Diagnostic and imaging

MES for Business Continuity in the Medical Device Industry

We talked in March 2020 about getting your MES selection going. The Pandemic was in the early stages of development, and industries were unsure of the extent and overall effect to business disruption. The post recommended a logical, systematic method of initiating and executing a MES selection process.

A later post in April 2020 discussed on how to use Partners for business continuity; again, assuming that disruption was a temporary, but an important issue to address. Partners can extend your reach; provide needed expertise and guidance, as well as oversight, project management and project execution.

Well here we are, after a year of pandemic. How have you fared? There are numerous studies, most recently McKinsey’s, that states the acceleration and adoption of digital technologies has been speeded by ‘several years’ as a result of the pandemic; that instead of stopping innovation, it’s facilitated, nudged, and brought digital transformation to the forefront as a means to not only sustain, but thrive in these trying times. Specifically for manufacturing, accelerators such as using advanced technologies in operations and automation, McKinsey found that 37% of organizations deployed solutions, and 50% believe that those changes will stick. So the changes are real and sustainable in at least half of the use cases.

Source: McKinsey

Digital transformation can represent a lot of different technologies, but normally includes AR (Augmented Reality); VR (Virtual Reality); Digital Thread/Digital Twin (simulated replicas of your plant or process); AI/ML (Artificial Intelligence & Machine Learning) and ‘edge’ technologies like IoT (Internet of Things). Collectively, they enrich the manufacturing environment to allow you to make better, faster and more informed decisions using the ‘real time’ or ‘live’ data that’s generated from your process. These technologies improve not only manufacturing itself, but the people and systems that are interconnected and depend on the results and outputs of the process. It’s a continuous improvement/quality initiative that’s become pervasive thanks to the technology advances and innovative applications of technology itself, as well as the increasing number of suppliers that’s made the technology commercially feasible.

What about MES?

Although a decades-old solution for manufacturing oversight and productivity, Manufacturing Execution System equally plays a distinctive and primary role in digital transformation. A ‘modern MES’ entails the very technologies that digital transformation/Industry 4.0 brings to industry, packaged up in a form that makes it simple to buy, deploy and use. It covers the entire value chain within a product’s lifecycle, from raw materials through finished goods through logistics, to ensure organizational responsiveness to market changes occur in a formalized, documented, regimented manner, utilizing the newest technologies, systems and infrastructure.

As the medical device industry grows despite the pandemic (current research shows a 7% market growth) the need for an MES for process oversight and guidance becomes an even stronger argument. Given that US President Biden just re-invoked the Defense Production Act, the need to address medical devices in short supply is now a national priority in the US, one of the largest markets in the world with 40% of the global medical device market in 2017. MES will again play a leading role in implementing the business continuity needed for organizations to quickly respond to demand and scale operations.

MES solutions have played a foundational role for over 20 years in managing quality, production and workforce productivity for medical device manufacturers. Ultradent Products’ use case is an example of using an MES cross-enterprise within a complex network of products, manufacturing styles and an extended supply chain. There are strict compliance requirements with paper-based capture of process data. Essentially, the MES is crucial to upholding the success of the manufacturing process and the value chain of Ultradent.

Another medical device company, Elekta Limited, uses Critical Manufacturing MES as a key component of their global manufacturing center of excellence for medical devices. This entails strict enforcement of manufacturing Quality Standards along with competitive, qualitative and cost effective processes for production. The implementation of Critical Manufacturing MES is helping to both enhance quality and ensure that products are manufactured at the ‘right cost’ for customers, increasing integration between processes and providing complete real-time visibility and intelligence across multiple manufacturing lines. 

MES as a foundation for Business Continuity

Relying on an MES as the foundation of a good manufacturing process ensures business continuity, as the key infrastructure is set for process and product control to meet customer demand and instill a culture of customer responsiveness. All of the underlying processes that are deemed to contribute to the correct performance of the organization are captured, documented, and ‘institutionalized’ within the application.

For medical device companies, we wrote about four main care-abouts that MES contributes to, or is the foundation for:

  1. Accelerating New Product Introduction
  2. Assuring Quality
  3. Establishing Traceability and Regulatory Reporting
  4. Boosting Efficiency and Profitability

Collectively, this underscores the need for production oversight and control; stringent quality management; compliance to regulations; and maintaining a profitable bottom line.

MES is at the core of productivity for maintaining business continuity. The boost to manufacturing practices from digital transformation initiatives are widespread, but generally include digitizing paper-based processes; achieving flexible, responsive operations to answer changing market conditions or customer requests; and adopting automation in key and definable ways to increase productivity and quality through standardized practices and repeatable production.

Automation is one area where the increase has been dramatic. Boosted by the pandemic, manufacturers are accelerating their automation investments. The World Economic Forum reported in October 2020 that 43% of businesses surveyed are set to reduce their workforce due to technology integration while 34% plan to expand their workforce for the same reason. By 2025, the time spent on current tasks at work by humans and machines will be equal. Although ‘automation’ in normal context refers to robotics, it can also include process equipment, machine vision, and other functions normally performed by people. MES can provide the necessary infrastructure to keep these digitized investments in line with current manufacturing practices, reinforcing GMP and providing guidance and education to the workforce, who may be employed in new areas, processes or tasks.

Overall, the role MES plays in business continuity is increasing, rather than decreasing, in importance. It provides the foundation for technology integration into an enterprise; generates reports, analytics and insight into productivity and performance; and is a platform for adding workforce enhancements associated with Industry 4.0, such as AR/VR, Digital Twin and Business Intelligence.

For medical device manufacturers, this business continuity extends into reinforcing and enforcing GMP; traceability/genealogy; workforce instructions and oversight; quality management and supporting validation. It’s the one overarching solution that not only builds the information infrastructure of a regulated manufacturing process, but provides a means to extend, enrich and collaborate with multiple sites, partners and customers.

Rebekah Cauthen
rcauthen@criticalmanufacturing.com

Sales Manager DACH at Critical Manufacturing

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