Medical device manufacturing

The MedTech industry is approximately half a trillion U.S. dollars in terms of global market size, per Statista. The largest businesses within the segment are IVD (In Vitro Diagnostics), cardiology, diagnostic imaging, and orthopedics, with IVD alone standing at $53 billion and projected to cross $80 billion by 2024.

The industry is projected to grow at a rapid pace, but with rapid growth comes great challenges. An industry that is so dynamic must establish efficiencies to deal with supply chain, customer, and manufacturing demands, including:

  • Changing customer preferences
  • Embracing rapidly evolving product/process/information technology
  • Maintaining and improving product quality
  • Managing reduced product lifecycles
  • Transforming culture to a future-proof one
  • Operating efficiently to reduce costs and improve profitability
  • Navigating the evolving regulatory compliance landscape

The COVID pandemic further increased the pressure on global MedTech manufacturers when demands for diagnostics and personal protective equipment products increased exponentially, while products associated with elective procedures plummeted. Supply chains were completely disrupted as contract manufacturers and third-party logistics partners grappled with lockdowns, workforce restrictions, and shortened component supplies. 

MedTech companies felt the impact of that ricochet—and many manufacturers responded with a renewed interest in digitization, Industry 4.0, and IIoT as a means to overcome the dynamics. 63% of leaders say COVID-19 made their organizations embrace digital transformation sooner than they had expected and were making greater investments in technology as a result.

From a medical device manufacturer’s perspective, what does the technology entail? Digital transformation for manufacturers in MedTech is synonymous with MES. It is the IT application that forms the very basis of Industry 4.0. Applied correctly, MES can transform a given supply chain rapidly to the desired level of digitization.

So what is the right MES for MedTech digital transformation? Looking at the structure of manufacturing in MedTech—normally multi-site, multi-plant with complex supply chains, it is not a simple answer. How does one implement an MES across multiple manufacturing plants, separated not just geographically but perhaps by operational style, IT infrastructure, work culture, and process technology?

An MES data platform

The answer for multi-site MedTech companies is using a modular IoT-enabled MES Data Platform. Modularity allows companies to implement specific functionality critical to address their digital transformation plans. It also allows them to iteratively add capabilities as they grow and mature from a utilization perspective.

For multi-site, a standard application blueprint can be adapted to each location’s specific implementation and functional capability requirements. This allows them to achieve the fastest possible deployment while conserving global best practices and local knowledge.

A modular MES with an underlying IoT Data Platform

The modular MES is a collection of ready-to-deploy, industry-specific modules, with core manufacturing execution functions at the base. Additional modules allow the creation of an all-inclusive platform, providing complete enterprise-level and supply chain-wide integration and automation, quality management, business intelligence, visibility, and operational efficiency improvement. Each module is configurable, without affecting the overall functioning of the core application. This is possible through agile and modern application development and deployment techniques using cloud computing and containerization.

The IoT Data Platform combines IoT, equipment integration, data processing, and analytics with contextual intelligence from the core MES to help manufacturers generate transformative insights to improve performance, efficiency, and innovation.

A modular MES, combined with an IoT data platform, facilitates a faster and more efficient deployment, as it combines standardization with flexibility, core manufacturing execution functionality, followed by customizations at a local level. It ensures MES rollouts with minimal disruption.

Multi-site approach

There are many possible approaches for a multi-site MES. It typically is a function of the organizational strategy, the homogeneity of the businesses, and the inherent complexity of deployment. The graphic below represents the various deployment approaches, ranging from highly standardized to highly customized. The majority of multi-site deployments have a common element: they retain, to a large extent, best practices for the businesses. These are captured in the MES and scaled over lines, sites, and locations. 

The graphic represents the various deployment approaches, ranging from highly standardized to highly customized.
Different approaches can be selected depending on desired process similarity, standardization and IT landscape.

The ideal approach for a multi-site deployment would be to identify a so-called ‘sweet spot,’ where the basic standardization requirements are met while preserving local knowledge and best practices through the right amount of site-specific customization. This happens when a universally acceptable baseline for performance is set across all manufacturing facilities. An initial baseline could be a combination of the core manufacturing modules, coupled with functionality deliverables which are deemed essential across all manufacturing plants. The baseline MES may vary from organization to organization and will most certainly be a derivative of market conditions, supply chain structure, operations, and information technology architecture, culture, and strategic goals.

Once a baseline is established, it can be deployed across plants by replicating the baseline application deployed in the first/core/flagship operation. A parallel deployment enables the most efficient scaling across manufacturing locations. They start leveraging the benefits a modern data platform has to offer in terms of scheduling, routing, recipe/lot management, tracking, efficiency gains, management dashboards, regulatory compliance, and quality management.

After baseline application deployment comes tailoring for the site or location, where requirements based on individual plant needs can be deployed in an agile iterative manner. It allows each plant to have a standard, yet targeted application. In complex organizations, such deployments are ideal and may drastically reduce the time and cost involved.

For example, let’s consider a global conglomerate In-Vitro Diagnostics manufacturer, with plants all across the world. The plants are a mix of organic legacy and those gained through acquisition. In such a value chain, the complexity of an MES deployment may be extremely high, as different plants may be at differing levels of operational maturity. There may be very little standardization in practices, and they may have completely different IT/OT systems in place. Manufacturing styles may differ, with some plants manufacturing all components in-house and some manufacturing only the core product, while outsourcing electronic components to contract manufacturers.

In such complex value chains, it is imperative to bring all manufacturing plants to a similar level of capability before a more intense digital transformation can begin. By establishing baseline MES functionality, all plants can be brought on par from a core manufacturing execution perspective. Depending on the IT/OT infrastructure and other local factors, such as level of automation, compliance, and specific workforce needs, configurations can be made to meet relevant business cases aligned with the overall strategy of the organization.

In such a scenario, the diagnostics company may be able to ensure that all plants are fully compliant with standard manufacturing practices, all personnel adhere to validated work instructions, and data is recorded automatically per regulatory requirements. The multi-site strategy allows individual plants to leverage the modern MES functionalities and IoT data platform, depending on their own technology curve and readiness.

Ultradent use case

A plant in the US already at a higher technological and IT curve is Ultradent, a manufacturer of medical products. They have vertically integrated supply chains starting with raw material production and faced the same issues as all MedTech companies: a mix of proprietary and custom solutions; the requirement for process validation, and a drive of standardization to scale the MES. They chose an MES that maintains models with similar manufacturing flows and data collection characteristics to maintain the standardization of a single MES instance. A roadmap was developed for future needs and to incorporate new use cases. 

The key takeaway is the Ultradent use case is applicable for most MedTech manufacturers. Whether you have multiple sites/locations/plants or a single plant with a widely diverse product mix, and regardless of your information technology maturity, if your vision is to pursue digital transformation and Industry 4.0 for your operations, a modern, modular, IoT-enabled MES can ensure the right balance of standardization and customization all of your the sites.