www.magazine-industry-usa.com
22
'26
Written on Modified on
Manufacturing Operations Platform supports regulated production
Critical Manufacturing demonstrates how manufacturers use MES, data, and AI to manage complexity and compliance.
www.criticalmanufacturing.com
Manufacturers in the medical devices and industrial equipment sectors operate in highly regulated environments while facing increasing pressure to improve responsiveness, productivity, and cross-site visibility. Production systems must ensure full traceability and compliance, but also cope with complex product variants, global operations, and growing data volumes.
Several manufacturers working with Critical Manufacturing identified limitations in traditional Manufacturing Execution Systems (MES), particularly when it came to integrating enterprise data, scaling across sites, and supporting advanced analytics or AI-driven use cases. Their objective was to establish a single operational backbone that could support shopfloor execution while enabling data-driven decision-making without compromising control.
Selecting a platform-based MES approach
To address these challenges, manufacturers deployed Critical Manufacturing’s Manufacturing Operations Platform, designed to combine MES functionality with connectivity, enterprise data management, analytics, and AI capabilities.
The platform was selected primarily for its suitability in complex and highly regulated production environments. Its MES layer manages real-time shopfloor execution, while maintaining traceability and compliance requirements typical of life sciences and industrial manufacturing. Rather than operating as an isolated system, the MES is designed to integrate with enterprise IT systems and external data sources.
A key differentiator was the built-in Enterprise Data Platform, which unifies manufacturing, operational, and business data across multiple plants into a governed architecture. This enables consistent performance comparisons across sites and provides a reliable data foundation for continuous improvement initiatives.
Deployment and operational support
Deployment was carried out with support from Critical Manufacturing’s partner ecosystem, including system integrators and technology partners experienced in regulated manufacturing environments. This ecosystem approach allowed the solution to be adapted to different production models while ensuring integration with existing automation, ERP, and analytics systems.
The platform was rolled out as a common operational layer across sites, helping standardize execution processes while preserving the flexibility needed for local production requirements.
Enabling practical AI in production
Building on the unified data foundation, manufacturers also introduced AI-supported tools such as MES Copilot and Analytics Copilot. These capabilities allow users to interact with production data using natural-language queries, reducing dependence on specialist roles for routine analysis.
Operators, engineers, and managers can access performance indicators, explore trends, and investigate deviations more efficiently, supporting faster and more informed operational decisions. The AI tools are designed to complement existing MES workflows rather than replace established controls.
Results and operational benefits
While specific performance figures vary by site, manufacturers report several measurable and structural benefits:
Several manufacturers working with Critical Manufacturing identified limitations in traditional Manufacturing Execution Systems (MES), particularly when it came to integrating enterprise data, scaling across sites, and supporting advanced analytics or AI-driven use cases. Their objective was to establish a single operational backbone that could support shopfloor execution while enabling data-driven decision-making without compromising control.
Selecting a platform-based MES approach
To address these challenges, manufacturers deployed Critical Manufacturing’s Manufacturing Operations Platform, designed to combine MES functionality with connectivity, enterprise data management, analytics, and AI capabilities.
The platform was selected primarily for its suitability in complex and highly regulated production environments. Its MES layer manages real-time shopfloor execution, while maintaining traceability and compliance requirements typical of life sciences and industrial manufacturing. Rather than operating as an isolated system, the MES is designed to integrate with enterprise IT systems and external data sources.
A key differentiator was the built-in Enterprise Data Platform, which unifies manufacturing, operational, and business data across multiple plants into a governed architecture. This enables consistent performance comparisons across sites and provides a reliable data foundation for continuous improvement initiatives.
Deployment and operational support
Deployment was carried out with support from Critical Manufacturing’s partner ecosystem, including system integrators and technology partners experienced in regulated manufacturing environments. This ecosystem approach allowed the solution to be adapted to different production models while ensuring integration with existing automation, ERP, and analytics systems.
The platform was rolled out as a common operational layer across sites, helping standardize execution processes while preserving the flexibility needed for local production requirements.
Enabling practical AI in production
Building on the unified data foundation, manufacturers also introduced AI-supported tools such as MES Copilot and Analytics Copilot. These capabilities allow users to interact with production data using natural-language queries, reducing dependence on specialist roles for routine analysis.
Operators, engineers, and managers can access performance indicators, explore trends, and investigate deviations more efficiently, supporting faster and more informed operational decisions. The AI tools are designed to complement existing MES workflows rather than replace established controls.
Results and operational benefits
While specific performance figures vary by site, manufacturers report several measurable and structural benefits:
- Improved real-time visibility across production and sites through unified data access
- Greater consistency in execution and compliance management across regulated operations
- Reduced effort required to access and interpret manufacturing data
- Stronger foundation for advanced analytics and continuous improvement initiatives
For medical device manufacturers, the platform supports tighter control over quality and compliance while improving responsiveness to change. For industrial equipment manufacturers, it enables scalable operations that can adapt to evolving product and production complexity.
Demonstration at MD&M West 2026
Critical Manufacturing presented these customer deployment scenarios at MD&M West, held from February 3–5, demonstrating how manufacturers are applying the platform in live production environments. The demonstrations highlighted how MES, enterprise data, and AI can function as a single operational system supporting both day-to-day execution and long-term operational improvement.
www.criticalmanufacturing.com
Demonstration at MD&M West 2026
Critical Manufacturing presented these customer deployment scenarios at MD&M West, held from February 3–5, demonstrating how manufacturers are applying the platform in live production environments. The demonstrations highlighted how MES, enterprise data, and AI can function as a single operational system supporting both day-to-day execution and long-term operational improvement.
www.criticalmanufacturing.com
