Pathology Systems
Regulated development and commercialization journeys where clinical, quality, and market access align.
This interactive experience is the shipped product itself — the same application code customers run in production, mounted read-only in your browser over a real sample journey. Not a video, not a mockup: because the demo and the product are one codebase, it can never drift from the real thing.
Inside this journey
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Clinical Outcome Discovery
Align on diagnostic goals, current pathology workflows, headcount constraints, and measurable success signals for digital pathology adoption.
Discovery Questions
Mapping Your Daily Diagnostic Flow
- On a typical weekday, walk me through how a case moves from grossing to sign-out in your lab.
- Which roles touch the glass slides and digital images at each step?
- Approximately how many glass slides and unique diagnostic cases does your department generate per typical day?
- How often does a case require off-site consult or subspecialty input today?
- Is there any campus, laboratory, or subspecialty where remote sign-out or primary-digital diagnosis is currently prohibited?
- When prohibitions apply, list the campuses, services, or policies that prevent remote sign-out and describe the reason (regulatory, clinical leadership, contractual, other).
Where Workflows Fray Under Pressure
- If slide volume increased 20% tomorrow, identify which part of your workflow would fail first and why.
- Walk me through the last time a scanner backlog or transport delay impacted patient care, who raised the issue, and what the consequence was.
- Choose up to three steps that most often create bottlenecks for turnaround time.
- Estimate the average time from slide completion to first pathologist review for routine surgical pathology cases.
- What downstream functions break when scanners fall behind on a high-volume day, for example tumor boards, frozen sections, or consult turnaround?
- Name the one bottleneck that, if removed, would shorten your overall turnaround enough to change clinical decisions.
The Real Cost of Staying Microscope-First
- If you keep a microscope-first model for three more years, identify the concrete costs you expect to accumulate in staffing, transport, or lost revenue.
- Provide a recent example where intra-system slide transport or access limitations caused a clinically significant delay or repeat testing.
- How many open pathologist FTEs do you currently have, and how long have those positions remained vacant on average?
- Point to the recurring expense that surprises executive leadership the most when you break down the pathology budget.
- Would your leadership approve capital or operating funds for a digital pathology investment that only returns parity after five years?
What's Getting in the Way of Digital Adoption
- Identify the regulatory, clinical validation, or policy barrier most likely to stop this project before pilot completion.
- Tell me about prior attempts to change diagnostic workflows here, how pathologists responded, and which actions helped or hindered adoption.
- Does your institution require a formal clinical validation protocol and written sign-off before enabling primary-diagnostic use of new imaging systems?
- List the top three technical concerns your IT or data governance teams raise about storing and serving whole slide images.
- Select up to two vendor capabilities that you believe would most reduce clinician resistance to digital sign-out.
- Confirm whether any institutional policy, accreditation, or legal constraint would prevent you from piloting AI-assisted diagnostic tools.
Who Else Is Trying to Solve This
- Who else are you actively evaluating for digital pathology options, including internal teams and outside vendors?
- Choose the approaches you are most likely to pursue, select any that apply.
- Describe the evidence or performance improvements that would have to exist for you to keep the current approach instead of moving to a new system.
- Has anyone on your leadership team formally proposed solving scanning or image management internally rather than partnering with an outside vendor?
- Could your team still prefer an internal solution even after an external pilot demonstrates equivalent diagnostic performance? Why or why not?
- If the pilot proves diagnostic parity, which contractual or organizational issue would most likely delay a purchase decision?
Can This Be Deployed Where You Need It
- Identify the single integration or infrastructure gap that would stop deployment before day one.
- List the laboratory information systems, middleware, and reporting systems that must exchange orders and results with the image management platform.
- Do APIs or HL7 interfaces already exist for those systems, and who in IT is the point owner for each?
- Estimate the number of IT FTEs you can allocate to integrations and validation work over the next 90 days.
- Where will slide scanning physically occur and do those rooms meet climate, power, and network requirements today?
- Are there documented data retention policies, storage tiering rules, or archival limits that will constrain whole slide image retention?
- Confirm whether named clinical leadership is prepared to own per-site validation, acceptance testing, and final sign-off before go-live.
Pilot Success and Acceptance
- Describe your fallback plan if the pilot cannot meet your image quality or diagnostic concordance thresholds.
- Select the objective acceptance criteria that matter most for pilot success, pick up to five.
- Who on your clinical and operational team must sign the pilot acceptance, and what evidence will satisfy each signer?
- Explain how you will measure AI tool performance during the pilot and which case types or subspecialties you will include.
- Provide the quantitative image quality thresholds, for example minimum resolution, color fidelity standards, or allowable artifact rates, that would cause you to stop the pilot.
- Assuming the pilot meets every stated acceptance criterion, can your procurement team commit to a purchase intent or PO within 30 days?
Decision Timing and Next Steps
- What single timing or budget issue could collapse your timeline and force an accelerated go/no-go decision?
- Provide the stakeholders, committees, and their review cadence that must approve this project before contract execution.
- Choose your target go-live window for primary-diagnostic use across the initial sites.
- Name the individual who controls budget approval and the person who will sign the final purchase order.
- Assuming budget approval this quarter, are you able to start a pilot within 4 weeks?
- Point out the one answer on this form that would cause you to stop the project immediately.
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Solution Walkthrough
Translate outcomes into realistic clinical workflows by walking through scanning, viewer, AI-integration, and remote consult scenarios with stakeholder priorities.
Solution Experience
- Solution Experience: Clinical Workflow Walkthrough
- Confirm the current state and its cost
- You confirm the demonstrated scanning workflow meets your required throughput and QC to prevent backlog and overtime.
- Run a site-specific scanner throughput simulation using the provided weekly slide volumes and deliver the results before the pilot planning meeting.
- You confirm the viewer workflow supports diagnostic parity for the subspecialties you prioritized.
- Prove the scanning throughput and quality workflow
- Produce a draft pilot validation plan that lists measurable acceptance criteria, test cases, timelines, and required clinical evidence.
- You confirm the AI triage scenario produces the expected reduction in manual review and is acceptable within your validation constraints.
- Provide per-site weekly slide volumes by case type, peak scanner-hours, and current consult turnaround metrics.
- Prove the diagnostic viewer workflow for primary sign-out
- You agree on specific pilot acceptance criteria, required evidence, and named owners for the pilot phase.
- Prove AI triage and integration in a realistic case flow
- Identify the named clinical owner(s) and the IT owner who will sign off on pilot acceptance per site.
- Confirm pilot site list and a target two-week window for pilot kickoff.
- Prove the remote consult handoff and collaboration flow
- Validation check, confirm this matches your needs
- Agree pilot acceptance gates and next evidence steps
- Solution Experience: Clinical Workflow Walkthrough
- Solution Experience Deck
- Solution Brief
- meeting
- slides
- document
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Solution Scope
Define scanners, storage architecture, viewer and integration modules, validation responsibilities, training, and phased adoption milestones.
Scope Configuration
- Install and Commission Whole Slide Scanners
- Calibrate Scanners and Establish QC Protocols
- Bulk Slide Digitization (Backlog Scanning)
- Deploy Enterprise Image Management Platform
- Integrate Image Platform with LIS/EMR
- Configure Diagnostic Viewer and Annotation Tools
- Enable Remote Consultation and Case Collaboration
- Integrate and Deploy AI-Assisted Analysis Tools
- Scanner and Workflow Validation for Primary Diagnosis
- Provision Enterprise Image Storage and Archive
- Configure Backup, Replication and Disaster Recovery
- Train Pathologists on Digital Diagnostic Workflows
- Train Laboratory Technicians on Scanning Operations
- Provide Equipment Financing and Incentive Qualification
Scope Questions
Install and Commission Whole Slide Scanners
- List the physical locations (building and room numbers) and available install windows for scanner delivery and on-site commissioning.
- How many scanners do you plan to install at each site?
- Provide target throughput per scanner expressed as slides per hour at 40x for routine H&E cases.
- Identify the slide and specimen types to be scanned routinely (H&E, immunohistochemistry, special stains, cytology, frozen sections).
- Specify required WSI output formats and any naming convention rules your archive or downstream tools expect.
- Who will be the on-site owner for commissioning activities and who provides building access and electrical/IT contact?
Calibrate Scanners and Establish QC Protocols
- Describe the calibration targets and reference tissue slides you will supply for optical and color calibration (e.g., color chart, tissue control).
- State the required frequency for optical calibration and white-balance checks for each scanner.
- List the quality-control (QC) metrics you require recorded per scanned batch (for example: focus score, resolution, color balance, z-plane completeness).
- Name the role responsible for QC triage and remediation when a slide fails automated QC.
- Are automated QC rejection workflows required to prevent failed WSIs from ingesting into the archive?
- Specify the required audit-log retention period for QC events and calibration records.
Bulk Slide Digitization (Backlog Scanning)
- Estimate backlog volume in number of glass slides and your preferred completion timeline for backlog digitization.
- Indicate the stain-mix composition of the backlog by percentage (H&E, IHC, special stains, cytology).
- Explain how accession identifiers on glass slides must be preserved or mapped to resulting WSI filenames to match your LIS records.
- Select the barcode symbology used for slide tracking in your lab.
- Describe chain-of-custody and interim storage requirements during bulk scanning and transport between stations.
- Choose the backlog QC sampling strategy you require for acceptance.
Deploy Enterprise Image Management Platform
- Select your preferred deployment model for the image management platform.
- Name the laboratory information system (LIS) and electronic medical record (EMR) products that the platform must integrate with.
- Identify required authentication methods for clinician access (for example LDAP/Active Directory, SAML single sign-on).
- Provide expected concurrent pathologist sessions and peak case-load numbers the platform must support.
- What evidence will validate platform integration with your LIS (for example HL7 message traces, successful order-pull and result-posting test cases)?
- List metadata fields required for indexing each case (accession number, slide ID, stain, magnification, barcode).
Integrate Image Platform with LIS/EMR
- Enumerate the HL7 message types and triggers required between the platform and your LIS (for example ORM order, ORU results, ADT updates).
- Provide available API endpoints or FHIR resources your IT team can provide for metadata exchange or document references.
- Describe required field mappings between LIS accession fields (case ID, patient MRN, specimen container) and image-platform metadata.
- Identify your LIS/EMR technical contact for interface testing and their preferred hours for integration work.
- Describe the test data set and sandbox access you will provide for end-to-end interface validation.
- Will patient-identifiers or MRN formats require transformation or mapping during integration?
Configure Diagnostic Viewer and Annotation Tools
- List the annotation and measurement tools your pathologists require in the viewer (for example caliper, polygon ROI, cell counter, bookmarks).
- Provide the acceptable first-image-load time over your WAN for a 40x WSI used in primary sign-out.
- State required stain-normalization or color-profile options (for example ICC profiles or stain-vector normalization) for consistent display across sites.
- Describe multi-monitor or synchronized-slide behaviors needed for shared sign-out or multi-site review.
- Who will approve viewer UI presets and workflow defaults for primary diagnosis?
- Will you require audit logs for viewer annotations, report edits, and sign-out events?
Enable Remote Consultation and Case Collaboration
- Select the remote consultation modes you plan to use.
- Provide your target turnaround SLA for remote consults (in hours or business days).
- Specify the expected number of external consulting pathologists and the access privileges they require.
- Describe secure-sharing and data-embargo policies that apply when WSIs are shared outside your firewall.
- Indicate concurrence, co-signoff or consult-to-sign workflows required for consult cases.
- List any regional data residency or HIPAA-related constraints that affect cross-site consultation.
Integrate and Deploy AI-Assisted Analysis Tools
- Enumerate AI use cases you want in scope (for example tumor detection, IHC quantification, mitotic count, tissue segmentation).
- Specify required model input and output formats and overlays (for example WSI tiles, JSON overlays, DICOM structured report).
- Provide target performance thresholds for each AI model you plan to deploy (for example sensitivity >= 90% for tumor detection).
- Describe available institutional validation datasets for benchmarking (number of annotated slides and cases by stain and subspecialty).
- Identify who will own clinical validation, regulatory traceability, and documentation for AI outputs.
- Select preferred runtime location for AI inference.
Scanner and Workflow Validation for Primary Diagnosis
- List the clinical subspecialties you intend to validate for primary diagnosis during the pilot (for example GI, dermatopathology, GU).
- Choose the concordance study design you prefer for primary-diagnosis validation.
- Provide the number of cases per subspecialty and the number of pathologists required to achieve statistically meaningful concordance.
- What measurable acceptance criteria will confirm diagnostic equivalence for primary diagnosis (for example concordance rate >= 95%, minimum image resolution metrics)?
- Name the clinical sign-off owners required for per-site validation and final acceptance.
- Specify the validation artifacts that must be archived for regulatory audit (validation protocol, case discrepancy logs, signed run sheets).
Provision Enterprise Image Storage and Archive
- Estimate average WSI file size at 20x and 40x for H&E and for typical IHC slides (MB or GB per slide).
- Provide total active and nearline storage capacity needs for Year 1 and Year 5.
- What retention periods and retrieval SLAs will confirm storage readiness (for example 7-year retention, retrieval latency < 10s for a 20x WSI)?
- Select storage access protocols required by your environment.
- Indicate whether eDiscovery and legal-hold workflows are required for pathology cases.
- Specify required encryption and transport standards for data at rest and in transit.
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Clinical Evaluation & Pilot
Run a site pilot to validate image quality, viewer usability, scanner throughput, AI performance, and acceptance criteria in the buyer's clinical environment.
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Mutual Commit
Finalize commercial and legal terms, acceptance gates, timelines, and responsibilities including regulatory and validation obligations.
Agreement Modules
- Master Services Agreement (MSA)
- Statement of Work (SOW)
- Hardware Purchase Agreement
- Software Subscription Order Form
- Service Level Agreement (SLA) & Support Addendum
- Data Processing Agreement / HIPAA Business Associate Addendum (BAA)
- Acceptance & Validation Criteria
- Regulatory & Validation Responsibilities Schedule
- Training & Knowledge Transfer Agreement
- Payment Schedule & Order Confirmation
- Change Order Agreement
- Termination & Transition Assistance
- Confidentiality Agreement
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Deployment
Operationalize rollout with readiness checks, execution, and outcome validation.
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Pre-Deployment Readiness
Confirm concrete readiness facts — facility access, LIS integration points, storage sizing, data retention policy, and named owners for each site.
Pre-Deployment Questions
Environment and site access
- Is this a single-site rollout or a multi-site rollout? (We schedule installs per site and will require per-site readiness facts.)
- Earliest available installation date per site (provide site name and earliest install window). This lets the deployment team book field engineers and shipments.
- Are physical site requirements confirmed for each site (scanner bench space, power availability, network drop on the install day)? (Select the best match.)
Data and configuration readiness
- Is the buyer's LIS environment identified for integration (production vs. test/staging) so we can plan mapping and test schedules?
- Has ownership of field mapping and data governance been assigned (who will approve mappings and be the source-of-truth for patient/case fields)?
- Has storage sizing and the data retention policy been approved for each site (retention period, archival tiering, cloud vs. on-prem intent)? (We need confirmation, not the size values.)
People and ownership (per site)
- Provide the named owner(s) per site for these workstreams: site access/logistics, IT/network/storage, LIS/integration, and clinical acceptance (format: Site — Role: Name, Email).
- Who has final go-live sign-off at each site (role and name — e.g., lab director, pathology chair)? This determines final acceptance responsibility.
Timing, constraints, and approvals
- Are there regulatory, validation, or operational blackout periods or milestone gates that block installations or go-live at any site? (If yes, list dates/milestones so we can avoid them.)
- Which IT or procurement constraints will materially affect provisioning timelines (select all that apply)? Examples: firewall change windows, storage hardware procurement, cloud approval, change-management lead time.
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Integration & Configuration
Lock exact configuration values the deployment team will use — API endpoints, credentials, field mappings, scanner settings, and storage provisioning.
Configuration Details
ENVIRONMENTS & ENDPOINTS
- Enter your production image-management API base URL (format: https://<hostname>[:port]/api). This exact value will be used by the deployment build.
- Primary storage deployment type (select one) — used to drive storage provisioning and deployment steps.
AUTHENTICATION & INTEGRATION ACCOUNTS
- Which identity provider (IdP) type will your pathologists use for SSO? Select one.
- Enter your identity provider metadata URL (format: https://<idp-metadata>) or your LDAP bind DN (format: cn=binduser,dc=example,dc=com). If No SSO, enter 'N/A'.
- Enter the non-secret integration API account username that the platform will call as (format example: service-imaging@yourorg). Do NOT paste a password or token — the secret will be exchanged via your secrets manager at kickoff.
- Enter the named owner of the integration credential and the secure channel for secret exchange in this exact format: "Full Name <[email protected]> | secure-channel" (secure-channel examples: 'Your secrets manager', 'SFTP to admin', 'Manual exchange at kickoff'). If TBD, enter 'TBD'.
LIS INTEGRATION & FIELD MAPPINGS
- LIS integration method for pushing/pulling cases to the platform (select one).
- Enter the exact LIS field name that will map to the platform's primary case identifier (examples: ACCESSION_NUMBER, ACC_NO). Use the exact field/key name as it appears in your LIS messages.
SCANNING, IMAGE SETTINGS & RETENTION
- Default scanning magnification to use for most diagnostic cases (select one). Default is 20x.
- Primary image retention period in days (numeric). Default is 3650 (10 years) — confirm or specify another value.
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Deployment & Site Rollout
Execute scanner installs, validation runs, LIS integrations, training, and phased handovers with clear owners and milestone tracking.
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Go-Live Validation
Formal per-site acceptance checklist verifying diagnostic equivalence, regulatory requirements, and sign-off from named clinical owners before primary-diagnosis use.
Checklist items
- Receive per-site validation report signed by the designated clinical owner
- Complete diagnostic equivalence case set with pass/fail results
- Confirm image quality checklist passed for each installed scanner
- Finalize viewer usability and annotation UAT with clinical user sign-off
- Verify end-to-end LIS/information-flow tests passed
- Validate storage, backup, and retention configuration and perform restore test
- Execute and document rollback/disaster-recovery plan with tested restore
- Confirm regulatory and site validation artifacts are complete and signed
- Obtain completed training records and acknowledged clinical responsibilities from named clinical owners
- Verify monitoring, alerting, and incident-escalation contacts and runbook are in place
- Record formal go/no-go decision and enable primary-diagnosis mode
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Post-Launch Success
Monitor adoption, diagnostic KPIs, issue tracking, and prioritized enhancements while running recurring outcome reviews with stakeholders.
Success Reviews
- Go-live Health Check (weeks 1-4)
- First Measurement Review (weeks 4-10)
- 90-day Realization Review
- Monthly Operational Check-in (recurring)
- Quarterly Outcomes Review (executive)
- Annual Outcomes and Capacity Review
Issues & Enhancements
- Agree the prioritized enhancement list for the next quarter with delivery timelines.
- Ensure operational KPIs remain within agreed thresholds or have active remediation plans.
- Reduce the count of critical unresolved tickets and document action owners and dates for remaining items.
- Agree next month's operational priorities and any required configuration changes to maintain throughput.
- Deliver the updated operational KPI extract and ticket status report before the next monthly check-in.
- Implement the agreed configuration change or patch in the test environment and report test results.
- Archive resolved incident records and update the incident review log for regulatory traceability.
- Executive KPI summary
- Confirm whether adoption and AI concordance are meeting executive expectations or require program-level adjustments.
- Re-confirm success criteria and owners
- Ensure regulatory and validation obligations are on track and assign any outstanding documentation tasks.
- Publish the quarterly outcomes dashboard with annotated trends and risk items.
- Deliver a prioritized enhancement plan with acceptance criteria for the next quarter.
- Compile and share validation evidence packages required for upcoming audits.
- Yearly trend analysis
- Validate whether long-term diagnostic turnaround and storage growth are within acceptable bounds or require strategic remediation.
- Ensure data retention and archival processes meet regulatory requirements and retrieval SLAs.
- Agree on capacity adjustments or storage tiering actions to cover the next 12 months.
- Produce the annual outcomes dossier including supporting logs and audit evidence for retention compliance.
- Publish the 12-month capacity plan with procurement or tiering recommendations.
- Schedule any required large-scale validation exercises for major configuration or storage changes.
- Confirm all planned per-site deployment tasks are complete or have a documented remediation plan with owners and dates.
- Identify the top three operational blockers that would prevent meaningful KPI measurement and agree remediation steps.
- Schedule the First Measurement Review with the data sources and owners identified.
- Publish a Go-live validation summary including outstanding defects and owners.
- Collect and share the data extract for the First Measurement meeting from the image management and LIS logs.
- Implement short-term mitigations for any critical integration failures and report status before the next meeting.
- Present first-cycle KPI data
- Decide whether weekly active pathologists using the viewer and diagnostic turnaround time for primary cases are on acceptable trajectories or require intervention.
- Produce a timebound remediation plan for each KPI gap with clear deliverables and dates.
- Confirm the data sources and cadence for ongoing KPI reporting.
- Deliver the cleaned KPI dataset and visualization for the 90-day Realization Review.
- Implement agreed scanner configuration or workflow adjustments that address identified bottlenecks.
- Close or reclassify low-priority tickets that do not affect KPI trajectories.
- Outcomes summary versus targets
- Agree final disposition for each outstanding remediation item with deadlines that close the onboarding window.
- Confirm the incumbent system is either decommissioned or formally retained read-only with documented data archiving and access controls.
- Validate clinician proficiency levels and commit to any final training required to sustain outcomes.
- Publish the 90-day realization report showing metric trajectories and remediation status.
- Execute the incumbent decommission or read-only retention plan and provide evidence of data archival completion.
- Schedule targeted refresher training sessions for clinician cohorts below proficiency thresholds.
- Operational KPI dashboard
- Deployment and migration validation
- Decision on remediation closure
- Root cause diagnosis for gaps
- Major incidents and risk register
- Retention and archival compliance
- Open tickets and burn-down
- Incumbent system decommission status
- Capacity planning and storage sizing
- Operational issues and defect review
- Early adoption signals and usage patterns
- Integration and backup health
- Enhancement prioritization
- Open issues and blockers
- Agree corrective actions and timelines
- Long-term enhancement roadmap
- Training and proficiency update
- Short-term enhancement priorities
- Regulatory and validation posture