{
  "dataset": "bioaccess® LATAM First-in-Human Benchmarks 2026",
  "source": "https://bioaccessla.com/latam-fih-benchmarks-2026",
  "publisher": "bioaccess®",
  "lastReviewed": "2026-07",
  "notes": "Planning benchmarks derived from bioaccess®'s operating data across the U.S. and 10 Latin American markets. Not guarantees of price, timing, or regulatory outcome. De-identified — no client, device, hospital, or investigator details.",
  "metrics": [
    { "id": "ethics-approval", "metric": "Ethics-committee approval", "latam": "4–8 weeks", "us_eu": "6–12 months" },
    { "id": "protocol-to-first-patient", "metric": "Protocol to first patient", "latam": "6–8 weeks", "us_eu": "6–12 months" },
    { "id": "per-patient-site-cost", "metric": "Per-patient site cost", "latam": "$15K–$35K", "us_eu": "$40K–$75K" },
    { "id": "ta-ophthalmology-outpatient", "metric": "Per-patient site cost — Ophthalmology (outpatient implant)", "value": "≈ $13K / patient" },
    { "id": "ta-orthopedics-surgical", "metric": "Per-patient site cost — Orthopedics (surgical implant, inpatient)", "value": "≈ $25K–$28K / patient" },
    { "id": "ta-peripheral-vascular", "metric": "Per-patient site cost — Peripheral vascular / endovascular (cath-lab)", "value": "≈ $23K–$38K / patient" },
    { "id": "country-mexico", "metric": "Regulatory startup → approval, Mexico", "value": "from ≈ $188K (excludes sponsor device, trial insurance, and study beyond approval)" },
    { "id": "country-colombia", "metric": "Regulatory startup → approval, Colombia", "value": "from ≈ $305K (adds INVIMA technical-dossier step — GICASE / Sala Especializada)" },
    { "id": "country-panama", "metric": "Ethics approval, Panama", "value": "≈ 3–5 weeks (MINSA + CNBI-registered committees)" }
  ]
}