Karl Stillman, Vice President, Strategic Sales, Rosti Group, explains to Medical Device Developments how technological capability and manufacturing knowhow must go hand in hand with management capability and years of experience to fully satisfy the industry’s requirements.
High-precision injection moulding is essential to the manufacture of many medical devices, but technology alone cannot meet the stringent quality levels demanded by today’s life sciences sector.
What crucial role do injection moulding specialists play in the development of new and innovative medical devices?
As an injection moulding specialist, our expertise and services are an integral part of the production process. We support our customers in navigating the complex landscape of medical device regulations, ensuring products meet necessary standards for safety and effectiveness.
To do so, we partner with customers in delivering customised, high-precision devices. This is particularly important since medical devices often need to be carefully tailored to ensure the uniformity and functionality of intricate and complex parts. This is crucial for devices like insulin pens, catheters and components for specialised surgical instruments. A contract manufacturer often plays an important role in providing material expertise, since medical devices require biocompatible polymers, elastomers, liquid silicone rubber and many other materials.
It is important to choose the right materials to ensure that regulatory standards for safety and performance, as well as stringent quality and sterilisation standards are met.
Medical devices containing moulded thermoplastic components benefit from a trusted partner like Rosti because we have more than 75 years’ experience in delivering value to the medical sector. That can be of paramount importance in navigating the complex regulatory landscape, as well as delivering consistent high-quality production processes, in which it is crucial to adhere to strict standards. We make sure that costly delays, legal issues and all other associated risks are mitigated. As an experienced global manufacturer, Rosti is able to scale up production to meet demand while maintaining consistent quality. Also, we view innovation as highly important, and our three strategically located innovation centres make us a strong partner in the innovation and design phase, which drastically reduces time to market.
We have seen trends such as an increased production outsourcing, where CDMOs have come to play a more important role as a partner to OEMs. We are also seeing a nearshoring trend, and as a global organisation Rosti can support customers investigating new supply chain set-ups. Through accredited facilities, experienced people, and state-of-the art equipment, we can walk the extra mile to exceed customer expectations.
With the same quality and standards across all our sites, we can speak to customers in one voice and give them one contact for our entire organisation. Moreover, a global footprint and a ‘One Rosti’ organisation enables us to help customers access and enter new markets, find optimal and diversified supply chain solutions and minimise the risk of supply chain disruptions. Calling on local presence and expertise in all the main medical markets in the world, we provide a deeper understanding of the regional regulations, standards and market preferences.
Our three innovation centres – in Asia, Europe and North America – support customers in shortening time to market and offering injection moulded prototypes within 72 hours. Recently, we helped a customer with full delivery from concept to reality of a Class II active medical device for the US market via the 510k pathway. We supported the client from the design phase, through proof of concept to product verification and finally mass production.
We have continuously invested time, money,
and engineering expertise to develop and
enhance our roadmap. We use an established
technology readiness levels (TRLs)
development process, originally developed
by Nasa, to show how mature a technology
is and when it can be used in production. It
rigorously scrutinises each developmental
stage to ensure only the best-fit and
commercially viable are put into production.
Our in-house knowledge of the regulatory environment in key markets helps our customers to navigate a highly complex regulatory landscape. As a leading medical CDMO, our aim is to support our customers from concept to reality, be a trusted partner in navigating the medical landscape and bring market leading innovation to our customers.
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