Project: Medical Device Development
This project will centre on the specification, design, construction and test of a wearable medical device, e.g. to measure a range of neurological tremors of differing frequencies and characteristics, such as those identified with Parkinson’s, essential tremor and Dystonia. An emphasis is placed on testing of the resulting device, which can also be designed and built by the students, e.g. a mechanical tremor inducer.
|A||Autumn Term 2022-23 to Summer Term 2022-23|
Subject content aims:
Specify a medical device in response to an established clinical need.
Design, implement and test a medical device according to the specification.
Robustly evaluate the resulting medical device according to industry requirements.
Graduate skills aims:
Form an effective team with allocated workloads and responsibilities.
Undertake relevant technical research and literature reviews.
Assimilate, communicate and document technical and non-technical findings and experimental results.
Identify and comply with relevant ethical and health & safety requirements.
Explore and comprehend commercialisation practices and opportunities.
Subject content learning outcomes
After successful completion of this module, students will be able to:
Develop a specification according to the customers’ requirements, with regard to technical, financial and other constraints.
Analyse the mechanical properties of a patient’s symptoms.
Design and build, a medical device utilising learnt mechanical, hardware and software skills.
Devise a relevant and robust test plan employing appropriate statistical methods to provide meaningful results.
Evaluate the device according to the customer's and other commercial requirements.
Graduate skills learning outcomes
After successful completion of this module, students will understand:
team roles and the stages of development of a team
the need for accurate laboratory record keeping
the need to work safely in laboratories
the need to appreciate the ethical implications of their work
the concept of a work breakdown structure and project management tools
the need to hold regular meetings to discuss progress and technical issues
that there are risks in any endeavour, and that risks can be rated and managed
the need to plan their own time to meet project deadlines
how to research, assimilate and communicate technical and non-technical literature, information and experimental results.
the need to consider data integrity, storage and security needs
Conceive, Design, Implement, Operate
Needs analysis, requirements capture & product specification
Students will be given a general overview of the project and briefed that they need to discuss with the client the application area and actual specification for their project. They will be given guidance on what a product specification should look like and that it should be able to be tested to verify the solution they come up with meets the specification. They should be given guidance on the basics of client meeting etiquette.
Students will be introduced to some creativity techniques and be expected to produce an innovative but practical solution to the defined problem as they have specified it. Groups will be encouraged to collaborate, support and give advice to other groups. How we do the later is a challenge.
Students will design the electrical, electronic and mechanical aspects of a device including writing microprocessor code to control the components and collect data. They will be provided with system components and/or some working subunits. The design will be supported with 'normalisation' events when all groups will be brought to the same phase in the project design and build process. The design will include a fairly simple printed circuit board.
Modelling and Simulation
Students will use CAD tools to enable them to fabricate the case for their device.
Students will be expected to undertake all the necessary process steps to enable their printed circuit board to be made. They will fabricate the case and any required internal mechanical parts for their device.
Students will understand the limitations imposed by the manufacturing capabilities of the Department including the choice of available materials compared to that available in the wider commercial environment and how this impacts the Technology Readiness Level that can be achieved taking into account real device usage (water ingress, UV stabilisation, etc.).
Assembly and Test
Students will learn about the need for a testing approach from the outset of the design process and develop a test plan for their device.
Cost and market evaluation
Students will be expected to be able to show understanding of the commercial potential their device has.
Specifications for use
For their device students will document their record of the meeting(s) with the client to agree the client specification, produce a functional specification and produce a user operational guide.
Product Usage & Life Cycle
Students should explore the issues of wearability, user comfort, need to recharge (replace batteries), ergonomics, durability and material choice for wearer allergies and recycling.
Record of their client meeting(s)
Device functional specification
Device user operational guide
All test results
Ethical compliance statement
Initial project presentation
Demonstration of final system
Individual contribution and reflection on project experience
Students will receive instruction on laboratory practice including how to solder, assemble components, general laboratory tidiness and how to use test equipment; they will also be instructed on how to keep a laboratory log book. The quality of their lab book record keeping will be assessed as part of this project.
Health and Safety
Students will receive instruction on safe working practices in the laboratory and will be expected to work safely at all times.
Students will be introduced to team roles and the stages in team development as the basic tools to understand their team composition and to help guide them when allocating tasks to team members. The role of group leader could be rotated around members to give them all the opportunity to lead.
Students will research, assimilate and communicate technical and non-technical literature, information and experimental results appropriate to their project.
Students will research, assimilate and communicate technical and non-technical literature, information and experimental results relating to their project.
Students will be introduced to the need to consider the ethical implications of the work they do in this project but also in Engineering in general. Groups will be expected to produce their own ethical approval form which will be reviewed carefully.
How typical roles and duties associated with project management would be introduced to the students, how the students will be guided whilst undertaking these roles and how would these be assessed? Students will be introduced to the concepts of Work Breakdown Structure, Gantt Charts and PERT Charts as tools to help them plan and then manage projects. They will be introduced to the need to have a project manager and individual who monitors the project plan and to regularly check progress. The cohort will be given a basic outline project plan with some 'normalising' milestones so that all groups work at a common pace and arrive at these common points at the same time - this will facilitate the introduction of new required 'theory'. Between each set milestone will be experimental and group driven phases.
Meetings & Meetings management
Students will be introduced to the need to hold regular meetings to discuss progress and discover the technical issues they face; to allocate tasks to individuals; to monitor who has done what through an action tracking system.
To understand that there are risks in any endeavour and that risks can be rated in terms of their probability of occurrence and severity of consequence.
Students will be introduced to the need to plan their own time so they meet project deadlines balanced against the other time commitments they have. They will be expected to produce a personal time plan which they will discuss with their academic supervisor.
Students will be introduced to the need for careful consideration of data integrity and security and the need to maintain data owner confidentiality for ethical reasons. This can be introduced contextualised to this project but should be generalised so students understand the broader issues of data storage at the personal as well as corporate levels.
|Task||Length||% of module mark|
Individual Project Report
Initial Project Presentation
|Task||Length||% of module mark|
Reassessment: Combined project specification & report
Weekly project supervisions
Within two weeks of initial project presentation
Within two weeks of initial project report
Within four weeks of project demonstration and final report submission
The Department of Electronic Engineering aims to provide some form of feedback on all formative and summative assessments that are carried out during the degree programme. In general, feedback on any written work/assignments undertaken will be sufficient so as to indicate the nature of the changes needed in order to improve the work. Students are provided with their examination results within 20 working days of the end of any given examination period. The Department will also endeavour to return all coursework feedback within 20 working days of the submission deadline. The Department would normally expect to adhere to the times given, however, it is possible that exceptional circumstances may delay feedback. The Department will endeavour to keep such delays to a minimum. Please note that any marks released are subject to ratification by the Board of Examiners and Senate. Meetings at the start/end of each term provide you with an opportunity to discuss and reflect with your supervisor on your overall performance to date