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F. UTURE. T he I nnovative and E ntrepreneurial C ulture – E xamples in H ealthcare. Richard M. Satava, MD FACS Professor of Surgery University of Washington. Innovation Forum Innovation Opportunities in Health University of Saskachewan Saskatoon , Saskachewan

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UTURE

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  1. F UTURE The Innovative and Entrepreneurial Culture – Examples inHealthcare Richard M. Satava, MD FACS Professor of Surgery University of Washington Innovation Forum Innovation Opportunities in Health University of Saskachewan Saskatoon, Saskachewan 13-15 September, 2009

  2. Presenter Financial Disclosure Slide Richard M. Satava, MD FACS Financial Support: None (… but still hoping) Consulting: Karl Storz ISIS Support Stryker SimuLab US Surgical Investment InTouch Technologies, Inc * There will be no discussion of products from these companies

  3. Greetings from Monterey California

  4. Storytelling Johns Hopkins

  5. “The Future is not what it used to be” ….Yogi Berra Disruptive Visions

  6. “The Future is here … . . . it’s the Information Age” Current Visions

  7. Entering a New Age The “Fourth Wave” ??

  8. Clayton M Christensen

  9. 2000 BC 0 1500 1800 1900 2000 AD TIME (year) BIO-INTELLIGENCE AGE AGRICULTURAL AGE INDUSTRIAL AGE CONSUMER ACCEPTANCE INFORMATION AGE TECHNOLOGY DEVELOPMENT BIOINTELLIGENCE AGE Fourth Wave? Satava 29 July 99

  10. BIO-INTELLIGENCE AGE Biosensors Biomaterials Biomimetic PHYSICAL BIOLOGIC FUTURE Genomics Bioinformatics Biocomputation Robotics HPCC/WWW MEMS/Nano INFORMATION Satava 2 Feb 1999

  11. Creating a New Age Pioneers Inventors Implement Discover The Future Entrepreneurship Innovators Adopt Satava 2 Feb 1999

  12. The Scientific Method Evidence Based Medicine is . . . The Scientific Method as Applied to Medicine The Evidence IS the Science In order to accept evidence-based medicine . . . we must accept the current method in Science

  13. METHODS Classical Renaissance Age of Industrial Age Information Age Period Enlightenment Observation phenomenon experiment scientific method …? Aristotle Archimedes DaVinci Michelangelo Newton Boyle Einstein Fermi Hawking Wolfram What is Science ? . . . study that relate(s) to the phenomena of the material universe and their laws Oxford English Dictionary Science is what we observe by using the Scientific Method

  14. What is the Controversy? Wisdom of Giants Evidence Creativity of Innovators Imagination

  15. THE STRUCTURE OF SCIENTIFIC REVOLUTIONS THOMAS S. KUHN METHODS Classical Renaissance Age of Industrial Age Information Age Period Enlightenment Observation phenomenon experiment scientific method …? Aristotle Archimedes DaVinci Michelangelo Newton Boyle Einstein Fermi Hawking Wolfram The Great Debate 4 Decades of Kuhn vs Popper The Logic of Scientific Discovery Science is Evolving . . . and so is the Scientific Method

  16. METHODS Classical Renaissance Age of Industrial Age Information Age Period Enlightenment Observation phenomenon experiment scientific method …? Aristotle Archimedes DaVinci Michelangelo Newton Boyle Einstein Fermi Hawking Wolfram AScientific Revolution occurs with a Breakthrough or “Crisis” in Knowledge …and a New Era emerges . . . and with each New Era a new method of discovery

  17. Scientific Method . . . . . . is DEAD? Not necessarily but . . . Not all science is explainable using the scientific method Where is the role of Imagination Intuition Innovation Creativity Serendipity Inspiration FURTHER PROOF: Current evidence is inadequate for Event horizons Cognition Genome Quantum mechanics Memes Etc New discoveries evolve from Emergent Properties

  18. SIMULATION The Industry Standard CAD/CAM Virtual Design Virtual Prototyping Virtual Testing & Evaluation

  19. Hypothesis Study Design Experiment Results Reporting Hypothesis Study Design Experiment Results Reporting W hereIstheScientificMethodfailingus? • Where does the hypothesis come from? • Can all evidence be demonstrated by • Randomized, controlled, double-blind trials? ? Creativity Intuition Inspiration Analogy & Metaphor Exception-to-the-rule Emergent properties Outliers, etc “We don’t know … what we don’t know” Yogi Berra

  20. Hypothesis Study Design Experiment Results Reporting Hypothesis Study Design Experiment Results Reporting HowhastheScientificMethodchanged? Simulation ? Creativity Intuition Inspiration Simulation 8 n= 10 Analogy & Metaphor Exception-to-the-rule Emergent Properties Outliers, etc

  21. Hypothesis Study Design Experiment Results Reporting Whereis the Scientific Method failing us? RCT 2. Can all evidence be demonstrated by Randomized, controlled, double-blind trials?

  22. SCIENTIFIC METHOD Controlled, randomized, double-blind trial Control GroupNo Parachute Test GroupParachute Still looking for volunteers for the control group

  23. $ Government Funding $ What Reseachers Need toKnow

  24. Role of the Innovator CrossingtheChasm

  25. Role of the Innovator CrossingtheChasm The Second Chasm Valley of Death Early Innovators Visionaries Early Adopters Pragmatic Inventor Technology Enthusiast Inventor Pioneer Innovator

  26. ( Tech Transfer ) (Sustainment) Pioneer Innovator Inventor Design TRL 1 2 3 4 5 6 7 8 9 Transition Scientific Method

  27. Gartner’s Hype Cycle of Innovation VISIBILITY TIME Peak of Inflated Expectations Technology Trigger Trough of Disillusionment Slope of Enlightenment Plateau of Productivity

  28. The Innovator Must • See the “big picture” • Understand the “science” • Possess entrepreneurship • Transition the technology • The inventor . . . Discovers • The pioneer . . . Adopts • but • The innovator . . . crosses the chasm …. Twice

  29. Research Product Disposal New Idea

  30. Technology Readiness Levels Clinical Trials TRL 1 2 3 4 5 6 7 8 9 Transition Scientific Method

  31. The Innovator Transitions Life-cycle Management • Medical Research is an “acquisition process” • Early discovery and concept • Research (through completed prototye – TRL 6) • Commercialization (including purchasing by users) • Maintenance and sustainment • Implication to researchers of “acquisition process” • Early research – need to consider long term needs • Research and development – understand transition strategies • Commercialization – about 90% to bring a product to market • Maintenance & sustain – did the research plan for this?

  32. What is radically new?

  33. Classic Education and Examination What is the REVOLUTION in Medical Education?

  34. Training forNew Technical Skills Halstedian Model: See One, Do One, Teach One

  35. SURGICAL EDUCATION The Revolution is . . . Now Roughly 100 year cycles (1908 – Flexner Report)

  36. It’s all about . . . Improved Patient Care through Advanced Surgical Education Virtual Reality Manikin

  37. S T killsraining The New Mandates Effective 1 July 2008 All residency programs must have RRC* a skills training (simulation) center 1 July 2009 All surgical residents must pass FLS** ABS in order to apply for board certificate • * Residency Review Committee (RRC) Accreditation Council of Graduate Medical Education • Approved by American Board of Medical Specialties • ** Fundamentals of Laparoscopic Surgery

  38. Two Components of the Revolution Using Modeling and Simulation • Objective Training of Technical Skills • Simulators (technology) • Curriculum (training method) • Assessment of Cognitive and Technical Skills • Criterion-based tools • Objective metrics

  39. Technology Current areas of simulation Manikin Models, tissue, animals VR CAI Virtual Virtual Constructive Live

  40. O SATS Methodology Objective StructuredAssessment of Technical Skills Richard Reznick, Univ of Toronto - 1998

  41. It’s not the Simulator It’s the Curriculum

  42. Standardized Curriculum Suggested template • Goals of the Simulation • Anatomy • Steps of the Procedures • Errors • TEST • Skills Training • Outcomes

  43. The 6Competencies 2003 Consensus by the AGCME & ABMS • Knowledge • Patient Care • Interpersonal and communication skills • Professionalism • Practice-based learning and improvement • Systems-based practice

  44. Mandates Recent mandates include: Sept, 1999 NBME - Medical students required to pass OSCE June, 2008 ACGME (RRC) - All residency programs must have access to a simulation center July, 2009 Amer Board Surg - All residents must complete and document Fundamentals of Laparoscopic Skills course or have board certification application returned Recent initiatives (curricula) to meet mandates Amer Coll Surg - Fundamental Skills Courses to meet ABS reqs - Basic, advanced surgical skills, team training Amer Soc Anes - Airway management, etc - esp team training Maintenance of Certification (MoC) - Retraining of all types Redeployment, pregnancy sabbatical, etc

  45. ACS/APDS Core Curriculum S C O R E • Three Phases • PhaseProductComplete • Phase1 Basic Skills Curricula July, 2007 • Phase 2 Full Procedures July, 2008 • Phase 3 Team Training July, 2009 ABS Training/Assessment Website Provides educational/training resources Clearly states expected performance outcomes (quantitative)

  46. ACS/APDS Core Curriculum Twenty Basic Skills Asepsis & Instrument Identification .Knot Tying . SuturingTissue Handling Dissection, Wound Closure, Wound Mgmt Advanced Tissue Handling: FlapsCatheterization, Uretheral and Skin Grafts Suprapubic Airway Management Chest Tube/Thoracentesis Central Line Insertion, Arterial LinesSurgical Biopsy Vascular Anastomosis Laparotomy Opening/Closure Principles of Bone Fixation & CastingIntroduction: Inguinal Anatomy Upper Endoscopy .Colonoscopy Basic Laparoscopy Skills Advanced Laparoscopy Skills Hand Sewn GI Anastomosis Stapled GI Anastomosis

  47. Pre-operative Warm-up

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