Strategische Führung auf Abruf

Strategische Führung auf Abruf | HelixTech
Leadership & Compliance

Strategische Führung auf Abruf

Die Brücke zwischen GxP-Compliance und KI-Innovation.

In der modernen Biotech-Landschaft reicht ein klassischer CTO oft nicht mehr aus. Sie benötigen eine Doppelkompetenz.

Strategische Führung und Architektur

Sie benötigen einen erfahrenen Architekten, der sich tiefgehend mit GxP- und HIPAA-Compliance auskennt – aber gleichzeitig einen Fractional CAIO (Chief AI Officer), der sicherstellt, dass Sie keine veraltete Software in einer KI-dominierten Welt bauen.

Viele Startups scheitern an diesem Spagat: Sie bauen entweder sicher, aber veraltet – oder innovativ, aber unregulierbar. HelixTech löst dieses Dilemma durch integrierte strategische Führung.

Der Mehrwert

Keine Experimente auf Kosten der Compliance. Keine Legacy-Codebasis trotz Innovation.

Die Umsetzung

Wir übernehmen die Verantwortung für zwei kritische Säulen Ihrer Technologie-Strategie:

1. Die Roadmap (SaMD-Strategie)

Wir entwerfen Ihre Strategie für Software as a Medical Device (SaMD) von Tag eins an korrekt.

  • Vermeidung von "Technical Debt", die später zu regulatorischen Sackgassen führt.
  • Integration von Qualitätsmanagement-Prozessen direkt in den Entwicklungszyklus (CI/CD).
  • Vorbereitung auf Audits durch FDA oder benannte Stellen (EU-MDR).

2. Die Governance (Build vs. Buy)

Unerfahrene Teams machen oft teure Fehler, indem sie Standard-Tools selbst bauen oder sich an falsche Anbieter binden. Wir treffen die harten Entscheidungen:

  • Kaufen: LIMS, ELN und Standard-Infrastruktur. Wir verhandeln mit Anbietern auf Augenhöhe.
  • Bauen: Nur Ihre Kern-IP und proprietären KI-Algorithmen.
  • Kostenkontrolle: Verhinderung von "Vendor Lock-in" und explodierenden Cloud-Kosten.

Sichern Sie Ihre Architektur

Vermeiden Sie teure Regulierungsfehler. Holen Sie sich erfahrene Führung.

Strategie-Gespräch buchen

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