Usability engineering and product design for clinical tools and device software
In a clinical tool, a use error can hurt a patient. We design and test software for ICU monitoring, diagnostics, and surgical workflows, and we plan the IEC 62366-1 usability engineering file from the first workshop.
What we see in health and medtech products
The problems we fix
The usability file gets written at the end
A lot of teams write the usability engineering file once the design is already finished. That's when the gaps show up: critical tasks that were never tested, and hazard-related use scenarios that don't match the risk analysis. We plan the file alongside the design, so the evidence is there when a notified body or the FDA asks for it.
Clinicians work under pressure
In an ICU, a nurse is dealing with interruptions, alarm fatigue, and time pressure. If an important change in a patient's status is buried in a dense screen, it can get missed. We design the visual hierarchy around the decisions clinicians actually have to make, and we test it with them before it's built.
New features change the risk
When you add a new parameter or an AI feature to a device, you add new failure modes, even if most of the workflow stays the same. We separate the new tasks from the ones that were already validated, so the testing focuses on where the new risk is.
Rules and deadlines
The rules your product has to meet
- Applies now
IEC 62366-1 and FDA human-factors guidance. The usability engineering standard notified bodies and the FDA expect for medical device software.
- 31 Dec 2027
MDR transition for higher-risk devices. Devices certified under the old directives have to move to MDR certificates.
- 31 Dec 2028
MDR transition for lower-risk devices. The later deadline for the remaining device classes.
- 2 Aug 2028
AI Act rules for AI in medical devices. AI built into regulated products, including medical devices, takes on the AI Act's high-risk obligations.
Where to start
Services for health and medtech teams
- Diagnose · from €6,000Usability ReviewWe check your usability engineering file against IEC 62366-1 and FDA human-factors guidance before you submit, and tell you exactly what to fix.
- Prove · from €9,500Evidence SprintWe design and build one core flow as a working app on a live URL, test it with 5 to 8 people from your user group, and give you a fixed price for the full build.
- Build · from €25,000BuildThe same team that ran the research designs and builds your product, at a fixed price for the scope we agree on.
Our work
Projects in health and medtech
Bayer · Critical careHow we made ARDS risk readable at a glance for ICU clinicians
Philips · Medical devicesAdding a new clinical parameter to an ICU patient monitor, safely
QIAGEN · DiagnosticsReducing use errors on a high-throughput molecular testing instrument
ORtelligence · Operating roomDesigning a surgical instrument scanner for the operating room
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