Darren Herron, UK national sales manager at Sumitomo Demag, analyses the injection moulding market and what is driving new developments for medical applications.
The global medical injection moulding market size was valued at $1.38 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 8.2% between 2020 and 2027. Much of this is being driven by advances in the home healthcare sector and an ageing population, which WHO predicts will double by 2050.
Plastic moulding continues to be used for many medical applications, including manufacturing implantable medical device components, test tubes, beakers, casings and housings for laboratory and medical equipment, drug delivery components and surgical equipment. With demand for medical devices at an all-time high across hospitals and laboratories thanks to COVID-19, this has had a positive impact on market growth.
All-Electric IntElect for hygiene sensitive markets
Sumitomo (SHI) Demag recently supplied a 75 tonne IntElect all-electric injection moulding machine to Avenue, a Nolato Company, in Sligo, Ireland. The investment supports the growth in the company’s healthcare division, providing dedicated capacity to mould precision parts during the product development phase. With demand for its medical device injection moulding and tool-building services increasing, Avenue recently installed a new 100 sqm ISO Class 8 cleanroom area.
The IntElect machine met Avenue’s brief for a small footprint machine for carrying out test runs during the development phase of projects.
Gerard Henn, Avenue’s general manager, said: “All medical programmes are lengthy as it can take two to three years to obtain approvals from the authorities, so there are many months of testing before a component or mould is ready to be scaled up to mass production.”
The machine’s small footprint is down to the use of its own motors and drives. The model also has wide tie bar spacing and high clamp force for its size, allowing the use of larger moulds than would normally be accommodated by a 75-tonne machine.
Traceability is key
Advanced batch tracking, contact-free inspection using cameras, and highly automated assembly are among the latest developments to meet the medical device market’s precision and quality control requirements. Traceability is not just about mandatory information and supply chain tracking. Real-time traceability is about being able to call up data and verify the exact settings used on the injection moulding machine when that individual plastic part was made, making connectivity to a Management Executive System (MES) vital.
For example, when parts are being produced on multi-cavity tools, like pipettes, robots are programmed to remove and place the components into cavity-assigned racks. This means that if an issue with cavity 1 arises, the rack containing all corresponding cavity 1 parts can be isolated and the rack recalled, with all the production information stored in the MES.
To enhance patient safety, there’s a drive towards using new and more innovative regulated materials with a better flow and high impact strength to mould components. The EU Medical Device regulations came into force 26 May 2021, following a one-year extension due to the pandemic. In Vitro Diagnostic medical device regulations (known as IVDR) become effective 26 May 2022. In the UK, the market is currently regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
This creates some complications in relation to the CE marking process on medical devices as the UKCA (UK Conformity Assessed) mark will replace the longstanding CE mark for goods, including medical devices, sold within England, Wales and Scotland. As there’s no hard border in Ireland, the CE mark still applies there.
Continued support for the Irish market
With a large proportion of Sumitomo (SHI) Demag’s Irish customers in the medical market in Ireland, we last year opened a service and support office in Limerick, Ireland. This was to support its installed base of predominantly all-electric machines, providing on-the-ground preventative and reactive machine maintenance and troubleshooting support.
Establishing an Irish office is also part of a post-Brexit insulation strategy that will moderate any potential concerns Irish moulders may have about dealing with a UK machinery supplier. A permanent in-country service and support base will facilitate timely spare parts sourcing and trading in euros without incurring hefty exchange fees. We firmly believe that Ireland’s talent base and this supportive infrastructure will continue to make Ireland very attractive to inward investment, especially in medical and biotechology R&D.
