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:
Feedback from clinicians
- Idea discussions and concept evaluation
- Workshops with clinicians
- Assessment from scientific advisory board across hospitals
- Discussions with clinical expert panel
- Validation of prototypes
- Adaption of medical devices for altered use or new users / patient groups
Studies in hospitals
- Preclinical studies (with certified personnel)
- Clinical validation studies
- Usability studies
- Clinical investigations of medical devices
Specialised services
- 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).
Infrastructure
- Available infrastructure with high-tech operating rooms (Operating Room of the Future + The Intervention Centre)
- Simulator centre in surgical methods – for skill training in minimally invasive techniques (laparoscopy, endoscopy, robotics).
- 3D lab with available resources for creating both physical and digital anatomic 3D models.
- Training centre for simulation of clinical procedures for healthcare personnel skill training
- Visualisation lab (high-resolution screens, projectors, live streaming devices, VR/XR/AR, simulation devices)
- Access to hospital laboratories for testing in connection with clinical studies
Hospitals Engaged in the Network
The network consists of hospitals across Norway with significant expertise on medical devices, testing and clinical investigations. Each hospital offers its own testbed facility with a broad range of services and infrastructure: