunity? The Opportunity Continuum ? ?  Invention  ? ? Business Model   ? Customer Acceptance   ? Technical Feasibility Opportunity Innovation Idea
TC Opportunity Drivers ,[object Object],[object Object],[object Object],[object Object]
Discussion Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Commercialization: HTR & Excell ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Research Invention Disclosures Patents Analyze Opportunity Validate Market Develop Bus. Plan Investor Presentation Commercial Prototype Conduct Beta Testing Find Qualified Mng’t Launch Company Dev. Marketing & Sales Strategy Seed Funding Large Scale  Manufacturing Develop New Products & Services Support Management  Development Develop Growth Strategies Support Network Development Expansion Funding HUMAN CAPITAL RESOURCE H T R   FINANCIAL CAPITAL RESOURCE EXCELL UNIVERSITY TECHNOLOGY TRANSFER STRATEGIC INVESTORS PRIVATE EQUITY VENTURE CAPITAL T C T   EXIT CONCEPT FORMATION GROWTH CONSULTING   INTERIM   MANAGEMENT PRE-SEED   SEED  EARLY STAGE  EXPANSION STAGE
Stage 3 Development Stage I Investigation Stage 2 Feasibility Stage 4 Introduction Stage 5 Growth Stage 6 Maturity Engineering  Prototype Technical  Analysis Technical Feasibility Pre-production Prototype Production Support Strategic Market plan Market need  Assessment Market  Validation Sales & Distribution Market Diversification Strategic B/plan Venture  Assessment Economic Feasibility Business  Start-up Business Growth Business  Maturity Technical Marketing Business Market Study Production COMMERCIALIZATION MODEL Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10 Step 11 Step 12 Step 13 Step 14 Step 15 Step 16 Step 17 Step 18
Stage 3 Development Stage I Investigation Stage 2 Feasibility Stage 4 Introduction Stage 5 Growth Stage 6 Maturity Engineering Prototype Technical Analysis Product new, unique &  technically feasible? Technical Feasibility Pre-production Prototype Production Support Strategic Market Plan MKT Need Assessment Market Validation Sales & Distribution Market Diversification Strategic Business Plan Venture Assessment Economic Feasibility Business  Start-up Business Growth Business Maturity Technical Marketing Business Market Study Production Key Go / No-Go Questions Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10 Step 11 Step 12 Step 13 Step 14 Step 15 Step 16 Step 17 Step 18 Working model? Total production costs? First article prototype? Limited production? Performance test? Production dependable, Reliable & optimized? Supporting &  Improving product? Meet clear market  demand or problem? Who will buy, how many & what price ? Profiled & finalized  target market? Sales? Growing market share? Identified next Generation product ? Product or venture make a profit? Generate return on investment? Finalized business model, identified total capital need & source ? Management team & business systems operational ? Business plan on  course to achieve  objectives? Maximizing return  On investment ?
Discussion Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Commercialization Paths ,[object Object],[object Object],[object Object],[object Object],[object Object]
Discussion Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
TC: Licensing ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Licensing – key issues ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Patents from Universities Patent Applications Since 2001 (AUTM Survey 2006) ,[object Object],[object Object]
Licensing  by licensee and type Licenses: By Licensee  ( 2006 AUTM Survey) Licenses Executed: Exclusive vs. Nonexclusive   (2006 AUTM Survey)
[object Object],[object Object],[object Object],Patents Gone Bad–  or why a patent is not enough * Josh Lerner – “Our Broken Patent System”
UR Royalty Distribution 25% IP Pool 25% IP Pool 20% IP Pool 20% School or College 15% School or College 10% School or College 20% Department 20% Department 20% Department 35% Inventors 40% Inventors 50% Inventors $250,001 and above $50,001 to $250,000 $1 to $50,000
Discussion Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
HTR’s Tech Comm. Model ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Tech Commercialization Process
Venture Development – Concept Stage ??? Average Valuation Grants Funding Sources 1-10 years Time to Achieve Milestones ~ $1-10M Funding Requirements  ???  Probability of Significant Liquidity None Customer & Sales Milestones Inventor? Management Team Milestones None Business Development Milestones Invention disclosure Patent Status Research Technology Milestones
Venture Development – Pre-Seed <$750K Average Valuation Grants, F 3 , Angels, SBIR I Funding Sources 1-3 months Time to Achieve Milestones $0-$50K Funding Requirements  1% Probability of Significant Liquidity none Customer & Sales Milestones Inventor + coach Management Team Milestones Quick Screen / Market Opp. Asses. Business Dev. Milestones OTT/Legal Dept. processing, Patent Status Pre-molecule – r& D Tech Milestone - Life Science Pre-prototype  - r& D Tech Milestone - Physical Science
Venture Development – Seed Stage $1M-$2M Average Valuation Angel & Seed Investors, SBIR Strategic Partners Funding Sources 1 – 3.5 Years Time to Achieve Milestones $250-$1MM Funding Requirements  1% - 12% Probability of Significant Liquidity Bio- Initial JV    LOI    pre-sales Customer & Sales Milestones CTO +  1-2 Manager/coach Management Team Milestones Bus. Plan, looking for JVs Business Dev. Milestones Provisional    Pending    Issued Patent Status Molecule    Animal trials Tech Milestone Life Science Lab    Alpha    Beta Tech Milestone Physical Science
Venture Dev. – Early-Stage / A round $4M-$6M Average Valuation Angels, VC, STR Partners, SBIR II Funding Sources 9-18 months Time to Achieve Milestones $1-4M Funding Requirements  15%-25% Probability of Significant Liquidity paying customers Customer & Sales Milestones >3 &quot;real&quot; managers Management Team Milestones Customers, sales & shipments Business Dev. Milestones Patent Extension Patent Status Pre-clinical trials Tech Milestone Life Science commercial prototype, first production Tech Milestone Physical Science
Discussion Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case Studies ,[object Object],[object Object],[object Object],[object Object],[object Object]
Discussion Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
TC - The Business Perspective ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Industry & Market – value proposition ,[object Object],[object Object],Rule of thumb:  Each step requires ~100% mark-up! $1 $2 $4 $8
Funding Tech Comm. Source: Kauffman - Encouraging Industry-University Partnerships
Questions? Rami Katz Director of Technology Commercialization Rami.katz@htr.org,  (585) 214-0596 High Tech Rochester www.htr.org

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Tech Comm- Medical Innovations

  • 1. Medical Entrepreneurship Rami Katz, MBA & Attorney (IL) Director of Tech Commercialization High Tech Rochester Commercializing Medical Innovations
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 10. What makes a good opportunity? The Opportunity Continuum ? ?  Invention  ? ? Business Model   ? Customer Acceptance   ? Technical Feasibility Opportunity Innovation Idea
  • 11.
  • 12.
  • 13.
  • 14. Stage 3 Development Stage I Investigation Stage 2 Feasibility Stage 4 Introduction Stage 5 Growth Stage 6 Maturity Engineering Prototype Technical Analysis Technical Feasibility Pre-production Prototype Production Support Strategic Market plan Market need Assessment Market Validation Sales & Distribution Market Diversification Strategic B/plan Venture Assessment Economic Feasibility Business Start-up Business Growth Business Maturity Technical Marketing Business Market Study Production COMMERCIALIZATION MODEL Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10 Step 11 Step 12 Step 13 Step 14 Step 15 Step 16 Step 17 Step 18
  • 15. Stage 3 Development Stage I Investigation Stage 2 Feasibility Stage 4 Introduction Stage 5 Growth Stage 6 Maturity Engineering Prototype Technical Analysis Product new, unique & technically feasible? Technical Feasibility Pre-production Prototype Production Support Strategic Market Plan MKT Need Assessment Market Validation Sales & Distribution Market Diversification Strategic Business Plan Venture Assessment Economic Feasibility Business Start-up Business Growth Business Maturity Technical Marketing Business Market Study Production Key Go / No-Go Questions Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10 Step 11 Step 12 Step 13 Step 14 Step 15 Step 16 Step 17 Step 18 Working model? Total production costs? First article prototype? Limited production? Performance test? Production dependable, Reliable & optimized? Supporting & Improving product? Meet clear market demand or problem? Who will buy, how many & what price ? Profiled & finalized target market? Sales? Growing market share? Identified next Generation product ? Product or venture make a profit? Generate return on investment? Finalized business model, identified total capital need & source ? Management team & business systems operational ? Business plan on course to achieve objectives? Maximizing return On investment ?
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 21.
  • 22. Licensing by licensee and type Licenses: By Licensee ( 2006 AUTM Survey) Licenses Executed: Exclusive vs. Nonexclusive (2006 AUTM Survey)
  • 23.
  • 24. UR Royalty Distribution 25% IP Pool 25% IP Pool 20% IP Pool 20% School or College 15% School or College 10% School or College 20% Department 20% Department 20% Department 35% Inventors 40% Inventors 50% Inventors $250,001 and above $50,001 to $250,000 $1 to $50,000
  • 25.
  • 26.
  • 28. Venture Development – Concept Stage ??? Average Valuation Grants Funding Sources 1-10 years Time to Achieve Milestones ~ $1-10M Funding Requirements ???  Probability of Significant Liquidity None Customer & Sales Milestones Inventor? Management Team Milestones None Business Development Milestones Invention disclosure Patent Status Research Technology Milestones
  • 29. Venture Development – Pre-Seed <$750K Average Valuation Grants, F 3 , Angels, SBIR I Funding Sources 1-3 months Time to Achieve Milestones $0-$50K Funding Requirements 1% Probability of Significant Liquidity none Customer & Sales Milestones Inventor + coach Management Team Milestones Quick Screen / Market Opp. Asses. Business Dev. Milestones OTT/Legal Dept. processing, Patent Status Pre-molecule – r& D Tech Milestone - Life Science Pre-prototype - r& D Tech Milestone - Physical Science
  • 30. Venture Development – Seed Stage $1M-$2M Average Valuation Angel & Seed Investors, SBIR Strategic Partners Funding Sources 1 – 3.5 Years Time to Achieve Milestones $250-$1MM Funding Requirements 1% - 12% Probability of Significant Liquidity Bio- Initial JV  LOI  pre-sales Customer & Sales Milestones CTO + 1-2 Manager/coach Management Team Milestones Bus. Plan, looking for JVs Business Dev. Milestones Provisional  Pending  Issued Patent Status Molecule  Animal trials Tech Milestone Life Science Lab  Alpha  Beta Tech Milestone Physical Science
  • 31. Venture Dev. – Early-Stage / A round $4M-$6M Average Valuation Angels, VC, STR Partners, SBIR II Funding Sources 9-18 months Time to Achieve Milestones $1-4M Funding Requirements 15%-25% Probability of Significant Liquidity paying customers Customer & Sales Milestones >3 &quot;real&quot; managers Management Team Milestones Customers, sales & shipments Business Dev. Milestones Patent Extension Patent Status Pre-clinical trials Tech Milestone Life Science commercial prototype, first production Tech Milestone Physical Science
  • 32.
  • 33.
  • 34.
  • 35.
  • 36.
  • 37. Funding Tech Comm. Source: Kauffman - Encouraging Industry-University Partnerships
  • 38. Questions? Rami Katz Director of Technology Commercialization Rami.katz@htr.org, (585) 214-0596 High Tech Rochester www.htr.org

Editor's Notes

  1. You probably are more familiar with this representation of TRLs. This is a NASA slide.