Rosti: A pioneer in injection molding and assembly for the medical device industry

In the rapidly evolving medical device industry, injection molding and assembly technologies have become increasingly critical. As a company specializing in precision injection molding and turnkey contract manufacturing, Rosti has established itself as a leader in the medical device sector. With its cutting-edge technical capabilities, innovative spirit, and unwavering commitment to international standards, Rosti provides customers with end-to-end solutions from concept development to product realization.

At the Plastics Innovative Materials Application & Processing Technology Congress 2025, Ms. Ke Rong, Operations and Quality Director of Rosti Medical Solutions, shared, "Rosti operates 13 manufacturing facilities, six of which are ISO 13485-certified. The company is equipped with over 550 injection molding machines and generates an annual turnover of €400 million. Its innovation center continues to drive technological advancements in this highly dynamic sector. With over 20 years of experience in medical injection molding and assembly, Rosti's products span a wide range of medical devices - including medical consumables, Microfluidic plate of diagnostic equipment, development and manufacturing of critical single-use components used in advanced medical eye lasers for refractive and therapeutic corneal surgery, and micro - current body massager -demonstrating extensive business scope and technical diversity."

A major breakthrough: 72-hour from concept to reality

Being first to market is critical. Without innovation, progress stagnates.

This is especially true in manufacturing, an industry renowned for being at the fore of the latest technology. Digital transformation is here, and artificial intelligence (AI), automation and machine learning are all playing lead roles.

And leveraging 3D printing at scale is Rosti. Rosti’s leading-edge technologies take products through a journey of concept to completion and deliver a full range of contract manufacturing services. Depending on the requirement, Rosti can manage the project from the beginning to the end while providing design support, supply chain management, assembly and logistics. 

Today, Rosti is leveraging 3D printing to deliver prototype products to clients in Asia within three days due to its digital innovation lab in China.

“3D printing has been around for a while, but we applied such technique to printing injection mold cores and cavities and allowing prototype parts to be manufactured in design intent material, which offers invaluable service for our customers and their new designs,” comments Patrick Williams, Senior Vice President of Rosti’s Asia operations. 

According to Ms. Ke Rong, the company has reverse engineering capabilities from products to digital 3D files and is able to use additive manufacturing technology to quickly produce full-color concept evaluation models and functional prototype components. Its advanced manufacturing method combines plastic parts with electronic functions, reduces printed circuit board components (PCBA), makes products more compact, and adds innovative features such as touch sensors.

Rosti has invested in Carbon's state-of-the-art additive manufacturing equipment, including the only M3 printer in Asia. Firstly, the M3 printer can achieve the manufacturing of parts with highly complex geometries and fine features, which is difficult to accomplish with traditional manufacturing methods. Through the digital light engine, UV images are projected through an oxygen-permeable window into a pool of UV-curable resin, and the parts are cured layer by layer with a slice thickness of 25 to 100 micrometers. This precise molding method gives designers unprecedented design freedom. Secondly, the printer has an excellent thermal management system, performing remarkably well in both heating and cooling, which greatly increases the printing speed and ensures that the printed parts have higher resolution and better surface finish. In addition, the M3 printer offers a wide range of material choices, including various materials such as rigid and flexible polyurethanes and silicones, meeting the diverse requirements for material properties in different industries and application scenarios.

"Rosti has made significant achievements in optical injection molding and turnkey manufacturing," Ms. Ke Rong stated. For example, the company provides optical injection molding and assembly services for a client specializing in vision correction surgeries, including LASIK, PRK, and SMILE. Rosti not only delivers high-quality injection molding and assembly, but also manages subsequent packaging, sterilization, overseas market documentation preparation, as well as regulatory consulting. Through technological innovation, Rosti meets the stringent requirements of domestic and international markets while enhancing the production operations of its customer.

In turnkey manufacturing, Rosti has also demonstrated its robust capabilities. "The company successfully developed an adult diaper monitor, a Class I medical device featuring a unique device identifier (UDI) and compliance with ISO 14971 risk management standards. The device's sensor is mounted on the outside of the diaper to monitor urine saturation, with the transmitter connected to the flexible circuit board of the sensor strip," stated Ms. Ke Rong. Additionally, Rosti developed a medical-grade portable body massager, a Class II active medical device fully compliant with 21 CFR 820 standards and cleared through the 510k process for the U.S. market.

Compliance to stringent standards and sustainable development

Rosti recognizes the critical importance of regulations and compliance in medical device manufacturing. In this aspect, the company focuses on continuously enhancing the professional capabilities and regulatory awareness of its medical subject matter experts (SMEs) to enable the delivery of safe and effective value-added services to clients. Its competency model includes foundational modules (such as ISO 13485/21 CFR 820/ISO 14971/MDR) and specialized requirements (such as safety and performance, software lifecycle and validation, process validation, PMSR and CAPA, packaging and labeling, etc.). Additionally, Rosti provides support in specialized areas such as cleanrooms, sterilization, and clinical trials.

Ms. Ke Rong stressed that Rosti develops medical products under the ISO 13485 management system to ensure alignment with user needs, including safety and efficacy. For example, a home healthcare device developed by Rosti adheres to the IEC 60601 standard and incorporates a rechargeable battery with wireless charging capabilities as well as visual signal lights during operation, all of which reflect strict adherence to regulations and user requirements.

Given the trends towards sustainable production operations, Rosti is committed to sustainable development as it implements measures geared towards emission reduction, renewable energy adoption, energy efficiency improvements, renewable material utilization, zero waste initiatives, and sustainable design to create greater value for customers and society. Ms. Ke Rong stated, "Sustainable development is a key pillar of our corporate strategy. We aim to drive positive social impact through technological innovation and environmental stewardship."

As a pioneer in injection molding and assembly for the medical device industry, Rosti offers comprehensive services from concept to commercialization, leveraging its technical expertise, industry experience, regulatory compliance, and sustainability commitment. By investing in advanced additive manufacturing equipment and through continuous innovation, Rosti not only accelerates product development but also reduces costs and enhances market  competitiveness. Looking ahead, Rosti is poised to continue leading industry advancements, delivering game-changing solutions and value to the medical device manufacturing sector.

For more information about Rosti, visit: https://rosti.com/.