biomedical textiles, specializing in braided and
nonwoven components for medical devices.
Biomedical Engineering and Textile Engineering Converge
In the current medical device environment, it is well understood that speed is an important factor in designing and commercializing new products. Device companies can ill afford to select vendors that are unfamiliar with the plethora of challenges the industry is facing today. Qualified suppliers will also be knowledgeable about FDA requirements for selecting & qualifying raw materials for medical use. Their engineers will have extensive prior experience working with biomedical engineers to develop components for medical devices. The quality system will be certified to meet ISO 13485 requirements.
A streamlined approach to vendor selection in this field is to engage the services of firms who are medical companies first and textile companies second. It is critically important that your design and technology partner is fluent in understanding the biological environment and anatomical context of the device. Bilateral communication is critical in a supply relationship where iterative design is part of the development process.
In all biomedical textile processes, there is a convergence of many layers of complexity. This includes raw materials control, their quality and cleanliness and the stability of their supply for the long run. The complexities further include the fabric structure and its mechanical performance, which extends to how the component interacts in the final device. Navigating these challenging waters is a requirement for all device designers, but doing so with an effective partner streamlines the process.
The convergence of biomedical engineering and textile engineering exists at US BioDesign, Inc. The company was formed by a group of seasoned medical device and textile industry executives who sought to launch a “customer first” medical company that involves the customer at every step.
A team has been assembled that excels in working directly with customers as an extension of their engineering group, to facilitate a product development process that moves smoothly and swiftly. By removing the historical, natural barriers that many vendors put in place, such as restricting access to the manufacturing floor, US BioDesign is positioned to freely collaborate toward the mutual end goal of a successful device product launch.
This open collaboration has proven vital in developing novel micro-braid products for US BioDesign’s customers. Due to the criticality of the implantable devices used in these advanced applications, an intricately engineered biomedical textile is required. US BioDesign has assembled the team, the processes, and the advanced technology to design medical device components for all stages of the product lifecycle.
For more information on how US BioDesign can accelerate your next medical device development project, please contact us at http://www.usbiodesign.com/contact-us.