Medical device manufacturing

This post is a summary of a webinar we did with our customer, Ultradent. Their use case is valuable because it covered a number of factors not normally found together within a single plant: vertical integration; a significant mix of products and stock keeping unit (SKU); multiple manufacturing styles and an extended supply chain that required coordination and updates.

“In preparing for battle, I have always found that plans are useless, but planning is indispensable.”

General Dwight D. Eisenhower

It is a well-known and established fact that any digitization-related change being made at a value chain-wide level needs to be driven by the top management of an organization. Digitization is a strategic change, and needs to be coupled with a dedicated cross-functional/internal team, working alongside external sources comprised of experts from consultant and vendor companies. Together, they need to plan what the new operating model would look like, and then pursue work on established timelines to execute planned activities, while incorporating insightful information from the course of implementation. The team needs to create and motivate necessary cultural changes to achieve a viable and enhanced version of the initial plan.

MES implementations today is focused on achieving value chain-wide digital transformation, driving the entire organization closer towards Industry 4.0. The ease or difficulty with which the MES is implemented is subject to the inherent complexity which exists within any value chain. 

Let’s examine a use case of MES implementation where there is a high level of vertical integration, multiple product variants, and production lines executing a mix of process and discrete manufacturing modes. There are also strict compliance requirements with paper-based capture of process data. Essentially, the MES is crucial to the manufacturing process and the value chain.

Source: Ultradent’s Presentation on the Webinar: Managing Extreme Vertical Integration with a Single MES

The Situation

The overall operation of the business is highly complex and regulated. There are multiple manufacturing sites, styles, and products, concerned with the intricacies of vertical integration. There is also an OEM component which makes products for other manufacturers. 

An added complexity is that all sites, lines, and plants already use single global instances of their foundational business systems applications: ERP, PLM, Quality Management and Document Management. The desire was to add a single MES to the stack.

Getting Started

In order to select an MES, a team was assembled and started their background research. Members included manufacturing, IT, operations and engineering. Their goal was to get educated, and then get alignment with the stakeholders to plan an initial pilot—a proof of concept. The pilot incorporated process, functional, strategic and business requirements, as well as project management and resource allocations.

MES was a given—the decision was to determine whether to keep manufacturing as-is, or to re-engineer for the ‘to be’ state. A detailed scope plan was generated, allowing them to test out their MES concept—producing their first batches of product using MES instead of paper.

The pilot modeled an end-to-end value stream for a product line, representing half of the business. It included data collection, work order management, integration of the enterprise systems (ERP, PLM, labeling) as well as shop floor-level equipment. Among the focuses of MES was manufacturing execution data collection, and exception management.

After many months, the pilot went live. The first milestone for performance is ‘minimum viable product.’ The next milestone will be ‘minimum scalable product.’

Robust change management is a necessary component. There can be as many as 500 affected items and documents on pending change orders at any given time. Since the goal is to convert paper into MES process steps and data collection points, change management workload and complexity is a critical input of MES. Expected enhancements include high volume change management, weigh and dispense, and mistake-proofing the material handling process.

A challenge that regulated industries face is software/system validation. Validation is ‘documented trust.’ Validated correctly, a MES can eliminate the need for double human verification, as was stated in the pilot plan. Software verification, another dimension, means that the system is performing to specifications; validation extends that to ensure availability, security, integrity, traceability, extending through the supply chain to ensuring user/consumer safety. 

Looking forward is extending the MES into new production lines. The MES uses models with similar manufacturing flows and data collection characteristics to maintain the standardization of a single MES instance. A MES roadmap was created looking 2 to 3 years ahead and was balanced with a modeling and development backlog of 2 to 3 quarters to incorporate new use cases. Continuous stakeholder feedback will constantly refine the backlog, as well as any changes in business direction.

What the Future Holds

The first near term goal is improving the MES rollout. This is to further expedite the implementation rollout. Constraints to be dealt with include size, skill level and focus of the team as implementing MES can only move ‘at the speed of trust.’

For Ultradent, this means investing in people for a change—ongoing education and investment in stakeholders at every level—sponsors, product owners, modelers, project managers, architects, IT administrators, controls engineers as well as their partners.

MES is necessarily data-driven, so understanding the physical processes and information flow continues to be an important discovery process. Procedures are being put in place for robust data collection and analytics; coupling observation with user feedback and empirical data being a powerful tool.

In the end, MES scalability is the overarching project goal. Incorporating a design that allows the MES to adapt, scale and sustain changes, while still prioritizing fundamental needs such as high security, high availability, and disaster recovery. Scalability needs to be both vertical and horizontal, with long term data retention, and the ability to adapt with product and process changes. The results will automatically strengthen the case for a wider application deployment.

The key here is to plan well, understanding the needs of process owners, and the way in which the MES needs to interact with the other IT applications, while delivering a coherent and effective system that aligns with strategic operation goals. These will be done on time and within the budget.

To learn more about how a successful MES implementation may be pursued in complex, vertically integrated value chains, please register here to view the webinar.