Diagnostics and Monitoring
Medical grade silicone elastomers for the manufacturing of diagnostic and monitoring devices
Diagnostics & Monitoring
Manufacturers of diagnostic or sensory devices use medical grade silicones in the production of disposable and home-health devices, microfluidic chips, gaskets and cushioning pads not only because of their inertness and ease of processing, but in particular due to their superior biocompatibility.
Constant health monitoring is not only important to track progression of an illness, it has also become a lifestyle trend to follow various health parameters on a daily bases. Innovative wearables solutions like watches, implantable sensors, smart textiles and many other devices enable healthcare professionals to have on-demand access to health data like oxygen, stress, blood glucose, or fitness level.
In Vitro Diagnostics (IVD) point of care test (POCT) are an emerging trend in the field of diagnosis as they include disposable and home health options for the patient. POCT devices are convenient since they are easy to use, eliminate the need of traveling to medical facilities and provide the test result within minutes. Among others, microfluidic cartridges are the heart of POCT devices. Condensed on a few centimeters, these chips enable sample drawing, sample preparation and parallel analysis of various parameters. Silicones facilitate the fabrication on a micrometer scale and integration of valves, micropumps and other components. Utilizing Silbione™ silicone materials will provide various benefits to manufacturers of In vitro diagnostic point of testing devices including biocompatibilty and application-specific solutions to limit absorption of both proteins and drugs.
Wearable devices such as activity trackers and continuous glucose monitors or blood pressure monitors allow users to keep track of their health and wellness data. Direct access to this data can help to initiate appropriate care measures if necessary. Since these devices can be worn directly on the skin for extended periods of time, the material used must provide comfort and offer hypoallergenic qualities. For skin-worn patches, Silbione™ Soft Skin Adhesives are the perfect alternative to traditional acrylic based adhesives, since Soft Skin Adhesives can be removed painlessly and repositioned multiple times.
Silbione™ medical grade silicones meet the highest quality and manufacturing standards, complying with the Elkem Silicones Quality Management System. This includes:
- Inhouse clean operation standards, applying the principles of Good Manufacturing Practices
- Certified ISO 9001
- Application of the Responsible Care Management System®
At Elkem Silicones, we believe in the safety and efficacy of our silicone products for healthcare and biomedical applications. Our medical Silbione™ products have been tested to meet USP Class VI and ISO 10993 requirements. Our regulatory support team is available to support customers with biocompatibility needs, either directly by providing the relevant documentation, or by supplying information to regulatory agencies in support of their medical device submissions.
At Elkem silicones, we are dedicated people located around the globe, committed to your success. Whether you are looking for a product recommendation, for customized silicone solutions, or for regulatory support, we have the people in place when and where you want them. If you have a medical device project, contact us and our experts will be there to help.