Due Diligence Checklists › HealthTech › Series A
HealthTech Startup Investment Checklist: Series A Stage (2026)
This checklist covers 24 due diligence items for HealthTech startups at the Series A 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
Series A Requirements
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$1M+ ARR or strong path within 12 months
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Proven repeatable go-to-market motion
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Net Revenue Retention >100% (expansion > churn)
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Gross margins indicating sustainable unit economics
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Management team capable of scaling to $10M ARR
✓
Clear competitive differentiation and moat building
HealthTech Sector
✓
FDA regulatory status confirmed (clearance, exempt, or pre-submission in process)
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HIPAA compliance program documented with BAA template
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Clinical evidence reviewed with methodology assessment
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Payor coverage or CPT code strategy documented
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Reference customer interviews completed
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Data security assessment and breach history reviewed
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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
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Interview reference customers (physicians, administrators, patients)
Regulatory
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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
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Verify: Stark Law and Anti-Kickback Statute: referral and compensation arrangements in healthcare
OSINT Signals
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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
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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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