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WHY HACKING MEDICINE?
     WHY NOW?
     WHY INDIA?
              ZEN CHU
      MIT HEALTHCARE VENTURES

   INNOVATOR CONCLAVE FOR MED TECH
       VELLORE INSTITUTE OF TECHNOLOGY
          CHRISTIAN MEDICAL COLLEGE
       MASSACHUSETTS GENERAL HOSPITAL

              MARCH 15, 2013

                   © ZEN CHU 2010
WHY NOW?

• HEALTHCARE CRISIS
• ALTRUISM INSUFFICIENT
• GLOBAL CLINICAL INNOVATION
• MACRO TECHNOLOGY TRENDS
• SUSTAINABLE VENTURES
• ENTREPRENEURS CRITICAL
              © ZEN CHU 2010
WHY INDIA?

• UNIQUE NEEDS
• DEMOGRAPHICS
• NEW CLINICAL INNOVATION
• RACIAL/REGIONAL DIFFERENCES
• EMERGING MIDDLE CLASS

                © ZEN CHU 2010
H@CKING MEDICINE
• CLEVER SOLUTIONS
• IDEAS ARE CHEAP
• PROVE OR FAIL FAST
• LEAN STARTUPS + DESIGN THINKING
• ACCELERATE DATA + PROOF
• ENTREPRENEURSHIP + MISSION
               © ZEN CHU 2010
WHAT DOES A
MEDICAL HACKATHON
     LOOK LIKE?
The birth of one of the first HackingMedicine venture-backed companies…
                    Amazing things happen in 36 hours!
H@ckMed Sessions on Top Floor of the MIT Media Lab
Craig Lipset, Director of Clinical Innovation, Pfizer
Faster, Better, Cheaper Data Generation = Central to Pharma Productivity
Joe Smith, Chief Med Officer of West Health Institute & MIT/HST Alum
Demonstrating disconnect between health spending and quality outcomes
The Pitch as central vehicle to test & hone mission, solution, business model
TEAM + SHARED MISSION
ONLY REQUIREMENTS:
PAPER + COFFEE + DIVERSE TEAM
VISUALIZE & PROTOTYPE
      ON PAPER
MEDICAL DEVICE
RAPID PROTOTYPING
GINGER.IO + VINOD KHOSLA




   FRESH EYES ON PROBLEMS
  FROM OUTSIDE HEALTHCARE
MENTORS VS. EXPERTS
        “The problem with experts is
        that they do not know what
        they do not know…
        The problem is that we like to
        have maps–and seem to prefer
        to have the wrong map of
        reality to no map at all.
        ~ Nassim Nicholas Taleb
         The Black Swan


SURROUND TEAMS WITH MENTORS
PULL EXPERTS IN LATER, BUT START WITH NEEDS
                     © ZEN CHU 2010
HEALTHCARE METRICS



         BETTER
         FASTER
        CHEAPER
   CHEAP IS NOT ENOUGH!
           © ZEN CHU 2010
HEALTHCARE METRICS
       CONVENIENCE
         CAPACITY

         TRUST
          BETTER
          FASTER
         CHEAPER
 TRUST + WORKFLOW ESSENTIAL
            © ZEN CHU 2010
HEALTHCARE FRAMEWORK
                              MONITORING




                                                     R
          EFFECTIVE TREATMENTS




                                                 GE O
                                               IA F
                                             TR CH
         DIAGNOSTICS




                                           & TE
                                          G &
                                        IN S
      PREVENTION




                                      UT EM
                                    RO ST
                                     SY
  EDUCATION


TECH ENABLES SCALABLE MEDICINE
                   © ZEN CHU 2010
WHICH RISKS TO PRIORITIZE?
             TYPICAL ORDER OF UNIVERSITY SPIN-OUT

                                 4
                                               Market Risk
                                              Payment
                                    Physician & Patient Adoption
                                     Packaged Whole Solutions
Value




                        3
                            Regulatory Risk
                             Safety & Efficacy

                2
                    Management Risk
        1
            Technology IP Risk

                              © ZEN CHU 2010
                                                     Time
WHICH RISKS TO PRIORITIZE?
  BEST ENTREPRENEURS + INVESTORS PRIORITIZE IN REVERSE


        CHOOSE BASED
        ON COST/PERFORMANCE
        REQUIREMENTS
                                               Technology IP Risk

                         Management Risk
Value




                Regulatory Risk
                  Safety & Efficacy

               Market Risk
                  Payment
        Physician & Patient Adoption                 ATTACK FIRST!
         Packaged Whole Solutions

                              © ZEN CHU 2010
                                                          Time
LET’S GET HACKING!
HACKATHON PROCESS
• START WITH PROBLEMS + JOBS TO DO
• EMPATHY FOR USER
• DIVERSE TEAMS AROUND THEMES
• LOTS OF WILD IDEAS
• DEFER JUDGEMENT
• BUILD ON IDEAS COLLABORATIVELY
• RAPID CLINICAL FEEDBACK
                © ZEN CHU 2010
OPEN INNOVATION

• OPEN YOURSELVES TO CRAZY IDEAS
• OPEN UNIVERSITY TO INDUSTRY NEEDS
• SEEK DIVERSE TEAMS
• SEEK CRITICAL FEEDBACK EARLY
• DEFER PATENTING UNTIL LATER INSIGHTS
                  © ZEN CHU 2010
JUST THE BEGINNING
    1st WEEKEND ACCELERATES PROCESS


 • CHOOSE THE MISSION
 • MAXIMIZE COLLISIONS
 • MAXIMIZE FEEDBACK
 • IDENTIFY CRITICAL EXPERIMENTS
H@CK PROTO DATA IP                VENTURE

                 © ZEN CHU 2010
THANK YOU VIT + MGH!
IMAGINATION IS MORE IMPORTANT
      THAN KNOWLEDGE
         ALBERT EINSTEIN


           HackingMedicine.MIT.edu
          Twitter: #HackingMedicine @hackmedMIT

             AboutMe.com/ZenVen
H@CK VIT - DAY 2
9 ORDER OF THE DAY

    NEW CLINICIANS

10 JUDGING CRITERIA

11 BIG PIVOT PITCHES

    MAD LIB PITCH

12 LUNCH



2   FIRST ROUND JUDGING - BREAKOUT ROOMS BY THEME

3   SEMI FINAL JUDGING - MAIN ROOM 412 GALLERY
4:30 JUDGES ANNOUNCE WINNERS
VALUE OF THE PITCH
•   56 PITCHES YESTERDAY!

•   LIMIT TO 3 MINUTES + 2 MIN Q&A

•   MISSION: WHY SHOULD ANYONE CARE?

•   RAPID FEEDBACK

•   FORCE CHANGE IN PROBLEM, SOLUTION, TEAM MIX

•   ROLE-PLAY AS ENTREPRENEURS

•   COMMUNICATE SOLUTION CONCISELY + ELOQUENTLY

•   PROVE OR DIS-PROVE VALUE + APPROACH

                            © ZEN CHU 2010
PIVOT ON YOUR IDEA
•   IDEAS GET CEMENTED IN OUR MINDS

•   ESPECIALLY AROUND TECHNOLOGY ORIGIN

•   SEEK JOBS THAT CANNOT BE DONE TODAY

•   START WITH DESCRIBING THE USER EXPERIENCE

•   NEW SERVICE, NEW LOCATION, FASTER, CONVENIENCE...

•   GET RAPID FEEDBACK FROM INTENDED USERS



          WHO LEARNED + PIVOTED?
                         © ZEN CHU 2010
SCALING MEDICINE
• CREATE NEW EXPERIENCE
• INCREASE CAPACITY
• NEW SERVICE / PROVIDER with CAPACITY
• CREATE NEW PLACE FOR SERVICE
• DE-SKILL COMPLEX DIAGNOSTIC / TREATMENT
• PATIENT SELF-SERVICE
                 © ZEN CHU 2010
WHAT IS NEW SERVICE
ENABLED BY YOUR TECH?

           DESCRIBE THE
EXPERIENCE, EXPERIENCE, EXPERIENCE!


               © ZEN CHU 2010
WHERE DOES SERVICE
   TAKE PLACE?
                                         TRAIN	
  
                                        STATION
                                             PHARMACY
                   PATIENT	
  HOUSE
                                                             CLINIC
                                                 SCHOOL                    HOSPITAL
                       VILLAGE         SPEC
                                              IALIZ
              CE                                   ATIO
    V   E NIEN                                          N	
  /	
  IN
 CON                                                                F   REQU
                          CITY                                              ENCY


                      MUMBAI

                      BOSTON

                      © ZEN CHU 2010
FUNDING IS A CRUTCH

•   CONSTRAINTS FORCE CREATIVITY

•   SEEK JOBS THAT CANNOT BE DONE TODAY

•   START WITH DESCRIBING THE USER EXPERIENCE

•   NEW SERVICE, NEW LOCATION, FASTER, CONVENIENCE...

•   GET RAPID FEEDBACK FROM INTENDED USERS



      EXPERIMENT CHEAPLY + QUICKLY
                         © ZEN CHU 2010
JUDGING CRITERIA
5+ CASH AWARDS FOR HACKING VALUES

  •   PROBLEM STATEMENT CLEAR + BRIEF
  •   DETAILED USER EXPERIENCE DESCRIPTION
  •   PITCH + SHOWMANSHIP
  •   WOW FACTOR = UNIQUE SOLUTION
  •   MOST CLINICAL FEEDBACK
  •   GENERATED NEW DATA OVER WEEKEND
  •   PROTOTYPE EXPERIENCE (PAPER, DRAWINGS, ETC.)
  •   TEAM DIVERSITY
  •   GET OUT OF THE BUILDING TO TEST
  •   SUSTAINABLE ECONOMICS
  •   WEIGHT: 1/3 PUBLIC HEALTH 1/3 TECH 1/3 BIZ MODEL

                       © ZEN CHU 2010
MAD LIB PITCH TEMPLATE
 •   I AM A _____________________
 •   MY GOAL IS TO IMPROVE
       •    QUALITY OF _________ (CLINICAL METRIC, EXPERIENCE, PAIN…)
       •    ACCESS TO _________ (SERVICE, SKILL,
       •    FREQUENCY/RATE OF _________________ (TEST, BEHAVIOR, DX, SURG)
       •    EFFICIENCY OF _________________ (TEST, DX, EXPERIENCE, SURG…)
       •    PROFITS OF _____________________ (PHARMACY, DOC, HOSP, FIELD…)
 •   FIRST TARGET CUSTOMER IS _________ (DESCRIBE SUB-POPULATION)
 •   THEY SUFFER FROM _________ (DISEASE, EXPERIENCE, PAIN…)
 •   WE CAN IMPROVE THEIR EXPERIENCE/HEALTH BY _________
 •   TODAY THEY SOLVE THIS BY _________ BUT THE PROBLEM IS _________
 •   OUR SOLUTION IS TO ATTACK _________
       •    STARTING WITH _________ (FOCUSED POPULATION)
       •    THEY WILL BE EARLY ADOPTERS BECAUSE (HIGHER SUFFERING, PAIN, COST, RISK, FEAR…)
       •    WE WILL REACH THEM THROUGH _________ (CHANNEL, SPECIALTY, RETAIL, PHARMACIES…)
       •    BUT WE CAN ALSO ATTACK LARGER MARKET OF _________ (NEXT USER TYPE)
 •   OUR PRODUCT/SERVICE WILL BE PAID FOR BY _________ BECAUSE THEY VALUE _________ (UNIQUE
     QUALITY,

                                         © ZEN CHU 2010
THANK YOU VIT + MGH!
SEE ONE - DO ONE - TEACH ONE
     APPLY HACKING PRINCIPLES
       TO WHAT YOU OBSERVE
      TO REMAKE THE FUTURE

           HackingMedicine.MIT.edu
          Twitter: #HackingMedicine @hackmedMIT

             AboutMe.com/ZenVen
BACKUP



         37
CLINICAL INNOVATION
  CRITICAL SUCCESS
 •   DESIRE TO HELP PATIENTS
 •   RIGOROUS ANALYSIS + DATA
 •   FOCUSED PLAN TO EARLY PROOF
 •   CREATIVE TEAM
 •   ADAPT TO NEW DATA
 •   EVIDENCE-BASED
 •   SUSTAINABLE MODEL FOR    PRODUCT/
     SERVICE

                 © ZEN CHU 2010
INNOVATION RULES
• MINIMIZE TIME TO DEMONSTRATION
• BUILD SMALLEST POSSIBLE TEAM
• DEVELOP ONLY THE BARE MINIMUM
• PROVE ONE IDEA / VARIABLE AT A TIME
• ITERATE FREQUENTLY BEFORE MANUFACTURING
  CONTROLS REQUIRED
• NEVER DEVELOP WHAT CAN BE BOUGHT
• INSIST ON HIGHEST QUALITY WORKMANSHIP FOR
  FINAL PRODUCT


    EMPHASIS ON SPEED & PROOF

                  © ZEN CHU 2010
BUILD TEAM TO EXECUTE
                               s e          Market Risk
                           e r Physician & Patient Adoption
                                     Reimbursement

                       e v
                     R                             n
                                   Packaged Solutions

                   in Regulatory Risk t          io
Value




                 n                           c u
              la          Safety & Efficacy
                                         x e
          ) P                          E
        1        Management Risk    m
                                e a
        Technology Risk )
                               T
                           2
                                                   Time
                           © ZEN CHU 2010
TIME IS LIFE
                 ACCELERANT                           DECCELERANT
REGULATORY       Device 510(k)                        New materials & claims
                 Euro CE Literature Claims            Unclear endpoints
                 Predictive animal models


CLINICAL         Existing human data                  Non-superiority
                 Reproducible published studies       Entrenched behavior
                 Acute episodic symptoms              Chronic disease endpoints


REIMBURSEMENT    Existing Codes DRGs                  Cost-Benefit Studies
                 Existing insurer coverage policies   New codes required
                 Private-pay, consumer


MARKET           Reduce skills needed                 Capital equipment purchase
                 Physician buying power               No physician benefit
                 Unambiguous diagnostic


SALES            Focused physician popul.             Learning curves
                 Existing distribution                Entrenched behavior




                                   © ZEN CHU 2010
INCREMENTAL vs BREAKTHROUGH
     Plenty of Incremental Value, BUT Different Strategy
 METRIC              INCREMENTAL                         BREAKTHROUGH
 Funding             $$                                  $$$$$$

 Market Size         Varies depending on funding         >$100MM
                     needed                              No current therapies

 Time Needed         Shorter                             Longer
 Adoption & Exit     Match opportunity to strategy       Regulatory path dependent

 Value @ Exit        Less                                More

 Major Risks         Window of opportunity               Technical/Clinical unknowns
                     Execution quality & critical path   Market adoption hurdles
                     Competition                         Reimbursement

 Success Factors     Focused execution                   Patents, Franchise Value
                     Management experience               Market adoption, Std of Care
                     Manufacturing economics             Investor expectations

 Patent Protection   Less                                More

 Competition         More                                Less


                                      © ZEN CHU 2010

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India Healthcare Summit + Hackathon VIT-MIT-MGH zenchu031513

  • 1. WHY HACKING MEDICINE? WHY NOW? WHY INDIA? ZEN CHU MIT HEALTHCARE VENTURES INNOVATOR CONCLAVE FOR MED TECH VELLORE INSTITUTE OF TECHNOLOGY CHRISTIAN MEDICAL COLLEGE MASSACHUSETTS GENERAL HOSPITAL MARCH 15, 2013 © ZEN CHU 2010
  • 2. WHY NOW? • HEALTHCARE CRISIS • ALTRUISM INSUFFICIENT • GLOBAL CLINICAL INNOVATION • MACRO TECHNOLOGY TRENDS • SUSTAINABLE VENTURES • ENTREPRENEURS CRITICAL © ZEN CHU 2010
  • 3. WHY INDIA? • UNIQUE NEEDS • DEMOGRAPHICS • NEW CLINICAL INNOVATION • RACIAL/REGIONAL DIFFERENCES • EMERGING MIDDLE CLASS © ZEN CHU 2010
  • 4. H@CKING MEDICINE • CLEVER SOLUTIONS • IDEAS ARE CHEAP • PROVE OR FAIL FAST • LEAN STARTUPS + DESIGN THINKING • ACCELERATE DATA + PROOF • ENTREPRENEURSHIP + MISSION © ZEN CHU 2010
  • 5. WHAT DOES A MEDICAL HACKATHON LOOK LIKE?
  • 6. The birth of one of the first HackingMedicine venture-backed companies… Amazing things happen in 36 hours!
  • 7. H@ckMed Sessions on Top Floor of the MIT Media Lab
  • 8. Craig Lipset, Director of Clinical Innovation, Pfizer Faster, Better, Cheaper Data Generation = Central to Pharma Productivity
  • 9. Joe Smith, Chief Med Officer of West Health Institute & MIT/HST Alum Demonstrating disconnect between health spending and quality outcomes
  • 10. The Pitch as central vehicle to test & hone mission, solution, business model
  • 11. TEAM + SHARED MISSION
  • 12. ONLY REQUIREMENTS: PAPER + COFFEE + DIVERSE TEAM
  • 15. GINGER.IO + VINOD KHOSLA FRESH EYES ON PROBLEMS FROM OUTSIDE HEALTHCARE
  • 16. MENTORS VS. EXPERTS “The problem with experts is that they do not know what they do not know… The problem is that we like to have maps–and seem to prefer to have the wrong map of reality to no map at all. ~ Nassim Nicholas Taleb The Black Swan SURROUND TEAMS WITH MENTORS PULL EXPERTS IN LATER, BUT START WITH NEEDS © ZEN CHU 2010
  • 17. HEALTHCARE METRICS BETTER FASTER CHEAPER CHEAP IS NOT ENOUGH! © ZEN CHU 2010
  • 18. HEALTHCARE METRICS CONVENIENCE CAPACITY TRUST BETTER FASTER CHEAPER TRUST + WORKFLOW ESSENTIAL © ZEN CHU 2010
  • 19. HEALTHCARE FRAMEWORK MONITORING R EFFECTIVE TREATMENTS GE O IA F TR CH DIAGNOSTICS & TE G & IN S PREVENTION UT EM RO ST SY EDUCATION TECH ENABLES SCALABLE MEDICINE © ZEN CHU 2010
  • 20. WHICH RISKS TO PRIORITIZE? TYPICAL ORDER OF UNIVERSITY SPIN-OUT 4 Market Risk Payment Physician & Patient Adoption Packaged Whole Solutions Value 3 Regulatory Risk Safety & Efficacy 2 Management Risk 1 Technology IP Risk © ZEN CHU 2010 Time
  • 21. WHICH RISKS TO PRIORITIZE? BEST ENTREPRENEURS + INVESTORS PRIORITIZE IN REVERSE CHOOSE BASED ON COST/PERFORMANCE REQUIREMENTS Technology IP Risk Management Risk Value Regulatory Risk Safety & Efficacy Market Risk Payment Physician & Patient Adoption ATTACK FIRST! Packaged Whole Solutions © ZEN CHU 2010 Time
  • 23. HACKATHON PROCESS • START WITH PROBLEMS + JOBS TO DO • EMPATHY FOR USER • DIVERSE TEAMS AROUND THEMES • LOTS OF WILD IDEAS • DEFER JUDGEMENT • BUILD ON IDEAS COLLABORATIVELY • RAPID CLINICAL FEEDBACK © ZEN CHU 2010
  • 24. OPEN INNOVATION • OPEN YOURSELVES TO CRAZY IDEAS • OPEN UNIVERSITY TO INDUSTRY NEEDS • SEEK DIVERSE TEAMS • SEEK CRITICAL FEEDBACK EARLY • DEFER PATENTING UNTIL LATER INSIGHTS © ZEN CHU 2010
  • 25. JUST THE BEGINNING 1st WEEKEND ACCELERATES PROCESS • CHOOSE THE MISSION • MAXIMIZE COLLISIONS • MAXIMIZE FEEDBACK • IDENTIFY CRITICAL EXPERIMENTS H@CK PROTO DATA IP VENTURE © ZEN CHU 2010
  • 26. THANK YOU VIT + MGH! IMAGINATION IS MORE IMPORTANT THAN KNOWLEDGE ALBERT EINSTEIN HackingMedicine.MIT.edu Twitter: #HackingMedicine @hackmedMIT AboutMe.com/ZenVen
  • 27. H@CK VIT - DAY 2 9 ORDER OF THE DAY NEW CLINICIANS 10 JUDGING CRITERIA 11 BIG PIVOT PITCHES MAD LIB PITCH 12 LUNCH 2 FIRST ROUND JUDGING - BREAKOUT ROOMS BY THEME 3 SEMI FINAL JUDGING - MAIN ROOM 412 GALLERY 4:30 JUDGES ANNOUNCE WINNERS
  • 28. VALUE OF THE PITCH • 56 PITCHES YESTERDAY! • LIMIT TO 3 MINUTES + 2 MIN Q&A • MISSION: WHY SHOULD ANYONE CARE? • RAPID FEEDBACK • FORCE CHANGE IN PROBLEM, SOLUTION, TEAM MIX • ROLE-PLAY AS ENTREPRENEURS • COMMUNICATE SOLUTION CONCISELY + ELOQUENTLY • PROVE OR DIS-PROVE VALUE + APPROACH © ZEN CHU 2010
  • 29. PIVOT ON YOUR IDEA • IDEAS GET CEMENTED IN OUR MINDS • ESPECIALLY AROUND TECHNOLOGY ORIGIN • SEEK JOBS THAT CANNOT BE DONE TODAY • START WITH DESCRIBING THE USER EXPERIENCE • NEW SERVICE, NEW LOCATION, FASTER, CONVENIENCE... • GET RAPID FEEDBACK FROM INTENDED USERS WHO LEARNED + PIVOTED? © ZEN CHU 2010
  • 30. SCALING MEDICINE • CREATE NEW EXPERIENCE • INCREASE CAPACITY • NEW SERVICE / PROVIDER with CAPACITY • CREATE NEW PLACE FOR SERVICE • DE-SKILL COMPLEX DIAGNOSTIC / TREATMENT • PATIENT SELF-SERVICE © ZEN CHU 2010
  • 31. WHAT IS NEW SERVICE ENABLED BY YOUR TECH? DESCRIBE THE EXPERIENCE, EXPERIENCE, EXPERIENCE! © ZEN CHU 2010
  • 32. WHERE DOES SERVICE TAKE PLACE? TRAIN   STATION PHARMACY PATIENT  HOUSE CLINIC SCHOOL HOSPITAL VILLAGE SPEC IALIZ CE ATIO V E NIEN N  /  IN CON F REQU CITY ENCY MUMBAI BOSTON © ZEN CHU 2010
  • 33. FUNDING IS A CRUTCH • CONSTRAINTS FORCE CREATIVITY • SEEK JOBS THAT CANNOT BE DONE TODAY • START WITH DESCRIBING THE USER EXPERIENCE • NEW SERVICE, NEW LOCATION, FASTER, CONVENIENCE... • GET RAPID FEEDBACK FROM INTENDED USERS EXPERIMENT CHEAPLY + QUICKLY © ZEN CHU 2010
  • 34. JUDGING CRITERIA 5+ CASH AWARDS FOR HACKING VALUES • PROBLEM STATEMENT CLEAR + BRIEF • DETAILED USER EXPERIENCE DESCRIPTION • PITCH + SHOWMANSHIP • WOW FACTOR = UNIQUE SOLUTION • MOST CLINICAL FEEDBACK • GENERATED NEW DATA OVER WEEKEND • PROTOTYPE EXPERIENCE (PAPER, DRAWINGS, ETC.) • TEAM DIVERSITY • GET OUT OF THE BUILDING TO TEST • SUSTAINABLE ECONOMICS • WEIGHT: 1/3 PUBLIC HEALTH 1/3 TECH 1/3 BIZ MODEL © ZEN CHU 2010
  • 35. MAD LIB PITCH TEMPLATE • I AM A _____________________ • MY GOAL IS TO IMPROVE • QUALITY OF _________ (CLINICAL METRIC, EXPERIENCE, PAIN…) • ACCESS TO _________ (SERVICE, SKILL, • FREQUENCY/RATE OF _________________ (TEST, BEHAVIOR, DX, SURG) • EFFICIENCY OF _________________ (TEST, DX, EXPERIENCE, SURG…) • PROFITS OF _____________________ (PHARMACY, DOC, HOSP, FIELD…) • FIRST TARGET CUSTOMER IS _________ (DESCRIBE SUB-POPULATION) • THEY SUFFER FROM _________ (DISEASE, EXPERIENCE, PAIN…) • WE CAN IMPROVE THEIR EXPERIENCE/HEALTH BY _________ • TODAY THEY SOLVE THIS BY _________ BUT THE PROBLEM IS _________ • OUR SOLUTION IS TO ATTACK _________ • STARTING WITH _________ (FOCUSED POPULATION) • THEY WILL BE EARLY ADOPTERS BECAUSE (HIGHER SUFFERING, PAIN, COST, RISK, FEAR…) • WE WILL REACH THEM THROUGH _________ (CHANNEL, SPECIALTY, RETAIL, PHARMACIES…) • BUT WE CAN ALSO ATTACK LARGER MARKET OF _________ (NEXT USER TYPE) • OUR PRODUCT/SERVICE WILL BE PAID FOR BY _________ BECAUSE THEY VALUE _________ (UNIQUE QUALITY, © ZEN CHU 2010
  • 36. THANK YOU VIT + MGH! SEE ONE - DO ONE - TEACH ONE APPLY HACKING PRINCIPLES TO WHAT YOU OBSERVE TO REMAKE THE FUTURE HackingMedicine.MIT.edu Twitter: #HackingMedicine @hackmedMIT AboutMe.com/ZenVen
  • 37. BACKUP 37
  • 38. CLINICAL INNOVATION CRITICAL SUCCESS • DESIRE TO HELP PATIENTS • RIGOROUS ANALYSIS + DATA • FOCUSED PLAN TO EARLY PROOF • CREATIVE TEAM • ADAPT TO NEW DATA • EVIDENCE-BASED • SUSTAINABLE MODEL FOR PRODUCT/ SERVICE © ZEN CHU 2010
  • 39. INNOVATION RULES • MINIMIZE TIME TO DEMONSTRATION • BUILD SMALLEST POSSIBLE TEAM • DEVELOP ONLY THE BARE MINIMUM • PROVE ONE IDEA / VARIABLE AT A TIME • ITERATE FREQUENTLY BEFORE MANUFACTURING CONTROLS REQUIRED • NEVER DEVELOP WHAT CAN BE BOUGHT • INSIST ON HIGHEST QUALITY WORKMANSHIP FOR FINAL PRODUCT EMPHASIS ON SPEED & PROOF © ZEN CHU 2010
  • 40. BUILD TEAM TO EXECUTE s e Market Risk e r Physician & Patient Adoption Reimbursement e v R n Packaged Solutions in Regulatory Risk t io Value n c u la Safety & Efficacy x e ) P E 1 Management Risk m e a Technology Risk ) T 2 Time © ZEN CHU 2010
  • 41. TIME IS LIFE ACCELERANT DECCELERANT REGULATORY Device 510(k) New materials & claims Euro CE Literature Claims Unclear endpoints Predictive animal models CLINICAL Existing human data Non-superiority Reproducible published studies Entrenched behavior Acute episodic symptoms Chronic disease endpoints REIMBURSEMENT Existing Codes DRGs Cost-Benefit Studies Existing insurer coverage policies New codes required Private-pay, consumer MARKET Reduce skills needed Capital equipment purchase Physician buying power No physician benefit Unambiguous diagnostic SALES Focused physician popul. Learning curves Existing distribution Entrenched behavior © ZEN CHU 2010
  • 42. INCREMENTAL vs BREAKTHROUGH Plenty of Incremental Value, BUT Different Strategy METRIC INCREMENTAL BREAKTHROUGH Funding $$ $$$$$$ Market Size Varies depending on funding >$100MM needed No current therapies Time Needed Shorter Longer Adoption & Exit Match opportunity to strategy Regulatory path dependent Value @ Exit Less More Major Risks Window of opportunity Technical/Clinical unknowns Execution quality & critical path Market adoption hurdles Competition Reimbursement Success Factors Focused execution Patents, Franchise Value Management experience Market adoption, Std of Care Manufacturing economics Investor expectations Patent Protection Less More Competition More Less © ZEN CHU 2010