On September 20th, NARLabs hosted a ceremony to launch the groups new 3D printing medical material, which recently underwent and passed the ISO-10993 biocompatibility international regulations verification. The artificial bone material, which is now being put through clinical testing, is preparing to be launched on the international market.
The process of creating the new biocompatible 3D printing material has relied on all the companies involved in the medical 3D printing alliance. For instance, the implant material is made from raw material supplied by the China Steel Corporation, which is then grounded into a fine powder by ThinTech Materials. Once the 3D printing material is prepared, the United Orthopedic Corporation is responsible for creating an implant or prosthesis design, which is then sent to the TongTai Group for 3D printing.
Significantly, the new and innovative 3D printed artificial bone material has already gained attention from a number of established metal 3D printing companies, including Renishaw, 3D Systems, and EOS. According to a source, these companies are seeking to establish ties with the alliance in order to use ThinTech Materials metal powder to create their own medical grade products and expand their services and business.
The 3D printing material itself is made from a high quality titanium, which was extensively tested until it met all biomedical material requirements. Currently, the new implant material is undergoing its biomedical system certification process, which is expected to be completed by the end of 2016. Once this certification has been approved (the ISO-13485), the new material will officially become part of the biomaterials supply chain. Notably, as the new material gets cleared at a number of stages, the medical 3D printing alliance is continuing its work to create even more advanced, and even lighter titanium powders for the 3D printing medical industry.
Currently, Taiwans first successfully tested 3D printing artificial bone material is undergoing human clinical trials in cooperation with the China Medical University Hospital. Subsequent trials, which will be done at the National Taiwan University Hospital, are expected to be completed within the next three years, and once completed results will be handed over to UL, a global independent safety science company who will choose whether to certify the new material. If all goes well, the certified material will then expand into the global market by applying for U.S. FDA approval.
3D printing has been increasingly used in the medical field in order to create custom prostheses and implants. Additive manufacturing has offered the medical industry a number of advantages over more traditional manufacturing methods, such as a much faster production time (a knee joint could take to as little as 17-18 hours to produce), and more complex implant designs (such as porous surfaces) which help to promote bone cell growth in the patient, thus reducing recovery time.
According to statistics from Business Monitor International (BMI), an international research organization, the global medical equipment market size is currently worth around $323.9 billion, and is expected to rise to 382.5 billion by 2018. Even just looking at the artificial joint global market you can see the growth, as it reached a high $15.4 billion in 2015 and continues to rise steadily. As Lin Yansheng, the chairman of the United Orthopedic Corporation, points out, artificial joints will move towards customized 3D printed products in the future, which are tailor made to become an inevitable trend.
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