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3D printing of new materials for medical devices: progress in regulatory science and innovation in clinical applications

2024-05-07 18:10

In the medical field, 3D printing technology, also known as additive manufacturing, is leading a revolution in material forming and medical device manufacturing with its unique bottom-up and layer by layer manufacturing approach. Compared to traditional material forming and machining techniques, 3D printing technology, with its high flexibility, complex geometric shapes, and variability in internal material composition, provides the possibility for low-cost manufacturing of single small batch and customized products.

With the gradual development of medical services towards precision and customization, additive manufacturing technology, relying on its alignment with the development direction of the medical industry, is promoting the rapid development of medical additive manufacturing technology and related medical devices, and forming a new disciplinary direction in the field of biological manufacturing. Especially in the research and development of new materials and medical devices, 3D printing technology continues to break through, basic research and application research progress rapidly, and many products have gradually achieved industrial application.

From the perspective of basic and applied research, the development of additive manufacturing medical devices can be divided into four levels: in vitro medical devices, non degradable regenerated hard tissue implants, degradable medical devices, and direct manufacturing of active tissues. Each level has its own unique challenges and opportunities, from the construction of non living organisms to the manufacturing of living organisms with vitality, 3D printing technology is gradually demonstrating its powerful potential.

In the field of extracorporeal medical devices, 3D printing technology has been widely used in the manufacturing of medical models, personalized navigation templates, and prosthetic orthotics. Among them, medical models can accurately simulate human body structure through 3D printing technology, providing great convenience for preoperative plan discussion, surgical simulation, and doctor-patient communication; Personalized navigation templates greatly improve the accuracy and safety of surgery; The 3D printed prosthetic orthosis, with its high degree of fit and comfort, has brought new solutions to the field of rehabilitation assistive devices.

With the acceleration of the construction of the scientific regulatory system for additive manufacturing of new materials and medical devices, the relevant standard system is constantly improving, and research on product quality control technology is actively carried out. In the future, additive manufacturing of new materials for medical devices is expected to be more widely used in clinical practice, providing higher quality and personalized protection for public health. Meanwhile, with the continuous progress and innovation of technology, we have reason to believe that 3D printing technology will play a more important role in the medical field, promoting the continuous progress and development of the medical industry.