FMI Instrumed has added a fifth industrial metal 3D printer to their Schiedam facility in the Netherlands.
FMI Instrumed is a subsidiary of FMI, a machining company first established in 1962.
FMI operates a number of metal 3D printers, including the Concept Laser M2 Cusing Dual Laser additive manufacturing system. The powder bed fusion M2 Cusing has a build volume of 250 x 250 x 280 mm and can 3D print with metal powders including Titanium, Aluminium and Stainless steel. GE describes the M2 metal 3D printer as “the workhorse of the Concept Laser system fleet”.
Metal AM “integral”
Henk Jansen, Managing Director at FMI Instrumed, said, “The increasing contribution of additive manufacturing in the medical device industry endorses further developments within our company.”
Medical devices made using additive manufacturing at FMI Instrumed include, “a whole new generation of spinal implants.” Other products developed with customers include the titanium cup of a hip implant and knee implants. Jansen added, “At FMI we don’t see additive manufacturing as a standalone process, but as an integral part of our production process”.
The expansion of FMI Instrumed’s additive manufacturing capabilities illustrates how a growing number of enterprises are incorporating additive manufacturing into their workflow. At FMI this involves having CNC milling tools available for post-processing at the same facility.
Matching technical ability with medical standards
In addition to machining capacity it is also vital to have appropriate processes and quality assurance procedures in place, especially when working in the medical device industry. FMI Instrumed is an ISO 13485 and 9001 certified company and is FDA compliant.
At the end of 2017, the FDA issued a statement the use of 3D printing for medical applications. Speaking at the time FDA Commissioner Dr. Scott Gottlieb noted the, “new era of 3D printing of medical products” and confirmed the agency has reviewed over 100 3D printed medical devices currently on the market.
The guidance was broadly welcomed by leading additive manufacturing enterprises. Speaking to 3D Printing Industry, Laura Gilmour, global medical business development manager at EOS, said “The FDA finalizing their technical guidance document on additive manufacturing means a lot for the industry, since the medical sector was an early adopter of additive manufacturing for device production.”
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