In-vitro diagnostics (IVD) is at a strategic inflection point. What was once a manual craft, defined by pipetting, microscopy, automated instruments and bench-based assays, is rapidly evolving into an automation-first, data-driven discipline.

The drivers for this shift are undeniable: paper-based records continue to fragment the digital thread; and variability in manual workflows compromises reproducibility and traceability. Meanwhile, the global IVD market is projected to grow to $144B by 2028 with a CAGR ranging from 3.6% to 5.62%, demanding diagnostic solutions that are faster, more accurate and scalable across increasingly complex care pathways.

At HCLTech, we see automation not as a mere toolchain upgrade, but rather as a foundational engineering shift.

It unites robotics, AI/ML, connected devices and cloud platforms with robust quality systems, empowering both laboratories and manufacturers to deliver consistent, compliant results at scale, reduce time-to-market and strengthen regulatory confidence, in an era where diagnostic precision is non-negotiable.

Why automation now: The strategic imperative

Healthcare providers and manufacturers face converging pressures: faster clinical decisions, reproducibility at scale and audit-ready traceability. Intelligent automation — spanning robotics, AI/ML and cloud platforms — reduces variability, captures data in real time and integrates with EHRs, to strengthen diagnostic confidence and streamline care pathways. For manufacturers, that same digital thread unifies MES, IoMT and quality systems, to enforce process control across the entire product lifecycle.

Key barriers to adoption

• Legacy IT and data silos: Modern platforms strain against aging LIMS/ERP estates, fragmenting data and slowing insight.
• Human enablement: Without role-specific onboarding and SOP redesign, high-value automation is underused or misapplied.
• Validation and regulation: IVDR 2017/746, ISO 13485 and FDA expectations demand rigorous evidence that automated systems perform as intended and preserve data integrity.
• Environmental control: Temperature, humidity and cleanroom parameters must be continuously monitored and logged, especially for sensitive products.
• Data volume and governance: Next-gen instruments produce torrents of data; value requires governed capture, storage, analytics and interpretation.

What next-gen automated IVD looks like

Next-generation automated IVD replaces manual variability with orchestrated, data-driven precision, delivering scalable throughput, reproducible results and built-in compliance across the diagnostic lifecycle:

• High-throughput analyzers: Thousands of samples/day with predictable turnaround for emergency and high-volume settings.
• Labor cost reduction: Automation minimizes manual handling, reducing staffing needs and operational costs. It also frees up skilled personnel to focus on complex tasks like data interpretation and system optimization.
• Accuracy by design: Closed-loop robotics and AI reduce human variability, delivering consistent, reproducible results.
• Regulatory-by-default: Built-in traceability, audit trails and automated documentation speed inspections and market access.
• Smart manufacturing integration: Sensors + MES enable real-time process control and end-to-end lot genealogy.
• Predictive maintenance: ML flags early wear and failure signatures to minimize downtime and extend asset life.
• Cloud-ready scale: Centralized monitoring, remote access and seamless EHR integration support decentralized and point-of-care testing.

Outcomes that matter to the business

Beyond the lab, intelligent automation translates into measurable business value, higher efficiency, stronger regulatory readiness, end-to-end data integrity and consistent environmental compliance:

• Operational efficiency: Fewer manual steps, fewer errors, faster cycle times. HCLTech’s SaMD and IVD solutions automate data capture and analysis, while complaint-investigation workflows shorten resolution and reduce human error.
• Regulatory readiness: Digital logs and continuous monitoring improve audit posture; our consulting accelerates multi-region approvals.
• Data integrity: Controlled lifecycle management ensures completeness, consistency and traceability, from instrument to insight.
• Environmental compliance: Continuous tracking of temperature, humidity and other parameters supports storage and production standards.
• Strategic Development
  • Automated Point-of-Care devices: Decentralized testing with minimal user input
  • AI-based diagnostic software: Decision support for interpreting results without manual review
  • Cloud-based laboratory systems: Remote access and centralized oversight for standardized processes

From lab to market: Validated, trained and compliant

Automation succeeds when validation and people strategy are first-class citizens. FDA-aligned CSV/CSA expectations require proof that systems function as intended, with robust controls for data integrity. Equally, teams need targeted training and SOP evolution to realize the full value of digital workflows, safely and repeatably.

At the core of this transformation is the IVD Centre of Excellence (CoE), which delivers end-to-end lifecycle support, powered by 60+ domain experts, including doctorates from top global institutions. The CoE specializes in immunology, microbiology, molecular biology and clinical chemistry, combining technical depth with a strong partner ecosystem.

Integrated services across five key stages:

• Planning and feasibility: Market analysis, regulatory mapping, infrastructure and material planning
• Design and development: Assay optimization, prototype creation and performance validation
• Production and technology transfer: LEAN manufacturing, QC, packaging, documentation and checklist-driven execution
• Post-production and sustenance: Stability studies, CAPA handling, customer feedback integration and calibrator value assignments
• Regulatory and quality compliance: Support for CAP, IFCC, NGSP, EQAS, with documentation aligned with CLSI, ISO 15189 and ISO 20916

Key differentiators:

• Partner ecosystem: Collaborations with hospitals, CROs and diagnostic labs
• Client-centric model: Defined checkpoints for client approvals and SME reviews

How HCLTech accelerates digital IVD

We partner with global MedTech and diagnostic leaders to enable digital transformation into every step of the diagnostic lifecycle.

• AI and GenAI for quality and RA: Automated complaint triage, regulatory document authoring, health-authority response acceleration; predictive analytics for quality events; GenAI-assisted smart content
• Connected lab and cloud platforms: MES, IoMT and EHR integration on secure, compliant cloud for real-time monitoring and decentralized diagnostics
• Data and analytics enablement: Governed pipelines, advanced analytics and predictive maintenance integrated with enterprise systems.
• Proven impact:
  • 650K+ complaints handled
  • ~50% cycle-time reduction via AI/ML
  • 480+ IVDR remediations
  • 600K+ labels updated for global clients

The HCLTech point of view

Automation in IVD is evolving from accelerating throughput to engineering trust. By integrating robotics, AI and quality systems within a governed digital thread, diagnostics can scale without compromising accuracy or compliance.

HCLTech is pioneering a forward-thinking automation strategy that goes beyond traditional lab workflows.

Our approach spans smart manufacturing, regulatory compliance and post-market tracking. Through AI, machine learning and generative AI, we enable predictive maintenance, intelligent complaint handling and efficient regulatory documentation.

Our cloud-native platforms integrate seamlessly with MES, IoMT and EHR systems, supporting decentralized diagnostics and real-time operational visibility for faster, data-driven decisions.

What sets HCLTech apart is our inherently compliant automation architecture. Features like built-in traceability, governed data flows and continuous environmental monitoring ensure that quality and oversight are never compromised. This design philosophy embeds validation, training and compliance into the very fabric of the system.

Is your IVD strategy engineered for autonomous quality? Let’s define a roadmap to modernize workflows, strengthen data integrity and accelerate approvals—delivering the right result, at the right time.