45

Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

  • Upload
    others

  • View
    0

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat
Page 2: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat
Page 3: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Making better the human’s life To become a global player in the healthcare field

North America

Latin America

Asia-Pacific

Mid-East &Africa

Europe

Our Vision & MissionOur Vision & Mission

Page 4: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Management Team

Co-Founder Manager

After Sale Service

Manager

CRM

Manager

Production

Manager

Quality Assurance

Manager

R&D

ManagerSale Manager

Financial Manager

Co-Founder

Page 5: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

CE Certificate

Page 6: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Personnel

280 PERSONNEL

Page 7: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

2005

2006

2008

Global Partners

2006

Page 8: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Global PartnersMasimo and

SAADAT

Page 9: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

TRIONARAProduction Line in Sweden

Page 10: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

SAADAT & …

Internal Joint Venture

ShezanDahian

Pezeshki PishroPEC

Equipment

Tarah Tajhiz Pooyesh

Page 11: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Awards & Honors

Page 12: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

SWOT

• Innovative and smart engineers• Low price manpower

Opportunity

• Low-quality Chinese products• Governmental companies

• Time consuming before launch

• Innovation from existing Technology• Knowing the global market• High-quality and low-price

SWOT

Strength

Weakness Threat

Page 13: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Competition

Low-Scale Global Companies

Large –Scale Global Companies

Philips

Drager

GE

Nihon

Mindray

Saadat

Biolight

Mediana

Biocare

Page 14: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat
Page 15: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Research & Development (R&D)

Page 16: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

R&D Personnel

Electrical Engineering36%

Industrial Engineering5%

Software Engineering22%

Mechanical Engineering

12%

Biomedical Engineering

25%

R&D Department Field of Study

Electrical Engineering

Industrial Engineering

Software Engineering

Mechanical Engineering

Biomedical Engineering

Page 17: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Design and

Development

Verification

& Validation

Clinical

Evaluation

Product Certification

Feasibility Study

R&D processes

Transition to

Production Line

• Saadat is a knowledge-base company with an active R&D department

• Designing with creativity, innovation, efficiency and using technical knowledge

Page 18: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Production

Page 19: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Production Division

Electronic Board Inserting (SMD)

Electronic Board Testing

Final Assembling

Accessory Manufacturing

Long term working

Page 20: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Production Division

Packaging

Quality Control

Storage

Page 21: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

CNC machines 4-axis & CNC 3-axis to fabricate mechanical parts

Industrial Machine

CNC punch machine for cutting plates and metal sheets

Manual milling machine

Laser & TAMPOO Printing

Page 22: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Industrial Machine

Automatic metal lathe machines & manual metal lathe machine

Injection machines for producing plastic parts and casing

Manual Drill Machine

EDM Machine (spark)

Page 23: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Meeting Customer Satisfaction

System installation, training, repair, and upgrades

24/7 customer care service

More than 30 representatives in Iran

After Sale Services

Page 24: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat
Page 25: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Global Marketing Exporting to more than 45 countries in Asia, Middle East, Europe and South

Africa

Marketing

Local Marketing Be the first choice in local market Holding more than 65% market share of patient monitor in Iran

Page 26: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Goal

Customer Relationship Management (CRM)

Customer satisfaction measurement

Customer complaint management

Communication Paths With Customers

Telephone

Meeting

Fax

Periodic Visit or Call

Exhibitions

… And Other Campaigns

Page 27: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

CRM

8082 81

8380

8682 82

50

55

60

65

70

75

80

85

90

2011 2012 2013 2014 2015 2016 2017 2018

PER

CEN

TAG

E

YEAR

SATI

SFA

CTI

ON

IN 8

YEA

RS

Page 28: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

• Establish, implement, maintain quality management system

• Analyzing data that collected from production line and service department

• Monitoring and measuring all processes that implemented in QMS

• Process risk analysis

• CAPA and manage technical committees

• Calibration and preventive maintenance of equipment

• Obtaining ISO 13485 compliance certificate

Page 29: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

1990s 2000s 2010s

Zagros sIntroducing Alborz

B5

Novin S1800/S1600 Introducing Aria and Dena 640 BFA

Ventilator

Wearable monitor andSuction

History

Founding of SAADAT

2019s

Holter & AED

2020s

CentralNovin S630/740

Page 30: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Bedside Monitor

Technical Specification ECG/SPO2(Masimo)/NIBP/RESP/2TEMPs/2IBPs modules

Connectibility to the central system network

18.5” screen color LED with anti-shock /anti-scratch

96-hours trend storage and 500 NIBP records

ARR and ST segment analyzer software

Working 4h with rechargeable internal battery

Configuring parameters in different pages (multi-page)

Alarm recall

Drug calculation

Displaying of OXY-CRG signal trace

Adult, neonate, and pediatric modes

Visual and auditory alarms

VGA output

Displaying 7 ECG leads simultaneously

Displaying 6 to 8 signal traces and 10 parameters

Optional Features

SPO2 Masimo Rainbow

Brain function assessment (BFA)

Upgrade 4IBPs

Recording of 3 waveforms simultaneously

Touch screen

ECG 12-leads

Etco2 measurements, multi gas analyzer

ICP (intracranial pressure) measurement

Cardiac output measurement

Page 31: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Central Monitoring System

Technical Specifications

• Dual-screen display, color TFT LCD/LED screen with high-resolution

• Up to 128 real time waveforms for 32 beds simultaneously

• ECG, SpO2, RESP, CO2, Dual IBP waveforms

• Selective waveforms and parameters • Various configurations of main screen

• Supporting LAN network (Wired / Wireless)

• Audible and visual alarms • Up to 96 hours trend store and review

• Up to 720 alarm events store and review

• Up to 1000 NIBP measurements store and review

• Up to 48 hours of disclosure store and review

• Set up the color of waveforms/parameters

• Exchanging the position of patient window

• Supporting external thermal recorder

• Supporting Laser printer

• Managing patient information

• Communicates with the PACS server to make and display DICOM files

Page 32: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Technical Specification• 12 ECG lead simultaneous acquisition

• Recording up to 6 channels on 110 mm paper

• 5"color TFT touch screen

• 16-key keyboard

• Isolated and protected against Electric shock

• Small size and light-weight

• User friendly

• Data storage and reprint of 100 ECG records (Save & Copy)

• Working 8h with rechargeable lithium battery

• (more than 150 ECG records with battery)

• Filter for rejection of muscle artifacts (EMG)

• Filter for rejection of high-frequency noises (25, 35, 75,150 Hz) and Drift

• Compliance with IEC 60601-2-25 standard

Electrocardiograph

Page 33: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Technical Specification ECG/SPO2(Masimo)/NIBP/RESP/2TEMP/2IBPs modules

5” screen touch color LED

96-hours trend storage and 100 NIBP records

Working 1:30 h with rechargeable internal battery

12 hours trough F1/F1R stations

Configuring parameters in different pages (multi-page)

Adult, neonate and pediatric modes

Visual and auditory alarms

Displaying 7 ECG leads simultaneously

Displaying 3 to 5 signal traces and 6 parameters

Compact and light-weight (<800 g) design

Aria

Optional Features SPO2 Masimo Rainbow( SpCO, PI, PVI, SpHb, SpMet, SpOC) Brain function assessment (BFA) Upgrade 4IBPs ECG 12-leads Etco2 measurements, multi gas analyzer ICP (Intracranial pressure) measurement

Page 34: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

•Remote monitoring solution to early diagnosis of MI•Preventing from unnecessary patient admission to hospitals

Page 35: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Technical Specification

• ECG(3,5,12 Lead)/ SPO2 (MASIMO)/NIBP/ RESP/ TEMP1/Modules

• 3 different modes of adult, neonate and infant

• Thermal printer with the ability to print ECG waveform

• Visual and voice alarm and lead wire disconnect indicator

• Online/offline transferring patient vital signs to clinical center through telecommunication platform of 3G/4G Mobile or LAN/WLAN internet

• Ability to conversation between physician in clinic center and operator during the mission

• 96- hours waveform trend and ability to save 100 NIBP records

• 8 hours of battery working and rechargeable internal battery in system and stand both

• Working with ambulance DC-power (using inverter) and AC

• Quick start up

• Small design and very light weight

Option:

• Upgrading into Masimo Spo2 Rainbow Module to measure SpCo, Pt, PVI, SpHb, Spo2

AriaTC

Page 36: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Technical Specification

• User-friendly Diagnostic aid software

• Glasgow university ECG signal analysis software

• ECG Signal measuring tools for reduce human error

• Displaying parameters of ECG (12 Lead) ,TEMP, NIBP, SPO2

• Ability to install on Windows, Mac, Linux, Android and loading software as a web

• Print 3-12 leads on A4 paper

• Saving data for more than 6 month

• Ability to append patient data and physicians opinion

TC-Viewer

Page 37: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Provides automated measurement and interpretation of ECGs

Developed over many years in a clinical environment

Based on careful scientific researches and publications

Meets all the standards including IEC 60601-2-25

Provides reliable and accurate diagnoses

Can be used in paediatric as well as adult

Diagnostic statements are available in multiple languages

The Glasgow Program used by famous companies worldwide

The Glasgow Program (ECG Signal Analysis)

Physio Control

Draeger

SpacelabsMediana

Mindray

Page 38: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

1. Occurrence of pain in the patient's chest andCalling with emergency center

2. Observation of remote patient’s vital signs (12-lead ECG) by the resident physician

3. Hospital pre admission arrangement andtransferring the patient to Cath Lab immediately

4. Rescuing the patient's life by early diagnosis of MI

SAADAT TeleCardio Operations

Page 39: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

39

Traditional Method

Our Method

Page 40: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Technical Specifications

Volume and pressure controlled ventilation (CMV- SIMV- SPONT modes)

Automatic leak and tube compensation

Pediatric through adult (20- 2000 ml tidal volume)

Modern pressure and flow triggering

Smart alarm system

Battery backup up to 2 hours

Smart user friendly interface

72 hours trend storage

IBW calculator

Ventilator

Page 41: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Technical SpecificationHigh-tech monitor in your hand

Integrating the benefits of bedside monitors and telemetry

Sending patient data to Central System by WiFi

Wide Variety of Measurements

ECG (3Lead/7 Lead) /SPO2(Masimo)/RESP/TEMP/

Accelerometer for patient fall detection

Audible and visible alarms on device and central system

3.5’’ Color capacitive touch screen display

Auto sleep mode to conserve battery

Screen orientation choice

Powered by 2 Rechargeable/ Disposable AA Batteries

Continues ECG monitoring for 24 hours

Charger station for charging batteries

Dimensions and Weight:

Dimension: 63mm × 28mm × 133mm

Weight: 218 gr (with batteries)

Wearable Patient Monitor

Page 42: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Technical Specifications

• Oil less and maintenance-free motor pump

• 180 W Power consumption

• 670 mmHg Max vacuum

• Less than 70 dB Noise level

• IP 21

• Compatible with standard jars

• Jar selection valve

Surgical Suction

Page 43: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

Automated External Defibrillator (AED)

Technical Specifications• Display size: 5” wide• Audio prompts and visual display provides the AHA/ERC's process of Survival• Using distinctive disposal PADs for adult and pediatric patients• Fully automatic feature available • Providing carrying handle for easy transportation• Using disposal lithium batteries with the capacity of 50 max discharges • Automatic self-testing helps ensure a state of readiness• Width x depth x height: 302mm× 100mm× 282 mm (main body)• weight:~3kg

Page 44: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

ECG Holter

Technical Specifications

• 200 Sample/Sec Sample rate• AA Alkaline battery• 100 g weight• Any orientation operating position• 5 electrodes ECG cable• Full disclosure of waveforms• Beat classification• ST segment is analyzed on all leads

separately

Page 45: Making better the human · Development Verification & Validation Clinical Evaluation Product Certification Feasibility Study R&D processes Transition to Production Line • Saadat

با تشکر از حضور شما