2009 AdvaMed Surgical Robotics Panel Presentations

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By: konishi (111 month(s) ago)

Dear Sir; I would like to down load the slides of "How Far and How Fast, Surgical Robot Technology, AdvaMed 2009", 2009 Advamed Surgical Robotics Panel Presentations.

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SURGICAL ROBOTIC TECHNOLOGY : 

SURGICAL ROBOTIC TECHNOLOGY PANEL MODERATOR William McIlhargey WPM Enterprise How Far and How Fast

Panel Discussions : 

Panel Discussions Commercializing the surgical robotic technology Surgeon barriers and incentives to technology Positioning a robot within a community What the future holds for surgical robotics Open to questions from the floor October 14, 2009 2

Introductions : 

Introductions William Bargar MD Asst Prof of Orthopedic Surgery, UC Davis Medical Center Maurice Ferre MD President & CEO, MAKO Surgical Jonathan Hwang MD Director of Robotic Surgery, Washington Medical Center Thomas Low Director of Medical and Telerobotic Systems, SRI International October 14, 2009 3

Market for Surgical Robots : 

Market for Surgical Robots Intuitive is considered to represent the market However other players of note: MAKO Surgical has 23 sites Accuray Cyberknife has an installed base of < 180 systems Curexo Medical has > 50 ROBODOC systems worldwide Various other robotic assist devices, i.e. Acrobot October 14, 2009 4

A View on Robotic Systems : 

A View on Robotic Systems NOT ALL SYSTEMS ARE THE SAME Shared-Control (Semi-Active) robot monitors surgeon performance and provides stability and support through active constraint challenge . . . . surgeon fatigue Example: MAKO – RIO Tele-surgical (Passive) doctor performs surgery from a console distant to the operating table challenge . . . . latency - time delay between console & robot Example: Intuitive Surgical - da Vinci Supervisory-Controlled (Active) surgeons must provide extensive preparatory work, inputting data which initiates controlled responses to complete the surgical action challenge . . . . no room for error – robot does not adjust in real time Example: Curexo Medical - Robodoc Main difference is how involved a human surgeon must be when performing a surgical procedure October 14, 2009 5

Advantages of Surgical Robots : 

Advantages of Surgical Robots Supports consistency in “best practices” Decreases surgeon fatigue during surgery Enhanced precision through stability MIS approach leads to reduced trauma As with all automation, reduces personnel ??? Expensive due to relatively early development, however anticipation for this science to reduce the overall cost of providing surgical care October 14, 2009 6

Panel Presentations & Themes : 

Panel Presentations & Themes Dr. Ferre commercialization Dr Bargar surgeon acceptance Dr Hwang market positioning Thomas Low what the future holds October 14, 2009 7

SURGICAL ROBOTICS TECHNOLOGY : 

SURGICAL ROBOTICS TECHNOLOGY Commercialization Maurice R. Ferré, M.D President & CEO MAKO Surgical

US Knee Market Opportunity : 

© MAKO Surgical Corp. 2009 US Knee Market Opportunity US Knee Arthroplasty Market 0.6 mm Implants Sources: Frost & Sullivan (2007); Orthopedic Network News (2008); CDC & US Census 9

The Progression of OA of the Knee : 

© MAKO Surgical Corp. 2009 The Progression of OA of the Knee Early to Mid Stage OA OA Causes Late Stage OA Watchful waiting Total knee implant Arthroscopy 10

Slide 11: 

© MAKO Surgical Corp. 2009 DISEASE STAGE: Early to Mid-Stage Uni- and Bi-Compartmental OA “MIS”ARTHROSCOPY Early Stage Sports Injuries Later Stage/Severe Total Joint Disease 11 Knee Replacement ARTHROPLASTY Knee Resurfacing Current Treatment Gap

Current OA Treatments: Tale of Two Procedures : 

© MAKO Surgical Corp. 2009 Current OA Treatments: Tale of Two Procedures Total Knee Arthroplasty (TKA) For late stage OA – all 3 compartments Invasive procedure Painful recovery Limited patient adoption Duke University survey (January 2006): ~92% of men and 87% of women say “No” to TKA or THA Partial Knee Arthroplasty For early stage OA – 1 compartment Technically challenging - alignment Inconsistent results Limited surgeon adoption 12

Slide 13: 

© MAKO Surgical Corp. 2009 DISEASE STAGE: Early to Mid-Stage Uni- and Bi-Compartmental OA “MIS”ARTHROSCOPY Knee Replacement Early Stage Sports Injuries Later Stage/Severe Total Joint Disease Current Treatment Gap MAKOplasty® ARTHROPLASTY Knee Resurfacing 13

The MAKOplasty Solution: RIO® : 

© MAKO Surgical Corp. 2009 The MAKOplasty Solution: RIO® RIO® Robotic Arm Interactive Orthopedic System Robotic Arm Patient Specific Visualization Resurfacing Implants Tissue Sparing, Minimal Incision, Shorter Recovery, Precise, Reproducible 14 RESTORIS® Implant System

Slide 15: 

© MAKO Surgical Corp. 2009 “Safe Zone” Interactive control of cutting instrument entry and exit from joint space Bone preserving and tissue sparing Tactile feedback at boundaries 15

RIO: Version 2.0 510(k) Cleared - Launched in Q1 2009 : 

© MAKO Surgical Corp. 2009 RIO: Version 2.0 510(k) Cleared - Launched in Q1 2009 16

Resurfacing Implants: Growth Platform : 

© MAKO Surgical Corp. 2009 Resurfacing Implants: Growth Platform Metal-Backed Onlay Poly Inlay Medial Femoral Lateral Femoral Patellofemoral & Patella RESTORIS MCKBicompartmental Knee System RESTORIS Unicompartmental (Inlay and Onlay) MAKO RESTORIS MCK: Medial UKA + PF Configuration 2009 + 17

MAKO Market Opportunity : 

© MAKO Surgical Corp. 2009 MAKO Market Opportunity Disease Therapy Mid stage Late stage Early stage 18 Source: Frost & Sullivan 2007 (est.)

Slide 19: 

© MAKO Surgical Corp. 2009 Disease Therapy Mid stage Late stage Early stage 19 Sources: Orthopedic News Network (2008); Medtech Insight (2005) TKA UKA MAKO Market Opportunity

Slide 20: 

© MAKO Surgical Corp. 2009 Disease Therapy Mid stage Late stage Early stage bi-compartmental MAKOplasty 20 Source: Medtech Insight (2005) TKA UKA UKA Potential MAKO Market Opportunity

Initial MAKOplasty Experience : 

© MAKO Surgical Corp. 2009 Initial MAKOplasty Experience 23 MAKOplasty Commercial sites 78 surgeons 1,405 procedures Consistently reproducible implant alignment Faster recovery Through Q2 2009 21

Commercialization Strategy: Two Sales : 

© MAKO Surgical Corp. 2009 RIO Sale Commercialization Strategy: Two Sales Profile surgeons High volume surgeons Early stage OA focus Target hospitals Technology savvy Leading in orthopedics High volume orthopedic facilities 1 Director of Sales, NA 8 RIO Direct Sales Force Support surgeons MAKO rep in every MAKOplasty Support hospitals Center of Excellence 22 9 Marketing Support Team 1 Director of Implant Sales 1 Clinical Sales Manager 23 MAKOplasty Specialists 3 Regional Market Development Managers MAKOplasty Implant Sales

Slide 23: 

© MAKO Surgical Corp. 2009 Knee Arthroplasty Decision Makers Surgeons Patients Hospitals MAKOplasty Mission: Deliver Value to All Constituents Shorter recovery Natural movement Restoring quality of life Less pain Minimal incision Reduced length of stay Bone preserving Competitive differentiator ROI model Attract patients Reduced length of stay Surgeons 23 Reproducible Precision Optimal Implant orientation Practice enhancement Patients

Procedure Ramp : 

© MAKO Surgical Corp. 2009 Cumulative Procedures Procedure Ramp Year-To-Date Procedures 13 42 71 242 13 55 84 423 21 34 168 181 102 283 * Not including research and evaluation sites 601 24 401 1,405 623 265 1,047 782 582 Cumulative Comm Sites * New Comm Sites 1 0 2 3 1 1 3 10 0 1 2 5 2 7 4 3 23 3 3 20 17 13

SURGICAL ROBOTICS TECHNOLOGY : 

SURGICAL ROBOTICS TECHNOLOGY Barriers and Incentives for Acceptance William L. Bargar, M.D Joint Surgeons of Sacramento

ROBODOC: Achieving Precision and Accuracy in Hip and Knee Replacement : 

ROBODOC: Achieving Precision and Accuracy in Hip and Knee Replacement As an Example

ROBODOC: The Idea! : 

ROBODOC: The Idea! The ROBODOC System was conceived to: Pre-operatively select the size and type of implant best suited to the individual patient. Position the implant cavity appropriately in the bone Machine the bone to tight tolerances comparable to the implant tolerances

ROBODOC : 

ROBODOC

ROBODOC in Action : 

ROBODOC in Action

ROBODOC In Action : 

ROBODOC In Action

ROBODOC: A Proven Clinical System : 

ROBODOC: A Proven Clinical System Long track record stretching back to 1992 Over 50 installations worldwide. >24,000 case of hip and knee replacement. Not “experimental” any more. This is unique for a new technology being introduce to the US market.

Acceptance of Robotic Surgery : 

Acceptance of Robotic Surgery By Whom? Surgeon Patient Hospital FDA Payers Incentives and Barriers

Incentives : 

Incentives Does it solve a real clinical problem? Does it save money? Is it more efficient? Better outcome? Avoid complications? Why Use It?

New Technology Assessment : 

New Technology Assessment Randomized Clinical Trials and Meta Analyses Problem with control group (ethics, appropriateness) How long to follow? Who conducts them? (academic vs. community hospitals) The myth of “evidence based medicine” “Lies, damn lies and statistics!” (Mark Twain) If you don’t like the result, just wait for another study Soy products, Vioxx, chocolate! Proving something doesn’t work is even harder than proving it works. Achieving adequate statistical power.

Surgeon Acceptance : 

Surgeon Acceptance INCENTIVES: Improving patient outcome (difficulty proving it) Decreasing complications Practice growth Increased reimbursement? BARRIERS: Once bitten, twice shy! We’ve been burned by new technology. We all wear rose colored glasses. The Terry Bradshaw Story We can’t spare the time. It’s a money thing.

Patient Acceptance : 

Patient Acceptance INCENTIVES: Better Outcome Faster Recovery Avoid complications BARRIERS: Fear of robots Television and Movies Computer errors in everyday life Patients want to have faith in their surgeon They want a surgeon with “hands of gold” They don’t want to know he’s “only human” The Tiger Woods Analogy This is key to acceptance

Hospital Acceptance : 

Hospital Acceptance INCENTIVES: Attracting new patients Preferably non-Medicare and non-capitated. Avoiding complications/surgical errors “Never events” BARRIERS: Cost Is it cost-effective? Increased time Lower productivity Surgeon Acceptance

Regulatory Acceptance : 

Regulatory Acceptance Safety and efficacy Safety is easy to prove Efficacy isn’t. “Clinical Utility” Not defined by FDA Does it solve a real clinical problem

3rd Party Payer Acceptance : 

3rd Party Payer Acceptance Does it save money in the short term? Preventing surgical errors! Do we really want coverage by insurance companies and Medicare? Insufficient fees to providers Balance billing The New Health Plan????

My Assessment : 

My Assessment The Industrial Revolution Analogy Surgeons currently are “artisans” Outcomes are variable In art that is a good thing In surgery it is not! Computers and robots offer the same improvement and quality control to surgery that they brought to the world of manufacturing.

Conclusions : 

Conclusions Robotic surgery is a movement that cannot be denied. It will happen because the drivers are there. The only question is: when? Is now the time?

Slide 42: 

Thank You

SURGICAL ROBOTIC TECHNOLOGY : 

SURGICAL ROBOTIC TECHNOLOGY Jonathan J. Hwang, MD, FACS Director of Robotic Surgery Associate Professor in Urology Washington Hospital Center/Georgetown University School of Medicine Market Positioning

Robotic Surgery,Evolution or Revolution : 

Robotic Surgery,Evolution or Revolution 1st Generation Open Surgery 2nd Generation Minimally Invasive Surgery 3rd Generation Robotic Surgery October 14, 2009 44

Why Robotics? : 

Why Robotics? Expand MIS to new surgical procedures and specialties Improve the surgeons clinical capabilities Potentially improves patient outcomes

Slide 46: 

da Vinci S Surgical System Seamless Integration High-resolution, 3D video Fully articulated instruments State-of-the-art robotic technology

Slide 47: 

Regulatory

Slide 48: 

July 2000 - Laparoscopic Surgery March 2001 - Thoracoscopic Surgery May 2001 - Radical Prostatectomy November 2002 – Cardiotomy July 2004 – Cardiac Revascularization March 2005 – Broad Urology April 2005 – Gynecology June 2005 – Pediatric Surgery Urologic Surgery & da Vinci Radical Prostatectomy Pyeloplasty Uretetro Transplant Donor Nephrectomy Nephrectomy Ureterolithotomy Adrenalectomy Cystocele Repair Excision of Renal Cyst Lymphadenectomy Testicular Resection Renal Cyst Decortication Sacral Colpopexy Nephropexy Pelvic Lymphadenectomy Ureterectomy Rectocele Repair Varicocele Ureteroplasty Ureteral Implantation Vaso-vasostomy

da Vinci® Surgical System U.S. Installed Base 1999 – 2008 : 

da Vinci® Surgical System U.S. Installed Base 1999 – 2008

Mid-Atlantic Robots : VA, D.C.,MD : 

Mid-Atlantic Robots : VA, D.C.,MD

Slide 51: 

DISTRICT OF COLUMBIA George Washington University (2) Walter Reed Army Medical Center (2) Washington Hospital Center Sibley da Vinci® U.S. Installed Base 1999 – 2008 MARYLAND Anne Arundel Medical Center – Annapolis Baltimore Washington Medical Center - Glen Burnie Greater Baltimore Medical Center – Baltimore Henry M. Jackson Foundation - Rockville Johns Hopkins Hospital – Baltimore (2) Memorial Hospital at Easton – Easton National Institutes of Health – Bethesda Peninsula Regional - Salisbury St. Joseph Medical Center – Towson Suburban Hospital - Bethesda Holy Cross Health – Silver Spring University of Maryland Medical Center – Baltimore VIRGINIA Bon Secours- Maryview Medical – Portsmouth Bon Secours -St Mary's Hospital – Richmond (2) Carilion Roanoke Memorial Hospital – Roanoke Henrico Doctors' Hospital – Richmond (2) Inova Fairfax Hospital – Falls Church Lynchburg General – Lynchburg Mary Washington – Fredericksburg Memorial Medical Center – Mechanicsville Potomac Hospital – Woodbridge Riverside Regional – Newport News Sentara Norfolk General Hospital – Norfolk (2) University of Virginia Health System – Charlottesville Virginia – Arlington Virginia Commonwealth University Health System – Richmond

Robotic Prostatectomy (DVP): Nationally Accepted Treatment for Prostate Cancer : 

Robotic Prostatectomy (DVP): Nationally Accepted Treatment for Prostate Cancer National Comprehensive Cancer Network (NCCN) A not-for-profit alliance of 20 of the world’s leading cancer centers National Practice Guidelines On January 29, 2007 Accepted robotic surgery for radical prostatectomy for the treatment of prostate cancer In experienced hands, results comparable to open technique with the benefit of decreased morbidity

Slide 53: 

All Radical Prostatectomies da Vinci™ Prostatectomy Open Radical Prostatectomy

dVP (daVinci Prostatectomy) Assessment 2008: Hospital Perspective : 

dVP (daVinci Prostatectomy) Assessment 2008: Hospital Perspective Growth Patterns / How the robot is driving incremental business.

Slide 55: 

INOVA Fairfax- Fairfax, Virginia Over 500% increase from 2004 to 2007 2004: 38 dVP’s 2005: 108 dVP’s 2006: 200 dVP’s 2007: 250 dVP’s

Slide 56: 

George Washington University-Washington D.C. over 300% increase from 2004 to 2007 2004: 75 dVP’s 2005: 135 dVP’s 2006: 200 dVP’s 2007: 250 dVP’s

Slide 57: 

Washington Hospital Center: DaVinci Surgical System acquired in October 2006 Before daVinci: 2005: 108 RRP 2006: 74 RRP daVinci 10/06 2007: 24 RRP, 215 dVP’s 2008: 14 RRP, 258 dVP’s

Establishing a DVP program : 

Establishing a DVP program Pros Meet patient demand for new technology Increase practice visibility Potential extension of a surgical career Maintain and/or increase prostate cancer market share Cons Time commitment Steep learning curve Increased exposure to malpractice lawsuits Cost effectiveness

Starting a DVP Program : 

Starting a DVP Program Initial planning Determine financial viability Involve other surgical specialties Market analysis – expected surgical volume OR preparation Staff training – a dedicated OR team Room modification as needed Hiring of a surgical assistant

Developing a Successful Robotics Program: Key Elements : 

Developing a Successful Robotics Program: Key Elements Recruitment of Champion Surgeons Steep learning curve >250 DvP cases to be considered proficient Higher complication rates during the early learning phase Ability to galvanize the “right” robotic OR staff Higher volume leads to improved clinical results* Website Development Targeting the public – “internet savvy consumers” Open access - 24/7 Pt testimonials/video clips Provide clinical outcomes data * Fandi et al: The impact of provider volume on outcomes from urological cancer therapy. J Urol: 174; 432-438

Developing a Successful Robotics Program: Key Elements : 

Developing a Successful Robotics Program: Key Elements Securing the referral sources CME based robotic surgery symposiums Personal invitations for live demo Focus group presentations Superior Surgical Outcomes Word of mouth phenomenon Ensures long-term referral pattern Publications and presentations at a national/regional level

Maintaining a Successful DVP Program : 

Maintaining a Successful DVP Program Determining the success? Establish a rigorous database Intraoperative and quality of life outcomes Comparison to other treatment modalities Periodic evaluation of financial viability Direct and Indirect costs Surgical efficiency (ie OR time, LOS, etc) Quality performance/control measures Cancer cure rates Complication rates Open conversion Credentialing and training of “new” surgeons* * Zorn et al: Training, credentialing, proctoring and medicolegal risks of robotic urological surgery. J Urol: 182(3); 1126-32

When to Purchase the 2nd Robotic System? : 

When to Purchase the 2nd Robotic System? Multi-specialty involvement (urology, GYN, colorectal surgeon, thoracic, cardiothoracic, etc) Attracting more surgeons to the hospital Staying ahead of competitions Related to financial viability ROI can be optimized by charitable donations, generous gifts from foundations.

Conclusions : 

Conclusions Incorporating robotic surgery into clinical practice is a major decision that requires the support of the hospital, partners, and office/OR staff Once started, establish the timeline and make arrangements (training, marketing, etc) ahead, and remain committed

VOGUE January 2006 : 

VOGUE January 2006

SURGICAL ROBOTICS TECHNOLOGY : 

SURGICAL ROBOTICS TECHNOLOGY What the Future Holds Thomas Low Director, Medical & Telerobotic Systems SRI International

Historical Perspective : 

Historical Perspective M4- The first telepresence surgical system (1986) 4 DOF x2 plus grip All haptic servos Intended for trauma care on the battlefield Stereo Video (LCD Shutter w/ Passive Glasses) Operated over 100 Km microwave data link Patent portfolio licensed to ISI in 1995

First MIS system (predecessor of the daVinci) : 

First MIS system (predecessor of the daVinci) 4 Haptic DOF + Haptic Grip x2 Developed in conjunction with ISI staff @ SRI Developed patented coordinate transformations to preserve consistent interface. Focus not on operation-at-distance, but on more “intuitive” interface than existing laparoscopic tools ISI went on to add 2 DOF wrist

The Technology Today : 

The Technology Today

What’s Next? : 

What’s Next? In Development Improved instruments Preoperative planning automated port placement Microsurgical Robots Near IR imaging Integrated Ultrasound Imaging Near term Single-port robotic tools Integrated telementoring Mid term Haptics? NOTES? Integrated image guidance? Future Autonomy of subtask? Autonomy of OR support?

Preoperative PlanningPort Placement : 

Preoperative PlanningPort Placement DLR prototype system Fuse Preoperative CT and non-contact surface scan Evaluate all possible port placement solutions with simulation Project solution onto patient

Microsurgical System : 

Microsurgical System SRI Microsurgical System Specs 4 DOF + Grip 2 DOF wrist later added 100 mm x 100 mm x 100 mm workspace 2 N continuous Force 25 Hz Bandwidth 7 μm resolution Developed for ophthalmic surgical procedures Tremor Filtering and Motion Scaling

Microsurgical System Results : 

Microsurgical System Results

Augmented Vision : 

Augmented Vision Use of multispectral cameras, conformal microscopy and contrast agents delineate diseased tissue confirm reperfusion image at cellular level

Single Port Instruments : 

Single Port Instruments

NOTES : 

NOTES

NOTES : 

NOTES

Long Distance Operation : 

Long Distance Operation

Image Guided Autonomy : 

Image Guided Autonomy

Fully Automated OR : 

Fully Automated OR SRI International “Trauma Pod” autonomous support

What does the future hold? : 

What does the future hold? How much will surgury be automated and pre-planned? Will long-distance surgery be a part of global healthcare? How will surgeons be trained and evaluated? How will surgical robotics work alongside other emerging healthcare technologies? Will requlatory agencies be able to balance what is technically possible with what can be proven to be safe?

Panel Questions : 

Panel Questions October 14, 2009 82 THANK YOU thomas.low@sri.com

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