IVDR-ready diagnostics programs LIS integration · FHIR result delivery · ISO 13485 QMS · Remote service desk
Innovation Lab

Digital diagnostics experiments that stay inside regulated guardrails.

The Roche Diagnostics Innovation Lab is a working page for AI-assisted diagnostics, connected point-of-care workflows, FHIR result delivery, and post-market software surveillance. The point is not to promise a cure, automate clinical judgment, or hide uncertainty behind a glossy interface. The point is to help clinical teams test new workflows with version control, validation evidence, subgroup review, cybersecurity documentation, and a clear path from pilot to production.

AI-assisted result review

Reader-in-the-loop dashboards can stage flagged results for authorized clinicians while maintaining override logging, model version history, and performance monitoring.

FHIR observation routing

Structured observations can move from analyzer or remote device workflows into clinical systems with provenance, consent checks, and exception reporting.

Point-of-care orchestration

Device enrollment, operator competency, QC lockout, and lot traceability can be tested before a regional fleet is rolled out.

Post-market model governance

Drift monitoring, bias audit updates, performance deltas, and retraining triggers are documented so AI-enabled workflows remain reviewable.

Digital diagnostics innovation lab

From pilot signal to validated workflow

Innovation programs begin with a defined intended workflow, not a loose technology demo. Teams document the clinical question, data sources, user roles, failure modes, validation cohort assumptions, integration points, and human review checkpoints. A pilot may include retrospective data review, shadow-mode operation, prospective reader study, or controlled point-of-care rollout depending on risk and intended use.

The lab also prepares practical artifacts: FHIR capability statements, interface test scripts, cybersecurity questionnaires, model change logs, subgroup performance summaries, and service handoff plans. When a pilot is ready for production review, stakeholders can see what changed, why it changed, and what evidence supports the next step.

Schedule a Lab Review

Bring a diagnostics workflow into the Innovation Lab.

Share the target test menu, patient monitoring signal, interface environment, and validation constraints. Roche Diagnostics can help scope a pilot that is ambitious enough to matter and disciplined enough to survive review.

Start a Pilot Conversation