1. Global Clinical Engineering Success Stories Smart methodology for evaluating new medical devices. Collaborating for safety and efficiency. Name:Stefano Gidaro; Luca Radice Location:Chieti, Italy; Seveso, Italy E-mail address for contact:s.gidaro@libero.it; lucaerre@medicaldev.eu Submitted by

2. Hospital admissions in Italy 2014 Total hospital admissions: 9.526.832 General surgery Total addmissions: 852.831 Gynecology Total addmissions: 821.901 Urology Total addmissions: 274.118 Colecistectomy: laparoscopy vs open 91,48 % SDO 2014 data Expenses I semester 2015 (italian Ministry of Health data) Devices for mini-invasive and electro surgery: 102.589.509,72 € March 2016Global CE / HTM Success Stories2

3. Robotic surgery in Italy SANTORO E. PANSADORO V. - LA CHIRURGIA ROBOTICA IN ITALIA INDAGINE NAZIONALE - 2011 March 2016Global CE / HTM Success Stories3 Interventi di Chirurgia Robotica per specialità 20102011 I°/3 Urologia26691225 Chirurgia Generale1053473 Ginecologia763344 Cardio / Toracica20279 Otorinolaringoiatria9787 Chirurgia Pediatrica-2 Totale47842210 AnnoN° tot Robot 19992 20003 20017 200210 200311 200415 200520 200625 200728 200834 200942 201047 2011-6 mesi2

4. Robotic surgery in USA March 2016Global CE / HTM Success Stories4

5. Competitor Milestones March 2016Global CE / HTM Success Stories5 July 1997: FDA Clears da Vinci ® System for Surgical Assistance - K965001 January 1999: da Vinci ® System Receives CE-Mark Approval July 2000: FDA Clears da Vinci ® System for Laparoscopic Surgery March 2001: FDA Clears da Vinci ® System for General Non-Cardiovascular Thoracoscopic Surgery November 2002: FDA Clears da Vinci ® System for Thoracoscopically-Assisted Cardiotomy May 2001: FDA Clears da Vinci ® System for Radical Prostatectomy July 2004: FDA Clears da Vinci ® System for Cardiac Revascularization April 2005: FDA Clears da Vinci ® System for Gynecology A long way … 1995 Frederic H. Moll, MD, acquired the license to the telepresence robotic surgical system

6. Questions and Target Key Success Story Developing new surgical treatment device:  Telemanipulated surgical endoscopic system. Clearly define the questions and target:  Scope of assessment should never go over necessary goals;  However, which are the real target? March 2016Global CE / HTM Success Stories6

7. Needs Steps for Success Story  Flexibility in expanding device feature;  Compliance to law and standards: CE Mark;  Safety for patient and user;  Time to market;  Costs. March 2016Global CE / HTM Success Stories7

8. Input data Steps for Success Story  Different point of view:  Medical doctor;  Biomedical engineer;  Industry.  Resources: human, money, material March 2016Global CE / HTM Success Stories8

9. The win-win method Steps for Success Story Using different knowledge, experience, education as a multidisciplinary resource and collaborate to develop new methodology.  Identify real target (performances stated vs risk vs benefit);  Define surgical procedure as an expert manual act (χείρ, χειρός, hand; έργον, act)  Break the act in subtasks;  Identify common part to reach the target;  Support idea with clinical evidence. March 2016Global CE / HTM Success Stories9

10. Conclusions Competitors: 7 years for approval on General, Gynecology, Urology, Thoracoscopic Our experience: 1 year for clinical evaluation and approval on General, Gynecology, Urology and partial Thoracoscopic surgery March 2016Global CE / HTM Success Stories10

11. Conclusions Manufacturer declared benefit from device usage:  For patient  Sensing natural fulcrum of trocars  Reduce operating time  Reduce tissue inflammation -> reduce time of reintegration into social life after surgery  For surgeon  Aptic force feed-back  Comfort and natural position  Precision of movements  Endoscopy gaze control  Open sight on patient and surgical crew March 2016Global CE / HTM Success Stories11

12. Conclusions Outcome  Effectively reach clinical evaluation;  Clinical evaluation plan: July 2011  CE mark approval: January 2012  Efficiency in expanding device feature Action plan Improve the process to safely and efficiently explore new medical device destination of use March 2016Global CE / HTM Success Stories12