Due Diligence Checklists › HealthTech › Growth / Pre-IPO
HealthTech Startup Investment Checklist: Growth / Pre-IPO Stage (2026)
This checklist covers 24 due diligence items for HealthTech startups at the Growth / Pre-IPO stage. Each item has been validated against institutional investor practice. DDR automates the majority of these checks from a single pitch deck PDF upload.
24 checklist items · 4 red flags automatically detected · See a sample DDR report
Growth / Pre-IPO Requirements
✓
$10M+ ARR with clear path to $100M+
✓
Profitability or credible path to profitability within 24 months
✓
Category leadership: top 1–2 in defined market
✓
CFO and board ready for public market scrutiny
✓
Revenue quality: multi-year contracts, low churn, high NRR
✓
Institutional governance: audit committee, independent board majority
HealthTech Sector
✓
FDA regulatory status confirmed (clearance, exempt, or pre-submission in process)
✓
HIPAA compliance program documented with BAA template
✓
Clinical evidence reviewed with methodology assessment
✓
Payor coverage or CPT code strategy documented
✓
Reference customer interviews completed
✓
Data security assessment and breach history reviewed
✓
Stark Law / Anti-Kickback compliance verified for any referral arrangements
Deep Dive
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Verify FDA clearance status and any 510(k) submission history
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Confirm HIPAA compliance framework: BAA templates, security officer, breach history
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Review clinical evidence: study design, sample size, statistical significance
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Assess payor coverage and reimbursement status
✓
Interview reference customers (physicians, administrators, patients)
Regulatory
✓
Verify: FDA 510(k) or PMA: medical device and diagnostic claims require pre-market review
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Verify: HIPAA: PHI handling requires BAAs, security officer, breach notification protocol
✓
Verify: Stark Law and Anti-Kickback Statute: referral and compensation arrangements in healthcare
OSINT Signals
✓
Check: FDA 510(k) database: verify clearance status and device classification
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Check: PubMed: search for published clinical studies mentioning the company
✓
Check: ClinicalTrials.gov: check for registered studies
DDR AUTOMATES THIS CHECKLIST
Upload a HealthTech startup pitch deck and DDR automatically completes 17+ of these 24 checklist items — sourcing data from 13 OSINT signals, benchmarking against 3 comparable companies, and detecting all 4 critical red flags.
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