What are biocompatible materials or biomaterials?

Biocompatibility (biomaterial is short for biocompatible material) refers to the ability of a material to perform with an appropriate host response in a specific application. Polymers and metals recommended by Secant Medical have been used successfully as long term implants. There are many factors that can affect the biocompatibility of a material, such as handling, process aids, cleanliness, environment, specific use, sterility, packaging, etc. Controlled environments, validated processes and validated systems are essential to ensure continued biocompatibility. Secant Medical cannot “certify” the biocompatibility of fabric components, since many downstream processes are not within our control. It is the responsibility of the device manufacturer to ensure biocompatibility of all materials that contribute to the final device. Please refer to ISO 10993 (Biological Evaluation of Medical Devices) for guidance on biocompatibility evaluation and testing requirements.

We would like to start working with Secant Medical on a new project. What is the first step?

The first step is to sign a mutual non-disclosure agreement. This agreement can be our standard agreement or your company's standard agreement. If necessary, the agreements may be revised to meet each parties requirements. Once this agreement is in place, our R&D engineers can begin an in-depth discovery process to determine how to best meet your needs. This will normally be followed with a development quotation.