Radiation medicine pioneer Elekta is growing fast. In anticipation of regulatory changes requiring more documentation and labeling, the company implemented a manufacturing execution system (MES) at three of its sites, one each in Europe, the UK, and China. The company implemented a manufacturing execution system (MES) at the three sites before regulatory changes went into effect that required more documentation and labeling. One facility is processing nearly 35 percent more manufacturing order lines per month than it did four years ago, without increasing the number of employees. They have already saved $85,000 in archiving costs over four years and expect $850,000 in savings over the 20-year storage period. Elekta has also reduced its time to implement an engineering change to a work instruction by about 97 percent.
Elekta, headquartered in Sweden, pioneered precision radiation medicine, revolutionizing cancer care with precise and individually tailored radiotherapy treatments. As a leading innovator for equipment and software used to improve, prolong, and save the lives of people with cancer and brain disorders, Elekta focuses on improving access to high-quality, cost-effective cancer care and advanced treatments for patients worldwide.
The company’s products include a comprehensive range of advanced treatment delivery systems for personalized radiation therapy and radiosurgery. With nearly 4,000 employees worldwide, it has products operating in more than 6,000 medical facilities.
In 2017, Elekta looked into the business benefits of implementing a modern MES. It used the simple equation that to increase the value of the devices it provided, it needed to raise quality while reducing costs (see Figure 1). Elekta already had strategic priorities defined for its business, including:
Elevate customer experience.
Act as an innovation leader.
Continuously improve its processes.
Sustain a competitive cost base.
Live its values.
Obstacles Between Elekta and Its Goals
Prior to implementing the new MES, Elekta’s existing production systems prevented the company from reaching its potential and presented risks for the future. The company used paper-based device history records (DHRs), manual checks for compliance, and paper work instructions with no electronic process validation.
Audits, and the interruption to production they create, were a top concern. The manual audit process was costly, prone to human error, and reduced production efficiency. One product, a medical linear accelerator called Linac, required some 800 manual signatures and produced 1,200 folders a year that the company needed to store for 21 years.
Further, manual methods and paper records did not provide visibility into processes and inhibited data analysis for continuous process improvements. As a result of these inefficiencies, products had long lead times.
Evaluating Modern MES Options
Elekta envisioned a new MES to support its business priorities. Specific improvements were needed in quality control, manufacturing lead times, supply chain performance, lean manufacturing, and employee engagement (see Table 1). Elekta’s “must have” criteria for MES solutions included:
Rapid and faultless execution of production processes.
Electronic device history records (eDHR).
Complete tracking and traceability.
Flexible and configurable process/line setup with easy adjustments.
Copying of configurations.
Digital work instructions in multiple formats, not just PDF.
Integration of employee certification.
Manufacturing process records.
Localization, such as the ability to use Chinese characters for the plant in China.
A single solution and interface for one way of working across all sites.
Elekta conducted a thorough evaluation of several MES providers to the medical device market to meet these requirements.
Mark Kaak, Elekta’s vice president of global manufacturing, says, “We reviewed several MES suppliers. We selected Critical Manufacturing, [an MES provider based in Portugal], because they have excellent reporting. The company is flexible and willing to partner to ensure we get the solution we need over the long term. It also scored highest overall in our evaluations.”
Other requirements Elekta specified for the MES included:
User-friendly, configurable graphical user interface (GUI).
Ability to interface with other business systems, including enterprise resources management (ERP), product life cycle management (PLM), and customer life cycle management (CLM).
Data flow to Elekta data warehouse.
Easy updates to system programming that could be performed by Elekta personnel for rapid changes.
MES Integration Rollout
Elekta rolled out the new MES across three sites: Veenendaal in the Netherlands, Crawley in the UK, and Elekta Beijing Medical Systems in China. As part of the project requirements, the implementation needed to be agile for phased introductions. The modularity and scalability of the MES allowed Elekta to deploy a single instance at the three sites over time at a rate to suit the company’s business goals. The total elapsed time from specifications to the third site’s go-live date was one year.
“We started with Veenendaal because it has a complex, job-shop-style production layout with 1500 different products moving across 50 stations. The project went exceptionally well. Critical Manufacturing met all of the project sprints on time. We implemented the first plant in eight months, the second in nine months, and the third plant in China in 12 months. In fact, it was hard for us to keep up with testing all the deliverables,” says Kaak (see Figure 2).
Engineers spent over a year configuring the system for each product, including entering all the work instructions into the MES. However, maintaining those configurations in the MES requires less than two people who also have other responsibilities, so those employees reported a noticeable decrease in frustration and improved user experience with the new system.
Richard Eweg, manufacturing engineer and MES champion at Elekta, reports: “Getting new products into the system is quite positive. It went from 20 hours over a few months to five hours in one day. You can build up the work instructions and flow structure, prepare it completely, and do a dry run to test it. When it looks right, and we’re ready to switch from an old to a new one, everything is ready. Once it’s live, we can easily see which steps are in the flow and the work instructions for that step for that item.”
Engineers are one of the five groups of users for the MES, which also includes managers, operators, planners, and quality personnel. Managers and quality personnel are particularly pleased with the new level of information, control, and visibility into the factory. Operators faced a few challenges at first that the engineers corrected. Now, operators also see benefits of the system.
A Single Truth
Elekta saw benefit from the new MES in having a single system collating and contextualizing data from all manufacturing areas. Prior to using the MES, the company had a dashboard to see operations; however, that view was not based on real-time information, and operators could not “dig deeper” into any collected data.
By installing the new MES, Elekta gained enhanced visualization and control of products, processes, specifications, and attributes. In a single window with real-time, up-to-date data, operators and engineers can click to go deeper and gain new insights. Advanced analytical capability translates masses of real-time shop floor data into accurate intelligence to enable them to optimize and make strategic decisions in manufacturing, quality, and for the wider business. For example, Elekta can now confidently price products to ensure profitability without making products too expensive.
Eweg reports, “Before, we made a guess and measured with a stopwatch to see how much time a step takes. Now MES keeps track of everything, and it is easy to report out the detail of how much time it takes for each step and production order.”
The MES also provides a flexible, configurable dashboard to report on key performance indicators (KPIs). For Elekta, real-time KPIs include:
Number of units to produce.
Actual value-added time versus planned cycle time.
Standard hours per the ERP versus actual labor hours.
Production capacity in working employees and available employees.
On-time, in full (OTIF) completion of orders — MES cannot close incomplete orders.
Cost of quality.
Wait time between steps.
Kaak says, “The Critical Manufacturing MES offers user-friendly interfaces with graphical overviews of processes per item with cycle times and standard hours. The system provides comprehensive process control and early issue alerts, so we can respond before quality issues arise. Flexible reporting and full eDHR make it easy to see what is happening and report on areas we are most interested in as a business. The solution is scalable and gives us the platform we need to stay at the forefront of medtech manufacturing into the future.”
The MES acts as a digital twin of the production supply chain, according to Elekta. Data from real-world, physical entities such as equipment, workers, and workstations flows into the virtual copy, providing a correct understanding of their state (see Figure 3). The current statuses of the plant and specific work centers are visible and color-coded in the Critical Manufacturing FabLive module.
The MES addressed many of Elekta’s needs (see Figure 4). The system’s configurable GUIs provide operators with clear work instructions and a view of only what matters to them, including future tasks and performance data.
Data for Traceability Without Paper
Before implementing the MES, Elekta’s manufacturing execution used “bills of process” and paper work instructions. Employees manually checked and signed paper-based DHRs. Implementing the MES transformed the company’s operations into a completely self-auditing electronic system.
Quality is now built into the manufacturing process, and the system automatically enforces the procedures. The MES streamlines compliance with FDA’s Title 21 CFR Part 11 for Electronic Records and Electronic Signatures. It also includes a quality module, which shows trends and results graphically (see Figure 5).
The MES imports picked lot or serial numbers automatically from the ERP, so the operator only has to confirm a match to materials assembled. As the MES collects data from throughout the shop floor, it provides context as well, creating complete traceability with all information, measurements, and meta data attached to the eDHR.
The MES also enables Elekta to ensure that its personnel always have correct work instructions, calibrated tools, and appropriate and up-to-date training. All of these system features improve quality, compliance, and productivity.
Eweg states, “Before, if we wanted to change the laser engraving procedure, for instance, we needed to change about 50 instructions. With the MES, it’s only one.”
Instead of inspecting or checking process and product data after a manufacturing step, the system facilitates these functions at the time of processing. As measurements are collected, the MES enables instant adjustment of processes or flags issues to prevent errors. Elekta can also remove any non-value-adding steps and waste to increase overall operating efficiency by analyzing process data.
Eweg says, “I really like how information from MES generates [unique device identifier] labels, thus effectively ruling out any human errors.”
Planned System Enhancements
Automating labels. Elekta is working to integrate the MES with their ERP to automate the entire labeling process for MDR. This workflow will better accommodate the varied regulatory requirements that these cancer-fighting products have in countries around the globe. It will also support custom orders.
Scheduling. The latest upgrade Elekta did for the MES in the fall of 2020 includes enhancements to scheduling. With some new planners on board, using this module fully may happen later in the cycle, yet it is a goal to ensure efficiency by using the best resources for each manufacturing order. Resource scheduling has historically been a pain point, and the scheduling module was a significant capability Elekta wanted in selecting the MES.
Benefits and Payback
Quality. Per the original vision, Elekta has significantly reduced the cost of poor quality. Using the MES interface to collect specific measurements provides the fuel for statistical process control (SPC). This MES also includes a quality module including SPC and other quality control capabilities (see Figure 4). Quality is up and costs in terms of wasted time and other resources are down.
Optimization. The MES displays steps and enforces that the operator follows them. In rolling out the MES, engineers realized that the processes they believed to be best practices were not always. The MES forced a new level of process understanding that allows them to optimize procedures.
Engineering efficiency. Fortunately, correcting a work instruction now takes only an hour when it might have taken three months in the past. The work instruction process needs 50 percent less labor and is no longer dependent on other departments. Now, everyone can work true to best practices as a standard approach.
Administrative efficiency. The company has nearly doubled revenue over the five years. Manufacturing orders (MOs) are up almost 35 percent over four years in one of the plants with MES (see Figure 6). Yet, the company has about the same number of employees. Eweg estimates they no longer need four FTEs just for administrative action work.
Audit efficiency. Using electronic records and signatures makes audits much easier and more cost-effective. Eweg reports, “For audits, it’s a really big benefit. Quality assurance is very happy to get an eDHR from five years ago in 20 seconds. Before, we had a process in place. But the main fears during an audit were finding the DHR and checking that it’s OK.”
Agility. Elekta can now make products to order, optimize inventory, and readily share best practice business processes. Real-time information helps minimize rework and exceptions and optimize manufacturing steps to reduce lead times.
Insight to Improve
The new MES, rolled out across three global Elekta production facilities, gives Elekta enhanced visibility, deeper understanding of manufacturing processes, and the tools it needs to enhance quality. Elekta builds some assemblies in both the UK and China. The MES enables easy knowledge transfers as work instructions and flows can be cloned and then only translated.
Collating and contextualizing masses of shop floor and broader business data to form valuable business intelligence, Elekta is reaping the benefits of increased production efficiency, reduced costs, and ensuring easier, ongoing compliance with future regulations.
Costs. The system has dramatically reduced the overhead associated with manual actions needed for regulatory compliance. With eDHR and easily searchable data, Elekta can prepare for and go through audits with far less time and effort. The company also enjoyed archiving cost savings from the first day. Elekta estimates archiving cost savings from printing, internal, and external storage to be $85,000 after four years and over $850,000 over 20 years.
Kaak says, “This is the start of a new future for Elekta. The payback on the MES is already coming from cost savings, increased efficiency, and easier compliance. We also benefit from freeing up resources to enable our business to innovate more and greater agility to respond to our customers’ demands.”
Coherent device data. Creating the DHR is not that different in terms of time and effort. However, in the previous approach using folders, not everything from a manufacturing order was in the same folder. So, the team had to find them in an external warehouse Besides, it’s far easier to check a label now that it’s attached to the eDHR than when it was separate.
Unexpected benefits. Elekta expected to reduce production lead times with the MES, but according to Eweg, “That’s not where we found the real benefits. Those are shaping up to be projects that are not directly for MES but use data from MES. The big benefits and cost savings are in improving the quality of our processes.”
MDRs and Labeling
Medical device records (MDRs) requirements have become dramatically more complex since the implementation. Country-specific labeling and translations for equipment manuals, once needed only for China, are now required for shipping to an ever-growing number of countries (see Figure 7). Checking the volume of specialized labels for lot and serial numbers could have led to improperly labeled items in the field. Each month, Elekta’s process triggers 2,000 label print jobs, most of them automatically, and the number is growing.
As that was not a requirement pre-implementation, the benefits are difficult to measure. Eweg says, “We could never have done it without MES. We connected the label solution to the MES so we can no longer make mistakes.”
Another unexpected event was the COVID-19 pandemic. With MES in place, the engineering and operations teams have been able to collaborate seamlessly, even when working from home. This ease of working has also supported Elekta through a surge in demand for new smaller applicator products.
MES has already supported Elekta’s healthy growth. By radiating the MES data throughout the business, Elekta is gaining benefits not only in the three plants using it but across disciplines and the enterprise.
This article was provided by Critical Manufacturing, Austin, TX, an MES provider headquartered in Portugal. For more information, visit here .