Somex Automation: A Proven Partner for Medical Device Automation
Michael Wall, Managing Director
Medical device manufacturing companies face many operational challenges in the areas of training, labor safety, and production scalability based on the clients’ demands. They have to perform precise and delicate tasks using equipment that heats, cuts, or mechanically manipulates the device under production. They need a trusted partner who can offer specialized and customized services to meet unpredictable and unique demands across the product manufacturing lifecycle. An expert in automation of many common medical device manufacturing processes, Ireland-based Somex Automation takes automated machine projects from concept to completion. Over the last 20 years, Somex has built a team that has expertise in equipment design and process improvement and takes a structured approach to understand client needs and to develop the automation concept in a way that mitigates the risks. Team Somex helps medical device manufacturers with a customized solution that addresses clients’ product and manufacturing needs. Clients can not only mitigate the regulatory, time, and cost challenges involved in manufacturing, but also achieve improved productivity and continuous improvement in the process.
In any project, Somex Automation follows a well-defined process of planning, specification, design, construction, testing, and installation for equipment design and development. The company involves clients right from the concept development stage to avoid unnecessary risks caused due to knowledge and information gaps. Team Somex builds a detailed design that encompasses the physical design of the equipment mechanics as well as the control system. Its specialized design team provides a 3D CAD model of the equipment, which gives a realistic visual image of the product under production and its key features. After design approval, the equipment building and testing begins and the entire project spans up to 4-5 months.
Somex has a range of test equipment that can be configured to perform physical testing of the process using automation in advance of committing to the actual equipment design & construction. Through testing, clients gain a clear understanding of the intended output from the automation solution as well as the process parameters that will be used, which helps in quality analysis and regulatory approval. Once the equipment is completed, it undergoes acceptance testing at the Somex Automation facility. The Somex Automation support team assists with installation and ongoing support throughout the equipment lifecycle. In addition, the company maintains a fully documented repository of its equipment designs that can be used for support & further development as required. All equipment is designed to comply with CE Machinery Safety Directive& is CE marked. “Through the use of well designed, robust equipment with automated control, we provide equipment which performs consistent processes for medical device manufacturing, minimizing human intervention“, says Michael Wall, Managing Director of Somex.
Somex Automation holds process specialties in the areas of catheter manufacturing using heat shrinking, lamination, coating of catheter shafts and balloons, adhesive application and curing, component assembly using vision-guided robotics, and automated handling of components, to mention but a few. It recently developed an “off the shelf” compact benchtop hot air CE marked unit to perform manual heat shrinking, lamination & balloon attach tasks. The unit has measurement and control over the key process parameters of air temperature and air flow. It has a process alarm function which highlights any deviations from the normal range.
In one instance, a client of Somex was striving to perform a heat shrinking process on a 2m long catheter shaft, followed by transfer into another machine to perform a process of stretching the core wire, all of which was time-consuming. The process was carried out in a cleanroom on 2 work stations, each of 3m of bench length. With an automated Combination Laminator and Core Wire Stretching Machine, both tasks are performed automatically on ten products, which halved the space requirement to a single 3m length and reduced labor input to 25%.
Somex Automation has a deep-rooted association with medical device manufacturers in Ireland, and with the launch of its new facility in Cork City, it is well positioned to support medical device companies in Europe.
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