Pharma & Medical Device

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Pharma & Medical Device

Pharma & Medical Device: Co Creating Trusted Solutions

Bridging Industry, Academia and Clinicians

Developing medical devices and digital health solutions requires rigorous quality management, regulatory compliance and user centred design. ISO 13485 sets the benchmark for quality management systems, ensuring that medical devices meet customer and regulatory demands for safety and efficacy. Open innovation models—where companies collaborate across organisational boundaries—can accelerate the development of solutions for human health. HCI’s Pharma & Medical Device service line blends these principles to help industry partners innovate responsibly.

What We Do – From Concept to Market Adoption

Our services are designed to support pharmaceutical companies, medical device developers and healthcare institutions:

Regulatory & Quality Consulting

Guidance on ISO 13485, MDR and local regulations. We help design quality management systems, perform regulatory diagnostics, and ensure compliance with Tunisian and European frameworks (INNORPI, CNDP, MDR).

Innovation Galaxies with Pharma Industries

Through immersive “Innovation Galaxy” experiences co‑developed with pharmaceutical partners and scientific societies, HCI demystifies innovation for healthcare professionals. At ICCO 2025, for example, an Innovation Galaxy brought clinicians, researchers, students and startup founders together to co‑create solutions for connected oncology. The journey was structured around thematic galaxies—Earth for information (to explain cutting‑edge oncology innovation), Mercury for interaction (hands‑on testing) and Venus for communication (dialogue and outreach)—with interactive stations such as the Global Innovations Map, Startup Valley and Innovation Orbit. These events bridge research, market needs and clinical practice, fostering knowledge exchange and accelerating adoption of digital health technologies

Human Centred Design & Co Creation

We facilitate Health Design Thinking workshops that integrate clinicians and hospital teams into the innovation process, ensuring that new technologies meet real world needs. Research shows that design thinking enhances innovation, efficiency and effectiveness by focusing on patient and provider needs.

Open Innovation Partnerships

HCI convenes pharmaceutical companies, startups and regulators to define national strategies and co develop solutions. Our open innovation process operates at three levels—top down policy shaping, horizontal market access and bottom up ideation—accelerating the adoption of emerging technologies.

Scientific & Clinical Validation

Through PRUVA AI and our network of accredited labs, we provide robust testing, expert matching and coordination of trials for medical devices, cosmetics and nutritional products.

Customized Digital Solutions

We build tailored digital tools (e.g., telemedicine platforms, AI driven diagnostics) leveraging our data science expertise and compliance frameworks.

Market Strategy & Access

Conduct market research, adapt solutions to Euro Mediterranean regulations, and develop go to market plans that integrate distribution channels and reimbursement pathways.

Capacity Building for Pharmacists & Clinicians

Programmes like Pharma 4 Novation equip pharmacists and students with business design thinking, regulatory readiness and access to funding. Participants move from idea validation to business modelling, gaining exposure to AI and software integration workshops and mentoring sessions.

Our Vision

HCI’s Pharma & Medical Device team combines regulatory specialists, clinicians, data scientists and quality assurance professionals. Our partners include leading pharma companies (Opalia Recordati, Roche, Novo Nordisk), universities (Faculty of Pharmacy and Medicine of Monastir), professional councils and international networks. Together, we build a multi actor alliance that links academia, industry and policy to drive national and regional change.

Who We Serve

Pharmaceutical & MedTech Companies

Companies looking to co create and validate new solutions while reducing internal R&D costs.

Healthcare Facilities & Clinicians

Seeking to integrate innovative technologies or co develop solutions through design thinking workshops.

Academic Institutions & Research Laboratories

Aiming to translate discoveries into market ready products and to train students in innovation.

Regulatory Bodies & Policymakers

Interested in building evidence based frameworks and engaging with industry through open innovation.

Flagship Programmes & Impact

Innovation Process with Doctors

A co creation programme that integrates clinicians into e health innovation. Using health design thinking, it identifies unmet clinical needs, re designs care pathways and launches solutions in areas such as clinical optimisation and AI powered diagnostics. Participating clinicians span ophthalmology, rheumatology, biotechnology and other specialities.

Open Innovation with Pharmaceutical Industries

A strategic initiative that aligns pharmaceutical company needs with startup agility. It operates at top down, horizontal and bottom up levels and has produced initiatives like the HCI Summit, Algiers Slush’D delegation and MedInTechs Paris delegation.

Pharma 4 Novation

Tunisia’s first pre incubation programme for pharmacists. It addresses gaps in training, startup creation and market access, providing business design thinking, regulatory readiness, prototyping and funding sessions. Over 15 projects have emerged, spanning AI based diagnostics, biotech and digital pharmaceutical tools.

Our Vision

HCI’s Pharma & Medical Device team combines regulatory specialists, clinicians, data scientists and quality assurance professionals. Our partners include leading pharma companies (Opalia Recordati, Roche, Novo Nordisk), universities (Faculty of Pharmacy and Medicine of Monastir), professional councils and international networks. Together, we build a multi actor alliance that links academia, industry and policy to drive national and regional change.