EPIC-X 2026 Application - Quality Review Checklist
Purpose: Ensure all 100 evaluation points are comprehensively addressed with evidence-based content
Review Date: December 22, 2024
Reviewer: [To be completed by Andy Aguilar + leadership team]
Evaluation Criteria Coverage (100 Points Total)
A. Excellence and Innovation (40 Points)
A.1 Relevance to EPIC-X Scope (15 Points)
Criteria: Deep-tech innovation, alignment with AI/ML + healthcare, scalability, market potential, S3 priorities
| Sub-Criterion | Weight | Section Location | Status | Evidence Provided | Gaps/Actions |
|---|---|---|---|---|---|
| Deep-tech AI/ML innovation | 5 pts | Section 2 (AI/ML Architecture) | ✅ Complete | CNNs, Vision Transformers, severity algorithms (7 scales, 239 conditions) | None |
| Clinical validation rigor | 3 pts | Section 2 (Clinical Validation) | ⚠️ Needs data | 7 studies, 1000+ patients mentioned | ACTION: Add specific patient counts (n) per study, publication DOIs |
| Regulatory achievements | 3 pts | Section 2 (Regulatory Excellence) | ⚠️ Needs data | CE MDR Class IIb, AEMPS, MHRA, ANVISA, FDA ongoing | ACTION: Add certificate numbers, exact dates |
| Scalability (horizontal/vertical) | 2 pts | Section 2 (Scalability) | ✅ Complete | 239→400 conditions (horizontal), 4 use cases (vertical), 3→30 countries (geographic) | None |
| SOTA performance comparison | 2 pts | Section 2 (Performance vs. SOTA) | ⚠️ Needs data | Tables created for melanoma, psoriasis, severity scales | ACTION: Fill UPDATE placeholders with actual performance metrics from PC files |
Subtotal A.1: 15 points - Status: 70% complete, 30% needs data
Overall Assessment: Strong foundation with detailed AI/ML architecture and regulatory achievements. Need to populate performance metrics and clinical study details.
A.2 Unbiased Mission (10 Points)
Criteria: Gender equality focus, inclusive AI design, bias-free models, social impact
| Sub-Criterion | Weight | Section Location | Status | Evidence Provided | Gaps/Actions |
|---|---|---|---|---|---|
| Women-led company evidence | 3 pts | Section 6 (entire), Section 2 | ✅ Complete | Andy: CEO + Co-founder + 33.33% + Board Chair, 8+ years leadership | None |
| Inclusive AI design (skin tone) | 3 pts | Section 2 (Fitzpatrick Equity), Section 6 | ⚠️ Needs data | PC-042 table created, Fitzpatrick I-VI training data distribution | ACTION: Fill Fitzpatrick performance equity table with actual accuracy % by skin tone |
| Gender-balanced performance | 2 pts | Section 2, Section 6 | ⚠️ Needs data | Gender performance comparison table created | ACTION: Add actual accuracy by gender for 4+ conditions |
| Women's health focus | 2 pts | Section 2, Section 6 | ✅ Complete | Melasma (90% women), pregnancy dermatoses (100%), lupus (90%), hormonal acne (70%) covered | None |
Subtotal A.2: 10 points - Status: 50% complete, 50% needs data
Overall Assessment: Strong narrative on women leadership and women's health focus. Critical gap: Need to populate Fitzpatrick equity and gender performance tables with real data from Performance Claims.
A.3 Business Coaching Plan (10 Points)
Criteria: Clear needs assessment, measurable outcomes, strategic fit, realistic EUR 20k allocation
| Sub-Criterion | Weight | Section Location | Status | Evidence Provided | Gaps/Actions |
|---|---|---|---|---|---|
| Needs assessment clarity | 3 pts | Section 5 (Needs Assessment) | ✅ Complete | 4 challenges identified with knowledge gaps and impact if unresolved | None |
| Coaching plan structure | 3 pts | Section 5 (4 Modules) | ✅ Complete | 20 days, EUR 20K (33.3% of grant), day-by-day deliverables for each module | None |
| Measurable KPIs | 2 pts | Section 5 (Success Metrics) | ✅ Complete | 6-month and 12-month KPIs for each module with specific targets | None |
| Integration with work plan | 2 pts | Section 5 (Integration) | ✅ Complete | Monthly alignment table showing Module activities mapped to Q2-Q3 2026 timeline | None |
Subtotal A.3: 10 points - Status: 100% complete ✅
Overall Assessment: Excellent. Coaching plan is detailed, realistic, and tightly integrated with implementation timeline.
A.4 European Added Value (5 Points)
Criteria: EU market focus, cross-border potential, regulatory compliance (GDPR, MDR)
| Sub-Criterion | Weight | Section Location | Status | Evidence Provided | Gaps/Actions |
|---|---|---|---|---|---|
| CE MDR 30-country access | 2 pts | Section 2 (European Value) | ✅ Complete | CE MDR Class IIb valid across 27 EU + 3 EEA = 30 countries | None |
| GDPR compliance | 1 pt | Section 2 (European Value) | ✅ Complete | Data minimization, consent, EU servers (AWS Frankfurt), DPIA completed | None |
| FHIR interoperability | 1 pt | Section 2 (European Value) | ⚠️ Needs validation | FHIR Resources implemented: Patient, Observation, DiagnosticReport, Media | ACTION: Confirm with Engineering team which FHIR resources are actually implemented |
| Cross-border value | 1 pt | Section 2 (European Value) | ✅ Complete | Pan-European dermatologist shortage (5.5 Spain, 4.2 Germany, 6.8 France, 5.1 Italy per 100K) | None |
Subtotal A.4: 5 points - Status: 80% complete, 20% needs validation
Overall Assessment: Strong EU alignment. Minor action: Confirm technical FHIR implementation details.
SECTION A TOTAL: 40 points - Overall Status: 75% complete, 25% needs data/validation
B. Impact and Market Potential (25 Points)
B.1 Impact on Growth (15 Points)
Criteria: Revenue trajectory, market size, expansion plan, short/medium/long-term impacts
| Sub-Criterion | Weight | Section Location | Status | Evidence Provided | Gaps/Actions |
|---|---|---|---|---|---|
| TAM/SAM quantification | 3 pts | Section 3 (Market Opportunity) | ⚠️ Needs source | TAM: USD $4.7B by 2030, 12.5% CAGR | ACTION: Add market research source (Mordor Intelligence, Grand View Research, etc.) |
| Historical revenue traction | 3 pts | Section 3 (Revenue Traction) | ⚠️ Needs data | EUR 192K+ won contracts (5 deals listed from HubSpot) | ACTION: Add 2022-2024 annual revenue figures, YoY growth % |
| Revenue projections credibility | 3 pts | Section 3 (Revenue Projections) | ⚠️ Needs data | 2025-2027 projections table created | ACTION: Fill 2024 baseline, validate 2025-2027 projections with Finance team |
| EPIC-X grant ROI | 3 pts | Section 3 (EPIC-X Funding Impact) | ✅ Complete | EUR 250K+ ARR impact Year 1 (4.2x return), detailed allocation table | None |
| Short/medium/long-term impact | 3 pts | Section 3 (Impact timelines) | ✅ Complete | 6-12 months (EUR 650K ARR), 1-2 years (EUR 1.2M-2.5M), 3-5 years (EUR 10M+) | None |
Subtotal B.1: 15 points - Status: 60% complete, 40% needs data
Overall Assessment: Strong ROI narrative and growth trajectory structure. Critical gap: Need actual historical revenue data and market research source citation.
B.2 Regional Ecosystem Impact (10 Points)
Criteria: Technological contributions, societal impact, environmental benefits, economic value, role model effect
| Sub-Criterion | Weight | Section Location | Status | Evidence Provided | Gaps/Actions |
|---|---|---|---|---|---|
| Research contributions | 2 pts | Section 3 (Technological Contributions) | ⚠️ Needs data | 6+ publications mentioned, table created | ACTION: Add full publication citations (authors, titles, journals, DOIs, citation counts) |
| Healthcare equity impact | 3 pts | Section 3 (Societal Impact) | ⚠️ Needs data | 50K patients target (2027), wait time reduction, rural access | ACTION: Add baseline metrics (current patients served, current wait times) |
| Women's health impact | 2 pts | Section 3 (Women's Health) | ✅ Complete | Melasma, pregnancy dermatoses, lupus, hormonal acne coverage with incidence rates | None |
| Environmental impact | 1 pt | Section 3 (Environmental) | ✅ Complete | 320 tons CO2 avoided annually (teleconsultations reduce travel) | None |
| Job creation | 1 pt | Section 3 (Economic Value) | ✅ Complete | 31→55 FTEs (2024→2027), indirect employment (clinical coordinators, consultants) | None |
| Role model effect | 1 pt | Section 3, Section 6 | ✅ Complete | Andy's visibility initiatives (5+ talks, 3+ media, 10+ mentees) | None |
Subtotal B.2: 10 points - Status: 70% complete, 30% needs data
Overall Assessment: Strong societal and environmental narrative. Need to add publication details and baseline healthcare equity metrics.
SECTION B TOTAL: 25 points - Overall Status: 64% complete, 36% needs data
C. Implementation and Capacity (35 Points)
C.1 Quality and Feasibility of Work Plan (20 Points)
Criteria: Clear milestones, realistic timeline, deliverables alignment, risk management, feasibility
| Sub-Criterion | Weight | Section Location | Status | Evidence Provided | Gaps/Actions |
|---|---|---|---|---|---|
| 12-month timeline detail | 6 pts | Section 4 (Q1-Q4 Work Plan) | ✅ Complete | Month-by-month, week-by-week breakdown (April 2026 - March 2027) | None |
| Milestone clarity | 4 pts | Section 4 (Deliverables Summary) | ✅ Complete | 6 EPIC-X tasks mapped, quarterly summaries, monthly deliverables | None |
| Risk management | 4 pts | Section 4 (Risk Register) | ✅ Complete | Top 5 risks with likelihood, impact, mitigation, contingency, owner | None |
| Feasibility assessment | 3 pts | Section 4 (entire) | ✅ Complete | Realistic based on 8+ years track record, 4 regulatory clearances, EUR 192K+ contracts | None |
| Integration across modules | 3 pts | Section 4, Section 5 | ✅ Complete | Coaching modules aligned with work plan timeline, synergies identified | None |
Subtotal C.1: 20 points - Status: 100% complete ✅
Overall Assessment: Excellent. Work plan is detailed, realistic, and well-integrated with coaching plan. No gaps.
C.2 Team and Resources (10 Points)
Criteria: Expertise, track record, organizational capacity, women in leadership emphasis
| Sub-Criterion | Weight | Section Location | Status | Evidence Provided | Gaps/Actions |
|---|---|---|---|---|---|
| CEO/Founder track record | 3 pts | Section 4 (Andy Aguilar), Section 6 | ✅ Complete | 8+ years CEO, Forbes 30 Under 30, 4 pre-Legit ventures, B.B.A. Tec de Monterrey | None |
| Management team expertise | 3 pts | Section 4 (Management Team) | ⚠️ Needs data | Table created for CTO, Head MDS, Regulatory, Commercial, CFO | ACTION: Add names, backgrounds, achievements for 5 management roles |
| Organizational certifications | 2 pts | Section 4 (Certifications) | ⚠️ Needs data | ISO 13485, CE MDR, GDPR listed | ACTION: Add certificate numbers and exact dates |
| Team diversity | 2 pts | Section 4, Section 6 | ⚠️ Needs data | 31 FTEs total, tables created for women % overall/leadership/technical | ACTION: Fill team composition tables with actual gender breakdown |
Subtotal C.2: 10 points - Status: 30% complete, 70% needs data
Overall Assessment: Strong CEO narrative. Critical gap: Need management team details and team diversity metrics.
C.3 Budget and Cost-Effectiveness (5 Points)
Criteria: Appropriate allocation, cost-effectiveness, ROI justification, co-financing
| Sub-Criterion | Weight | Section Location | Status | Evidence Provided | Gaps/Actions |
|---|---|---|---|---|---|
| EUR 60K allocation justification | 2 pts | Section 4 (Budget Breakdown) | ✅ Complete | Detailed line items with rationale (US 58.3%, EU 25%, Women 16.7%) | None |
| Co-financing demonstration | 2 pts | Section 4 (Co-Financing) | ✅ Complete | EUR 270K co-financing (EUR 150K personnel, EUR 30K infra, EUR 50K studies, EUR 40K in-kind) | None |
| ROI calculation | 1 pt | Section 4 (ROI) | ✅ Complete | Direct: 4.2x Year 1, Indirect: 714-1,429x (Series A), 3.9x more cost-effective than alternatives | None |
Subtotal C.3: 5 points - Status: 100% complete ✅
Overall Assessment: Excellent. Budget is well-justified with strong ROI narrative and substantial co-financing.
SECTION C TOTAL: 35 points - Overall Status: 71% complete, 29% needs data
Overall Application Status
| Criterion | Max Points | Status | % Complete | Critical Gaps |
|---|---|---|---|---|
| A. Excellence & Innovation | 40 | ⚠️ Needs data | 75% | Performance metrics (SOTA, Fitzpatrick, gender), clinical study details |
| B. Impact & Market | 25 | ⚠️ Needs data | 64% | Historical revenue, publication citations, market research source |
| C. Implementation & Capacity | 35 | ⚠️ Needs data | 71% | Management team details, team diversity metrics, certificate numbers |
| TOTAL | 100 | ⚠️ Needs data | 71% | 29% gaps to fill |
Critical Data Collection Priority List
Priority 1: Performance & Technical Data (Section 2 - 40 points at stake)
Owner: Medical Data Science Team + Product Team
| Data Needed | File Location | Action |
|---|---|---|
| PC-042 Fitzpatrick equity table | /packages/ui/src/components/PerformanceClaimsAndClinicalBenefits/performanceClaims.ts | Extract actual accuracy % by Fitzpatrick type I-VI, populate Section 2 table |
| Gender performance comparison | Performance Claims file | Extract accuracy by gender for acne, psoriasis, melanoma, atopic dermatitis |
| SOTA benchmarks | Performance Claims file or literature | Populate melanoma, psoriasis, severity scale comparison tables with actual % |
| FHIR implementation status | Engineering team | Confirm which FHIR Resources are actually implemented (Patient, Observation, etc.) |
Estimated Time: 2-3 hours (MDS team extracts data, copies to UPDATE placeholders)
Priority 2: Clinical & Regulatory Data (Sections 2, 3 - 55 points at stake)
Owner: Clinical Team + Regulatory Team
| Data Needed | Source | Action |
|---|---|---|
| 7 clinical studies details | Implementation plans at /apps/qms/docs/records/GP-009/r-009-001/ | For each study: patient count (n), exact dates, hospital name, publication status |
| 6+ publication citations | Clinical team bibliography | Authors, title, journal, year, DOI, citation count for 6+ papers |
| Certificate numbers | Regulatory files | ISO 13485 cert #, CE MDR cert #, AEMPS license #, MHRA registration #, ANVISA registration # |
| Exact CE MDR clearance date | Regulatory files | Month and year of CE certificate issuance |
| FDA 510(k) predicate device | Regulatory team | Identify predicate device for substantial equivalence strategy |
Estimated Time: 3-4 hours (Regulatory + Clinical gather docs, extract data)
Priority 3: Financial & Team Data (Sections 3, 4 - 40 points at stake)
Owner: Finance Team + HR Team
| Data Needed | Source | Action |
|---|---|---|
| 2022-2024 annual revenue | Financial statements | Total revenue for 2022, 2023, 2024 + YoY growth % |
| 2025-2027 revenue projections | Financial model | Validate projections in Section 3 table, adjust if needed |
| Market research source | Commercial team or Finance | Cite source for USD $4.7B TAM (Mordor Intelligence, Grand View Research, etc.) |
| Management team details | HR + Leadership | For CTO, Head MDS, Regulatory, Commercial, CFO: Name, background (education/experience), 2-3 key achievements |
| Team gender breakdown | HR records | % women overall, % women in leadership, % women in technical roles (MDS + Engineering) |
| Co-founders 2 & 3 details | Legal/Finance | Names, roles, board positions |
Estimated Time: 2-3 hours (Finance + HR extract data from existing docs)
Priority 4: Andy Aguilar Personal Data (Section 6 - 10 points at stake)
Owner: Andy Aguilar
| Data Needed | Source | Action |
|---|---|---|
| Board Chair appointment date | Corporate records | Year appointed Presidenta del Consejo |
| Forbes category | Forbes award details | Confirm specific Forbes 30 Under 30 category (Healthcare, Tech, Entrepreneurs?) |
| 2-3 recent board decisions | Board meeting minutes | Examples of strategic decisions led by Andy (with dates) |
| Conference speaking log | Andy's calendar | List of conferences where Andy spoke in 2023-2024 |
| Personal statement | Andy writes | 2-3 paragraphs on women in deep-tech, inclusive AI vision, role model responsibility |
Estimated Time: 1-2 hours (Andy provides info, writes personal statement)
Data Collection Sprint Plan (Recommended)
Timeline: 1-2 days concentrated effort
Day 1 Morning (3 hours):
- Medical Data Science team extracts Performance Claims data (Priority 1)
- Clinical + Regulatory teams gather study details and certificates (Priority 2)
Day 1 Afternoon (3 hours):
- Finance + HR teams extract revenue, team composition data (Priority 3)
- Andy provides personal info and writes statement (Priority 4)
Day 2 Morning (2 hours):
- Update all 6 sections with collected data (find/replace UPDATE placeholders)
- Cross-check all tables for consistency
Day 2 Afternoon (2 hours):
- Final quality review (re-run this checklist)
- Stakeholder review meeting (Andy + MDS + Regulatory + Commercial)
Total Effort: ~10 hours concentrated work across 5-6 people
Stakeholder Review Meeting (Recommended)
Duration: 1 hour
Attendees:
- Andy Aguilar (CEO) - Overall review, women leadership content, coaching plan
- Head of Medical Data Science - Technical accuracy (AI/ML architecture, performance claims)
- Head of Regulatory - Compliance content (CE MDR, FDA strategy, ISO 13485)
- Head of Commercial - Market data (revenue, contracts, customer retention)
- CFO - Financial projections, budget allocation, ROI calculations
Agenda:
- Review each section for factual accuracy (20 min)
- Validate performance metrics and claims (15 min)
- Confirm regulatory/compliance statements (10 min)
- Verify financial projections and co-financing (10 min)
- Final approval and sign-off (5 min)
Content Strengths (No Action Needed)
✅ Narrative & Structure: All 6 sections well-organized, professional tone, evidence-based assertions
✅ Coaching Plan: Exceptional detail (20 days, EUR 20K, day-by-day deliverables, KPIs)
✅ Work Plan: Detailed 12-month timeline with monthly/weekly breakdown, risk register
✅ Women Leadership: Comprehensive Andy Aguilar biography, ownership evidence, role model narrative
✅ Budget Justification: Strong ROI (4.2x direct, 714-1,429x via Series A), EUR 270K co-financing
✅ EU Alignment: CE MDR 30-country access, GDPR compliance, cross-border value proposition
Final Checklist Before Submission
- All UPDATE placeholders filled with real data (0 remaining)
- Performance Claims tables populated (Fitzpatrick equity, gender performance, SOTA)
- Clinical study details complete (7 studies: n, dates, hospitals, publications)
- Publication citations complete (6+ papers with DOIs, authors, citations)
- Certificate numbers added (ISO 13485, CE MDR, AEMPS, MHRA, ANVISA)
- Management team details added (5 leaders: names, backgrounds, achievements)
- Team diversity metrics added (% women overall/leadership/technical)
- Historical revenue added (2022-2024 actual, YoY growth)
- Market research source cited (TAM source attribution)
- Andy's personal statement added (2-3 paragraphs)
- Co-founders 2 & 3 details added (names, roles, board positions)
- FHIR implementation confirmed (which Resources actually implemented)
- Stakeholder review completed (Andy + MDS + Regulatory + Commercial sign-off)
- Language/tone review (professional, no typos, consistent terminology)
- Tables formatted correctly (all columns aligned, no broken Markdown)
- External forms completed (Annexes 2-4 copy content from sections)
- Pitch video recorded (2-minute Andy presentation)
Scoring Confidence Assessment
If all data collected and no gaps:
| Criterion | Estimated Score Range | Confidence Level |
|---|---|---|
| A.1 Relevance to EPIC-X (15pts) | 13-15 pts | High (strong deep-tech, SOTA performance, CE MDR Class IIb) |
| A.2 Unbiased Mission (10pts) | 8-10 pts | High (women CEO, Fitzpatrick equity, women's health focus) |
| A.3 Coaching Plan (10pts) | 9-10 pts | Very High (detailed 20-day plan, EUR 20K, clear KPIs) |
| A.4 European Value (5pts) | 4-5 pts | High (CE MDR, GDPR, FHIR, EU expansion) |
| B.1 Growth Impact (15pts) | 12-14 pts | Medium-High (strong trajectory, need credible projections) |
| B.2 Ecosystem Impact (10pts) | 8-10 pts | High (publications, healthcare equity, role model) |
| C.1 Work Plan Quality (20pts) | 18-20 pts | Very High (detailed timeline, risk register, feasibility) |
| C.2 Team & Resources (10pts) | 8-9 pts | High (8+ years track record, ISO 13485, diverse team) |
| C.3 Budget (5pts) | 5 pts | Very High (detailed allocation, strong ROI, co-financing) |
| ESTIMATED TOTAL | 85-95 pts | Competitive (50pt minimum to pass) |
Minimum Threshold: 50 points required to pass → Expected to exceed by 70-90%
Competitive Positioning: With all data filled, application should be highly competitive for 1 of 20 selected startups
Recommended Next Actions
Immediate (Next 24 hours):
- Share this checklist with Finance, Clinical, Regulatory, HR, MDS teams
- Schedule 2-day data collection sprint
- Assign specific UPDATE placeholders to each team member
Short-term (Next 2-3 days): 4. Populate all UPDATE placeholders with collected data 5. Conduct stakeholder review meeting (1 hour) 6. Final quality review pass (re-run this checklist)
Before Dec 19, 2025 (Internal Deadline): 7. Complete external forms (Annexes 2-4) 8. Record 2-minute pitch video 9. Prepare all supporting documents (certificates, publications, contracts)
Before Jan 5, 2026 (Official Deadline): 10. Upload to EPIC-X portal: https://ec.europa.eu/eusurvey/runner/ce2aa52e-20db-8c4b-7e39-396bbdcc9e91 11. Submit and save confirmation 12. Update CLAUDE.md task tracking (mark all deliverables complete)
Conclusion
Application Status: 71% complete structurally, 29% data gaps
Strengths: Excellent narrative structure, detailed coaching plan, comprehensive work plan, strong women leadership evidence
Priority Actions: 2-day data collection sprint across 5 teams to fill UPDATE placeholders (estimated 10 hours total effort)
Confidence Assessment: With all data collected, application is highly competitive for EPIC-X selection (estimated 85-95 points out of 100)
Timeline to Completion: 2-3 days from data collection to final submission-ready application
This application represents a strong foundation that, once data gaps are filled, will demonstrate Legit.Health's exceptional qualifications as a women-led deep-tech company ready for EPIC-X acceleration.