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In recent years, there have been more and more researches on 3D printing, and the technology has become more mature. In the field of medical devices, 3D printing technology has been applied to include auxiliary tools, implants, surgical instruments, software and other fields, can be designed according to the needs of patients, instantly print out products from the design drawings, and customize medical equipment of different sizes and parts.
We discovered that global 3D printing patents have expired, FDA has officially announced 3D printed medical device guidelines, and global population aging. Based on three key foundations and trends, this study further combined with the Hype Cycle of 3D printing technology development in recent years, and according to the five-force analysis model. We expected to find how does Taiwan's biomedical industry cut into and integrate the competitive strategies in the two fields of 3D printing technology and orthopedic medical devices. The results of this research, the world's internationally 3D printing equipment manufacturers have only expensive equipment but no quality management system (QMS) in medical devices, and also have not passed the relevant certification. In addition, most of the internationally orthopedic medical company have no experience in 3D printing technology, and still taking M&A as a strategy. At present, the 3D printing medical device of the orthopedics mainly focused on the Class 1 medical devices. The next step should be to use Taiwan's 3D printing equipment to independently develop energy and high-end medical device talents to develop advanced medical device (Class 2 & Class 3). One-stop service will be the development strategy of the next generation in medical device.
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