Medical Device Keyboard Case Study | GMI Solutions

In the highly regulated and precision-driven world of medical device manufacturing, every detail matters in critical-use applications. Any missteps or malfunctions have consequences, ranging from opening the door to competitors’ solutions to dire outcomes posed by vulnerabilities in patient safety.

Assuming this level of risk requires medical device manufacturers to have a comprehensive understanding of what’s at stake and their role in consistently delivering to rigorous standards of device quality, performance, and compliance. 

It doesn’t happen by chance. Careful alignment with outsourcing suppliers with the expert capabilities to support critical-use medical device manufacturing is a top priority, as illustrated in this case study.

Established Relationship, New Challenges

GMI Solutions invests in building customer relationships. We stand behind that commitment even when our customers’ team members accept positions at different companies.

Such was the case with a complex keyboard for a critical-use medical device. The person leading the project was a former GMI customer who remembered her positive experience with our team, Midwestern work ethic, and the expert assistance we provided. When she ran into ongoing production issues with her contract manufacturer, she pivoted away from her CM and returned to GMI for help with getting the product back on track.

Project Challenges Overview

Data accuracy and accessibility are paramount in critical-use applications, and reliable data input keyboards are essential. Several issues prevented the CM from fulfilling production, leaving our customers with unresolved quality issues, field failures, and inventory disruption. Exorbitant in-process scrap rates and unpredictable delivery rounded out the list of concerns and helped GMI develop a robust plan to address the program’s shortcomings.

A Multi-Pronged Solution

Upon careful examination of samples from the former CM and related design and requirements documentation, the GMI team identified several immediate opportunities for improvement. Correcting deficiencies in assembly process automation and repeatability along with testing simplification would lead to optimized processes, productivity, and product quality.

Dedicating team members and an assembly cell on the manufacturing floor solely to the keyboard project ensured GMI would deliver a time-, cost-, and labor-efficient solution.

Process Improvements

The GMI team made 4 key process adjustments:

• Revised assembly process plan and created a dedicated assembly cell to monitor, manage, and improve assembly flow
• Added new automated gluing equipment to increase control over glue placement, improve product consistency and quality, and significantly reduce scrap components caused by errant gluing
• Replaced handheld ultrasonic welding with single-operation heat staking to increase part joining consistency and better manage time and process flow
• Reworked inventory process to guarantee needed components were always available on the GMI shop floor

Productivity Improvements

The GMI team implemented 3 targeted process improvements:

• Designed and created custom fixtures and jigs to aid in assembly, including a device to secure and place fastener nuts during keyboard assembly, and a roller tool to simplify elastomer handling
• Purchased dedicated equipment and tools for heat staking, automated gluing, and handheld assembly to increase time and labor efficiencies
• Introduced innovative clamp/curing solution that doubles as packaging, thereby significantly reducing the use of plastic bags, fillers, and manufacturing floor space required for storing keyboards during glue curing

The Results

In addition to helping our customer achieve her main objective of defect-free, on-time keyboards for a critical-use medical device, GMI process and productivity improvements returned some impressive results:

• Reduced Takt Time by as much as 75% for some operations
• Reduced scrap, with waste nearly eliminated for some components
• Improved keyboard field reliability and increased customer satisfaction

Your Next Steps

The returning customer is now a customer for life, and we appreciate her continued confidence in GMI Solutions. Our adaptability, expertise, and innovative customization is ideal for applications in all industries and we’re willing to work as hard to find top-quality, high-performance solutions for you as we did in helping our medical device manufacturer.

Learn more about how GMI skills, culture, and capabilities contribute to successful partnerships and outcomes by reading 5 Reasons to Choose a Specialized Medical Contract Manufacturer. Click below to download your guide.