Medical device UX and UI design for operating theatre use

A precise user interface for surgical instruments

Lääkinnälliset laitteet

Käyttäjäkokemus

Interface Design

ASIAKASdeSoutter Medical / Zethon
SIJAINTIAylesbury, UK
TIIMIUX-suunnittelija, UX-tutkija, UI-suunnittelija, vuorovaikutussuunnittelija, projektipäällikkö, tuotepäällikkö.
Videoyhteenveto
Greg näyttää, miten uusi käyttöliittymä vaikuttaa ultraäänileikkuria käyttäviin kirurgeihin.
2:32

The client is a European manufacturer of powered surgical instruments, comparable to the more advanced producers of orthopaedic and trauma tools in the region. Their portfolio combines mechanical precision with electronically controlled systems for operating theatres. Within this context they developed an innovative ultrasonic cutter with rotational speeds from approximately 200 revolutions per minute up to around 85 000 revolutions per minute. The device required a safe and reliable embedded GUI that would support surgeons during procedures and satisfy medical device usability and compliance requirements.

This project is part of our continued work in medical devices and safety-critical interfaces, where evidence based UX, IEC 62366 compliance and clinical workflow validation shape interfaces for regulated healthcare environments.

We applied Dynamic Systems Design, a method that grows solutions through embedded experimentation, resolves tensions between local optimization and system coherence, and stewards implementation until organizations gain independence.

The company regarded the graphical user interface as a strategic element rather than a cosmetic layer. They wanted the medical UI design for this ultrasonic cutter to become a recognisable signature of their brand, particularly for orthopaedic and trauma surgeons who use powered tools daily. The surgical user interface needed to signal a serious instrument designed for mission-critical use, not a generic display adapted from consumer electronics.

The collaboration ran over roughly three months. Day to day work took place with a product owner and an embedded software engineer who knew the internal architecture of the device. A broader steering committee, which included clinical, regulatory, quality and commercial roles, met every two weeks. From the beginning the work was framed within the IEC 62366 usability engineering process and related medical device standards, so every decision in the medical device UX design could be traced back to explicit use scenarios and risk considerations.

The project acknowledged the realities of surgery in detail. Surgeons interact with the display in very short glances while their primary attention remains on the patient and the surgical field. They operate the GUI with the non dominant hand, through gloves, often in constrained positions. They rely on recognition rather than reading. The embedded interface therefore had to reduce decision load, prevent unnecessary visual search, and maintain predictable behaviour under stress. This combination of clinical constraints, regulatory expectations and brand ambition defined the scope of the work on UX for medical devices in this case.

PANOKSEMME

IEC 62366 Requirements Analysis

Surgeon Interviews

Human Factors Research

Option Space Mapping

Interaktioarkkitehtuuri

Surgical Scenario Validation

Gloved-Hand Prototyping

Medical Device UI Design

Design System

Regulatory Documentation

Engineering Alignment

Implementation Partnership

LIMITATIONS OF THE LEGACY INTERFACE

Before the project began the engineering team had created a first version of the surgical device interface. The screens followed the internal software structure and exposed all functions, which is typical for an engineer designed embedded interface. From a clinical perspective, however, this early embedded GUI did not function as a safe surgical user interface.

Eight surgeons who were familiar with ultrasonic and powered tools reviewed the legacy screens. They reported that activation states and readiness conditions were difficult to interpret at a glance. Several parameters that matter during cutting were visible but not clearly prioritised. Warnings were presented in ways that required reading rather than instant recognition. In a busy operating room this profile of interaction is not acceptable.

Commercial and marketing stakeholders added their own view. They judged that the interface did not reflect the performance or refinement of the hardware. It looked like a functional but provisional engineering surface rather than a flagship medical device interface design. For a product that competes in a crowded market of high performance surgical tools this presented a risk.

At the same time the legacy GUI provided a useful functional map. It listed all the controls that influence energy delivery and cutter behaviour, including cartridge handling, speed selection and safety interlocks. The design team used this baseline as a catalogue of essential functions and constraints through constraint respecting. Respecting the work already done, they treated it as a starting point for a more clinically coherent and evidence-based medical device UX rather than as something to discard.

Edellinen Design

REQUIREMENTS, RESEARCH AND CONSOLIDATION

Because the device would be subject to IEC 62366 usability engineering expectations, the project began with a deliberate consolidation of knowledge through Sandbox Experiments. Internal documentation, software specifications, surgeon comments and regulatory interpretations were collected and organised into a structured set of candidate requirements. The goal was to move from scattered insight to a coherent view of what the interface must support.

To address gaps in this early map the team carried out thirteen sessions with eight surgeons from orthopaedic, trauma and related specialties. These sessions combined structured interviews and walkthroughs of typical procedures where ultrasonic cutting is used for bone or hard tissue. Surgeons described their actions as if they were teaching a junior colleague. They explained when they verify cartridge seating, when they check speed or power, how they coordinate with assistants, and which moments are most sensitive to delay or confusion.

In parallel the team reviewed twelve human factors studies and ergonomics papers on touch performance with gloved hands, visual search under time pressure, attention switching and medical device usability. This material included research on minimum effective target sizes, spacing, and feedback timing for professional software UX in clinical environments.

All these inputs were integrated into a single requirements catalogue. Each requirement was linked to observed workflows, medical human factors engineering evidence, or explicit regulatory or safety constraints. This catalogue then became the reference for decisions on information architecture, interaction design and later the visual language. Instead of relying on intuition, the project anchored every significant choice in documented evidence and clinical reality.

Discovery ja Feature Mapping

INFORMATION ARCHITECTURE AND STRUCTURAL OPTIONS

The next step focused on information architecture for the embedded GUI. Surgical equipment UX has to work within strict spatial limits. The display can show only a small set of elements at any one time and surgeons cannot afford deep navigation or abstract menu structures. They must reach critical functions in very few steps and they must understand system state immediately.

Eight structural patterns were developed and evaluated through option space mapping. These included a single hub model, a step based sequence, clustered tabs, a flat layout organised by device states, a tool centric view with persistent status, a parameter centric view, a state machine oriented screen set and a hybrid model that combined aspects of several approaches. For each pattern the team analysed how many interactions were needed to reach essential functions, how often users would switch screens during cutting, and how clearly readiness and warnings could be understood.

The patterns were tested against representative workflows derived from the interviews. For example, switching cartridges and adjusting rotational speed mid procedure, confirming that safety interlocks remain satisfied, or preparing the device for the next case while maintaining sterile practices. The team examined how each structure supported these complex workflows in terms of time, cognitive effort and risk of omission.

The chosen structure organised screens by procedural relevance rather than by software modules through tension-driven reasoning. It limited navigation depth, ensured that the most critical status information is always visible, and removed intermediate confirmation steps that did not contribute to safety. The result was an interaction model that supports the decision cycles surgeons actually follow during cutting, and that satisfies medical device interface design requirements for clarity and predictability.

Information Architecture

BENCHMARKING SURGICAL INTERFACES IN CONTEXT

To position the new interface credibly, the team benchmarked six comparable surgical devices that combine mechanical power with embedded interfaces. These included ultrasonic tools, powered saws and other high speed instruments used in orthopaedic and trauma surgery. The objective was to understand how the best devices handle state feedback, error messaging and control grouping, and also where they fail.

The benchmarking focused on practical aspects rather than visual style. It examined how quickly a surgeon could verify readiness, how consistently warnings were presented, how mode changes were reflected, and how well the devices supported preparation, use and post use cleaning phases. Some interfaces relied too heavily on colour, which becomes unreliable under operating theatre lighting and across different monitors. Others compressed too much information into small areas, leading to extended visual search times. In several cases consumable handling and cartridge status were underrepresented despite their role in safe operation.

By comparing these patterns with the emerging architecture for the ultrasonic cutter, the team identified opportunities to improve on common weaknesses. For example, by combining redundant cues for state indication rather than relying on colour alone, or by grouping all cartridge related information in a consistent area that remains visible during activation. This benchmarking work informed decisions that made the new surgical tool UI recognisably part of the medical device category while also addressing long standing frustrations that surgeons reported with existing equipment.

UX Research

PHYSICAL DEVICE, CONTROLS AND SCREEN AS ONE SYSTEM

The ultrasonic cutter is first a physical instrument. The surgeon experiences the device through the handpiece, the mechanical response during cutting, the cartridge system and the physical controls on the console. The embedded GUI is one element in this chain, not a separate product. Effective medical device UX design for this kind of instrument must therefore treat physical and digital parts as one system.

Surgeons interact with the display using the non dominant hand, often while holding other tools and maintaining a stable position relative to the patient. Reachable zones on the screen are constrained by arm position, draping and sterile field boundaries. Gloved hands reduce precision and tactile feedback. For this reason the interface avoids small targets or controls placed at extreme corners. Interaction paths are kept short and concentrated in areas that match realistic reach envelopes.

The console includes physical buttons for essential actions and slots for cartridges. These elements were mapped against on screen controls so that state changes are always reflected both mechanically and graphically. For instance, when a new cartridge is inserted and locked in place, the display confirms the type and readiness in a consistent region with clear iconography and text. This integration of physical and digital behaviour reduces the risk of misinterpretation and supports safe use in the operating room, where sterile handling and device cleaning practices also limit unnecessary contact with the display.

Fyysisen konsolin ominaisuudet

HUMAN FACTORS AND COGNITIVE FOUNDATIONS

Human factors engineering was not treated as a separate activity. It formed part of every design decision. The twelve research studies reviewed at the beginning of the project continued to guide detailed work. Findings on touch performance with gloved hands influenced minimum control sizes and spacing. Research on dual task performance and attention switching helped determine how much information could be presented without overwhelming the user at critical moments. Visual perception literature informed choices on contrast, grouping and the use of colour.

For example, evidence shows that users under time pressure and with divided attention rely primarily on spatial patterns and consistent icon forms rather than on text. The interface therefore adopted stable layouts where the relative position of key indicators never changes between screens. Colour was used to reinforce rather than replace these patterns, which mitigates variability in lighting and display characteristics. Feedback timing for state changes, such as reaching a safe speed range, was aligned with findings on reaction times and confirmation delays in complex tasks.

These principles were presented to the product owner, engineers and clinical representatives in a clear and practical way. Instead of abstract theory, the team explained how each principle addressed a specific use-related risk identified in the requirements catalogue. This created a shared understanding that helped the steering committee evaluate trade offs and provided a documented rationale that can support regulatory submissions and future medical device human factors reviews.

Todisteet Based Suunnittelu
Colle, H. A., & Hiszem, K. J. (2004). Standing at a kiosk: Effects of key size and spacing on touch screen numeric keypad performance and user preference. Ergonomics, 47(13), 1406-1423.
Tao, D., Yuan, J., Liu, S., & Qu, X. (2018). Effects of button design characteristics on performance and perceptions of touchscreen use. International Journal of Industrial Ergonomics, 64, 59-68.

ITERATIVE DEVELOPMENT AND GOVERNANCE

With the requirements, architecture and human factors foundations in place, the team progressed through a series of iterative design cycles during Concept Convergence. The first cycles focused on low fidelity sketches that explored different layouts within the chosen structural model. Later cycles refined interaction details and edge cases in higher fidelity wireframes. Throughout, the emphasis remained on clarity for surgeons and robustness for engineers implementing the embedded medical software.

Thirteen structured review sessions involved the core client team and subject matter experts. In each session the team worked through representative scenarios, including initial setup, cartridge changes, speed adjustment during use, response to warnings and preparation for cleaning. Comments were captured directly on the wireframes, which made questions about feasibility, safety and clinical relevance visible to all disciplines.

The two week steering meetings provided a formal governance rhythm. At these sessions the team presented the evolution of the surgical user interface, the impact of new findings, and the rationale for key decisions. Clinical preferences, regulatory interpretations and engineering constraints could be reconciled while maintaining momentum. This process supported transparency, which is particularly important for complex workflows in regulated environments, and ensured that the emerging design remained acceptable for all critical stakeholders.

Prototyyppi & Product Thinking

VISUAL INTERFACE AND ATTENTION MANAGEMENT

Only after the interaction model had stabilised did the team move to visual design. The goal was to support attention and recognition, not to express style for its own sake. The visual layer of this medical UI design emphasised hierarchy, grouping and legibility. Typography, spacing and contrast were tuned so that the most critical elements could be read correctly during very brief glances from the surgical field.

States such as ready, not ready, active and fault are distinguished through a combination of spatial arrangement, icon form and reserved colour usage. Power or speed levels, cartridge type and safety interlock status are visible at all times in locations that surgeons learn quickly. The result is a surgical device interface where a surgeon can confirm the essential state of the instrument in a fraction of a second, which is the practical requirement in many orthopaedic and trauma procedures.

The visual language also reflects the manufacturer's position as a producer of serious theatre equipment. The interface looks consistent with high performance hardware rather than with consumer touchscreens. Commercial teams reported that they could present the device without needing to excuse the GUI, and surgeons who tested the prototype noted that the interface behaved in a way that matched their expectations for a modern surgical tool, which is a subtle but important form of acceptance.

UI Design
Quotes
Tämä käyttöliittymä helpottaisi työtäni. Minun ei tarvitsisi huolehtia siitä lainkaan. Kaikki on selkeää ja suoraviivaista, kuten Teslani.
Tom Frilling, MSc MBBS FRCS(Tr&Orth)
Hip & Knee Trauma and Orthopaedic Surgeon
Tunne se
Kokeile nappeja
HDS-121
RUNNING
Pump
Paired
Unpaired
Speed (RPM)8,500

DESIGN SYSTEM AND PORTFOLIO ORIENTATION

The final phase of the project focused on constructing a design system for the device. This system documented every component of the embedded GUI, including indicators, controls, messages and containers, together with their states and transitions. It described behaviour in normal operation, in non happy paths and in relevant failure modes. For each pattern the system specified when it must be used, what inputs it accepts and what feedback it provides.

This level of detail reduces ambiguity for engineers working on the embedded platform. They can implement the interface with confidence that a given state machine or screen will behave correctly and consistently. It also supports activities related to verification and validation, since inspectors and internal quality teams can see how user interface behaviour relates to identified risks, use scenarios and medical device standards.

The design system was written with reuse in mind. Many elements, such as alarm patterns, confirmation dialogues and basic status indicators, can be applied to other devices in the manufacturer's portfolio. Over time this supports a coherent language for medical device UX across instruments. It also makes future regulatory submissions more efficient because common design patterns and their justifications do not need to be recreated for each product.

UX- JA UI-SUUNNITTELU LÄÄKINNÄLLISISSÄ LAITTEISSA

Within three weeks the team delivered a first clickable prototype of the new embedded GUI. This prototype embodied the agreed information architecture, key interaction patterns and an initial version of the visual language. It allowed surgeons and internal teams to experience the medical device UX directly and gave engineers a concrete reference for implementation.

Over the full three month collaboration the project produced a documented usability engineering trail that aligns with ISO 62366 and IEC 62366 expectations. Requirements, research findings, design decisions and human factors justifications were all traceable. This supported internal compliance work and prepared the ground for formal verification and validation activities.

Feedback from the eight surgeons involved in reviews was consistent. They reported that they could verify device state more quickly than with the legacy interface and that adjustments to speed and other parameters no longer interrupted their workflow. Internal stakeholders judged that the new surgical user interface represents the performance level of the ultrasonic cutter more accurately and that the design system provides a stable basis for future products.

The organization gained intangible resources: judgment about what matters in surgical device interfaces for high-stakes procedures, shared product intuition about how safety-critical medical controls should behave under operational pressure, and reasoning capability that allows teams to extend the interface across future surgical instruments without fragmenting the interaction model. The system maintains competitive position by supporting rapid, confident decision-making in demanding operating theatre conditions, while competitors who prioritize feature exposure over clinical clarity and regulatory rigor struggle to serve surgical teams working under real-time pressure with patient safety responsibilities.

The case illustrates how careful, evidence-based interaction design and medical human factors engineering can transform an engineer built interface into a clinically credible, regulatory aware and portfolio ready medical device UX.

TULOKSET

Ensimmäinen napsautettava prototyyppi toimitettiin 3 viikossa

ISO 62366 ja IEC 62366-1 -standardien noudattaminen

Teollisuuden määrittelemä GUI-suunnittelu

Täydellinen suunnittelujärjestelmä, jota voidaan käyttää koko tuotevalikoimassa.

Saumaton luovutus ja tuki insinööritiimille

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