Design and manufacturing of a floor-standing video colposcope for cervical cancer staging
The DySIS video colposcope is a revolutionary advance in cervical cancer staging in that it is capable of measuring aceto-whitening automatically, providing an on-screen map of the results rather than requiring the clinician to perform a visual check.
With limited resources and a tight timescale, ITL were tasked with developing solutions in order to improve the ergonomics for the end-user and optimise the patient experience whilst controlling manufacturing costs.
The R&D team at ITL began by interviewing end-users in hospitals across the country in order to define exactly what improvements they felt were required. Following this initial market research several concepts were developed and again tested by nurses and clinicians. Having significantly improved the ergonomics of the DySIS, ITL were now able to explore any further opportunities for improvement.
The redesign work culminated in ITL delivering the following:
- Changes to the way in which the DySIS was operated by the clinician, improving their ability to control the arm of the device whilst also using the touch screen during sensitive procedures.
- Development of a revolutionary electronic braking system to ensure that once connected to the patient, the DySIS would remain perfectly stable.
- A unique locking base solution to hold the entire unit in place during use.
- An easy coupling system for connection of the camera to the speculum with minimal force
ITL also helped DySIS through the regulatory approvals process for CE marking, IEC 60601 and the Medical Device Directive. This was conducted by liaising with the DySIS regulatory team in Greece.
Based on the success of the re-design work, ITL and DySIS then agreed a full scale manufacturing contract. Beginning with a pilot manufacturing phase supported by our production engineers, DySIS now has a dedicated work cell within the ITL factory with custom jigs and CA testing procedures.
The DySIS received NICE approval in 2012 and won both the Scottish Life Science Award and the Medilink Innovation Award in 2013.
In the future, DySIS are likely to take advantage of our facility in Richmond, Virginia, USA in order to minimise turnaround times for maintenance of units sold to US based end-users.