Feature #1233
open[A] SANATECH — Jérôme Inesta (pharma_medtech_exec)
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Description
**Founder:** Jérôme Inesta — Président (CEO & Fondateur)
**Background:** pharma_medtech_exec | verified: True — Jérôme Inesta has a genuine pharma/medtech executive background, consistent with the "pharma_medtech_exec" claim. He is a Doctor of Pharmacy (Docteur en Pharmacie) and Health Economics specialist. Before founding SANATECH (where his LinkedIn title is "CEO & Fondateur de SanaTech | HealthTech"), he spent roughly 5.5 years at Laboratoire CEVIDRA, a French pharmaceutical laboratory (Grasse, SIREN 488324658), and is also professionally associated with INTEGRALPHARMA, a pharmaceutical company in the Bordeaux area. His professional activity (chronic-pain therapeutics, the RHINICLEAN nasal-irrigation medical device, French pharma/health-market topics) sits squarely in the pharma/medtech/healthtech space. He is based in Montayral and studied law at Faculté de droit d'Aix-Marseille III.
**Stage / fundraise:** Pre-seed / build stage. SAS incorporated 2026-02-01, no employees (tranche_effectif "NN"), sole director. Product (Sana-e) is live as an early MVP but legal pages still carry a "[DATE]" placeholder, indicating very recent / pre-formal launch. / No public fundraise round confirmed. Brand-new SAS (founded 2026-02), zero employees, founder-funded build stage — consistent with imminent pre-seed need but not verified. (No source confirms an active round; do not claim one.)
**Regulatory trigger:** Borderline SaMD. Sana-e ("plateforme intelligente de santé mentale") offers a therapist side with "alertes cliniques", "détection de signaux" and AI-generated pre-consultation reports feeding a clinician's decision — features that can pull a product into MDR/IEC 62304 medical-device-software scope. Site currently positions as health IT (not explicitly SaMD), so the CE/MDR qualification question is open and unaddressed — a classifying decision the founder will face before scaling clinical claims. (Source: sanatech.fr product pages.)
**Email:** contact@sanatech.fr (confidence high) — contact@sanatech.fr is published directly on sanatech.fr (appears in the product pages and twice in the privacy policy). This is a confirmed published address, not a pattern guess. A direct founder address (e.g. j.inesta@sanatech.fr) is plausible but unverified — not asserted.
**LinkedIn:** https://fr.linkedin.com/in/j%C3%A9r%C3%B4me-inesta-b2270a94 **Website:** https://sanatech.fr/
**Score:** 12 -> Tier A
**Hook:** Jérôme is a Docteur en Pharmacie / health-economist who has shipped Sana-e solo with no CTO and no dev team — yet Sana-e already does clinical alerts, signal detection and pre-consultation reports that feed a therapist's decision, the exact features that drag a product toward MDR/IEC 62304 SaMD scope. OmDev gives him a senior dev team + a dedicated CTO at a fixed monthly price ~3x cheaper than hiring in-house, he owns the code, and our pipeline produces the compliance evidence (SOUP register signed every build + requirements-to-code-to-test traceability) that feeds an IEC 62304/MDR file — so he can decide and document the SaMD question instead of guessing. References CadSmile and SpeechLink show the model in regulated digital health.
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## Founder & background
Jérôme Inesta (b. 1975) is sole **Président** of SANATECH SAS and, per his LinkedIn, **"CEO & Fondateur de SanaTech | HealthTech"**, a **"Docteur en Pharmacie et expert en Économie de la Santé"** ([LinkedIn](https://fr.linkedin.com/in/j%C3%A9r%C3%B4me-inesta-b2270a94)).
A pharma/health-economics founder — non-technical, no engineering background visible. Registry lists him as the only dirigeant of a 0-employee SAS ([Annuaire, SIREN 100116730](https://recherche-entreprises.api.gouv.fr/search?q=sanatech)).
**Why OmDev fits:** a clinically-credible but non-technical founder is exactly who needs a rented senior team + dedicated CTO rather than a costly, slow in-house hire.
## Funding & momentum
SANATECH SAS was incorporated **2026-02-01** in Montayral (47500), NAF **62.01Z** (custom software dev), **0 employees** ([Annuaire](https://recherche-entreprises.api.gouv.fr/search?q=sanatech)). Four months old.
The Sana-e product is already live but legal pages carry a **"[DATE]" placeholder**, marking a very recent, founder-funded MVP ([cgu.html](https://sanatech.fr/cgu.html)). No public round confirmed — classic pre-seed/build window.
**Why OmDev fits:** a fixed monthly price ~3x cheaper than building a team preserves a pre-seed runway while still moving fast.
## Product & regulatory
**Sana-e** is an AI mental-health platform: patient tracking (mood/stress/sleep/energy, wellness scoring, AI recommendations) plus a therapist dashboard with **clinical alerts, signal detection and AI pre-consultation reports** ([sanatech.fr](https://sanatech.fr/)).
Those clinician-facing decision features make SaMD classification an open question — the product is positioned as health IT today, but alerts feeding a therapist can pull it into **MDR / IEC 62304** scope.
**Why OmDev fits:** our pipeline produces SOUP register (signed each build) + requirements-to-code-to-test traceability feeding an IEC 62304/MDR file (we don't certify), so the SaMD question gets documented, not guessed (cf. CadSmile, SpeechLink).
## Pain & buying signals
Non-technical solo founder, **no CTO, no dev team** (0 employees), yet shipping clinical-grade features — a structural capacity and compliance gap.
Published contact **contact@sanatech.fr** ([confidentialite.html](https://sanatech.fr/confidentialite.html)); thin placeholder legal pages signal a fast MVP needing a durable build + compliance partner.
**Why OmDev fits:** senior devs + dedicated CTO + compliance engine, fixed price, client owns the code — fills the team gap and de-risks the regulatory path in one move.
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**Sources:** https://recherche-entreprises.api.gouv.fr/search?q=sanatech (SIREN 100116730, SANATECH SAS, NAF 62.01Z, créée 2026-02-01, Montayral 47500, dirigeant Jérôme Inesta) · https://fr.linkedin.com/in/j%C3%A9r%C3%B4me-inesta-b2270a94 (CEO & Fondateur de SanaTech | HealthTech; Docteur en Pharmacie et expert en Économie de la Santé) · https://sanatech.fr/ (produit Sana-e, plateforme santé mentale, pricing, contact@sanatech.fr) · https://sanatech.fr/confidentialite.html (SanaTech, contact@sanatech.fr) · https://sanatech.fr/cgu.html (CGU avec placeholder [DATE], stade très précoce)
RA Updated by Redmine Admin about 1 month ago
- Status changed from Submitted to Design
DRAFT Email 1 (outcome-sell, 3x value prop):
To: Jérôme Inesta — contact@sanatech.fr (confiance high) · Redmine #1233
From: damien@omdev.tech
Objet: sana-e et la question samd (iec 62304 / mdr)
Bonjour Jérôme,
Vous avez sorti Sana-e seul, sans CTO ni équipe dev. Bravo. Mais les alertes cliniques, la détection de signaux et les rapports de pré-consultation qui nourrissent la décision du thérapeute sont exactement les fonctions qui peuvent tirer un produit vers le périmètre SaMD (MDR, IEC 62304). C'est une décision à documenter, pas à deviner.
OmDev vous donne une équipe de dev senior et un CTO dédié à budget mensuel fixe, environ 3 fois moins cher que de recruter l'équivalent en interne, sans rien lâcher sur les normes. La chaîne produit la preuve au fil de l'eau : registre SOUP signé à chaque build, traçabilité entre les exigences, le code et les tests. Le code reste chez vous. Le marquage CE reste le vôtre. Voir CadSmile et SpeechLink.
On en parle ? https://calendly.com/pollet-dam/discussion ou répondez-moi simplement.
Si ce n'est pas le moment, dites-le et je n'insiste pas.
Damien
OmDev, omdev.tech
RA Updated by Redmine Admin about 1 month ago
- Status changed from Design to In development
Email 1 envoye le 2026-06-25 (depuis damien@omdev.tech). Relance Email 2 le 2026-06-30, Email 3 le 2026-07-04 si pas de reponse.