NorTrials Medical Devices - National Hospital Testbed Network
NorTrials Medical Devices has established a national network that unites testbed facilities within Norwegian public hospitals that offer expertise, and infrastructure to support early-phase testing and clinical studies on medical devices.
What is a Testbed?
A testbed is a specialised environment within a hospital, offering the necessary infrastructure and expertise needed to test and evaluate the safety, performance, and clinical benefit of medical devices in a controlled setting.
Purpose
One point of contact
Establish a single point of contact for requests to hospital testbeds related to clinical investigations of medical devices. Here, one will encounter teams with expertise in testing and clinical investigations of medical devices in clinical environments.
Distribute NorTrials requests
Streamline the process of matching requests from industry with suitable clinical teams in Norway, for medical device testing. Through the network, hospitals get the chance to promote their highly competent clinical teams, and express their interest in participating with testing and clinical investigations of medical devices from industry.
Discuss and share
Provide hospitals with the opportunity to engage in discussions and forward requests the hospitals have received directly, facilitating for NorTrials Medical Devices and the network to assist with expertise when necessary.
Enhance competence
Acquire information on challenges and needs related to clinical studies with medical devices. This aims to support the development of guidelines, procedures, templates and contracts.
Testbed Services
Testbeds at different hospitals may offer a broad range of services intended for testing and clinical investigations of medical devices, covering phases from early prototype testing to clinical investigations for CE-marking purposes or post-market studies.
Our national hospital testbed network provides the following infrastructure and services:
- Idea discussions and concept evaluation
- Workshops with clinicians
- Discussions with clinical expert panel
- Assessment from scentific advisory board across hospitals
- Access to hospital laboratories for testing in connection with clinical studied
- Validation of prototypes
- Usability studies
- Clinical validation studies
- Clinical investigations of medical devices
- Adaption of medical devices for altered use or new users / patient groups
- Preclinical studies (with certified personnel)
- Regulatory guidance for medical devices (MDR)
- Evaluation of technical solution with regards to cybersecurity and data privacy
- Research devices for minimally invasive and image-guided therapy available for lending (NorMIT)
- Training centre for simulation of clinical procedures for healthcare personnel skill training
- Available infrastructure with high-tech operating rooms (Operating Room of the Future + The Intervention Centre)
- Visualisation lab (high-resolution screens, projectors, live streaming devices, VR/XR/AR, simulation devices)
3D lab with available resources for creating both physical and digital anatomic 3D models.
Simulator centre in surgical methods – for skill training in minimally invasive techniques (laparoscopy, endoscopy, robotics)