H.B.T Group France – Consulting in medical devices and digital health technologies

H. B. T Group France is an international consulting firm specialized in medical devices and digital health technologies. With recognized expertise, we support innovative companies at every stage of their development, combining strategic vision, operational excellence, and in-depth mastery of healthcare regulatory challenges.

We operate in the following areas:

We help companies turn innovation into measurable market traction. We consolidate clinical evidence and the product’s unique selling proposition, segment target audiences (payers, institutions, professionals, patients), define the business model and pricing strategy, and build an R&D roadmap aligned with clinical and regulatory requirements. On the execution side, we establish operational steering and performance indicators covering revenue, adoption, quality, and timelines.

Key deliverables: market and competitive analysis, business case & pricing, R&D/clinical roadmap (TRL/CRL), go-to-market plan, KPI/OKR dashboard.

We take the lead on critical programs involving hardware, software (including AI/ML), health data, and clinical components, often across multiple sites and stakeholders. We structure governance, critical path, and risk management, coordinate suppliers, CROs, pilot sites, and authorities, and industrialize practices. The goal: delivering on time and at the required quality level, with full budget transparency and traceability.

Key deliverables: project charter, risk matrix & mitigation plans, detailed planning & milestones, executive progress reports, scale-up plan.

We advise boards of directors and executive committees on strategic trade-offs, investment prioritization, and financing trajectory. We clarify the clinical and economic value proposition, align the organization with performance rituals, and support change management.

Key deliverables: 18–36 month strategic plan, executive cockpit/dashboard, investor package & equity story, transformation and communication plan.

We design and deploy compliant quality management systems and prepare technical files according to target frameworks. We define clinical evaluation strategies, integrate cybersecurity and data protection by design, and develop reimbursement dossiers (clinical/economic evidence, HTA/payer interactions). We establish post-market surveillance and vigilance systems for continuous improvement.

Key deliverables: complete QMS, technical documentation & trial plans, multi-region regulatory strategy, payer/HTA dossiers, PMS/PMCF plan & safety indicators.

We design and deliver impactful events—advisory boards, conferences, decision-making workshops—built around precise objectives: consolidating evidence, aligning stakeholders, and accelerating adoption. We engage KOLs, public decision-makers, payers, clinicians, and industry players, produce scientific deliverables (abstracts, white papers), and ensure flawless logistics (programming, moderation, recording).

Key deliverables: program & scientific committee, speaker selection and management, content & deliverables, communication plan, impact report & post-event roadmap.

Our mission: turning our clients’ ambitions into concrete success, helping them navigate a complex and ever-evolving environment.

Guiding the informed adoption of digital health technologies.

H.B.T Group France

Hicham TEMSAMANI
Founder

Accomplished global business executive with a track record of delivering results. Possesses extensive expertise and a profound dedication to the healthcare sector. Demonstrated proficiency in effectively managing profit and loss, driving new business initiatives, orchestrating successful product launches, and executing business turnarounds.