Design and manufacturing of a floor standing video colposcope for cervical cancer staging
Requirements
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.
Approach
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.
Results
This redesign work culminated in ITL delivering the following:
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 servicing centre in Virginia, USA in order to minimise turnaround times for maintenance of units sold to US based end-users.