Medical
Medical device engineers often contact Nye after encountering excessive or unexpected friction or wear in mechanical or electromechanical device mechanisms, or between components. This can be uncovered during the proof-of-concept, design, verification, manufacture or even field trials of medical devices. Friction and wear can compromise device performance and perhaps even the success rate of a medical procedure.
However, protecting against friction and wear is not the only way that a gel or fluid can improve device performance. As the ‘MedTech’ industry is large and diverse, our products are called upon to serve many uses. Nye is your partner in selecting and designing the right formulations that serve not only to lubricate, but also to seal, protect, and control motion.
Our products perform in a vast array of critical applications including:
- Medical devices
- Drug delivery devices
- Diagnostic equipment & instrumentation
- Robotic automation
- Assembly processes
- Powered surgical tools & equipment
How Do Gels & Fluids Optimize Performance?
Spring-loaded mechanisms, bearings, gears, linear positioning devices, hand-held actuators, lead screws and O-ring seals represent only a few examples of the diverse range of components within medical devices that can benefit from our specialty gels and fluids. Examples of performance benefits include:
- Extending operating life
- Broadening of operating temperature range
- Controlling or damping of energy release
- Eliminating undesirable noise
- Controlling free motion
- Optimizing haptic feedback
- Sealing against dirt, debris, oxygen, or moisture in the environment
- Reducing force required during assembly or connection
- Mitigating the effect of tolerance stacking
Nye adds value to breakthroughs in medical technology every day. We provide a high level of support, augmented with a robust quality system, ISO 13485:2016 certification, and an appreciation of the need for innovation as well as risk reduction.
Considerations When Selecting Gels & Fluids for Medical & Pharmaceutical Applications
To reduce risk, high-quality standards and fully qualified, consistent processes are critical considerations when selecting supply partners for drug delivery devices and other medical applications. As an ISO 13485:2016 certified manufacturer, Nye Lubricants’ quality management system meets regulatory requirements for medical devices and related services. Our manufacturing processes are strictly followed and documented to support our customers’ need for product traceability as well as audit and regulatory support.
An official ‘medical-grade’ certification does not exist for lubricants. In critical applications where patient exposure is a possibility, lubricants backed by biocompatibility testing should be considered. Our NyeMed® product line is tested to:
- ISO 10993-5: Cytotoxicity (Direct Contact)
- ISO 10993-10: Skin Irritation (Direct Contact)
- ISO 10993-11: Acute Systemic Toxicity (Direct Injection)
Nye offers fully qualified gels and fluids to ensure that our lubricants can be manufactured the exact same way, every time, to reduce variation in device and component operation. 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.
It is important to select a lubricant that stays in its intended location, is structurally stable over a long time, and is compatible with all the materials of construction in your design. Some lubricants can plasticize and soften certain plastics and elastomers. Nye offers material compatibility testing and other testing services to ensure you select the best product for your application.
Partner with the Experts!
Leading medical device, biopharmaceutical, engineering, contract design and manufacturing organizations have partnered with Nye for over 20 years. We have developed a broad range of products and formulation technologies with raw materials selected for safety, materials compatibility, and long-term product availability for our customers. Our innovative lubricants are conceptualized, developed, and extensively tested in our state-of-the-art research and development laboratories. We provide custom solutions and specialized testing and are proud to support our customers from Proof-of-Concept to Industrialization to Post-Production…... and far beyond! We’ll be there when you need us.
Want to learn more? Contact us to let us know how we can help with your application.
