Medical Device Manufacturer Deploys Andon Across FDA-Regulated Clean Rooms

Response time tracked for the first time across clean rooms. Multi-phase deployment from proof of concept to full production coverage.

At a Glance

Detail	Value
Industry	Medical Devices — FDA-Regulated Manufacturing
Facility	Multiple production areas including FDA-regulated clean rooms
Key Result	First-ever response time tracking in clean room environments
Deployment	Multi-phase: proof of concept → full production rollout with expansion
System	3-key call buttons, watch pagers, wireless stack lights, signal repeaters, advanced software with SMS/email escalation

The Challenge

This medical device manufacturer produces dialysis products in an FDA-regulated facility with clean room environments. Their manufacturing engineering team had been using a basic paging system for approximately four years, but it provided no data — no response times, no resolution tracking, no escalation when calls went unanswered.

"I like it. The system seems very deployable, very easily deployable. A lot of times we try to stand up different systems and we have constraints, whether it's our IT systems or whatever. But this seems fairly straightforward and easy to get stood up."

The Director of Manufacturing Engineering identified several gaps:

No metrics on response time. When operators called for quality support or maintenance, there was no record of when the call was made, when someone arrived, or when the issue was resolved.
Clean room constraints. Any hardware deployed in clean rooms had to be disinfectable. Wearable devices needed to withstand sanitization protocols.
RF welding interference concerns. The facility uses RF welding equipment, raising questions about whether a radio-frequency alert system would cause or experience interference.
IT security requirements. As a large healthcare company, every new application required a formal risk assessment covering security, data storage, and network architecture.

Why They Chose an Andon System

The manufacturing engineering team needed a system that could operate in FDA-regulated clean rooms without adding IT complexity or violating data security policies.

They evaluated the existing paging system against a modern Andon approach:

Existing paging — functional but zero data capture; no response tracking, no escalation
Cloud-based solutions — rejected due to corporate IT restrictions and data custody concerns
Wireless Andon with local storage — no cloud dependency, radio-frequency operation independent of plant Wi-Fi, formal IT risk assessment passed

The deciding factors were:

RF independence. The system operates on a dedicated low frequency (462.750 MHz) separate from any Bluetooth, Wi-Fi, or industrial RF equipment — no interference with RF welding machines
Waterproof watch pagers. Can be cleaned with liquid disinfectants, meeting clean room hygiene requirements
Local data storage. No patient data, no cloud — the system runs on a standalone PC with no inbound internet required
Minimal IT footprint. Passed the company's formal IT risk assessment; optional subnet for SMS/email escalation

The Implementation

Phase 1: Proof of Concept

After passing the IT risk assessment, the facility ran a structured proof of concept:

Remote software installation on a dedicated laptop
SMS and email functionality verified through corporate firewalls
IT architecture reviewed with the company's cybersecurity team (MySQL database, JavaScript stack, network isolation options)

The IT team confirmed the system could run on an isolated subnet without touching the corporate network, satisfying their security requirements.

Phase 2: Full Clean Room Deployment

The facility deployed across multiple production areas:

6 three-key call buttons (call, assistance tracking, resolution) at production stations
Watch pagers for technicians — waterproof, disinfectable for clean room use
Wireless stack lights for visual department-coded alerts in areas where wearable devices are restricted
Signal repeaters — both button-side (2611D) and transmitter-side (2611DP) to cover the full facility including clean rooms separated by heavy walls
Advanced software with escalation sequences, documentation portal, and full reporting

Configuration Details

The team configured repair time tracking (yellow button) with 30-minute escalation to supervisors, plus separate escalation sequences for quality, maintenance, and engineering calls. Each escalation level had assigned recipients to ensure no call went unanswered.

Phase 3: Expansion

Based on results from the initial deployment, the facility continued expanding:

Additional call buttons for new production areas
Software license upgrades to accommodate expanded coverage
Two-key call buttons added for specific workstations requiring simpler alert workflows

The Results

Clean Room Viability Confirmed

The system proved fully operational in FDA-regulated clean rooms:

Watch pagers withstood daily disinfection protocols without degradation
No interference detected with RF welding equipment — the dedicated frequency operated independently
Signal repeaters provided full coverage through clean room walls and across building sections

Response Time Visibility

For the first time, the manufacturing engineering team had data on:

When each support call was placed and from which station
How long it took for the assigned team to arrive (time-to-respond)
How long the repair or inspection took (time-to-fix)
Which stations and shifts generated the most calls

IT Security Maintained

The deployment satisfied all corporate IT requirements:

No inbound internet connections required for core alerting
Data stored locally on a dedicated PC — no cloud exposure
SMS/email escalation routed through an isolated subnet
User credential management handled in-house

Sustained Adoption

The facility has been an active customer since early 2024, with multiple expansion orders over 18+ months — confirming that the system delivered ongoing value beyond the initial deployment.

What They Said

The Director of Manufacturing Engineering emphasized two things during evaluation: the system's ease of deployment compared to other IT projects they'd attempted, and the importance of showing cost savings and response time improvements to justify the investment.

"I think the other part is to look at how we show cost savings. When we implement this system, what are we gaining? We know it's going to help with response times, machine availability — we have an advantage there, making sure we document and capture that."

The IT risk assessment process — typically a barrier for new technology at large healthcare companies — was completed without issues. The system's radio-frequency architecture and local data storage aligned with the company's security posture, avoiding the months-long approval cycles that cloud-based solutions typically require.

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