Materials : Medical Plastics Data Service

Previous Issues

A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY

Our 28th Year of Publication

Page 1 of 4

Materials

Understanding The Complexities Of Medical Grade Polymers

Jennifer Green
Technical Marketing Manager,
Medical Polymers
Lubrizol Life Science Health, Medical Device, USA

The appropriate selection of component materials is often very important in the development and sustainability of a medical device. For many devices, that selection often begins with a designer’s consideration of a range of known medical polymers.

So, What is a Medical Grade Polymer?

While the question seems simple enough, it may surprise you that a globally accepted, agreed-upon definition and standard does not exist.

Globally, the vast majority of polymers produced are used in industrial and consumer segments, with only a small percentage the polymer volume being used in medical devices. In order to differentiate

grades supplied into the medical device market, raw material suppliers distinguish these material as “medical grade.” Currently there is no regulatory definition of a medical grade polymer and no prescriptive regulatory requirements for raw materials used in medical devices, so material suppliers and others in the medical device industry have assigned their own meaning to “medical grade polymer.” Consequently, polymers designated as medical grade from different suppliers are not necessarily equivalent in performance, quality and associated support. This situation can create confusion and uncertainty for the device designer when selecting materials.

When it comes to specifying medical device materials, considerations need to be given not just to product specification and required performance attributes but the robustness of quality systems, manufacturing consistency, management of changes and understanding the possible implications on a finished device so the process is well managed by the supplier and effective communication systems are in place.

In this article, the Lubrizol Life Science Health (LLS Health) team examines the complexities surrounding medical grade polymers and what you should know when selecting your medical device materials.

Considerations When Selecting Medical Polymers

Medical device development is often a long-term endeavor, requiring rigorous testing, quality control systems, and compliance to an ever-evolving set of regional and global regulatory requirements. As the need for new and innovative medical devices grows, the need for materials (especially polymers) to support device development becomes stronger.

The choice of polymer for a specific device application is often based on many considerations. For example, an interventional guidewire may need a polymer coating to provide a cushioning tip, biocompatible hydrophilic surface, radiopaque character and abrasion resistance while maintaining manufacturing efficiencies in the guidewire production process. Selection of a material for a pacing or neuromodulation lead may hinge more on a material’s blood/tissue biocompatibility and resistance to degradation inbody (oxidative and hydrolytic resistance) over many years, its dielectric properties, its physical strength and flexibility and the ability to produce the material in thin-walled constructions and assemble over electrical wires and other components.