Safety Technology: Partnering for Rapid ATEX Market Launch

Summary

A pioneer in safety technology designed an innovative personal safety device intended to provide superior performance and ergonomics for professional safety teams and emergency services personnel. These users operate in high-stakes environments where equipment failure is not an option. Recognizing the criticality of a rapid, high-quality new product launch, the manufacturer turned to Plexus, its long-term strategic partner, to leverage its expertise as a proactive engineering extension. The customer gained access to specialized expertise in contract manufacturing and complex system integration.

Plexus executed a comprehensive manufacturing strategy that included rigorous engineering trials and root cause analysis to drastically reduce initial product failure rates during manufacturing. This collaboration led to the adoption of advanced manufacturing techniques, such as laser welding for hermetic seals and strict adherence to stringent regulations for hazardous environments. The partnership delivered a successful market launch and established the agility needed to swiftly produce new international variants.

The Challenge: High Stakes in “Smart” PPE

The customer’s R&D team identified a significant market opportunity in the shift toward “Smart” Personal Protective Equipment (PPE), leveraging technological advancements to design an advanced personal safety system. A primary business imperative for the product launch was the need for both rapid deployment and quality manufacturing.

However, manufacturing challenges emerged during the New Product Introduction (NPI) phase:

• Quality Issues: Early engineering trials showed that electronic boards were failing initial leak tests. This required a partner who could perform deep root cause analysis rather than just reporting the failure.
• Global Regulatory Compliance: Because the device operates in hazardous atmospheres, it must meet strict regulatory compliance standards across different regions. Specifically, it required adherence to Atmosphères Explosibles (ATEX) regulations for Europe and National Fire Protection Association (NFPA) standards for the United States. These rules ensure the device is “intrinsically safe.” An intrinsically safe device cannot ignite a spark in a volatile or explosive environment.
• Specialized Capability: The design required laser welding to create hermetic seals. These seals are better than adhesives because they withstand industrial decontamination and extreme temperatures.

The Solution: A Proactive Engineering Extension

Plexus delivered an integrated solution focused on quality assurance and de-risking the launch. This approach allowed the customer to focus on innovation while Plexus managed the technical manufacturing requirements.

Proactive Quality Resolution via PFMEA – The Plexus team performed a detailed root cause analysis to solve the leak test failures. We identified issues at a specific component supplier that were affecting the final assembly.

To fix this, our engineers used Process Failure Mode and Effects Analysis (PFMEA) and process mapping. We defined a Critical-to-Quality (CTQ) requirement for a key component bond. By helping the supplier improve their own internal processes, we boosted supply chain resilience and significantly reduced scrap levels.

Dual-Standard Compliance and Level 5 Traceability – Meeting both ATEX and NFPA standards requires perfect data management and precision. Plexus quality teams implemented Level 5 traceability for every component.

This is the “gold standard” of tracking. It documents every single part, down to the specific resistor, to ensure no non-compliant materials enter the build. This level of quality control in manufacturing is essential for devices used in explosive environments.

Joint Investment in Advanced Joining – Our team recognized that the product needed a specialized joining process to ensure a long lifecycle. Plexus and the customer jointly invested in new laser welding equipment. This strategic move ensured long-term scalability for the product line. We optimized the welding process to create durable seals that survive repeated high-pressure wash cycles and harsh field use.

Comprehensive Manufacturing Test Strategy – Plexus developed a comprehensive manufacturing test strategy to support high-volume production. This included:

• Influencing PCB layout for optimal In-Circuit Testability (ICT) early in the design phase.
• A multi-technology approach combining Automated Optical Inspection (AOI), Automated X-Ray Inspection (AXI) and Functional Testing (FCT).
• Specialized stations for leak testing and a sound chamber for alarm verification, utilizing automated solutions for increased throughput.

The Results: Agility for Global Market Entry

The proactive steps taken during the NPI phase led to a market launch that exceeded all performance goals. By solving quality issues early and securing both ATEX and NFPA compliance, we created a flexible framework that allowed for rapid global expansion.

When the customer needed a new variant for the Asia market, our team was ready. We initiated manufacturing and delivered completed units in just three months, even with an incomplete initial data package. This quick turnaround was possible because of the strong collaborative relationship between our teams. This case study proves that a proactive partner is vital for managing the demands of modern safety technology.