HAD Digital (Oncology Home-Hospitalization) market product
MVP complete and delivered for Dr Kais Aldabbagh (CTCAE v5.0 grading, 19 API endpoints, shipped desktop exe). Build is done; the open investment question is the commercialisation path — licence, hosted service, or close out as delivered work.
Why we hold it: A finished, clinically serious MVP exists. As an investment, the remaining upside depends on choosing a commercialisation path with the owner-client: it needs regulatory (SaMD) decisions, hosting, and support commitments before it can earn recurring revenue.
MVP v1.0.0 delivered 2026-09-05: 24/24 capabilities, 94 tests green (37 Tier-1) — open question: licence, hosted, or close.
✅ Proceed when
A paying path exists that covers SaMD + hosting + support with margin
⏸ Park when
Owner-client ambivalent — leave as completed work, revisit on trigger
⛔ Kill when
Regulatory burden makes SME commercialisation uneconomic — record lessons to 08_Reusable_Knowledge and close
💡 Advisor: 2026-09-12: Do not let this drift in 'finished but undecided'. One conversation either opens a revenue path or cleanly closes the record. The build cost is sunk; only forward costs matter to the decision.
🗺️ Engagement Flow — Stages, Gate & Exits
⚠️ What could sink it — top risks
RSK-01Regulatory (SaMD qualification): auto-grading + urgent/emergency alerting meets the MDSW definition — Class IIa minimum under MDR Rule 11; deploying or selling without CE marking is an offence in France.high 16RSK-02Data security: the MVP stores health data in local SQLite with no MFA or encryption — not a deployable architecture for real patients.high 12RSK-03Low adoption by clinicians and patients — the workflow changes daily practice for 8 roles.med 9✅ What to do next
ACT-001Talk to Dr Kais Aldabbagh: is there appetite to commercialise (licence/hosted) or is this delivered work?2026-10-17ACT-002If commercialising: scope SaMD regulatory pathway + hosting costs into a business_plan.json (v4.0 governance)2026-11-14Gate criteria — Market → Revenue (or Close)
- Owner-client conversation held
- Path chosen: licence / hosted service / close as delivered work
- If continuing: business plan with regulatory + hosting costs approved
Unstructured home monitoring of chemo toxicity causes avoidable escalations; the MVP solves the workflow, the business path is unsolved. · Convert a delivered, tested clinical MVP into a deliberate commercialisation decision — or a proud close — using one owner-client conversation instead of drift.
🗣 Problem Statement
In hospitalisation a domicile (HAD) oncology, toxicity monitoring runs on phone calls and paper forms: the oncologist, HAD nurse, community nurse and GP each see different information at different times, and grade 1-2 toxicities are typically caught only at escalation. The consequences are avoidable ED visits and re-hospitalisations plus heavy clinician transcription burden. The delivered MVP solves the workflow (structured CTCAE v5.0 capture, rule-based auto-grading, tiered alerts, shared timeline); the unsolved problem is commercial — no path has been chosen and the asset currently earns nothing.
Pain points (severity)
Evidence & sources
- MVP_PLAN.md problem table: unstructured phone/paper monitoring, fragmented information silos, delayed grade 1-2 detection → avoidable ED visits and re-hospitalisations
- Project_Status.md (v1.0.0, 2026-09-05): 24/24 capabilities, 19 API endpoints, 10-table SQLite, 12 CTCAE terms, 8 roles, French patient guidance, 18 MB standalone .exe
- TEST_READY.md (2026-09-05): 94-test pytest suite across 5 tiers (Tier 1: 37 tests) + 8-step acceptance script, 100% pass in under 9 seconds; 2 defects found and fixed during testing
- Journey to Market France (2026-09-06): auto-grading + alerting meets the MDSW definition (MDCG 2019-11) → Class IIa minimum under MDR Rule 11; oncology télésurveillance forfaits of EUR 28-70/patient/month inscribed 2024-25; no competitor owns the HAD-specific workflow
🎯 Purpose & Objectives
Convert a delivered, tested clinical MVP into a deliberate commercialisation decision — or a proud close — using one owner-client conversation instead of drift.
Objectives
📐 Scope
The delivered MVP plus the commercialisation decision. Everything forward-looking (SaaS rebuild, CE marking, clinical pilots) is conditional on the ACT-001/002 outcome and belongs to a future business plan, not this record.
✅ In scope
- MVP v1.0.0 as delivered and baselined (2026-09-05)
- The commercialisation decision (licence vs hosted vs close)
- If continuing: SaMD regulatory + hosting cost scoping (ACT-002)
- Owner-client relationship (Dr Kais Aldabbagh)
⛔ Out of scope
- Production SaaS rebuild on HDS-certified hosting (post-decision)
- CE-marking / Notified Body engagement (Journey stages 2-6)
- Clinical pilot or PMCF study
- Connected devices, DMP interoperability, ML risk-scoring (spec S4.2 / V2 items)
- Billing / PMSI workflows
Constraints
A CTCAE-native toxicity watchtower built for the HAD oncology workflow — structured capture, rule-based auto-grading, tiered alerts and a shared care timeline — existing today as a finished, tested MVP, with clinical-founder authenticity competitors cannot copy.
💎 Value Proposition
A CTCAE-native toxicity watchtower built for the HAD oncology workflow — structured capture, rule-based auto-grading, tiered alerts and a shared care timeline — existing today as a finished, tested MVP, with clinical-founder authenticity competitors cannot copy.
Value drivers
Pricing anchor if licensed (EUR)
Per-site platform licence if licensed (EUR)
Clinical value target
Delivered asset value today
Build cost to date
Revenue model: None yet. If commercialised per the playbook: per-site annual licence + per-active-patient monthly fee anchored to the French télésurveillance forfaits. Otherwise none — completed client work.
⚖️ Cost–Benefit Analysis
Sunk build cost is $0 cash; every forward cost is conditional on the path chosen at the gate. The full France CE-mark journey is estimated at EUR 150k-300k over ~24 months to first paid licences — only relevant if the owner-client commits.
Costs vs benefits (scaled)
Method & assumptions
EUR figures are the owner's France market playbook estimates (Journey to Market, 2026-09-06) shown at range midpoints; they are scenario costs, not commitments. No AUD conversion applied because nothing is committed. NDIS-style payback math is impossible until a path exists.
Sunk-cost discipline: the build is delivered and paid for; only forward costs matter to the decision. Hold exactly one conversation with the owner-client by 2026-10-17 and let the answer pick the path — licence (France playbook), hosted SaaS (EUR 150k-300k CE journey, grant-coverable), or close as completed client work. The rejected path is drifting.
🧭 High-Level Strategy
Sunk-cost discipline: the build is delivered and paid for; only forward costs matter to the decision. Hold exactly one conversation with the owner-client by 2026-10-17 and let the answer pick the path — licence (France playbook), hosted SaaS (EUR 150k-300k CE journey, grant-coverable), or close as completed client work. The rejected path is drifting.
📍 Positioning
If commercialised: a CTCAE-native toxicity watchtower for hospitalisation a domicile, built by an oncologist, graded for the ward, reimbursable (playbook positioning line). Today: delivered client work awaiting a decision.
🏰 Moat / defensibility
None operative. Potential moats if the France path is taken: clinical founder authenticity, the unowned HAD-specific workflow position, and the CE / ISO 13485 regulatory barrier — the barrier is the moat, and it costs EUR 150k-300k to build.
Strategic options
Decide by conversation (ACT-001 by 2026-10-17) adopted
One hour of owner time resolves the portfolio's cleanest zombie risk.
Licence per-site + per-patient in France watching
Real reimbursement anchors (EUR 28-70 forfaits) exist; requires Class IIa CE mark — 18-30 months and EUR 100k-250k.
Hosted SaaS funded by grants (i-Lab up to EUR 600k) watching
Highest upside and longest path; depends entirely on owner-client commitment.
Close as delivered work watching
Zero further cost, forfeits the option value — but delivered work is a win.
Drift undecided rejected
Consumes attention without producing evidence.
🚦 Decision Rules (pre-committed)
✅ Proceed when
A paying path exists that covers SaMD + hosting + support with margin
⏸ Park when
Owner-client ambivalent — leave as completed work, revisit on trigger
⛔ Kill when
Regulatory burden makes SME commercialisation uneconomic — record lessons to 08_Reusable_Knowledge and close
💡 Advisor note
2026-09-12: Do not let this drift in 'finished but undecided'. One conversation either opens a revenue path or cleanly closes the record. The build cost is sunk; only forward costs matter to the decision.
4 actualisation steps · 0 done · 2 active · next: Hold the ACT-001 conversation with Dr Kais Aldabbagh
🧭 Dependency Map — Steps to Actualisation
Arrows show what each step needs before it can start; the longest left-to-right chain is the critical path.
📅 Stages & Time
🪜 Steps to Actualisation
Click any step to expand its sub-steps, owner and dependencies.
Hold the ACT-001 conversation with Dr Kais Aldabbagh active
- Appetite check: licence, hosted service, or completed work?
- Due 2026-10-17
If commercialising: scope SaMD pathway + hosting costs (ACT-002) planned
- business_plan.json under v4.0 governance
- Entry point = Journey stages 0-1 (IP lockdown, SASU)
- Due 2026-11-14
If no appetite: close the record with pride planned
- Lessons to 08_Reusable_Knowledge
- Stage → closed; delivered work is a win
Keep the asset verified and protected while undecided active
- Test suite stays green
- No unprotected demos of specs/deck if IP matters (Journey stage 0 discipline)
🔁 Development Process
Governance-standard staged delivery: AI Project Governance Standard v3.9, specification-first (S4.1 scope), multi-agent build tracks with challenger/auditor gates, and a 5-tier E2E test suite as the release gate.
Specification
Original request and spec: standalone .exe, role-based auth, toxicity reporting, care timeline.
- ORIGINAL_REQUEST.md
- HAD_Digital_Specifications.docx
- MVP_PLAN.md
MVP build
Multi-agent build (orchestrator, workers, reviewers, sentinel) against the governance standard.
- MVP application (12 Python files, ~2,500 LOC)
- SQLite schema (10 tables)
- 19-endpoint API
Verification
5-tier pytest suite plus zero-dependency acceptance script; 2 defects found, escalated and fixed during testing.
- 94/94 tests green in under 9s (37 Tier-1)
- verify_mvp.py acceptance script
Baseline & handover
v1.0.0 packaged as an 18 MB standalone Windows .exe; transfer pack with prohibitions and open items.
- HAD Digital.exe
- 00_Handover transfer pack
- Registers: 7 decisions, 5 risks
Market-stage hold
Asset delivered and held at market stage: keep the test suite green and IP discipline while the commercialisation path is undecided.
- 94-test suite kept green
- IP-disciplined demo handling
Commercialisation decision
Owner-client conversation, then licence / hosted / close; business plan if continuing.
- ACT-001 outcome
- business_plan.json if continuing
The build was agent-led under governance; from here this record needs one conversation, not build capacity.
The build was agent-led under governance; from here this record needs one conversation, not build capacity.
💵 Budget
Total budget: $0 · Source: Portfolio record (investment block) + HAD_Digital_Journey_to_Market_France.md (conditional EUR scenarios)
Allocation by phase (bar = allocated, amber = spent)
Playbook scenario costs, none committed: stage 0 IP EUR 15-1,500; SASU EUR 300-1,000; medical-device-grade build EUR 30k-80k; data protection EUR 5k-15k; CE EUR 60k-150k; clinical EUR 20k-60k; market access EUR 20k-80k; NB fees EUR 20k-60k initial + EUR 10k-25k/yr. Bars show 0 because nothing is allocated yet. Ranges overlap the bundled cost lines above: the CE-mark gauntlet line (EUR 100k-250k, in cost_benefit) already includes NB fees (EUR 20k-60k), and the medical-device-grade build (EUR 30k-80k) includes data protection (EUR 5k-15k). Per-stage ranges therefore overlap and must not be summed; the journey total remains the playbook's own EUR 150k-300k.
🧾 Investment Ledger
Capital at risk: Zero new capital unless a commercialisation path is chosen; then hosting + SaMD compliance costs.
👥 People & Tools
People
| Name | Role | Commitment | h/week |
|---|---|---|---|
| Zaid Al Dabbag | Project owner & governance authority (all project decisions per GOV-A1.5) | One conversation + scoping if continuing | 0.5 |
| Dr Kais Aldabbagh | Client / concept originator / clinical authority | Commercialisation decision + clinical review of grading rules | 0 |
| AI advisor (ZCode) | Advisor / portfolio review | Fortnightly flip-through (portfolio overhead) | 0 |
Tools
| Tool | Purpose | Cost |
|---|---|---|
| HAD Digital.exe (18 MB standalone) | Demo / training sandbox — to be labelled non-clinical if shown | built — $0 cash |
| 94-test pytest suite + acceptance script | Regression safety while the record is held | built |
| Journey-to-Market playbook (France) | The commercialisation playbook if the path opens | done — advisor time |
🤝 Stakeholders
Keep informed · high interest / low influence
AI advisor (ZCode) championManage closely · high / high
Dr Kais Aldabbagh championZaid Al Dabbag championMonitor · low / low
Care-team roles (oncologist, HAD nurse, GP, pharmacist) neutralFuture HAD structures (prospective customers) neutralKeep satisfied · low interest / high influence
Notified Body / ANSM (prospective) neutralFull stakeholder register (6)
| Name | Role | Interest | Influence | Needs / notes |
|---|---|---|---|---|
| Dr Kais Aldabbagh | Client / concept originator / clinical authority | high | high | Decide commercialisation appetite (ACT-001); review grading rules and French guidance content |
| Zaid Al Dabbag | Project owner / governance authority | high | high | A clean decision — open a revenue path or close the record; no drift |
| Care-team roles (oncologist, HAD nurse, GP, pharmacist) | Future users | med | low | Workflow fit; user testing before any pilot |
| Notified Body / ANSM (prospective) | Regulators if the EU path is taken | low | high | Class IIa conformity file, EUDAMED registration, UDI |
| Future HAD structures (prospective customers) | Buyers / pilot sites | med | med | Evidence: PMCF data, re-admission outcomes, sub-EUR-40k entry pricing |
| AI advisor (ZCode) | Advisor | high | low | One conversation booked this month; honest close if no appetite |
6 risks (2 high/critical) · 4 upside opportunities · 5 assumptions · 2 open issues
⚠️ Risk Register
L = likelihood, I = impact (1–5). Tint = severity band: low / medium / high (L×I ≥ 12) / critical (≥ 20).
Full risk register (6)
| ID | Risk | Category | L/I | Severity | Mitigation | Owner | Status |
|---|---|---|---|---|---|---|---|
RSK-01 | Regulatory (SaMD qualification): auto-grading + urgent/emergency alerting meets the MDSW definition — Class IIa minimum under MDR Rule 11; deploying or selling without CE marking is an offence in France. | regulatory | 4/4 | high | Engage regulatory counsel before any pilot; write the intended-purpose/classification memo anticipating an IIb challenge (Journey stage 2.3). | Dr Kais Aldabbagh | open |
RSK-02 | Data security: the MVP stores health data in local SQLite with no MFA or encryption — not a deployable architecture for real patients. | security | 3/4 | high | Any real-data path requires SaaS on HDS-certified hosting, MFA and encryption (register RSK-002 + Journey stage 2). | Technical Lead (unassigned) | open |
RSK-03 | Low adoption by clinicians and patients — the workflow changes daily practice for 8 roles. | adoption | 3/3 | med | User testing with real patients and clinicians; iterative design (register RSK-003). | Dr Kais Aldabbagh | open |
RSK-04 | Data quality: patient self-report can mis-grade symptoms. | clinical | 3/3 | med | Clinician confirmation required for Grade >= 2 (register RSK-004). | Dr Kais Aldabbagh | open |
RSK-05 | IP protection: ideas and CTCAE mapping logic are not copyright-protected, and AI-authored code stretches have weak copyright. | legal | 2/4 | med | Journey stage 0: e-Soleau deposit (EUR 15), NDA discipline before demos, documented human authorship, patent decision this month if continuing. | Dr Kais Aldabbagh | open |
RSK-06 | Portfolio zombie risk: the record drifts as finished-but-undecided, consuming attention without producing evidence. | portfolio | 3/2 | med | ACT-001 by 2026-10-17; if no appetite, close the record with pride (advisor note, 2026-09-12). | Zaid | mitigating |
🌱 Upside Opportunities
Licence path anchored to French forfaits
Per-site EUR 8k-20k/yr + EUR 15-35/active patient/month inside EUR 28-70 télésurveillance forfaits; hospitals buy under the EUR 40k simplified procedure.
Upside: med · Effort: high
Hosted SaaS with grant-funded CE journey
Bpifrance i-Lab grants up to EUR 600k (60% of costs) could fund the EUR 150k-300k journey; PECAN / forfait innovation provide early coverage routes.
Upside: high · Effort: high
Close cleanly as delivered work
A delivered, tested MVP for a client is a portfolio win; lessons feed 08_Reusable_Knowledge and the EMS Suite product track at near-zero cost.
Upside: low · Effort: low
Reusable delivery pattern
The governance-standard + multi-agent + 5-tier-test delivery pattern proven here is reusable for the next build in the portfolio.
Upside: med · Effort: low
🧩 Assumptions
🔴 Issue Log (live)
| ID | Issue | Impact | Raised | Status | Resolution |
|---|---|---|---|---|---|
ISS-01 | Commercialisation decision not made (DEC-008 not yet opened per the record KPI). | Record cannot leave the market stage; gate due 2026-11-14 | 2026-09-12 | open | |
ISS-02 | Record KPI 'Tests passing' showed 37 while TEST_READY.md reports 94/94 — 37 is the Tier-1 subset, not the suite total. | Test-count figure differed between portfolio record and project source | 2026-09-12 | resolved | Unified 2026-09-13: KPI and dossier now both state 94 (37 Tier-1). |
Stage KPIs · next gate: Market → Revenue (or Close) (due 2026-11-14) · 2 open owner actions · full progress log.
📊 Stage KPIs
| KPI | Current | Target |
|---|---|---|
| Capabilities delivered | 24 / 24 | kept at 100% |
| Tests passing | 94 (37 Tier-1) | green at every release |
| Open risks | 5 project + 1 portfolio (mitigating) | owned before commercialisation |
| Commercialisation decision | Not made | DEC-008 opened and closed |
🚪 Next Gate — Market → Revenue (or Close)
Due: in 45d (2026-11-14)
- Owner-client conversation held
- Path chosen: licence / hosted service / close as delivered work
- If continuing: business plan with regulatory + hosting costs approved
✅ Next Steps & Actions
| ID | Action | Due | Status |
|---|---|---|---|
ACT-001 | Talk to Dr Kais Aldabbagh: is there appetite to commercialise (licence/hosted) or is this delivered work? | 2026-10-17 | open |
ACT-002 | If commercialising: scope SaMD regulatory pathway + hosting costs into a business_plan.json (v4.0 governance) | 2026-11-14 | open |