The medical device industry imposes extremely stringent requirements on product precision, compliance, and safety. 

As a core production equipment, precision injection molds directly determine the molding quality, performance stability, and market access qualification of medical components. Suzhou Donghao Precision Manufacturing Co., Ltd. has been deeply engaged in the medical field for 17 years. Relying on integrated molding technology accumulation and compliant production systems, it has realized the in-depth application of precision injection molds in segmented scenarios such as minimally invasive devices, diagnostic equipment, and rehabilitation instruments, providing core support for the high-quality development of the medical industry.

The primary core of the application of precision injection molds in the medical device industry is compliance adaptation. Medical products need to pass drug regulatory authority audits and market supervision inspections, so mold design and production must meet the requirements of the ISO13485 medical quality management system. Donghao Precision's medical-specific molds are all manufactured in a 1,200-square-meter Class 100,000 cleanroom. Medical-grade certified mold steel is adopted, which undergoes vacuum quenching and cryogenic treatment to ensure no impurity contamination of the material. At the same time, the ERP+MES system is used to realize full-process traceability of mold production. Each set of molds is accompanied by a complete qualification document package to help downstream customers successfully pass compliance audits. For high-precision requirements such as minimally invasive surgical instruments, the mold cavity tolerance is controlled within ±0.005mm to ensure the molding accuracy of microstructures (such as infusion components with a diameter of ＜1mm).

In the molding of core medical components, the process adaptability of precision injection molds is particularly critical. In the field of minimally invasive devices, Donghao realizes the biocompatible molding of medical catheters, seals and other components through liquid silicone rubber (LSR) injection mold technology. The mold adopts a special runner design to avoid harmful substances generated by silicone material degradation. The products have passed ISO10993 biocompatibility tests and have served more than 100 medical consumable manufacturers. In the field of diagnostic equipment, for sensor housings, precision probes and other components of testing instruments, the mold integrates insert injection molding technology to achieve integrated molding of metal and plastic, solving the pain points of easy loosening and insufficient precision of traditional assembly processes. The mold life exceeds 800,000 cycles, meeting the needs of mass production.

The adaptation of special materials and composite processes has expanded the application boundaries of medical devices. Donghao Precision's precision injection molds are compatible with high-temperature special materials such as PEEK and PEI. For the molding needs of implantable medical components, the mold is treated with a corrosion-resistant coating to avoid material reaction with the cavity affecting product purity. In the field of rehabilitation equipment, through overmolding injection mold technology, the composite molding of soft silicone and hard plastic for medical handles and grip components of rehabilitation equipment is realized. The mold's temperature control system ensures that the bonding strength of the two materials meets the standard, improving product comfort and durability. In addition, for the mass production needs of disposable medical consumables, the mold adopts a multi-cavity design with a maximum number of single mold cavities of 32, and the production efficiency is 40% higher than the industry average.

The full-process service capability maximizes the application value of precision injection molds. Donghao Precision provides one-stop services for medical customers from mold design, process verification to mass production and delivery. During the mold development stage, it deeply participates in the customer's product design, optimizes the cavity structure through 3D simulation, and shortens the mold trial production cycle to 30 days. During the mass production stage, the MES system is used to lock process parameters to ensure that the batch product size fluctuation error is ≤0.5% and the defect rate is controlled below 0.3%. For the small-batch trial production needs of small and medium-sized medical innovation enterprises, a flexible mold customization plan is launched to reduce the minimum order quantity threshold while maintaining the same precision standards as mass orders.

With the development of medical devices towards minimally invasive, intelligent and integrated directions, the technical requirements for precision injection molds will continue to upgrade. With 17 years of industry experience, more than 40 core patents and a complete compliance system, Suzhou Donghao Precision continues to optimize mold design and manufacturing processes, making the application of precision injection molds in the medical field more accurate, efficient and safe. It creates compliant, controllable and stable performance production solutions for global medical customers, helping the development of new quality productive forces in the medical manufacturing field.