The gap between an MVP feature that works in the sandbox and an AI feature that runs on real patients in a real hospital is bigger than most teams expect. The MVP demonstrated that the architecture is sound and the model produces useful output on test cases. Pilot-Ready Sprint is the work that turns that demonstration into something safe to deploy on actual patient encounters — with drift monitoring catching model degradation in real time, an evidence package the hospital security committee will accept, FDA SaMD documentation prepared when applicable, and pilot operations support during the first weeks of clinical use.
Twelve weeks. $145,000. Six two-week internal sprints of hardening, validation, regulatory documentation, and pilot launch support. Final tier of the productized pathway.
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Vendors in healthcare AI use “pilot-ready” loosely. To be specific about what we mean and what we don’t:
Pilot-Ready means the feature is safe to use in a controlled clinical pilot. A defined patient cohort, a defined clinical workflow, supervising clinicians who can override, an active eval harness, an incident response plan, and operational support for the pilot weeks. Real patients. Real clinical decisions. Real outcomes data being collected.
Pilot-Ready is not general availability. General availability — running on all eligible patients across all clinical sites with reduced supervision — is what comes after a successful pilot. The pilot produces the evidence that supports going to general availability. Building for general availability before having pilot data is how healthcare AI projects burn through Series A budget without learning anything.
Pilot-Ready is not the same as FDA SaMD clearance. If the feature requires FDA clearance, the SaMD pathway runs in parallel via the FDA SaMD pathway add-on — $60K, 8 weeks. Pilot-Ready hardens the engineering and operations side. The two pieces complete around the same time and complement each other.
Pilot-Ready scope is bounded by the MVP it hardens. New use cases or significantly expanded scope become a second engagement, not a Pilot-Ready scope expansion. This is what makes the $145K fixed price possible.
Each two-week internal sprint targets a specific domain of hardening work.
Build the live drift monitoring infrastructure. Eval harness moves from periodic batch evaluation to streaming evaluation against production traffic. Alerts wire up to on-call rotation. Threshold tuning based on MVP eval results.
Output: live drift monitoring running against a stream of test patient encounters. Alert rules tuned to actual model behavior baselines.
Harden the clinician override workflow. Build the “break-glass” path for when a clinician needs to act in a way the AI did not anticipate. Add safety thresholds that gate model output (e.g., output below a calibration threshold is suppressed and the clinician sees “AI declined to answer this”).
Output: full safety control stack with audit logging of every override, suppression, and break-glass event.
Produce the documentation package required for hospital IT security committee review, SOC 2 evidence, HITRUST control documentation, and FDA SaMD if applicable. PHI flow diagram updated. Audit log retention policy in writing. Risk assessment documented. Penetration test scheduled or completed.
Output: a documentation package suitable for hospital security committee submission. See companion engagements for HIPAA AI compliance checklist, SOC 2 for healthcare AI, and HITRUST CSF for healthcare AI.
Set up the operational layer that will support the pilot. Clinical user training materials. On-call rotation for the engineering team during pilot weeks. Incident response runbook covering AI-specific incidents (hallucination harm, prompt injection, embedding store re-identification, tool-call escape). Pilot metrics dashboard tied to the success criteria defined back in Discovery.
Output: pilot operations package — training, runbooks, on-call, dashboards — ready for clinical pilot launch.
The pilot launches. Real patients. Real clinical decisions. The engineering team is on-call for the first two weeks of clinical pilot operations. Daily drift and override review. Rapid response to clinical issues that surface. Per-encounter eval data collection.
Output: 10 business days of pilot operations support with documented per-day debrief notes, incident log, and emerging-pattern report.
Review pilot outcomes against the success criteria. Document what worked, what did not, and what changes are needed before general availability. Recommend the next phase: continued pilot with iteration, expansion to a second site, general availability rollout, or wind-down if the pilot did not validate the approach.
Output: pilot outcomes report, recommendation document, and handoff package for ongoing operations.
What changes between MVP output and Pilot-Ready output, across six engineering domains:
Eval harness. MVP: batch eval against held-out test set. Pilot-Ready: streaming eval against production traffic with real-time drift detection and alerting.
Audit logging. MVP: append-only audit log at HIPAA §164.312(b) granularity. Pilot-Ready: same logging plus cryptographic tamper-evidence, override-and-feedback correlation, and inspection-ready evidence collection. See the healthcare AI audit logging service.
Safety controls. MVP: model produces output, clinician decides. Pilot-Ready: calibration thresholds gate output, suppression patterns documented, break-glass workflow operational.
Documentation. MVP: PHI flow diagram, model card, as-built architecture, override workflow spec. Pilot-Ready: same plus risk assessment, SOC 2 / HITRUST evidence package starter, FDA SaMD documentation if applicable, pen-test report.
Operations. MVP: feature works in sandbox. Pilot-Ready: full pilot operations layer — training, runbooks, on-call, dashboards, incident response.
Clinical validation. MVP: clinician sees demo twice. Pilot-Ready: clinical pilot runs on real patients with structured outcomes review.
Sprint 5’s pilot operations support is the most operationally intensive piece of the engagement. What it covers:
Many healthcare AI features that reach Pilot-Ready also need FDA clearance. The two pieces of work are complementary but separate.
FDA SaMD pathway add-on — $60K, 8 weeks. Predicate analysis. Design history file skeleton. Risk classification. 510(k) or De Novo submission strategy. Runs in parallel with Pilot-Ready Sprint, ideally starting at Sprint 2 of Pilot-Ready so that the regulatory work completes around the same time as the engineering hardening.
What Pilot-Ready does for FDA work. Produces the engineering evidence — eval harness results, audit logs, safety control documentation, pilot outcomes data — that the SaMD submission references. The SaMD add-on produces the regulatory artifacts that wrap that engineering evidence into FDA submission shape.
The combined package (Pilot-Ready + SaMD pathway = $205K, 12 weeks) is the typical pathway for AI features that will be commercialized as medical devices. See the FDA SaMD pathway add-on page for the regulatory side.
Combined cost: $285,000 over 24 weeks for the full pathway from contract to clinical pilot.
For comparison: a typical healthcare AI engagement that does not follow this structure runs 12–18 months and costs $500K–$1.5M, with high failure rates. The productized pathway is the cost-controlled path to the same outcome.
For estimates on your specific scope, see the Discovery Sprint page and the MVP Sprint page.
Pricing. $145,000 fixed. Three payment milestones: 33% on contract signature, 33% at end of Sprint 3 (evidence package delivered), 34% at end of Sprint 6 (pilot outcomes report delivered).
Timeline. 12 weeks calendar from kick-off. Kick-off typically 2–4 weeks after MVP Sprint closes when the MVP was with us.
Contracting. MSA plus SOW. BAA in place from MVP carries forward.
IP ownership. Buyer owns the code. Work-for-hire under standard terms.
Team size. Typically 4–6 engineers including the healthcare AI lead from MVP, plus a clinical-pilot operations engineer, a compliance/security engineer, and (where applicable) an FDA regulatory engineer running the FDA SaMD pathway add-on in parallel.
MVP Sprint builds a working feature in a sandbox or staging environment, evaluated on test cases. Pilot-Ready Sprint hardens that feature for real patient use in a controlled clinical pilot — adding drift monitoring, safety controls, evidence documentation, pilot operations support, and the regulatory documentation needed for the clinical site to deploy on actual patients.
Yes, in a controlled clinical pilot during Sprint 5. Defined patient cohort, supervising clinicians, active eval harness, incident response plan. Real clinical decisions and real outcomes data. Not yet general availability across all eligible patients — that comes after the pilot validates the approach.
Typically 3–10 supervising clinicians for an initial clinical pilot. Smaller cohorts produce noisy outcomes data; larger cohorts make it harder to maintain the supervision intensity that initial pilots require. The exact number depends on the use case, the patient volume per clinician, and the success criteria. We define this during Discovery and refine during MVP.
This is the most important question Pilot-Ready answers. If drift monitoring or live eval show the AI does not meet safety thresholds during Sprint 1–4 hardening, the recommendation at end of Sprint 6 is to extend MVP-style iteration rather than launch the clinical pilot. The $145K is not wasted — the hardening work produced the evidence that the feature is not yet ready. That’s the right outcome from a safety standpoint, even if not the desired commercial one.
Rarely, and only when the buyer is bringing an MVP-equivalent feature from elsewhere that has been validated to MVP-quality standards. Most engagements that try to skip MVP discover during Sprint 1 that the underlying feature needs MVP-level work first, which means the Pilot-Ready scope effectively becomes MVP plus partial Pilot-Ready work. Honest conversation during Discovery prevents this.
When the feature requires FDA clearance, the FDA SaMD pathway add-on at $60K runs in parallel with Pilot-Ready Sprint, ideally starting at Pilot-Ready’s Sprint 2. The engineering evidence Pilot-Ready produces (eval results, audit logs, safety control documentation) feeds the SaMD submission package. Total combined pathway is $205K over 12 weeks.
Three common paths: (1) Continued clinical pilot with iteration based on Sprint 6 findings, supported by dedicated engineers at $8K per engineer per month. (2) Expansion to a second clinical site or expanded patient cohort, supported by a second targeted engagement. (3) General availability rollout, typically requiring additional work on scaling, multi-tenant isolation if applicable, and clinical change management across sites. The recommendation in Sprint 6’s outcomes report names the right next path.
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