There’s a difference between medical components and devices that is nuanced and can often be missed.
Medical components make up the bulk of silicone injection molding, and often do not require a clean room to be made. They do not have FDA classifications. Components are often then placed into devices at a later stage using a cleanroom.
Medical devices, in contrast, are finished devices that have FDA classifications depending on use and intended use that is risk based. These are:
- Class I – Low Risk, examples of these could include dental floss and toothbrushes
- Class II – Medium Risk, examples of these could be wheelchairs, contact lenses, ultrasound scanners and condoms
- Class III – Highest Risk, examples of these would be orthopedic implants
- Class IV — Implantables
Some medical devices don’t require a clean room, but others do. Class I makes up around 45% of medical device manufacturing and these can be ideally suited for a white wall facility rather than a clean room.
It is important to understand that many devices are made of components, and these medical components can be manufactured in a white wall room while still exceeding expectations. At Extreme Molding the components we produce are suitable for use by medical device manufacturers within the medical devices they are producing.