Going stateside: UK Injection moulder heads to US
With a new cleanroom, UK-based Boddingtons is boosting its US profile.
Injection moulder Boddingtons anticipates increased sales and commercial activity in the US medtech sector, thanks to increasing demand for its modular Class 7 cleanroom. This was launched last November as part of the company’s £4.6m new factory investment.
Managing director Andy Tibbs attended this year’s MD&M West, Anaheim California in February – indications then and subsequently have pointed to the Kent moulder increasing its profile within the US medtech market.
“We have healthy existing USA sales already,” said Tibbs, “Through our partnership with ARC Medical and our work with Olympus. We see the potential for much much more,’ he adds. ‘We know the features of the US market very well. All of our manufacturing processes and procedures are FDA approved, and we have a long and successful track record in achieving 510 (k) clearances for our clients there.”
Tibbs hinted that the timing is favourable for the company’s increased transatlantic activity and sales. “The current trading conditions seem very favourable in terms of the dollar-based purchaser. The current USA/UK political relationships – post Brexit – also seem to be ready to facilitate a renewal of trade between our two countries.”
Tibbs added that, “in the right circumstances Boddingtons is able to consider local manufacturing and supply, most likely along the US Eastern Seaboard. We have a clear vision of what we are capable of and what the market needs and we are in a good position to take action.”
Boddingtons services for Class 1 and Class 2 device manufacturing are a key part of its brand new £4.6m molding facility, which, for the transatlantic buyer, is less than an hour’s drive from London’s Gatwick Airport.
Since the new factory launch, business has been brisk. The Class 7 cleanrooms are now equipped with a total of eight molding machines, beside the press automation, in line printing and other technical services, all producing a great variety of medtech parts; from DNA trays to needle holders, endoscopy products, medical tubing and many other medtech devices.
Boddingtons client services range from conceptual design, prototyping, tooling, automation and full manufacture together with the added benefit of the company having its own dedicated regulatory manager on site.
Tibbs added: “We are happy to provide this regulatory help in order to support the generation of technical files, ensuring that all relevant documentation and registration with the correct governing bodies has been taken care of. This includes all FDA-related matters of 510 (k) approval.”
The advanced moulding environment at Boddingtons is designed for maximum flexible assembly and high-spec production, including the ability to create finished components and shelf-ready medtech components. The new facility also reduces bioburdens and particulates. New white rooms offer a minimum of contaminants and fibres. Disaster recovery safeguards and many other customer benefits have been built into the new buildings.
Boddingtons has won the Plastics Industry Awards (Industrial Design category) for three years in a row and two of the three winning designs were in the medtech field; the Braidlock device for use in emergency and battlefield situations and the colonoscopy.
At the new factory launch Lord Digby Jones said that: “British manufacturing has a pearl of opportunity at this moment - and we should seize it.”
Lord Jones also praised the Boddingtons team for its ‘amazing new manufacturing facilities’ and for the company’s forward thinking and strategic investments in plant, people and technology.