Jacob Cohen, Mechanical Engineering
Vladimir Krylov, Opto-Mechanical Engineering Manager
Flammability, Biocompatibility, Environment Compatibility, DFcx
When selecting the materials that will make up a medical device, one of the most important steps is considering the FDA requirements for flammability, biocompatibility and environment compatibility. These requirements are necessary for a marketable device, but not for a functional prototype. It is common during technology development to focus on core functionality and delay meeting some regulatory requirements until the product design stage. Once the product design commences, it is possible to experience difficulty finding materials that meet both core functional and regulatory requirements. When compromises have to be made, the core functionality may be affected, impacting time to market and project costs due to the need for revisiting the design. Just as important as making the right choice, is making it at the right time. Early consideration of regulatory requirements can pay dividends later in the project, eliminating the time and effort of correcting previous oversights.
Any manner of medical device is very likely to have material requirements for these attributes, and navigating the design process can be challenging. It takes experience to know which substitute materials are suitable for prototype parts, and at which stage in testing they are no longer suitable. It is highly valuable to have a resource with knowledge of the range of materials that can be used for prototyping, and the most cost efficient and readily available materials that can be used in the earlier design stages. It is also necessary to understand which properties are the most important when selecting a substitute material. If one key property is satisfied, but several other physical properties are not representative of the final product, false assumptions can be made.
Having a materials expert, or a design team such as the Cogmedix DFcx™ (Design for Compliance and eXcellence) engineering team, assist in the design process can help prevent any of the difficulties described above and will often accelerate the time to market. Cogmedix is proud to offer a full suite of medical device product development and manufacturing services, always keeping compliance at the forefront.