Medical device market challenges and opportunities for DEMGY in thermoplastics processing

The global medical device market* poses major challenges for the plastics industry, which is influenced by regulatory, technological, economic and environmental factors.

Thanks to its innovations in the processing of engineering plastics, thermoplastics and microfluidics, DEMGY is ideally positioned to meet the demands of the medical device market, including in vivo devices, and to anticipate the needs of the medical sector. DEMGY offers advanced expertise in thermoplastic injection molding and micro-injection molding, precision machining and mechanical assembly to meet the specific needs of the medical sector (excluding in-vitro).

Discover how the Group transforms the expectations of the medical sector into concrete, high-performance and sustainable solutions.

* The French Public Health Code (art. L5211-1 and R5211-1 du) defines a medical device as being

“Any instrument, apparatus, equipment, material, product, with the exception of products of human origin, or any other article used alone or in combination, including accessories and software necessary for the proper functioning of the product, intended by the manufacturer to be used in the home.

for medical purposes and whose principal intended action is not obtained by

pharmacological or immunological means, or by metabolism, but whose function can be assisted by such means.

but whose function can be assisted by such means”.

Designing and manufacturing medical devices to international standards

In a context of rapidly evolving regulatory standards, DEMGY guarantees medical devices that comply with the most stringent standards, thanks to its advanced ISO13485-certified technologies and ISO 7 and ISO 8-certified cleanrooms.

Our assets for maximum compliance:

• Cleanrooms dedicated to production and assembly in controlled environments, eliminating the risk of contamination.
• Expertise in biocompatibility and materials traceability.
• Certification of our processes to meet international regulations: DEMGY Normandie, DEMGY Atlantique, DEMGY Frasne and DEMGY Chicago.

Excellence in thermoplastic injection molding for medical devices

Thermoplastic injection molding is at the heart of modern medical technology, and DEMGY excels in the production of complex, biocompatible parts for critical devices.

Our strengths in medical device injection molding :

• Micro-injection molding: Production of miniaturized parts with micrometric tolerances, ideal for implantable or wearable devices.
• Biocompatible technical polymers: Use of materials approved for contact with the human body.
• Cleanroom production: Injection molding in ISO 7 and ISO 8 certified environments, guaranteeing cleanliness of parts.

Main applications: Catheters, endoscopy devices, medical pump components, infusion devices and prostheses in technical polymers.

High-precision machining for critical medical devices

Machining is essential to guarantee a perfect finish and rigorous tolerances, especially for parts used in critical medical contexts. DEMGY combines modern equipment with proven expertise to meet these requirements.

Machining highlights at DEMGY :

• Multi-axis precision: Production of complex shapes for functional devices.
• Specialized materials: Machining of polymers, composites and biocompatible polymers.
• Quality control: Each machined part undergoes rigorous checks to ensure optimum reliability.

Key applications: Components for orthopedic devices, respiratory assistance systems and surgical tools in technical polymers.

Technical and automated assembly for complete medical solutions

Assembly is a strategic step in the supply of ready-to-use medical devices. DEMGY masters advanced robotized assembly techniques to guarantee robustness and reliability, while respecting the constraints of the medical sector.

Our assembly processes :

• Ultrasonic and laser welding: for precise, resistant assembly of sterile devices, as well as for applications requiring hermetic sealing.
• Hybrid polymer assembly: Ideal for devices combining lightness and strength.
• Technical bonding: using medical adhesives for long-lasting performance.
• Cleanroom assembly

Key applications: Insulin pumps, wearable monitoring devices and connected medical systems.

Eco-design and circular Multiplasturgy®: an integrated offering for medical device manufacturers

DEMGY places sustainable development at the heart of its strategy with its circular Multiplasturgy® offering, an exclusive solution that optimizes the life cycle of polymers by integrating recyclability and bio-sourced materials into the design of medical devices. By combining its expertise in injection molding, machining and assembly, DEMGY offers a unique integrated solution to accelerate the development of medical devices and reduce time-to-market.

Eco-design at DEMGY:

• Reuse of high-performance engineering polymers or use of just the right amount of material thanks to new production technologies.
• Development of production technologies using bio-sourced materials adapted to medical applications.
• Reducing the carbon footprint of the production chain.

The advantages of circular Multiplasturgy® integration at DEMGY :

• Dedicated clean rooms: ensure the cleanliness and sterility required for medical applications.
• Optimized production chain: reduced lead times thanks to complete process control.
• Customized solutions: meet manufacturers' exact specifications for tailor-made devices.

With its circular Multiplasturgy® offering, DEMGY is committed to providing durable solutions that meet the stringent requirements of medical devices.

Miniaturization and complexity thanks to micro-injection from DEMGY Frasne

DEMGY Frasne is a center of excellence for micro-injection molding, specializing in the production of miniaturized, high-precision thermoplastic parts for complex medical devices.

Our solutions for advanced medical needs:

• Plastic micro-injection molding, ideal for applications requiring extreme precision.
• Manufacturing in certified environments (ISO 7 and ISO 8 cleanrooms).
• Integration of cutting-edge technologies for miniaturized, connected medical devices.
• In-house design and manufacture of micro-injection molds.

Innovation in microfluidics for medical applications

Microfluidics, also known as lab-on-a-chip, is revolutionizing medical diagnostics. DEMGY Frasne develops plastic solutions for these innovative technologies, enabling complex biological analyses to be miniaturized and automated.

​ Advantages of DEMGY Frasne's microfluidic solutions:

• Manufacture of high-precision plastic microchannels for perfect fluid control.
• Use of biocompatible, transparent technical polymers for reliable analysis.
• Main applications: point-of-care diagnostics, rapid testing and biotechnology.

Cutting lead times and optimizing costs

Thanks to automation and digital tools, DEMGY can guarantee short lead times while maintaining optimum quality. Our cutting-edge technologies, such as clean-room injection molding and micro-injection molding, enable us to respond rapidly to the needs of medical device manufacturers.

Our key technologies :

• Robotization of plastics processes, for greater productivity and efficiency.
• Computer-aided design (CAD/CAM) to speed time-to-market.
• Additive manufacturing for customized prototypes and small series production.

Clean rooms and cutting-edge technologies

DEMGY produces in ultra-clean environments thanks to its certified cleanrooms, guaranteeing the sterility of parts. These facilities are essential for sensitive medical devices, such as microfluidic components.

Our commitment to sterile production:

• Production capacity in controlled atmosphere at DEMGY Frasne and DEMGY Chicago.
• Manufacturing to ISO 13485 medical standards.

Adoption of new manufacturing technologies

DEMGY continues to innovate by integrating cutting-edge technologies, such as advanced composites, to meet the customization and performance needs of medical devices.

Our innovations for the future:

• Hybrid manufacturing combining polymers and composites.
• Design of thermoplastic components incorporating sensors for connected devices.
• Development of advanced biocompatible polymers for critical applications.

DEMGY, your partner for medical devices

By combining innovation, technical materials expertise and sustainability, DEMGY is the partner of choice for medical device manufacturers to meet the specific needs of their customers and anticipate future challenges. Our circular Multiplasturgy® offer includes customized, miniaturized and eco-designed solutions, perfectly adapted to the specific needs of the medical device sector.

Our certification :

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DEMGY is a member of SNITEM (Syndicat National de l'Industrie des Technologies Médicales). As an innovative medical device company, this membership demonstrates our commitment to high industry standards. We are delighted to be part of this dynamic community, which fosters collaboration, the exchange of expertise and the adoption of best practices. This membership reinforces our position as a reliable and qualified partner, and enables us to actively contribute to shaping the future of the medical technology industry.