Meeting stringent medical device standards

The medical device supply chain has experienced tremendous challenges as a result of the Covid-19 pandemic. The speed by which testing has been made available is integral to fast and efficient response to disease control. Recently, Rosti Group (Rosti) was chosen by a European high-tech biological company to deliver quick test results at laboratory-level within 15 minutes by extracting saliva. Patrick Williams, Senior Vice President, Rosti Asia, talks about how the company has been able to rise up to the challenges.

What is Rosti’s role in the medical device supply chain?

Mr. Williams: As of March 17, the World Health Organisation (WHO) data show that there were around 121 million COVID-19 cases around the world with around 2.7 million deaths. This is a staggering figure and although vaccines are now being produced and made available in various countries, the great uncertainties and risks caused by the virus’ mutation remind people that prevention and control efforts should be continuously implemented. In the midst of the pandemic, testing is one of the effective ways to contain the rapid spread of the coronavirus and we see consistent high demand for effective testing kits. 

As a specialised precision injection contract manufacturer, Rosti provides solutions for the whole medical device value chain to support customers’ fast and flexible responses during the pandemic. To achieve this, early involvement in customers product design, certified clean room for medical device manufacturing, short development cycle to fast mass production are essential aspects of Rosti’s operations.

In the area of Covid-19 testing, what is Rosti’s recent innovation? 

Mr. Williams: In October 2020, Rosti was chosen by a global molecular diagnostics company to begin manufacture of a Covid-19 saliva test, providing laboratory-quality results in 15 minutes. This will allow non-medical personnel to obtain fast, on-site detection of the SARS-CoV-2 virus at point of need. Rosti was selected based on its manufacturing proposal utilising state of the art digital innovation laboratory. The deployment of 3D printing of prototype injection moulding tools allowed engineers to have prototypes within 72 hours of receiving data in production intent material. Additionally, the tooling solution incorporates cutting edge technology delivering 32 cavity tools in 5 weeks and serial manufacturing under ISO13485 conditions.

This is not the first time that Rosti won such order. What is special behind this order is, the whole process from business negotiation to production start up with all the communication was under the context of the pandemic. This European customer has never been to the Rosti factory until the confirmation of the order, which is a good confirmation of their recognition of our product design and production capabilities.

Rosti has its presence in China. How would you describe Rosti’s operation in this region and its impact on the company’s customers? 

Mr. Williams: Rosti China was founded in 2001 and at that time, the company mainly specialised in high-end customised moulding. Over the years, Rosti developed into a contract manufacturer that today, it is committed to provide system solutions for the production of plastics, metal and electronic integrated modules. By incorporating its R&D and laboratory capabilities with its part and machine assembly expertise, Rosti is able to provide added value for customers in every step.

The Rosti digital innovation lab 

The Rosti digital innovation laboratory was set up in the Suzhou factory to help customers speed up product development and production. It houses 3D printers, scanners and test instruments. Customers who want to verify their design by testing the performance of plastics parts can have the work done within 72 hours by 3D printing test mould cores and cavities, then with an injection machine processing to obtain the data from the tests. As the plastics parts are injection moulded, the physical performance is the closest to that of mass production, thus helping customers to market the product in the shortest time possible. This revolutionises the whole process. In addition, Rosti China factory is able to produce and deliver ISO13485 standard mass production, thanks to its more than 10 years of experience in medical device manufacturing and management.  

What is Rosti’s plans as far as developing and expanding in other Asian markets? 

Mr. Williams: Early in 2012, Rosti detected business opportunities in Southeast Asia and established a production base in Malaysia where it also implements the same standards adopted in the Suzhou factory. As contract manufacturer, we must be close to our customers. In recent years, more customers want to diversify and reduce their risks, among them the concern over tariffs. Many companies are also entering the high value-added industries like medical device manufacturing. With factories in Suzhou and Malaysia, we are able to help our customers diversify the risks. Currently, Rosti manufactures commercial machines, consumers products including high end appliances at the Malaysia plant but we hope to be able to provide more medical and life science related products. 

How is Rosti adjusting to the current demand for medical products?

Mr. Williams: In the context of Covid-19, Rosti changed its business growth strategies. We need online systems to communicate with customers and let them fully understand what we can do for them. Most customers need to conduct on-site verification, therefore, we invited authorised third party to do this job. Thanks to our digital factory platform, we have three new leading medical and personal care customers from European and America even at the height of the pandemic last year. 

What are the key factors that should be taken into consideration in the production of essential products, like medical devices, at present?

Mr. Williams: I would name some essential factors based on our years of working experience with customers, and these are design and processing innovations and reliable operations. Accuracy and quality are fundamentals in plastics manufacturing but the most important is reliability – all the designs, engineering plans, product quality delivered, time of delivery, and response of technical team must be reliable. For Rosti, doing everything right the first time is rooted in our process quality management philosophy, where the highest level of manufacturing quality and delivery to customers of products with zero defect are top priority.. 

Today, many factories are short of operators. However, Rosti sees this as a big opportunity. We have been investing in automation with the awareness of labour cost increase and younger generation unwilling to work in factories anymore in the future. As a response, we will further incorporate more information technologies in every manufacturing process and automation technologies in assembly lines.

As a contract manufacturer, Rosti keeps close eyes on the market trends. It is no wonder that we achieve today battles and look at the new innovation for tomorrow to ensure we have a sustainable growth going forward.

Rosti Integrated Manufacturing Solutions (Suzhou) Co., Ltd.

E-mail: sales@rosti.com

Website: www.rosti.com