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发布日期: 2019-07-18   浏览次数: 98 次

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.

While a certification list of medically approved lubricants may not exist, Nye operates a quality management system that complies with the requirements of ISO 13485: 2016, a certification that sets the standard for the design, manufacture, and distribution of synthetic lubricants for medical devices. 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 is uniquely positioned to serve the needs of this growing industry with our new and expanding NyeMed® biocompatible product line of gels and fluids, which are backed by documented ISO 10993 biocompatibility testing, including cytotoxicity, skin irritation, and acute toxicity. 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. Nye serves several subsegments of the MedTech industry including drug delivery, surgical equipment, and diagnostic equipment. The NyeMed® product line represents a broad range of chemistries and serves applications ranging from electrical components to critical moving parts. 

Motion Control & Sealing

One important issue for those in the MedTech industry is motion control. For example, if a needle retracts from a hand-held injector too slowly, it can cause the patient pain. Devices such as catheters, hand-held pumps, and injectors all rely on motion control to ensure proper performance, reduce risk and improve treatment outcomes. An effective way for design engineers to enhance functionality, quality, and usability is by selecting the proper lubricant. In medical devices, viscous damping greases or gels can smooth operation, eliminate noise, and reduce the impact of environmental factors by sealing gaps and orifices. NyeMed® damping products provide appropriate viscous drag to control moving parts. This resistance to motion minimizes free-motion problems, such as backlash, stick-slip, or coasting.

Innovative Solutions for Innovative Designs

When it comes to the operation of MedTech devices, there is no room for error. This means that designers of medical devices must carefully consider all parts of their design, including the lubricants. 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. NyeMed® products utilize a broad range of material classes and specialty packages that meet the requirements of Medical device and equipment designers.

The result of utilizing a NyeMed® product is enhancement of functionality, quality, and usability, thus leading to higher patient compliance, lower risk, and better treatment outcomes.

Jay Weikel – EU Engineering Manager

Jay have been with Nye for 24 years. Prior to his role as the EU Engineering Manager, Jay served as Nye’s Southeast Engineering Manager. Jay specializes in providing lubrication solutions for medical applications and PFPE technology. He holds a Bachelor of Science in Chemical Engineering from North Carolina State University and an MBA from the University of Delaware.