Reduce Risk with Medical Gels & Fluids
The MedTech industry develops an array of innovative medical devices that help people all over the world receive the care they need. This everchanging industry challenges design engineers to solve diverse problems, often requiring a specialty product or solution that ensures performance while mitigating regulatory risk.
Many MedTech designers don’t consider adding a lubricant to their design, or, they assume that medical applications require “medically approved” lubricants—a certification that does not exist. However, as an ISO 13485:2016 certified manufacturer, Nye Lubricants’ quality management system meets regulatory requirements for medical devices and related services.
How Do Nye’s Gels & Fluids Reduce Risk?
They Ensure Consistent Performance
When lubricants are selected as a critical design material, they can control free motion, reduce unwanted noise, broaden operating temperature, and lengthen the overall life of a device Consistent performance is key to ensure every device operates to its design intent, providing each patient with the same experience every time.
Nye offers fully qualified gels and fluids to ensure that our lubricants can be manufactured the exact same way, every time, to ensure that the drug delivery device operates reliably. This process verifies that formulated lubricants are manufactured reliably with excellent batch-to-batch consistency. Our manufacturing processes are strictly followed and documented to support our customer’s and regulatory needs for traceability.
They’re Backed by Biocompatibility Data
Nye is uniquely positioned to serve the needs of this growing industry with our new and expanding NyeMed® product line which is backed by biocompatibility data. Nye’s NyeMed® product line is tested to ISO 10993 Cytotoxicity (Direct Contact), Skin Irritation (Direct Contact), and Acute Systemic Toxicity (Direct Injection) standards, thus minimizing this risk.
They’re IP Protected
In addition to understanding regulatory risks, we also understand the importance of confidentiality and have extensive experience in protecting our customer’s intellectual property. Nye has partnered with leading pharmaceutical companies and contract design and manufacturing organizations for over 20 years to manufacture custom and off the shelf formulations that meet our customers design requirements.
NyeMed® products meet the needs of customers with diverse performance requirements who appreciate risk reduction and motion control, but don’t necessarily have the time for a custom development program. As a starting point for a custom design, designers can select from our NyeMed® product line or Fluorocarbon Gel 890 series of damping products which share important physical characteristics:
- Carefully controlled flow properties
- Low oil separation
- Good compatibility with plastics.
Visit our Medical page to learn more about how lubricants can benefit your application.
