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Inventing & Funding  High-Impact Medical Innovations   Zen Chu CIMIT Forum Harvard Medical School April, 2008 © zen@acmedx.com
Discipline of  Clinical Innovation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Innovation without Impact is Worthless ,[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
High Impact Innovation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Pattern of Successful  Medical Products [email_address] ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Necessary But Insufficient
Clinician Innovators Critical to Medical Technology ,[object Object],[object Object],[object Object],© zen@acmedx.com Anticipate Path Standard of Care
Physician’s View of Value © zen@acmedx.com Time   Market Introduction   FDA Approval    Patent grant First in Man Animal testing Patent disclosure Prototype/Reduction to Practice Idea Milestones Value Conflicts of Interest perceived & real Hand off to Licensing office
Investor’s View of Value © zen@acmedx.com Value Time Milestones   Acquisition/IPO Exit   Reimbursement   Published clinical results   Market Introduction   Salesforce hired   Europe & Japan distribution   FDA Approval    Manufacturing ramp   Human pivotal study   Corporate partnership   First human data   First Hiccup & Danger of Momentum Loss   Management team hired   Pilot manufacturing    Patent grant   First FDA  meeting   Regulatory opinions CEO hired Animal testing Clinician feedback  Patent disclosure Prototype/Reduction to Practice Market Analysis Idea Anticipate  Potential Exits
Investor’s View of Risk © zen@acmedx.com Value Time Milestones Technology Risk Management Risk Regulatory Risk Market Risk Reimbursement Risk Address These First
Typical Early-Stage Medical Failure Non-optimal Design Process, Clinical Focus ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Myth of the Lone Inventor ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
“ Physicians and engineers often have no sense of the requirements to create a company…In a start up environment, more is not always better. Hiring the appropriate people at the right time can determine success or failure.”   - Thomas Fogarty, MD – Founder & investor in over 30 medical companies Professor of Surgery, Stanford University [email_address]
Building Teams ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[email_address]
Cultural Barriers to Med Innovation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[email_address]
Development Best Practice  © zen@acmedx.com Value Time Milestones   Acquisition/IPO Exit   Published clinical results   Market Introduction   Salesforce hired   Europe & Japan distribution   FDA Approval    Manufacturing ramp   Human pivotal study   Corporate partnership   First Hiccup & Momentum Loss   Management team hired   Pilot manufacturing    Patent grant   First FDA  meeting   Regulatory opinions CEO hired Animal testing Clinician feedback  Patent disclosure Prototype/Reduction to Practice Market Analysis Idea 2) Hire team & Execute 1) Plan in Reverse
Traction for New Technology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[email_address]
Innovation Landscape ,[object Object],[email_address]
Innovation Landscape Match Resources to Opportunity Size  ,[object Object],Low  Capital Required  High Big Opportunities Complex Solutions,  Fragmented Services Philanthropy/NIH Basic Research Unknown Mechanisms  $100MM $500MM © zen@acmedx.com Large Established Companies May Discover New Applications & Technologies Venture-Backed Companies Focused Teams to  Prioritize, Execute Equity Discrete Product Product-Line Extensions License or Product Acq Royalties May Discover New Larger Opportunities
Innovation Landscape Match Resources to Opportunity Size  Philanthropy/NIH Basic Research Unknown Mechanisms  Gates Foundation Off-Label Uses Ortho Lumbar Disc ,[object Object],Low  Capital Required  High Big Opportunities Complex Solutions,  Fragmented Services $100MM $500MM © zen@acmedx.com Stem Cells RNAi for AMD Cystic Fibrosis Ischemic Stroke Gastric Bypass Unfocused &  Requires  Segmentation Aortic Abdominal Aneurysm
Incremental vs Breakthrough © zen@acmedx.com METRIC INCREMENTAL BREAKTHROUGH Funding $$ $$$$$$ Market Size Varies depending on funding needed >$500MM No current therapies Time Needed Adoption &  Exit Shorter Match opportunity to strategy Longer Regulatory path dependent Value @ Exit Less More Major Risks Window of opportunity Execution quality & critical path Competition Technical/Clinical unknowns Market adoption hurdles Reimbursement Success Factors Focused execution Management experience Manufacturing economics Patents, Franchise Value Market adoption, Std of Care Investor expectations Patent Protection Less More Competition More Less
Valuable Incremental Products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Time is Life © zen@acmedx.com ACCELERANT DECCELERANT REGULATORY Device 510(k) Predictive animal models New materials & claims Unclear endpoints CLINICAL Existing human data Reproducible published studies Non-superiority Entrenched behavior No practice benefit REIMBURSEMENT Existing Codes DRGs Private-pay, consumer Cost-Benefit Studies MARKET Reduce skills needed Physician buying power Unambiguous diagnostic Capital equipment purchase  SALES Focused physician popul. Existing distribution Learning curves Entrenched behavior
Getting Paid ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[email_address]
Accelerants Amplify  Clinical Impact & Return on Investment © zen@acmedx.com Value Cashflow Time Milestones $0 COMPRESS  TIME TO MARKET FASTER CURES
Techniques to Identify New Opportunities & Invent New Cures ,[object Object],[object Object],© zen@acmedx.com
Simply put “Interventional”  in the name ,[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
© zen@acmedx.com Michael Porter, tiesberg Economics drive innovation to interventions
Opportunities from Wider View Surgical Procedure Example ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Productize the Procedure ,[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Remove Treatment Ambiguity ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Driving Solutions & Costs Down Healthcare Value Chains ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com Improves reimbursement economics Convenience, simpler use Complexity of diagnosis & Treatment Christensen  Seeing What’s Next,  2004
Eliminate A Provider or Facility Heresy! ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com Facility Fee Device Cost
Compete at the Consumption Void ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Reframe the Need © zen@acmedx.com ,[object Object],[object Object],[object Object],[object Object]
Import Solutions ,[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Value =  Efficacy  Invasiveness^2  ,[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Identify Opportunity from Off-Label Usage © zen@acmedx.com
Disease has Process & Timeline Different Interventions in Lifecycle ,[object Object],[object Object],[object Object],[object Object],[email_address]
Feedback Loop Shortcuts ,[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Ride Down the Cost Curve ,[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Simplify Unknowns & Process ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Conclusion It’s not brain surgery… Success requires both MDs & MBAs working in concert to maximize clinical impact © zen@acmedx.com
Innovation is Spark… but Development drives Value ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
See One, Do One, Teach One ,[object Object],[object Object],Zen @ acmedx.com
Helpful Reading & Resources ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com
Sources of Critical Feedback ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],© zen@acmedx.com

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Medical Technology Innovation Techniques & Funding

  • 1. Inventing & Funding High-Impact Medical Innovations Zen Chu CIMIT Forum Harvard Medical School April, 2008 © zen@acmedx.com
  • 2.
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  • 7. Physician’s View of Value © zen@acmedx.com Time Market Introduction FDA Approval Patent grant First in Man Animal testing Patent disclosure Prototype/Reduction to Practice Idea Milestones Value Conflicts of Interest perceived & real Hand off to Licensing office
  • 8. Investor’s View of Value © zen@acmedx.com Value Time Milestones Acquisition/IPO Exit Reimbursement Published clinical results Market Introduction Salesforce hired Europe & Japan distribution FDA Approval Manufacturing ramp Human pivotal study Corporate partnership First human data First Hiccup & Danger of Momentum Loss Management team hired Pilot manufacturing Patent grant First FDA meeting Regulatory opinions CEO hired Animal testing Clinician feedback Patent disclosure Prototype/Reduction to Practice Market Analysis Idea Anticipate Potential Exits
  • 9. Investor’s View of Risk © zen@acmedx.com Value Time Milestones Technology Risk Management Risk Regulatory Risk Market Risk Reimbursement Risk Address These First
  • 10.
  • 11.
  • 12. “ Physicians and engineers often have no sense of the requirements to create a company…In a start up environment, more is not always better. Hiring the appropriate people at the right time can determine success or failure.” - Thomas Fogarty, MD – Founder & investor in over 30 medical companies Professor of Surgery, Stanford University [email_address]
  • 13.
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  • 15. Development Best Practice © zen@acmedx.com Value Time Milestones Acquisition/IPO Exit Published clinical results Market Introduction Salesforce hired Europe & Japan distribution FDA Approval Manufacturing ramp Human pivotal study Corporate partnership First Hiccup & Momentum Loss Management team hired Pilot manufacturing Patent grant First FDA meeting Regulatory opinions CEO hired Animal testing Clinician feedback Patent disclosure Prototype/Reduction to Practice Market Analysis Idea 2) Hire team & Execute 1) Plan in Reverse
  • 16.
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  • 20. Incremental vs Breakthrough © zen@acmedx.com METRIC INCREMENTAL BREAKTHROUGH Funding $$ $$$$$$ Market Size Varies depending on funding needed >$500MM No current therapies Time Needed Adoption & Exit Shorter Match opportunity to strategy Longer Regulatory path dependent Value @ Exit Less More Major Risks Window of opportunity Execution quality & critical path Competition Technical/Clinical unknowns Market adoption hurdles Reimbursement Success Factors Focused execution Management experience Manufacturing economics Patents, Franchise Value Market adoption, Std of Care Investor expectations Patent Protection Less More Competition More Less
  • 21.
  • 22. Time is Life © zen@acmedx.com ACCELERANT DECCELERANT REGULATORY Device 510(k) Predictive animal models New materials & claims Unclear endpoints CLINICAL Existing human data Reproducible published studies Non-superiority Entrenched behavior No practice benefit REIMBURSEMENT Existing Codes DRGs Private-pay, consumer Cost-Benefit Studies MARKET Reduce skills needed Physician buying power Unambiguous diagnostic Capital equipment purchase SALES Focused physician popul. Existing distribution Learning curves Entrenched behavior
  • 23.
  • 24. Accelerants Amplify Clinical Impact & Return on Investment © zen@acmedx.com Value Cashflow Time Milestones $0 COMPRESS TIME TO MARKET FASTER CURES
  • 25.
  • 26.
  • 27. © zen@acmedx.com Michael Porter, tiesberg Economics drive innovation to interventions
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  • 36.
  • 37. Identify Opportunity from Off-Label Usage © zen@acmedx.com
  • 38.
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  • 41.
  • 42. Conclusion It’s not brain surgery… Success requires both MDs & MBAs working in concert to maximize clinical impact © zen@acmedx.com
  • 43.
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  • 46.

Editor's Notes

  1. Important to decide where you want to innovate, how markets view that innovation Market size is addressable subsegment of larger market, FOCUS KEY Often, initial products or R&D morphs into larger opportunity, but tough to anticipate
  2. Important to decide where you want to innovate, how markets view that innovation Market size is addressable subsegment of larger market, FOCUS KEY Often, initial products or R&D morphs into larger opportunity, but tough to anticipate
  3. Incremental doesn’t mean low value, but often does - Cardiac surgery and interventional cardiology, plenty of examples of wonderfully valuable products improving on prior ideas One can apply these same metrics to PRODUCT TYPES: IMPLANTABLES, DISPOSABLES, CAPITAL EQUIPMENT
  4. Another view of investor perspective includes cash burn and eventual cashflow
  5. Great map of care value chains and cycles Michael porter Opportunities at each point, but as we all know often healthcare system is rewarded for interventions Fundamental misalignments in the system, but entrepreneurs and clinicians must work within this system, imperfect as it is
  6. Intend where you want to work in the innovation landscape Ensures alignment toward common goal Gating factor for Boston Medical Innovation is training MD/Vcs to accelerate high impact innovation