# OUR INNOVATION JOURNEY — Methodology | Health Factory

Canonical URL: https://healthfactory.io/en/methodology-innovation-health/

> **BLUF Executive Summary** : The Health Factory Methodology structures healthcare innovation across four sequential stages — Research, Validation, Creation, and Execution — governed by strict clinical, regulatory, and health-economic Go/No-Go stage gates to eliminate hospital non-adoption risk and align executives, clinicians, patients, and engineering teams.

## Execution Dossier — Stages 1 to 4 — End-to-End Innovation Governance (Research, Validation, Creation, Execution)
### Target B2B Actors
- **Big Pharma** (`?acteur=big-pharma`) : Move beyond molecule-only models to deploy "Beyond the Pill" care pathways adopted by clinicians and patients.
- **Health Insurers & Mutuals** (`?acteur=assureurs`) : Design prevention and care-support programs with measurable health-economic ROI and high member engagement.
- **Hospitals & Clinics** (`?acteur=hopitaux-cliniques`) : Streamline patient-caregiver workflows, reduce administrative burden, and structure hospital living-lab experimentation.
- **MedTech & Healthcare Manufacturers** (`?acteur=industriels-sante`) : Validate hospital ergonomics, ward or OR integration, and EU MDR 2017/745 readiness prior to scale-up.
- **Healthcare Professionals** (`?acteur=professionnels-sante`) : Translate frontline clinical expertise into validated digital protocols or devices without adding clinical burden.

### Concrete Phase Deliverables
- Stage 1 — Clinical Research & Exploration: Clinical opportunity diagnostic and field mapping of unmet care needs.
- Stage 2 — Validation & Field Experimentation: Living Lab-tested Proof of Concept (PoC) and validated health-economic model.
- Stages 3 & 4 — Creation & Scale-Up Execution: Interoperable production solution and guided multi-facility rollout.

### Go / No-Go Stage-Gate Criteria
- Clinical desirability confirmed by healthcare professionals and patients.
- Measured proof of utility and regulatory/security pathway sign-off.
- Routine clinical adoption and demonstrated health-economic ROI.

### Verified Partner Proofs
- **Assurance Maladie (CNAM)** (National Public Payer & Care Pathways) : Health-economic evidence structuring and integration into national reimbursement pathways.
- **Hôpitaux Universitaires de Strasbourg (HUS)** (University Hospital & Clinical Immersion Site) : In-ward clinical immersions and direct co-design with frontline hospital care teams.
- **Sanofi** (Global Biopharmaceutical Leader) : Deployment of clinical immersion and open-innovation initiatives across chronic care pathways.
- **Viatris & Humanis / Allianz** (Health Prevention & Protection Providers) : Design and facilitation of prevention innovation and patient care pathways.

### Regulatory & Interoperability Checkpoints
- **RGPD / CNIL Santé** (Healthcare GDPR & CNIL Reference Methodologies (MR-001 / MR-004)) : DPIA pre-framing, processing registry, and patient consent workflow specification.
- **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.
- **Doctrine ANS / CI-SIS** (ANS National Doctrine: Mon Espace Santé, CI-SIS, ProSanté Connect & MSSanté) : ANS Convergence compliance matrix and national teleservice integration roadmap.
- **PECAN / LPPR / CNAM** (Early Reimbursement Access (PECAN) & Remote Monitoring Pathways) : Real-world evidence collection protocol (PROMs / PREMs / caregiver workflow impact).

## Detailed Sections
### 1. SEARCH: ACCULTURATE & EXPLORE (DESIGN THINKING)
*Deeply understand clinical and patient realities before writing a single line of code*

The first stage raises awareness of exponential technologies and applies Design Thinking directly in clinical and everyday healthcare settings.

By bringing together patients, healthcare professionals, UX designers, and engineers, we move from initial intuition to a testable prototype.

- Acculturate: inspire teams around digital and medical breakthroughs (keynotes, immersions).
- Empathy: observe and listen to patients and caregivers in their real environment.
- Define: frame the core high-impact problem to solve.
- Ideate: generate creative concepts without self-censorship in collaborative workshops.
- Prototype: rapidly build mockups, functional demonstrators, or service blueprints.
- Test: put prototypes directly into the hands of end users.
### 2. VALIDATION: ITERATE EVERY 2 DAYS TO 2 WEEKS
*Build, measure, and learn until achieving Product / Market Fit*

After an initial workshop or hackathon prototype, the classic mistake is locking a team away for 18 months of isolated engineering. Instead, we run ultra-short iteration loops (2 days to 2 weeks).

Using our physical and virtual experimentation platform, every clinical, usability, and economic hypothesis is tested in the field until the solution achieves true Product / Market Fit.

- Desirability validation (adoption by patients and clinicians).
- Feasibility validation (technical architecture, interoperability, health data hosting compliance, CE medical device regulation).
- Viability validation (business model, hospital procurement, or reimbursement pathway).
### 3. CREATION: STRUCTURE PRODUCT & USER ACQUISITION
*Turn a validated prototype into a compliant, scalable solution*

Once Product/Market Fit is confirmed, we support the operational structuring of the venture (either internally or through excubation):

- User acquisition: onboarding pilot hospitals, clinical departments, and patient communities.
- Product building: software/hardware engineering, GDPR/HDS security compliance, and medical regulatory pathways.
- Company structuring: governance, intellectual property, funding, or spin-off creation.
### 4. EXECUTION: SCALE & TRANSFORM THE ORGANIZATION
*Embed innovation for long-term impact*

The final stage executes the validated business model and drives change management across partner organizations (hospitals, pharmaceutical companies, insurers).

Excubated projects can then be seamlessly reintegrated into the parent organization or scaled as independent digital health startups.

## Frequently Asked Questions (FAQ)
### Why separate Business Model Search from Business Model Execution?
Inspired by Steve Blank and medical Design Thinking, our methodology separates exploration of an unknown model (requiring agility and 2-day to 2-week field iterations) from large-scale execution (requiring industrial rigor and regulatory compliance).