Medical Device Materials

Medical Device Materials Provide Design Options and Performance

DuPont polymers support medical applications with tested performance, manufacturing control, and regulatory conformance.

Regulatory Support Matrix

DuPont has a broad range of medical device materials, including Delrin®, Hytrel®, Crastin® and Zytel® polymer families. These materials are backed by testing, regulatory review, and DuPont resources who will work with you from your material specification through manufacturing.

Range of Grades

In addition to standard grade materials, our polymer portfolio includes food contact compliant (FG) grades, as well as both Special Control (SC) and Premium Control (PC) grades. Both of the SC and PC grades are differentiated by a greater degree of testing, manufacturing control and regulatory support.

Special Control (SC) and Premium Control (PC) Grades

DuPont SC and PC grades offer:

  • Manufacturing according to GMP principles
  • Food contact statements (EU/FDA)**
  • Testing against selected parts USP Class VI
  • Testing against relevant parts ISO 10993
  • Sterilization data
  • Global availability

** Some grades may not have EU food contact approval

Innovative Design Uses

Disposable and reusable insulin pens are helping dramatically advance diabetes treatment. The pens are manufactured using several grades from our medical device material portfolio, which can include Crastin®, Hytrel®, Delrin®, and Zytel® polymer families. These materials are utilized in the intricate system of ratchets and gears which function as the delivery mechanism of the injector pens. Materials that deliver excellent dimensional stability, in combination with resistance to creep, and a certain level of natural lubricity, are needed.

DuPont™ Hytrel® thermoplastic polyester elastomer, Delrin® acetal resin and glass-reinforced Zytel® nylon are being employed for use in NuDrive, the world’s first lightweight and compact lever-drive accessory for manual wheelchairs. The ergonomic lever-drive propulsion accessory reduces the force required to self-propel a wheelchair by up to 40%. Beyond the high performance of these engineering polymers, they are also lighter and more cost-effective to produce than metal components.

Sterilization Resistance

Sterilization is vital for both single-use and multiple-use devices, and it is important that materials used in medical components are not affected by the sterilization process. DuPont medical device materials have properties that withstand the conditions required for nearly every sterilization approach. This feature provides material selection flexibility so that manufacturers can select the best material for their specific application requirements.

Low Friction

DuPont plastics also offer options for low wear/low friction applications, both when in contact with themselves and with other materials, such as steel. This is particularly important, as additional lubricants applied during a secondary operation tend to be avoided by medical device manufacturers, due to concerns regarding consistency of secondary operations, and uniform performance of the end product.

Lasting Flexibility

Hytrel® provides flexibility and the ability to return to its molded shape even when subjected to repeated stress. For example, it is used in the Niagara Foot™ prosthetic foot design. Its energy-return design relies on the stiff, yet flexible properties of Hytrel® to provide user benefits in terms of stability, durability, effectiveness and comfort. Available in the range of shore D30 to D82 hardness, Hytrel® is also economical to process, using a variety of molding or extruding technologies.

Tested and  Demonstrated

An important differentiator for Delrin®, Hytrel®, Crastin® and Zytel® Special Control (SC) and Premium Control (PC) grades is the high degree of testing, manufacturing control, and regulatory compliance they offer. DuPont provides experienced application support worldwide, excellent quality control, and consistent/demonstrated supply.