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How Medtech Manufacturers Can Achieve End-to-End Digitization in Manufacturing

Digitization in manufacturing icon concept

Most medical device and diagnostics manufacturers view digital transformation in manufacturing as necessary to tackle immediate challenges and ready themselves for long-term success. In a 2022 survey of medtech and other life sciences manufacturing executives, MasterControl found that 64% highly prioritized digitizing their manufacturing.1

Yet while manufacturing executives prioritize digitization in manufacturing departments, the same findings show that only 9% of surveyed organizations have a manufacturing execution system (MES) fully implemented at all facilities. In MasterControl’s findings, more than 90% of respondents either don’t have an MES or have gaps in their digitization:

  • 62% have an MES fully implemented at only one site.
  • 25% have an MES partially implemented at a site.
  • 4% purchased an MES but just started implementation.

Even those manufacturing organizations with an MES on some lines or at some sites reported having critical production processes that are disconnected and even paper based. The undigitized processes spread across manufacturing and impact all areas of the organization, resulting in siloed production systems, manual process inefficiencies, preventable human errors, excessive rework, delayed review/release, compliance issues, and poor traceability.

The findings indicate that for most production environments, the barriers of adopting a traditional MES – particularly high costs, complexity, and customization for predominantly high-volume lines – have kept many organizations from complete, end-to-end digitization of their manufacturing operations. The top three reasons companies reported for not moving forward with digital transformation in manufacturing are:

  • Price of a new digital manufacturing solution.
  • Disruption to current manufacturing processes/procedures.
  • Time to implement a new manufacturing solution.

What emerges from the digital priorities and concerns reported by medtech and other life sciences manufacturers is a demand for light, configurable MES solutions that enable complete digitization in manufacturing across all production lines – including high-variability, low-volume, or lot-size-one lines – lines that a traditional MES has difficulty serving.

The medtech manufacturers poised for long-term success are taking steps to reshape their operations through digital connectivity across their production processes, lines, and sites.

A Smarter, Faster Path to Digital Transformation in Manufacturing

In a new brief exploring medical device industry trends driving medtech organizations to modernize their operations through digital transformation in manufacturing, MasterControl lays out three practical ways to put into practice the unprecedented digitization of every aspect of manufacturing.

  1. Think Big, Start Small

  2. Instead of initiating a traditional MES that is so rigid, cumbersome, and expensive that it is cost-justified and rolled out only on select high-volume/margin lines, consider a light, nimble MES solution that is easy to install and scale as needed. A light MES like MasterControl’s cloud-based Manufacturing Excellence can be implemented fast – typically within six months. It allows manufacturing organizations to quickly, affordably scale up and out across multiple production lines and sites – ensuring that, in the pursuit of digital transformation in manufacturing, no production line is left behind.

  3. Prioritize Speed and Flexibility

  4. Not only can a cloud-based MES solution like Manufacturing Excellence be implemented fast, but its no-code configuration lets organizations configure quickly, while supporting existing processes and workflows, and enables rapid user adoption. A highly configurable no-code master eDHR builder and product family tool allow for the flexibility to quickly design, modify, approve, and templatize master eDHRs, as well as easily manage product variations, substitutions, and change control. It gives users the right tools to circumvent IT bottlenecks and speed up digital transformation in manufacturing.

  5. Connect End-to-End

  6. A modern MES provides the digitization in manufacturing needed to remove paper from production entirely, digitally connect every step of the manufacturing process rather than just a selection of steps, and easily create the entire, beginning-to-end electronic device history record (eDHR). Further, the modern MES solution extends beyond the factory floor, creating productive connections between enterprise systems, data sources, processes, and people throughout the organization, for a holistic view of data. Ultimately, it enables any-sized company to fully utilize their MES across all lines and sites, truly digitizing from end-to-end.

To learn more about how digital transformation in manufacturing and other medical device industry trends are changing the industry, plus ways to put the trends into practice, download “2023 Medical Device Manufacturing Trends.”



David Butcher has covered business and technology trends in life sciences and industrial manufacturing for more than 15 years. Currently a content marketing specialist at MasterControl, he previously served as editor of Thomas Publishing’s Industry Market Trends and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.

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