Manufacturing technology
“The practical challenge is therefore not simply to connect everything,” he says. “It is to establish a secure, scalable architecture that can collect and contextualise information from a mixed-vendor environment while protecting existing investments.”
Starting without ripping anything out For manufacturers with decades of investment in existing systems, the scale of the challenge can be daunting. Both Zoelfl and Clerc argue the answer is not wholesale replacement, but a phased approach built around defined outcomes. The industry’s own self-assessment supports that caution. In a 2023 survey of 100 executives at large medtech companies across the US, Europe and Asia, the Deloitte Center for Health Solutions found that just 20% of respondents considered their organisations “early adopters” of technology, while 26% described themselves as “laggards”. Within manufacturing and supply chain specifically, building smart factories was by far the leading digital priority, selected by 89% of respondents.
Zoelfl suggests quality as a natural entry point: processes such as CAPA (corrective and preventive action), non-conformances and audits expose fragmented information particularly clearly, since an audit can become an exercise in simply locating evidence. A connected environment establishes relationships between requirements, designs, manufacturing activities and quality records, making evidence easier to find and understand in context. Other organisations begin with engineering, where modern devices increasingly combine mechanical, electrical and software elements, creating dependencies that are hard to manage across fragmented systems. Clerc frames the starting point operationally: focus on high-value business decisions like speeding up deviation investigations, refining electronic device history records or tracking downtime, rather than rushing to replace equipment.
“Beginning with a defined outcome helps determine which data is required and where connectivity will deliver the greatest value,” he says. Existing automation can often be retained and connected through industrial networking, gateways and standards-based interfaces such as OPC UA (open platform communications unified architecture), which can bridge equipment from different suppliers and generations “without forcing every underlying system onto the same platform”. A manufacturer might start in one constrained production area, demonstrate value, then extend that architecture across additional lines, turning modernisation into an incremental programme rather than a rip-and-replace project.
This connects to a broader industry shift: designing quality into products rather than demonstrating it at the end of development. Zoelfl describes this as a move towards “quality left” – introducing quality and
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regulatory considerations earlier, so manufacturers can catch problems before they become expensive to fix. A reduced time to market is one of the major benefits of a mature digital thread – and for medical devices, faster development can mean patients gain access to new technologies sooner.
What a mature digital thread delivers Clerc describes a successful digital thread as “a continuous, contextualised flow of trusted information across the product and production life cycle” – extending from design through manufacturing, quality, regulatory and post-market processes. As a result, production and quality teams work from the same current data rather than a single centralised repository. The reported gains are concrete. In Rockwell Automation’s published case material, one manufacturer that had relied on paper-based data collection achieved a 20% increase in productivity after implementing real- time production visibility and electronic device history records. A second reported the same 20% productivity gain after using connected software to support automated FDA reporting, alongside improved equipment efficiency and less waste.
A third consolidated three data silos into a unified MES (manufacturing execution system), QMS (quality management system) and ERP (enterprise resource planning) environment, creating a single source of truth across engineering, manufacturing and quality; a fourth reported a further 20% gain after moving away from paper-based processes, supported by automated alerts. “The value of connectivity is not confined to a single system or metric,” Clerc says. For regulated manufacturers, operational efficiency is only part of it: demonstrating data lineage and consistent execution improves audit readiness. “The strongest digital thread programmes connect operational improvement with quality and regulatory outcomes, rather than treating them as separate initiatives.”
Beyond the factory gate
The digital thread also extends beyond a manufacturer’s own operations. Medical device supply chains can be difficult to change because suppliers and components may be subject to validation and certification requirements – a manufacturer cannot replace a problematic supplier as quickly as in other industries. A connected environment gives earlier insight into that risk: if a component becomes unavailable, a manufacturer can identify which products and designs depend on it and whether alternatives exist. Clerc extends this into the wider ecosystem of suppliers and contract manufacturers: the priority, he says, is usually to establish consistent data and governance internally first – “without common definitions, product identifiers, contextual models, access controls and accountability for information, expanding connectivity to external organisations can simply reproduce internal silos on a larger scale.”
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