Healthtech clinical evidence pipeline — what to build alongside the product

4. Patient-reported outcomes baked into normal flow. Brief, validated PROs (PHQ-9, GAD-7, SF-12 — domain-specific) integrated into the product cadence. Quarterly is usually enough. The data compounds.

5. Anonymisation pipeline live in production. A separate research database with HIPAA-compliant de-identification. Researchers query the research DB, not the operational one. Setup cost: ~80-120 engineering hours; ongoing cost: low.

The first three studies

Study 1 (Year 1) — Real-world evidence paper. Observational data on N=100-500 patients, ~6 months of follow-up. Publishable in a clinical journal. Cost: $5-15k for statistical support and publication fees. Value: first peer-reviewed evidence; usable in payer conversations.

Study 2 (Year 2) — Retrospective comparative effectiveness study. Compares outcomes for your users against a matched cohort from claims data or registries. N=500-2,000. Cost: $30-80k. Value: comparative claims about your effectiveness.

Study 3 (Year 2-3) — Prospective pragmatic study. Real-world randomised or quasi-randomised study at one or more clinical sites. N=200-1,000. Cost: $300k-$2M depending on scope. Value: the clinical claim you can make in marketing, regulatory filings, payer contracts.

By Series B you should have these three threads in motion. Companies that don't have observational + retrospective evidence at Series B struggle to fund the prospective study at Series C and never get a clinical claim that differentiates them.

What's a waste pre-Series-A

• Premature randomised controlled trial. Without observational evidence to inform study design, an RCT is expensive guess-work. Generate observational first.
• Academic partnerships before you have data to share. Researchers don't want to partner on potential; they want to partner on existing data. Build the data; then the partnerships are easy.
• Hiring a Chief Medical Officer in year 1. Fractional CMO at $3-8k/month is more than enough. Full-time CMO at $400k+ is for Series B+.
• FDA/CE pre-submission meetings without a regulatory plan. Bring a strategy, not a question. Otherwise you waste the agency's time and your credibility.

What to do today

1. Identify your one most important clinical claim (the one outcome you want to defend in 3 years).
2. Design the product to capture the data that proves it from day one. Schema, consent, PROs, structured outcomes.
3. Set up the de-identified research database parallel to the production database.
4. Plan the Year-1 observational paper now; commission it 9-12 months from today.
5. Pick a regulatory consultant who's shipped 5+ products in your category. The first conversation is usually free; the relationship matters from day one.