Single-Use, Sterilized Products
Single-use, disposable products in sterilized packaging are a booming segment. But manufacturing, assembling and packaging these medical devices requires the use of certified Clean Rooms and other advanced technology to avoid contamination and meet stringent compliance requirements.
It’s a challenge for OEMs and startups, especially when scaling production volumes. Clean Rooms are capital-intensive to build, time-consuming to maintain, and require ISO13485:2016 certification, making in-house manufacturing both financially risky and resource-intensive.
Sterling Industries has over X,000 square feet of flexible and compliant Class 7 Clean Room space. We have deep experience in designing and maintaining workflows for manufacturing, assembling and packaging that ensure cost-efficiency, repeatability, quality and compliance.
Besides familiar single-use categories like syringes, catheters and surgical instruments, we are seeing rapid growth in innovative single-use medical devices that include sophisticated digital functionality.
Falling costs for single-board computers (SBCs), microcontrollers, optics and sensors, combined with rising costs and stricter compliance procedures for sterilization of traditional, re-usable devices is leading to an impressive new category of complex, single-use devices that can replace capital-intensive multi-use systems that are expensive to maintain and re-sterilize. We have experience with single-use, digital imaging solutions, including arthroscopes and endoscopes, as well as wireless sensors and diagnostic testing kits that include advanced microelectronics.