COMPANY PROFILE. TaiDoc Technology Corporation

Transcription

1 TaiDoc Technology Corporation B1-7F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan Tel: Fax: COMPANY PROFILE TD201610A-01

2 Company Profile Over the last decade, TaiDoc has been dedicating to manufacturing and marketing premium medical devices to improve people s health and the quality of life. TaiDoc is now one of the top healthcare products manufacturers in 2010, Taidoc become the listed company tw: 4736 in Taiwan. We focus on providing complete solutions covering Diagnostics, Home Care, Professional Instrument and TeleHealth System. Moving forward in a demanding and dynamic business environment, TaiDoc projects itself as a world-class healthcare solution provider in the future Establishment of TaiDoc Founded by Dr. C. W. Chen, TaiDoc was a medical IC design & medical device solution providing company Expanded into the Biochemical Field Built up the Biochemical R&D team and blood glucose strip manufacturing facility. Manufacturing with World Class Quality System Built up the first manufacturing facility and pass the audit of ISO, QSR related quality regulation Vertical Integration Built up the second factory in Nan-Kan, Taiwan. For Mold Tooling & Plastic Injection. Market Around the World Increasing on global market share and had become a significant player at global market level Professional Instrument Division TaiDoc successfully launched V-TRUST Professional Instrument products Multiple parameter monitoring system Develop meters for multiple parameters measurement: Glucose, Hematocrit, HbA1c, Ketone, Uric acid, Cholesterol, Hemoglobin, Lactate. Development of 4 Product Lines Focused on 4 core technologies and developed 4 product lines. Public Limited Company 4736 (TPE) TaiDoc has been listed as a public company in Taiwan Stock Exchange Corporation. Diagnostics Professional Home Care TeleHealth 02 03

3 Core Values Mission TaiDoc aims to obtain the world-class reputation on R&D and manufacturing by Partnership The connection established on long-term mutual trust and collaboration to grow further. successive innovation and integration. Thus, becoming the best medical device manufacturer worldwide and leading Taiwanese healthcare industry towards the top world class, are the commitment to our clients. Partnership Commitment The complete devotion to Innovation The driving force that meet clients needs as bring various aspects from Our Vision respectful promises. Commitment Innovation technology, management, manufacturing and To be the leading medical product supplier in Taiwan. business strategy. To be one of the top 5 suppliers for blood glucose monitoring system in global biotech market. Integrity Integrity The foundation being honest as according to our values, beliefs and principles

4 Organization Chart Factories President Mike C.W. Chen Electronics Factory Biochemistry Factory General Manager Mike C.W. Chen Molding & Plastic Injection Facility Strip Printing Facility Quality Assurance Dept. Electronic QA Biochemical QA Electronic R&D Taipei Factory TaoYuan Factory Research & Development Dept. Biochemical R&D Business Development Dept. Regulation & Projects International Sales Dept. Sales Team Administration Dept. Marketing & Planning Customer Service World-Class Quality Assurance Being a quality oriented company, TaiDoc offers a best-in-class, worldwide medical device quality management system that enables the company to meet stringent quality and process controls. Taipei Factory Device production and assembly lines unit Biosensor packing house TaoYuan Factory High precision automated molding facilities Plastic injection for device housings facilities Strips manufacturing facilities TaiDoc's Quality System Control Center was established in 2003, which is combined of 5 different divisions: Document Control Center, Auditing Section, Medical System Section, Complaint Handling Unit, and Return Merchandise Authorization. TaiDoc s Quality System Certificates» ISO 9001: 2008» ISO 13485: 2003» GMP» QSR Compliance» CMDCAS» Medical Device Directive 93/42/EEC» In Vitro Diagnostic Medical Device Directive 98/79/EC 06 07

5 Manufacturing Capacity Product Certificates Pulse Oximeter Thermometer Nebulizer BP Meter BG Meter Test Strip 4.5K 22K 52K 63K 176K 2,200K boxes (50 strips/box) FDA 510(K) Clearance 2-in-1 Blood Glucose plus Blood Pressure Monitoring Systems Multi-Parameter Spot-Check Monitor Health Canada Approval CFDA Approval 2-in-1 Blood Glucose plus Blood Pressure Monitoring Systems PMDA Approval Test Strips CE Mark 2-in-1 Blood Glucose plus Blood Pressure Monitoring Systems Blood Glucose plus ß-Ketone Monitoring Systems ß-Ketone Monitoring Systems Multiple Parameter Monitoring System Test Strips Control Solution Lancing Device with Sterile Blood Lancet Ultrasonic Nebulizer ECG Recorder Vital Sign Monitor ANVISA & INMETRO Approval Test Strips COFEPRIS Approval One Shift / Per Month KFDA Approval Test Strips DIGEMID Approval TFDA Approval 2-in-1 Blood Glucose plus Blood Pressure Monitoring Systems Lancing Device with Sterile Blood Lancet Ultrasonic Nebulizer ECG Recorder Vital Sign Monitor 08 09

6 R&D Capability To pursue and dedicate for excellency, TaiDoc never stop its aim and vision. By developing a strong R&D structure, TaiDoc provides with full service in regulatory professionals, clinical suggestions, engineering resources and certified manufacturing system. Through these services, we are able to shorten the lead-time of product launch at low cost while maintaining high quality. Moreover, complete control and management of the in-house procedures allows our customer to keep track of their project anytime. Comprehensive Solutions Our comprehensive capability can commercialize your idea from scratch Tooling Design Mechanical Design Through the comprehensive capabilities, TaiDoc is able to thrive for many years and continued to prove itself a world class leading manufacturer in the medical device industry. Industrial Design PCBA Fabrication Human Resource Regulation Compliance With more than 600 employees, TaiDoc has been investing over 5% of its annual sales revenue in continuous research, development and improvement. Our R&D team takes up approximately 20% of the total human resources. 20% 12% Business Developmemt Dept. 48% Production Dept. Bio-sensor Development 7% 6% 7% 12% 48% 20% R&D Dept. 7% Administration Dept. 6% International Sales Dept. 7% Quality Assurance Art Design Contract Manufacturing Software Programming R&D Structure R&D Department Industrial Design Electronic Engineering Biochemical Research Software Artwork Design Regulatory Affairs Industrial Design Mechanical Diagnostic and TeleHealth Product Home Care and Professional Instrument Patent Regulatory Affairs Clinical Program Document Control Center 10 11

7 Cutting Edge Technology 2+2 Bio Signal 2+2 technology Patent No.: TW I440853/CN /DE Patents: Core Technology Blood Glucose Meter 19 Blood Glucose Strip 27 Medical Electronics Based on the advanced electronics and IT capability in Taiwan, TaiDoc develops minimized and user-friendly medical devices. Biosensor TaiDoc provides accurate quantitative results in terms of test strips and cartridges for bio-signal detection. Blood Pressure Monitor 23 IR Thermometer 26 Nebulizer 10 Telemedicine 9 Other 35 TaiDoc is dedicated to the development of unique technology and currently holding 149 worldwide for IR thermometer, blood glucose meter, test strip, cardiovascular care products and other medical related applications. TaiDoc focuses on 4 core technologies - Medical Electronics, Biosensor, Photometry and Software programming. We utilize our core technologies to develop products in Diagnostics, Home Care, Professional Instrument and TeleHealth. What is Hematocrit(HCT)? Hematocrit (HCT) is the percentage of the red blood cells in your blood. The higher HCT level will lead to a lower blood glucose result, and the lower HCT level will lead to a higher blood glucose result. Hematocrit (HCT) level varies between individuals, the normal HCT level for Adult Male 42% - 54% Adult Female 38% - 46% Kidney Dialysis Patients > 33% - 36% Benefits of the Technology TaiDoc patented (HCT Interference Compensation; 2 enzymes plus 2 signals) technology uses two different wales on the strips to detect HCT value by AC signal and glucose value by DC signal. Utilizing AC signal to calculate the hematocrit value in order to compensate the correct value from a small volume, fast and accurate test. Utilizing DC signal to calculate the glucose value. Hematocrit <55% AC DC Plasma White Blood Cell Red Blood Cell Hematocrit >55% 100% 75% 50% 25% 0% Photometry TaiDoc employs Photometric technology Feature AC DC to develop devices for qualitative and quantitative measurement. AC Software TaiDoc develops the vertical software integration DC to link personal health data with smart phone application and telehealth system. Microprocessor (16 bit / 8 MIPS) 12 13

8 Xper Technology Medication Cup Technology Patent No: CN / DE Xper is a cutting edge technology not only combining with biosensor and biomedical technology, but also integrates with our latest material science technology- The ring structure design in the medication cup can shorten the AIR FLOW AEROSOL PARTICLE Stable material: 99.9% Gold Bricks nebulization process and further Sputtering coating membrane for steady resistance enhance the nebulization efficiency. Laser cutting for precise reaction area Through the combination of this technology and TaiDoc air compressor, we offer high nebulization efficiency without Dual filter mechanism to filter out the small particles Air inlet enhances the air flow increasing the noise interference and the size of pump. The ring structure shorten the nebulization process, enhance the nebulization efficiency Compressor air Material Science Ultrasonic Mesh Technology Aerosol Particles Biosensor Biomedical Ultrasonic Vibration Mesh: Micro-nozzle Plate Micro-electroforming (<3µm) Piezoelectric Actuator To provide a miniature ultrasonic nebulizer with less noise, minimized drug waste, and also eliminate the heating issue, ultrasonic mesh technology utilizes lower-frequency waves to force liquid medications through multiple apertures in a mesh to generate aerosol

9 Infrared Sensor Technology Cardiovascular Evaluation Technology Patent No.: : TW I / US Taidoc develops infrared thermometer which has the ability to measure temperature from a distance without minimizing accuracy. This technology is characterized by specifications of accuracy, angular coverage and 8 9 safety concerns. Bluetooth Smart Technology TaiDoc offers different types of devices with Bluetooth Smart Technology. This technology enables low power consumption communications at a longer working distance. Smartphone APP can capture and analyze the signal from semiconductor sensor on the blood pressure monitor. Our smartphone App can give the indications of high risk factors- Fast Heartbeats Slow Heartbeats Irregular Heartbeats Atrial Fibrillation Cardiovascular Evaluation 16 17

10 Product Portfolio Diagnostics Base on electrochemistry and photometry technology, TaiDoc diagnostics line provides meters for multiple parameters measurement- TeleHealth TaiDoc TeleHealth System provides devices and multiple App parameters: blood glucose, blood pressure, thermometer, oxygen saturation and weight- Professional TaiDoc Professional line provides accurate measurement results for following instruments- Hemoglobin A1c Uric Acid Hemoglobin Glucose Ketone Cholesterol Lactate Vital Sign Monitor Handheld ECG Monitor Pulse Oximeter Home Care TaiDoc design Home Care medical device with compact size, low noise, and easy operation- Nebulizers Thermometers Blood Pressure Monitors 2-in-1 Blood Glucose and Blood Pressure Monitors Blood Glucose Blood Pressure Mobile Network (GPRS/GSM) Cloud Server Traveling Home use Portable design Pulse Oximeter Thermometer Weight Scale Smart Phone 18 19

11