# Pharma & Medical Device

> Source: https://healthcareinnovation.tn/service/pharma-medical-device/
> Author: healthcareinnovation.com
> Published: 2025-05-09
> Updated: 2026-09-24

## Pharma & Medical Device: Co Creating Trusted Solutions

 Bridging Industry, Academia and Clinicians Developing Pharma & 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. Partnering with pharmaceutical companies,[hospitals and academic](https://healthcareinnovation.tn/institutions_category/academic-hospital-center/)institutions to co create, validate and deploy digital health solutions and medical devices (see the Pharma & Medical Device section below).

## Frequently asked questions

### 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.
