Innovation in the healthcare sector is driving medical devices to achieve higher levels of performance, precision… and complexity. But what does “complex” really mean in this context?
A high-value system
A complex medical device is not simply a sophisticated object. It is a system that combines several demanding technical characteristics, such as:
- Advanced miniaturization, with components measuring only a few millimeters
- Multiple functions: administration, diagnostics, monitoring, connectivity…
- Integration of thermosensitive or electronic components
- Assembly of heterogeneous materials (silicone, metals, high-performance polymers…)
- Prolonged contact with the human body, requiring flawless biocompatibility
Stringent technical and regulatory constraints
These devices must comply with strict standards (ISO 13485, ISO 10993, MDR, FDA…), ensure complete traceability through labelling (UDI, CE…), and require manufacturing in controlled environments.
Material expertise and industrial know-how: the key
In the demanding field of medical devices, silicone has become a benchmark material thanks to its biocompatibility, flexibility, chemical resistance and long-term stability. Processing silicone calls for advanced expertise and a perfect command of industrial processes that meet the sector’s stringent requirements.
At EXSTO, with nearly 30 years of expertise in silicone, we master a wide range of technical know-how:
- Mono- or multi-lumen extrusion, co-extrusion
- Molding and overmolding of sensitive components
- Micro-injection for miniature parts
- High-precision assembly, cutting, deburring, marking
- 3D printing for prototyping
We process medical-grade silicone in ultra-protected, dedicated environments.
Are you developing an innovative medical device?
Let’s talk! Our team of medical device experts supports you at every stage, from design to production.
We provide comprehensive expertise in co-development, process validation and custom manufacturing of critical technical components, ensuring performance, regulatory compliance and industrial quality.