The overall objective of this class is to help students experience and learn key ingredients for the successful medical device development in an industrial engineering context. Upon successful completion, the students will be able to: (1) understand the process for identifying unmet health needs, (2) develop the product concept, (3) analyze the market opportunities, (4) define the product requirements, (5) understand the regulatory perspectives of the medical device, (6) understand the medical device development process and (7) lead the cross-functional environment..

– Individual homework (5%)
– Active participation (15%)
– Mid-term project 1 and 2 (20% each)
– Final project & presentation (40%)

1. Product Design and Development, K. Ulrich & Eppinger, 5th Edition, McGraw Hill
2. Biodesign: The Process of Innovating Medical Technologies, 1st Edition, Cambridge University Press
3. Setting the Pace in Product Development, M.E. McGrath, Revised Edition, Butterworth-Heinemann

1. Concept development
 Identifying medical unmet needs
 Inventing concepts

2. Product development process
 Benefits of an effective development process
 Integrated product development process
 Stages in the product development process
 Development process for the advanced technology
 Core team approach to project organization
3. Medical device perspectives
 Regulatory process
 Standards for medical devices
 Quality management system
 Design techniques

– Lectures
– Invited speakers
– Active discussions
– Team activities
– Individual project proposals
– Team projects

This class is about industrial process of developing a medical device from a clinical idea. In order to maximize the effectiveness of students’ learning, the class will be operated in a different manner than classical engineering courses. The meetings will be filled with rather discussions than one-way lectures. Your active participation will be very important!!!