Kognio®
Services

Consultation packages built for regulated work.

Safety-critical human factors across three practice areas: medical devices, intelligent mobility (ADAS, AV, aviation), and human-AI systems (clinical AI, autonomous decision support, EU AI Act compliance). We deliver end-to-end support from concept to market.

Indicative starting prices in USD. Final scope and quote depend on study design, participant counts, and regulatory context.

Discovery Sprint

$10k

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
Inquire
Most engagements

Formative Studies

From $25k

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
Inquire

Summative HFE

Quoted

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
Inquire

Embedded HFE Lead

$2,000/day retainer

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
Inquire

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
Consultation by context

Consultation packages by application context.

We offer scoped engagements tailored to the workflows we know best - clinical environments, medical devices, and high-stakes systems.

MedTech / SaMD
and 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
Inquire

Healthcare UX
and 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
Inquire

Safety-Critical Systems

Aviation, mobility, and Human-AI autonomy research - applying the same safety rigor across mission-critical interfaces.

  • Aviation & FlightDeck Systems:
  • Cognitive task analysis, heads-down time, and situational awareness
  • Use-error analysis for charts, weather, NOTAMs, and taxi navigation
  • High-fidelity flight simulation testing
  • Mobility & Complex Human-Device Interaction:
  • Human-device interaction in complex, safety-critical, and mobility contexts
  • In-vehicle interface UX, heads-up displays, and multi-modal control systems
  • Human-AI & Autonomy:
  • Trust calibration & reliance studies
  • Explainability and operator handoff testing
  • Error-mode analysis for AI co-pilots and decision support
Inquire
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)
View case study
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
View case study
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
View case study