Excellence for diagnostic laboratories

Together, we boost the efficiency of your laboratories

Finding not just any solution, but the right one

The German diagnostics market is facing fundamental structural change: increasing regulatory requirements under the IVDR, growing cost pressures within the statutory health insurance sector and the shortage of skilled MTLA staff demand a radical rethink. ISO 15189 accreditation is now a prerequisite, not a unique selling point. The key differentiating factors are turnaround time, data quality, system integration and the ability to scale analytically. All whilst ensuring maximum cost efficiency.

adesso combines in-depth diagnostic domain knowledge with end-to-end transformation expertise, specifically for leading diagnostic laboratories, medical care centres (MVZ) chains and laboratory networks in Germany and Europe.

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Our services are relevant to these sectors

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  • Clinical chemistry
  • Haematology
  • Microbiology
  • Molecular diagnostics
  • Pathology
  • Immunology
  • Haemostasis
  • Point-of-care testing (POCT)
  • Toxicology
  • Genetics

15 % Average reduction in laboratory costs

27 % Reduction in turnaround time (TAT)

36 % Increase in the level of automation

The diagnostics market at a crossroads

Market drivers

M&A consolidation & post-merger integration

The diagnostics market is consolidating rapidly, requiring large laboratory networks to efficiently integrate heterogeneous systems and processes without jeopardising accreditations.

IVDR & Regulatory Change

Stricter regulations such as the IVDR, as well as new requirements for data protection, quality and traceability, are significantly increasing the regulatory burden.

Skills shortage & pressure to automate

The shortage of qualified staff is forcing laboratories to increasingly automate their processes across the entire value chain.

Challenges

Fragmented IT & lack of interoperability

Inconsistent systems and a lack of interfaces prevent seamless, transparent and efficient data processing in laboratory operations.

Cost pressure & statutory health insurance reimbursement system

Rising costs and stagnating reimbursements are leading to falling margins and necessitating fundamental operational changes.

Device integration & data silos

A lack of integration between analytical instruments and IT systems results in manual effort, sources of error and compliance risks.

Six proven levers for improvement

LIS optimisation

Workflow redesign, custom configuration and module extensions for diagnostic-specific processes and SLA requirements.

Device integration

Bidirectional LIS device integration, IoT gateways for legacy devices, real-time measurement data capture without manual input.

AI-based result validation

Automatic plausibility checks, delta checks, anomaly detection and AI-powered decision support for MTLAs.

Lab Data Analytics

Real-time KPI monitoring, lab performance management and predictive capacity planning for laboratory management.

Laboratory Chat Agent

NLP-based AI assistant for MTLAs and laboratory physicians: immediate answers regarding IVDR requirements, RiliBÄK guidelines, SOPs and methods — on-premise, GDPR-compliant.

Regulatory

Automated IT system validation (CSV) in accordance with ISO 15189, complete audit trails, digital IVDR documentation for in-house diagnostics (LDTs) and KRITIS-compliant IT risk management.

Digital laboratory transformation

  • Post-Merger Integration

    In a rapidly consolidating diagnostics market, the value of an acquisition is determined within the first 100 days. The integration of LIS systems, process standards and quality systems requires in-depth laboratory domain expertise, not generic IT playbooks.

    • Digital Due Diligence: Pre-acquisition assessment of the target company’s IT and LIS architecture, data integrity risks and accreditation transfer complexity.
    • IT Consolidation Roadmap: Consolidation of fragmented application landscapes (LIS, order entry, billing software) onto unified platforms.
    • SOP & Quality Harmonisation: Alignment of all SOPs and quality systems to ensure ISO 15189 compliance across all acquired sites.
    • Synergy Tracking & Process Efficiency: KPI-based milestone monitoring and delivery reporting for the integration steering group.

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  • Portfolio & margin management

    Moving away from blanket P&L cost allocation towards precise margin management at the individual parameter level. In the margin-compressed GKV/GOÄ environment, granular cost transparency is a decisive competitive advantage.

    • Activity-based costing: Determination of exact reagent, energy, depreciation and personnel costs per analytical method (e.g. LC-MS/MS, ELISA, PCR).
    • Service portfolio rationalisation: Separation of low-margin niche parameters from high-margin high-throughput analyses for optimal capacity allocation.
    • Cross-site benchmarking: Comparison of analyser utilisation and unit costs across the entire laboratory network for consolidation planning and make-or-buy decisions.
    • Portfolio analysis: Data-driven contribution margin analysis provides clarity on the actual profitability of parameters.

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  • Digital growth strategy

    The most sustainable competitive advantage in diagnostics stems not from price, but from the depth of integration. Laboratories that embed their findings and expertise directly into referrer processes transform from interchangeable service providers into indispensable strategic partners.

    • CRM migration: Selection, replacement, migration and further development of CRM systems, taking laboratory-specific requirements into account
    • Patient portals & practice management: Integration of and process optimisation through patient portals, appointment scheduling, practice management
    • Proactive trend alerting: Automatic notification of doctors in the event of critical values or values approaching thresholds, before problems escalate.
    • Digital Referrer Portal: Real-time order status, historical trend graphs and digital delivery of results reduce telephone enquiries by up to 60%.

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  • Challenge

    Manual result validation, time-consuming searches in method databases and a lack of support for interpreting results increase the risk of errors and the workload on medical laboratory technicians.

    Solution

    AI-supported result validation, automatic anomaly detection, Gen-AI assistants for regulatory compliance and IVDR documentation, embedded in daily laboratory processes.

    Use cases

    • Automated visual inspection & defect detection
    • Predictive analytics & anomaly detection
    • AURA - Doctor’s Letter AI
    • Lab Chat Agent

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  • Challenge

    Historically evolved LIS landscapes with inadequate HIS/EPR integration, proprietary interfaces and a lack of FHIR capability prevent end-to-end data transparency.

    Solution

    Vendor-neutral LIS evaluation, FHIR R4 migration, multi-site harmonisation and seamless ERP/HIS/PVS integration for the entire laboratory network.

    Use cases

    • Cross-site LIS workflow standardisation
    • HL7-FHIR migration & interoperability architecture
    • Automated transmission of results to HIS/PVS

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  • Challenge

    Fragmented on-premises infrastructure with high maintenance costs, limited scalability, cybersecurity risks and inadequate GDPR compliance for patient data.

    Solution

    Private cloud architecture, BSI-C5-compliant hosting concepts and zero-trust security models, specifically developed for diagnostic data protection requirements.

    Use cases

    • Private cloud migration (LIS, DMS, archive)
    • BSI-C5-compliant security architecture
    • Disaster recovery & business continuity

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  • Challenge

    Manual data entry from analysers (Roche, Siemens, Abbott, Beckman) into the LIS causes transcription errors, delays in results and compliance gaps.

    Solution

    Fully automated, bidirectional device-to-LIS integration. Vendor-independent, across all analyser generations, via middleware and IoT gateways.

    Use Cases

    • Bidirectional LIS data exchange (ASTM, HL7)
    • IoT environmental monitoring (temperature, humidity, cold chain)
    • Legacy device integration via middleware

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IT applications for diagnostic laboratories

SAP S/4HANA

ERP backbone for finance, procurement and HR management within a laboratory network. adesso implements and migrates S/4HANA with deep LIS and billing integration, including DATEV and GKV connectivity.

Electronic transmission of test results

Fully digital communication of test results via HL7 v2/FHIR R4, KIM (Communication in Healthcare) and medical information systems. Paperless, audit-proof, with qualified electronic signature.

CRM

Referrer and customer relationship management: order volume tracking, visit planning, complaint handling and churn analysis for GPs, medical centres and hospitals.

Order Entry

Digital order entry directly by the referrer. Web-based or via app. Reduces queries, data entry errors and media breaks. Integration into PVS via HL7/FHIR.

ELN – Electronic Laboratory Notebook

Audit-proof, GLP-compliant documentation of experiments, method development and validation runs. Direct LIS connection for automatic data transfer and IVDR record-keeping.

WMS – Warehouse Management

Inventory management for reagents, consumables and sample archives. Automatic reordering, batch tracking, best-before date monitoring and storage location optimisation, integrated with SAP and LIS.

AI Platform

On-premise or private cloud AI infrastructure for diagnostic laboratories: RAG knowledge systems (Laboratory Chat Agent), anomaly detection, AURA medical report generation and predictive analysis models. GDPR-compliant.

Device middleware

Cross-vendor connectivity layer between analysers and LIS. Bidirectional data exchange via ASTM, HL7 and proprietary protocols, including for legacy devices.

Use cases for laboratory AI

  • Automated visual inspection & defect detection

    Computer vision models analyse microscopic images, blood smears or histological sections in real time and identify abnormalities. More consistently than the human eye. According to industry data, error rates can be reduced by up to 50 per cent and diagnostic cycles accelerated by 30–50 per cent.

  • Predictive analytics & anomaly detection

    ML algorithms analyse historical laboratory data, identify patterns and predict potential deviations, for example in blood count analyses, immunoassays or clinical chemistry follow-up checks. This allows abnormalities to be detected earlier in the diagnostic process and quality issues to be addressed proactively.

  • AURA – AI for medical reports

    AURA is a platform-independent, AI-powered documentation solution from adesso that supports doctors in drafting medical letters and findings reports. Through ambient listening, automatic laboratory data interpretation and GenAI letter generation, AURA reduces the manual documentation workload by around 70 per cent, thereby freeing up significantly more time for patients

  • Lab Chat AI Agent

    A Retrieval-Augmented Generation (RAG) system links the IVDR database, the SOP library, the RiliBÄK regulations, the service catalogue and the laboratory’s methods archive with a secure, on-premise language model. This enables the Chat Agent to generate immediate, traceable, fully source-cited answers for MTLA staff and laboratory physicians, without patient data ever leaving the premises. Queries regarding reference ranges, sample processing, FAQs, specific details for sample senders, device commissioning, correct profiles and parameter authorisation result in an average time saving of 40 per cent.

Selected References

Do you have any questions?

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