Manufacturing technology
The digital thread E
Rising recalls and the AI boom are forcing medical device manufacturers to finally connect their fragmented data. Catherine Longworth reports on why the digital thread matters now.
nd-to-end traceability is the goal for medical device leaders, yet true product visibility remains frustratingly elusive. Data isn’t missing – it is trapped across fragmented engineering, quality, regulatory and supplier systems. The result is a paradox: manufacturers have more data than ever but still can’t see the full story.
The stakes are rising. A recent US Government Accountability Office (GAO) review found that the US Food and Drug Administration (FDA) oversaw the recall of nearly 4,000 medical devices between 2020 and 2024, out of roughly 200,000 devices it monitors – and FDA officials have separately reported that Class I recalls, the most serious category, rose 232% over the same period. With insufficient staffing and organisational turmoil, the same GAO report found that the FDA is failing to meet its three-month goal for closing out recalls. As regulatory oversight falters, the burden of fast, accurate root-cause analysis falls squarely on manufacturers – a gap the digital thread is designed to fill.
Islands of automation
According to René Zoelfl, industry principal for medtech at PTC, one fundamental problem is how organisations think about information. “Organisations still tend to work with a document-centric mindset,” he says. Even when documents are digital, the underlying
information isn’t necessarily structured in a way that lets it connect to other data. Joel Clerc, a life sciences leader at Rockwell Automation, sees a parallel problem on the manufacturing floor. A medical device facility may run equipment from different manufacturers and generations of control technology, using different data models or protocols.
“These assets may perform their individual functions
reliably, but they were not necessarily designed to exchange information with one another or with modern quality and enterprise systems,” he says. The result is a facility full of ‘islands of automation’ – useful information held separately within production equipment, maintenance applications, quality systems and spreadsheets.
Both problems compound at the seams between functions – whether a design choice affects manufacturing, a supplier shift impacts quality, or a non-conformance points to a missing requirement. Without strong digital connections, teams must bridge these gaps manually, creating costly friction and error risk.
Clerc points out that modifying validated processes demands careful management. Upgrading legacy gear just for connectivity brings steep costs, downtime and revalidation needs – and bringing isolated systems online opens new cyber vulnerabilities unless access control and governance are established up front.
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