From Design to Delivery, Every Step Built to Withstand Scrutiny #
Hsiner describes itself as a specialist rather than a general-purpose contract manufacturer: more than thirty years of expertise in respiratory and anesthesia medical devices, with every critical process completed in-house under an ISO 13485-certified quality system.
Capabilities at a Glance #
- Experience: 30+ years in respiratory and anesthesia devices
- People: 400+ employees across two facilities
- Facilities: Shengang headquarters and Houli plant
- Floor area: approximately 60,000 m² in total
- Processes: silicone injection, plastic injection, blow molding, tube forming and LSR extrusion
- Machine fleet: more than 50 injection and forming machines
- Cleanrooms: ISO 7 (Class 10,000) and ISO 8 (Class 100,000)
- Warehousing: automated storage and retrieval equivalent to about 140 forty-foot containers
- Regulatory experience: FDA, CE, MDSAP and other global frameworks
OEM/ODM Partnership #
Hsiner provides OEM/ODM services across the product lifecycle. From concept discussions and structural evaluation through mold development, trial verification, volume assembly and packaging, every step is completed in its own facilities, supporting IP protection and full quality traceability.
Four-step process:
- Requirements review and feasibility assessment — Discuss specifications, target markets and regulatory requirements; provide material and process recommendations, confirm feasibility and a preliminary timeline.
- Design development and tooling — Industrial design, structural simulation and prototyping; the in-house tooling department produces precision molds.
- Trial verification and design freeze — Functional testing and dimensional verification, with refinements until mass-production standards are met.
- Volume production, inspection and shipment — Cleanroom assembly, ISO 13485 quality inspections, packaging and delivery.
Why partners choose Hsiner (official points):
- All processes in-house — IP stays protected
- In-house tooling for shorter development cycles
- 30+ years of respiratory expertise, not a general-purpose factory
- Multi-market regulatory experience to help evaluate approval pathways
- Design experience backed by multiple patents
- Strict confidentiality across extensive partnerships
Research and Design #
Hsiner’s R&D team has focused exclusively on respiratory care and anesthesia devices for more than thirty years. Development spans industrial design, structural analysis, material selection, prototyping and functional verification, in close coordination with production so designs translate into mass-producible products.
Core capabilities:
- Industrial design and structural development — Human factors engineering, clinical workflow analysis and patient comfort, balancing functionality with manufacturability.
- Prototyping and rapid iteration — In-house tooling for fast mold production and revision, paired with internal trial lines to compress design-to-verification timelines.
- Material engineering — Expertise in liquid silicone, PE, EVA, PP, PVC, PC and other materials, optimizing formulations and process parameters.
- Design for regulatory — Regulatory affairs participates from the design stage so product architecture meets FDA, CE/MDR, MDSAP and target-market requirements, reducing downstream rework.
Multiple patents in structural innovation, material applications and functional improvements reflect the company’s design investment.
Manufacturing #
The two facilities house more than 400 employees across approximately 60,000 m² of total floor area. The Houli site is four times the size of the original headquarters; full relocation was completed in 2025, leaving room for future expansion.
Processes:
- Silicone injection molding
- Plastic injection molding — connectors, housings and functional components
- Blow molding
- Tube forming and tiny-component precision injection
- Liquid silicone rubber (LSR) extrusion
All assembly takes place in ISO 7 (Class 10,000) and ISO 8 (Class 100,000) cleanrooms. The Houli facility’s automated storage and retrieval system has capacity equivalent to approximately 140 forty-foot containers, supporting on-time delivery at high volumes. The building rises seven floors to a height of 32.7 m.
Quality Management #
Hsiner’s quality system is built around ISO 13485, with standard operating procedures and traceable records from supplier management and incoming inspection through in-process control and final release.
- QA (Quality Assurance) manages system maintenance, internal audits and complaint handling.
- QC (Quality Control) performs physical inspections.
- Regulatory Affairs operates independently, managing product registrations and technical documentation for market access across countries.
This separation allows multi-market compliance without compromising the independence of quality decisions.
Official Quality Management page · Read more about quality management