Case Study: Drug Delivery Device Components

Scaling Up From Zero To Hundreds of Millions

In 2013, Precision Engineered Products began working with an OEM that had designed an exceptional multi-part drug delivery device with significant market potential. Their requirement was for precision, micro-molded and stamped components manufacturing that could be scaled rapidly in tandem to meet the anticipated demands.

Manufacturing processes were developed for several complex stamped components, molded parts and ultra precision micro molded components. These all had to be assembled efficiently and perform in a coordinated fashion to enhance the structural integrity and performance of the device.

The five metal stampings incorporated into this device were geometrically complex and had to be held to extremely tight tolerances. PEP worked with the OEM early on to develop tooling that would provide these exceptional tolerances where needed but also allow for cost-effective manufacturability.

As anticipated, the demand for the product grew rapidly and PEP quickly plunged into scaling up its manufacturing processes to deliver increasingly large quantities. This was easier to do for the stamped components since they are delivered via a standardized manufacturing complex that provides fast-turns of components for a large number of OEMs.

The manufacturing processes for molded and micro molded parts required designing a modular complex of automated molding cells that could be scaled up incrementally by adding more cells. Within just eight months, the complex was installed, qualified and producing parts 24/7. Which incorporates automated presses equipped with high-speed robotic part removal with custom end of arm tooling, automatic runner and part separation, and traceability to individual cavities.

By focusing on the critical details up front, PEP rapidly scaled from zero to nine million parts/week for our customer’s drug delivery device without sacrificing quality.

Major Considerations For Micro Molding Scale Up

Here’s a rundown of some of the major considerations that were addressed along the way:

Single Cavity Mold Designs: With the part design still in flux, PEP started out by designing single-cavity molds. Any part design change was incorporated at this stage. This approach allowed for rapid scalability from one to four to 16 cavities.

Nailing Critical Molding Process Variables: A DOE (Design of Experiments) protocol was developed to determine the most critical process variables, an ideal range of settings, and the widest window of variability for these settings – so that, if necessary, the process could be adjusted to allow for normal variation in process and material variability.

Tooling Development and Validation Processes: Even at this early stage, a team of PEP engineers representing tooling, processing and quality were actively engaged in the project. The same process was followed through the entire ramp-up process, up to 16 cavities.

Close Supply Chain Coordination: Early on, PEP also reached out to our supply chain to secure commitments from molding machine manufacturers, material suppliers, production mold builders and automation suppliers to ensure a uniform footprint across all mold cells. 

Bottom Line

PEP took a concept at the end of the first year of our project and we were able to scale it up to the point where we were making six million parts per week across four different parts produced in 16-cavity molds. Two of those parts required holding critical dimensions to ± 0.0005”.  Another part had nine critical dimensions that had to be tightly controlled within the 16-cavity molding process.

As of early 2015, the manufacturing cell was running 24/7 producing close tolerance drug delivery parts at rate of several hundred million parts per year. These parts and stampings are being delivered on time to assembly operations where they have performed flawlessly.