The Value of Robotics for Surgery Training

1. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com© 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com The Value of Robotics Simulation for Surgical Training Jeff Berkley, PhD CEO, President & Founder Mimic Technologies Inc SKIP INTRO © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com

2. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com According to the federal Agency for Healthcare Research and Quality (AHRQ), patient safety has been declining leading to over 250,000 deaths a year at a cost of approximately $30 billion* As a result of the Affordable Care Act, medicine is transforming from a “Pay per Service” to a “Pay for Performance” industry Our Medical System is Broken! • “To Err is Human – To Delay is Deadly…Ten years later, a million lives lost, billions of dollars wasted”, Consumers Union, SafePatientProject.org, May 2009 • BMJ 2016; 353 doi: http://dx.doi.org/10.1136/bmj.i2139 (Published 03 May 2016) Equivalent to seven jumbo jets crashing every week

3. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Epidemiology of Surgical Errors Primitive Causes of Surgical Errors 8.85 10.27 11.58 2010 2014 2018 Incidence of Surgical Errors (Million Cases) Procedural Incompetence 41.81% Lack of Adequate Preoperative Planning 19.56% Indecorous Work Process 13.45% Poor Peer Communication 12.18% Meager Negligence 9.24% Fatigue 2.23% Usage of Alcohol during Procedure 1.53% CAGR: 3.19% Surgical Errors BIS Research, “Robotics Simulators: An Emerging Frontier in the Era of Healthcare Robotics”, July 2019 Addressable with training

4. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Why Robotics? Robot assisted surgery increases the applied dexterity and accuracy of the surgeon because of the following advantages: • The surgeon’s hand motion is scaled so large movements results in small instrument motion • Hand tremor can be filtered out • The surgeon controls his or her own camera • The surgeon can switch control between multiple instruments • High definition 3D visualization enables better depth perception • The da Vinci robot has been clinically shown to be equivalent or superior to open or laparoscopic surgery in Urology, Gynecology and is developing in General Surgery Conducting surgery through a robot is analogous to shrinking the surgeon and placing them inside the body

5. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Challenges for Healthcare Systems Multiple Hospitals Many Robots Central Robotics Committee but Decentralized Local Committees Need for improved Risk Management Need for improved Efficiency in the OR Comprehensive Credentialing & Privileging SOLUTION Comprehensive Robotics Program built on Proficiency, Data & Simulation

6. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com New Concerns with Credentialing Surgeons are being sued for lack of informed consent regarding their skill and experience level Medicolegal Review of Liability Risks for Gynecologists Stemming from Lack of Training in Robot-Assisted Surgery Yu L. Lee, Gokhan S. Kilic, MD, John Y. Phelps, MD, JD, LLM. JMIG, 2011; 18(4), 512-515. Hospitals are now being sued for negligence regarding credentialing policies

7. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Recent Landmark Robotic Case Bremerton WA Taylor v. Intuitive “…responsibility for training, credentialing, and privileging surgeons to use new technologies belongs to physicians and the hospitals where they work.”

8. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Traditional Surgical Credentialing Take a course Get proctored Good until you retire © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com

9. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Traditional Surgical Credentialing Problems with Traditional Credentialing One Time Event doesn’t address skills degradation with no ongoing maintenance of certification or proficiency Doesn’t Anticipate Changes in technology Review of privileges usually Only Triggered by Traditional Morbid Events, not by deviations from normal © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com

12. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com What the Aviation Industry Can Teach Us Aviation Industry Initial Pilots License Upgrade Certification Demonstrate Competency Annual Currency Required Annual Recertification Medical Industry Initial Surgical Privilege New Procedure Training None None None © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com

13. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Who Would Benefit From Better Training? Uniquely positioned to set the standard for robotic surgery simulation across most robotic platforms Surgeons Hospitals Med Device Industry Nearly every surgeon who uses the da Vinci robot has trained with Mimic’s virtual reality platform Mimic’s advanced analytics help executives assess surgeon risk & efficiency before they enter the OR Medical device companies use Mimic’s simulation to optimize robot design and deliver exceptional training  With +1M robotic surgeries conducted last year, there is a tremendous opportunity to reduce costs through simulation training and evaluation  Partnered to deliver simulation with nearly every company launching a minimally invasive surgical (“MIS”) robot  Mimic is ready to expand its product and services offering as new surgical robot companies enter the market  Robotic surgery will replace most manual surgery and Mimic has significantly enabled adoption  Extensive data collection and analytics allow surgeons to compare themselves to surgeons in “rest-of- world”

15. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Laparoscopic skills development for the surgical assist Mimic Simulation Platforms S U R G E O N T R A I N I N G T E A M T R A I N I N G Innovation, through leadership in robotic simulation On demand, stand-alone simulation training for da Vinci Xi®, da Vinci Si®, and da Vinci S® Portable simulation training for da Vinci Xi®, da Vinci Si®, and da Vinci S® www.MimicSimulation.com

16. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Mimic Simulation Software High fidelity virtual reality training for learning robot control, advanced surgical skills, first assistant skills and team collaboration. Procedure-specific augmented reality training where expert surgeons lead you through interactive video of real surgical cases.

17. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Mimic Simulation Software  120+ laparoscopic and team training exercises included with Mimic’s dV-Trainer® and FlexVR™ (compared to 35+ on the ISI ‘backpack’)  Over 4.3 million training sessions since 2007 launch of dV-Trainer®  Regular software updates continue to deliver new and novel content to keep trainees engaged and entertained High fidelity simulation engine that runs dV-Trainer®, FlexVR™, and XTT™ BAC K

18. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Mimic Simulation Software  Features world-class surgeons and educators and live surgery footage to mentor trainees in VR and AR through procedure specific learning  Features real 3D video footage with embedded virtual content to enable an interactive experience  Develop decision-making skills and procedure knowledge Scoring system, sophisticated admin tools and cloud back up for proficiency assessment and curriculum customization. BAC K

19. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Immersive VR Training for the Entire Team Operating room setup Patient positioning Robot draping and prep Trocar placement Robot positioning and docking Emergency procedures

20. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Internal Video Review Optimize follow-up curriculum training based on video review of initial surgeries Customize Curriculum (Leverage Machine Learning) Conduct Internal GEARS Review Record Video of Surgery

21. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Robot vs. Simulator 0 50 100 150 200 250 300 350 DVSS dVT Hopsital Flex VR TIME TO COMPLETE COMPARISON 75% 25% Median +60% +33% 0 50 100 150 200 250 300 350 DVSS dVT Hospital Flex VR TIME TO COMPLETE COMPARISON 75% 25% Median + 2% -6% When no feet involved in the exercise difference in performance noticeable When feet involved in the exercise difference in performance variable decreases

22. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Utilization Comparison Mimic Team Trainer Total Sessions (Dec 2016 – Jan 2017) : 1351 XTT Team Training Sessions (Dec 2016- Jan 2017) : 450 ISI Skills Simulator Total Sessions (2014-2016): 209

23. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Benefits of Stand-alone  Access to training anytime  Training does not sacrifice valuable OR and robot time  Allows for independent training without supervision and observation  Surgeons and teams are trained to proficiency before robot even installed  Better program management with data access and cloud-based analytics  Utilizes low cost capital for training  Greater efficiency in multi robot systems through a common training platform

24. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com© 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Distributed Simulation Hospital Program Unify training, testing, and monitoring across ALL system hospitals utilizing the Mimic MScore Portal™

25. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com© 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com TRAINING HUB dV-Trainer® XTT™ Distributed Simulation Hospital Program TRAINING & PRIVILEGING Training Hub sets standards and provides premium training. Leverages Mimic’s simulation platforms such as dV-Trainer®, XTT™ and the real robot.

26. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com© 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com TRAINING HUB dV-Trainer® XTT™ SATELLITE SATELLITE SATELLITE SATELLITE MOBILITY OF FlexVR™ Transfer FlexVR between satellite locations as needed Distributed Simulation Hospital Program TRAINING & TESTING Satellite hospitals train and test surgeons with portable FlexVR™ Systems. TRAINING & PRIVILEGING Training Hub sets standards and provides premium training. Leverages Mimic’s simulation platforms such as dV-Trainer®, XTT™ and the real robot.

27. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com© 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com TRAINING HUB dV-Trainer® XTT™ SATELLITE SATELLITE SATELLITE SATELLITE MOBILITY OF FlexVR™ Transfer FlexVR between satellite locations as needed Distributed Simulation Hospital Program TRAINING & TESTING Satellite hospitals train and test surgeons with portable FlexVR™ Systems. TRAINING & PRIVILEGING Training Hub sets standards and provides premium training. Leverages Mimic’s simulation platforms such as dV-Trainer®, XTT™ and the real robot.

28. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com© 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com TRAINING HUB dV-Trainer® XTT™ Surgeons seeking advanced training or in need of remediation are sent to the Training Hub SATELLITE SATELLITE SATELLITE SATELLITE Distributed Simulation Hospital Program TRAINING & TESTING Satellite hospitals train and test surgeons with portable FlexVR™ Systems. TRAINING & PRIVILEGING Training Hub sets standards and provides premium training. Leverages Mimic’s simulation platforms such as dV-Trainer®, XTT™ and the real robot.

29. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Visibility into your data anytime, anywhere Superior analysis tailored specifically to your needs Simulation Assessment Platforms Custom Reporting Proficiency-based scoring is the core of our simulation platform

30. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Performance Analytics and Reports  Easy admin tools to setup and manage users and curricula  Proficiency-based scoring that is derived from experienced surgeon data  Data backed up in the cloud with MScore Portal™ for managing users, implementing programs, generating reports, etc.  Advanced analytics and comparisons to rest-of-world Scoring system and sophisticated admin tools for dV-Trainer®, FlexVR™, and XTT™

31. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Custom Reporting and Program Management  Mimic builds customized training curriculums and helps hospital systems manage their programs.  Focus is on training, privileging and credentialing through objective simulation data.  Mimic distills data down to dashboards that can be absorbed by stakeholders at a glance.  Mimic facilitates the continuance of robotics simulation programs despite the turnover over program managers and stakeholders. Mimic brings 18 years of experience in robotics training to help customers understand best practices for utilizing simulation.

32. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Quality and Efficiency Example Example data from Beaumont Hospital -5 -4 -3 -2 -1 0 1 2 3 4 5 -5 -4 -3 -2 -1 0 1 2 3 4 5 Includes time to complete task, economy of motion, and master workspace range MORE EFFICIENT use of the device SHORTER OR time MEASURES commitment to learning process METRICS for surgical case privilege METRICS for skill degradation = Increased Quality & Efficiency Established Benchmark Training Based on Dreyfus Model

33. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com -5 -4 -3 -2 -1 0 1 2 3 4 5-5 -4 -3 -2 -1 0 1 2 3 4 5 LEADS TO fewer mistakes & complications MEASURES commitment to program METRICS for surgical case privilege METRICS for skill degradation Risk and Safety Example Example data from Beaumont Hospital Includes instrument collisions, dropped objects, moving instruments when out of view, excessive force, and missed targets = Increased Safety & Decreased Risk Training Standards S T A R T F I N I S H Training Based on Dreyfus Model

34. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Predictive Analytics Mimic uses machine learning and advanced statistic to identify top performers and anticipate curriculum durations Distribution of hypothetical hours to competency in all exercises of curriculums at STAN (Nancy, France) and the Nicholson Center (Florida) 22% competent in over 20 hours 22% competent in over 20 hours “Distribution of Innate Psychomotor Skills Recognized as Important for Surgical Specialization in Unconditioned Medical Undergraduates”, Moglia, et al., Surgical Endoscopy, 2018 Innate Ability Curve 37% competent in under 10 hours STAN Curricula Nicholson Center Curricula BAC K

35. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Hysterectomy Cost Models Activity Cost Top 25% Cost per case Bottom 25% Cost per case Delta per case OR Times $50/minute 90 mins $4,500 140 mins $7,000 $2,500 Complications $20,000/ complication 1% $200 4% $800 $600 LOS $500/day 1 day $500 1.8 days $900 $400 Re- Admissions $20,000/ re-admission 1% $200 3% $600 $400 Total $5,400 $9,300 $3,900 Delta = $3,900 per case Data/study from CAVA Robotics, Dr. Rick Low et al, 2015. Data from 250 surgeons, 200,000 robotic cases, 36 institutions A hospital group doing 4,500 cases per year using 20 robots, with the lowest performing 50 surgeons doing approximately 225 cases a year: Potential Savings from training bottom performing 50 surgeons and teams: Data/study from Loftus Health Healthcare Consulting, 2015) INCREASED HOSPITAL EFFICIENCY = REDUCED CASE TIME IN THE OR $926K/year

36. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Culligan Study – Morristown Protocol Culligan, et al, FPMRS, Jan/Feb 2014 EXPERT SURGEONS STUDY GROUP CONTROL Number 5 14 4 Demographics N/A Same (49.1) Same (53.5) Average simulation hours Some 20 (9.7 to 38.2) 0 No of cases Average 142/year 0 Enough to be granted privileges Mean Hyst operative times 20.2 minutes 21.7 minutes 30.9 minutes EBL 25ml 25.4ml 31.25ml Goals score 50 34.7 31.1 Completing this protocol IN THE STUDY GROUP of robotic simulator skills translated to EXPERT-LEVEL SURGICAL TIMES during live human surgery. As such, we have established predictive validity of this protocol.” BAC K

37. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Skills Degradation Prevention Mimic develops a plan for a SKILLS MAINTENANCE CURRICULUM Required integration of surgical specialty benchmarks Skills Maintenance and Remediation Core robotic psychomotor skills begin to degrade significantly in 2–4 weeks Particularly true for surgeons new to robotics Efficiency – Accuracy – Safety FOCUS ON Guseila LM, Saranathan A, Jenison EL, Gil KM, Elias JJ (2013) Training to maintain surgical skills during periods of robotic surgery inactivity. Int J Med Robot; doi:10.1002/rcs.1562. Jenison EL, Gil KM, Lendvay TS, Guy MS (2012) Robotic surgical skills; Acquisition, maintenance, and degradation. J Soc Laparoendoscopic Surgeons 16:218-228.

38. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Pre and Post Exercises were performed Both Surgeons 1 & 2 attended MIS/Mimic Courses Skills Degradation Study 0 200 400 600 800 1000 1200 1400 Energy Switching 1 Peg Board 1 Ring & Rail 1 Energy Switching 1 Peg Board 1 Ring & Rail 1 Aug-15 15-Oct Skills Degradation Surgeon 1 Performance remained consistent • Performed 5 Robotic Procedures • Practiced on a simulator Surgeon 2 Performance declined significantly • Performed 0 Robotic Procedures • Did not practice on a simulator

39. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com What we did in Tacoma 2005: Acquired robot 2007: Decision to form Robotics Committee 2008: Formal robotics committee for system  Multi-disciplinary  Independent  Medical Director position ‒ Under COO ‒ Peer Review Authority  Gives advice to other Medical Staff Departments

40. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Annual Recertification: ALL Pass 2 Consecutive Peg Board 2 90% Energy Dissection 2 90% Ring Walk 2 90% Suture Sponge 2 90% Simulator

41. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com C&P at MultiCare Health Systems Robotic Credentialing: Basic, Advanced simulation requirements (pass 5 with 2 consecutive passes) Annual Certification: Minimum 12 cases per year, all surgeons pass 2 consecutive Sim exercises  Program adopted in 2008  All robotics surgeons required to pass annual simulation test to prove proficiency  Failure to complete at least 12 cases per year results required simulation training and testing  62 surgeons credentialed (all specialties), 35 currently have privileges at all 4 hospitals  5 surgeons have relinquished privileges ‒ Could not pass simulation due to physical conditions not otherwise apparent  5 low volume surgeons have maintained privileges by passing simulation training and testing requirements Multi-Care: Only Health Care System in the Pacific Northwest that has NOT had a robotic surgery lawsuit.

42. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com The Evolving Role of Simulation  Training ‒ Basic: Psychomotor skills ‒ Advanced: Procedures ‒ Team: Bedside assist Current Uses of Simulation  Credentialing, privileging and remediation  Surgical Warm-up Gaining Momentum

43. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Complication-Simulation Training Basic Management  Vascular injuries  Bowel and urinary tract injuries Advanced Management  Worsening complication scenario Procedure-specific Complications  Major vessel injury and repair with pelvic lymph node dissection

44. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com The Evolving Role of Simulation  MScore™ portal cloud links simulators to central admin for review ‒ Data Analytics available to all program directors as well as surgeons/students ‒ Link to simulation performance to clinical outcomes ‒ Compare performance and outcomes on different robotic systems ‒ Reduce insurance rates for high utilization and proven simulation performance  Remote surgical planning  Virtual Reality for OR setup and docking Connected, Smart Simulation

45. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com The Evolving Role of Simulation  Surgical Planning ‒ Practice complex procedures on actual patients based on imaging input into simulator ‒ Practice simulated procedures new to surgeon with Augmented Reality  Practice on different robots prior to actual surgeries if you use more than one system  Machine learning: Identify skills necessary to improve clinical outcomes, then practice 2019 and Beyond!

46. © 2019 Mimic Technologies, Inc. All rights reserved. www.MimicSimulation.com Conclusions  Robots will take over the operating room!  Over 1 million robot assisted surgeries  Procedures growing at 17%  Simulation enables surgeons to learn, improve and maintain skills, especially during periods of robotic inactivity, without training on patients  Need to establish a credentialing and privileging system (high stakes testing) that relies on simulation  Simulation will eventually enter the operating room  Pre-operative planning  Tele-collaboration  Assisted surgery through augmented reality and machine learning

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