HEALTH & DIGITAL EXPERTISE
An international network of specialists mobilized at every critical milestone of your project.
Our Digital Health Expertise practice guides manufacturers, hospitals, and startups through medical-grade software architecture, French ANS national standard integration (Mon Espace Santé, CI-SIS, ProSanté Connect, MSSanté), HL7 FHIR hospital interoperability, and operational readiness for HDS hosting, healthcare GDPR, and EU MDR 2017/745 regulations.
Health Factory’s second pillar provides an international network of specialists across the 5 critical domains of digital health: 1. Technical Expertise (security, cryptography, data anonymization, certified health data hosting HDS, and medical apps such as Résurgences, Docteur Gratis, toubib.co), 2. Legal & Regulatory Expertise (GDPR, CE medical device marking), 3. Medical & Clinical Expertise, 4. UX/UI & Service Design Expertise, and 5. Entrepreneurial & Business Model Expertise.
DELIVERABLES, STAGE GATES & REGULATORY CHECKPOINTS
Operational Deliverables
- Phase 1 — Architecture Audit & Regulatory Qualification: Health data flow map, SaMD qualification analysis (MDCG 2019-11), and DPIA/HDS pre-framing.
- Phase 2 — Digital Health Engineering & Interoperability: Application build, HL7 FHIR / EHR connectors, and ANS national teleservice integration (INS, ProSanté Connect, MSSanté).
- Phase 3 — HDS Production Rollout & Handover: Deployment on HDS-certified infrastructure, IEC 62304 technical documentation, and team handover.
COMEX Go / No-Go Criteria
- Regulatory scope and security architecture approved by DPO and CISO.
- CI-SIS interoperability test completion and zero critical findings in security audit.
- Clinical production sign-off and live activation across partner healthcare facilities.
Regulatory & Partner Proofs
- Agence du Numérique en Santé (ANS) — Alignment with the French national digital health doctrine (Mon Espace Santé, CI-SIS, ProSanté Connect, MSSanté).
- InterSystems & Medasys — Integration of digital health workflows and HL7 FHIR streams into hospital information systems (HIS / EHR).
- Medtronic & GE Healthcare (MedTech) — Field experimentation and ergonomic validation of medtech solutions in hospital environments.
- Assurance Maladie (CNAM) — Health-economic evidence structuring and integration into national reimbursement pathways.
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.
AN INTERNATIONAL NETWORK OF EXPERTS
Succeeding in digital health requires mastering medicine, software engineering, healthcare law, UX design, and entrepreneurship simultaneously. Health Factory connects your project with top specialists across Europe and North America.
TECHNICAL EXPERTISE (ARCHITECTURE, HDS, SECURITY, AI)
From distributed architectures to high-security systems handling sensitive health records (cryptography, anonymization, HDS compliance), our technical experts guide your engineering decisions.
Our team has also built pioneering medical applications including Résurgences, Docteur Gratis, and toubib.co.
LEGAL & REGULATORY EXPERTISE
Navigate GDPR, medical confidentiality, health data hosting (HDS), intellectual property, and Software as a Medical Device (SaMD / CE marking) requirements from day one.
MEDICAL & CLINICAL EXPERTISE
Backed by world-renowned medical advisors (including Prof. Jacques Marescaux, founder of IRCAD and IHU Strasbourg) and practicing clinicians, we ensure clinical relevance and seamless workflow integration.
UX / UI & SERVICE DESIGN EXPERTISE
In healthcare, poor usability leads to immediate clinician burnout or patient non-adherence. Our designers craft intuitive, accessible, and empathetic user experiences.
ENTREPRENEURIAL & BUSINESS MODEL EXPERTISE
Build sustainable business models (hospital B2B, pharma B2B2C, institutional reimbursement), prepare fundraising, and accelerate go-to-market execution.
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).