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Company insight


A global manufacturing network for customers


Carclo is a specialist custom manufacturer of bespoke plastic components and assembled devices for the healthcare market, focused on disposable products in applications across surgery, critical care, diagnostics, drug delivery devices and eye care. Martin Day, sales and marketing director, Europe and India, describes how the company’s global network of ISO 13485:2016-accredited manufacturing facilities help customers of all sizes market a product across different regions while keeping lead times and distribution costs down.


What are the advantages of Carclo’s global footprint for customers? Martin Day: Put simply, we are able to manufacture products closer to their end markets, minimising distribution costs and lead times for medical device companies conscious of the need to save money and reach their customers as quickly as possible. By spreading our manufacturing capacity across multiple sites with identical injection moulding machines, mould tooling, automation and metrology equipment, we are also able to greatly reduce supply chain risks like non-compliance and production shortages or outages. Carclo customers can effectively dual source while maintaining the benefits of a sole source – without sacrificing quality, delivery, price or intellectual property.


Key to our offering is the fact that our global manufacturing network doesn’t compromise on quality. A single quality management system, with individual sites accredited to ISO 13485, means customers can rest assured that production is being conducted in accordance with international standards. Within this framework, local procedures and work instructions in the local language ensure that the requirements are fully understood and met. Furthermore, Carclo manufactures products in accordance with customer’s individual specifications. Customers also audit Carclo on a regular basis to ensure the company continues to meet market expectations within ISO 13485. Carclo’s largest customer currently uses five of our facilities to produce IVD consumables, such as pipette tips and diagnostic cuvettes. Before expanding its manufacturing footprint, this customer was


paying the equivalent of its ex-works manufacturing costs to ship products from the US to southern Asia. As well as effectively doubling the company’s supply chain expenditure, this journey took several weeks. By manufacturing the product locally, Carclo drove the cost reductions required by the customer and helped expedite supply to the global market.


How do you ensure your various facilities are all able to meet customers’ needs?


Our engineering structure and global operating systems allow us to work closely with customer design teams in their home geographic region and then transfer the equipment to the Carclo facility closest to the point of use, or to a lower cost region. As well as using identical equipment across all sites, Carclo thoroughly trains all employees in our systems and processes. Troubleshooting and improvement mechanisms are quickly communicated to every facility, while KPIs such as scrap rates, cycle times, production output/efficiency are monitored on a monthly basis and shared across sites to engender a competitive yet supportive spirit within the global Carclo team. For customers looking to expand their manufacturing to new markets, we transfer engineers from our receiving facility to the current manufacturing plant so they can be properly trained on existing systems over several months. On their return to their home plant, these engineers have all the knowledge required to operate new manufacturing lines as soon as they arrive. Carclo also employs the industry- accepted process of factory acceptance tests and site acceptance tests followed by


Medical Device Developments / www.nsmedicaldevices.com


installation qualification, operational qualification and performance qualification. We have a standard approach to this, but are flexible enough to allow customers to add their own specific requirements.


What other challenges come with injection moulding on a global scale? How do you address them? Complex mould tools and automation systems running 24/7 need to be regularly maintained and serviced; this is done locally within the toolroom at each Carclo facility following a set of globally agreed procedures to ensure consistency. When a tool or mould needs more detailed investigation, it is returned to its original manufacturer and replaced with spare moulds or components that Carclo holds on-site to minimise downtime. One of the biggest challenges for global production is the fact that raw materials are often not absolutely identical when manufactured in different chemical plants. In these cases, we may need to slightly modify moulding process parameters, such as pressures and temperatures to ensure the part meets specification with good process capability. The alternative is to ship polymers from one source, but that defeats the objective of manufacturing locally.


Minimising supply chain risk has been a particularly important factor throughout the global pandemic, when the availability of capacity, labour and materials have become constrained and global logistics costs and lead times have soared. ●


www.carclo-ctp.co.uk 33


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