From Prototype through High Volume, Clean Room Production

Background

The global continuous glucose monitoring (CGM) market has experienced significant growth since its inception, driven by a rise in diabetes, technological advances, and most recently OTC (over-the-counter) use by consumers.

SIMTEC Silicone Parts was approached by a global leader in the medical and healthcare industry, interested in partnering with SIMTEC for a new product being introduced to the market—a wearable CGM device. This revolutionary new diabetes care product required three very small silicone components: one LSR part and two LSR + Polycarbonate 2K parts.

From the onset, SIMTEC’s engineering team worked closely together with the medical device leader to optimize part designs, material selections, and performance requirements.

Challenges

Complex Geometry and Size
- The production process presented challenges due to the complex geometry and small size of the parts. In addition to tight tolerances and stringent quality requirements, the parts were exceptionally small, weighing 0.03 grams, 0.11 grams, and 0.33 grams.
Production and Handling
- Manufacturing these tiny components at high volume required specialized processes. The inherent static electricity generated by LSR materials was significantly amplified by the lightweight nature of the parts, necessitating innovative handling and manufacturing solutions.

Solution

Design Optimization and Prototyping
- To meet the customer’s need for fit, form and product testing, specialized tool inserts were built to deliver production-quality prototypes needed for assembly and sterilization testing.
Mold Development and Capacity
- After successful tests and pilot production runs, two high-quality 32+32 cavity 2K molds and one 128-cavity 1K mold, provided the capacity and precision automation needed for full-scale production at SIMTEC’s US facility in South Florida.
Custom Clean Room Manufacturing Cell and Inline Processing
- SIMTEC’s process engineering team developed a unique solution: a custom manufacturing cell capable of molding and handling the high volume of parts produced during each cycle, within an ISO class 8 clean room environment. The tailor-made, environmentally controlled, clean room molding cell included inline customized devices for separating the molded parts by cavity, and special parts handling technology designed to control the static inherent in LSRs and amplified by the lightweight parts.
Ongoing Partnership and Growth
- The CGM program continues to evolve and expand as product demand grows. To support increased production capacity, multiple additional molds are built and added into production.
- The valued partnership continues to grow. The success of this program has further strengthened the partnership, reinforcing confidence in SIMTEC as a trusted and innovative partner and paving the way for continued collaboration and growth.