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Case Study: Human-Centered Decision Enablement at Global CDMO

Human-Centered Decision Enablement Drives Real-Time Operational Efficiency and Production Performance Improvements

We helped a global supplier of pharmaceutical and biotechnology services, analytical instruments, life sciences solutions and specialty diagnostics double their OEE and bring in millions more in quarterly revenue.

The company’s expansive portfolio was built through a series of mergers and acquisitions creating high operational complexity. As priorities shifted from building capacity with new assets and plants to increasing operational time from existing equipment, the highly heterogeneous processes, systems and hardware posed a significant challenge to gaining real-time production performance visibility and optimization insights.

Kalypso and Rockwell Automation were brought in to partner with internal subject matter experts to form a dynamic digital transformation group and deliver purpose-fit, human centered-solutions that combine automation and human expertise to meet innovation, quality and profitability business imperatives.

Initially focused on improving overall equipment effectiveness (OEE) the client recognized early that the work would be foundational to a broader transformation strategy, and adopted a comprehensive view on measuring success in operational efficiency. This nuanced approach has paid dividends in operational efficiency, revenue and institutional knowledge retention.

Real Results

  • Within 16 weeks, the first optimized line doubled the average OEE and quality metrics

  • Providing an additional $5 million in quarterly revenue

  • Subsequent lines are now optimized in six weeks, accelerating time to value

Challenges

In the pharmaceutical industry, complexity is an inherent aspect of the production environment. For our client, this complexity is amplified by the diversity of equipment, variance in product mixes and evolving regulatory requirements. These factors make it challenging to maintain consistent operational efficiency and quality in production.

High turnover rate of staff and the retirement of experienced personnel contribute another layer of complexity. As experienced professionals leave the company, they take with them years of institutional knowledge. Capturing and preserving this knowledge for future use to meet this shift in the workforce was a key requirement and critical to success.

Approach

The main goal was to achieve real-time operational efficiency.

We adopted a strategy that marries automation and human expertise to deliver quality and revenue. Rooted in a human-centered design, the approach considers people and automated systems as a comprehensive whole, working together in a collaborative and cooperative relationship.

Building a Digital SME

We created a solution that combines the depth of human expertise with the efficiency and accuracy of automation by integrating the practical wisdom and insights of production teams into a digital system that also processes large volumes of equipment data. This approach transforms vast data into information that is contextual, role-relevant and easy to consume and apply. A true Digital SME.

The Digital SME, built on Rockwell and PTC's robust platforms and tailored to suit the pharmaceutical industry's unique needs, was designed for real-time efficiency. Operators, line managers, automation teams and maintenance teams all gained the benefit of actionable insights to help prevent potential issues, minimize the impact of any issues that do arise and protect quality.

Intentionally designed to be non-GXP and non-GMP*, the Digital SME focuses on providing guidance based on existing validated parameters. This ensures that the quality team is always brought in to validate when substantial change is needed.

The Digital SME proved instrumental in preserving essential knowledge and improving decision-making processes. It has significantly enhanced operational efficiency while also maintaining product quality. Within 16 weeks, the first optimized line achieved double the average OEE and Quality metrics and brought in an additional $5 million in quarterly revenue.

The optimization timeline has since been reduced to six weeks, allowing for parallel optimizations of three to four lines and consistent value realization within a quarter.

What is a Digital SME?

First-of-its-kind, purpose-fit capabilities for real-time operational efficiency with automated data capture and analysis:

  • Performance Monitoring: Accurately assesses production performance in real time
  • Problem Trouble-shooting: Delivers timely, actionable information to resolve issues expertly and reduce downtime
  • Preventative Action: Alerts operations team of potential issues before they arise to avoid downtime via fine tuning
  • Predictive Data Analytics: Provides rich operational data for advanced analytics to optimize production process

A Human-Centered Digital Transformation

This digital transformation journey exemplifies how a well-thought-out, human-centered approach to automation can drive operational efficiency and maintain high-quality standards in a complex production environment.

By focusing on the needs of their teams and embedding best practices into a digital solution, we were able to navigate the challenges posed by a complex production environment and a changing workforce. This has resulted in improved operational efficiency while maintaining high-quality standards, ensuring continued delivery of life-saving medicines quickly and safely.

Thought Leaders

Sachin Misra
Principal & Global Leader - Pharmaceutical, Biotechnology and CDMO Practice