Advanced technology and continuous developments in our healthcare are characteristics of the times we live in today. In this dynamic environment, medical devices are crucial in improving diagnostics, treatments, and patient care. However, the path from concept to a medical device ready for the market is challenging. In this journey, clinical studies play an indispensable role. These studies serve as a compass to guide developers through the evaluation process and ensure both safety and efficacy before the medical device reaches the market.

In this MedTech Twente Building Blocks, we dive into the complexities of clinical studies, which are receiving increasing attention in the context of responsible innovation. Within MedTech, a step-by-step evaluation process is often used, starting in the early stages of innovation development. This approach is described in the IDEAL framework, which consists of 6 stages: 0) preclinical studies, 1) initial patient study, 2a and 2b) cohort studies, 3) clinical comparative studies, and 4) long-term studies.

During this session, Maroeska Rovers, scientific director of the TechMed Center at the University of Twente, will elaborate on clinical studies from a scientific perspective. She will explain the framework using concrete examples of these six stages and their associated studies. Gerdienke Prange-Lasonder, senior researcher at Roessingh Research & Development, will share her experiences with (clinical) evaluation concerning rehabilitation technology.

IN SHORT

What: MedTech Twente knowledge session

Date: Tuesday, June 4

Time: 9:00 – 13:00 hrs

Location: TechMed Centre, Universiteit Twente, Enschede

Language: Dutch