If you are considering working with a Custom Manufacturing Organization (CMO) on a medical device or component that requires silicone, you may want to keep in mind the following considerations, all of which can significantly impact the outcome of your project:
Industry Longevity and Experience
Check that the CMO has an existing track record in the medical device industry, and with very specific experience in your particular market. For example, a CMO that manufactures thermoplastic access devices may not necessarily succeed with your next silicone catheter, shunt, drain, or dilator project, so make sure you discuss the variety of devices and components that the CMO has manufactured in your industry, especially if your project involves silicone molding or extrusion.
Demonstrated Expertise in Silicone
While many CMOs have significant experience in thermoplastic molding and extrusion, a deep level of experience with silicone is not common. That’s because silicone’s unique properties and manufacturing intricacies require a distinct set of skills and knowledge. As demand for silicone components and devices grows, make sure that your selected CMO has a substantial, in-depth level of expertise in silicone molding and extrusion, and can demonstrate a nuanced understanding of the specific challenges posed by silicone.
Vertical Integration and Post-Processing Operations
A vertically integrated CMO can assist with Design for Manufacturability (DFM) to optimize costs, materials, and specifications during the manufacturing process.
When all stages of the product process are managed under one corporate umbrella, from raw material acquisition to delivery of a finished, packaged product, workflow efficiency is optimized, lead times are minimized, and resulting products consistently demonstrate superior quality.