Speed to Market

Production Quality Parts, So Little Time

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

The Challenge

Relating to a specific speed-to- market case, a global drug delivery company challenged Flambeau with manufacturing production quality parts for 510k submission in less than 12 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 financial requirements of a medical project is often a difficult decision because gestation period from prototype to commercial launch can take from 12 to 48 months. Engineers desire a “high quality” mold which will give them a production level part. On the other hand, finance 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.

The Answer

Understanding the tight 12 week timeline our engineering team went to work. When balancing cost vs. speed our recommendation was to use a trusted offshore medical tooling partner to build a Class 103 mold. By utilizing our trusted offshore supplier 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 PMGS (Project Management Gate System). When a complete scope of work was developed the solution was summarized as follows:

• Produce bridge tool which can be used in conjunction with production tool
• Explore alternative offshore and onshore mold trial options
• Utilize air freight to reduce logistical lead times

The Result

By producing a Class 103 mold with minimal customization, shooting T1 samples offshore and subsequently bringing the mold to the United States for additional trials, we shipped via air freight were able to execute the single cavity mold and produce production quality prototypes while also providing relevant processing data in 8 weeks. This represents a 33% improvement in speed to market.

In addition to time, our customer saved over 50% on hard prototype/bridge tooling costs and will save additional funds when bridge tool cavitation is retrofitted to the full commercial tool or simply kept for mold spares.

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