CASE STUDIES
Visual Fixation System
Design for Manufacture
User Centered Design
3D Printed
The Visual Fixation System, or VFS, is a simple, hand-held optical device invented and patented by Simon Berry, a specialist optometrist from Durham. Simon invented VFS because he was often finding it impossible to examine the eyes of a person, of any age, who reacted badly to a close proximity, confrontational examination. Some people can’t tolerate another person being too close and peering into their eye, often using an ophthalmoscope. It is particularly challenging for people with an autism spectrum disorder. VFS uses a split optical path so the clinician can look closely into the patient’s eyes along the direct path from a hidden position behind the box, whilst the patient looks into the box and is distracted by videos playing on the reflected path.
Headquarters
Durham, England, UK
Founded
2007
Services
Industrial Design
Sector
Ophtalmology
The Challenge
Crucible was involved with the VFS project from an intermediate prototype stage. The proof of concept had been successfully completed and Simon was at an early commercial stage and looking to refine the product, reduce costs to bring it to an acceptable price point, and drive sufficient market traction to attract follow-on investment to scale up for mass market uptake.
The Process
To meet the brief, we reviewed the patent and the key features of the product needed to fulfill its purpose. From our understanding of the product and the clinical need, and working closely with Simon to maintain his vision, we refined the design including simplifying the optical path, eliminating internal reflection, sourcing key components, and implementing a quick-change interchangeable handle system to more simply accommodate accessories like an ophthalmoscope as needed. We improved the ergonomics of the handle to a comfortable pistol grip. A benefit of the simplified optical path was the reduced size and weight of the device relative to the previous prototype, and improved balance. The finished device is registered as a Class 1 UKCA-compliant medical device for sale in the UK.
The Crucible version of the VFS was intended for low-volume proof of market activities and demonstration of market traction to attract potential investment in scale-up. To minimise set-up and tooling costs, the main body is 3D printed in-house from sustainable PLA, and the device is currently manufactured by Crucible in small batches (between 10 and 25 units per batch) to support Simon’s early market needs.
The Outcome
The Crucible version VFS has been demonstrated at various optometry expos and specialist conferences across the UK. It has generated considerable interest including from key paediatric and special needs optometry/ophthalmology centres. Several 10s of units have been sold, confirming interest and demonstrating traction. Simon has now signed an agreement with a major UK optometry company for investment in scale-up and mass market access. This case study clearly illustrates Crucible’s transitionary role in a successful product development and market access strategy. We have passed on the baton and an evolved VFS, based on our proof of market version and re-designed for mass production at low cost, is due to be launched in 2025.
Pathway
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an advantage?
"Crucible did a great job designing a revised VFS, managing supply chain, manufacturing, and ensuring device registration as class 1 UKCA compliant. Their small-scale manufacturing has enabled traction in the market and transition to a mass-produced version."
