Putting it all together at Boddingtons

Chris Philpott, business development manager at Boddingtons, outlines the factors involved in components and assembly.

Although the Covid-19 situation may seemingly be calming down, the early stages of the pandemic revealed much about the world’s medical supply chains, the awareness of the design and manufacturing process and the state of healthcare supply generally. 

Chris Philpott says that "Covid was not so much a wake up for medical devices but more like a spotlight on practices in the sector – some good, some bad."

Marden-based Boddingtons was involved in several Covid device projects from the outset, including the company’s role in contributing to the UK’s ventilator manufacturing effort: At its peak, Boddingtons was manufacturing seamlessly for 24 hours a day for this project to satisfy demand. 

The emergency project came about due to the high volumes required but with exceptional turnaround via a tool transfer request from the OEM responsible and teamed Boddingtons with other OEM participants. 

At the end of this road, the outcome for Boddingtons clients is that the company moulds, assembles, tests, packages and sterilises all medical components and devices that leave the factory gate. 

"All components are manufactured under our Quality Management System (QMS) certified to ISO 13485:2016 MDSAP," says Philpott "and we thereby provide full control and traceability for all raw materials, manufacturing and sterilisation processes."

He adds that "as the manufacturer, it is also our legal responsibility to make sure that all product is packaged and protected before it leaves us for the customer. The comprehensive validation processes demand full testing of the chosen specification that will go into the marketplace. We must continually monitor the performance of medical device packaging – for example sealed pouches for actual seal strength to make sure they maintain integrity and meet the initial validation and product specification."

The sterility of injection moulded products within medical devices and the protection of the sterile barrier is key. Chris says that "a whole host of pull tests, die penetration tests - including visual inspection - are performed throughout the process."

This also requires components and assemblies to be clearly labelled and identified – and here lot traceability is key; in-process product testing is also performed at Boddingtons. 

This ‘belt and braces’ approach to client management means that Boddingtons is often approached by OEMs when their management of suppliers has become too distant, or when quality issues have deteriorated to unacceptable levels.

"These component projects are not necessarily too complex," says Chris, "but they often reflect a breakdown of priorities between moulder and customer." Some may simply involve optimising the volume and quality for a single high-volume component. Some may also involve reshoring mouldings from the Far East simply to improve lead times, project management and product quality.

Such tooling and moulding transfers regularly involve a complete re-examination of what may have been considered best business and industrial practice some years prior. Since then, the tooling may have had many tens of thousands of hours in use and may need extensive repair, reconstruction, or replacement. Grades of polymer may have developed and improved since the original component design – again, Boddingtons will review and recommend upgrades and changes when recommissioning production of the new component. 

Assembly cells at Boddingtons might include automation, welding, hand assembly, Hi-Resolution supported Camera QA inspections, packaging, and printing services before dispatch. 

And then this line might be relocated, disassembled and/or modified to accommodate further med-tech business or a changing order. 

"At no stage", says Chris, "did we feel hampered in terms of production resource or production space. Several manufacturing aspects – sharps inclusion and handling; automated UV curing and others – were completely new to us."