Module Code - Title:
ME4427
-
MEDICAL DEVICE DESIGN AND PLACEMENT
Year Last Offered:
2025/6
Hours Per Week:
Grading Type:
N
Prerequisite Modules:
Rationale and Purpose of the Module:
To expose the student the areas of medical device design with an emphasis on the non-engineering factors that affect medical device design. The module is loosely based on the Stanford Biodesign course.
Syllabus:
This module focuses on areas such as anatomical fundamentals, pathogenesis, intellectual property fundamentals, medical device regulation, ethical and sustainable considerations and requirements. When permitted students will observe surgeries to develop need statements and undertake a group research project on the design of a medical device to address an unmet medical need. Create a value proposition and an elevator pitch for their project.
Learning Outcomes:
Cognitive (Knowledge, Understanding, Application, Analysis, Evaluation, Synthesis)
On successful completion of this module, students will be able to:
1. Demonstrate an understanding of the medical device regulatory systems in the European Union
2. Apply engineering principles to design features of medical devices
3. Demonstrate an understanding of the importance of the patenting system within the arena of medical device design
4. Develop an understanding of the design process as applied to medical devices and the associated commercialisation issues
5. Develop and articulate a value proposition for a medical device within the biomedical engineering ecosystem
6. Demonstrate the ability to communicate a scientific concept to a non-engineering audience
Affective (Attitudes and Values)
On successful completion of this module, students will be able to:
7. Demonstrate an appreciation of the importance of legal, ethical and sustainable aspects of medical device design and development
Psychomotor (Physical Skills)
N/A
How the Module will be Taught and what will be the Learning Experiences of the Students:
A series of lectures will be employed to present the main concepts/topics of the module. Typically, the module will be run in groups of 4/5 students. Team charters will be developed to manage group dynamics. Group meetings will be held each week and continuous assessment of progress and learning will be carried out throughout the semester. Current research by the module leaders in design and commercialisation of medical devices informs the module.
Research Findings Incorporated in to the Syllabus (If Relevant):
Prime Texts:
Stefanos Zenios (2010)
The process of Innovating Medical Technologies
, Cambridge University Press
Other Relevant Texts:
Programme(s) in which this Module is Offered:
BEBIENUFA - BIOMEDICAL ENGINEERING
BEDEMAUFA - DESIGN AND MANUFACTURE
Semester(s) Module is Offered:
Autumn
Module Leader:
John.Mulvihill@ul.ie