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tszyin@itri.org.tw 2008/06/04

80 70 60 50 40 30 20 10 4 4.3 4.7 5.4 6.8 Baby Boomer 8.1 9.2 9.8 11.3 Aged Baby Boomer 12.7 13.1 13.9 17.3 21.1 25 21.6 21.7 20 15 10 5 65 2011~2029 0 1900 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 2020 2030 2040 2050 GDP $4,000 $3,500 $3,000 $2,500 $2,000 $1,500 $1,000 $500 $0 1998 1999 2000 2001 2002 2003 2004(e) 2005(f) 2006(f) 2007(f) 2008(f) 2009(f) 0 2010(f) 2011(f) 2012(f) 2013(f) 2014(f) 20% 18% 16% 14% 12% 10% 8% 6% 4% 2% 0% 2

65 (CHF) (COPD) 3

1991 1995 2002 No Data <10% 10% 14% 15% 19% 20% 24% 25% (*BMI 30, or ~ 30 lbs overweight for 5 4 woman) 4

100% HOME CARE Healthy, Independent Living Community Clinic Chronic Doctor s Disease Management Office RESIDENTIAL CARE Assisted Living Skilled Nursing Facility Specialty Clinic ACUTE CARE Community Hospital ICU 0% $1 $10 $100 $1,000 $10,000 5

From Work Productivity Need Commodity To Enjoyment Happiness Individualized 8

Battelle 2005 Medical treatment using highly accurate sensors 2006 Genetic-based medical treatments 2007 Home health monitors 2008 Affordable home-based health care 2020 Genetic-based medial and health care (Wellness) : Battelle Technology Forecast 9

/ 10

FDA (Official National Formulary) (United States Pharmacopeia) / 11

EucoMed EucoMed 12

20,00080,000 Bjork-Shiley Dow CorningDalkon Shield 2006Boston Sci GuidantJohnson & Johnson Conor Medsystems 13

/ IEK 14

Premarket Notification {510(k)}Premarket Approval Class I General Controls Class II General Controls + Special Controls CLASS III Premarket Approval 510(k) Review Investigational Device Exemption Marketing 510(k) Clearance Letter Marketing GMP Pre-approval Inspection GMP Routine Inspection PMA Approval Marketing 16

EU Regulations Directives Harmonized Standards (& Guidelines) Recommendations, Opinions 17

EU (essential health) (Essential Requirements) Requirements3rd party Active, Implants III EU MDD Conformity Assessment Procedures from 93/465/EEC Annex 2 EC Declaration of Conformity + Examination of the Product Design (Section 4) Full Quality Assurance System (Section 3) (EN 46001) Evaluation by the Notified Body Annex 2 EC Declaration of Conformity +Full Quality Assurance System (Section 3) (EN 46001) Technical Document checked during audit Evaluation by the Notified Body II b, II a, Annex 4 EC verification Statistical Verification Examination and Testing by the Notified Body Active Implants, III, II b, II a I* (Meas/Ster) Annex 3 EC-Type Examination Examination by the Notified Body Annex 4 EC verification 100% Verification Examination and Testing by the Notified Body III, II b, II a I* (Meas) Annex 5 EC Declaration of Conformity Production Quality Assurance (EN 46002) Evaluation by the Notified Body Active Implants III, II b, Active Implants III, II b, II a I* (Meas/Ster) I, I* II a I*- Sterile -Measuring Function Class I* Sterile products and measuring devices II b, II a, I* (Meas) Annex 6 ECDeclaration of Conformity Production Quality Assurance (ISO 9003) Evaluation by the Notified Body Annex 7 EC Declaration of Conformity Self Certification with Documentation available Surveillance CE 18

(MDEA) MDEA) MDEA(2006)IEK 24

J&JAbbott BDBio- RadPromegaRoche GETycoPhilips Siemens Hitachi PanasonicIntelNTT Pride MobilityInvacareSunrise MedicalYAMAHA Suzuki 25

26 -- --Medtronic Medtronic 1957 1973 1983 1986 1987 1989 2001 2002 2004 45.9% 21.1% 17.8% 6.7% 8.5% 2005

--Intel Intel (AI ) 27

--A&D Medical A&D Medical 28

(%) (%) 98.4 21.8 68.1 19.1 59.5 17.5 62.5 18.6 72.6 17.3 73.3 21.8 82.5 26.3 Ernst ; Young & Dow Jones Venture, VentureOne. 29

- 0.4~0.5% 20?? 30

2300 214 8.27 8.25 4.64 31

/ 8.19 20 5.7 4.5 0.78-1.29 5.89 29 4.7 9.5 2.0 4.73 4.49 32 4.3 7.7 1.8 3.4 13.0 19 8.8 17.6 1.98 8.7 1.75 48 7.2 13.1 1.81 5.9 10.13 21 28.1 35.1 1.25 7.0 32

700 114 1.77 5.75 10.1 33

530 200 6.64 5.2 9.4 34

540 227 1279 9.5 18.6 35

420 138 5.15 19.8 84.1 IMD 36

360 40 1.77 15.4 20.7 37

39 Espicom(2007)IEK 2006 2006 254 1926 10 10 3495 Zimmer 179 1941 9 9 5405 Stryker Na 1962 7 8 7573 Tyco International 268 1979 8 7 7821 Boston Scientific 98.5 1891 6 6 8458 Philips 107 1967 3 5 1032 2 Siemens 127 1912 5 4 1081 0 Fresenius 176 1949 4 3 1005 4 Medtronic 184 1892 2 2 1515 3 General Electric 161 1887 1 1 2028 3 Johnson & Johnson 2005 2006 2006 20011002006

Medical Device LinkIEK(2005/09) 41

0.6%2015 6,160 42 IEK

43 2007 2007 / 1 IEK % 9.62% 16.71 15.24 1788 5.87% 22.83 21.56 (4104) -9.70% 3.79 4.20 3266 18.12% 3.97 3.36 3218 5.91% 4.86 4.59 (4116) 12.71% 8.33 7.39 (4126) 12.02% 5.48 4.89 (4107) -1.30% 1.19 1.2 (4117) 163.12% 0.40 0.15 (4131) -75.37% 0.35 1.40 (4113) 12.59% 11.27 10.01 (1733) 21.42% 6.31 5.20 (4129) -17.20% 15.97 19.29 (1729) 14.98% 17.36 15.09 (1565) 14.43% 13.19 11.52 (4106-2.17(11) 3.51 (4125) 2007/12/13-3.61(10) 4.29 (3373) 39.90% 16.24 11.61 (4121) -4.85% 37.59 39.51 (4103) 9.14% 11.64 10.67 (1781) / (%) 2007 2006

44 2007 2007 % 19018-29021- IEK(2008/05)

2007 2007 Depuy2007Zimmer Stryker 200740% Cooper VisionOcular Science 20075(18)6 1 45

2007 () 2 CMS2006 2~3 46

47 2008 2008 / 1 IEK-ITIS(2008/05) 6.32% 4.04 3.80 1788 6.18% 5.5 5.18 (4104) -5.15% 0.92 0.97 3266 31.52% 1.21 0.92 3218-9.18% 0.89 0.98 (4116) 15.54% 2.23 1.93 (4126) 4.69% 1.34 1.28 (4107) -14.81% 0.23 0.27 (4117) 133.33% 0.14 0.06 (4131) -100.03% -0.00006 0.24 (4113) -2.09% 2.34 2.39 (1733) -3.57% 1.35 1.40 (4129) 7.17% 3.44 3.21 (1729) 29.78% 5.23 4.03 (1565) 21.07% 3.16 2.61 (4106 96 12 27 (4125) 8.93% 1.22 1.12 (3373) 15.10% 3.43 2.98 (4121) 1.59% 7.67 7.55 (4103) 8.72% 2.12 1.95 (1781) / (%) 2008Q1 2007Q1 %

48 2008 20081~2 1~2 % 19018-29021- IEK (2008/05)

2009 BOOTS 20072008 2008 GlucoSure Voice FDA 510KK073137 (IR- SoC)ODMBeurerLutterSamsung MastercoolCPL SPX IEK 49

() 54% (FDA)20062007 1Invacare2008 52007 28%200830% 6 CE () CE 14 50

2008 IEK -ITIS(2008/05) 51

ODM/OEM OTC 52

2006 56.80.73% 1,832 14.7 ITRI-IEK (2006) XMRI 53

-TEMPOL 1. Technology 2. Expansion 3. Motivation 4. Profit() 5. Opportunity 6. Leverage (TEMPOL) 54

() 55

_ Technology Expansion Motivation Opportunity Profit (Technology) (Expansion) 1980(Technology) 1995(Motivation) PVC(Oppurtunity) (Expansion) 56

_ Technology Expansion Motivation Opportunity Leverage Opportunity (Technology) 2005CooperOcular 57

_ Technology () Expansion Motivation Motivation Profit 58

59 _ HDPE HDPE

( ) Baxter( ) ( ) ( ) ( ) ( ) ( ) ( IVD ) Biomet ( ) Zimmer( ) ( ) ( ) ( ) ( ) OMRON( ) ( ) ( ) ( ) ( ) -60% -40% -20% 0% 20% 40% 60% 80% 100% 60

1,200.0 1,000.0 A B C D E F 800.0 600.0 400.0 200.0 0.0-100,000.0 0.0 100,000.0 200,000.0 300,000.0 400,000.0 500,000.0 600,000.0 700,000.0 800,000.0-200.0 () 61

100 2,300 62

() 64

ODM/OEM 65

1-2 ITRIY.D.Cheng 2007) 66

() HEMA() LED IEK 67

() 68