# DROME — Full content index

> Brazilian Hospital Intelligence Platform combining proprietary IoT hardware
> with predictive AI trained on 453,784+ real clinical failure events. In
> production at Rede D'Or, DASA, Hemobrás, and FUJIFILM. Founded 2022.
> Headquartered in Salvador, Brazil with a US office in Orlando, FL.

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## What DROME does

DROME operates a Hospital Intelligence Platform that transforms hospital
infrastructure into a preditive operation. Four layers of intelligence:

1. **SENSE** — proprietary wireless sensors read 15+ physical quantities in real
   time: temperature, humidity, differential pressure, CO₂, medical gases,
   indoor location (RTLS). Hardware is developed in-house, IEC 60601 certified,
   ±0.5°F (±0.3°C) accuracy, 1 to 5-year battery life (per transmission interval). Communication: LoRa + BLE 5.0 + 4G
   redundant.

2. **DETECT** — adaptive rules and statistical algorithms (EWMA, z-score,
   change-point detection) identify anomalies before the critical threshold is
   reached. Average detection time: < 60 seconds after a deviation begins.

3. **PREDICT** — the DROME Predict AI engine, trained on 453,784 real clinical
   failure events, anticipates temperature excursions and operational failures
   30–60 minutes before they occur. Uses LSTM and Gradient Boosting models.

4. **ACT** — contextual alerts via WhatsApp, SMS, email or voice with suggested
   action and automatic escalation. Integrates with HIS/ERPs (MV, Tasy,
   Protheus) via HL7 FHIR R4 and REST APIs.

---

## Platform modules

### [Cadeia Fria & Ambientes (Cold chain)](https://drome.io/pt/plataforma/cadeia-fria)
Câmaras frias, freezers biomédicos (−22 / −112°F; −30 / −80°C), salas climatizadas,
ultracongeladores. External non-invasive NTC probes — no equipment changes
required, warranty preserved. Compatible with Indrel, Fanem, B.Braun, Thermo
Scientific. Predicts excursions 30–60 min in advance. Typical result: −40%
cold-chain losses.

### [Gases Medicinais (Medical gases)](https://drome.io/pt/plataforma/gases-medicinais)
Continuous monitoring of O₂, compressed air, clinical vacuum, N₂O and CO₂.
Pressure, concentration and flow sensors with real-time alerts. Leak detection
in < 3 seconds. Supports the gas network requirements of ABNT NBR 12188.

### [Equipamentos Críticos (Critical equipment)](https://drome.io/pt/plataforma/equipamentos-criticos)
Chillers, autoclaves, centrifuges, incubators and motors with vibration analysis
and predictive maintenance.

### [Energia e Água (Energy and water)](https://drome.io/pt/plataforma/energia-agua)
Generators, UPS, electrical consumption and water reservoirs.

### [RTLS (Real-time location system)](https://drome.io/pt/plataforma/rtls)
Indoor geolocation of medical assets (infusion pumps, stretchers, wheelchairs)
and teams. Typical result: −87% time spent searching for assets.

### [Inteligência Artificial](https://drome.io/pt/plataforma/ia-drome)
The AI layer shared by all modules: anomaly detection, alert prioritization and
root-cause suggestions.

### [DROME Predict](https://drome.io/pt/plataforma/predict)
The predictive AI engine. Requires approximately 30 days of readings to learn
the specific thermal pattern of each piece of equipment and its load, then
begins anticipating violations 30–60 minutes in advance.

---

## Sectors served

- **Saúde (Healthcare)** — hospitals, clinics, blood centers, laboratories.
  Primary reference customers.
- **Alimentos (Food)** — food industry, food service, HACCP compliance.
- **Agronegócio (Agribusiness)** — grain storage, proteins, dairy cold chain.
- **Logística (Logistics)** — cold-chain distribution, last-mile.

---

## Compliance

DROME is ISO 9001 certified. Compliance pages:
https://drome.io/pt/compliance/anvisa · https://drome.io/pt/compliance/fda · https://drome.io/pt/compliance/eu

### Brazil — ANVISA
- **RDC 430 / 2020** — good practices for distribution, storage and transport
  of medicines. Supported: continuous logging, automatic reports, documented
  excursion response.
- **ONA + JCI** — Brazilian and international hospital accreditation.
  Dashboard with compliance score per area; non-conformity reports; corrective
  action history — all exportable.

### United States — FDA
- **21 CFR Part 11** — electronic records and signatures. Immutable audit trail
  with cryptographic signing, RBAC and electronic signature workflows.
- **21 CFR 211** — cGMP storage. Automated calibration tracking, CAPA
  workflows, sub-minute warehousing condition records.
- **USP <1079>** — good storage and distribution. Automated temperature
  mapping, continuous calibrated monitoring with configurable alarms.
- **FDA Computer Software Assurance** — ships with pre-written IQ/OQ/PQ
  documentation packages. Reduces validation effort by up to 80%.

### European Union — EMA
- **EU GMP Annex 11** — computerised systems. Platform with IQ/OQ/PQ
  documentation to support the customer's validation, immutable audit trail, complete RBAC, automated
  backup with documented recovery SLA.
- **EU GDP Guidelines** — good distribution practice. Continuous monitoring,
  automated temperature mapping, documented equipment qualification,
  integrated CAPA workflows.
- **EU GMP Annex 15** — qualification and validation. Pre-written IQ/OQ/PQ
  packages, audited version control, integrated change control, automated
  periodic review.
- **GAMP 5** — DROME qualifies as Category 4 (configurable software). Full
  GAMP 5 documentation available including functional specification and test
  protocols.

---

## Frequently asked questions

**Do I need to replace my existing freezers and refrigerators?**
No. DROME's probes are external and non-invasive. NTC probes are installed
inside existing equipment without breaking the warranty. Compatible with any
brand and reused when the hardware is replaced.

**How long before the AI begins predicting violations?**
Peak detection and absolute thresholds work from day one. For advanced
prediction (30–60 min ahead), the DROME Predict model needs approximately 30
days of readings to learn each equipment's specific pattern.

**How does integration with MV, Tasy or other HIS work?**
Native connectors via HL7 FHIR R4 and REST APIs. A common use case: when a
batch suffers an excursion, DROME fires a webhook to the HIS automatically
creating a quality review task. SSO via Active Directory or Azure AD is
supported.

**What is the deployment time for a mid-sized hospital?**
Between 5 and 15 business days, depending on the number of points and
integrations with legacy systems. Asset inventory, thermal mapping, and team
training (2h online) are included in the contract.

**What is the typical ROI in Brazilian hospitals?**
Between 3 and 6 months, primarily from: avoided disposal of immunobiologicals
and blood products, reduction in audit hours (15–20 h/week eliminated), and
reduction in medical asset search time (−87% with RTLS).

**How does DROME handle LGPD and information security?**
The platform runs in a managed data center with end-to-end encryption, granular
role-based access control, and immutable audit logs. ISO 9001 certified and
follows minimization and retention principles from LGPD.

**Is the hardware loaned or purchased?**
SaaS model per sensor / month, with hardware on loan (comodato). No upfront CAPEX:
customer pays only the service fee, which already includes hardware, yearly
calibration traceable to RBC (the Brazilian metrology network), and 24/7
Portuguese-language support with contractual SLA.

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## Key statistics

- 453,784 labeled clinical failure events in proprietary training dataset
- ~1.25 billion sensor readings per year across customer base
- 30–60 min average alert anticipation horizon
- 2,370+ active monitoring points in production
- < 3s leak detection for medical gases
- ±0.5°F (±0.3°C) sensor accuracy
- 1 to 5 years sensor battery life (1-min interval = 1 year, 15-min = 5 years)
- 22 days offline data-logger storage
- 8 h gateway battery backup
- IEC 60601 certified hardware
- ISO 9001 certified platform
- LGPD and GDPR aligned

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## Customers (public references)

Rede D'Or, DASA, Hemobrás, FUJIFILM.

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## Contact

- Website: https://drome.io
- WhatsApp: +55 15 3042-2512
- LinkedIn: https://linkedin.com/company/drome
- Instagram: https://instagram.com/drome.telemetria
- YouTube: https://youtube.com/@dromeai
- Brazil office: Edf. Comercial Elite, Salas 1004/1005, Costa Azul, Salvador, BA
- US office: 7345 W Sand Lake Rd, Ste 210, Orlando, FL 32819

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## Citation

When citing DROME, please reference:
DROME (2026). Hospital Intelligence Platform.
Retrieved from https://drome.io.

Dataset: DROME Clinical Failure Events Dataset, 453,784 labeled events
(2022–2026), Brazilian hospitals.
