Medical Device Assembly / Glucose Monitor

A global tier-1 medical device manufacturer engaged Sterling Engineering to support them in the coordination of custom automation machines from several other suppliers onto the new lines in production. 

This innovative product was to supply the global market for glucose monitors. Like many biotechnology devices, the main components are printed circuit boards (surface mount technology) and injection molded parts. 

The team comprised a program manager supported by mechanical designers, technical writers, and validation engineers with Lean and cGMP expertise. 

PROJECT SIZE  - $500 million 

DURATION - 4+ Years 

PROJECT MANAGEMENT TEAM - 20 Technical Resources 

GEOGRAPHY - Multiple U.S. Locations 

Project Challenges 

Developing the automation to produce a quality product is critical to the medical device industry. Speed to market is paramount so the scheduled delivery of product was moved earlier at every opportunity. 

As a medical device with sterile components, they needed a strong validation team to quickly move them through start-up and into production. 

Developing the automation to produce a quality product is critical to the medical device industry. Speed to market is paramount so the scheduled delivery of product was moved earlier at every opportunity. 

The client needed an automation manager who would assure that each assembly machine achieved the required OEE (Overall Equipment Effectiveness), understood what it took to reliably test components, and had the knowledge of what made vision systems reliable. 

Reference: CS60/2876540