Lab Manager Digital Pathology Insight Series

What to Ask at a Digital Pathology Demo: A Lab Manager’s Evaluation Guide

A vendor demo is only useful if you arrive knowing what to measure. Without a pre-specified scorecard, the most compelling demo wins, and the most compelling demo is not necessarily from the best scanner for your laboratory. This buyer’s guide gives you the scorecard.

Most lab managers book a digital pathology demo to see the technology in action. That is the right instinct, but it is only half the purpose a demo should serve. The other half, the part that separates a structured evaluation from a purchasing experience shaped by the vendor’s presentation skills, is the set of questions you bring with you.

A vendor demo is a controlled environment. The scanner runs on optimal slides, chosen by the vendor. The demonstration workflow shows the platform at its best. That is not deceptive. It is a reasonable way for a vendor to present their product. But it means that if you do not ask the questions that reveal how the platform performs outside those optimal conditions, in your environment, at your volume, with your tissue types and your staffing levels, you will leave the demo with an impression rather than an evaluation.

This digital pathology buyer’s guide is structured around seven sections of evaluation questions, organized from the operational criteria that determine daily laboratory performance to the clinical and regulatory evidence criteria that determine whether a platform can be deployed for primary diagnosis. Each section includes a prespecified scorecard item and the diagnostic question that reveals whether a platform meets it. Bring this guide to every demo. The vendors who answer it well are the vendors worth evaluating further.

Before You Walk In: The Pre-Demo Checklist

A structured demo evaluation begins before you arrive. Three preparation steps ensure that the session produces evidence rather than impressions:

irst: bring your own slides. Specifically, bring slides from the diagnostic categories your laboratory finds most challenging, such as fine nuclear morphology cases, borderline dysplasia, high mitotic count assessments, tissue types with thin sections or significant background staining. These are the categories where image quality differences between platforms become visible in practice. A vendor will scan their own slides expertly. What you need to know is how the scanner performs on yours.

Second: bring your volume profile. Your current daily average, your documented peak day, your annual slide count, your projection for years 3 and 5 assuming 5–10% annual volume growth (Munari et al., 2024). You need the vendor to respond to your actual demand, not a generic case study.

Third: bring this guide. Not to read from it, but to use the questions as a structured scorecard. Record the vendor’s answer to each question immediately. You will be evaluating multiple platforms, and the differences between vendor answers become clear only when they are recorded consistently.

This section determines whether the scanner can physically handle your volume profile in a live clinical environment, not just in theory.

Section
1
Throughput and Loading Architecture
□
Ask for a live demonstration of the loading workflow at your target daily volume, not a curated demo case
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Ask: what is the loading architecture — batch loading (fixed rack sizes) or continuous loading from the coverslipper?
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Ask: how many loading transitions are required per shift at my volume profile, and what is the staff attendance requirement at each?
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Ask: what is the documented effective throughput in a live clinical deployment at a comparable institution, rather than rated throughput under optimal conditions?
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Ask: what happens when an urgent case arrives mid-batch or mid-scan run? Walk me through the exact workflow

The loading architecture question is the most important in this section and the one most vendors will not volunteer. Published operational data shows that scanner throughput in routine clinical practice consistently falls below rated specifications, with loading overhead as a primary cause (Schwen et al., 2023). A scanner that requires staff-attended batch transitions three times per shift at your volume profile is consuming staff time and scanner capacity that a continuous-loading architecture eliminates.

Ask: Show me an urgent case being prioritized mid-run at your documented peak volume. What happens to the current batch?
What a strong answer looks like:
Continuous loading with priority queue insertion: the urgent slide enters the queue and advances without interrupting the run.

This section determines how much of your scan team’s time will be consumed by quality exception management.

Section
2
Automated QC and Rescan Architecture 
□
Ask: what is the scanner’s automated QC tier? Does it detect quality issues and alert staff (Tier 1/2), or does it detect and act autonomously without staff intervention (Tier 3)?
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Ask for a live demonstration of the QC rescan function: load a suboptimal slide and show what happens without staff intervention
□
Ask: what is the documented rescan rate in a live clinical deployment at a comparable institution? Not under optimal demo conditions
□
Ask: when a suboptimal slide is identified, does it stop the scanning run for other slides, or is it isolated while the run continues?
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Ask: what QC monitoring data is available remotely, and can it be accessed without being physically at the scanner workstation?

Published benchmarks identify 1 FTE per 3–4 WSI scanners as the staffing requirement for image QC in a well-automated digital pathology operation (Schwen et al., 2023; Ardon et al., 2023). The fraction of that FTE consumed by rescan management depends on automation tier. At 5% rescan rate across 500 slides per day, a Tier 1 or Tier 2 system generates approximately 25 manual interventions per day, or 6,250 per year. Tier 3 autonomous QC eliminates focus-failure interventions entirely.

Ask: Show me the automated focal map rescan triggering without any staff action. What exactly happens from quality failure detection to rescan completion?
What a strong answer looks like:
The scanner detects an out-of-focus area, automatically triggers an advanced focal map rescan, completes it and flags the result without requiring a staff member to identify the issue, retrieving the slide, or initiating the rescan. Vendors should be able to demonstrate their approach to automated quality management and provide supporting validation data
6,250
Manual QC interventions avoided per year (Example)
Example: At 5% rescan rate, 500 slides/day, 250 working days: a Tier 3 autonomous QC system eliminates 6,250 staff interventions per year compared to a Tier 1/2 system requiring manual identification and rescan initiation. At 5 minutes per intervention = 520 staff-hours/year ≈ 0.25 FTE. Over a multi-year asset life, this is a permanent and compounding staffing cost differential.

This section tests whether the vendor’s quality claims are supported by evidence from sources other than the vendor.

Section
3
Independent Quality Evidence
□
Ask: has this scanner been evaluated by the EMPAIA International Scanner Benchmark (ISB) program? What was the result?
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Ask: is this scanner FDA 510(k) cleared for primary clinical diagnosis in surgical pathology? What is the clearance number and when was it granted?
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Ask: what was the major discordance rate in the FDA clearance study? Where does that rank among the six cleared platforms?
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Ask: is there a published peer-reviewed paper comparing the clinical performance of this platform against other cleared platforms using the FDA clearance study data?
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Ask: what between-site reproducibility was demonstrated in the clearance study, and did it meet the FDA acceptance threshold?
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Ask: What specimen types are included within the FDA-cleared intended use, and which applications require additional validation or are outside the intended use?

Independent quality evidence is the criterion that distinguishes a platform backed by regulatory review and third-party benchmarking from one supported primarily by manufacturer claims. As of March 2025, six WSI platforms hold FDA 510(k) clearance for primary diagnosis. The first peer-reviewed comparative analysis of all six platforms (Kuhlman et al., 2025) shows a more than three-fold range in major discordance rates. The EMPAIA ISB 2025 provided independent multi-laboratory quality evaluation by a panel with no commercial affiliation. Both evidence sources are publicly available. Independent benchmark data can provide an additional point of comparison when available.

Ask: Walk me through your EMPAIA ISB 2025 results and your FDA clearance study major discordance rate.
Where does this platform rank among cleared systems on both?
What a strong answer looks like:
A strong answer names the specific EMPAIA ISB 2025 awards received at 20x and 40x, and cites the major discordance rate from the clearance study. For the Epredia E1000 Dx Digital Pathology Solution: EMPAIA triple award and a reported FDA study major discordance rate of 2.54% (Kuhlman et al., 2025; EMPAIA, 2025).

This section uses your own tissue to evaluate what the vendor cannot control.

Section
4
Image Quality on Your Sldes
□
Load your pre-selected challenging slides — fine nuclear morphology, borderline dysplasia, high mitotic count, thin sections
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View and assess: can you confidently assess mitotic figures? Nuclear chromatin detail? Subtle stromal infiltration?
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Ask the vendor to scan one of your own slides on-site and view it on a diagnostic-grade display
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Ask: what is the pixel resolution, and what display is part of the cleared end-to-end configuration?
□
Ask a pathologist colleague present in your demo to assess diagnostic confidence on your own slides without the vendor’s guidance

The CAP 2022 guideline requires that local validation studies use cases representative of the intended clinical application (Evans et al., 2022). This means your challenging cases, not curated easy cases, are the ones that will determine whether your local validation succeeds. A platform that performs well on vendor-selected tissue but struggles with your actual diagnostic workload will produce a difficult validation study and ongoing diagnostic confidence issues in clinical deployment.

This section determines whether the scanner integrates with your existing infrastructure or creates a parallel workflow.

Section
5
LIS Integration and Workflow Connectivity
□
Ask: which LIS systems has this scanner been integrated with in live clinical deployments? Is your LIS on that list?
□
Ask: is the system DICOM compliant? Which DICOM conformance statement applies to this configuration?
□
Ask: does automated case assembly from LIS work in the background, or does it require staff to manually assemble cases from the scanner interface?
□
Ask: request contact details for two reference sites using your same LIS, at comparable volume, rather than only reference sites selected by the vendor
□
Ask: what is the expected IT infrastructure requirement (network bandwidth, storage, server) for your volume profile? Ask for a written estimate.

IT integration is the hidden implementation risk in digital pathology deployments. Published operational data from high-volume implementations identifies LIS integration gaps and undersized network infrastructure as the most commonly reported post-go-live performance problems (Schwen et al., 2023). A demo conducted on a vendor’s own network and LIS does not test integration with your specific IT environment. Reference sites can provide valuable insight into real-world integration performance.

This section determines the operational resilience of the platform in a live clinical environment.

Section
6
Uptime, Service, and Redundancy
□
Ask: what is the documented uptime rate in live clinical deployments? Ask for contractual uptime SLA terms
□
Ask: what is the mean time to repair (MTTR) for critical component failures at your institution’s site location?
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Ask: what is the recommended redundancy configuration for a laboratory at your volume, and what happens to clinical operations during planned maintenance?
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Ask: is there a loaner scanner program for unexpected downtime, and what is the response time commitment?
□
Ask: can the scanner be monitored remotely for performance issues before they become service failures?

Published operational requirements for clinical digital pathology specify scanner uptime targets of 99.9% for a platform treating scanning as a critical clinical infrastructure function (Schwen et al., 2023). At 500 slides per day, even 0.1% unplanned downtime represents approximately 12 hours of scan capacity lost per year — a manageable figure if service response is fast and a serious operational problem if it is not. The service model and MTTR commitment are as important as the scanner specification for a high volume clinical deployment.

The vendor who can answer every question in this guide with specific, independently verifiable data is the vendor whose platform was built for the operational reality you are managing. Impressive demos are easy. Documented rescan rates, EMPAIA ISB results, and FDA clearance data are not.

Scoring Your Demo: The Evaluation Matrix

After completing a demo using this guide, score each vendor against the seven checklist sections on a simple three-point scale: strong (specific, independently verifiable answer with documented evidence), adequate (plausible answer without independent verification), or weak (unable to answer or deflected to ‘it depends’). A platform that scores strong on all seven sections has demonstrated that its performance claims are independently verifiable across every operational dimension that determines daily lab outcomes.

The sections are not equally weighted for every laboratory. For a high-volume lab primarily focused on throughput and staffing efficiency, Sections 1 and 2 carry the most operational weight. For a lab preparing for a CAP inspection cycle, Section 3 and the FDA clearance questions carry the most regulatory weight. Apply the guide to your institution’s specific priorities and score accordingly.

The filter that helps
A platform that can answer all seven sections with specific, documented evidence has demonstrated: FDA clearance for primary diagnosis (Section 3), documented effective throughput at clinical volume (Section 1), Tier 3 autonomous QC (Section 2), independent image quality recognition (Section 3), LIS integration at comparable institutions (Section 5), and contractual uptime commitment (Section 6).

Conclusion: The Demo Is a Test, Not a Presentation

A well-run demo evaluation using this guide produces a structured evidence base for platform comparison rather than a collection of vendor impressions. It produces specific, recorded answers to specific, operational questions and answers that can be verified against independent evidence, compared across platforms, and defended in a capital request to a finance committee or a platform selection decision to clinical colleagues.

The vendors who deliver the strongest answers to these questions are the vendors that can support their claims with documented evidence across clinical, operational, and technical criteria and not for the controlled environment of a product demonstration. That is the distinction this buyer’s guide is designed to surface. Book the demos. Bring this guide. The answers will tell you what the specification sheet cannot.

Key Takeaways: Running a Structured Demo Evaluation

1
Bring your own slides to every demo. Specifically select your most challenging diagnostic categories — fine nuclear morphology, borderline dysplasia, high mitotic count. These are the cases where image quality differences become visible, and they are the cases your local CAP validation study will need to include. (Evans et al., 2022)
2
Ask for a live demonstration of priority insertion mid-run. This single test separates continuous-loading from batchloading architectures. If an urgent case mid-batch requires either waiting hours or interrupting the run, the loading architecture is not designed for clinicalpriority management. If it advances in the queue without interrupting the run, it is.
3
Ask for a live demonstration of Tier 3 automated QC: show the focal map rescan triggering without any staff action. If the vendor cannot demonstrate autonomous rescan (detection plus corrective action) with no staff intervention then the system does not have Tier 3 automation. 
4
Ask for EMPAIA ISB 2025 results and FDA clearance study major discordance rate by name. A vendor who cannot cite these specific independent evidence sources either has not been evaluated by them or has results they prefer not to discuss. For the E1000 Dx: EMPAIA triple award, FDA K241717, 2.54% major discordance, the lowest of all six cleared platforms. (Kuhlman et al., 2025; EMPAIA, 2025)
5
Ask for reference site contacts at institutions using your specific LIS, at comparable volume. Not sites selected by the vendor, sites you can contact independently. LIS integration gaps are the most commonly reported post-go-live performance problem in published digitization experience. (Schwen et al., 2023)
6
Score each vendor on all seven sections using a three-point scale (strong / adequate / weak). A platform that scores strong across all seven has demonstrated that its claims are independently verifiable on every operational dimension. Apply heavier weighting to the sections most relevant to your institution’s specific priorities.

Learn More

E1000 Dx Product Page

Specs, throughput, and full solution overview.

View product

EMPAIA ISB 2025 Report

The independent benchmark behind Section 3 of this guide.

Read the report

ROI & Business Case Template

Published savings data for your capital request.

Get the template

Request a Demo

Apply this guide to the E1000 Dx in a live session.

Book a demo

References

  1. Schwen, L. O., Kiehl, T. R., Carvalho, R., Zerbe, N., & Homeyer, A. (2023). Digitization of pathology labs: A review of lessons learned. Laboratory Investigation, 103(11), 100244. Read more.
  2. Evans, A. J., Brown, R. W., Bui, M. M., Chlipala, E. A., Lacchetti, C., Milner, D. A., Pantanowitz, L., Parwani, A. V., Reid, K., Riben, M. W., Reuter, V. E., Stephens, L., Stewart, L., & Thomas, N. E. (2022). Validating whole slide imaging systems for diagnostic purposes in pathology: Guideline update from the College of American Pathologists. Archives of Pathology & Laboratory Medicine, 146(4), 440–450. Read more. 
  3. Kuhlman, B., & Bedi, R. (2025). Comparative analysis of FDA-cleared whole slide imaging systems for primary diagnosis. International Journal of Pathology and Clinical Research, 11(1), 165. Read more.
  4. EMPAIA (Ecosystem for Pathology Diagnostics with AI Assistance). (2025). 2025 International Scanner Benchmark: Award results. 37th European Congress of Pathology, Vienna. Read more.
  5. US Food and Drug Administration. (2025). 510(k) premarket notification K241717: Epredia E1000 Dx Digital Pathology Solution. FDA CDRH. Read more.
  6. Ardon, O., Klein, E., Manzo, A., Corsale, L., England, C., Mazzella, A., Geneslaw, L., Philip, J., Ntiamoah, P., Wright, J., Sirintrapun, S. J., Lin, O., Elenitoba-Johnson, K., Reuter, V. E., Hameed, M. R., & Hanna, M. G. (2023). Digital pathology operations at a tertiary cancer center: Infrastructure requirements and operational cost. Journal of Pathology Informatics, 14, 100318. Read more.
  7. McGenity, C., Clarke, E., Jennings, C., Matthews, G., Cartlidge, C., Freduah-Agyemang, H., Randell, R., Treanor, D., & Bankhead, P. (2024). AI in pathology: A systematic review of clinical performance across cancer types. Lancet Digital Health, 6(8), e545–e555. Read more.
  8. Munari, E., Zamboni, G., Cecchini, M. J., Zamo, A., Sommaggio, M., & Brunelli, M. (2024). Pathology in motion: Automation from specimen to report. Annals of Diagnostic Pathology. Read more.
  9. Hanna, M. G., Reuter, V. E., Samboy, J., England, C., Corsale, L., Fine, S. W., Klimstra, D. S., & Travis, W. D. (2020). Implementation of digital pathology offers clinical and operational increase in efficiency and cost savings. Archives of Pathology & Laboratory Medicine, 143(12), 1545–1555. Read more.

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