Kognio®
Services

Consultation packages built for regulated work.

Pick the engagement model that matches your stage. Every package is mapped to IEC 62366-1, ISO 14971, FDA HE 75, EU MDR, or applicable sector guidance.

Discovery Sprint

Two-week diagnostic for early-stage products.

  • Heuristic & regulatory gap analysis
  • Use-related risk pre-screen (ISO 14971 alignment)
  • Stakeholder & user interviews (n≤8)
  • Roadmap with prioritized HFE actions
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Most engagements

Formative Studies

Iterative testing through development.

  • Protocol design aligned to IEC 62366-1
  • Moderated sessions (sim or in-context)
  • Use-error analysis & severity coding
  • Design recommendations & retest cycles
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Summative HFE

Submission-grade validation.

  • FDA HE 75 / EU MDR-ready protocol
  • n=15+ representative users per group
  • Critical task analysis & residual risk
  • Full HFE/UE report for regulator submission
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Embedded HFE Lead

Fractional HF leadership inside your team.

  • 1–3 days/week embedded with product
  • Risk file & UE process ownership
  • Coaching design and engineering
  • Regulator response support
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Methods

  • Contextual inquiry
  • Cognitive task analysis
  • Heuristic evaluation
  • Use-error & root-cause analysis
  • Eye-tracking & physiological measures
  • Simulation-based testing

Deliverables

  • HFE/UE engineering report
  • Use specification & user profiles
  • Task analysis & known-use errors
  • Protocols, scripts, moderator guides
  • Regulator-ready summative report
  • Design recommendations & wireframes
Domain-specific consulting

Consultation packages by application context.

Scoped engagements for the workflows we know best — clinical, surgical robotics, and Human-AI.

Healthcare — EHR & Clinical Workflows

EHR modules, clinical decision-support, and clinician-facing tools.

  • Contextual inquiry in clinical settings (inpatient, ambulatory, home, community)
  • Cognitive walkthroughs of order entry, charting, handoff
  • Alert-fatigue & alarm-management studies
  • ONC Safety-Enhanced Design (§170.315(g)(3)) test plans
  • NIST IR 7741/7804-aligned summative reports
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MedTech — SaMD, Devices & Surgical Robotics

End-to-end research for SaMD, connected devices, and surgical robotics — including console, instrument, and OR-workflow validation.

  • Use specification & user-profile development
  • Mock-OR / sim-clinic protocol design with sterile-field fidelity
  • Console ergonomics and hand-control calibration studies
  • Surgeon and bedside-team workflow modeling
  • Formative + summative HF aligned to IEC 62366-1
  • Companion-app & home-use HF studies
  • 510(k) / De Novo / EU MDR HFE/UE reporting
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Aviation — Flight Deck & EFB

Electronic Flight Bag, cockpit displays, and crew workflow research for commercial aviation.

  • Cognitive task analysis on preflight, in-flight, and diversion workflows
  • High-fidelity flight simulation testing with line pilots
  • Heads-down time and situational-awareness measurement
  • Global gap analysis across airline operating procedures
  • Use-error analysis for charts, weather, NOTAMs, and taxi navigation
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Human-AI & Autonomy

AI-assisted and autonomous workflow research.

  • Trust calibration & reliance studies
  • Explainability & confidence-display patterns
  • Operator handoff & takeover testing for autonomous systems
  • AI Act / NIST AI RMF readiness reviews
  • Human-AI workflow mapping & error-mode analysis
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Case studies

Selected engagements.

Recent work across MedTech, healthcare, and aviation. Names and identifying details have been generalized to respect client confidentiality.

Robotic surgical system arms above a patient drape
MedTech · Robotic Surgery

Mock-OR validation for a next-generation surgical robot

Leading medical device manufacturer developing a next-generation surgical robot for minimally invasive procedures.

IEC 62366-1ISO 14971FDA HE 75FDA 510(k)
Clinicians reviewing a patient record on a tablet
Healthcare · State Medicaid EHR

Statewide Medicaid EHR rollout for IDD care coordination

State Medicaid agency implementing a new electronic health record system for intellectual/developmental disabilities (IDD) care coordination, including an embedded Level of Care Tool for clinical decision support.

Ethnographic researchCognitive task analysisONC SED §170.315(g)(3)NIST IR 7741
Two commercial airline pilots in the cockpit using iPad-based Electronic Flight Bags
Aviation · Commercial Flight Deck

Electronic Flight Bag (EFB) for commercial aviation

Leading aerospace company developing an integrated Electronic Flight Bag (EFB) application for commercial airlines, consolidating flight planning, weather, NOTAMs, charts, and crew coordination into a single platform.

Cognitive task analysisFlight simulation testingHuman factorsGlobal gap analysis