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Demos don’t ship. Deployments do.

We deploy AI systems into healthcare, mobility, IoT, and logistics — and the regulatory wrapper around the model (validation, traceability, audit-ready MLOps) ships as a first-class deliverable, not a post-launch retrofit.

See How We Deploy
Birds flying

Connecting Systems to Strategy

Everyone is doing AI demos.
Almost nobody is shipping into regulated workflows.

Most AI engagements stall on the same things: data plumbing, model evaluation, validation packages, and audit-readiness. We don't sell a model integration. We sell the regulatory wrapper around the model — the part a compliance officer signs off on — and ship the working system underneath it.

The Knowledge Network

Organizes and retrieves what your team already knows.

Answers queries based on existing internal documentation.

A utility for marginal productivity gains.

The Intelligence Engine

Analyzes real-time operational data streams.

Generates predictive insights that never existed before.

Creates competitive advantage from proprietary data.

What we deploy into regulated environments

The systems we ship — and the standards we ship them against

We embed as your product lab. Fixed teams. Senior engineers. Outcomes tied to your business metrics. We don't sell hours — we build businesses.

HIPAA-aligned AI in clinical workflows
a) HIPAA • IEC 62304 • SaMD • IRB-ready

HIPAA-aligned AI in clinical workflows

We deploy generative-AI agents and predictive systems into hospital workflows with the validation package the compliance officer needs on day one. Data plumbing, model evaluation harnesses, and audit-ready MLOps ship together — not as a post-launch retrofit.

b) ISO 26262 • ASPICE • IEC 62443 • NIS2

Edge ML for mobility and connected IoT

We build edge-to-cloud ML pipelines for vehicle telemetry, smart implants, and industrial IoT — with the ISO 26262 / ASPICE / IEC 62443 traceability matrix and evidence pack scoped into the engagement, not bolted on after.

Edge ML for mobility and connected IoT
Agents and decision systems in production
c) Eval Suites • MLOps • Audit Trails

Agents and decision systems in production

We ship agents and autonomous decision systems that survive a regulator's review — closed-loop control, dynamic optimization, and human-in-the-loop oversight, all instrumented with the eval suites and audit trails needed to defend a deployment.

d) Reference Architectures • Agent Templates • Integration Patterns

An IP library that compounds across engagements

Every Bootcamp and Pod produces an artifact that lands in our IP library: vertical reference architectures, agent templates, eval harnesses, integration patterns for Epic, Cerner, OEM telematics buses, MES/ERP. Your next milestone starts at a higher floor than your last.

An IP library that compounds across engagements

AI Deployment Studio

One regulatory wrapper, across verticals

The same discipline that ships HIPAA-aligned AI into a hospital workflow ships ISO 26262 / ASPICE evidence packs into a Tier-2 automotive supplier. Different standards, same wrapper. We sell the regulatory wrapper around the model — and we travel the engineering library between verticals so your next milestone starts at a higher floor.

See Our Case Studies

Case Study

Smart implant telemetry into HIPAA-aligned recovery guidance

An AI orchestration layer between smart orthopedic implants and post-op care — deployed into a clinical workflow with the validation package, IRB sign-off, and audit trail the compliance team required.

The Constraint

A medical-device company had smart implants generating millions of biomechanical data points per patient. Surgeons were making recovery decisions on intuition. The constraint wasn't the model — it was deploying anything into a clinical workflow with HIPAA, IRB, and SaMD-adjacent risk on the table.

The Deployment

We embedded a senior pod with the customer's team and shipped a real-time analytics engine that ingests sensor streams, identifies recovery patterns across cohorts, and generates personalized protocols. The validation package, evaluation harness, and audit trail shipped on the same cadence as the model — not after.

The Outcome

The system is live in clinical workflows. Surgeons make data-driven recovery decisions in production. The customer owns the model, the eval suite, and an internal champion trained on the system — and a proprietary data asset that compounds with every cycle.

What Our Clients Say About Us

“SpiceFactory didn't just build a platform — they deployed a capability into our regulated workflow. The validation package, the eval suite, the audit trail all shipped with the system.”
Kevin R&D Manager at Canary Medical

The Deployment Process

How a deployment actually runs

  1. Deployment Bootcamp

    Five days, onsite at least two of them, with your real data. Our pod ships a working AI prototype, an eval harness, an architecture document, and a 90-day production roadmap. $75K fixed — $125K for high-regulation (FDA SaMD, ISO 26262, NIS2).

  2. Decision on Day 5

    Scale to a Pod, take the prototype and run it yourself, or part better-informed. The Bootcamp pays for itself standalone — no commitment to continue.

  3. Deployment Pod

    An embedded senior pod ships one named regulated-AI milestone every six weeks. Your repos, your tools, your compliance officer in our standups. Every milestone names an internal champion we transfer capability to.

  4. Outcome Contract (graduation)

    After Bootcamp + two quarters of Pod, we'll name a binary state-change in the contract — 510(k), ASPICE Level 2, agent in production with HIPAA sign-off — and gate the final 20% on outcome verification.

Abstract architectural illustration

Three SKUs

Start with a Deployment Bootcamp

Five days, fixed price, your real data. A working system at the end, and a 90-day production roadmap with the regulatory path scoped. Engagements start at $75K for a Bootcamp, $85K/month for a Pod (6-month minimum), and $500K+ for a named-outcome contract. If those numbers aren't a fit, we'll save you the call.