App screens showing neurosurgical planning prototype

Creating a custom SaMD application for surgical planning

Neurosurgery planning is complex, often relying on anatomical models that can lack the flexibility and detail necessary for precise planning. Our client, XRlabs, had developed an innovative mixed reality application that enables clinicians to visualise anatomical models, plan and rehearse for surgery in 3D. They needed a partner to develop a desktop application that would help transform their technology into software as a medical device (SaMD) and enable it to meet regulatory standards for use in surgical planning.

We rapidly developed a surgical planning application to work alongside their existing headset app, featuring a streamlined user workflow and effective UX/UI design. The result was a functioning SaMD prototype, ready to advance XRlabs’ development efforts and support its FDA submission.

Front End Innovation

Strategy and requirement workshop

To better understand our client’s long term product vision, we began by carrying out a strategy and requirement workshop. The session focused on exploring the technology’s maturity, discussing regulatory strategy and capturing key requirements for both surgical planning and visualisation, as well as tracking and navigation. The result was a clear alignment on a product vision for a minimal viable product (MVP), as well as a route to regulatory submission.

Mixed reality

Bespoke application design

Our client required a desktop application that would improve the user experience during surgical planning. The app needed to allow clinicians to upload medical images to produce detailed 3D models of the patient’s anatomy, which could then be transferred to their mixed reality headset.

We quickly developed a prototype desktop application that integrates seamlessly with the client’s existing mixed reality headset app, featuring a simple user workflow for ease of use:

  1. Import medical images: Clinicians upload patient scans from the hospital system into the desktop application.
  2. Image processing and AI: The application uses image processing and AI to create detailed 3D models.
  3. Transfer to headset: A QR code is generated, allowing users to transfer the models from the desktop to the headset for 3D visualisation and planning.
Software

Agile software development

Rapid development was a key priority for our client to allow them to meet their regulatory submission deadlines. To achieve this, we implemented an Agile methodology across an 8-week development phase. This involved short design sprints with weekly feedback from the client’s team, to gather continuous feedback and consistently improve the end product.

Using Agile is an effective way to ensure a fast and flexible approach to software development. We worked closely with the client’s team throughout to make sure the software met their needs and aligned with their wider development goals.

Thorbjorg Petursdottir, Consultant Electronics & Software Engineer, Team Consulting
UXUI

UX/UI optimisation

Current surgical planning applications on the market have complex workflows, which can result in poor usability for clinicians. Collaborating with the client’s design team, our UX/UI experts rapidly visualised a new app concept that was more user-friendly, while maintaining a consistent user experience with XRlabs’ existing headset app. This included grouping sets of tools within the app and creating clear hierarchies to promote ease of use and access.

One of the key challenges was how to display the information and settings that users needed to apply. To tackle this, we created a clear hierarchy for the input data, with a simplified UI for accessing tools and settings that are essential for the surgical planning. The result was a less cluttered and less intimidating UI for the user, based on robust UX/UI design principles.

Chris Davies, UX Design Consultant, Team Consulting
Human factors regulatory assessment

Human factors documentation

To ensure XRlabs were prepared to meet regulatory expectations and streamline their product development, we prepared their key human factors documentation early in the process. This included defining the use-related specification and carrying out a high-level risk analysis to identify foreseeable use-related hazards. As a result, we were able to effectively guide early design decisions and help the client address safety and usability proactively.

App screens showing neurosurgical planning prototype

Outcome

XRlabs now has a prototype surgical planning application to showcase to investors, along with documentation ready for the next phase of detailed design. This solution not only met our client’s immediate needs, but also positioned them for future success in the medical software market.

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