This module introduces the student to a range of common medical devices and the analysis techniques in the design and understanding of how these complex systems operate within the human body. The module builds on traditional mechanics and materials into the medical arena of biomechanics, bio-fluids, structural mechanics and biomaterials. In addition, the students are provided with an introduction to Medical Device Regulatory Affairs, design control in a regulated environment and topics covering manufacture of medical devices. A number of case studies are covered with an applied focus on commonly encountered technologies, including joint replacements, such as the hip and knee, and cardiovascular devices, such as heart balloons and stents. These design and analysis strategies, coupled with a greater applied knowledge of current technologies, will prepare the student for a role in this multi-disciplinary field.
Indicative syllabus covered in the module and / or in its discrete elements:
- Intro to medical devices
- Regulation and approval of medical devices
- Medical device design process
- Human factors design
- Biomaterials including use of ISO10993
- Biomechanics
- Risk management processes for design, process and user
- Validation of manufacturing processes and equipment including custom built equipment
- Quality Management Systems and documentation including CAPA systems
- Sterilisation of medical devices
Case Study: Human Factors/ Recalls/ Ethics in Design
Case Study: Cardiovascular Devices
Case Study: Fracture Fixation Systems and Bone Implant Systems
- Lectures
- In class team based discussions
- Workshops
- Case Studies
- Tutorials
- Self-Directed Learning
- Team based design activities
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Formal Examination | 60 |
| Other Assessment(s) | 40 |