Triteq have worked with Zilico, a spin out from the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust to help develop a product (ZedScan I) that offers quicker, more accurate detection of cervical dysplasia in real time, removing several weeks of waiting time for diagnosis.
Triteq have a long standing relationship with Zilico and have been involved from the initial stages of development, through the fund raising applications, supporting clinical trials and design for manufacture, through to volume production. Triteq are proud to have had the opportunity to be closely involved in this entire process from conception through to delivery to market.
Zilico has developed Electrical Impedance Spectroscopy EIS, an objective scientifically-proven method to differentiate between normal and pre-cancerous and cancerous tissues (neoplasias), into a technology that can address the need for improved detection and diagnosis of neoplasia. The ZedScan system consists of a portable hand-held device, a single-use EIS sensor and docking station and is safe and painless. Using EIS technology, it can measure the resistivity of cervical tissue and so detect changes as cells progress from normal to precancerous and then to cancerous.
Cervical cancer affects around 500,000 women worldwide each year and is responsible for 300,000 deaths. Under current screening practices in the UK, a woman will have a screening test every three or five years. If the test is positive, she will be referred to a colposcopy clinic for a detailed cervical examination.
The Zedscan is aimed at patients referred for colposcopy after an initial screening test. A second product is being developed for the initial screening of women. Zedscan I address the needs of the referral population, will reduce the number of biopsies taken and has the potential to facilitate the wider use of ‘see & treat’ modality. Clinical data on over 450 patients has demonstrated superior performance over existing diagnostic procedures.
Triteq has a long standing history of successful medical device design and frequently works with clients on long termprojects that must successfully proceed through many challenging stages before a product is ready for commercial manufacture and routine use by medical practioners.
Medical device design is as much about managing risk and overcoming challenges as it is about producing a safe and effective product. The obstacles faced by medical device manufacturers during a product’s lifecycle include the requirement for continual improvement and feedback systems, technology changes, obsolescence of components, environmental constraints, material reliability, documentation and certification. For some manufacturers such as those producing high cost capital equipment, product lifecycles must be supported for five to ten years. Thus good design is paramount to reducing the risk associated with long complex lifecycles.
The starting point for a design project is often selecting a design consultancy with the correct approvals for the design of medical devices. Choosing consultancies that are unable to provide the proper level of medical design certifications or documentary evidence that their products have been designed to the correct standards presents problems. They have led to manufacturers having no option but to redesign their product from scratch using the correct design channels, which is costly and time consuming.
Crucial to good medical device design is careful consideration of all aspects of usability and user scenarios. The aim should always be the well-considered balance of these requirements against technical performance and this approach brought to light many user/patient specific issues that required novel solutions. Interface design between clinician and this medical device brought further opportunities resulting in a coherent and intuitive workflow. In addition to these human factors the design for manufacture of a device based upon a novel technological approach often poses challenges for reliable, cost effective manufacture. Existing processes required adaption to achieve our goals as well as careful material choice.
Thoughtful combination of all these requirements has provided our client and the clinical community with a product that will prove immensely beneficial.
For further information please visit http://www.zilico.co.uk/