Medical Device Technology – Group Assignment – Written Report & Presentation

The Learning outcomes for this module are as follows:

(i) M1_LO1 Research the medical device product life cycle phases from product design, development, validation, manufacturing, testing, packaging to distribution.

(ii) M1_LO2 Critically assess the impact of mobile health (m-Health) and connected medical devices on the future direction of medical device design and development

(iii) M1_LO3 Use learnings of human biology and disease to provide a rationale for scientific/technical procedures medical devices - in the diagnosis, treatment and basic research associated with human disease.

(iv) M1_LO4 Assess the concepts of biocompatibility and the processes involved in biomaterials and biomechanics in the design of medical devices.

(v) M1_LO6 Analyse the concepts of Quality Risk Management and determine how it can be applied to medical device design and manufacture.

This Group Assignment accounts for 50% of the module grade and is designed to assess learners’ ability to research and critically evaluate key topics related to the medical device product life cycle. In accordance with MIMLO learning outcomes (i), (ii), and (v) - learners will explore and analyse each phase of the medical device life cycle—from product design, development, and validation to the integration of connected medical devices and emerging trends in the field. The assessment also requires a thorough understanding of the medical device design process and the application of Quality Risk Management (QRM) principles in alignment with regulatory standards.

Successful completion of this assessment will require both independent and collaborative research, the application of relevant scientific principles, and the ability to communicate findings clearly and effectively through a group presentation.

Level 1 (AI) for Planning is the acceptable level of AI for use in this assignment.

Level 1 AI – for PLANNING - to form ideas, structure, and research) on the Artificial Intelligence Assessment Scale Framework is the acceptable. AI use permitted in this assignment

Any AI process must be declared.

- All AI use must be declared in provided Giffith College Cove Sheet page.

- Learners must add an appendix showing the ideas, structures and recommended research given

by an AI*

Acceptable use in this level defined as:

Idea Generation: Using AI to generate suggestion on specific topics that could be included in their assignment. The Learner would then have to research and write the assignment content without AI assistance.

Structure: Asking AI to give an overview or to plan how to discuss the topic of the assignment (e.g. a short bullet points list). The learner would be required to take that list and expand it into a full assignment without further assistance from AI.

Research: Asking AI for references to appropriate sources that discuss in topic. Learners would then be required to read those references. If any of the references are relevant to the assignment it should be then cited in the assignment work.

AI summaries of any source are not permitted.

Assignment Instructions:

Students will be assigned to groups. Students are expected to work together to complete tasks. Part 2 of the assignment is done individually but must be aligned and consider the other sections of part 1 and 2

The report should include the following:

- Griffith College Cover letter.

- Additional cover letter containing title of report, Student Name & Student number & Date uploaded.

- Each student must upload their report separately

- Each student must identify what section of Part 2 they have completed

- Each of the tasks below are addressed in separate sections:

PART 1:

In your pre-assigned groups identify a Novel Medical Device. This should be a device of a new design and be Class 2a or higher. Briefly describe the operating principles of the device, and a high-level strategy for how this device would be designed. Include the Intended Use and the Indications for Use for this device [ALL] [4+]

Note: Maximum 4 pages; This section is to be completed by all group members together.

30%

PART 2:

Risk Management - Describe the risk management approach that should be taken during development of the design. Give examples of potential risks and how these may be mitigated against. Include how a benefit risk analysis would be completed [STUDENT 1] [Group of 4+]

Note: Maximum 4 pages.

38%

Design Inputs - Describe how the design requirements would be developed for this product. Consider how the environmental impact could be captured as part of the design effort. Give examples of the design inputs for this device that are based on its intended use. [STUDENT 2] [Group of 4+]

Note: Maximum 4 pages

Design Outputs - Describe how the manufacturer would generate the design output based on design inputs. Consider how the environmental impact could be captured as part of the design effort. Give examples of the design outputs for this device that are based on the design requirement. [STUDENT 3] [Group of 4+]

Note: Maximum 4 pages.

Design Verification

- Describe the design verification strategy for this device and include detailed examples of how this maybe completed. Consider potential local and systemic responses to the device, with respect to biocompatibility [STUDENT 4] [Group of 4+]

Note: Maximum 4 pages.

Design Validation - Describe the design validation strategy for this device and include detailed examples of how this may be completed. [STUDENT 5] [Group of 5+]

Note: Maximum 4 pages.

Clinical Benefits – Describe the clinical benefits of the device, outlining any intended therapeutic or diagnostic benefits. Describe how you would demonstrate the clinical benefits. Consider the state of the art by completing an assessment of alternative treatment methods for the same indications. [STUDENT 6] [Group of 6]

Note: Maximum 4 pages.

PART 3:

Presentation

Present an executive summary of the device and the design effort. This should be completed in PowerPoint and include an overview of the medical device and how the product was designed and tested. [ALL] [Group of 4+] Note: Maximum 15 slides/15 minutes Presentation.

25%