Medical Device Prototyping For Cogmedix
Because medical device manufacturers face FDA scrutiny and approval before bringing a medical device to the marketplace, there is an urgency to start medical device prototyping in end-use materials as swiftly as possible in the product development process. This can be a challenge for plastic parts that are going to be made using injection molding because of the long lead-times and costs associated with tooling.
The sooner a medical device company can make a leap from traditional prototype materials to production materials, the faster you can discover potential performance issues. That translates into better products getting to market in less time.
Medical device companies are often up against an arduous and time-consuming FDA approval process. If you’re not using end-use material, your entire project will be ‘frozen’ by the FDA for design, material, manufacturing methods, and function.
The goal is to freeze the design as quickly as possible so reapproval won’t become necessary. Delays like this are exorbitantly expensive and can be prevented with proper planning.
One way to finalize the design more quickly is by using end-use material earlier in the prototyping stage. Doing so at a much earlier stage enables you to avoid material-related issues during the FDA approval process. However, historically this has been hard to do because making prototypes using production-grade injection molding materials was expensive and time-consuming.
Empire Group worked with Cogmedix to overcome those historical obstacles by using high-strength 3D printed composite injection molded tooling. This breakthrough technology can deliver prototype injection molded parts in days instead of weeks, even using difficult-to-mold materials such as glass-reinforced nylons and Ultem.