Technologies & Know-how

Autonomy and responsiveness:
assets for the manufacture
of medical devices

In-house processes and know-how

In nearly 50 years, STATICE has accumulated a great deal of know-how that allows it to make controlled technical choices that meet the expected performance.

To guarantee maximum responsiveness in development and series production, STATICE has internalized a large number of manufacturing processes.

Silicone processing

A recognized expert since 1990, STATICE transforms silicones and chooses them according to the specific needs of the device (wall thickness, hardness, fatigue resistance,…).

We use implantable silicones (short or long term) in a wide range of hardness ranging from 00 to 80 Shore A type:

High Consistency Silicone (HCR) or liquid (LSR)
High-performance silicone
Ultra-low viscosity silicone
Silicone dispersion

The transformation of silicones is carried out in an ISO7 cleanroom using various processes:

Moulding or overmoulding (compression, transfer, injection)
Calendering (for silicone sheetings)
Dipping (for thin-walled pockets without parting line)

We have 6 presses, 2 calenders and post-curing ovens. Moulds are designed and manufactured in-house via our mechanical workshop.

Processing of biocompatible thermoplastics

STATICE is equipped with an injection press suitable for the production of PEEK or Polyurethane micro-parts for cardiology or neurology applications requiring high levels of quality and precision.

STATICE can also carry out technical overmoulding (e.g. electrodes or connectors on micro-cables).

Terlux Other injected materials: Pebax, Santoprene, PC, ABS Terlux.

STATICE has ~~CNC machining~~ equipment suitable for medical grade engineering thermoplastics (PEEK, RADEL, ULTEM, PROPYLUX,…).

Thermoplastic tubes

For multilumen tubes and reinforced tubes, STATICE has developed partnerships with a network of expert subcontractors.

STATICE has in-house equipment to carry out tip forming and tube welding operations (PEBAX, PUR, etc.).

Processing of bioresorbable materials

STATICE masters several processes to transform different bioresorbable materials (PGA, PLLA, PCL, PDO). These processes guarantee the precision and performance of the parts while preserving the integrity of the material:

Specific moulding to limit material degradation
Electrospinning used for applications in tissue engineering, wound healing or controlled drug delivery

Other materials

Other materials are implemented in hybrid designs.

They are chosen according to their mechanical and/or electrical properties and their biocompatible nature.

We find Nitinol , Platinum-Iridium, Titanium , MP35N, Stainless Steel 304L/316LVM, synthetic ruby, …

Mechatronics

Through its mechanical and electronic/software R&D departments, STATICE develops mechatronic solutions for Active Implantable Medical Devices (AMIDs).

These technologies are also used for invasive devices (e.g. active catheters, robotic endoscopy, etc.), IVDDs (In Vitro Diagnostic Devices) or laboratory equipment.

Assembly processes

STATICE has internalized a large number of assembly processes in clean rooms.

STATICE identifies the assembly processes adapted to the materials involved and the expected performance (sterilization mode, mechanical performance, sealing, etc.).

The assembly processes are subject to validation after sterilization and accelerated aging.

Our main assembly processes:

cyanoacrylate/UV/silicone/epoxy glueing
Epoxy potting
Plasma treatment
Welding, tipping and thermoforming of thermoplastic tubes/parts
Micro welding laser for wires/electrodes (Platinum /Iridium, Gold, MP35N Nickel alloy)
Laser welding of complex mechanical parts
Electrical welding
Ultrasonic (US) / High Frequency (HF) Welding

Robotisation

Robotisation d’opérations de trempage ou de collage
Automatisation d’opérations de découpe en commande numériques de pièces silicones

Other production processes

Coatings (antibacterial, friction reduction, sealing, …)
Laser engraving of polymers and metals
Shaping and assembling nitinol parts
Laser cutting of silicones
Micro-winding (application: antenna, micro-motor, sensor)
Drying cabinet, oven, climatic chamber
Cleaning of production tooling with supercritical CO₂ .

Cleaning / Packaging / Labelling

STATICE defines cleanings adapted to the nature of the materials and admixtures used by the manufacturing processes. STATICE has ultrasonic tanks, automatic washer-disinfectors and purified water generators.

For sterile barrier packaging, STATICE uses scroll sealing means compatible with Tyvek/paper bags/sheaths. STATICE also has semi-automatic machines for sealing Tyvek lids on blister packs.

STATICE prepares “print proof” for labels that comply with regulatory requirements (ISO15223). The printing of legal information is carried out by printers connected to our ERP guaranteeing full traceability and compliance with UDI requirements in the form of QR codes and barcodes.

Metrology and performance verification

To verify the conformity of assembled parts or devices, STATICE relies on a wide range of control equipment and metrology toolsbut also on more advanced equipment:

Automated profile projectors
Non-contact measurement of thin walls made of silicone
Laser interferometry measurement
Sealing: Automatic control / Helium leak test

STATICE has also developed tailor-made test equipment for performance verification (impedance measurement bench, tensile bench Specific, fatigue bench, …).

STATICE, un partenaire de confiance

Thanks to the vertical integration of our technologies and our high quality standards, we offer you a global solution to transform your ideas into innovative medical devices, Efficient and industrializable.