Dear All, Thanks !! for going across TATA Elxsi Medical Device service offerings deck. If you have any curiosity to know more about our services , Please let me know on below communicable details: Mobile: +91-7387192909 Mail: harsha@tataelxsi.co.in Regards, Harshwardhan

1. 1
Overview - Medical Electronics Practice

2. 22
India’s largest business group
with businesses in sevensectors
and operations in over 80countries;
with products and services available in over 85countries,
and over 455,000employees
Group revenue of $ 100Billion;
58%in geographies outside of India
TATA Group

3. 33
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

4. 44
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, WiMAX
Bluetooth, Wifi
M2M & Telematics,
Cloud & Analytics
Control Systems,
Chassis, Body,
Infotainment,
Safety & Security
Audio, Voice
Video, Imaging & Graphics
Broadcast TV
Apps for mobile, web
Product Design & Engineering Services
Semiconductor, Hardware, Firmware, Multimedia
Medical Devices
& Electronics
Diagnostics,
Therapeutics,
Surgical, Point-of-care,
Personal Healthcare

5. 5
• 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

6. 6
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

7. 7
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

8. 8
•Unit / White box
testing
•Regression testing
• Performance
testing
Software
Verification
• Tensile, Yield,
Elongation
•Hardness/Flexural /
Compression
•Thermal Analysis
•Corrosion Fracture
Mechanics
Mechanical
Verification
•EMC testing
•IEC 60601-1
3rd Edition
Standard
Electrical
Verification
•ISO/IEC 62366
•Design audits
•Heuristic analysis
•Expert reviews
Usability
Verification
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

9. 9
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

10. 10
Domain Focused Delivery
Tata Elxsi
Domain
Expertise
Domain Team
Doctors &
Hospitals
Academic Tie
-Ups
Workshops &
Training
Prototyping &
Testing
 In-house domain engineers & SMEs from Bio-Medical
background
 Domain Training Material
 Conduct Domain Trainings for project teams
 In house Regulatory Specialist - Consulting on
Regulatory Frameworks for Medical Devices
 Collaboration with Multi specialty
Hospitals & MDs
 Sinhgad Hospital, Pune
 Narayana Hrudayalaya,
Bangalore
 Noble Hospital, Pune
 TATA Memorial Hospital
 Demo Sessions on various
Modalities
(TEL team in one
of the hospitals in
Pune,
understanding the
demo of Dialysis
machine)
 Tie-up with premier institutes like
IITs(Mumbai & Chennai)
 Jointly collaborate for R & D projects
 Hire trained resources
 Consultation
 Technology/Domain Workshops
 Seminars– Standards relate to
Medical Devices, Various
Modalities, FDA regulations
 CETE
 STQC
 Shogini
Technologies
 Kinetic
Communications Ltd
 Titan Timeproducts
Ltd
 Avlon Technologies
• Well Developed EMS Ecosystem
• Component purchase, Bare board mfg., Assemble
operations, Testing, packing

11. 11
Initiation Opportunity and
Risk Analysis
Formulation/Concept and
Feasibility Phase
Design and
Development/Verification &
validation Phase
Final validation/Product
Launch Preparation Phase
Product Launch and Post-
Launch Assessment
Initial evaluation of
possible development of
commercial product
– Requirements Engineering
Definition of design input
based on customer needs
and technical requirements
Development of product
design and of
manufacturing process;
verification & Validation
Final validation of
manufacturing process;
preparation of product
introduction
Market introduction of
product; continuous
improvement
Phase I Phase II Phase III Phase IV Phase V
Acceptance/ConceptCharter
InitialDesignAcceptance/DevelopmentAgreement
Gate
1
FinalDesignAcceptance/RampupReadiness
ProductlaunchAcceptance/launchReadiness
Gate
4
Gate
3
Gate
2
Market Analysis
Market Analysis
Competitive Assessment
Project Plan & Timeline
Customer input/VOC
Requirements Engineering
Concept Development/
Design inputs
Prototype Analysis
Initiate & Maintain DHF
Initial design Risk analysis
(dFMEA)
Initiate DFM (Tooling,
Fixturing)
Customer/Manufacturing
Prototype Evaluation
Product Design Development
Design V&V
Maintain DHF/DMR & Project
Timeline
Design Risk Analysis
(dFMEA)
Patent Review
Regulatory Strategy update
Regulatory Submission
support
Reimbursement strategy
update
Supplier Collaboration
Initial Process FMEA
Detail Producibility Analysis
Product Branding
DHF/DMR Completion
Market Launch Plan
dFMEA Update & Review
Design O/p = Design I/P
Final patent Review with R&D
Obtain Regulatory Approval
Finalize Reimbursement
Strategy
Mfg/Ops Scale up
Full Process Qualification
Clinical Validation
Sales Training
Physician Training & sales
efforts
Product improvements
Post Market Surveillance
Update Reimbursement as
needed
Process Improvement as
needed
Update Design Control Docs
Quality Audits
Continued Clinical Validation
Reps Attend Surgical Cases
Begin Process
IQ/OQ/PQ/PPQ
Clinical Validation Plan
Tata Elxsi’s Medical Device Development Methodology*
Financial Review
Early Risk Assessment
Legal/IP Analysis & Filings
Regulatory & clinical Path
Reimbursement Path
Investigational Clinical
Evaluation
IP landscape, review of filings
Initial Regulatory Strategy
Initial Re-imbursement
Strategy
Feasibility testing
Design Output
Early stage technology
Assessment
Pre Clinical testing
Tata Elxsi’s Scope
* This is typical Medical Device Development methodology. Highlighted
area (Blue) is the services that can be outsourced to TATA Elxsi

12. 12
TELOrganizationalStructure
Requirements / User Needs
Usability
Concept, Design &
Development
Verification
Regulatory
Manufacturing
Post Market / Sustenance
Qualified Business Analyst & Requirement Specialist
• Requirements Gathering – VoC, Primary & Secondary market research
• Requirement elicitation, analysis & verification
• Translate into technical requirements
Independent Usability Group
•Key – Next Generation Devices
•End user study – for concept generation phase
•IEC 62366
Supported by team of qualified Electrical, Mechanical / Industrial Design,
Embedded, Software Engineers
• Feasibility studies, Concept ideation
• Functional Prototypes
Independent V & V team
• Design V & V
• Independent V & V
• Pre Compliance tests
Qualified Regulatory Head
• Design & Testing as per regulatory standards (e.g. IEC 60601)
• Maintaining & Updating DHF
• Documentation for Regulatory Submission
Research Analyst team and Qualified Engineers
• For Emerging market / New market
• Revisions / Upgrades / Document changes / Bug fixing
• Value Engineering – Cost reduction, obsolescence management, RoHS
compliance
Production manager
•Design transfers for manufacturing
•Limited production using contract manufacturers
Tata Elxsi’s MEBU: Organizational Structure - Key Differentiator
Replicating OEMs Org Structure

13. 13
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