Company insight
osti is on an exciting journey of growth and transformation in the medical sector. One of its most significant areas of focus is the continuous investment it is making in its global cleanroom capabilities.
Global reach, local precision R
Rosti is expanding its global cleanroom and injection moulding capabilities, combining local precision with international reach to help medical device customers scale efficiently and confidently.
providing customers with direct access to production within North America, closer to their end markets.
The company is expanding and upgrading its facilities across three key continents – extending and modernising in Poland and China, while also building a purpose- built cleanroom in North America. This commitment provides medical customers with the ability to benefit from Rosti’s global reach while still being able to serve their local markets efficiently and effectively. Some of Rosti’s investments are made hand-in-hand with customers, directly linked to specific projects where its cleanroom expansion supports their product launch and growth. Rosti also takes a proactive approach, investing in its medical injection moulding capabilities in anticipation of future opportunities. By doing so, Rosti places itself in a strong strategic position to support customers when they are ready to scale. Combining the expertise of its people with cutting-edge capabilities, Rosti is positioning itself as a global leader in the medical device and injection moulding sector. Its new US investment is particularly exciting, strengthening the global offering and
The importance of a unified global quality system To truly serve its customers, Rosti must ensure that quality and compliance remain consistent across every region. Rosti makes sure that it is working within a framework that ensures a single, consistent way of working, no matter where in the world it is manufacturing. Gustav Reingsdahl, VP medical solutions at Rosti, explains how “our unified global quality system ensures every site operates to the same rigorous standards, harmonised to market regulations – giving customers consistent, compliant and reliable outcomes worldwide. “Importantly, our NPI (new product introduction) and NPD (new product development) processes sit within this framework, meaning that quality is embedded right from the very start of our involvement.”
A unified quality management system offers a very practical benefit: it accelerates speed to market. For example, when scaling production from Europe to Asia or North America, Rosti can replicate a validated production cell quickly, without needing to
restart extensive analysis and verification processes. This is a significant advantage for customers who are looking to launch or scale products globally.
Tailored manufacturing capabilities With facilities of different sizes and specialisms across Europe, North America and Asia, Rosti is able to tailor its injection moulding capabilities and production volumes precisely to customer requirements. Whether it is relatively small volumes of intricate, high-value diagnostics or large-scale production of consumables and single-use products, Rosti is ideally positioned to deliver. This flexibility is not only the result of its global capacity but also of the diverse experience it has gained across sectors with similar high-precision and high-volume requirements.
Innovation centres: accelerating speed to market Rosti’s digital innovation centres provide unique value to its medical customers by offering speed to market, production readiness and assured quality. By investing in advanced 3D prototyping and testing technologies, it can move from concept to reality in a matter of days and weeks. The innovation centres give customers access to rapid prototyping, manufacturability assessments and design for manufacturing expertise – all of which ensure that products are not only developed quickly but also designed for efficient, compliant and scalable production. For medical partners, this means a faster route from concept to market, supported every step of the way by Rosti’s technical knowledge and global resources. “By expanding our cleanrooms, ensuring a unified QMS, tailoring our manufacturing capabilities and harnessing the power of our innovation centres, we are building a platform that enables medical device companies to grow with confidence,” Reingsdahl concludes. ●
Rosti is expanding its cleanroom capabilities globally with continuous investment.
www.medicaldevice-developments.com
https://rosti.com 47
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