Strategy & planning
Right-size human factors activities across a product pipeline, from feasibility research through post-launch monitoring—and shape your strategy for implementing the right AI in your products.
Safer use. Stronger submissions.
Design out use risks
Human factors and usability engineering for medical devices, drug delivery systems, and AI-enabled products—from early research through FDA/EMA-ready validation.
Medical devicesDrug deliveryAI-enabled products
What we do
Support across the product lifecycle.
From a focused expert review to a complete human factors program, each engagement is shaped around your product, development stage, team, and regulatory path.
Use-related risk analysis
Analyze user tasks and foreseeable use errors, then connect findings to design, labeling, and training mitigations.
Formative & summative studies
Plan and run iterative formative research and validation studies that support confident design decisions and regulatory submissions.
Heuristic reviews
Evaluate concepts and prototypes early to uncover usability issues before they become expensive to change.
User & usability research
Turn contextual inquiry, interviews, surveys, personas, and user journeys into actionable product and technical requirements.
Teams, systems & data
Build in-house capability with hiring, procedures, templates, contract support, and biometric, anthropometric, and behavioral data collection.
Why act early
Find use errors before validation.
Late-stage use issues can force costly changes to the product, labeling, training, or submission plan. A deliberate human factors program brings those issues forward—when there is still time to resolve them.
Review your programUnderstand the real context
Study users, environments, workflows, and the conditions that shape safe use.
Connect evidence to risk
Translate observed behavior into clear priorities for product and program decisions.
Iterate with purpose
Test changes, resolve critical issues, and build a coherent evidence trail toward validation.
Where we focus
Complex products. Human realities.
Technical sophistication only creates value when people can use it safely and effectively. SEIFION connects product design, user evidence, risk, and regulatory expectations.
Regulated products
Human factors programs for medical devices and drug-device combination products, aligned to FDA and EMA expectations.
Critical interactions
Research and analysis that expose where interfaces, instructions, training, and real-world behavior can break down.
The right AI, by design
We help teams decide where AI belongs in their product—and where it doesn't. Strategy and UX research that turns AI features into interfaces people can understand, trust, and use safely, with validation evidence ready for FDA/EMA review.