Precision In Medical Practice — Machining Medical Device Components
Annika Langéen, Vice President Offer Management and R&D Sandvik Coromant, explains how small part machining supports precise, accurate medical device component manufacturing.
In the intricate world of medical device manufacturing, where precision is paramount and innovation saves lives, a strong production process is key. From crafting tiny bone screws to fabricating complex hip replacement parts, there is high demand for accuracy, reliability and efficiency.
The medical device industry encompasses a wide array of products designed to diagnose, monitor and treat medical conditions. From diagnostic equipment to implantable devices, the industry caters to the evolving needs of healthcare professionals and patients worldwide.
Today, there are an estimated two million different kinds of medical devices on the global market, categorised into more than 7,000 device groups, according to the World Health Organisation (WHO).
Challenges In Medical Device Manufacturing
Manufacturing components for medical devices presents unique challenges that demand advanced machining solutions. End-users rely on these devices being manufactured to the highest quality, as any products that do not meet quality standards can cause huge disruption. Entire operations could be paused, products recalled, organisational reputation damaged and patients’ lives at risk.
Additionally, regulatory requirements are stringent in this field. There are international standards around quality management — such as ISO 13485, risk management and ISO 14971 — as well as regional regulations such as 21 CFR and FDA for the US and EU MDR for the European Union, which all devices must meet.
The requirement for such high accuracy means manufacturers cannot risk even a millimetre of differentiation between components, so having a robust machining setup is paramount.
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