Press release: FMI Instrumed to start serial printing of titanium implants

Schiedam, Netherlands 30/03/2016: FMI Instrumed in Schiedam is one of the first companies in the Benelux to produce serial orthopaedic titanium implants using a metal 3D printer. To obtain this capability, this high-precision supplier invested in a Concept Laser M2 Dual Laser metal printer with QM quality monitoring systems. FMI Instrumed strives to expand its competencies by producing new types of implants that cannot be made with existing CNC technology. How will FMI achieve this?

As a contract manufacturer, the company has specialised in producing medical implants and instruments, such as poly-axial bone screws and other orthopaedic implants for European and American OEMs. With its specialised high-precision machining processes the company has profiled itself as a technically advanced supplier of components. Quality, price and a broad spectrum are the keys to success in this market with stringent quality requirements and price pressure.

Knowledge and experience acquired through AddLab

Inspired by the wish to make implants with porous structures and components that cannot be produced with existing CNC technology, metal 3D printing has been on FMI Instrumed's agenda since 2012. In 2013, FMI and 8 other companies joined AddLab - a shared facility for metal 3D printing. During a three-year project, these 9 companies used a number of metal 3D printers to gain experience in existing 3D printing technologies. The participants tackled the various aspects, such as design for AM, process & parameters, materials and process qualification, together and shared the obtained knowledge. The objective was for every partner to be able to go its own way at the end of the three-year project. FMI Instrumed has been the first to take this step and emphasises the importance of AddLab as the precursor to this decision.

Turning metal 3D printing into a fully-fledged business

On the back of that experience, FMI Instrumed was keen to use metal 3D printing as a serious production technology. Managing Director Henk Jansen commented “Having a metal 3D printer alone is not enough, because metal 3D printing is just one part of the process. You also need to be able to do all the finishing in house. We are talking about wire-EDM and milling to separate the products from the supports; post-machining like milling, polishing, tapping screws and other surface finishes, such as passivation and anodising. We can even use laser welding to connect a 3D printed component with a machined component. With all these competencies in house, the metal 3D printing process broadens our spectrum as an additional competency and we strive to develop it into a fully-fledged production technology. Globally speaking we are a relatively small company with just 50 employees, but with this broad spectrum of competencies we are certainly unique.”

Choosing Concept Laser

Henk Jansen continued “Our ambitions require a metal 3D printer that has a proven track record as a production machine. Concept Laser is one of the few to offer systems that can be used immediately as proven technology. Other manufacturers are certainly promising, but for our application they are often still working with a Beta version. The German manufacturer Concept Laser offered the option of 2 lasers (Dual Laser), which enables us to run dual production or to continue with just one laser if the other one is down. Furthermore, the fact that the powder does not come into contact with air is important to us as it makes the process ATEX-secure and in turn that guarantees the safety of our employees. Concept Laser is also advanced in terms of process monitoring. We purchased the various QM quality modules together with the printer. We specifically liked the construction of the printer itself and the manufacturer's DNA and we liked the installation and service of supplier Landré, guaranteeing service support close to home.”

Specialist in house

Although FMI Instrumed built up an advantage with the experience and knowledge gained in AddLab, the company did not have a real in-house specialist. In order to develop the integration of the 3D printing technology into a fully-fledged business, Ruben Wauthle recently joined the company. Ruben has more than 7 years of experience in metal 3D printing and worked for LayerWise in Belgium and through his PhD at Leuven University he specialised in producing implants with metal 3D printing. This has enabled FMI Instrumed to strengthen its position even further and to work on its competitive advantage.

Process validation

In this sector OEMs will only start working with a supplier when it has its quality assurance and certification in order. Henk Jansen said ”That guarantees the client 100% reliable products and a repeatable process. Therefore we are monitoring every process step in detail. The QM quality-monitoring systems make an important contribution to that. We expect to complete the process validation within the next few months and will be the first in the Benelux to start printing medical implants, integrated in other machining and finishing processes.

Focus on medical implants

With presentations at international orthopaedic trade shows we hope to obtain new leads for producing medical implants. Existing and new clients can join the new programme, which sometimes have a ramp-up time of up to 2 years. During this period we move from prototypes to engineering, 0-series and proving the reliability of the process. Our knowledge of the manufacturability is our greatest added value. The fact that we can carry out all the processes in house is our most important USP. As soon as we have validated the process, the route to other markets, such as the semi-conductor industry, is open. However, for the time being our focus will continue to be on serial production of medical implants with a high variation within a high volume.