Research, Development and Innovation of Medical Devices 2

Objective

After completing the course, the student will be familiar with the innovation processes of medical devices, be able to ideate and conceptualise new medical devices using appropriate methods, understand the business aspects of medical device development, be able to use the knowledge and methods appropriately, and be able to communicate fluently and in a timely manner.

Content

• RDI methods and their application in the development of medical devices and software
• Medical devices business environment
• Clinical evaluation and research
• Concept development for a new innovation

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.