Medical Electronics
Delivering technology to save lives: our role in bringing Elekta’s ground-breaking cancer treatment system to market
The manufacture of any product requires flawless attention to detail and strict adherence to regulations and controls. In the medical sector, there are even more robust standards to meet and gaining clinical approval is as tough as it is vital. Here’s how we contributed to a genuine medical breakthrough by taking our customer’s pioneering cancer treatment system all the way from initial drawings to clinical approval and CE mark
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All about Elekta: Innovative technology and life-saving solutions
lekta is a world-leading innovator of radiotherapy equipment and software used to improve, prolong and save the lives of people with cancer and brain disorders. More than 6,000 hospitals worldwide rely on Elekta technology, including state of the art Linear accelerator (Linac) MRI machines used to treat cancer patients.
The technology: A breakthrough in cancer therapy The product Elekta tasked Chemigraphic with manufacturing is the Elekta Unity, a unique radiotherapy device that is set to revolutionise the way that clinicians can treat cancer patients. Unity employs a premium high-field diagnostic-quality (1.5 Tesla) MRI that provides unparalleled image clarity, giving clinicians greater flexibility in their approach to radiation therapy and ensuring that each patient receives optimal care and highly targeted treatment. Elekta Unity integrates MR imaging, linear accelerator technologies and advanced treatment planning into a single platform, allowing clinicians to see and track difficult-to-visualise soft tissue while each dose of radiation is being delivered. This means that for the first time in the history of cancer treatment, clinicians are
26 December 2018/January 2019
able to confidently see and track the target or tumour during the treatment process and respond accordingly, personalising therapy for each patient every time they are treated.
The scope of the challenge The biggest challenge for any medical manufacturer is getting the product up to the strict standards set by medical regulatory bodies, in order for each device to gain clinical approval, CE mark and be ready for sale and distribution. Elekta came to Chemigraphic in 2014 with incomplete drawings and an initial Bill of Materials (BOM), needing help to develop Unity beyond the initial concept stage, into an established, viable product ready for manufacture, testing and clinical approval. As well as finalising the product design, one of the major requirements was to set up and maintain an effective supply chain to manage all components and assemblies of the complex product, which contains no fewer than five main controller systems.
What we did: Design, supply chain management and assembly As we were involved right from the product’s conception, the first job for us was to review the BOM, advise on materials and components and start the sourcing process. Once this was established, we set about ensuring the
Components in Electronics
supply chain was set up properly and processes put in place to manage and monitor these effectively.
The next step was to begin assembling the various elements of the product, including complex mechanical and bespoke PCB assemblies, metal work and cable assemblies. Our focus on precision and early engagement, plus our ability to handle multiple assemblies from concept to production, has been a vital contributing factor in progressing the Unity’s route to market and securing its clinical approval.
What we did: Prototyping, testing and kit development Once the product design was finalised and entered the manufacturing production process, the next stage was to start readying the product for testing and clinical trials. Through extensive testing and rapid prototyping we were able to incorporate a number of engineering changes whilst maintaining consistency. Next came the development of kits for clinical trials, readying the product for approval and formal distribution throughout the healthcare sector.
The outcome and what’s next The ultimate goal for any medical
device but especially one as ground- breaking and life-saving as Unity, is formal clinical approval and CE mark, enabling the product to be in active use in the medical environment. Unity achieved CE mark and passed clinical trials in June 2018, meaning it can now be sold to medical establishments and put into active service. Suffice to say the client is very happy with this result and, given the remarkable possibilities this product presents to the world of cancer treatment, we are also extremely proud to have played our part in this product’s journey.
The Chemigraphic difference: How we could help you too We pride ourselves on helping you from design to ramp with cost-effective, scalable solutions fired by engineering excellence and comprehensive knowledge of your market. From early- stage design engagement through to effective and flexible manufacturing fulfilment, we are there with you every step of the way of your manufacturing journey, regardless of the challenges which may lay in your path.
www.elekta.com
www.chemigraphic.co.uk
www.cieonline.co.uk
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