In recent years, 3D printing has been widely used in many different areas, the most prominent ones are aerospace and medicine. Therefore the Ministry of Science and Technology has established a “Factory of Intelligent Additive Manufacturing Medical Devices” (FoiAM-MD) at the Southern Taiwan Science Park. The goal is to bring all local manufacturers together and make use their smart devices to enter the biomedicine market.
One-stop services, FoiAM does everything
In the past, the research of 3D printing and its collaboration with the industry often faced difficulties. This is where FoiAM comes in, to assist researchers and medical equipment manufacturers in design, trial production and mass production, through one stop services.
With creativity from Taiwan’s doctors and scholars, equipment from Tongtai, and metal powder from Chia Yi Steel and ThinTech, these services are entirely Made in Taiwan. A business cluster like this helps to retain talent. Deputy Minister Yu-Chin Hsu of the Ministry of Science and Technology also said that he looks forward to a 3D printing cluster that is as successful as the Hsinchu Science Park.
“The best thing about this business model is that it allows the industry and the scholars to focus on their creativity, and not worry about manufacturing.” Says National Chiao Tung University Associate Professor Nien-Ti Tsou.
When it comes to medical device manufacturers, Catcher Technology is one of the best in Taiwan. It is the first Taiwanese manufacturer to receive ISO 13485/GMP verification for their Class I devices. They’re planning to have their Class II and III devices verified this August as well.
Unlike the rigid, uniform medical devices from the past, 3D printing can create devices that are much friendlier to the human body. Take the intramedullary nail for instance. There is a limit to the capability of a traditional intramedullary nail, which simply “fits to the bone.” With 3D printing, it is possible to add tiny holes to the nail, to allow cells and blood vessels to grow into it, so that it “fuses with the bone.”
3D printed medical devices are complex and difficult to come to fruition
To make an porous intramedullary nail that is light, hollow and able to fuse with the bone at the same time is not easy. You have to go through a few stages in the park first.
The first step in manufacturing your medical device, is to create a 3D image of it and have it evaluated for feasibility and performance. Once your product passes the evaluation, it will then be printed.
Titanium powder is the main type of material for 3D printed medical devices. It is melted, superposed, and then printed out as different products. Additive manufacturing like this is customizable and able to save resources. During the process, waste can be recycled, filtered and reused. If done correctly, the waste recycling rate can go up to as high as 80%.
When a product is printed, it still has to go through post-process, which can vary according to each customer. Besides polishing and fine tuning the surface, most devices still need to be heated in high temperature to ensure even material distribution and product stability.
The final stage is “reverse restoration”: Examining the product with optical scanning, to make sure it matches the original design. Once everything is finalized, it will be vacuum packed, barcoded, and delivered to the manufacturer.
Even though FoiAM currently focuses on the research of dental and orthopedic devices, this place does a lot more than that. Besides assisting scholars and manufacturers in the research of 3D printed medical devices, FoiAM also helps them acquire ISO and GMP verifications, to speed up the commercialization of their products. We can expect to see many 3D printed medical devices coming to our lives very soon.