BIOC40250 Biomedical Diagnostics&Devices

Academic Year 2021/2022

During the course, the students will learn how biomedical diagnostics provides information to aid the screening, detection, diagnosis and monitoring of disease, and how medical devices (with a focus on implantable medical devices) are used in disease diagnosis or for the cure, mitigation, treatment or prevention of disease. These devices will include example of Orthopaedic Implants, Cardiovascular Medical Devices, and Tissue Engineering/Cell-based platforms. Students will also learn about Combinational medical device products (devices incorporating therapeutics) in the Cardiovascular System.

For the biomedical diagnostics component, there will be a focus on how advances, particularly in ‘omics’ approaches (especially genomics, transcriptomics, proteomics, and metabolomics), are increasing the application and range of biomedical diagnosis modalities.

Beyond the science & technology, the students will develop an understanding of how technological advances, increased expectations for medicine, longer life expectancy and legal, ethical and economic factors are all playing a role in this burgeoning billion-euro industry.

However, a crucial bottleneck has emerged in respect to translating the discovery of novel biomarkers into commercially relevant assays and devices. This is combined with the shift towards multiplex biomarkers assays and 'point-of-care' tests that are rapid, robust and cost-effective.

Therefore, this module will also outline the challenges and issues around the development of biomedical diagnostics and the design and deployment of medical devices, including challenges of combinational products from Clinical and Industrial perspectives.

Some lecture topics will be complemented by workshops on areas such as evolution of clinical trials, the overall regulatory domain, and the design process.

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Curricular information is subject to change

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)

Student Effort Hours: 
Student Effort Type Hours
Lectures

18

Small Group

6

Tutorial

6

Specified Learning Activities

30

Autonomous Student Learning

60

Total

120

Approaches to Teaching and Learning:
The primary mode of delivery of content within this module will be through lectures including instructors from scientific, business, and regulatory domains.

Case-based study exemplars from existing biomedical diagnostic and device companies are included during the module to help consolidate the learning outcomes of the course.

Project work in the form of a group project and presentation on hot-topics in the subject area is also used to help promote learning and communication skills. Grades will be assigned based on an evaluation of the project presentation.

A student peer assessment will be included where each student will grade at least one other presentation. A contribution of 30% of the project grades will be assigned based on these peer assessments.

 
Requirements, Exclusions and Recommendations
Learning Recommendations:

Basic understanding of cell and molecular biology - from any standard textbook (e.g., Molecular Cell Biology by David Baltimore and Harvey Lodish)
Basic understanding of cancer biology - from any standard textbook (recommend: The Biology of Cancer, 2ndEd
Robert A. Weinberg)


Module Requisites and Incompatibles
Not applicable to this module.
 
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Assignment: Answer one long form essay assignment (to be submitted online). Coursework (End of Trimester) n/a Standard conversion grade scale 40% No

60

Presentation: Group project presentation (from a topic and group assigned to the student) on a biomedical diagnostic or device. Includes tutor (25/40) and student (15/40) peer assessment of the presentations Week 11 n/a Standard conversion grade scale 40% No

40


Carry forward of passed components
No
 
Resit In Terminal Exam
Spring Yes - 2 Hour
Please see Student Jargon Buster for more information about remediation types and timing. 
Feedback Strategy/Strategies

• Feedback individually to students, on an activity or draft prior to summative assessment
• Feedback individually to students, post-assessment
• Group/class feedback, post-assessment
• Peer review activities
• Self-assessment activities

How will my Feedback be Delivered?

Group formative feedback session prior to the exit exam will provide students with a better understanding of the expectations of the exit exam. Formative Feedback individually to students by email or face-to-face meetings will be provided for queries they submit on the course content or questions over the exit exam. Formative Feedback individually to students and by group by two workshop classes, and by email or face-to-face meetings will be provided for queries they have on preparing the group project (with a tutorial also on tips for preparing the student project). Student formative feedback will be solicited as part of the tutorial on project preparation on their evaluation of previous examples of projects. Group summative feedback will be given based on their project grading and evaluation comments. Peer feedback will be incorporated in the peer assessment of other students' projects Feedback to students after the exit exam can be provided upon request.

PDFs of research papers and documents relevant to the lecture content will be uploaded on Brightspace.
Name Role
Professor Michael Duffy Lecturer / Co-Lecturer
Dr Peter O'Brien Lecturer / Co-Lecturer
Dr Craig Slattery Lecturer / Co-Lecturer
Ms Emer Conroy Tutor
Dr Cormac G Kilty Tutor
Dr Jens Rauch Tutor
Dr Ena Walsh Tutor