Services · Phase 1
User research and human-centered design for medical devices and combination products.
Identify user needs, workflows, and use-related risks early — and translate them into product direction, design inputs, and IEC 62366 evidence that holds up downstream.
When teams call us in
- Early user research needs to become a clear product direction.
- A combination product is approaching summative evaluation and the use-related risk file is not yet aligned with IEC 62366.
- Customer and user research needs to be calibrated into design inputs, not just left as qualitative findings.
- A submission reviewer has flagged the human-factors evidence package and remediation needs to land before the next round.
How we approach it
- Field and contextual research first — clear users, environments, and use scenarios before user-interface decisions.
- Use-related risk analysis (URRA) as a peer to broader hazard analysis, not a downstream artifact.
- Formative evaluation as a design feedback loop, not a checkpoint.
- Summative protocols designed to demonstrate critical tasks under representative conditions — and to survive scrutiny.
Typical deliverables
- Field research and workflow mapping.
- Use specification (IEC 62366-1).
- User-interface specification.
- Use-related risk analysis (URRA) integrated with the ISO 14971 risk management file.
- Formative and summative evaluation plans, protocols, and analysis.
- Human factors engineering report (HFE/UE report).
Frequently asked questions
- What does user research cover at the front of the lifecycle?
- Workflow and contextual research with the actual users in the actual environments — clinicians, technicians, patients, lay users — to identify needs, pain points, decision points, and use scenarios. Research is structured to feed design inputs, the use specification, and the use-related risk analysis, not to sit as standalone qualitative findings.
- How does this work integrate with IEC 62366 and ISO 14971?
- IEC 62366-1 specifies the usability engineering process; ISO 14971 governs risk management. In practice, the use specification, user-interface specification, and use-related risk analysis (URRA) need to integrate cleanly with hazard analysis. We treat URRA as a peer to the broader hazard analysis, not a downstream artifact, so summative results land cleanly.
- What is the difference between formative and summative evaluations?
- Formative evaluations happen iteratively during development to identify use-errors and refine the user interface. Summative evaluations happen on the validation build and demonstrate that critical tasks can be performed correctly under representative use. Skipping formative work, or running summative on an unfrozen design, is the most common reason summative results don't hold up.
- Combination products — is the human-factors evidence different?
- Yes. FDA expects combination products to demonstrate that the user can correctly perform critical tasks across both constituents. URRA and the use specification need to span the whole use scenario, including the drug constituent's preparation and administration steps where applicable.
Need user research or HFE evidence that holds up?
Engagements typically start with a scoping call to map where the product is in the lifecycle and the timeline you are working toward.