Medical grade plastics

Plastics solutions for medical technology

Ready for new possibilities

Ensinger one-stop shop for medical technology

Achieving the best possible quality of life and mobility into old age, the desire to live as pain-free a life as possible from childhood - the major trends in the medical industry are leading to an increase in surgical interventions and new treatment options. This is increasing the price and cost pressure on both healthcare systems and medical device manufacturers.
At the same time, efforts are being made to improve patient safety, for example by requiring unannounced audits, intensifying clinical evaluation and introducing additional testing procedures for certain higher class medical devices.
This includes increased consideration of physiological safety, even for short-term patient contact. 
In order to meet these requirements in the future, the development of innovative products is of great importance for medical device manufacturers. Product safety, patient benefit and cost control must be at the forefront.

More than Just one solution

As a full-service provider for solutions in medical technology, Ensinger supports manufacturers of medical products with alternative but proven materials and process technologies. We cover the entire value chain in-house, offering our customers the highest level of quality, safety and flexibility. Together with our customers, we develop and manufacture products that are precisely tailored to their needs. The safety of the patient comes first, both for the selection of physiologically safe materials as well as for the evaluation respectively testing of the biocompatible properties. Ensinger medical grade plastics are marked with the trade name abbreviation MT respectively MED for Compounds.
Our comprehensive portfolio of Ensinger Medical Grade (MT, MED) plastics offers designers a wide range of options for developing innovative medical products with high levels of safety and functionality. Our wide range of manufacturing processes, such as extrusion, machining, injection molding, profile extrusion and compounding, also offer our customers maximum flexibility. From material to finished part, we offer the highest quality along the entire value chain and provide the entire portfolio of solutions to the finished part in-house.
Within the Ensinger medical grade (MT, MED) plastics, high compliance standards apply with regard to documentation, traceability and notification of changes. This also enables consistent knowledge and data transfer towards authorities for the approval of products worldwide. 
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BENEFITS FOR THE MEDICAL TECHNOLOGY INDUSTRY

Quality management system DIN EN ISO 13485:2016

Ensinger GmbH has introduced a quality management system in accordance with DIN EN ISO 13485:2016 in many areas for the development, production and distribution of thermoplastics at its sites in Nufringen and Cham. With this certified quality management system for medical technology, Ensinger offers its customers additional security.

Decades of experience

With our extensive experience in the medical industry, we work together with our customers to develop the optimum solution, from the idea to the production of the product.

Medical experts across the globe

Thanks to the global presence of the Ensinger team in the medical industry segment, our customers on all continents are able to benefit from our high-quality solutions.

Order-related and consistent

Due to strict documentation during the individual process steps, consistent traceability with regard to the products and the raw materials used is standard at Ensinger. For plastic materials within the Ensinger MED- / MT-standard-portfolio, a declaration of conformity is issued on an order related basis. This enables our customers to have clear traceability.

Reliable change notification

For medical grade products, the aim is, to keep the materials and the manufacturing process as unchanged as possible. In case of changes, high evaluation standards apply within the scope of the medical grade change management and the customers are informed of relevant changes as early as possible with a change notification. The aim is, to always provide equivalent products despite necessary adjustments. 

One-Stop SHop for medical technology

Ensinger value chain for the medical industry
To offer our customers the highest quality and exemplary service, we combine materials expertise and process know-how in a fully integrated value chain. From initial contact and material selection to the appropriate manufacturing technology and the implementation of follow-up processes and quality assurance: the Ensinger One-Stop Shop with its cross-divisional approach enables us to create tailor-made solutions for medical technology from a single source.

Finished Parts for the medical industry

Products for the medical industry

Solutions for medical technology

  • Plastic materials within the Ensinger MED- / MT-standard-portfolio are tested according to ISO 10993 pursuant to their intended use, preferably on the product. They fulfil the requirements specified in the respective test. However, the evaluation of biocompatibility can also be completely adapted to the customer's individual needs.
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  • A wide range of medical devices such as surgical instruments can be reused after intensive cleaning, disinfection and sterilisation. Ensinger Medical Grade (MED / MT) materials have good chemical resistance and excellent sterilisation resistance to common processes.
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  • In many procedures, X-ray images support the verification of the exact positioning of the medical device, such as the trial implant in a joint operation. The Ensinger Medical Grade (MED / MT) portfolio therefore includes special X-ray detectable XRO types, which allow a precise view of the instruments during image-guided interventions.
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  • The increasing number of operations and surgical procedures demand increasingly effective instruments that are light in handling. Ensinger Medical Grade (MT) materials have a low specific weight, which leads to significant weight savings compared to metal instruments.
  • In global competition, differentiation through colour corporate branding is of increasing importance. The colour differentiation of different versions or sizes of medical products is also increasingly done through a corresponding colour scheme. The Ensinger Medical Grade (MT) portfolio includes a range of materials with a variety of different colours.

Applications

Torque wrench for dental applications

  • For steam sterilisation
  • High dimensional stability
  • Chemical resistant
  • FDA and USP compliant
  • Assemblies

Target arm

Part of an internal fixation system (traumatology)

  • Best mechanical strength 
  • High thermal dimensional stability

Machined from composite TECATEC PEEK MT CW50 black

Capillary carousel

Used for PCR-analysis (medical technology)

  • Low thermal expansion at fast temperature changes
  • Good chemical resistance to disinfectants and detergents
  • High precision machining
  • Intensive pigmentation (deep black) allows very accurate measurement results

Injection-molded and machined TECAPEEK MT black

Case Studies

Knee trial implant

Knee trial implants

made of TECASON P MT

Test Implants for Knee Joint Reconstruction
Manufacturers of knee reconstruction products are now in a global market for sales and customers. Apart from the actual implant, tools and instruments are of increasing importance. These facilitate handling during the operation, enhance patient safety and may even reduce the follow-up expenses for reprocessing. These instruments include test implants, which sometimes serve to differentiate products from the competitors. 
Target arm

Target arm

made of TECATEC PEEK MT CW50 black

Orthopaedic Trauma Internal Fixation Systems

The goal of orthopaedic trauma treatment is to restore a broken bone to its correct position and orientation. When this is done by means of surgical intervention, fixation systems are used to secure the bone in the anatomically correct position. Manufacturers of such internal fixation systems need to meet many and exacting requirements in terms of function, weight and appearance, at the same time as keeping an eye on the overall costs in view of increasingly tight budgets. 

All Case Studies

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We would be happy to discuss your medical technology project with you personally, so please contact us using the contact form and one of our experts will get in touch with you.
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