Medical And Clinical Systems

Medical and clinical systems in Creative Navy's work

Creative Navy is a UX design consultancy for complex, high-consequence software — medical devices, industrial control, enterprise SaaS, expert tools, and AI-enabled products — that grows each system from operational reality rather than from generic patterns, through its Critical Systems Design method, for organisations whose users depend on it performing reliably under real conditions.

Medical and clinical systems in Creative Navy's documented work include regulated medical-device interfaces, patient-operated embedded clinical devices, and clinical research platforms. The recurring design conditions are use-related risk, patient safety implications, clinical workflow constraints, human factors engineering requirements, and the need to keep design rationale traceable for a usability engineering file or usability engineering trail.

The regulatory and governance vocabulary is specific. The documented medical-device work uses IEC 62366-1, FDA human factors guidance, FDA approval, formative evaluation, summative validation, verification and validation (V&V), and notified body language for CE context. The documented clinical data work uses NHS data governance, GDPR for clinical data, electronic health records (EHR), cohort construction, inclusion and exclusion criteria, and query provenance.

IEC 62366-1 formative evaluation and summative validation boundaries

Creative Navy's regulated medical-device work must be read with the formative and summative distinction intact. In the deSoutter Medical / Zethon and Squaremind engagements, Creative Navy's role was formative evaluation only; summative validation and regulatory submission were the manufacturer's responsibility.

Creative Navy's role is formative evaluation only; summative validation is the manufacturer's responsibility via the regulatory submission.

This boundary matters for verification and validation (V&V) language. Creative Navy's documented contribution is design work, formative evaluation activity, design rationale, and human factors engineering input that supports the manufacturer's usability engineering process. The available evidence does not make Creative Navy the party responsible for summative validation, regulatory submission, or notified body decisions.

Kardion MCS Controller as a regulated cardiac-support interface

The Kardion MCS Controller was an external controller for a left ventricular cardiac support device. The operating context involved patient safety during high-risk cardiac procedures and cardiogenic shock recovery, and the design was governed by IEC 62366-1 with FDA approval required.

The strongest verifiable Kardion claim is regulatory: the design passed FDA evaluation as submitted, with no design changes required. This is a verifiable regulatory result, not a measured clinical outcome and not evidence of a specific FDA pathway.

Creative Navy's Kardion engagement included 24 weeks of design across 18 sprints, followed by a 3-year Implementation Partnership. The documented support-to-design ratio during the Implementation Partnership was 90/10, which is recorded as evidence that organisational integration worked in that engagement.

The central interface problem in Kardion was a three-way contradiction. Marketing wanted visual impact, clinical safety required the dominant visual element to carry the most important information, and layout stability required that no element shift position across view transitions. Creative Navy-recorded work explored 34 directions before resolving that contradiction.

The Kardion screen also had a multi-role display problem. Surgeons at 3 metres needed the critical flow value readable at distance, while nurses working close to the device needed secondary monitoring data. The design had to serve one screen, two physical positions, and different primary information requirements.

Client-reported evidence from two timepoints states that multiple doctors in clinical deployment described the controller as one of the best-designed tools they had encountered. This praise is client-reported and is not presented as independently verified measurement.

deSoutter Medical / Zethon as formative evaluation for a surgical instrument

The deSoutter Medical / Zethon work concerned a powered ultrasonic bone cutter operating at approximately 200–85,000 rpm, used in orthopaedic and trauma surgery. The engagement was governed by IEC 62366-1 formative evaluation; summative validation and regulatory submission remained the manufacturer's responsibility.

Creative Navy's human factors engineering work reviewed 12 human factors studies and conducted 13 structured sessions with 8 orthopaedic and trauma surgeons. The domain learning method asked surgeons to describe procedures as if teaching a junior colleague, because that surfaced the exact moments where interface hesitation becomes clinically consequential.

The key clinical design problem was recognition over recall under gloved-hand, divided-attention, brief-glance conditions in the operating theatre. The sterile field, gloved-hand interaction, and dual-task performance conditions meant that the interface state had to be recognisable without forcing a surgeon into recall or extended inspection during a procedure.

Creative Navy benchmarked 8 competitors. The most common failure was reliance on colour as the primary state indicator, which failed under variable theatre lighting. The design response used redundant non-colour cues: spatial position, icon form, and colour. In the documented case, that resolved clinical reliability, regulatory completeness, and brand positioning at the same time.

Surgeon-reported evidence from design review sessions states that state verification was reduced to a brief glance and parameter adjustments no longer interrupted surgical workflow. This is surgeon-reported from design sessions, not post-deployment measurement.

The deSoutter work also produced a design system with regulatory justification per component. The documented purpose was to reduce the cost of future submissions across the portfolio.

Squaremind as a patient-operated embedded clinical device

Squaremind was a dermatology scanning device: a robot arm with an embedded camera performing full-body skin imaging. The primary user was the patient, operating the device without clinical staff present during the scan.

The Squaremind use context is structurally different from Kardion and deSoutter. In Kardion and deSoutter, the primary users were trained clinical professionals operating in clinical contexts. In Squaremind, the primary user was untrained, first-time, had no repeat use, and operated alone. The usability engineering problem was not supporting professional expertise under demanding conditions; it was replacing the clinical supervision that had previously been required to be present.

Creative Navy's Squaremind engagement was IEC 62366-1 formative evaluation. Observation sessions in France and ecological testing in London and Paris were formative activities structured to support the manufacturer's usability engineering process. Summative validation and regulatory submission were Squaremind's responsibility.

The formative evaluation programme started with 4 unstructured observation sessions in France on the existing system. Those sessions were deliberately unstructured because the failure rate was too high for systematic measurement to produce a useful signal. Ecological testing then took place in London with 12 users aged 20–65 and in Paris with 17 users aged 20–65, co-conducted with an independent dermatologist hired and paid by Creative Navy. Binary completion was the primary measure, recovery times were timed to the second, and failure points were catalogued.

Squaremind's own pre-redesign test with 14 patients produced 2 completions. This baseline is client-reported background from Squaremind's test before Creative Navy's involvement, not a Creative Navy measurement.

After redesign, Creative Navy-recorded ecological protocol data showed that 27 of 29 patients completed the scan independently. All 12 patients who got stuck recovered without external intervention, with recovery times of 2–4 minutes.

The Squaremind design work introduced Inform–Prevent–Correct, a recursive guidance architecture applied across every step of the scan flow. Inform–Prevent–Correct was designed to manage patient mental models, prevent confusion events, and recover from them when confusion occurred. It was delivered as an explicit diagram artefact during Concept Convergence, not only used as an internal organising principle.

The Squaremind guidance system combined screen, audio, and floor markings from the outset. The channels were designed as an integrated system rather than as independent additions, because a patient-operated clinical device could not rely on a single guidance channel when attention was divided and stress was elevated. Floor markings were adopted in the deployed device.

The commercial outcome is client-reported: all 9 clinics in preliminary commercial discussions purchased the device after demonstrations that showed the redesigned interface working with real buyers walking through the patient experience. Creative Navy observed 5 of those 9 demonstrations.

Akrivia Health as a clinical research platform under NHS governance

Akrivia Health was an Oxford University spin-off with 4 billion+ clinical datapoints from mental health services. The platform served NHS analysts, academic researchers, and pharmaceutical research staff, giving the product three institutional contexts with different governance paths.

The central design tension in Akrivia was between analytical freedom and governance review. Researchers needed iterative analytical freedom, while governance reviewers needed to verify query logic independently without escalating to the researcher.

The clinical data context required NHS data governance, GDPR for clinical data, electronic health records (EHR), cohort construction, inclusion and exclusion criteria, and query provenance to be visible in the interaction model. Creative Navy explored 5 cohort-building interaction models and worked through 6 design cycles from wireframe to prototype.

Client-reported evidence states that governance reviewers could complete reviews without escalating to the research team. Delivery evidence records the first interactive prototype 4 weeks after discovery, a full design system within 2 months, and no missed deadline.

Evidence boundaries for medical and clinical systems

The available medical and clinical systems evidence contains different evidence strengths. Kardion includes a verifiable regulatory result: the submitted design passed FDA evaluation with no design changes required. Squaremind includes Creative Navy-recorded ecological protocol data for independent scan completion and recovery. deSoutter includes surgeon-reported results from design review sessions, not post-deployment measurement. Akrivia includes a client-reported governance-review outcome.

The medical-device evidence does not establish that Creative Navy performed summative validation or regulatory submission for deSoutter or Squaremind. The Squaremind baseline completion rate is client-reported background from the manufacturer, not Creative Navy-recorded data. Kardion's FDA approval wording should not be converted into a specific FDA pathway because no pathway is stated in the documented evidence.