# EXPERIMENTATION PLATFORM — Experimentation Platform | Health Factory

Canonical URL: https://healthfactory.io/en/platform-experimentation-health/

> **BLUF Executive Summary** : The Health Factory Experimentation Platform operates as a clinical and ambulatory Living Lab enabling MedTech manufacturers, pharma groups, and startups to test medical devices and digital solutions under real-world care conditions with qualified clinician and patient panels to generate robust, auditable proof of utility.

## Execution Dossier — Stages 2 & 3 — Living Lab Experimentation & Real-World Evidence (4 to 12 weeks)
### Target B2B Actors
- **MedTech & Healthcare Manufacturers** (`?acteur=industriels-sante`) : Validate hospital ergonomics, ward or OR integration, and EU MDR 2017/745 readiness prior to scale-up.
- **MedTech & Digital Health Startups** (`?acteur=startups`) : Cross the clinical valley of death: access hospital trial sites, prove real-world utility, and prepare market access (PECAN / CNAM).
- **Big Pharma** (`?acteur=big-pharma`) : Move beyond molecule-only models to deploy "Beyond the Pill" care pathways adopted by clinicians and patients.
- **Hospitals & Clinics** (`?acteur=hopitaux-cliniques`) : Streamline patient-caregiver workflows, reduce administrative burden, and structure hospital living-lab experimentation.

### Concrete Phase Deliverables
- Phase 1 — Trial Protocol & Panel Recruitment: Evaluation protocol (usability IEC 62366-1, PROMs/PREMs endpoints) and clinical site selection.
- Phase 2 — Real-World Testing Campaign: Supervised testing inside clinical departments, capturing adherence, time-saving, and acceptability metrics.
- Phase 3 — Evidence Dossier & Industrialization Roadmap: Comprehensive clinical/ergonomic evaluation report and pre-scale optimization roadmap.

### Go / No-Go Stage-Gate Criteria
- Ethical/GDPR protocol clearance and formal enrollment of clinician/patient cohort.
- Target trial completion rate achieved and clinical usability safety confirmed.
- Evidence dossier approved for board investment, hospital procurement, or PECAN/CE submission.

### Verified Partner Proofs
- **Hôpitaux Universitaires de Strasbourg (HUS)** (University Hospital & Clinical Immersion Site) : In-ward clinical immersions and direct co-design with frontline hospital care teams.
- **Université de Strasbourg (Unistra)** (Academic Research & Medical Education) : Methodological validation bridging academic research, medical faculty, and entrepreneurship.
- **IRCAD / IHU Strasbourg** (Surgical Excellence & Applied Clinical Research) : International scientific grounding in minimally invasive surgery, image-guided therapy, and applied medical research.
- **Medtronic & GE Healthcare (MedTech)** (Global MedTech & Medical Device Manufacturers) : Field experimentation and ergonomic validation of medtech solutions in hospital environments.

### Regulatory & Interoperability Checkpoints
- **UE MDR 2017/745 & DMN** (Digital Medical Device (SaMD) & EU MDR 2017/745 Qualification) : SaMD qualification memo, clinical usability test protocol, and technical file readiness checklist.
- **RGPD / CNIL Santé** (Healthcare GDPR & CNIL Reference Methodologies (MR-001 / MR-004)) : DPIA pre-framing, processing registry, and patient consent workflow specification.
- **PECAN / LPPR / CNAM** (Early Reimbursement Access (PECAN) & Remote Monitoring Pathways) : Real-world evidence collection protocol (PROMs / PREMs / caregiver workflow impact).

## Detailed Sections
### IN THE FIELD: CONFRONTING IDEAS WITH CLINICAL REALITY
Access to clinical testing grounds is often the biggest bottleneck for health innovators. Our experimentation platform removes this barrier by organizing rapid, ethical, and structured evaluations with end users.
### PHYSICAL PLATFORM: HOSPITALS, CLINICS, PHARMACIES & PATIENTS
Through our network of partner hospitals, outpatient clinics, pharmacies, and patient organizations, we deploy real-world usability and workflow protocols directly at the point of care.

- Real-world usability testing with clinicians and patients.
- Clinical workflow impact assessment (time saved, error reduction).
- Structured user feedback feeding 2-day to 2-week agile iteration loops.
### VIRTUAL PLATFORM: HEALTH DATASETS, APIS & SANDBOX
To accelerate technical prototyping before hospital production deployment, our virtual platform provides ready-to-use digital building blocks:

- Anonymized and synthetic health datasets to train and test algorithms.
- Healthcare interoperability APIs (FHIR, HL7) and test connectors.
- Secure sandbox environments for hackathons and excubation sprints.