A launch GTM for ProofX — NovintiX's own AI-native product: test-proof / V&V-evidence management for SaMD and Medical Devices — and how NovintiX pushes it into adjacent regulated markets.
ProofX is the system of record for test proof — it captures, generates, links and defends the verification & validation evidence a medical device or SaMD needs to pass audit, with AI doing the assembly work that today eats engineers' weeks.
ProofX is NovintiX's own product — the productization of the V&V / test-proof evidence work NovintiX already runs most often for MedTech clients. NovintiX builds it, owns it, and sells it as a services-attached offer, which is exactly why it carries the regulated-domain credibility a pure software startup can't claim: the people who ship ProofX are the people who pass the audits.
In regulated device development, the product isn't done when the code works — it's done when the evidence is complete: requirements linked to tests, tests to results, results to a risk, and every artefact traceable and audit-ready. Teams assemble this by hand across spreadsheets, ALM tools and documents. It's slow, brittle, and the #1 cause of submission delay and audit findings.
ProofX is AI-native: it generates test cases from requirements, mines coverage gaps, drafts V&V protocols and reports, auto-builds the requirements-to-test traceability matrix, and keeps an always-current, notified-body-ready evidence file — with a human approver on every artefact that reaches a regulator.
The wedge is narrow and deep on purpose: test-proof management for SaMD & medical devices first (IEC 62304, ISO 14971, FDA design controls, EU MDR) — then the same evidence engine into every industry that must prove software is safe.
Not the engineering — the proof of the engineering.
…I need its test evidence complete, traceable and audit-ready — without pulling senior engineers off the roadmap to assemble paperwork.
The assembly work — generation, gap-mining, drafting, linking — is exactly what LLMs do well, with human sign-off.
Regulated buyers won't accept a black box.
Start where the pain is regulated, acute and repeatable: SaMD and medical-device teams (and their India GCCs) that live or die by V&V evidence.
One device family / one submission — prove ProofX cuts evidence time and passes review, then expand across the portfolio.
ProofX is NovintiX's product, so NovintiX's own services engagements (SaMD Assurance, Design-Control Accelerator) are its built-in distribution — the tool NovintiX's pods already use becomes the product the client buys.
Category: "AI-native test-proof management for regulated products." Not a test-automation tool, not an ALM, not an eQMS — the evidence layer that sits across them and makes the proof audit-ready.
Against ALM / test tools (Polarion, Jama, codebeamer, Azure DevOps): they store requirements and tests; ProofX generates the evidence and keeps it audit-ready on top of them — integrate, don't replace.
Against eQMS (Greenlight Guru, MasterControl): they manage quality processes; ProofX produces the V&V/test evidence that feeds them.
Against manual / consulting: ProofX turns a weeks-long human assembly job into a reviewed, always-current artefact — the productized form of what a validation consultant does.
One-liner: "ProofX turns your requirements and tests into audit-ready V&V evidence — automatically, with a human in the loop."
Land with a low-friction pilot; expand on seats + evidence volume; anchor value to the audits passed and engineer-weeks reclaimed.
Why this shape: the pilot removes procurement risk; seats capture team adoption; the platform tier captures the CFO-level value (submissions on time, audits passed). The services-attached tier is the moat — NovintiX delivery makes ProofX sticky and de-risks adoption for cautious buyers.
| Offer | Promise | Price · time |
|---|---|---|
| Pilot (one program) | Fixed-scope proof on a single device family / submission | $15k–$30k · 6–8 weeks |
| Team | Per-seat for a V&V/RA team + a program allowance | $1.5k–$3k / seat / yr |
| Platform | Org-wide, unlimited programs, SSO, audit exports, integrations | $120k–$400k / yr |
| ProofX + NovintiX pod | The product plus an expert pod that runs it for you (services-led) | custom |
| Regulated-cloud / on-prem | Validated deployment, data isolation, compliance add-ons | + premium |
The defensible edge: regulated-domain depth (62304/14971/MDR built in), a human-in-the-loop trust model auditors accept, and a services channel (NovintiX) that no pure-software competitor has.
| Category | Examples | ProofX angle |
|---|---|---|
| ALM / requirements & test | Polarion, Jama, codebeamer, Azure DevOps | Integrate; ProofX adds AI evidence generation + audit-ready assembly on top |
| eQMS | Greenlight Guru, MasterControl, Qualio | Feed them — ProofX produces the V&V/test evidence their processes consume |
| Test automation / gen | Copilot-style code/test tools | Domain-specific + regulated: traceability, risk linkage, notified-body-ready output |
| Manual / consulting | Validation consultancies, in-house | Productizes the weeks-long human assembly job with a human-in-the-loop AI |
The evidence engine is the product; the standard is a plug-in. Every safety-critical and regulated industry has the same job-to-be-done — prove the software is safe — so ProofX expands by adding standard packs, not rebuilding.
Sequence expansion by regulatory adjacency and pull: markets whose evidence discipline is closest to MedTech go first, and each is entered on a design partner + a standard pack (the compliance mapping, artefact templates and rule set for that standard).
| Market | Standard / driver | Why ProofX transfers | Entry |
|---|---|---|---|
| Pharma / GxP software | GAMP5, 21 CFR Part 11, CSV | Computer-system validation is the same requirement→test→evidence job | Warm via NovintiX pharma work + a GAMP5 pack |
| Automotive | ISO 26262, SOTIF, ASPICE | Functional-safety V&V & safety cases need identical traceability & evidence | One ADAS/EV software design partner + a 26262 pack |
| Aerospace & Defense | DO-178C / DO-254 | Certification evidence is traceability + V&V artefacts — ProofX's core | One avionics-software partner + a DO-178C pack; ITAR-aware hosting |
| Industrial / OT | IEC 61508 / IEC 62443 | Functional-safety + security evidence for industrial control software | One industrial-controls partner + a 61508 pack |
| BFSI model risk | SR 11-7, EU AI Act | Model validation & documentation is evidence management for AI | One bank/insurer AI team + a model-risk pack |
| Horizontal QA/test evidence | SOC2, internal audit | Any team that must prove test coverage & traceability | Self-serve tier once the regulated packs mature |
Expansion rule: never enter a market without (1) a design partner in it and (2) a standard pack that makes ProofX speak that industry's evidence language on day one. The core generation/traceability/human-in-the-loop engine never forks — only the packs multiply.
North star: audit-ready evidence artefacts produced & accepted — the unit of value that ties to submissions on time and audits passed.
Activation: first program traced end-to-end in ProofX. Value proof: evidence-assembly time reduced (target 50–70%) with zero new audit findings.
Growth: pilots → team → platform conversion; seats per account; standard-packs adopted. Retention/moat: programs under management, services-attached accounts, audits passed on ProofX evidence.
From design partners to a category product with an expansion engine. Each horizon has a goal, work items and hard exit criteria; the year card carries the launch KPIs.
Goal. Lock design partners and define the narrowest lovable wedge.
Exit criteria. 3–5 design partners signed, MVP wedge specced, trust model defined, baselines captured.
Goal. Ship the wedge to design partners and prove time-saved on live V&V work.
Exit criteria. Beta live on real submissions, 1–2 integrations, measured ROI, 2–3 case studies drafted, pricing validated.
Goal. Launch to the SaMD/MedTech market on references and convert NovintiX engagements into product revenue.
Exit criteria. Public references, paying customers, ProofX attached to services deals, first adjacency pack (GAMP5) started.
Goal. Establish ProofX as the SaMD/MedTech evidence standard and prove the standard-pack expansion model in one adjacent market.
Exit criteria. Category presence in SaMD/MedTech, recurring ARR, one adjacent market proven via a standard pack, packs roadmapped for year two.
One click seeds the ProofX worked example so you can click through the launch — the product in Launch OS, the capability maps in Capability Explorer, and a design-partner outreach campaign.
Before it writes anything, the loader downloads a backup of your current platform data, then merges the ProofX example in. You can also load <code>proofx-platform-seed.json</code> via <strong>Settings → Restore full backup</strong>.