To help MDCs better manage today’s highly complex, high-stakes commercialization process, their partners must be well positioned to help them mitigate risk and minimize cost by engaging in the quality practices that will support MDCs in meeting their design specifications. Beyond the design spec, the device must ultimately pass biocompatibility tests and clinical studies and all the many other complex aspects of gaining regulatory approvals. But the obligation doesn’t end there, of course. To help ensure MDCs maintain their reputations in the industry as quality manufacturers, partners must also adhere to the practices that maintain the quality of the device over the long haul and help MDCs to avoid issues that could lead to product recalls or other adverse events.
A Quality Device Requires Quality Ingredients
Passing the biocompatibility tests at the end of the process depends primarily on two factors: the manufacturing process and the material chosen at the beginning of the design phase. And the ultimate quality of an implantable medical device utilizing fiber components relies first and foremost on the quality of the fiber it is built upon.
One fiber that has been attracting the attention of MDCs for device projects utilizing medical grade fibers is DSM’s Dyneema Purity® fiber, which is a UHMWPE fiber designed for use in the human body. The fiber possesses unique properties that help enable MDC designers to meet the market’s demand for higher-performing implants that are stronger, smaller and last longer. For example :
- Dyneema Purity® fiber is not only 15 times stronger than cable steel, but is also soft and highly pliable, which can improve comfort and compliance.
- Dyneema Purity® fiber’s resistance to fatigue and abrasion are advantageous in vascular applications that require thin structures, lowering the risk of complications due to internal or external stressors.
- Dyneema Purity® fiber’s near-zero stretch enhances fixation in orthopedic applications, such as knee and shoulder arthroscopy and also adds value to non-compliant balloon catheters.
Equally important, however, is the fact that Dyneema Purity® fiber is a raw material specifically designed for applications in the human body during surgery or over the longer-term lifespan of an implant. And unlike many textile developers, DSM, which makes Dyneema Purity® fiber and other highly advanced, innovative biomaterials, was formed with a specific focus on materials for medical applications. The Dyneema Purity® fiber has been through extensive biocompatibility and hemocompatiblity testing and has a Master File on record with the FDA, which can give MDCs a critical advantage in navigating an increasingly rigorous regulatory process to bring new products to market.
Dyneema Purity® fiber’s heritage as a medical-grade material demonstrates DSM’s commitment to the medical application market through its focus on meeting challenging material requirements. The company invested in clean-production capabilities and quality systems at its Heerlen, NL facility, to create a medical-grade UHMWPE fiber. One of the earliest successful collaborations was with an orthopedic sutures manufacturer that sought to maintain its competitive dominance in the field of rotator cuff repair, where uncompromising strength and performance were critical. Today, DSM’s Dyneema Purity® fiber is the gold standard in many high-strength sutures used in sports medicine applications.