Kognio Labs is a human factors and UX research practice embedded with product teams shipping in MedTech/SaMD, healthcare UX, and safety-critical systems.
Enhancing safety-critical systems across healthcare, MedTech, and high-stakes domains.
Every recommendation traces back to evidence - from contextual inquiry to summative testing.
Reports written to be read by FDA reviewers and EU notified bodies, not just product teams.
We work the way modern teams work - in design tools, in standups, in your risk file.
Human Factors Engineering (HFE) studies how people perform under real operating conditions - workload, error, risk, and the residual likelihood of harm. In safety-critical work it's tied to regulation: IEC 62366-1, FDA HE 75, EU MDR, and equivalent sector guidance.
UX Research (UXR) studies how people understand, decide, and act inside a product. It shapes flows, language, hierarchy, and trust. In MedTech, healthcare, and autonomy the two overlap heavily - but HF carries the regulatory burden, and UXR carries the product one. Kognio runs both, in the same engagement.
Safety isn't a feature - it's the emergent property of a well-designed socio-technical system. We don't optimize interfaces in isolation. We study the work, the workers, the tools, the policies, and the consequences. Then we design for the human as they actually are - under load, under stress, under regulation - not as we wish they were.
Kognio Labs is led by Anastasia Sternberg, Founder and Principal Human Factors Engineer specializing in safety-critical systems across MedTech, healthcare, and aviation.
Her work sits at the intersection of cognitive psychology and systems design, applying the behavioral science of how people perceive, decide, and fail under pressure to the engineering of interfaces, workflows, and devices where error has consequences.
Her background spans over a decade: statewide Medicaid system rollouts and clinical training programs, formative and summative studies across a broad MedTech portfolio including surgical robotics, endoscopy, cath lab, contrast media delivery, wound care, and neonatal systems; and in aviation, full-cycle UX research at ForeFlight, contributing to a platform used by over 80% of the commercial aviation market, full-motion flight simulation testing, and ground control contextual inquiry at one of the largest domestic U.S. carriers.
Kognio Labs was founded on a specific premise: that as AI systems enter clinical and safety-critical environments, the field needs human factors practitioners who understand both the regulatory burden and the cognitive reality of the humans in the loop.
Active in the professional societies that set the standards we work to.
Filter the glossary below for terms like summative, simulation, or use error. For regulatory standards (IEC 62366-1, FDA HE 75, EU MDR, ISO 14971, EU AI Act, and more), ask Kognio.
Designing systems - devices, software, environments, procedures - around the realistic capabilities and limits of the people who use them. In safety-critical domains, HFE focuses on preventing use-related harm and is required by regulators including FDA and EU notified bodies.
Studying users and workflows to inform product decisions. UXR overlaps with HFE in method but is typically optimized for product–market fit, adoption, and satisfaction rather than risk control.
HFE outputs go into a regulatory file: use specifications, task analyses, use-error analyses, and a summative validation report tied to ISO 14971 risk controls. UXR outputs go into the product backlog: opportunity maps, journey models, design recommendations.
Formative happens during design - small samples, fast turnarounds, no pass/fail. Summative happens once the design is essentially frozen - representative users, representative environment, scripted scenarios, and a defensible result for a regulatory submission.
MedTech: mock-OR labs, simulated wounds, home-use environments, high-fidelity manikins. Autonomy / Human-AI: scripted decision sessions with synthetic patient or operational data, scenario-based handoff and takeover testing.
The unit Kognio designs for: people, the tools they use, the procedures they follow, the organization they work in, and the environment they operate in - all coupled together.