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.
Programma
09.15 - 09.30 | Walk-in with coffee and tea |
09.30 - 09.40 | Welcome by innovation cluster MedTech Twente. |
09.45 - 10.30 | Maroeska Rovers, Scientific director Techmed Centre | University of Twente |
10.30 - 10.50 | Break |
10.55 - 11.40 | Gerdienke Prange-Lasonder, Senior Researcher Roessingh Research & Development |
11.45 - 12.45 | Network lunch |
Registration
Although this is a free event, please note that registration for this event is not obligation-free. If you cannot attend the event for which you have already registered, we kindly ask that you let us know by sending an email to this email address.
Organisation
MedTech Twente is the innovation cluster where medical technology is accelerated. Here, businesses and health care institutions work closely together with researchers from the knowledge institutes to invent innovations for the health care of the future. Innovations are being developed, validated and implemented in close collaboration with parties, facilitated and accelerated by supporting organizations such as Novel-T, Oost NL, TechMed Centre | Universiteit Twente, Kennispark Twente, World Trade Center Twente, Hogeschool Saxion and Health Valley Netherlands. It’s also not surprising that successful MedTech companies such as Demcon, Medspray, Micronit, Lipocoat and IamFluidics were founded and grown in Twente.
