Learning Outcomes:
The learning objectives of the Biomedical Diagnostics and Devices module should enable you to:
1. Develop an appreciation of how omics technologies are identifying new diagnostic biomarkers for health assessment and disease status in humans and animals.
2. Understand the role that biomedical diagnostics approaches play in drug development and translational medicine, such as in the use of companion biomarkers for optimal drug selection.
3. Describe the development process from clinical observation/scientific research and clinical trials through to the application of the biomedical diagnostic assays or biomedical devices in patients.
4. Gain a comprehensive insight into the general technological framework underlying the biomedical diagnostics and medical devices industry, with emphasis on more recent developments.
5. Analyze the role and potential of companion biomarkers in the biomedical diagnostics sphere and in combinational products within the implantable devices sector.
6. Describe the core issues, challenges and contributors associated with the development, use, and commercialization of biomedical diagnostic assays and implantable medical devices.
7. To undertake a presentation on developments in new biomedical diagnostic or biomedical devices (continuous assessment via the individual project presentation).
Indicative Module Content:
The following topics are covered within this module:
- The role of biomarkers in disease detection and management
- The principles of medical diagnosis, screening and monitoring
- Omics approaches used in biomarker discovery
- The application of biomedical diagnostics and devices in translational medicine
- Principles of design and production in the diagnostics and medical devices Industry
- Economics, ethics, IP, and legislation affecting medical diagnostics & devices
- Several case studies of biomedical diagnostics encompassing oncology, toxicology, and digital pathology
-Case studies of companion biomarkers in oncology
- Case studies of non-invasive biomarkers and medical devices in health monitoring and disease treatment and management
- The design and uses of Orthopaedic devices / implants and Cardiovascular medical devices
- The host response to implantable medical devices
- Some lecture topics will be complemented by workshops on areas such as evolution of clinical trials, the overall regulatory domain, and the design process.
-There will also be Industry presentations on their biomedical diagnostics and devices (e.g., Oncomark, Biosensia)