In the medical device industry, timelines are long and standards are high. It can take years to commercialize a medical project, so every step taken needs to be in the right direction. Every material has to be verified as fit-for-use for each application. At every phase, the entire project has to meet rigorous standards for performance and safety. Teknor Apex is committed to being a reliable long-term partner to help manufacturers develop and support life-saving and life-changing technology across the globe.
Creating with Confidence in the Healthcare Industry
Challenges in the Healthcare Industry
Balancing Performance with Safety
Healthcare device manufacturers navigate a complex web of regulations to ensure safety and efficacy including adherence to standards for biocompatibility, sterility and chemical leaching. At the same time, the performance requirements for healthcare materials are incredibly demanding. From kink resistance for medical tubing to chemical resistance properties to the durability required to withstand the stresses of daily use and sterilization. Finding materials that manage to deliver both high-quality performance and reliable safety is an ongoing concern in the healthcare space.
Sustainability
The environmental impact of disposable plastics in healthcare is a growing concern. The industry is challenged to find ways to reduce reliance on single-use plastics, develop plastics made from bio-based or recycled materials, and improve recycling and waste management practices in healthcare facilities. Teknor Apex is actively exploring these areas. Along the way, it’s essential that these new solutions maintain the quality and performance to align with regulations and keep patients safe.
The Use of PVC in Medical Devices
PVC is still a widely used material in the healthcare industry, due to its established track record of safety and performance, coupled with cost-effectiveness. However, misconceptions about PVC have led to regulatory changes resulting in some manufacturers seeking alternatives. As a leading compounder of both PVC and alternatives like TPE, we understand the regulatory landscape and can help guide you through the process of selecting the right option.
Applications
Trusted Compound Solutions for Healthcare and Medical Devices
At Teknor Apex, we understand the critical nature of trust in the healthcare industry. That's why we offer a comprehensive range of compound solutions specifically formulated for medical devices and applications. Our materials are designed to meet the most stringent safety regulations, ensuring the well-being of patients and the success of your medical devices.
Why Choose Teknor Apex for Your Medical Device Needs?
- Unmatched Expertise: We possess decades of experience in developing and manufacturing high-performance compounds for medical applications. Our team of experts collaborates closely with customers to create solutions that meet their exact requirements.
- Regulatory Compliance: Our compounds are formulated using FDA 21 CFR compliant ingredients and are designed to adhere to various global regulatory standards, including EU REACH SVHC, EU MDR, EU ROHS, and CA Prop 65.
- Material Performance: We offer a variety of compounds, including:
- Medical Grade PVC Compounds: Featuring non-DEHP plasticizer options, exceptional color hold after sterilization, and ultra-clear properties, ideal for tubing and injection molding applications.
- Thermoplastic Elastomers (TPEs): These versatile materials provide excellent flexibility, biocompatibility, and chemical resistance, making them suitable for a wide range of medical device components (including as an alternative to silicone.)
Ready to Partner with a Trusted Supplier?
Teknor Apex is committed to providing medical device manufacturers with the highest quality compound solutions. Contact us today to discuss your specific needs and explore how our materials can contribute to the success of your medical devices. Click or scan below to fill out the Healthcare Application Requirements form today!!
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