Due Diligence Checklists › HealthTech › Pre-Seed
HealthTech Startup Investment Checklist: Pre-Seed Stage (2026)
This checklist covers 24 due diligence items for HealthTech startups at the Pre-Seed 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
Pre-Seed Requirements
✓
Founding team quality and relevant domain expertise
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Problem evidence: clear pain, ideally lived experience
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Market size: TAM must justify a venture-scale outcome
✓
Early signal of demand: waitlist, LOIs, or first customers
✓
Founder-market fit: why this team for this problem
✓
Proprietary insight competitors don't have
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
✓
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
✓
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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