The engineers in the Labs will process stress analysis and plot stress-strain diagrams of the prototype of the products. The FEA method is used to simulate the implantation of the products in the spine system, monitoring the structural change of the products and the spine, and determine the reliability of the products under different circumstances. Based on the analysis, the engineers and designers will improve the products to make it more suitable for practical use.
The 3D printing technique is used to model the prototypes of the products using plastic materials. The designers will first evaluate the appearance and comfort of the model, and then setup the model with related devices to evaluate assembly effects. We may also implant the models into skeleton frameworks to further evaluate the implantation effects.
The prototype is manufactured after FEM analysis and 3D printing. The engineers in the workshop program the manufacturing process based on prototype plots. We currently have one Willemin 508MT and one DMG 60mono Block machining center, two DMG Sprint20-8 and one Citizen M20-TypeV slitting machine, one F023UP EDM, one mid-speed DK7732H EDM, and one Cut20P low-speed EDM. The equipment is properly used and carefully maintained to keep high quality of the prototype products.
The products are tested by static and dynamic experiment to determine the stiffness, the yield stress and the fatigue limit. Tytus Labs currently have one INSTRON ElectroPuls E10000 All-Electric Test Instrument for Material and Component Tests and one INSTRON ElectroPuls E10000 Linear-Torsion All-Electric Test Instrument to process the mechanical experiments. These equipment can automatically measure and calculate compression/tension stress, peeling strength, torque, and other important mechanical properties. The gathering of data, controlling of motion, and post-processing are all done by computers.
The implantation products require biomechanical tests besides mechanical tests. The spine biomechanics is a hybrid project including engineering mechanics and orthopedics. It mainly focuses on the mechanical properties of spine and the influences of all kinds of surgery techniques on the spine. The stability in three directions of spine is the most common mechanic requirement, also known as flexion /extension, left/right bending, and left/right torsion. The biomechanics analysis of spine can help doctors choose better surgery techniques on different symptoms and correct some problems occurring in the surgery (such as screw/rod broken issues). Meanwhile, with the combination of biomechanics and clinical practice, the doctors can further improve their understanding in spine surgery.
Mr. Mingyan Liu,Chairman of Shanghai Sanyou has engaged in research and development in the Orthopedic medical device industry for more than 20 years.He researches and develops in cooperation with many internationally renowned spine specialists.So his own experience of the Orthopedic product innovation insights was published in the journal of <International Medical Devices>.