In the intelligent manufacturing landscape of Dongguan, known as the “World Factory,” a group of technological pioneers deeply engaged in niche sectors is reshaping the industry landscape with disruptive innovations. As a professional medical mould manufacturer, Yize Mould, with its dual-core driven technological system of “medical mold design – clean-room injection molding production,” has become a crucial participant in the global high-end medical device supply chain. It has established an integrated system from medical mold design and development to the production of Class II medical device injection molding accessories, with products covering niche areas such as minimally invasive surgical instruments, in vitro diagnostic equipment, and wearable medical sensors. Its business extends to over 30 countries in the EU, North America, and along the “Belt and Road” initiative.
Vision
I. Precision Revolution from Medical Mould Manufacturer
Micron-level Manufacturing Capability
Yize Mould pushes its precision machining capabilities to the extreme: In the development of medical laryngoscope molds, medical surgical clamp molds, and life detector molds, it achieves stable molding of high-transparency microchannels. For medical implantable tie molds, it reduces the PEEK material surface contact angle from 110° to 48°, significantly enhancing cell adhesion performance, with relevant parameters passing ISO 10993 biocompatibility certification.
II. Intelligent Manufacturing System in 100,000-Grade Clean Room
Medical-Grade Environmental Control
The 6,000㎡ clean room adopts a laminar flow air supply system to dynamically maintain ISO 13485 Class 7 cleanliness, with key workstations reaching Class 5 standards. The temperature and humidity control system is precise within ±1℃ and ±5% fluctuation ranges, coupled with an online particle monitor, ensuring that the concentration of ≥0.5μm particles is below 35pc/m³, meeting the stringent requirements of the “Medical Device Production Quality Management Regulations.”
Breakthrough in Special Injection Molding Technology
The clean room houses 15 all-electric injection molding machines forming an intelligent production line, equipped with a three-loop PID temperature control module, controlling mold temperature fluctuations within ±0.2℃. In the production of COVID-19 test kit sealing covers, it innovatively applies in-mold micro-pressure injection molding technology, reducing the CV value of 96-well plate hole depth consistency from the industry average of 1.2% to 0.5%. For implantable devices, it develops a nitrogen barrier system that completes sealed packaging within 3 seconds after part demolding, with residual oxygen content below 0.1%.
III. Benchmark Cases Rewriting Industry Rules
Medical Implantable Tie
Facing the technical challenge of ±0.02mm tolerance for 0.8mm inner diameter catheters, Yize Moulds develops a 12-level gradient stretching module, using intelligent compensation algorithms to offset material rebound, increasing the elongation rate of 316L stainless steel tubes to 380%. The accompanying anticoagulant coating co-injection system achieves directional distribution of heparin molecules on the tube wall. After passing FDA certification, this product helps customers reduce costs by 45% and shorten the supply cycle to one-third of that of European counterparts.
Fully Automatic PCR Reagent Kit Production Line
To meet the demand for tens of millions of nucleic acid tests, Yize Mould designs a 32-cavity medical mold, integrating visual positioning and laser marking systems. Its unique thermal balance compensation water circuit reduces the molding cycle of 96-well plates from 28 seconds to 19 seconds, with a hole-to-hole temperature difference not exceeding 0.5℃. This production line has passed CE IVDR certification, with a daily production capacity exceeding 3 million pieces, becoming a core piece of equipment for domestic IVD enterprises.
IV. Strategic Layout for the Future
From Class I Medical Injection Molding Accessories to Class III Implantable Injection Molding
From medical consumable injection molding to pharmaceutical packaging injection molding, and from medical clean-room injection molding to sterile implantable injection molding, Yize Mould is gradually laying out for the future, continuously exploring medical businesses in medical mold accessories, medical molds, and medical injection molding, contributing to the cause of medical and health supplies.
Cell Factory-Level Cleanliness Standards
The GMP+ workshop under construction introduces a nano-photocatalytic sterilization system, controlling the concentration of airborne floating bacteria below 5cfu/m³, reaching cell culture-level environmental standards.
From Dongguan’s manufacturing workshops to operating room supplies worldwide, Yize Mould is reshaping the medical injection molding consumables and accessories supply chain with disruptive innovations. It develops surgical clamp molds, medical examination laryngoscope molds, medical implantable tie molds, etc. Amidst the dual opportunities of medical device localization and precision medical upgrades, this enterprise rooted in Dongguan is using the combination of “medical precision + industrial intelligence” to write a model for China’s high-end manufacturing breakthrough.
