US Robotic-assisted Surgery Market, 2016

As a Third Generation of Technology Emerges, Where is the Market Headed?

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This research traces the history of the first clinical applications for robotic devices and all associated technology required to create a true robotic-assisted surgical device (RASD). The study examines the people (leaders) and entities that became pioneers and founders of the RASD industry vertical. With fundamental original equipment manufacturers (OEM) in place, Frost & Sullivan investigated which companies profited and how they profited. This research service concludes with a presentation of 3 possible scenarios for the development and proliferation of a third generation of RASDs.

This study will assist healthcare providers, hospitals, and health systems in assessing how to increase strategically and economically the number of robot-assisted surgeries as a percentage of total facility surgeries.

Analysis of the subject matter results in presentation-feasible robot-assisted technology research and development (R&D) over the immediate future, where capitalization is centered, and how RASD OEMs hope to capture market share.

Moreover, this study extrapolates the current industry vertical for robot-assisted surgery applications to a broadened value-based reimbursement surgical continuum by examining how robot-assisted surgery fits or does not fit in current Centers for Medicare & Medicaid Services (CMS) pilot studies (Comprehensive Care for Joint Replacement). Lastly, this study positions readers to adapt their current relationship with robot-assisted surgery by better understanding the sustainable business model created by Intuitive Surgical, Inc. (da Vinci®) and how this company has achieved 100% market share for over a decade.

Table of Contents

Research MethodologyResearch Methodology Research Methodology (continued)An Introduction to Robotic-assisted and Minimally Invasive SurgeryExecutive SummaryMapping the Accelerated Evolution of Robotic SurgerySRI System Begins to be NoticedScientists, Entrepreneurs, and the Human Desire to Perform Surgery Faster and with More AccuracyThe Move to MISThe Beginnings of a Concept for Robotic Surgery Invasive Surgery Evolves SlowlySolving the Paradox of Poor ResolutionThe Tipping Point—Surgeons Lose Both Tactile and Direct Visualization to Technology CAS in the Digital AgeAcademic Impetus for Ongoing ChangeLaparoscopy—Adapting the Hands of SurgeonsA Historic Convergence of Science and TechnologyRobotic-assisted Surgical Devices—First GenerationWhat Exactly is Robotic Surgery?Autonomous Surgical Robots—First GenerationAutonomy Gives Way to Assisted and Collaborative EffortsA Timeline of First and Second-generation ProductsRobotic-assisted Surgical Devices—Second GenerationMaster/Slave System—A Second Generation Takes ShapeAssessing the Early Vendor Landscape Assessing the Initial Vendor LandscapeAssessing the Initial Vendor Landscape (continued)The da Vinci Surgical System—an Industry Icon Seizes 100% US Market ShareEmergence of an Industry Giant—Intuitive SurgicalIntuitive Surgical Stretches FDA Clearance CriteriaCompetition Heats Up (2002 to 2003)And Then There Was One—2003The da Vinci General Purpose Surgical Robot Product Line—US MarketThree System Components Common for all da Vinci Surgical Robots—US Marketda Vinci Surgical System Sells Itself as a Brand Intuitive Surgical’s Si-e, Si, and Xi General Purpose Surgical RobotsKey Differences for All US Market da Vinci Surgical Systemsda Vinci Surgical System Models and Attributes for the US MarketThe da Vinci Surgical System Intuitive Surgical Launches a 2-pronged Medical Advertising and Sales Shock and Awe CampaignIntuitive Surgical Understands Early on that Robotic Surgical Procedure Volume Is the Key to SuccessSales Force Focuses on Driving Robotic Surgical Procedure Volume—Salesmen in the Surgical SuiteThe US Market Responds—da Vinci Surgical System Enjoys Double-digit Growth from 2003 to 2008With the US Market in Hand, the da Vinci Surgical System Sets out to Capture Global Market Share (2008–2016)The da Vinci Surgical System—Challenges to Market Entry Growth Strategy Scrutinized—2012 to 2013ISRG—Roller Coaster Ride on Wall Street for InvestorsDespite the 2013 Challenges, Intuitive Surgical Captures 100% US Market Share (General Purpose Surgical Robots)The da Vinci Surgical System—Pricing and Sales by Product da Vinci Surgical System General Purpose Surgical Robots—Percent Sales by Modelda Vinci Surgical System List and Quoted Price da Vinci Surgical System Service and Support CostsThe da Vinci Surgical System—Q2 2016 Financial Performance Intuitive Surgical Global Performance (Q2 2016)Intuitive Surgical—Recurring Revenue ModelQ2 2016—HighlightsThird-generation RASD—Revelations in a Value-based US MarketMixed Claims on the Need for Third-generation Surgical RoboticsDefining a Cost Containment and Quality Outcome-driven Healthcare Ecosystem Defining a Nexus of Science, MIS, and Improved Quality Outcomes that Reduce CostsEmpowering the Surgeon’s Hands through Scientific Advances in Surgical Techniques and Robotic AssistanceRASD Market Responding to an Accelerated Demand for Specialized Surgical CapabilitiesThird-generation RASD—da Vinci Hoping to Capture the New RASD Surgical Procedure MarketIntuitive Surgical—Strategic Intent Moving ForwardIntuitive Surgical—2016 Priorities and Corporate AssetsIntuitive Surgical Creating New RASD Companies Third-generation RASD—Understanding the RASD FDA 510(k) Application Requirement for Market EntryFDA Clearance—Make-or-break Proposition for RASDStep 1—Understanding FDA’s Definition of an RASDStep 2—Understanding the US FDA Medical Devices Classification SystemStep 3—Becoming Aware of Key Factors That the FDA BelievesThird-generation RASD—The All Important FDA Challenge of Substantial EquivalenceDemonstrating Substantial Equivalence to a PredicateMoving Beyond Class II Medical Device Classification for RASDsThird-generation RASD—Moving Beyond da Vinci—Margin in an Era of Bundled PaymentsTypes of Value-based Payments (VBP)Bundled PaymentsRASDs in CMS’s Hip and Knee Bundled Payments Program Third-generation RASD—Moving Beyond da Vinci—The Search for AnswersImpetus for Third-generation RASDsSurgeries Where da Vinci Challengers May Specialize Can Anyone Challenge da Vinci?Third-generation RASD—Who are the New Innovators?How Will Intuitive Surgical Competitors Enter the Market?TransEnterixTransEnterix (continued)TransEnterix (continued)Stryker—Orthopedics (Total Knee and Hip Replacement)MedtronicSmith & NephewTitan MedicalMedtechIntuitive SurgicalVerb SurgicalRobotic-assisted Surgery and Minimally Invasive Surgery—The Way ForwardThe Way ForwardThree Possible Scenarios for RASD Market GrowthSurgical Robots as the Next Standard of Care—2020Scientific Evidence (Statistical Significance)—Prostatectomy RASD versus Open Surgery Technique CostsROI for da Vinci—To Be DeterminedScenario 1—The General Concept RASDScenario 2—Specialized RASDsScenario 3—Comprehensive Surgical Solutions Platform (Surgery 4.0)Key TakeawaysKey TakeawaysKey Takeaways (continued)Key Takeaways (continued)Key Takeaways (continued)Legal DisclaimerAppendixMarket Engineering Methodology




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