生醫手冊-連結版.pdf

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2 新竹生醫園區生醫產業研發成果展摘要目錄點選欲閱讀之標題, 可直接連結至該頁面科學工業園區管理局新竹生物醫學園區辦公室...2 新竹生物醫學園區開創產業聚落新價值... 2 生醫園區資訊系統服務機能... 2 生醫產業諮詢服務... 3 行政院國家科學委員會...4 生技醫藥國家型科技計畫... 5 智慧電子國家型科技計畫... 6 醫療器材跨部會發展方案計畫... 7 財團法人國家實驗研究院...8 可程式化皮膚影像檢視分析系統手持式螢光生命週期顯微影像儀膚質照妖鏡 - 智慧型手機皮膚品質檢測器無電池式脈衝射頻電刺激 (PRF stimulation ) 止痛植入系統遠距健康照護之即時心臟狀態監測及警示系統 15 聖母峰即時心電圖遠距傳輸 - 世界的第一次愛相隨生醫行動照護系統新竹雲端健康城市脈得多睡眠品質腦波分析儀具動態學習心肺復健健康顧問系統之 A+Care 無線心電圖機高能超音波結合磁振造影 - 新世代癌腫瘤治療系統磁振影像導引聚焦超音波 (MR-HIFU) 治療系統原型機數位控制式奈米磁粒熱療高週波加熱器世代磁振造影寬頻磁共振造影技術脊椎手術用 CT 影像輔助導航系統骨科手術用 C 臂影像輔助導航系統中風患者復健用之智慧型功能性電刺激系統智慧型輕量化載具財團法人工業技術研究院...34 具適應性訊號處理之無線心電圖機居家睡眠檢測儀睡眠與心血管疾病風險監控技術可攜式負壓輔助睡眠呼吸照護系統微型手持式肌力計光學斷層掃描大腸鏡系統曲式咽喉鏡可拋棄及抽換的內視鏡穿戴式先進創傷照護系統定點照護微血檢測儀生物電子鼻兩相骨關節修復技術微創脊椎融合固定產品創新醫療器材開發與法規評估方案科學園區廠商...47 普生股份有限公司揚泰光電股份有限公司五鼎生物技術股份有限公司晶宇生物科技實業股份有限公司永昕生物醫藥股份有限公司國璽幹細胞應用技術 ( 股 ) 公司百丹特生醫 ( 股 ) 公司聯合骨科器材 ( 股 ) 公司台灣先進手術醫療器材 ( 股 ) 公司錫安生技 ( 股 ) 公司聲博科技 ( 股 ) 公司茂傑產業股份有限公司

3 , / m / m ~4.26 ( ) 7~11 ( ) 50 ( ) (03) (03) Hsinchu Biomedical Science Park Office Address No.16, Sec. 2, shengyi Rd., Zhubei City, Hsinchu County 302, Taiwan, R.O.C. Tel Fax hbmsp@sipa.gov.tw http //

4 SSO (03) (03)

5 (critical mass) 4

6 National Research Program for Biopharmaceuticals, NRPB / / / / value identification value creation / / / 5

7 MG+4C IC IC MG+4C IC IC 3D IC 6

8 ( ( ) market-driven medical need 7

9 8

10 AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International, AAALAC International) AAALAC (Full Accreditation) 1965 AAALAC AAALAC AAALAC 2007 AAALAC 2008 AAALAC AAALAC AAALAC AAALAC AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International) AAALAC AAALAC (ACP) 1965 AAALAC AAALAC 1996AAALAC AAALAC International AAALAC AAALAC AAALAC 9

11 ( ) 95 ( ) 98 10

12 11

14 - 1,500 13

NeuroPace NeoStim Trifectas Medical (neurostimulator) (neuromodulator)

15 (PRF stimulation) (Dorsal root ganglion, DRG) ( ) (guiding needle) PRF: ( ) (nociceptive pain) Failed back surgery syndrome 2010 : NeuroPace NeoStim Trifectas Medical (neurostimulator) (neuromodulator) ( ) million USD 14% billion USD Control PRF C-fiber 14

16 SoC Frost&Sullivan % / 5% 2000 Johnston, Wheeler, Deuser 1,948 2,674 (Cardiovascular Disease, CVD) ( 1700 ) followup POCT(Point Of Care Testing) (Electrocardiogram, ECG) (Bedside Monitor) SoC 15

17 (VF) AF VF ROC SoC Patent Number Date Country /11/02 TW 11/967, /12/31 US /09/23 TW 12/350, /1/8 US 16

18 --- () ( ) 5% K220%

camp A x x 220 - age baropressure at summit FiO2 at summit = measured resting heart rate at

19 342009/5/18 (7854 ) 38 (8848 ) ( 150/min) 2009 Estimated percentage of Resting age-related Heart Rate at Summit = measured resting heart rate at camp A baropressure at camp A FiO2 at camp A x x age baropressure at summit FiO2 at summit = measured resting heart rate at camp A altitude at summit FiO2 at camp A x x age altitude at camp A FiO2 at summit 18

20 I-tracker mobile care system SOS Juniper Research, TRI(2008) IEK(2008) ( ) 19

21 - (i236)

22 Mindo EEG-Based Sleep Quality Analyzer EEG Headband % 22.9% 14.4% 40.07% 93.8% ECG 65 ECG ECG 98 2,457,648 (a) (b) ,206 (a)*(b) 20% ECG ECG $72,000 ECG 307,206 * 20% * $72,000 = $4,423,766,400 ( ) B2B2C ECG ,000 5 ECG166,000 * 5% = 8,300ECG 57, ,080,000 ( ) 4,406,384,563 21

23 2(2 channel EEG)- - (Complementary Metal-Oxide-Semiconductor, CMOS)(AFE) Digital signal processing (DSP) (Open Multimedia Application Platform, OMAP) DSP OMAP A+Care A+Care Wireless ECG Holter with Intelligent Cardio- Pulmonary Rehabilitation Consultant System (1) (2) (3) 22

50 (b) 98 307,206 (a)*(b) 20% ECG ECG $72,000 ECG 307,206 * 20% *

24 % 22.9% 14.4% 40.07% 93.8% ECG 65 ECG ECG 98 2,457,648 (a) (b) ,206 (a)*(b) 20% ECG ECG $72,000 ECG 307,206 * 20% * $72,000 = $4,423,766,400 ( ) B2B2C ECG ,000 5 ECG166,000 * 5% = 8,300ECG 57, ,080,000 ( ) 4,406,384,563 (1) (1) (2) : (1) (2) (3) 23

25 - - (a) (55 ) (b) (43-46 ) (c) (a) (b) (c) (d) 4-element (Cheng, TY et al., Medical Physics, 2008.) (a) (b) (c) (a) X-Y (b) X-Z (Lin, CY et al., Journal of Controlled Release, 2010.) 24

26 (Doxil[6mg/kg]+MB+US) (Tseng HC et al., ISTU 2011) (Doxil[6mg/kg]+MB+US) (Tseng HC et al., ISTU 2011) 25

27 (MR-HIFU) (HIFU) ( ) (MRI) GE FDA : (a) MRI (b) (c) : (z ) 6 (14 20 )(a) (x ) 6 (b) : DCIS ( ) MRI MRI HIFU

28 (a) (b) (c) (a) (b) (c) (a) (b) (a) (z ) (b)(x ) (a) (b) 27

29 42 (1) (2) (3) LC 28 ( )

30 Next Generation MRI (I) Wideband MRI 2~8,

31 CT Pedicle Screw (CT) (MRI) CT CT (Registration) (CT/MRI/US) () 3. 30

32 C C-arm X- X- C-arm C-armC-arm X- C-armC-arm C-arm, CT 3. CT/MRI C-arm (Registration) CT/MRIC-arm

33 30 (FES cycling) % ( 50,000 * 3 * 200% = 3 12 ) 35,000 10% 3.5 ( FES 50,000 * 35,000 * 10% * 200% = 3.5 ) 32

34 (1) -- (2) --- (3) (1,2,3) (4) (5) (6) 33

35 HHT ITRI HHT HHT ITRI 34 HHT based filter

36 / (Apnea Hypopnea Index, AHI) 1. AHI 2. PSG

37 90% 45 36

38 USB IRL 37

39 38

40 Class-II Medical Device (RPC, Rapid Prototyping service Center)

41 3.9mm 40

42 15%

43 all in one 5 l % ICT

(peptide) 198 93 (on site monitoring) 98

44 (peptide) (on site monitoring) OEM ODM 5 16 SCI Journal Sensors and Actuators B (2001) SCI Journal Sensors and Actuators B in press (2010) 43

45 30~

46 PEEK PLGA Spin-off 45

(Food and Drug Administration, FDA) (The Critical Path to Medical Products, Section 603 of the Food and Drug Administration Amendments of 2007) CDRH(CDRH Medical Devices Innovation Initiative,

47 (Food and Drug Administration, FDA) (The Critical Path to Medical Products, Section 603 of the Food and Drug Administration Amendments of 2007) CDRH(CDRH Medical Devices Innovation Initiative, February 2011) (Innovative Medicines Initiative) SRI International University of Arizona C-Path Institute [ FDA CDRH (CDRH Medical Devices Innovation Initiative White Paper, February 2011)] 46

48 A. (1) A (HAV), B (HBV), C (HCV) (2) (HIV) (3) (AFP), (CEA), (CA125, CA153, CA199), (PSA) B. PCR (1)B (2)C 1. PCR 2. (1) (2) (3)PCR (ELISA plate) 47

49 48 3. (1) (2) (3) (4) (5) OEM( ) ODM( ) % 29% 100% 8 / 18, C cgmp T ISO IVD HBVPCR C V HBVPCR

C B (SNP) 058179 050226 US 2004/0191776 A1 200418991, 200819542, 200819543 CN 1995982A 200418990 US

50 C B (SNP) US 2004/ A , , CN A US 2004/ A1 Preventing Therapy & GBC Liver Care Center HBV, HCV BioFibroScore TM AFP Screening B /C Monitoring 49

51 (High frequency ultrasound imaging system) (Panoview 1500),, (Real-time), 30, (PC-based) (Software-based),. (Pre-clinical) (Small animal imaging),,,,, (color Doppler), (Contrast mode),, (Pre-clinical) (Small animal imaging) Frost & Sullivan 9 %20% ( Visualsonics Sonosite),, (Compactness) (Mobility),, SAFT Coded excitation., 2010 (Memorandum of Understanding) (Pilot sales stage). 50

B-mode (Brightness-Mode) Displays the object under examination, with the

M-mode (Motion-Mode) Displays the motion of tissue detected by one line

estimation at a specific scan line as a function of time.

In both modes, blood flow information is measured and color-coded.

inflammation, and quantification of mocrovascular structure using

52 B-mode (Brightness-Mode) Displays the object under examination, with the graylevel representing the intensitiesof echo signals. M-mode (Motion-Mode) Displays the motion of tissue detected by one line in the B-Mode image over time and is commonly used in the cardiovascular related research. PW Doppler Mode (Pulased-wave Doppler Mode) Displays the velocity estimation at a specific scan line as a function of time. Doppler Mode Provides two modes: color Doppler and power Doppler mode. In both modes, blood flow information is measured and color-coded. Contrast Mode Offers the ability to image tumor angiogenesis, inflammation, and quantification of mocrovascular structure using targeted contrast agents. 3D Imaging Mode Provides an automatic scanning stage for 3D image acquisitions. The developed 3D image reconstruction alorithm is specifically optimized for tumor research. 51

53 Cardiovasular Using PW Doppler Mode to measure the flow velocity of aorta. Using Color Doppler Mode to observe the bifurcation of carotid arteries. Cancer Research Using 3D scanning to acquire and measure tumor sizes. Using Contrast Mode to mark vascular angiogenesis inside tumors. Abdomen Research Embryo Research Mouse liver image under B mode. Using Color Doppler mode to observe flow directions of hepatic vessd and abdomen aorta for mice. Opthalmology Real-time embryo imaging Mouse eyeballs is detected with velocity profiles in retinal vein and arterv. 52

54 1997 FDA510(K) APEX 1.Acuity 2.Partnership 3.Evolution 4.Expension GlucoSure Plus / 10 / 92 95AgriPro 15 A1C 53

55 GMP FDA CE0197 ISO ISO GlucoSure / GC / 54

56 1985 Model sensorex Touch In Plus 2002 MultiSure 55

57 ~ 2008 Forbes Asia Best Under A Billion Frost and Sullivan 2008 Alc Xpress 56

58 87 10DR. CHIP - (Devote) (Revolution) (Customer)(Humanity) (Innovation) (Promise) - TOTAL SLOUTION % % % % % (CNS 15330) ( ) 57

59 cgmp 15 90% TuNEX 58

60 ( ) / 98 59

61 60

62 ( ) Biodenta System 1. Dental Implant System 2. Prosthetics 3. DentaSwiss Concept 4. Services (Biodenta Corporation) (Biodenta) (Biodenta Corporation) For further information please visit our website 61

We project the dental CAD/CAM prosthetics market to grow 13 fold from

63 We project the dental market to grow 9 fold from USD 3 bn today to USD 26.9 dn in 2040, a CAGR of 7.3% over three decades. We project the dental CAD/CAM prosthetics market to grow 13 fold from USD 900 mn today to USD 11.8 bn in 2040, a CAGR of 8% over three dacades. Biodanta Structure 62

64 Solution Provider Concept Biodenta Implant System Prosthtics CAD / CAM DDL Certificates 63

65 ( ) ( ) : (A) : (B) PSA : Revision FDA CE (C) : , , FDA 40%

66 (a) (b) (c) (a) : (b) (c) Femoral screw Femur #1~#5 Insert 9~25mm Straight Stem 75,100 mm Femoral Augment #1~#5 Offset Adapter 2,4,6 mm Tibial Baseplate #1~#6 Curve Stem 150 mm Tibial Augment #1~#6 PSA 65

67 ( ) (Endoscopic Multifire Clip Applier) (Surgical Clip) (Class II) (Implantable) ICT ICT 66

68 ( ) (Proton Stereotactic surgery, PSRS) (proton synchrotron) (proton beam scanning system) (robot chair for proton therapy) / / 3D 67

69 68

70 ( ) CE0197 FDA510(K) GMP (GOST-R) (ANVISA) : 0.25mm ( )

71 X (Panoramic X-Ray System) X (Intraoral X-Ray System) (Dental CT Dental Computed Tomography) / 70

2015 DMS Parents’ Day 國立清華大學醫學科學系新生家長日

2015 DMS Parents’ Day 國立清華大學醫學科學系新生家長日 2015 DMS Parents Day 國立清華大學醫學科學系新生家長日系主任莊永仁 2015/09/06 為何要來唸清華? 按讚清華大學的十個理由 1. 學術表現, 以師均數計臺灣第一 2. 國際交流 - 出國人數除以總人數平均, 為最容易出國交換學生的