Research, Development and Innovation of Medical Devices 1 (5 cr)

Objective

Upon completion of the course, the student will be familiar with the innovation processes in medical devices, be able to identify, assess and justify new genuine needs for medical devices, be able to take into account the specificities of the clinical application environment, be able to use the knowledge and methods learned appropriately, and be able to communicate fluently and in a timely manner.

Content

• Medical devices research, development and innovation (RDI)
• RDI methods and their application in the development of medical devices and software
• Clinical environments, users, processes and care practices
• Implementation of needs assessment for an innovation

Evaluation scale

0-5

Assessment criteria, satisfactory (1)

The student will identify the specificities of medical device development and the clinical application environment. The student will be familiar with RDI methods for needs assessment of a medical device to be innovated. The student will be able to communicate and report the results.

Assessment criteria, good (3)

The student understands the specificities of medical device development and the clinical application environment. The student knows and is able to use RDI methods for the needs assessment of a medical device to be innovated. The student will be able to communicate and report the results clearly within a given timeframe.

Assessment criteria, excellent (5)

The student is familiar with the specificities of medical device development and clinical application environment. The student knows and is able to use RDI methods appropriately for the needs assessment of a medical device to be innovated. The student will be able to communicate and report the results convincingly within the given timeframe.

Assessment criteria, approved/failed

The student will identify the specificities of medical device development and the clinical application environment. The student will be familiar with RDI methods for needs assessment of a medical device to be innovated. The student will be able to communicate and report the results.