Top three reasons why manufacturers choose medical grade silicone for medical devices

Silicone is a very versatile material widely used in many industries. Over the past 60 years, medical grade silicone has been a material of choice for medical device OEMs, and the number of complex and safety-critical applications in this field continues to grow – from surgical devices and implants to orthotics, prostheses, etc. .

The unique properties of silicone are at the root of all of its benefits for medical device manufacturers. In this blog post, our medical grade silicone experts explore the main characteristics that make silicone a must have for medical devices.


There are many criteria for selecting the right materials for a medical device, but biocompatibility remains firmly at the top of the list. Extensive testing is needed in this area to ensure that the device does not produce any toxic or immunological response in the patient.

Due to their chemical inertness, the wide variety of silicone technologies have an excellent level of biocompatibility, making them safe for use in surgical applications. In fact, medical grade silicones certified to ISO 10993 requirements are one of the few materials that meet strict standards for long-term implants.


The Si-O-Si bonds that make up the chemical backbone of silicone are extremely strong, resulting in high levels of durability of the material. As a result, silicone materials offer strong resistance to aggressive outdoor conditions including UV rays, oxygen and a wide temperature range.

Healthcare professionals need equipment and devices that can withstand the harsh realities of their environment, including the extreme conditions of their sterilization processes. Medical grade silicone holds up well when sterilized with a variety of methods, from autoclaving and chemical solutions to gamma irradiation and more. While other plastics are known to degrade, color, and damage over time, silicone remains stable.


When a patient’s body is already under a lot of stress, the last thing a doctor wants to do is put more trauma on them with uncomfortable procedures and equipment. In the worst case, this could lead to secondary treatment-related injuries.

Silicone is both comfortable and conformable thanks to the flexible structure of its Si-O-Si chain. Using medical grade silicone in any part of the device that interfaces with the patient’s skin (and even the surgeon’s hand) is a great choice. This is important not only for equipment such as catheters, but also for long-term implants such as stents and pacemakers and for technologies worn outside the body such as prostheses, wearable devices, and cardiac implants. respiratory masks.

The softness of silicone also makes it suitable for low trauma wound care products such as dressings, bandages and surgical tapes. Using a medical grade silicone product with a soft adhesion reduces irritation and sensitization associated with the removal of traditional medical adhesives.

In addition, no harmful chemicals such as phthalates and additives are added to silicone to achieve its softness, flexibility and durability. These endocrine disrupting chemicals are widely used in other plastics and are under intense scrutiny. The fact that silicone never needed to be treated with them further confirms its suitability for clinical use, where patient safety is naturally of the utmost importance.

In addition to these three key benefits, medical grade silicone continues to be a popular choice due to its impressive versatility. Under the Silbione â„¢ brand, Elkem Silicones offers medical grade technologies with different softness properties, meeting the diverse needs of so many medical devices.

Finding the perfect supplier for your product can be a difficult task, with three main areas to consider. These include the company’s ability to innovate, deliver and support along the path to regulatory approval. In the webinar below, Elkem discusses these three requirements for a successful partnership and describes its own approach to collaboration. To learn more, please download below.

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Solve the challenges of medical technology using medical grade silicones

The current pandemic has revealed to the public three critical aspects of the medical device industry. First, this industry is of the utmost importance to keep health systems functioning around the world. Second, the manufacture and supply of medical devices can be disrupted by local events; therefore, the robustness and responsiveness of their supply chain should be improved. And third, their use and provision is subject to regulatory approvals, the speed and complexity of which vary by region of the globe.

In this exclusive webinar, Elkem Silicones tackles these challenges head-on, showing how to overcome these obstacles when developing and manufacturing medical devices. Three case studies will cover: supporting the design of medical devices with medical grade silicones with a focus on the performance of the final component, supply chain challenges with a presentation of manufacturing options around the world and the journey of medical companies through regulatory changes and challenges.

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