Consultation packages built for regulated work.
Safety-critical domains 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.
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
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
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
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
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 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
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
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
Selected engagements.
These engagements are drawn from prior and current practice across MedTech, healthcare, and safety-critical systems. Names and identifying details have been generalized to respect client confidentiality.
Mock-OR validation for a next-generation surgical robot
Leading medical device manufacturer developing a next-generation surgical robot for minimally invasive procedures.
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.
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.
Modernizing an ablation UI console
A medical device company's microwave ablation system for interventional radiology and oncology, undergoing a console UI modernization, consolidating a legacy two-screen, dual-arm configuration into a single consolidated display for use in the IR suite. Confidential client (NDA).
AI sales intelligence for biotech SaaS
A biotech company developing a SaaS sales coaching platform needed HFE-grounded design and evaluation for a dashboard used by sales representatives during and after client calls. No existing product benchmarks were provided; the engagement ran entirely from client-supplied process videos and whiteboard documentation. Confidential client (NDA).
Reducing cognitive load and flight delays
No Delay: redesigning a legacy pilot operations platform for one of the world's largest airline carriers, running a 40-year-old platform for pilot and ground-support operations.