Medical Device Manufacturing just got Smarter with Shibaura Machine

ELK GROVE VILLAGE, IL, September 23, 2025 -

Medical device manufacturing leaves no room for error. Success depends on three non-negotiables: precise parts, repeatable results, and verifiable proof that every lot met the plan. Achieving this consistently requires more than just equipment — it requires systems designed to support compliance, efficiency, and innovation.

That’s why Shibaura Machine builds process data collection into every system, capturing the critical variables needed for Statistical Process Control (SPC). The result: manufacturers not only run with precision, but also gain the data foundation for traceability and regulatory confidence.

What Leading Medical Manufacturers Prioritize

• First-pass yield: Stable, repeatable control that delivers more good parts on the first run.
• Cleanroom readiness: Equipment that minimizes particles and streamlines sanitation.
• Audit-ready compliance: Digital records and clear production histories that stand up to regulatory scrutiny.
• Operational efficiency: Lower costs through energy savings, smooth motion, and fewer unplanned stops.

How Shibaura Machine Supports These Outcomes

Shibaura Machine integrates high-performance all-electric injection molding machines, robotics, auxiliaries, and built-in data tools to help manufacturers achieve these goals every day. For example:

• The EC-SXIII All-Electric series ensures precise injection and clamp control for connectors, housings, and micro features, while its oil-free design supports cleanroom compliance.
• Virtual Machine Expert, an on-machine AI advisor, detects early signs of drift and guides operators to maintain yield.
• machiNetCloud IIoT platform provides live visibility into OEE, energy per part, and cycle data, supporting electronic device history records (eDHR).

Medical-Ready by Design

Configurations include stainless-steel guarding, chrome-plated platens, raised bases for easier cleaning, NSF H1-certified lubricants, and locked recipes with traceability — all features that align with cleanroom and regulatory demands.

What that means for manufacturers: cleaner operation, faster changeovers, and production histories that stand up to audits and validation.

K-2025 proof point: See the EC75SXIII mold sleek business card holders from rPET in a fully automated cell—molding, handling/assembly, and precise printing in one flow. Virtual Machine Expert keeps the cell on track, while machiNetCloud shows live data at a glance.

Protecting the Process Window Through Integration

In medical manufacturing, the machine is only one part of the equation. Consistent quality requires a stable ecosystem:

• Robotics options manage take-out, assembly, inspection, and packaging with repeatable accuracy.
• Closed-loop auxiliary control allows dryers, chillers, and handling to be monitored and adjusted directly from the machine HMI, ensuring stability across the workflow.
• Integrated marking and labeling simplify device identification, lot IDs, and date codes, supporting regulatory traceability.

Data That Delivers Confidence

Audit readiness and operational insight come from data that is actionable at every level:

• Virtual Machine Expert (machine-level AI) detects deviations early, provides step-by-step operator guidance, and helps prevent downtime.
• LEO (Line Efficiency Operator) extends visibility beyond the machine, aggregating machine, auxiliary, and cell-level data in one interface. By simplifying complex process information, LEO empowers operators to make informed decisions on the floor without needing deep technical expertise.
• machiNetCloud (plant-wide IIoT) highlights bottlenecks, tracks energy per part, quantifies OEE, and builds a secure digital trail for compliance.
• Process data collection built into all systems captures the critical variables needed for Statistical Process Control (SPC). While the machines don’t generate SPC charts themselves, data can be exported to quality systems for real-time monitoring and compliance reporting.

At K-2025, every live cell connects to machiNetCloud, offering visitors a chance to explore real-time dashboards, alarms, and event histories—and see how these records feed directly into electronic device history records (eDHR).

Injection Molding built for cleanrooms and compliance

• Low-emission machine designs that support cleanroom classifications
• Stable temperature and pressure control to protect dimensions and weld lines
• Traceability by default with machine-level data and plant-wide analytics
• Medical-Ready options—stainless guarding, chrome-plated platens, raised base, NSF H1 lubrication—to reduce particle risk and speed cleaning
• Validation-friendly setups with locked recipes, parameter limits, alarms, and historical trends (to support ease of calibration and IQ/OQ/PQ steps)

Bring your medical use case—we’ll map the right cell

From micro features to long thin cores, optical clarity to high-volume packaging, we’ll configure a cell that fits your requirements:

• Choose the platform: EC-SXIII for cleanroom-critical precision
• Select the tools: mold and material guidance for medical-grade resins
• Right-size the automation: handling, drying, and temperature control
• Turn on the intel: Virtual Machine Expert on the machine, machiNetCloud across the plant
• Show your proof: locked recipes, alarms, audit trails, and reports

Let’s build your next validated cell

Cleaner, smarter, and more connected—this is the future of medical device molding. Meet the team at K-2025 for a live demo, or contact us to scope a proof-of-concept cell tailored to your device, materials, and cleanroom needs.

FAQ

1) What makes the EC-SXIII all-electric machine “Medical-Ready” for cleanroom molding?
The EC-SXIII is built for cleanroom environments and regulated runs. Key options include all-electric actuation (oil-free), chrome-plated platens, stainless-steel guarding, a raised base for faster sanitation, NSF H1-certified lubrication, extended ejector stroke, and locked recipes with traceability. Together with stable temperature/pressure control and smart tuning to keep fill time steady, these features support ISO-style cleanroom needs and repeatable medical device injection molding.

2) How do Virtual Machine Expert and machiNetCloud help with compliance, eDHR, and audits?
Virtual Machine Expert (on-machine AI) learns normal behavior, flags drift early, and guides operators step-by-step to prevent scrap and downtime. machiNetCloud (plant-wide IIoT) aggregates cycle, alarm, material, and energy-per-part data; quantifies OEE; and maintains event timelines and audit trails. Together they create the structured records quality teams need for electronic device history records (eDHR), UDI/lot tracking, and validation evidence.

Register today

Tel: (888) 593-1616

Email: im-success@shibaura-machine.com