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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