The advent of COVID-19 has added a layer of complexity to product development. Agility is more important than ever as it has made it critical to get products to market quickly. While manufacturers generally spend a lot of time and energy on prototyping parts and development tooling, they must now streamline these processes and deliver custom design intent parts in hours rather than weeks.
To put this in perspective, in recent years a four-week prototype lead time was considered world-class rather than the norm. Rosti Group has reduced this process to as little as 72 hours. By getting involved in customers’ designs at the concept stage, we maximize our value and help evolve the design with manufacturing processes in mind. For example, at the start of the coronavirus pandemic, we were able to quickly start manufacturing parts for PPE (personal protective equipment) in our innovation center and get the PPE where it was needed, in super-quick time. From cleanroom production to the development of precision parts, this type of innovation is made possible with agile medical device manufacturing.
So now more than ever, producing custom prototype parts quickly is essential while also delivering them in design intent materials that are produced to the same specifications as the final product. Rosti, for example, uses state-of-the-art 3D printing techniques in the tooling creation process, which has inreased the speed with which customer’s designs are brought to life.
Traditional steel prototype tooling methods take time and money, and usually a lot of both. So, there are many obvious advantages to 3D printing the cores and cavities of the designs. It is quick, relatively cheap, and scalable for low-volume production. And perhaps more importantly, 3D printed tooling enables a product to be created in the same injection-molded material that will be used in the final product.
Conventional part prototyping means that parts are often 3D printed in a material that does not reflect the final product. This was an accepted process for many years. This is simply because there was no better alternative. When 3D printed prototypes cannot reflect the actual material and production intent, it can only go so far in approximating what the final product will become. However, this presents significant disadvantages. And during the pandemic — when products must get to market quickly — this may not be sufficient. Being able to deliver 3D printed tools closes this gap. Because the parts are injection molded and not grown by 3D printing, they are fully representative and capable of user interaction and mechanical testing — qualities that you cannot always have confidence in with printed prototype parts.
The benefit for OEMs is not only accelerated development schedules but also greater design confidence to fail forward. They can try new things in the design stage without the traditional burdens of cost and lead times. This, in turn, enhances the design to achieve the greatest possible product that is not only production ready but also market ready, which is good news for everyone from the manufacturer to the end user.
Maintaining Quality in Medical Manufacturing
Hand-in-hand with getting products to market quickly during the pandemic is ensuring that they meet the highest standards in safety, quality, and environmental sustainability. Certifications such as ISO 13485 — quality management within medical devices — and other standards including ISO 14001 for the environment, ISO 9001 for quality, and ISO 18001 for occupational health and safety are essential. As well as being approved under both British and American food production standards Rosti, for example, meets full compliance with standards for the medical industry, including:
- ISO 9001 – quality management
- ISO 13485 – quality management within medical devices
- Cleanroom, class 100,000 – GMP
- ISO 14001 – environmental management
- OSHAS 18001 (HSSE) – health & safety management
- A medical device manufacturing certification tells regulators and customers that your contract manufacturing partner has undergone an objective evaluation by a third party and met all the requirements for producing safe goods.
The Importance of ISO 13485
Because of strict industry requirements, companies responsible for selling finished medical devices should be using an ISO 13485 certified manufacturer. This certification helps to avoid errors in design and manufacturing by ensuring that there is a clear understanding among all parties of the device’s end use. As the plastics used in medical devices are the parts most often seen and touched by the end users, it is important to choose a manufacturer with not only the certification but also the experience in producing medical devices.
ISO 13485 adds another layer onto ISO 9001, as the standard for quality management systems aimed specifically at medical devices. Its emphasis is on managing risk and foreseeing and fixing problems before they occur.
The standard ensures that safeguards are in place for medical manufacturers, to make sure that each component of a medical device meets the most rigorous safety standards. These include regulatory requirements for documentation and records, medical-device-specific product and process verification procedures, and re-evaluating a contractor’s entire supply chain. Working with a contract manufacturer that has ISO 13485 certification can also help OEMs meet the strict standards of government quality standards like the U.S. Food & Drug Administration’s Quality System Regulation.
The COVID Effect
It is clear that one of the greatest effects of the COVID-19 pandemic has been a need for innovative companies to rethink traditional approaches to manufacturing and to do things quicker and more efficiently. The current COVID-19 situation has accelerated that need, and thus faster concept-to-reality lead times have never been more important.
This article was written by Karl Stillman, Regional VP of Sales for Rosti Asia. The global precision plastic injection molding company and contract manufacturer has production sites in Sweden, Germany, UK, Poland, Romania, Turkey, China, and Malaysia. For more information, visit here .