Singmed

Suzhou Singmed Medical Device Science and Technology Ltd focuses on the fields of pulmonary drug delivery, nasal drug delivery, and brain-targeted drug delivery devices. The company conducts independent intellectual property research and development in core technology areas such as structural design of drug delivery systems, silicon-based aerosolization development and manufacturing, precision molds, and automation. It provides integrated service solutions for innovative and generic drug-device combination formulations, covering structural design, patent FTO (Freedom to Operate), tolerance analysis, medical materials, precision molds, process validation, precision injection molding, product validation, and product assembly. Singmed's industrial manufacturing center has a 1,500-square-meter ISO-8 & ISO-7 grade cleanroom, equipped with world-class production equipment (including all-electric injection molding machines from Japan’s Sumitomo and Fanuc, robotic assembly systems), and a commercial silicon-based aerosol chip production workshop. The facility includes an independent microbiological testing lab (positive and negative controls), microscopic optical inspection, NGI testing specifically for inhalation products, and a physical-chemical testing laboratory capable of performing tests according to USP standards and relevant requirements set by China's National Medical Products Administration (NMPA). From R&D design, large-scale manufacturing, to supply chain management, the entire process complies with the ISO-13485 standard for medical device design and manufacturing. Singmed's inhalation drug delivery devices also fully meet the relevant evaluation guidelines for inhalation drug formulations issued by the U.S. FDA. Suzhou Singmed has achieved years of commercial development and manufacturing of inhalation devices and nasal drug delivery devices in collaboration with leading publicly listed biopharmaceutical companies in China, covering multi-dose blister-type DPI devices, single-dose capsule-type DPI devices, soft mist devices, and nasal spray devices.