For funds where clinical evidence and regulatory pathway determine outcome.
The Healthtech overlay is in design. Our work on the live Impact engagement already exercises some of the underlying primitives because that engagement intersects clinical evidence. We're looking for our first dedicated Healthtech engagement to formalize the segment-specific overlay.
FIG. 01 ── HEALTHTECH SIGIL · CLINICAL · REGULATORY · REIMBURSE
Three things every Healthtech fund deals with.
FIG. 02 ── EVIDENCE ASYMMETRY · CLAIM vs LITERATURE · κ 0.85–0.90
01
CLINICAL EVIDENCE ASYMMETRY
Founders' decks claim clinical efficacy. The underlying literature is partial, contested, or non-existent. The cost of accepting weak evidence is multi-year, multi-million-euro. Counter-evidence search at the 0.85–0.90 confidence band catches most asymmetries. The audit chain preserves the rigor for every claim.
02
REGULATORY PATHWAY UNCERTAINTY
FDA, EMA, MHRA, BfArM pathways diverge by product class. Software-as-a-Medical-Device (SaMD) regulatory posture is still evolving. Reimbursement pathways diverge further. Funds without rigor on pathway assessment over-invest in unwinnable regulatory positions.
03
REIMBURSEMENT RISK COMPOUNDED
Even when regulation clears, reimbursement may not. CMS · NICE · G-BA · HAS each have different evidence thresholds. Phase 3 trial design that satisfies regulation may not satisfy reimbursement. The overlay tracks both pathways in parallel.
What we're designing.
FIG. 03 ── DUAL-PATHWAY BLUEPRINT · REGULATORY ∥ REIMBURSEMENT
01
CLINICALTRIALS · PUBMED · COCHRANE · NICE
Real-time integration. Counter-evidence search auto-triggered. Replication-status weighting. Mechanism-of-action documentation requirements. Partner-defined source weighting (pharma-funded studies vs independent).
02
REGULATORY PATHWAY TRACKING
FDA 510(k) · PMA · De Novo · breakthrough designation. EMA centralized · decentralized · mutual recognition. SaMD-specific (FDA Pre-Cert · MDR class IIa/IIb/III). MHRA, BfArM, HAS posture tracked per portco.
03
REIMBURSEMENT RISK MODELING
CMS coding (CPT, HCPCS, DRG). NICE technology appraisal track record. G-BA AMNOG assessment patterns. HAS HTA outcomes. Phase 3 endpoint design assessed against reimbursement evidence requirements, not just regulatory.
04
MECHANISM OF ACTION DOCUMENTATION
Founder claims about MOA traced to underlying biology. Where MOA is novel, overlay flags additional rigor requirements. Where MOA is established, prior reference data becomes evidence weight.
05
PHASE PROGRESSION ANALYTICS
Series A through commercialization. Phase 1/2/3 progression rates by therapeutic area. Cohort-context retrieval ("how do dementia digital therapeutics typically progress through Phase 3?").
Same eight KPIs. Healthtech calibration.
FIG. 04 ── KPI BAND · NOW → TARGET · HEALTHTECH-CALIBRATED
INBOUND TRIAGE
3×
vs partner baseline · therapeutic area routing
DECISION TURNAROUND
≤ 30 min
including evidence-asymmetry flag
CLINICAL SCORE
≤ 10 min
full evidence stack with counter-search
INTER-RATER κ
≥ 0.85
Cohen's κ weighted · across partners · clinical judgment
EVIDENCE COVERAGE
≥ 95%
verified · counter-evidence checked
PATHWAY LEAD TIME
≤ 14 days
regulatory shift flagged before material
AUDIT COVERAGE
100%
clinical claims + pathway + reimbursement
PARTNER TIME FREED
+ 50%
time on founder + clinical engagement
Co-design terms.
First-engagement funds in a new segment get co-design pricing and naming-as-reference rights (if mutually beneficial). Phase 0 remains free (10 working days, framework + synthetic-data PoC). Phase 1 scope reflects co-design. All artifacts — including the Healthtech overlay v0.1 — yours unconditionally regardless of gate outcome.
§ END ── FIRST HEALTHTECH FUND