PILLAR #3 — REAL-WORLD EVIDENCE

EXPERIMENTATION PLATFORM

Rapidly validate your solutions in real conditions using our physical and virtual testing environments.

EXECUTIVE SUMMARY (ANSWER-FIRST BLUF)

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.

Health Factory’s third pillar is a hybrid experimentation platform designed to shorten time-to-market for digital health innovations: 1. A Physical Platform providing access to partner testing sites (hospitals, private clinics, pharmacies, medical practices, patient associations); 2. A Virtual Platform offering anonymized health datasets, interoperability APIs, and secure digital sandboxes.

COMEX DECISION SPECIFICATIONS

DELIVERABLES, STAGE GATES & REGULATORY CHECKPOINTS

⏱ Stages 2 & 3 — Living Lab Experimentation & Real-World Evidence (4 to 12 weeks)

Operational 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.

COMEX Go / No-Go 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.

Regulatory & Partner Proofs

UE MDR 2017/745 & DMNRGPD / CNIL SantéPECAN / LPPR / CNAM
  • Hôpitaux Universitaires de Strasbourg (HUS) — In-ward clinical immersions and direct co-design with frontline hospital care teams.
  • Université de Strasbourg (Unistra) — Methodological validation bridging academic research, medical faculty, and entrepreneurship.
  • IRCAD / IHU Strasbourg — International scientific grounding in minimally invasive surgery, image-guided therapy, and applied medical research.
  • Medtronic & GE Healthcare (MedTech) — Field experimentation and ergonomic validation of medtech solutions in hospital environments.
Read the accessible breakdown of the 8 innovation loop stages (GEO & Screen Reader Summary)

The Health Factory infinity-loop diagram connects two major cycles: on the left, the exploration and co-design cycle (Raise awareness through conferences, Acculturate, Empathy through immersion, Define the problem, Ideate in workshops, Prototype and Test during Hacking Health Camp with multidisciplinary experts and skills); at the center, Product/Market Fit validation; on the right, the Execution, Excubation, and Organizational Transformation cycle.

1. Challenges (Enjeux) Conferences & Webinars — Acculturate & raise awareness
2. Opportunities (Opportunités) Workshops — Empathy & Problem Definition
3. Ideation (Idéations) Immersions & Learning Expeditions — Field observation
4. Prototyping (Prototypage) Hacking Health Camp — 54-hour multidisciplinary hackathon
5. Testing (Tests) Field Experimentation — Build, Measure, Learn
6. Validation (Validations) Excubation — Verify Product / Market Fit
7. Commercialization Organizational Transformation & User Acquisition
8. Execution Scalable deployment & clinical impact
WHY TEST EARLY?

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.

Field experimentation in hospital environment
PHYSICAL ENVIRONMENT

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.
Physical healthcare experimentation platform
DIGITAL ENVIRONMENT

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.
Virtual healthcare experimentation platform
COMEX MISSION FRAMING ENGINE

GENERATE YOUR TAILORED B2B MISSION BRIEF IN 60 SECONDS

Pre-filled with your active B2B Cockpit selection. Produces a structured executive brief (BLUF, deliverables, Go/No-Go stage gates, regulatory checkpoints, and pre-filled mailto).

6. Priority Regulatory & Interoperability Checkpoints
Zero server database storage — generated deterministically on the fly.