For years, the conversation about going digital in pathology centered on the wrong thing: image quality, scan speed, and how polished the viewer looked. Those things matter, but they were rarely the hard part. Most US labs still aren't fully there.
Labcorp's 2024 Pulse of the Lab Leader report put the share that had started or planned to adopt digital pathology at about a third. And among labs that have, a 2025 survey of US pathologists and lab directors found it is used mostly to share slides at tumor boards and archive cases, less for advanced analysis.
The hard part is everything around the image: the operational pathway it sits in. In my experience, the labs that go digital smoothly tend to treat it as a workflow decision more than just a viewer decision.
The operating model more than the viewer
A scanner and a good viewer put a picture on a screen. They don’t, on their own, tell you whether the solution will impact the lab or pathologists in a positive way. Digital pathology touches case accessioning and ingestion, grossing, staining, scanning and image management, AI tools, collaboration, reporting and traceability, and the storage and lifecycle of the data behind all of it. Those aren’t independent steps. They form one continuous pathway, and a weak point anywhere along it tends to limit the whole.
Integration with the lab information system (LIS) is often where this shows up first, along with the quieter questions of traceability, data handling, and how a change gets validated. In the 2025 survey, labs already working with these tools ranked interoperability between platforms near the top of their obstacles, ahead of anything to do with the images themselves.
The questions IVDR brings forward
Europe's experience here is useful well beyond its borders. IVDR has raised the bar, pushing the market away from narrow point solutions toward platforms that can support a clear intended use, stronger documentation, and disciplined quality systems.
The questions it brings forward aren’t limited to Europe; they are the ones any lab might reasonably ask: what is the intended use, what evidence supports performance, how does the software fit the clinical workflow, and what controls govern change?
There is no need to wait for a local regulatory trigger to start asking them. We recently took Fusion AP through IVDR, earning CE marking in Europe, and we are working through the FDA process in the US. Going through that first-hand, we have found that regulatory maturity tends to track platform maturity.
Why phased adoption works
A common misstep is assuming that going digital has to happen all at once. It doesn't, and trying to can introduce more friction than it removes. The labs that handle this well start by solving one defined workflow problem, see the efficiency gains, and expand from there. Those gains are real once the workflow is right.
A 2025 single-lab study comparing nearly 12,000 biopsies before and after the switch found mean turnaround time about a third shorter with digital, from 10.6 to 6.9 days.
Integration is a natural place to phase: a lab might begin with manual result entry, prove the workflow, and add LIS integration later to cut transcription and tighten traceability as volumes grow. Deeply integrated, AI-based workflow tools are what deliver the efficiency gains that justify the investment.
Key takeaways for clinical labs
A few things seem to hold up regardless of where a lab operates:
- Adoption tends to go more smoothly when a lab weighs the whole operating model, not just the viewer.
- The IVDR questions are worth asking in any jurisdiction: intended use, evidence, workflow fit, and change control.
- Starting with one defined problem and expanding from there tends to be more durable than betting everything on a single transition.
- Demand solutions that provide deeply integrated, AI-based workflow tools
When those pieces line up, digital pathology stops feeling like a technology project. The line between a capable tool and a workable platform is showing up less in the image and more in the operating model around it. When that part is right, the platform takes the operational weight, and the people doing the work keep their attention on the judgment only they can make.
