Medtech | Birlasoft

Our Impact in MedTech — Proven, Measurable, Scalable

The MedTech industry is at a transformative crossroads, where AI, data, and regulatory innovation are redefining patient care. Clinical specialties, such as surgery, Orthopaedics, Cardiology, and Renal care, are being transformed through robotic-assisted platforms, personalized surgical planning, remote monitoring, patient-specific implants, and digital care platforms. Birlasoft partners with global medical device leaders to accelerate innovation, enhance compliance, and enable connected, patient-centric healthcare. From R&D and smart manufacturing to regulatory intelligence, commercialization, and digital health, we bring deep domain expertise and next-gen technologies to modernize the MedTech value chain—driving faster launches, smarter operations, and better patient outcomes.

30–40%

Effort Optimization in QA & Validation (TAAS-led QA Transformation)

Up to 70%

Boost in Global Compliance Adherence

5–20%

Efficiency Gains in MedTech Field Operations

Up to 40%

Reduction in Device Maintenance Effort with predictive monitoring & remote diagnostics

Proven Real-World Impact

$2M Annual Savings with AI-powered R&D Data Lake

Challenge: Fragmented R&D and compliance data leading to slow innovation and limited insight.
Solution: AI-powered Data Lake integrating clinical, engineering, and compliance data for real-time analytics.
Impact: ~$2M annual savings, faster design cycles, and improved compliance reporting.

Challenge: Legacy PLM, siloed MES and ERP, compliance complexity, and operational inefficiencies.
Solution: Integrated PLM + MES + JDE ERP ecosystem with AI-augmented quality and closed-loop manufacturing.
Impact:
- 30% improvement in efficiency
- 50% faster changeovers
- 40–60% reduction in scrap/rework
- 2x faster decision-making and 20–35% quicker time-to-market

30% Efficiency Lift with AI-integrated Manufacturing

40% Reduction in Maintenance Effort with IoT-enabled Remote Monitoring

Challenge: Limited device visibility, manual maintenance, fragmented firmware updates, and security gaps.
Solution: AI + IoT + edge-based remote monitoring and device engineering for portable oxygen systems.
Impact:
- 40% reduction in maintenance effort
- 20% faster service delivery
- 30% collaboration improvement
- 25% fewer security incidents

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Transforming MedTech Operations: AI + Integrated Systems deliver 30% Efficiency Lift.

From Data to Dollars: AI-powered Data Lake boosts MedTech R&D and Compliance with $2 Million Annual Savings

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Overview

A Fortune 10 global medical device manufacturer partnered with Birlasoft to revolutionize its research and development (R&D) operations through an AI-powered, cloud-native data lake platform. The initiative aimed to unify fragmented data sources, enhance regulatory reporting, and accelerate innovation by embedding artificial intelligence and advanced analytics into the core of its data strategy.

Unified clinical, laboratory, and regulatory data into a centralized, intelligent platform
Empowered researchers with AI-driven insights for faster, more accurate decision-making
Enabled scalable, secure infrastructure to support global R&D collaboration
Positioned the client as a leader in data-driven medical device innovation

The Challenge

The client’s R&D ecosystem was constrained by legacy systems and data fragmentation, limiting its ability to innovate and respond to regulatory demands efficiently.

Data Silos: Critical research data was dispersed across clinical trial systems, lab databases, and external sources, making it challenging to derive holistic insights
Scalability Limitations: The infrastructure couldn’t support the growing volume of device telemetry, clinical feedback, and global regulatory data
Data Quality and Consistency: Manual integration introduced inconsistencies, affecting the reliability of AI models and analytics
Regulatory Compliance: Managing sensitive health and device data required strict adherence to HIPAA, GDPR, and FDA regulations, with no unified governance in place

The Solution

Birlasoft implemented a next-generation R&D Data Lake infused with AI and automation to address the client’s challenges and future-proof their innovation pipeline.

AI-Enabled Data Integration: Built a centralized data lake that ingested and harmonized structured and unstructured data from clinical trials, lab systems, and global regulatory bodies
Cloud-Native Scalability: Leveraged elastic cloud infrastructure to support high-speed data processing, real-time analytics, and global accessibility
Automated Data Governance: Deployed AI-driven data validation, cleansing, and standardization to ensure consistent, high-quality data across the enterprise
Gen AI & Predictive Analytics: Embedded generative AI models and advanced analytics tools to enable predictive modelling, intelligent data visualization, and accelerated discovery cycles.

The Impact

The AI-powered data lake delivered measurable improvements in operational efficiency, innovation speed, and regulatory compliance across the client’s global R&D operations.

Regulatory Reporting Efficiency: Achieved a 50% improvement in global regulatory reporting timelines, reducing manual effort and ensuring compliance
Accelerated Innovation: Reduced device discovery and development timelines by 20%, enabling quicker go-to-market strategies
Global Safety Monitoring: Integrated and analysed 240K+ adverse events using AI-powered surveillance, improving post-market surveillance and compliance
Operational Cost Savings: Realized $2 million in annual savings through infrastructure optimization and automation.
AI-Driven Automation: Achieved >85% automation in code conversion and >50% faster dataset generation, boosting R&D agility
Scalable Innovation Platform: The solution supports expansion into new device categories, geographies, and research domains, with AI at its core

This transformation positioned the client at the forefront of AI-driven medical device innovation. By integrating Gen AI, cloud, and data engineering expertise, Birlasoft enabled a more innovative, faster, and more compliant R&D ecosystem—empowering the future of healthcare technology.

30% Efficiency Lift with AI-integrated Manufacturing

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Overview

A global medical device manufacturer partnered with Birlasoft to modernize its manufacturing operations using an AI-augmented, integrated digital ecosystem. The goal: break down data silos, ensure regulatory compliance, and accelerate product innovation.

The Challenge

The client faced multiple operational and technical hurdles that slowed down innovation and compromised quality.

Data Silos: Legacy systems created isolated data environments, limiting visibility and collaboration
Compliance Challenges: Urgent need to standardize intercompany transfers, lot number etching, and meet FDA/global compliance requirements
Technical Debt in PLM: Windchill PLM faced reduced agility due to outdated third-party libraries, monolithic architecture, and poor documentation
Operational Inefficiencies: These issues collectively hindered streamlined operations, product quality, and speed to market

The Solution

Birlasoft delivered a unified, AI-augmented manufacturing ecosystem that connected design, production, and planning:

Integrated Manufacturing Solution: PLM + MES + JDE ERP

Seamless Closed-Loop Manufacturing: Integrates design (PLM), production (MES), and planning (JDE ERP) to eliminate silos and improve coordination across departments and supply chain partners
Real-Time Quality Management: MES provides live production data linked to PLM specifications, enabling early issue detection and consistent product quality.
Accelerated Product Development: Facilitates faster communication between engineering and manufacturing, allowing quicker adaptation to design changes and reducing launch timelines.
Optimized Resource Utilization: This minimizes duplication and delays, improves scheduling, and maximizes the use of materials, labour, and equipment.
Foundation for Smart Manufacturing: Supports digital transformation through model-based enterprise practices, ensuring data continuity and accuracy across the product lifecycle

The Impact

The transformation delivered measurable improvements across operations, cost, and compliance:

Operational & Cost Efficiency: Up to 25% reduction in expenses through optimized resource allocation and 15–25% lower energy consumption
Production Performance Boost: 30% improvement in efficiency, 50% faster changeovers, and 40–60% less scrap/rework via real-time scheduling and quality checks
Full Traceability & Compliance: 100% material/product traceability supports regulatory compliance and recall readiness
Accelerated Decision-Making & Market Response: 2x faster decisions and 20–35% quicker time-to-market enabled by integrated MES-PLM workflows and predictive maintenance

By integrating AI and enterprise systems, Birlasoft enabled the client to overcome legacy challenges and build a future-ready, compliant, and efficient manufacturing operation—setting a benchmark for digital transformation in the MedTech industry.

40% Reduction in Maintenance Effort with IoT-enabled Remote Monitoring

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Overview

A global market leader in portable oxygen technology partnered with Birlasoft to modernize its smart medical devices through advanced remote monitoring, intelligent device engineering, and cloud-enabled upgrades. The goal was to reduce operational overhead, improve service quality, and deliver superior product experience to patients and healthcare providers. By integrating AI, IoT, and edge computing, Birlasoft enabled real-time visibility, predictive maintenance, and secure device management across geographies.

Enabled real-time monitoring and proactive maintenance of oxygen delivery systems
Integrated AI and edge connectivity for smarter diagnostics and firmware upgrades
Delivered secure cloud communication and centralized device management
Positioned the client for scalable, data-driven innovation in respiratory care

The Challenge

The client faced several operational and technical challenges in managing its fleet of portable oxygen devices across global markets.

Limited Device Visibility: Lack of real-time monitoring led to delayed issue detection and reactive maintenance
Manual Maintenance Processes: Field service teams relied on manual checks, increasing downtime and service costs
Fragmented Firmware Updates: Devices lacked centralized control for software upgrades, risking outdated functionality
Security and Scalability Gaps: Managing device data across geographies required robust encryption and scalable infrastructure

The Solution

Birlasoft implemented a comprehensive AI-powered remote monitoring and device engineering solution, combining embedded systems, IoT integration, and cloud infrastructure.

Real-Time Monitoring & Data Security: Enabled continuous tracking of oxygen purity, battery status, and device health with secure data transmission
Proactive Maintenance via Analytics: Leveraged AI to analyse usage patterns and error alerts, enabling predictive servicing and reduced downtime
Firmware & Cloud Communication: Delivered seamless software updates and secure cloud connectivity using MQTT, Python, and embedded Linux
IoT & Edge Integration: Designed sensor-based connectivity plans and enabled real-time data exchange between devices and cloud platforms via cellular networks
Azure Infrastructure & Telemetry Testing: Set up encrypted telemetry pipelines and validated data routing for scalable application integration

The Impact

The solution delivered measurable improvements in device performance, service efficiency, and customer satisfaction.

30% Improvement in Collaboration: Real-time ETA and updates empowered customers and third-party service providers with better coordination
20% Faster Service Delivery: Intelligent alerts and remote diagnostics enabled quicker issue resolution and reduced field visits
40% Reduction in Maintenance Efforts: Centralized global portal streamlined device management and minimized manual interventions
25% Fewer Security Incidents: Enhanced encryption and access controls improved data protection across the device ecosystem

Birlasoft’s AI-powered remote monitoring and device engineering solution enabled the client to transform its smart medical device operations—delivering real-time insights, predictive maintenance, and secure cloud connectivity. By integrating embedded systems, IoT, and AI, the solution reduced operational overhead, improved service quality, and positioned the client as a leader in intelligent respiratory care.

AI-Powered Regulatory Intelligence: Driving a 70% boost in Global Compliance adherence for a leading Medical Device Company

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Overview

A leading MedTech company partnered with Birlasoft to streamline its global operations using an AI-powered regulatory intelligence platform. In a landscape marked by complex, overlapping domestic and international regulations, the company needed a more innovative way to monitor health authority guidelines, consolidate competitive intelligence, and ensure timely compliance. Birlasoft’s solution leveraged Gen AI, deep learning, and intelligent automation to simplify regulatory workflows, reduce submission risks, and accelerate time-to-market for innovative medical technologies.

Unified global regulatory surveillance with AI-driven automation
Enabled real-time insights and proactive compliance across local operating companies (LOCs)
Consolidated digital health and real-world evidence (RWE) for strategic regulatory learning
Positioned the client for faster innovation and reduced regulatory liabilities

The Challenge

Navigating the global regulatory landscape posed significant challenges for the client’s Global Regulatory Affairs (GRA) teams.

Fragmented Regulatory Systems: Multiple health authorities with varying guidelines created confusion between domestic and international compliance requirements
Inconsistent LOC Reporting: Each local operating company had unique submission formats and timelines, complicating centralized oversight
Limited Competitive Intelligence: Scarcity of structured data on competitor filings and agency trends hindered strategic planning and investment decisions
Manual Monitoring Burden: Regulatory surveillance relied heavily on manual tracking, increasing the risk of missed updates and delayed submissions

The Solution

Birlasoft deployed an AI-powered regulatory intelligence platform, combining GenAI, deep learning, and automation to transform the client’s compliance operations.

Health Authority Monitoring Automation: Implemented a surveillance system that continuously tracks global regulatory updates, ensuring proactive compliance.
GenAI-Powered Summarization: Used large language models to condense complex publications and extract key insights for faster understanding
Intelligent Recommendation Engine: Analysed agency behaviour patterns to suggest relevant literature and streamline device identification and filings
Competitive Intelligence Mining: Leveraged deep learning neural networks to classify and extract strategic data from global regulatory sources
Real-Time Broadcasting Network: Enabled instant communication of regulatory changes to LOCs, ensuring alignment and timely action

The Impact

The AI-powered platform significantly improved regulatory efficiency, compliance accuracy, and strategic decision-making.

70% Improvement in Global Guideline Adherence: Automated tracking and AI-driven insights ensured consistent compliance across geographies
100% Submission Milestone Adherence: Eliminated delays and liabilities through intelligent scheduling and proactive alerts
Touchless Notification Enablement: Fully automated updates on new guidelines, reducing manual effort and improving responsiveness
Consolidated RWE & Digital Health Data: Enabled strategic learning from real-world evidence and digital health trends for future filings

Birlasoft’s AI-powered regulatory intelligence platform transformed the client's global compliance strategy—moving from reactive monitoring to proactive, insight-driven decision-making. By integrating GenAI, deep learning, and intelligent automation, the solution streamlined regulatory workflows, reduced submission risks, and accelerated innovation in the MedTech space. This transformation ensured adherence to global standards and empowered the client to lead confidently in a highly regulated and competitive industry.

From Complexity to Efficiency: TAAS-Led QA Transformation with 30-40% Effort Optimization

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Overview

A global medical device manufacturer partnered with Birlasoft to overcome critical challenges in its IT Quality Assurance (QA) landscape. With high testing costs, extended test cycles, and complex regulatory requirements, the organization sought a scalable, intelligent QA solution. Birlasoft implemented a centralized, AI-driven QA Center of Excellence (QA COE), significantly improving testing maturity, efficiency, and cost-effectiveness.

The Challenge

The client faced several pressing issues in their QA operations:

High QA implementation costs: Rising expenses across multiple IT projects
Extended test cycles: Delays in product launches due to slow regression and validation
Regulatory complexity: Numerous compliance requirements across geographies
Fragmented IT ecosystem: Multiple SaaS platforms (SAP, Oracle, Salesforce) create integration and testing hurdles
Limited process control: Inadequate visibility and governance over vendor-led testing
Heavy SME dependency: Excessive reliance on domain experts, slowing down QA scalability

The Solution

Centralized QA COE: Established an AI-based Quality Assurance Centre of Excellence
Business-aligned structure: QA COE mapped to functional towers for better ownership and traceability
TCOE standards: Enforced 100% test case reviews to ensure quality and consistency
Automation uplift: Stabilized frameworks and upgraded API testing with AI-based defect prediction
AI-powered tools simplified the workflows:
- Test Case Recorder
- Test Script Generator
- Smart Test Case Prediction model for regression optimization
Scalable operations: Enabled flexible demand management and QA COE scalability
Maturity assessment: Used TMMi framework to evaluate and enhance QA maturity levels

The Impact

30% Reduction in Overall Testing Spend - The client significantly reduced costs associated with manual testing, vendor management, and inefficient processes by centralizing QA operations and leveraging AI-driven automation.
60% Faster Regression Cycles - Streamlined test execution and intelligent test case selection enabled quicker regression cycles, helping the client accelerate product releases and improve time-to-market
30-40% Reduction in Manual Testing Efforts - Automation frameworks and AI-based tools minimized the need for manual intervention, allowing teams to focus on strategic tasks and reducing overall effort
Achieved 98% Defect Removal Efficiency - Rigorous test case reviews and predictive defect analysis ensured that nearly all defects were identified and resolved before reaching UAT and production environments
81% Decrease in SME Dependency - Standardized processes and centralized knowledge reduced reliance on subject matter experts, freeing up 48 valuable resources (59 to 11)

Birlasoft’s strategic implementation of an AI-enabled QA COE empowered the client to streamline testing operations, reduce costs, and accelerate product launches. The TAAS maturity journey enhanced QA effectiveness and positioned the organization for scalable, future-ready digital transformation.

AI-Powered Sales Enablement: Transforms MedTech Field Operations with 15–20% Efficiency Gains

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Overview

A leading global medical devices company partnered with Birlasoft to enhance the productivity of its field sales teams through a GenAI-powered chatbot solution. In a rapidly evolving healthcare landscape, where precision and speed are critical, the company sought to improve the quality of interactions between its field representatives and medical professionals such as cardiologists and cardiac surgeons. The goal was to empower sales teams with instant, intelligent access to product information, enabling more effective communication, faster response times, and improved customer satisfaction.

Transformed field sales operations with AI-driven, real-time product intelligence
Enabled seamless, contextual interactions between sales reps and healthcare professionals
Reduced dependency on manual document searches through intelligent automation
Positioned the client for scalable, tech-enabled sales growth in the medical devices sector

The Challenge

The client’s field sales teams faced significant hurdles in delivering timely and accurate information to medical professionals, impacting engagement and sales outcomes.

Delayed Information Access: Sales reps struggled to respond quickly to product-related queries due to reliance on extensive documentation
Fragmented Knowledge Delivery: Lack of centralized access to product data led to inconsistent messaging and missed opportunities
Limited Training Tools: Traditional training methods didn’t support dynamic learning or real-time scenario handling
Customer Experience Gaps: Delays in query resolution affected the quality of interactions with cardiologists and surgeons, risking customer satisfaction

The Solution

Birlasoft implemented a GenAI-powered chatbot solution to optimize sales enablement and elevate field team performance.

AI-Enhanced Sales Support: Integrated GenAI to deliver instant, contextual responses to product queries, improving field efficiency and confidence
Retrieval-Augmented Generation (RAG): Combined retrieval and generative AI methods to ensure accurate, up-to-date information delivery
Interactive Training Tools: Enabled role-play simulations, active recall questions, and scenario-based learning to boost rep readiness
Quick Auto-Referencing: Provided direct access to product details without manual document navigation, saving time and reducing errors

The Impact

The GenAI chatbot solution delivered measurable improvements in sales productivity, training effectiveness, and customer engagement.

25–30% Growth in Autonomous Learning: Empowered global teams with enhanced self-driven learning capabilities
15–20% Productivity Boost: Streamlined workflows through seamless integration with existing enterprise tools
Stronger Customer Confidence: Delivered informed, consistent responses that built lasting trust
50%+ Increase in Knowledge Consistency: Standardized expertise across global field teams for unified service delivery
Scalable AI Platform: Future-ready architecture that evolves with business growth and expanding clinical knowledge

This GenAI-driven transformation empowered the client’s field sales teams to operate with greater agility, precision, and confidence. By integrating intelligent automation, real-time product access, and interactive training tools, Birlasoft helped the organization elevate its customer engagement and sales effectiveness.

Birlasoft’s Unified AI Strategy for MedTech

AI as the Engine for MedTech Transformation

AI is the unifying engine across Birlasoft’s MedTech transformation stack, driving innovation, safety, compliance, supply chain visibility, commercial excellence, and patient engagement throughout the product lifecycle.

AI/ML + GenAI for R&D Acceleration

Accelerate device design, simulation, and clinical validation through AI/ML, GenAI-powered testing, and data-driven R&D workflows.

Digital Twins for Prototyping & V&V

Real-time prototyping, virtual validation, and “first-time-right” design cycles for devices, systems, and smart factories.

Autonomous Code & Test Generation

GenAI and platforms like Birlasoft Lynx™ for automated test authoring, execution, and optimization across UI, API, and data layers.

AI-Powered Regulatory Intelligence

GenAI-led surveillance and summarization of global health authority updates, automated submissions, CAPA, and competitive intelligence.

Predictive Manufacturing & Smart Devices

AI and IIoT for predictive maintenance, yield optimization, and device performance monitoring across manufacturing and in-field usage.

GenAI for Commercial & Field Operations

Virtual assistants, AI-powered sales enablement, and predictive analytics to improve field rep productivity and customer engagement.

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Fast-track your Digital Transformation with Birlasoft Accelerators

Pre-built Frameworks, Accelerators, and Enablers to streamline and accelerate your releases

Birlasoft Cogito: AI/ML, Gen AI

AI platform that accelerates the development and deployment of AI-driven applications across the Medical Devices value chain by 30 to 50%

BTruBI : Data & Analytics

A business intelligence platform that enhances decision-making and operational efficiency through advanced analytics and data visualization

IntelliAsset, MachineLogix, ProdLogix: Connected Devices

IIoT, analytics, and action platform for real-time monitoring, data-driven insights, and proactive device management

BConnect: Remote monitoring, Wearables and Sensors

Enables IoT integration, remote monitoring, predictive maintenance, data analytics, and robust security measures

BSecure: Cybersecurity

Protect healthcare organizations from cyber threats by ensuring the security of patient data and healthcare systems through proactive monitoring and automated responses

Birlasoft Lynx: AI Led Testing

GenAI-powered, unified test automation solution that optimizes software testing across UI, API, and data layers for faster, smarter, and for the first time right releases

Case Study

Driving ERP Consolidation for a Global MedTech Manufacturer with JD Edwards EnterpriseOne 9.2

Reimagining MedTech with AI: Faster Innovation, Safer Devices, Connected Care

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