Flambeau has been bringing plastics to life for over 70 years, and speed to market has become the centerpiece of our world-class organization during this time. Whether using rapid prototyping technology, scientific molding methods, or custom project management processes, speed to market is critical to the successful execution of medical projects.

In a specific speed to market scenario, a global drug delivery company challenged Flambeau with manufacturing production-quality parts for 510k submission in less than twelve weeks. Typically, a working prototype made with machined components will satisfy regulatory requirements for demonstrating efficacy and can be completed in days instead of weeks. However, in this case, Flambeau’s customer required components produced under normal molding conditions in a single cavity mold and asked Flambeau to provide supporting processing documentation along with sample parts.

Besides execution, the key challenge in producing injection-molded prototypes is cost. Balancing mechanical needs along with the financial requirements of a medical project is often a difficult decision, because gestation period from prototype to commercial launch can take from 12-48 months. Engineers desire a “high quality” mold, which will give them a production level part. On the other hand, finance management personnel wants to build as “inexpensively” as possible in the preliminary phase, as this is a non-recurring engineering charge and should be limited in spend.

Understanding the tight 12-week timeline, our engineering team went to work. When balancing cost versus speed our recommendation was to use a trusted offshore medical tooling partner to build a Class 103 mold. By utilizing this partner we were able to keep tooling costs in check, while at the same time manage the program efficiently and effectively through Flambeau’s offshore tool build SOP (Standard Operating Procedure) and our Project Management Gate System (PMGS) with a fully vetted offshore tooling supplier. When a complete scope of work was developed, the solution was summarized as follows:

By producing a Class 103 mold with minimal customization, molding T1 samples offshore, and subsequently bringing the mold to the United States for additional trials via air freight, Flambeau was able to execute the single cavity mold and produce production quality prototypes, while also providing relevant processing data in eight weeks. This represented a 33% improvement in speed to market.

In addition to time, our customer saved over 50% on hard prototype/bridge tooling costs and saved additional funds when the bridge tool cavitation provided the opportunity to be adapted into the full commercial tool or simply kept for mold spares.

By combining Flambeau’s PMGS, along with trusted offshore tooling execution, we were again able to deliver on our promise of bringing our customers products to market faster than the competition.