Study Guide

Objective

After completing the course, the student is familiar with the innovation processes of medical devices, knows how to ideate and conceptualize new medical devices using suitable methods, understands business perspectives related to the development of medical devices, knows how to use learned information and methods appropriately, and knows how to communicate smoothly and on time.

Content

• RDI methods and their application in the development of medical devices and software
• Medical device business environment
• Clinical evaluation and investigation
• Concept development for an innovation

Evaluation scale

0-5

Assessment criteria, satisfactory (1)

The student recognizes special features related to the business environment of medical devices, and the purpose of clinical evaluation and investigation in the development of medical devices. The student knows RDI methods for ideation and conceptualization of an innovative medical device. The student knows how to communicate and report the results.

Assessment criteria, good (3)

The student understands special features related to the business environment of medical devices, and the purpose of clinical evaluation and investigation in the development of medical devices. The student knows and knows how to use RDI methods for ideation and conceptualization of an innovative medical device. The student knows how to communicate and report the results clearly within the given schedule.

Assessment criteria, excellent (5)

The student masters special features related to the business environment of medical devices, and the purpose of clinical evaluation and investigation in the development of medical devices. The student knows and knows how to, appropriately use RDI methods for ideation and conceptualization of an innovative medical device. The student knows how to communicate and report the results convincingly within the given schedule.

Assessment criteria, approved/failed

The student recognizes special features related to the business environment of medical devices, and the purpose of clinical evaluation and investigation in the development of medical devices. The student knows RDI methods for ideation and conceptualization of an innovative medical device. The student knows how to communicate and report the results.