WhaleTeq Co., Ltd Company Profile and Introduction

Transcription

1 The Accurate and Com pliant Test Solution Provider WhaleTeq Co., Ltd Company Profile and Introduction

2 Content About WhaleTeq Co., Ltd Global Customers Core Competences Vision Test Solutions Test System Software and Service Product Development Goal Product Planning and Applications Challenges in Product Development Product Development Target Vital Sign Simulator Product Value Test Recommendations WhaleTeq Innovation Statement ECG Algorithm Verification PWTT Measure and Applications

3 About WhaleTeq Co., Ltd The Accurate and Compliant Test Solution Provider We design, produce, and sell test tools and solutions for medical devices. Founded by a team of experts specialized in test equipment and medical certification, WhaleTeq strives to produce simple, accurate, and compliant test solutions to help clients save time, improve product quality, and go to market more efficiently. WhaleTeq has been working on ECG standard testing tools and solutions for years, offering test solutions to leading medical device manufacturers and test labs from over 30 countries.

4 Global Customers 300+ Customers Worldwide Since 2013, more than 400 clients from 30 countries, whose domains include healthcare equipment manufacturer, OBMs and related certification laboratories, have adopted test solutions from WhaleTeq.

5 Global Customers New Customers Across Industries IC Designers EMS/ODMs/OEMs Brand Owners

6 WhaleTeq Core Competencies Profession and Customer Service An Expert Team with Various Specialties New Business Model to Fulfill Customer Needs Talents across four domains Knowledge about international standards and regulations for medical devices Integration capabilities of software and hardware Managing experiences from global testing instrument manufacturer Familiarity with medical device industry Collaboration with Worldwide Customers We keep working on ECG test field and already have 300+ clients from over 30 countries, including leading global medical device manufacturers and certification labs. Especially, adoption from noted labs had direct effect on vendor's choice of WhaleTeq testers. Innovative Business Model Being the first one to integrate test requirements of international medical standards into test equipment as effective and time-saving test solutions for medical devices. Fulfill Customer Needs Clearly illustrates purpose, meaning, theory and method of test clause that are subject to standards and regulations, to help clients improve product quality. Provide completed test solutions for medical device verification, including product development, quality assurance, and clinical trials.

7 WhaleTeq Vision Empower Executive Mission and Values Reduce customer time to market Values Mission Popularity of medical devices drives Preventive Medicine to happen Vision Lower the entry barrier to launch medical devices

8 WhaleTeq Test Solution For Medical and Healthcare Devices 9

9 Test System Test Equipment Controlled by PC Software ECG SECG 4.0 MECG 2.0 CMRR 2.0 / CMRR 3.0 AECG100 EEG PPG SEEG100 HRS200 HRS100+ ECG, PPG and PWTT AECG100 ECG Performance Tester ECG Database Player Common Mode Rejection Ratio Tester Common Mode Rejection Ratio Tester Advanced Heart Rate Simulator EEG Performance Tester ECG, PPG and PWTT Multifunction Generator Heart Rate Simulator

10 Software and Service Exclusive Design to Increase Efficiency Assistant Software Pack Enhancement software pack for SECG 4.0, SEEG 100, CMRR 3.0 Simplify medical standards into adjustable test parameters and selectable options ECG Algorithm Analysis Software CTS/CSE Database Comparison PhysioNet/AHA Database Analysis Production Line Testing Auto/Semi-auto Testing Line Design Test Flow Design Test Data Collection and Analysis System Validation Report Compliance with ISO rd Ed. Requirements

11 WhaleTeq Product Development Goal Identifying Market Trends and Compliant with Standards 13

12 WhaleTeq Product Planning Medical and Healthcare Applications Application Product Lines Vital Signs Monitoring ECG, Blood Pressure, EEG, SpO2, Temperature Blood Glucose, Respiration Home Health Care Wearable Mobile Health Care HR, Blood Pressure, SpO2

13 Challenges in Product Development Accuracy does matter Weak Biological Signal and Unapparent Pulse Sensors, hardware design, assembling quality all these factors can impact accuracy of measurement.

14 Challenges in Product Development Accuracy wins customers The Key Point is Algorithm The approval of clinical trials decides everything. Database test is a good way to verify the system.

15 WhaleTeq Product Development Target High Precision Vital Sign Simulator 18

16 5 Major Vital Signs Electrical and Optical Analog Signals Heart Rate ECG heart rate simulator PPG heart rate simulator Blood Pressure ECG Single-lead ECG and heart disease simulation system Cardiac rhythm disease algorithm verification software Real blood pressure simulator Real blood pressure database RA LA Respiration Respiration simulator Blood Oxygen Level Transmissive SpO2 Tester Reflective SpO2 Tester RL/N LL WhaleTeq Existing Test Solutions ECG (electrocardiograph) Test System Wearable Biological Signal Tester EEG (electroencephalograph) Test System ECG Algorithm Verification Software

17 WhaleTeq Product Value Function, Features and Benefits Ingrate test clauses of medical standards into adjustable parameters, selectable options and test sequences Replay recorded clinical data in a easier way Noise simulation includes myoelectricity, respiration, ambient light, motion interference and main interference Medical Standard Interpretation Raw-data Playing Noise Simulation Built-in Test Parameters for international medical standards Save time and cost proceeding required tests Effectively verify system and algorithm Capable of Playing Raw-Data Ensure HW/SW can detect and handle possible noises PPG database with built-in AF, IHB and various skin tones PPG Special Waveform Database Ensure PPG device can be compatible with innovative functions Verifications can be performed before clinical trials Customized testing software can be easily programmed Support Medical Database File Formats Software Development Kit Effectively reduce time and cost caused by repeated clinical trials Product Line Testing Automation - SDK Noise Simulation Support Medical Database Format Increase test efficiency and can be used for automated test

18 Test Recommendations For Medical and Healthcare Device Development Application & Customer Type RD RD RD RD / QC QC Production After Service Hardware/ Firmware Algorithm Compliance Test System Validation IQC / OQC System/ Semifinished Goods Customer Support IC Designer Optical Sensor Module Design House ODM/ OBM Algorithm Developer

19 WhaleTeq Innovation Statement Exclusive Features For Medical and Healthcare Devices 22

20 Existing Industry Challenges WhaleTeq Offers the Optimal Solutions Exclusive System and Algorithm Verification Solution Complex System Verification (hardware + software + algorithm) Noise Simulation Accurate Signal Output Signal is weak and easy to be affected Testing Challenges Complicated Standards Requirements Profession Interpretation Software Integration Clinical trial is costly and inefficient Pre-clinical Database Verification Solution

21 ECG Algorithm Verification WhaleTeq Provides the Easy and Effective Solution PhysioNet MIT Physiological Parameter Database AHA American Heart Association AHA and PhysioNet cardiovascular disease database are all accredited by international standards.

22 PWTT Measurement WhaleTeq Provides the Industry-leading Test Solution Blood flow velocity can be calculated with time difference between electrocardiography (ECG) and ECG Waveform photoplethysmography (PPG) on the same heartbeat when they both reach the measuring point (wrist). Physical condition differs from person to person. Calibrating with armband for sphygmomanometer can improve accuracy. PWTT Pulse Wave Transit Time Clinically speaking, specific characteristic of waveforms would help improve measurement accuracy. PTTp : Pulse Transit Time (peak-to-peak) PPG Waveform

23 PWTT Applications Brings Significant Vital Signs Heart Rate Heart Rhythm Disorders (Arterial fibrillation, Ventricular fibrillation, Ventricular Tachycardia ) HRV SpO2 Blood Pressure Vascular elasticity / arteriosclerosis Respiration Sleeping quality And the following diagnosis functions (mainly determined by ECG) Cardiac output, vascular assessment, arterial disease, artery compliance and aging, venous assessment, endothelial function, microvascular blood flow, vasospastic conditions, autonomic function monitoring, Vasomotor function and thermoregulation, blood pressure and heart rate variability, and other cardiovascular variability assessments

24 Contact WhaleTeq