Custom fit

Medical Device OEMs and their contract manufacturing partners are under increasing pressure to get new devices and iterations of current products from concept through the regulatory channels and into the market place in a short time period with minimal cost.

Those OEMs with in-house tubing extrusion capabilities are now outsourcing the development and manufacturing of tubing for their new devices to a custom extruder. They realise that extrusion is not part of their core competency and they can better concentrate their efforts on supporting and growing higher revenue finished devices.

The custom extruder can provide a dedicated team to partner with the customer, providing focused expertise in polymer materials, extrusion technology and process development. The result is shorter lead times, faster development cycles and ultimately a reduced time from concept to market.

Once the OEM requires volume, the custom extruder can increase volume rapidly, usually on the same equipment used to develop the product, at a rate much faster and with less cost and waste when compared with a vertically integrated OEM. The custom extruder utilises their process expertise to drive cost from the process resulting in savings for the customer.

The distinct advantage of the custom extruder is the experienced engineering and quality resources that utilise the latest technology in the areas of material selection and testing, polymer processing and quality inspection to provide the customer with high quality, repeatable medical tubing.

In an effort to reduce cost and increase output the current trend for device manufacturers is to assemble and pack their products using complex automation cells. The success of this automation often lies in the repeatability of the critical inputs with the tubing component being a significant factor due to its flexibility and challenges in handling. The difficulties encountered in the automated assembly processes would not have been a factor in manual assembly due to the operators’ ability to manipulate the product into position. 

Close cooperation between the device manufacture and their extrusion partner is critical in the early stage development of the automation process to ensure all of the tubing characteristics are understood and captured on a specification. Dimensionally accurate product is a given however subtle differences in parameters such as transparency, flexibility, orientation and hardness can have a major impact on the throughput and yield of an automation cell. A deep understanding of the extrusion process and the ability to capture, monitor and review key process indicators and data is pivotal to the successful partnership between device manufacturer and custom extruder.

Most OEMs will demand that their suppliers are ISO 13485 accredited or at the very minimum have ISO 9001:2008. This ensures both parties have a similar quality management system and talk the same language from design control right through to continuous improvement. Process validation is an essential component of any new product and the custom extruder should be able to remove as much as possible, the burden of validation from the customer.

Working in a controlled environment is a distinct advantage. Class 8 cleanrooms are becoming the norm for component manufacture for medical devices.

If a custom extruder has global operations, located in the various medical clusters, this can be a big win for the device manufacturer as they can enjoy reduced transport costs, taxes and tariffs through local sourcing. They have a global risk management strategy with built in redundancy and the device manufacturer can reap the benefits of a global supply agreement through economies of scale and the custom extruders leverage in terms of volume purchasing of raw materials. The global extrusion sites give the OEM global options to easily transfer production to different international manufacturing locations without changing component supplier.

“We like to think of it as a partnership with our customers,” said John Brennan, plant manager at Kelpac Medical Ireland.

“Where we can support their product development, process validations, and production and even manage their inventory and incoming inspection through VMI and supplied data programmes.”

“To provide a best in class service to our customers we use the latest extrusion and inspection technology combined with data acquisition and statistical process control. We use data collected electronically from the processing equipment and inspection systems to add as much science as possible to the art of extrusion”.

“Our key strengths are our people – their knowledge of materials, processes and operating in an ISO regulated, controlled environment is key to providing cost focussed solutions and exceptional service.”