...1...3...3 (1)...3 (2)...5 (3)...6 (4)...7...9 (1)...9 (2)...10 (3)...13 (4) 14 (5)...15...16 (1)...16 (2)...19...21 (1)...21 (2)...22 (3)...24...26...26 (1)...26 (2)...28 (3)...30 (4)...31 (5)...35 (6)...38 (7)...40...43 (1)...43 (2)...44 (3)...45...46 (1)...46 (2)...47 (3)...52...54 (1)...54 (2)...56...60...63...63 (1)...63 (2)...64 (3)...69 (4)...70 (5)...76...77 (1)...79 (2)...82 (3)...84 (4)...85 (5)...87...88...90...90 (1)...90 (2) OEM..91 (3)...92 (4)...92 (5)...93 (6)...94...95..98...98...99 (1)...99 (2)...105 (3)...112 (4)...118 (5)...126 (6)...128 (7)...133 (8)...134 (9)...137..138 (1)...138 (2)...140 (3)...140 (4)...141 (5)...142 (6)...143...146...149...167
1
2
2000 1.91 2001 1.89 1990 1.26 10 2 7.2 1.4 2.0 2.4 2.8 2002 7 12 1.5 2001 1 2000 2002 1.8 2000 2001 3
42 26 15 8 36 19 10 65 2000 Eucomed EU EU GDP 5.7 13.9 7.1 66 125 116 Medical Devices Experts Group, Report On The Functioning of The Medical Devices Directive: Final report 05-06-2002 corr 1. EU 4
2000 30.4 7.98 1.89 6 1984 15 16 2000 30 1999 2000 2000 GDP 1990 1980 1979 1994 6 1999 8.1 2000 7.98 8 2001 1.89 1984 9,200 2.2 1984 =100 5
1960 1970 1990 1961 1960 1970 1960 1980 6
7 1990 1990 1999 65 10 3,909 3564 337 17 2010 23 2020 28
1990 20.6 30.4 4.0 OECD 2000 GDP 13.0 10.7 10.6 9.5 7.8 OECD 8.0 2010 2.32.8 2000 1.9 8
10 9
10 1980 2000 30.5 16.1 14.9 10.0 4.5 6.1 6.4 27 2000
11 1986 1999 1970 80 90 95 2000 0.0 1.4 2.6 4.7 9.2 1988 1985 1988 1
1980 1990 1990 1990 1990 1960 1970 1980 1990 1990 1970 1961 1980 1980 (2) 12
) 1980 1990 120 50 60 1993 30 14 17 14 (2)(3) ) 20 5 13
MRI CT 63 4 6 15 2 14
15 1951 1958 1971 1987 1998
16 1999 2001 1.89 117,309 1,614 29.4 24.6 20.3
25.6 2001 100 3,843 20.3% 3,589 19.0 2,712 14.3 1,454 7.7 17
18
1,051 5.6% 176 0.9% 300 100200 64.2 1990 1.26 2001 1.89 10 6,300 50 1999 1988 1998 10 19
20 1988 1998
1950 1951 1950 1960 70 1958 1962 1950 1960 1960 1970 1980 1972 EMI CT 1978 MRI CT MRI PET CT MRI 5 (*) 1985 1995 1995 2001 2002 21
1940 50 '50 '51 '58 ME 1960 '62 70 '72 CT 1970 '74 PTCA 80 '78 MRI 1980 '85 87 90 IVR PET ESWL DDS 2001 IVR DDS 22
1970 1.7 3.5 1990 IVR 1929 1953 1964 IVR PTA 1974 PTCA 1985 2002 1950 23
1957 1968 1987 1990 40 10 IVR 24
25 a) b) c)dds d) e) f) g) h) i) QOL 2001 DDS
2000 2,576 53,338 1 4,358 1997 5,388 300,138 548 120 6 5,760 2.1 5.6 4.6 5 4.5 6.4 25.5 12.9 2.2 29.8 26
27
1995 2000 2,286 2,349 1,169 1,218 96,604 90,176 2000 2,349 2,576 3 37.8 49 32.7 200 42 1.6 4 33.6 59 17.4 250 5.4 EU medical technology business entities 50 70 250 94 Eucomed 28
29
2000 1,580 1,487 93 1,020 259 301 56 2 1.6 5 30
Medical Device & Diagnostic Industry 40 19 25 31
CT 32
1 () X CT MRI 2 ()MRI CT X X TV 3 () CT X TV 4 () X X X X II X TV X X X X ECT CT 5 () X X X 6 X CT X / C () IT MR 7 X CT MRI () X 8 X X CT () X TV X X ECT CT 9 COMPUTED RADIOGRAPHYCR X () 10 () 11 () 12 () 13 () 14 () 15 () 16 () 17 () 18 () 19 () 20 () 33
21 () 22 () 23 () 24 () 25 () 26 () 27 () 28 () 29 () 30 () 31 () 32 () 33 () 34 () 35 () 36 () 37 () 38 () 39 () 40 () 41 () 42 () 43 () 44 () CT 45 () 46 () 47 () 48 () 49 () 50 () 2000 34
5000 1,006 63.7 35
36 2000 2000
2000 37
22.2 10 2 500 10 3 1 1.5 2000 3.79 4.04 50 50 38
19971999 (4) 39
40
41
42
2001 1 8,932 8,363 44.2 1985 2122 15 1990 2001 1 5,170 3,975 26.2 15 2025 1990 43
32 105 49 1999 44
10 774 872 1990 1990 5,273 63.1 6 1,790 21.4 859 10.3 5 2001 45
15 2 4 46
47 (*) 2000
48
49
1,700 1,000 90 IVR 42 1992 1.000 100 50
95 MRI 1980 90 90 1970 51
(3) 52
53
54 12.1 19.122.4 29.4 12.5
12.1 22.4 29.4 19.1 1997 33.8 39.8 21.8 6.8 9.8 5,712 2,894 50.7 2,762 48.4 55
PTCA (*) (**) 1985 1990 (*) 11 (**) 14 8 56
1980 1990 1990 57
58
59 4 4 1997 4 3 5 2002 4 1.3
12 1.5 0.3 0.8 6 8 1.35 ODA 60
(a) BECON (b) (c) NIH 12 4 BECON (*) METIS (*) Bioengineering Consortium 1997 NIH 61
62
63 1) 2) 3) 4) 5) 6) GMP 7) 8)
64 9) 10) PL PL 11) 12) 3) 9) 2) 10) 11) 12) 14
MRI GCP GMP GPMSP GCP GMP GPMSP 65
1 34 1.0 3 0.5 0.1 2.0 *1 5 1.01.5 0.2 PTCA 1.0 0.5 1 *1 14 8 2 FDA 2002 4 66
12 GMP GPMSP 67
68
1994 2001 1992 FDA 1998 BAA 69
70 GDP 8 30 10 14 5,500 35
71 10 250 270 59 74 70 25 14 1,668 1,216452 20 155 20 200 10 7 716 493+223 650 3,800 8,000 28 32 3,600 1,140 85 148 1,660 9 6 81 155 1,400 660 660 390 340 392 1,630 9,600 7,470 63,700 20,500 19,900 500 800 2 5,930 110 1,920 14
1.3 1.4 2.7 25 21 20 17 180 85 15 18 110 70 18 FDG 7,500 655 620 1,660 1,140 (2)) 14 14 1,490,000 263,000 338,000 14 4.112.31 1,420,000 239,000 331,000 15 1.112.31 1,360,000 218,000 328,000 1,310,000 213,000 324,000 5 9 24 72
C2 73
74,700 74
GDP 10 1983 (*) (**) 1989 14 25 21 14 (*) Diagnosis Related Group / Prospective Payment System 500 DRG (**) DRG/PPS 9.6 7.4 2 2000 75
1991 76
24 77
No 1 19 3,000 2 108 3 200 No 4 1975 300499 5 1871 300499 6 1948 1,000 7 1965 1,000 8 1976 1029 9 1984 1029 10 G 1999 1029 11 1992 3049 12 1986 1029 No 13 1976 10 14 I 1960 5099 1996 15 1969 10 1980 16 1939 500999 1995 1999 17 1953 300499 1994 18 1970 1029 1994 No 19 2000 1029 3PL 20 1947 1029 21 1996 100299 No 22 200300 PTCA 750 23 24 78
(5) QOL 79
TLO 80
81
10 34 45 82
2 2 4 2 6 1 OEM 83
M&A 100 84
100 10 1 3)5) 1 3) 5) 1) 1 2) 1 3) OEM 4 4) 1 5) 4 6) 1 5) 5) 6) 1)2) 85
86 1 OEM 1 1
2 1 30 87
1) 2) 3) 4)PL FDA 88
14 8 89
OEM (4) 2002 9 10 3 90
OEM OEM OEM OEM OEM 91
92
93
94
1 6,500 5 7 2002 4 18 OEM 1999 11 50 400 1 95
1970 45 28 2,000 6 2 2001 1986 61 2 96
2 122 4 5 2001 27 (4) (1) 97