[Manufacturing Example] Medical Valve Control Device
Introducing a case study on the mass production of a waterproof valve device using two-color molding (TPU on PC) and FDA compliance!
We received an inquiry from a medical device distributor in the United States regarding the development and mass production of a valve device that controls the flow of liquids, etc., with ON/OFF functionality. This product requires intuitive operation with one hand and IP58 waterproof performance to withstand use in medical environments. Additionally, achieving full compliance with FDA regulations while optimizing costs is a critical challenge. The annual production quantity is between 30,000 and 50,000 units, with a defect rate of 1 in 10,000. The mold production period is 35 to 45 days, and the mass production period is 2 years. 【Technical Challenges】 ■ Ensuring waterproof performance: Achieving stable IP58-level waterproof performance in mass production while maintaining precise fitting tolerances for slider components. ■ Compliance with FDA regulations: Establishing material selection, process management, and documentation systems in accordance with U.S. FDA regulations, and passing regulatory authority reviews. ■ Precision tolerance matching: Designing precise tolerances considering the thermal expansion differences between materials in two-color molding and stabilizing mass production. ■ Cost optimization: Achieving competitive cost targets while maintaining high-quality standards (defect rate of 1 in 10,000). *For more details, please download the PDF or feel free to contact us.
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【Applicable Technologies and Materials】 ■ Molding Technology: Two-color molding (double injection) — TPU over PC substrate ■ Material Standards: FDA-compliant materials (equivalent to USP Class VI) ■ Quality Assurance: Full airtight inspection using air leak testing fixtures ■ Design Verification: Precision tolerance matching plan using matrix testing method ■ Regulatory Compliance: Completion of FDA regulatory review and establishment of document management system ■ Electronic Components: One-hand operation compatible, flow control slider mechanism *For more details, please download the PDF or feel free to contact us.
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YOMURA JAPAN Office (Opereted by Minnano Modeling Service) YOMURA JAPAN Office
YOMURA JAPAN is the Japanese sales office of YOMURA Technologies, a Taiwanese precision molding manufacturer with 36 years of history, over 300 employees, and certifications including ISO 13485, US FDA 510(K), GMP, and AS9100D. Operating five factories in Linkou, Taiwan, the company provides precision manufacturing for medical devices and healthcare products in a Class 100,000 cleanroom-certified environment. From our Japan office, we support the entire manufacturing journey — from product development using advanced 3D printing technologies (silicone, biocompatible resin, flexible TPU, and micro SLA) to full-scale production at our certified factories utilizing micro molding, two-shot molding, LIM/LSR molding, IMD, IME, and contract assembly. We also offer consulting services on material selection and medical device certification, as well as support for expanding into overseas markets. Through our "prototype in Japan, mass-produce in Taiwan" model, we deliver both quality and efficiency. From early-stage technical challenges to certification and production, please feel free to contact us.
