Section 5: Business Coaching Plan (10 Points)
EPIC-X Requirement: Minimum EUR 20,000 (33.3% of EUR 60,000 grant) allocated for business coaching over 15-20 days
Legit.Health Commitment: EUR 20,000 (33.3% of grant) for 20 days of coaching across 4 strategic modules
Needs Assessment: Critical Growth Challenges
Legit.Health has achieved strong product-market fit (EUR 192K+ won contracts, CE MDR Class IIb, 7 clinical studies) but requires expert coaching to overcome four critical barriers to scale:
Challenge 1: US Regulatory & Market Entry
Current State:
- CE MDR Class IIb certified in EU (2023)
- FDA Small Business Program participant (preparatory stage)
- Zero US market experience or US hospital contracts
Knowledge Gap:
- FDA 510(k) submission process (predicate device selection, clinical data requirements, pre-submission meeting strategy)
- US healthcare system navigation (reimbursement pathways, hospital procurement, EHR integration standards)
- US quality system regulations (21 CFR Part 820) vs. ISO 13485 differences
Impact if Unresolved: 6-12 month delays in FDA clearance, lost first-mover advantage in US market (330M population), inability to compete for US clinical trial partnerships
Challenge 2: Series A Fundraising
Current State:
- Bootstrapped to date (founders' capital + CDTI grant EUR 2.5M)
- Zero prior institutional VC fundraising experience
- Limited European deep-tech healthcare VC connections
Knowledge Gap:
- VC pitch deck best practices for medical AI (not generic startup advice)
- Term sheet negotiation and valuation expectations for CE MDR-certified deep-tech
- Due diligence preparation (clinical data, regulatory documentation, IP strategy)
- Investor targeting (which VCs focus on healthcare AI, check sizes EUR 5-10M)
Impact if Unresolved: Failed fundraising or unfavorable terms (excessive dilution), runway exhaustion before profitability, inability to scale team for US/EU expansion
Challenge 3: European Hospital Partnerships (Cross-Border)
Current State:
- Proven traction in Spain (3+ hospital contracts closed)
- CE MDR valid across EU (regulatory clearance not a barrier)
- Zero contracts in Germany, France, Italy markets
Knowledge Gap:
- German/French/Italian hospital procurement processes (public tender requirements, pricing benchmarks)
- C-suite decision-maker engagement strategies (who are the buyers: CIOs, CMOs, procurement directors?)
- Pilot contract structuring for European public health systems (risk-sharing, performance guarantees)
Impact if Unresolved: 12-18 month delays in European expansion, concentration risk in Spain market, EUR 150K+ ARR opportunity lost (2026)
Challenge 4: Women Leadership Visibility & Ecosystem Engagement
Current State:
- Andy Aguilar: Forbes 30 Under 30, Forbes 100 Most Creative, 8+ years CEO
- Limited conference speaking (1-2 talks in 2024)
- Minimal media presence (0-1 articles in tech/healthcare press)
Knowledge Gap:
- PR strategy for deep-tech founders (media targeting, pitch templates, journalist relationships)
- Conference speaking engagement pipeline (how to get invited to EIT Health, HIMSS Europe, etc.)
- LinkedIn thought leadership content strategy (what resonates with investors, hospital decision-makers, women entrepreneurs)
Impact if Unresolved: Lost visibility opportunities, underutilization of Andy's role model potential, missed investor/partnership introductions via conferences, limited influence on women-in-deep-tech ecosystem
4-Module Coaching Plan (20 Days, EUR 20,000)
Module 1: US FDA Regulatory Strategy
Objective: Achieve FDA 510(k) clearance by Q4 2026 through expert regulatory guidance
Duration: 5 days (spread over April-June 2026)
Budget: EUR 5,000 (25% of coaching budget)
Coach Profile:
- Former FDA reviewer (CDRH - Center for Devices and Radiological Health) OR
- Regulatory consultant with 10+ successful 510(k) submissions for AI/ML medical devices
- Expertise in dermatology or diagnostic imaging devices preferred
Deliverables:
| Day | Activity | Output | Success Metric |
|---|---|---|---|
| 1 | Kick-off: FDA landscape overview, predicate device analysis workshop | - Predicate device shortlist (3-5 candidates) - Substantial equivalence strategy memo | Predicate device selected |
| 2 | Clinical data package review | - Gap analysis for FDA requirements - Bridging study recommendations (if needed) | Clinical package completeness: 90%+ |
| 3 | Pre-submission meeting preparation | - FDA pre-submission meeting deck (draft v1.0) - Q&A preparation (anticipated FDA questions) | Pre-submission meeting scheduled |
| 4 | Mock FDA Q&A session | - Pre-submission meeting deck (final v2.0) - Response scripts for anticipated FDA concerns | Andy + Regulatory team FDA-ready |
| 5 | 510(k) submission package review | - 510(k) submission checklist (completeness audit) - Final submission package recommendations | 510(k) submission filed |
Expected Outcomes:
- 6-Month: FDA pre-submission meeting completed (Q2 2026), 510(k) submitted (Q3 2026)
- 12-Month: FDA 510(k) clearance obtained (Q4 2026 or Q1 2027)
Integration with Work Plan: Aligned with Section 4 timeline (Months 1-3 for pre-submission, Month 4 for submission)
Module 2: Series A Fundraising
Objective: Raise EUR 5-10M Series A by Q3 2026 with favorable terms and strong investor partners
Duration: 7 days (spread over April-September 2026)
Budget: EUR 7,000 (35% of coaching budget, highest allocation reflecting complexity and importance)
Coach Profile:
- European VC partner with healthcare/deep-tech focus (active investor in medical AI companies) OR
- Healthcare investment banker with Series A fundraising track record
- Portfolio/deal experience: EUR 5-20M rounds, post-Series A companies achieving EUR 10M+ ARR
Deliverables:
| Day | Activity | Output | Success Metric |
|---|---|---|---|
| 1 | Fundraising landscape overview, investor targeting | - Investor target list (20+ VCs) - Outreach prioritization (Tier 1, 2, 3) | 20+ investor pipeline |
| 2 | Pitch deck workshop (structure, storytelling) | - Pitch deck v2.0 (draft) - Narrative refinement (problem-solution-traction-vision) | Deck passes coach approval |
| 3 | Financial model workshop | - 3-year financial model (revenue, expenses, headcount) - Unit economics (CAC, LTV, payback period) | Model credibility validated |
| 4-5 | Pitch rehearsal and feedback (2 sessions) | - Pitch deck v2.1 (refined based on mock pitches) - Pitch delivery coaching for Andy | Pitch delivery confidence: 8+/10 |
| 6 | Term sheet negotiation workshop | - Term sheet negotiation playbook - Valuation benchmarking (comparable medical AI companies) | Andy prepared for term sheet discussions |
| 7 | Due diligence preparation | - Due diligence checklist (clinical, regulatory, financial, legal, IP) - Virtual data room structure | DD materials ready |
Expected Outcomes:
- 6-Month: 20+ investor meetings conducted, 2+ term sheets received, 1 term sheet signed (Q3 2026)
- 12-Month: Series A funding closed (EUR 5-10M)
Integration with Work Plan: Aligned with Section 4 timeline (Months 2-6 for investor outreach, Month 6 for closing)
Module 3: European Hospital Partnerships
Objective: Sign 3-5 pilot contracts in Germany, France, Italy by Q3 2026
Duration: 5 days (spread over April-July 2026)
Budget: EUR 5,000 (25% of coaching budget)
Coach Profile:
- Healthcare business development executive with 10+ years experience selling to European public health systems
- Germany/France/Italy hospital contracting experience required
- Background in medical devices or digital health preferred
Deliverables:
| Day | Activity | Output | Success Metric |
|---|---|---|---|
| 1 | Market entry strategy workshop (Germany/France/Italy) | - Market entry strategy document (3 countries) - Target hospital shortlist (10-15 hospitals per country) | Hospital target list validated |
| 2 | Procurement process navigation | - Procurement process guides (tender requirements by country) - Pilot contract templates (public vs. private hospitals) | Procurement understanding: 90%+ |
| 3 | C-suite engagement playbook | - Decision-maker mapping (CIO, CMO, procurement) - Engagement scripts and email templates - Value proposition customization (Germany/France/Italy) | Outreach materials ready |
| 4 | Pilot proposal workshop | - Pilot proposal deck (PowerPoint) - Pilot study protocol (methodology, timeline, KPIs) - Pricing strategy (pilot vs. full contract) | Pilot proposals submitted (5+ hospitals) |
| 5 | Contract negotiation coaching | - Negotiation playbook (common objections, risk-sharing structures) - Legal review checklist for EU contracts | Commercial team negotiation-ready |
Expected Outcomes:
- 6-Month: 15+ C-suite meetings conducted, 5+ pilot proposals submitted, 3-5 pilot contracts signed (Q3 2026)
- 12-Month: Pilots converted to full contracts (EUR 150K+ ARR from Germany/France/Italy)
Integration with Work Plan: Aligned with Section 4 timeline (Months 1-4 for market research and C-suite engagement, Months 4-6 for contract signature)
Module 4: Women Leadership Visibility & Thought Leadership
Objective: Establish Andy Aguilar as a visible thought leader in women-led deep-tech and inclusive AI
Duration: 3 days (spread over April-June 2026)
Budget: EUR 3,000 (15% of coaching budget)
Coach Profile:
- PR strategist or communications consultant with deep-tech startup experience
- Media connections in European tech/healthcare press (TechCrunch, Sifted, MobiHealthNews)
- Conference programming experience (EIT Health, HIMSS Europe, etc.)
Deliverables:
| Day | Activity | Output | Success Metric |
|---|---|---|---|
| 1 | PR strategy development | - 12-month PR calendar (key milestones, media hooks) - Media target list (10+ journalists/outlets) - Press kit (Andy bio, company fact sheet, images) | PR strategy approved |
| 2 | Conference speaking strategy | - Conference target list (10+ conferences: EIT Health, HIMSS Europe, ML4H, etc.) - Conference application templates - Talk topic recommendations (inclusive AI, women in deep-tech) | 5+ conference applications submitted |
| 3 | LinkedIn thought leadership strategy | - LinkedIn content calendar (weekly posts for 6 months) - Content themes (inclusive AI, FDA journey, fundraising lessons, women in STEM) - Engagement tactics (hashtags, commenting strategy) | LinkedIn content plan launched |
Expected Outcomes:
- 6-Month: 5+ conference talks delivered, 3+ media features published, +2,000 LinkedIn followers
- 12-Month: 10+ conference talks, 5+ media features, mentorship program launched (10 mentees), Andy recognized as thought leader in women-led medical AI
Integration with Work Plan: Aligned with Section 4 timeline (Months 1-2 for PR launch, Months 2-6 for conference speaking)
Coaching Delivery & Logistics
Format
Primary Delivery: Remote (video calls via Zoom/Teams)
- Allows flexible scheduling around Andy's CEO operational responsibilities
- Reduces travel costs and carbon footprint
- Enables recording for knowledge transfer to team
Occasional In-Person (if budget allows):
- Module 2 (Series A): 1-2 in-person pitch rehearsals with coach (if based in Europe)
- Module 3 (EU Partnerships): Join C-suite meetings in Germany/France/Italy if coach has local connections
Schedule
Weekly Commitment: ~1 day/week of coaching engagement (20 days over 6 months = ~3-4 days/month average)
Flexible Pacing:
- Front-loaded: Modules 1-2 concentrated in Q2 2026 (critical path for FDA and fundraising)
- Ongoing: Modules 3-4 spread across Q2-Q3 2026 (conference speaking and partnerships build gradually)
Knowledge Transfer
Documentation:
- All coaching sessions recorded (with coach permission)
- Deliverables stored in shared Google Drive folder (accessible to Legit.Health team)
- Key insights distilled into playbooks for future use (e.g., "FDA 510(k) Submission Playbook" for future product submissions)
Team Involvement:
- Regulatory team joins Module 1 sessions (FDA)
- CFO joins Module 2 sessions (Series A)
- Commercial team joins Module 3 sessions (EU partnerships)
- Marketing team joins Module 4 sessions (PR/visibility)
Integration with EPIC-X Program
Alignment with 6-Month Timeline
EPIC-X Program Duration: April 1 - September 30, 2026
| Month | Module 1 (FDA) | Module 2 (Series A) | Module 3 (EU Partnerships) | Module 4 (Visibility) |
|---|---|---|---|---|
| April | Days 1-2 | Days 1-2 | Day 1 | Day 1 |
| May | Days 3-4 | Days 3-4 | Days 2-3 | Day 2 |
| June | Day 5 | Days 5-6 | Days 4-5 | Day 3 |
| July | - | Day 7 | - | - |
| Aug-Sep | - | Follow-up (Series A closing) | Follow-up (contract negotiations) | Follow-up (conferences) |
Synergies Between Modules
Module 1 + Module 2: FDA clearance strengthens Series A pitch (de-risks US market entry, expands TAM)
Module 2 + Module 3: Series A funding enables European team scaling (BD hires for Germany/France/Italy)
Module 4 → All Modules: Conference speaking generates investor leads (Module 2) and hospital decision-maker introductions (Module 3)
EPIC-X Network Leverage
EIT Health Connections:
- EIT Health Alumni introductions to hospital decision-makers in Germany/Italy (supports Module 3)
- EIT Health Summit speaking opportunities (supports Module 4)
European Commission Visibility:
- EPIC-X program participation itself generates PR opportunities ("1 of 20 women-led deep-tech startups selected")
- EC networks introduce VCs focused on European deep-tech (supports Module 2)
Success Metrics & Evaluation
Module-Level KPIs (6-Month Outcomes)
| Module | KPI | Target | Measurement |
|---|---|---|---|
| 1 (FDA) | Pre-submission meeting completed | ✓ | FDA meeting minutes |
| 1 (FDA) | 510(k) submitted | ✓ | FDA acknowledgment letter |
| 2 (Series A) | Investor meetings conducted | 20+ | CRM log |
| 2 (Series A) | Term sheets received | 2+ | Term sheet PDFs |
| 3 (EU Partnerships) | C-suite meetings conducted | 15+ | Meeting logs |
| 3 (EU Partnerships) | Pilot contracts signed | 3-5 | Signed agreements |
| 4 (Visibility) | Conference talks delivered | 5+ | Speaker confirmations |
| 4 (Visibility) | Media features published | 3+ | Press clippings |
Overall Program KPIs (12-Month Outcomes)
| Objective | Baseline (Dec 2024) | Target (Dec 2026) | Success Criteria |
|---|---|---|---|
| US Market Access | FDA Small Business participant | FDA 510(k) cleared | ✓ Clearance letter |
| Funding | EUR 2.5M (CDTI grant) | EUR 5-10M (Series A) | ✓ Funding closed |
| European Revenue | EUR [Baseline from Spain] | EUR 150K+ ARR (Germany/France/Italy) | ✓ Invoices/receipts |
| Visibility | 1-2 conference talks/year | 5+ talks in 6 months | ✓ Speaking confirmations |
| Team Growth | 31 FTEs | 41 FTEs | ✓ Headcount increase |
Coaching ROI
Direct Coaching Investment: EUR 20,000
Expected Returns:
- Module 1 (FDA): EUR 500K+ ARR from US market (2027-2028) = 25x return over 2 years
- Module 2 (Series A): EUR 5-10M raised = 250-500x return (capital mobilized)
- Module 3 (EU Partnerships): EUR 150K+ ARR from Germany/France/Italy = 7.5x return in Year 1
- Module 4 (Visibility): 10 mentees launched, 500+ women inspired = Ecosystem impact (non-monetizable but mission-aligned)
Total Coaching ROI: 282-533x over 2 years (combining monetizable outcomes from Modules 1-3)
Conclusion: Strategic Coaching for Maximum Impact
Legit.Health's EUR 20,000 coaching plan (33.3% of EPIC-X grant) is strategically designed to address the four most critical growth barriers:
✅ US FDA Regulatory Strategy (Module 1, 5 days, EUR 5,000): Expert guidance to navigate 510(k) submission process, accelerate FDA clearance by 6+ months, unlock 330M population market
✅ Series A Fundraising (Module 2, 7 days, EUR 7,000): VC expertise to raise EUR 5-10M with favorable terms, enabling European expansion and US market entry team scaling
✅ European Hospital Partnerships (Module 3, 5 days, EUR 5,000): BD coaching to close 3-5 pilot contracts in Germany/France/Italy, diversifying beyond Spain market concentration
✅ Women Leadership Visibility (Module 4, 3 days, EUR 3,000): PR strategy to establish Andy Aguilar as thought leader, amplify role model impact, inspire next generation of women in deep-tech
This coaching plan is tightly integrated with the 12-month work plan (Section 4), delivers measurable KPIs at 6-month and 12-month milestones, and generates 282-533x ROI over 2 years—demonstrating exceptional cost-effectiveness and strategic alignment with EPIC-X's mission to accelerate women-led deep-tech companies.