Silicone elastomer moulding for the production of grade medical implantable devices 
AFC/O/F-2003/01

Abstract
A French SME specialised in the design and manufacturing of implants and medical devices according to customers specifications is offering its know-how for the production of silicone parts implantable in the human body. This know-how encompasses materials biocompatibility, materials processing under controlled atmosphere including shape complexity and ability to manage small batch of production. It proposes manufacturing agreements to industrial partners of the medical sectors.

Description
This French SME, EN 46002 certified, specialised in the design and manufacturing of implants and medical devices has developed a know-how and non-conventional tools for the production of silicone parts which are implantable in the human body.
Generally, classical industrial processes such as compression moulding, injection moulding and dipping process do not always meet the requirements of the medical field. However silicone due to its biocompatibility is often prescribed by implants manufacturers and is widely used in many medical sectors such as ophtalmology, neurology, ENT, abdomen surgery, orthopaedics, aesthetic surgery. These implants are oftten characterised by a small size and a complex shape.
The tools needed to form such parts are also of very small size and require a good experience of micro-machining. Because traditional machines are not well adapted to these tools, the company has developed its own tools, moulds and manual or semi-automatic machines.
Different moulding processes are used : dipping, compression, injection transfert, with cold or hot moulds, with or without inserts which allow to design thin membranes, materials of various hardness, complex thin parts or hollow body parts.
The SME offers its technologies to medical devices manufacturers willing to produce new implants from initial design to industrialisation.

Innovative Aspects:
- Moulding under controlled environment (class 100)
- Both moulding and insert moulding technologies
- Removable moulds, inserts cold-mold pre-filling

Main Advantages:
- Adapted to medical requirements
- Silicone biocompatibility
- Shape complexity
- Miniaturisation

Current Stage of Development: Available for demonstration

Intellectual Property Rights:Secret know-how

Collaboration details
- Manufacturing agreement (Subcontracting & Co-contracting)
- Type of partner sought: Industry
- Specific area of activity of the partner: Medical sector, maufacturer of medical devices and implants

 For more information
Anne-Marie VIEUX

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