EX 2015 FROM THE NOTEBOOKS OF A TROUBLED INVENTOR & Moving from the defense industry to the medical instruments industry Gavriel J. Iddan, D.SC. November 11, 2015 I REMEMBER AS A CHILD, THE DOCTOR CARRIED ALL THE INSTRUMENTS IN A BLACK CASE…….. FEW URINE AND BLOOD TESTS IMAGING MENT X-RAY SURGERY WAS RARE AND COMPLICATED November 11, 2015 2 MEDICAL KNOWHOW AND SURGERY PROGRESED BY MILITARY MEDICINE…… FEW DEVICES AND INSTRUMENTS LAB TEST BASED ON CHEMISTRY AND SIMPLE MICROSCOPY MEDICATION WAS LIMITED AND INCLUDED ASPIRIN, SULFA….. NO REGULATION…… November 11, 2015 3 ENTERS WW 2 AND THE COLD WAR MILITARY RESEARCH AND SPENDING WENT WILD…….(FEAR, BIG SPENDING, NO ATTENTION TO COST…) NEW TECHNOLOGIES INVENTED INCLUDING: SEMICONDUCTORS AND ELEC. INSTRIMENTS POLYMERS CERAMICS, METALS…. November 11, 2015 4 COMPLEX MACHINARY - JETS, ROCKETS, SUBMARINES, SATELITES, COMMUNICATIONS… ADVANCED MANUFACTURING CNC AND LATELY 3D PRINING NEW SYSTEMATIC APPROACH TO MANEGEMENT WORK BY CODES AND REGULATIONS……. November 11, 2015 5 DEFENSE TECHNOLOGY OF YESTERDAY: MECHANICS, BINOCULAR OPTICS, RADIO AND RADAR ELECTRONICS, CHEMISTRY OF EXPLOSIVES, 7 THE MAGNIFICENT THAT EVOLVED FROM THE MILITARY/SPACE ACTIVITY : 1. MINIATURIZATION, of electronic circuits and other components 2. MATERIALS, polymers, ceramics and high quality steels titanium and other metals that are bio compatible! November 11, 2015 6 3. System - interdisciplinary engineering 4. Regulation and standards 5. Computer assisted design and manufacturing 6. Computer assisted management. 7. Robotics THESE MAGNIFICENT 7 SHAPED OUR MODERN MEDICAL INSTRUMENTS INDUSTRY November 11, 2015 7 IN ADDITION: LIFE SCIENCE AND MEDICINE ARE CHANGING FROM EXPERIMENTAL DISCIPLINE INTO A QUANTITATIVE EXACT SCIENCE IT LEADS TO OUR ABILITY TO USE ENGINEERING APPROACH IN THE DESIGN OF MEDICAL INSRUMENTS. November 11, 2015 8 SOME EXAMPLES: 1. MEDICAL IMAGING INCORPORATING IMAGE PROCESSING CT, MRI, ULS, OCT – my new initiative…. 2. BIOCHEMISTRY (MINIATURE INSULIN PUMPS ) 3. MINIATURIZATION (LAPARASCOPY, PCR, DEFIBRILATION) 4. MATERIALS (TOTAL HIP REPLACEMENT…..) 5. ROBOTICS (DA VINCHI…..) 6. TISSUE ENGINEERING THE LIST GROWS DAILY….. November 11, 2015 9 A PHYSICIAN IDENTIFIED A NEED AND THE ENGINEER PROPOSED A SOLUTION SO, YOU HAVE DECIDED TO BECOME AN INNOVATOR……… TO HAVE A STARTUP……… GOOD LUCK ! YOU ARE GOING TO NEED IT ! Here are some helpful advises November 11, 2015 10 OR, AS L. PASTEUR SAID: “LUCK FAVERS THE PREPERED MIND” 1. ALWAYS, but ALWAYS START WITH TRUE MARKET NEED 2. EXAMINE MANY OPTIONS AND AVOID NIH 3. CHECK CAREFULEY THE IP SCENE 4. PREPARE A CONSERVATIVE WORK PLAN BUT, DO NOT OVER DO IT November 11, 2015 11 R/D TRIANGLE Technology Required spec’s competitive edge & strong IP R/D cost Tech. gap Current technology (limited knowhow) Tech. Slope, true TEAM knowhow 1st year launch 2nd year 3rd year Project time Ready for manufacturing TRUE KNOWHOW REQUIRES INFORMATION ON WHAT’S COOKING IN LAB’S AND OTHER COMPANIES * Iddan G. J. ・From the note books of a troubled inventor・ SPIE Vol. 6083 608301-1 2006 12 Always be on watch for a DISRUPTIVE TECHNOLOGY * : IF YOU DON’T YOU MAY BE SURPRIZED AND LOSE YOUR PROJECT November 11, 2015 13 REVOLUTION EVOLUTION HYBRID CARS14 November 11, 2015 18 TRANSISTOR EVOLUTION REVOLUTION IC CELLULAR SMART PHONE REVOLUTION November 11, 2015 15 MY EXAMPLES November 11, 2015 16 3DV SYSTEMS GREAT IDEA……. GENERATE 3D IMAGES BY SENDING A SHORT LASER LIGHT PULSE “LIGHT WALL” . THE REFLECTED WALL HAS IMPRINT OF THE 3D SCENE. REFLECTD WALL IS CAPTURED BY A CAMERA . BY CHOPING THE WALL, A BW IMAGE IS CREATED WITH THE GRAY LEVEL BEING AN INDICATION OF EACH PIXEL RANGE. November 11, 2015 17 Laser pulsed illuminator Light wall object gate Reflected imprinted wall imager Gated wall November 11, 2015 18 November 11, 2015 19 BUT…….. NO SPECIFIC MARKETING GOAL EXISTED, AND WE WERE SURE THAT EVERYBODY WILL RCOGNIZE THE BENEFITS…………… OUR FIRT GOAL WAS TO OFFER IT TO TV STUDIOS AS A SMART REPLACEMENT TO CHROMA - KEY IT WAS NICE BUT THE IMAGES WERE NOT PERFECT NOT GOOD ENOUGH FOR STUDIO MONEY WAS RUNNING OUT WE DECIDED TO GO FOR VIDEO GAME……….TOO LATE THE COMPANY WAS SOLD TO MICROSOFT WITH MINIMAL RETURN TO THE INVESTORS. November 11, 2015 20 ENDOSCOPIC VIDEO PILL WHILE TALKING WITH A GASTROENTEROLOGIST FRIEND I WAS TOLD OF SOME SHORT COMINGS OF THE ENDOSCOPES AND WAS ENTICED TO FIND A SOLUTION. THE MARKET NEEDED IT……… R.D.C. HAS BEEN ESTABLISHED BY RUVEN KRUPIK FOR THE PURPOSE OF INVESTING IN “RAFAEL” TECHNOLOGIES. G. MERON WAS HIRED AS THE CEO AND FOUNDED “GIVEN IMAGING” We transformed the world of GI from science fiction to reality November 11, 2015 21 1st GI Diagnostic Breakthrough in 25 Years Rigid Endoscopy 1960 Flexible endoscopy 1970 1980 Capsule endoscopy 1990 November 11, 2015 2000 23 November 11, 2015 24 First Generation PillCam SB 1. Optical dome 2. Lens holder 3. Lens 4. Illuminating LEDs (light emitting diodes) 5. CMOS (Complementary Metal Oxide Semiconductor) imager 6. Batteries 7. ASIC (Application Specific Integrated Circuit) transmitter 8. Antenna November 11, 2015 25 The Given® Diagnostic System M2A® Capsule Ambulatory DataRecorder™ on a belt RAPID® application for image processing and viewing November 11, 2015 26 Mouth to Cecum Teeth Multiple telangiectasia on a gastric fold Epiglottis Small Intestine Barret’s Esophagus Wall of right colon 27 Time Line 10 Years 1981: Gabi Iddan meets Eitan Skapa M.D. and learns about the need to examine the small intestine. Technology not available! 1986: small CCD are available. 1990: small transmitters are available. 20 Years 1992: The capsule conceptual design born. 1993: experiments begin, CMOS imager appears. 1994: patent application. 1995: ASIC transmitter appears. 1997: Given Imaging incorporated 2001: FDA granted November 11, 2015 CHANGES..…… 1981 2002 2011 Prof. Eitan Skapa Dr. Gabi Iddan First Thoughts on capsule Working on Solutions November 11, 2015 Enjoying Grandchildren 29 WHAT SHALL WE DO IN THE AGE OF GLOBALIZATION ????? November 11, 2015 30 ECONOMY AND INDUSTRY WERE BASED ON ADAM SMITH AND HIS UNSEEN HAND AND THE DEVISION OF LABOR FOLOWWING WW I JOHN MAYNARD KEYNES INDICATED THE NEED FOR GOVERNMENT INTERVENSION AND REGULATION TODAY THAT IS NOT ENOUGH ENVIRONMENT, FAR EAST AND REGULATIONS ARE GAME CHANGERS WHICH SHOULD BE DELT WITH WHEN CONCIDERING A NEW PROJECT. November 11, 2015 31 TRADITIONAL INDUSTRIES HAD TO CLOSE: IN ISRAEL…ATA TEXTILE, ONE OF THE FLAG SHIPS CLOSED ITS GATES FOLLOWING MORE THAN 50 YEARS OF ACTIVITY SIR ARTHUR WAUCHOPE BRITISH HIGH COMMISIONER OF PALESTINE VISITS “ATA” 1937 BUT, OSEM, ISCAR SUCCEDED BY HAVING FINE INNOVATIVE MANEGEMENTS November 11, 2015 32 OTHER PLAYERS SUCH AS RAFAEL, ELBIT , AIA AND NETFIM SUCCEDED BY MANEGEMENT SENSING THE CHANGES AND ENTERED NEW FIELDS THE HIGH TECH REVOLUTION SAVED OUR ECONOMY (AND THE NEW IMMIGRANTS FROM RUSSIA…….) CHECKPOINT, INTEL AND GIVEN IMAGING TO NAME A FEW, CHANGED THE NATURE OF OUR INDUSTRY November 11, 2015 33 FACTORS EFFECTING THE NEW DESIGNS (MEDICAL INDUSTRY) 1. TOUGH SAFETY REGULATIONS (FDA…..) 2. HIGH COST OF MEDICAL CARE 3. LOW COST MANUFACTURING IN CHINA, INDIA ETC. EFFECTS THE PRODUCT DESIGN. 4. TOUGH ENVIRONMENTAL LOWS 5. INVESTORS ARE MIXEDUP IN THE COMPANY OPERATION 6. PATENTS ARE CONSUMING FUNDS 7. FUELS ARE EXPENSIVE 8. TERROR IS EFFECTING THE WAY WE WORK November 11, 2015 34 HOW SHOULD WE SECURE OUR ECONOMICAL FUTURE UNDER THE CHANGING RULES ??? INNOVATION AND QUALITY HOW CAN WE DO IT??? November 11, 2015 35 HARD WORK…… INTERDISSPLINARY EDUCATION DO NOT BE AFRAID IN CASE OF FAILURE MIND THE ALTERNATIVES BE RESPONSIBLE WITH EXPENSES. DO NOT GIVE UP WHEN IN TRUBLE November 11, 2015 36 SOME POSITIVE INDICATIONS: CSO FUND ARE GREAT FOR STARTUPS DEMAND FOR NEW TECHNIQUES AND HIGH TECH PRODUCTS IS ON THE RISE RAPID TECHNOLOGICAL PROGRESS IS PROVIDING NEW POSSIBILITIES November 11, 2015 37 THANK YOU November 11, 2015 38