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CASE STUDY

Console for Calcified Artery Disease Treatment

We have collaborated with an innovative medical device company to design and develop the latest commercial version of their console.

  • Projects
  • Console for Calcified Artery Disease Treatment

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Industrial Design / Product – Medical & Scientific Apparel

Médical

Console for Calcified Artery Disease Treatment

We have collaborated with an innovative medical device company to design and develop the latest commercial version of their console.

  • Projects
  • Console for Calcified Artery Disease Treatment

A console designed for endovascular treatment of patients with calcified occlusive vascular disease

Company

SoundBite Medical

Industry

MedTech

Sector

Cardiovascular Health

Product Type

Medical Device with Digital Interface

Expertise

  • Electronic Engineering, Embedded Software Development, Human Factors Engineering, Industrial Design, Innovation Strategy, Mechanical Engineering, Quality Assurance, Software Development, UX & UI Design

CTO crossing: a medical procedure to break calcified plaque in arteries

Chronic total occlusion (CTO) of peripheral arteries is an increasingly common condition, especially in older patients. It can be associated with severe health issues like myocardial infarction, stroke, limb loss, and even sometimes death.
Recently, new techniques and tools have been developed for its treatment, including the CTO crossing procedure. This involves inserting a guidewire into the artery to facilitate the revascularization.

CLEIO's expertise in action: A large-scale project nearly unveiled

CLEIO was contracted to design the commercial version of a Class II device in the US and Class IV in Canada for CTO crossing. In collaboration with the experts of the SoundBite Medical, our teams in human factors, UX/UI and industrial design, software and embedded software development, mechanical and electronic engineering, and quality assurance, took part in this multidisciplinary project. They redesigned the console incorporating a large number of interconnected components while reducing the size, and overhauled the device’s volume and user interface.

In the first part of this case study, we’ll dive deeper into the work carried out on the device’s design, thanks to our formative usability evaluations.

How did formative usability evaluations shape the device's design?

At the project’s onset, the human factors and design teams made multiple visits to a procedure environment in hospitals to conduct formative evaluations with nurses and physicians.
Using a foamcore volumetric mock-up and low-fidelity wireframes, their observations enabled them to refine the prototype and to retest, confirming the improvements made.
Observing user interaction with the device helped us better understand the user environment, gather feedback on the interface, and significantly enhance the device through iterative improvements.
  • Learnings from the user environment

Space constraints due to other equipment

In the procedure environment, we gathered concrete data on the device and peripheral equipment positioning, including clearance issues.
Notably, a large screen near the physician, above the treatment table, significantly limited their field of vision and obscured the device.
  • Solutions

Balancing physical and ergonomic constraints

Our first formative evaluation helped optimize the device by considering the environment’s layout and ergonomic constraints.

Integrated accessory management

We have consolidated all the essential accessories for the device (AC cable, footswitch, user manual, and maintenance access) into one convenient location.

Console height optimization

We designed the device to be low enough not to be obscured by the screen but high enough to remain visible over the treatment table and patient.
We also ensured comfortable handling by setting a minimum height and adjusting the disposable wire exit angle.

Three handling zones

We added a handle covering three sides of the device.
  • Front: Moving the unit forward and backward
  • Left & Right: For lateral adjustments near the table

Two interfaces for different user needs

Recognizing different information needs between the nurse and physician, we have different information displayed on both screens during a procedure. From the sterile area, the physician can see the time remaining clearly and without distractions.

From the formative evaluation, we defined the size of the screens, the information displayed and the layout and size of the content.

A progress circle displaying time remaining

Testing the low-resolution wireframes with users helped us refine how information is displayed on the small and large screens.

Focusing on user-relevant information

To reduce the nurse’s mental load and ease decision-making, we simplified the interface, prioritizing useful information like the time remaining.
When the user opens the device settings, the time remaining shifts to the left to stay visible at all times.

Illustration design for ease of use

We used illustrations rather than just text to guide users in setting up the console, enhancing interaction while using the interface.

Handling tests of various user interface components

We rigorously tested each physical user interface component to ensure optimal handling, including storage compartments, wheel locking, disposable wire connection, and maintenance panel access.

An ergonomically adapted medical device for field conditions

The device’s angles, clearances, and inclines are not just aesthetic; they result from field observations during formative evaluations:

  • Adequate legroom to prevent knee contact with the device when the console is moved.
  • Upward-angled screens for information accessibility from either side.
  • Handles for three-sided adjustments.
  • Device’s height ensuring visibility without compromising comfort.

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