Plastic solutions for the medical industry

Facing new challenges

The major trends in the medical industry such as managing the mobility needs of ageing patients, as well as younger peoples' desire for a pain-free life, are resulting in an increase in surgical procedures as well as new treatment options. This can lead to added cost pressures for healthcare providers, and for medical product manufacturers, but there are also increasing opportunities for engineering plastics to improve medical devices and patient comfort.

Agency requirements to carry out unannounced audits, along with the tightening of clinical assessments, and additional testing procedures for certain medical products are all designed to enhance patient safety. This includes increased consideration of physiological safety even with short-term patient contacts, which leads to further emphasis on the product safety requirements.

For the manufacturers of medical products, this will mean the development of new, innovative products under the premises of
product safety, patient benefits and cost control in future.

More than one solution...

Ensinger helps to meet these requirements by supporting medical product manufacturers in creating product solutions with alternative, but tried and tested, materials and process technologies.

The wide range of Ensinger medical grade materials (MT) offers product designers a wide choice of options from which can be developed innovative medical products, all of which which provide a high degree of safety and added value. The different manufacturing methods used by Ensinger such as extrusion, (intended for machined parts), injection molding, profile extrusion and compounding, offer the customer a versatile selection of plastics to develop and produce their product together with Ensinger along the value added chain.

The high compliance standards met by Ensinger's medical grade materials (MT) also enable reliable and quick approval of health care products.  Ensinger materials are supplied with all necessary documentation, traceability information, and change notifications. Due to the physiological safety standards typical of Ensinger MT materials, patient safety is always accounted for. The bio compatible Ensinger medical grade plastics (MT) thus make a significant contribution to ensuring medical products are reliable for the manufacturer, and safe for the patient.


Benefits FOR THE Medical Industry

Certified according to DIN EN ISO 13485:2012

Ensinger's manufacturing facility in Germany has introduced a quality management system in accordance with ISO 13485:2012 for the development, manufacture and sale of semi-finished products, profiles, finished parts and compounds made of thermoplastic materials. Likewise the Ensinger manufactring facility in the U.S. is capable of meeting the same requirements, and is also ISO 9001/2008 certified.  With this accredited quality management system for medical technology, Ensinger provides its customers with additional safety.

Decades of experience 

Experience in the medical industry helps to develop the optimal solution for our customers from product design, through to manufacture. 

 

Medical experts across the globe

Thanks to the global presence of the Ensinger medical industrial segment team, our customers on all continents can benefit from our high quality solutions.

 

Seamless and order-related

Competent quality management is reflected in seamless traceability. Due to the strict documentation during the individual process steps, consistent traceability is standard at Ensinger. For this reason, Ensinger always issues the corresponding conformities for all medical grade (MT) materials on an order-related basis, thus ensuring seamless traceability down to the raw materials. 

 

Reliable change notification

Ensinger has a change notification process in place for its medical grade (MT) materials. This helps to assure customers always receive comparable, approved material for their medical applications, or are informed in a timely basis about relevant changes as part of the change management process. 


Solutions for THE Medical industry

Biocompatible plastics

Even in the case of medical applications with a short term patient contact (up to 24 hours), physiological safety must be ensured. All Ensinger medical grade materials (MT) are therefore biocompatible and tested on the semi-finished product according to ISO 10993.

Sterilisation resistant plastics

Many medical products such as surgical instruments are used again after being intensively cleaned, disinfected and sterilized. Ensinger medical grade (MT) materials have good chemical resistance as well as excellent sterilization resistance to the commonly used methods.

X-ray opaque plastics

In many procedures, X-ray images help to exactly position the medical product, for example trial implants for joint replacement. The Ensinger medical grade (MT) portfolio, therefore, has special X-ray impermeable XRO types in the range, which enable an exact view of the instruments during image-guided surgical procedures.

Low density plastics

The growing number of medical operations and procedures require increasingly effective instruments that are also easy to handle. The Ensinger medical grade (MT) materials have a low specific weight, resulting in significant weight savings in comparison to metal instruments. 

Colored plastics

In the face of global competition, differentiation through colored corporate branding is increasingly important. Different versions or sizes of medical products are also increasingly differentiated by a corresponding color scheme. Ensinger's medical grade (MT) portfolio covers a range of materials with a number of different colors.  

Machinable Plastics for Medical USE

We offer a wide spectrum of engineering and high performance materials for medical applications. All MT plastics (medical grades) are tested in accordance with ISO 10993-1, -4, -5, -18 and follow the step-by-step approach stipulated in the standard for biological risk assessment.

PEEK medical grade

Composite PEEK medical grade

PPSU medical grade

PP medical grade

POM-C medical grade


Medical Technology CASE STUDIES

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

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. 

Sterilisation trays

made of TECAPRO MT

Surgical caddies

Trays and caddies for transporting and storing surgical instruments, as well as those for screws and other implants are subject to stringent requirements such as easy transport through the sterile supply cycle and long product service life. On the basis of these requirements, the materials TECAPRO MT (PP) and TECASON P MT (PPSU) are an optimum solution.

Frequently Asked Questions on MEdcial Plastic Material

  • Generally speaking, no biocompatibility tests are required for semi-finished products for a particular application, as the finished components have to be tested and approved at the end of the processing steps.
    However, qualification of semi-finished products does provide an aid to ensuring product quality and subsequent approval of the final medical product.
     
  • These materials are not generally suitable for use as long-term implants. All MT materials from the Ensinger portfolio are approved for direct body contact for up to a maximum of 24 hours. One exception to this is the material TECAPEEK CLASSIX, which is approved for direct body contact as a temporary implant for up to 30 days or 180 days.
  • Using a coding system for its semi-finished products and by means of order-specific certificates, Ensinger ensures the capture and documentation of all product and process data and therefore complete traceability back to the original material. In this process, all integrated procedures are included - from the raw material to the used finished part. In the unlikely case of a claim, this allows the possible fault to be quickly localized.
  • By processing the plastic materials to create semi-finished products, it is not possible to directly match specific RAL colours. Certain deviations can occur for production-related reasons. For this  reason, it is only possible to provide a color indication which is similar to RAL.
  • Semi-finished products marked with coding ink have been tested in accordance with ISO 10993-5. During this testing process, all inks used are tested. The results show that all sections comply with the requirements of ISO 10993-5 and are consequently physiologically harmless.