A global vision for medical molding – Medical Device Developments
Karl Stillman, Vice President, Strategic Sales at Rosti Group, describes to Medical Device Developments how technological capability and manufacturing expertise must go hand in hand with strong management skills and years of experience to fully meet the needs of the industry.
High-precision injection molding is critical in producing many medical devices, but technology alone isn’t enough to meet the strict quality standards required by today’s life sciences industry.
What crucial role do injection molding specialists play in the development of new and innovative medical devices?
As an injection molding specialist, our knowledge and services are a core part of the manufacturing process. We help our clients navigate the complex landscape of medical device regulations, making sure products meet all necessary safety and effectiveness standards.
To achieve this, we partner with clients to deliver customized, high-precision devices. This is especially important because medical devices often must be precisely tailored to maintain the uniformity and function of intricate and complex components. This is vital for items like insulin pens, catheters, and parts for specialized surgical instruments. A contract manufacturer often plays a key role in providing materials expertise, since medical devices require biocompatible polymers, elastomers, liquid silicone rubber, and many other materials.
Selecting the right materials is crucial to ensure regulatory standards for safety and performance are met, along with strict quality and sterilization requirements.
Why is it important to have an experienced contract manufacturer overseeing the injection molding process?
Medical devices with molded thermoplastic components benefit from a trusted partner like Rosti because we have over 75 years of experience in providing value to the medical sector. That can be absolutely essential in navigating the complicated regulatory landscape and in delivering consistently high-quality manufacturing processes, where adherence to strict standards is critical. We ensure that costly delays, legal problems, and all related risks are reduced. As an experienced global manufacturer, Rosti can scale up production to meet demand while maintaining consistent quality. Innovation is also very important to us, and our three strategically located innovation centers make us a strong partner during the innovation and design phase, drastically shortening time to market.
How have your customers’ needs changed, and how does Rosti keep pace with its customers?
We’ve observed trends like increased outsourcing of production, with CDMOs taking on a more significant role as a partner to OEMs. Nearshoring is also on the rise, and as a global organization, Rosti can support customers exploring new supply chain setups. Through accredited facilities, experienced staff, and state-of-the-art equipment, we go the extra mile to exceed customer expectations.
You mentioned that Rosti is a global organization, so how important is it for a contract manufacturer to have a global footprint?
Because we maintain the same quality and standards at all of our sites, we can communicate with our customers as one unified organization with a single point of contact. Additionally, having a global footprint and a ‘One Rosti’ approach helps our customers access new markets, find optimal and diversified supply chain solutions, and minimize the risk of supply chain disruptions. With local presence and expertise in all key medical markets worldwide, we offer a deeper understanding of regional regulations, standards, and market preferences.
Can you give examples of Rosti’s involvement in the manufacture of innovative medical devices?
Our three innovation centers – in Asia, Europe, and North America – help customers reduce time to market and can provide injection-molded prototypes within 72 hours. Recently, we helped a customer bring a Class II active medical device for the US market from concept to reality via the 510k pathway. We supported the client through the design phase, proof of concept, product verification, and finally, mass production.
How does Rosti’s global technology roadmap help bring new technologies to a production-ready stage faster?
We have made continual investments of time, money,
and engineering expertise to develop and
refine our roadmap. We use an established
technology readiness level (TRL)
development process, originally developed
by NASA, to determine how mature a technology
is and when it can be implemented in production. It
rigorously reviews each stage of development
to ensure that only the best-fitting and
commercially viable technologies are brought into production.
Our in-house expertise in the regulatory environment of key markets helps our customers navigate a highly complex regulatory landscape. As a leading medical CDMO, our goal is to support our customers from concept to reality, serve as a trusted partner throughout the medical industry, and bring leading market innovation to our clients.
