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Overview - Medical Electronics Practice

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India’s largest business group

with businesses in seven sectors

and operations in over 80 countries;

with products and services available in over 85 countries,

and over 455,000 employees

Group revenue of $ 100 Billion;

58% in geographies outside of India

TATA Group

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TATA Elxsi

Corporate overview• Public Listed company, Established in 1989• Focus on Product Design, Technology & Innovation (no IT !)• Awarded No. 1 mid-tier services exporter for 2012-13 (KTPO)

Global Presence•20 overseas offices servicing customers in US, Europe, Asia, Africa•India Centers - Bangalore, Chennai, Pune, Thiruvananthapuram

World-Class Delivery Capability•Multi-disciplinary team of over 4000+ technologists, engineers and designers•Quality processes certified for CMMi Level 5 and ISO 9001:2008•Robust Information Security Management Systems as per BS 7798

Medical Devices & Healthcare Focus and credentials• Integrated design capabilities from research and insights to system development • Multi-disciplinary team including technologists, ID and embedded designers• Certified for ISO 13485; experience with FDA, CE and IEC60601

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Wireless &Communications

Technology consulting, R&D, new product development, system integration, testing, sustenance and maintenance engineering services

+ Rich portfolio of licensable software components and intellectual property to enable time-to-market and product differentiation

Transportation & Industrial

Broadcast & Consumer Electronics

3G, LTE, WiMAXBluetooth, Wifi

M2M & Telematics, Cloud & Analytics

Control Systems,Chassis, Body,Infotainment,

Safety & Security

Audio, VoiceVideo, Imaging & Graphics

Broadcast TVApps for mobile, web

Product Design & Engineering Services

Semiconductor, Hardware, Firmware, Multimedia

Medical Devices & Electronics

Diagnostics,Therapeutics,

Surgical, Point-of-care,Personal Healthcare

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• Provider of Design & Innovation, R&D and Product Engineering Services to Medical Equipment Manufacturers since 1996

• Experience with medical devices in multiple segments including Diagnostics, Drug Delivery, Cardiology, Orthopedics, Diabetes care, Endoscopy, Surgical, Point of care , Infusion pump & Critical care, Therapeutic, IVD devices.

• Expertise includes Re-engineering medical devices for emerging markets

• Service delivery supported by ISO 13485 certified processes, IEC60601 series, FDA-21 CFR part 820 , CE & EU directive

• Ongoing partnerships with leading hospitals and clinicians - Narayana Hrudayalaya, TATA Memorial Cancer Research Center, Sinhgad Hospital etc.

• Cross functional domain expertise in communication technologies (Wireless, Bluetooth, Wi-Fi), Mobility solutions, System design, Industrial design

TATA Elxsi – Medical Devices & Diagnostics Practice

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Embedded Product

Development

Industrial Design & User

Experience

Regulatory Compliance Support

Complete Product Design & Engineering

Solutions

Complete Product Design & Engineering Solutions

Core team includes:

• Industry and domain experts for medical devices and healthcare

• Usability Experts, Ethnographers, Market Analysts, Hardware, Software, Mechanical Engineering experts

• Certified auditors for regulatory compliance support and quality assurance experts

• Tie-ups with Hospitals and Physicians

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Medical Devices- Product Design & Engineering Services

CONCEPT GENERATION

PRODUCT DEVELOPMENT

VERIFICATION & VALIDATION

SUSTENANCE ENGINEERING

• Market Requirement• User, Market & Technology research • Preliminary Proof of Concept

• System Architecture & Design• Hardware Design• Software Design• H/W & S/W Integration• Prototyping

• Software Verification• Electrical Verification• Mechanical Verification • Usability Verification

• Maintaining & Sustaining• Feature Enhancements• Value Engineering• Performance Engineering• Product Re-engineering

• Communication Technologies (Bluetooth, Wi-Fi, Wireless)

• Mobility Solution (Android, iOS, Windows)

• Industrial & Mechanical Design• HMI Development• Electronic Control Systems

• GUI Development• Software Application Development• Connectivity / Protocol Software• Firmware / Middleware Development

• Image Processing & Visualization• Audio/ Video Streaming & Compression• Algorithm Development & Optimization

• Board Design / ASIC / FPGA / VLSI / SoC Design

Healthcare Standards• DICOM / RoHS2• HL 7 / IEEE11073• HIPAA

Medical Electronics Expertise

REGULATORY COMPLIANCE SUPPORT

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•Unit / White box testing

•Regression testing• Performance testing

SoftwareVerification

• Tensile, Yield, Elongation•Hardness/Flexural / Compression

•Thermal Analysis•Corrosion Fracture Mechanics

MechanicalVerification

•EMC testing•IEC 60601-1 3rd Edition Standard

ElectricalVerification

•ISO/IEC 62366•Design audits•Heuristic analysis•Expert reviews

UsabilityVerification

Assessment & Strategy

•New Product V&V

•V&V for Re-engineering

•Gap Analysis & Recommendations

•Manual vs Automation

•Test and Metrics plan

•Industry recognized Test Methodologies

Independent V&V

• V&V as a service

•Ownership of Product V&V

•Toll gate for product quality

•Close collaboration with Prgm Mgmt and multifunctional teams

•Robust Change Mgmt

•Offshore deliver centers – Cost Arbitrage

Non Functional Testing

•Performance : Profiling and benchmarking

•Stress and Load Testing : Simulation using custom and COTS tools

• Security : HIPAA compliance

•Scenario- based: Simulation of extreme/boundary scenarios

• Development of custom tools, device simulators, software simulators

Compliance

• Generation of DHFs, DMRs, CSV reports

• Reverse engineering & documentation

• Tools validation

•Pre- clinical and Clinical Validation

•Pre-submission support for PMA, 510K filings

•Expertise across Class I, II and III categories

Test Automation

• Automation framework development and scripting

•Manual to Automated conversion

•Custom framework and tools development

•COTS tools usage and customization

•Cycle time reduction and ROI calculations

•Continuous Integration (CI) harness

Medical Devices – Verification & Validation Services

ISO 13485, 21 CFR Part 820, ISO 14971

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21CFR Part 820, ISO 13485, CE & EU Directives Compliance

Regulatory guideline compliance – Assessment & GAP analysis

Documentation support for 510 (K) / Pre-market approval

Process, Tools Validation and Post market surveillance support

Testing- EMC/LVD/Biocompatibility (ISO 10993) & compilation of clinical data

Guidance support - Correct labeling / Instruction manual / SOP

Design & development- Risk based approach for validation (ISO 14971)

Maintaining & updating design dossier for higher risk classified devices

Maintaining of DHF/DMR- (Identification & Traceability)

CAPA support

RoHS / REACH compliance

Regulatory Compliance Support & Services

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Thank You