The medical devices industry is booming. Global profits have jumped by nearly $80 billion in five years, a trend that seems likely to continue with an increasingly elderly population. But with new opportunities come new challenges. With sophisticated equipment like interventional catheters becoming a crucial part of medical life, high-quality cables and interconnectors are vital for machines to work reliably. At the same time, companies are under special pressure to keep their manufacturing environments clean.

Carlisle Interconnect Technologies is making huge strides in adapting to these changes. Its new production facility, in the Chinese city of Dongguan, is a case in point. At 400,000ft² – with 258,000ft² of manufacturing space – it’s 25% larger than the company’s previous factory. All this space enabled it to lay out production lines efficiently, explains Marc Socquet, Carlisle’s director of sales.

"[The size] allowed us to really lay out the facility in the most efficient way, particularly in terms of how we were able to separate out the different production areas," he says. "We have a production area that is specifically focused on surgical, electrosurgical [and] patient monitoring equipment."

Customers have outsourced a lot of their manufacturing and engineering [duties], and may not have engineers that have the right experience with cable assemblies. We can guide them.

Maintaining separation

Carlisle took the same care placing customers in the facility, Socquet continues. "[The new factory] also gave us the opportunity to segregate customers into different [areas]," he says. "Obviously we have customers that are competitors with each other, so we needed to be protective of their information. Where there was a potential conflict of customers, we had to keep them completely segregated."

Whoever the client, Carlisle has worked hard to give them all the same spotless environment, explains Kirk Mikkelsen, the company’s new product development engineering manager. "The whole space is environmentally controlled," he says. "We’ve got two designated clean manufacturing spaces that were built to ISO Class 8 [standards]. Then we have a sterile packaging area, which is built to ISO Class 7."

Other innovations are just as exciting, adds Patty van Austen, Carlisle’s director of project management. "We’ve additionally invested heavily in our incoming inspection equipment," she says. "Our customers are expecting more and more of that, but find it painful to accomplish alone. Helping our customers in this way differentiates us from our competitors."

Automation is another area where Carlisle is taking the lead. "We’re investing heavily in processes of automation," says Mikkelsen. "Partly, this involves automating equipment on the floor. We also have to engage in the automation design of individual products. We’ve actually redesigned some of the products to make them more automationfriendly." All this saves money, he adds. "We’ll do whatever makes the most economic sense in terms of productivity and product cost."

Effective development

A joined-up approach colours all of Carlisle’s work. "The ideal situation is when the customer comes in very early in their development cycle," says Mikkelsen. "Customers have outsourced a lot of their manufacturing and engineering [duties], and may not have engineers that have the right experience with cable assemblies. We can guide them to meet their requirements and at the same time be cost-effective.

"We’ll help them right from very early prototyping all the way through to helping them with their process validation, with the design characterisation and character verification. We’ll then support them up through pilot release and on to full production. We also help them build the data file that they’ll have to submit to FDA for approval."

This mix of technical know-how and detailed support puts Carlisle in a great spot to build on these successes. "Our plan in general is to be the number one provider of cable and interconnect assemblies throughout the surgical, interventional, electrosurgical and patient-monitoring medical markets," says Socquet. With a gleaming new factory ready to go, this seems like an eminently achievable goal.