BIOMENG 791 : Advanced Biomedical Engineering Design

Engineering

2025 Semester One (1253) (15 POINTS)

Course Prescription

An engineering project requiring the application and integration of material taught in technical and professional engineering courses to the design of medical devices and software to meet client needs. The project also requires consideration of ethical issues, social impact, safety in design, and international regulations.

Course Overview

Lectures cover the medical industry; the product lifecycle; intellectual property; the regulatory environment and standards; ethical, societal, sustainability and risk issues in medical devices; software engineering practice; ergonomics, manufacturing and commercial considerations.

Design Project:

Each team of 4 to 6 students will consult with a commercial/clinical client to address a complex biomedical engineering problem, with guidance from an academic or industry mentor.

Philosophy:

A complex, integrative biomedical engineering design experience. Specifically, a successful design will require integration of knowledge from across the breadth of the biomedical engineering curriculum, including solid and fluid mechanics, instrumentation, mathematical modelling, and the medical sciences. In the real world, though, successful designs are about more than pure scientific and technical know-­how; a good design must account for the social and political environment surrounding the problem. Thus, this course will aim to equip students with knowledge of the cultural and regulatory context for medical devices, and we expect this knowledge to be applied throughout the design process. Real designs are also created to solve complicated, messy problems; there is no one right answer, and there is no single clear question to answer. Thus, this course requires students to determine the parameters of the design problem through consultation with a clinical client, and the technical approach taken to solve it will be entirely up to the students.

Course Requirements

Prerequisite: BIOMENG 341, and a further 45 points from non-elective courses listed in Part III of the BE(Hons) Schedule for Biomedical Engineering

Capabilities Developed in this Course

Capability 1: People and Place
Capability 2: Sustainability
Capability 3: Knowledge and Practice
Capability 4: Critical Thinking
Capability 5: Solution Seeking
Capability 6: Communication
Capability 7: Collaboration
Capability 8: Ethics and Professionalism

Learning Outcomes

By the end of this course, students will be able to:
  1. Explain the phases of the product life cycle and their impact on product design. (Capability 3.1 and 5.1)
  2. Describe the impact of FDA and EU regulations and international standards on the development, marketing, and maintenance of medical products. (Capability 1.1 and 5.1)
  3. Describe the potential environmental and social impacts of medical product production, maintenance, and disposal, as well as ways to mitigate those impacts. (Capability 1.1, 2.1 and 5.1)
  4. Analyse and discuss the potential social impact, ethical and cultural concerns, and Treaty of Waitangi issues associated with a medical product design and its use. (Capability 1.1 and 8.1)
  5. Describe the role of intellectual property protections in the medical product lifecycle, and the resulting issues that must be considered. (Capability 1.1 and 4.2)
  6. Design and implement a prototype hardware and/or software system to meet identified needs and accounting for risk, social and ethical concerns, and the product lifecycle. (Capability 1.1, 4.1, 4.2, 5.1 and 7.1)
  7. Critically analyse biomedical user and client needs to develop a design problem statement and appropriate specifications. (Capability 1.1, 4.2 and 5.1)
  8. Examine risks associated with medical products, and develop mitigations for those risks. (Capability 4.1 and 5.1)
  9. Prepare, plan and execute a project timeline and allocate group effort to meet milestone objectives. (Capability 7.1)
  10. Understand and communicate a design and the multiple constraints and considerations that were involved in its creation. (Capability 6.1 and 7.1)

Assessments

Assessment Type Percentage Classification
Reflections 10% Individual Coursework
Test 30% Individual Test
Project Notebook 5% Individual Coursework
Peer Evaluations 5% Individual Coursework
Reports 30% Group & Individual Coursework
Presentation 10% Group Coursework
Design Review 10% Group Coursework
Assessment Type Learning Outcome Addressed
1 2 3 4 5 6 7 8 9 10
Reflections
Test
Project Notebook
Peer Evaluations
Reports
Presentation
Design Review

Students must sit the test to pass the course. Otherwise, a DNC (did not complete) result will be returned.

A passing mark is 50% or higher, according to University policy.

Late assignments are penalised at 4% of the total mark for each hour they are submitted late, unless prior arrangmenets are made for excused late submissions.

Workload Expectations

This course is a standard 15 point course and students are expected to spend 10 hours per week involved in each 15 point course that they are enrolled in.

For this course, you can expect 24 hours of lectures and in-class assessments and 24 hours of scheduled time in the project laboratory. Since the course as a whole represents approximately 150 hours of study, that leaves a total of 102 hours across the entire semester for self-directed independent and group study, e.g. reading, reflection, studying for the exam, and working on the project.

Delivery Mode

Campus Experience

Attendance is expected at scheduled activities, including project meetings, to complete components of the course.
Lectures will be available as recordings. Other learning activities, including project meetings, will not be available as recordings.
The course will not include live online events.
Attendance on campus is required for the design review and final presentation.
The activities for the course are scheduled as a standard weekly timetable.

Learning Resources

Course materials are made available in a learning and collaboration tool called Canvas which also includes reading lists and lecture recordings (where available).

Please remember that the recording of any class on a personal device requires the permission of the instructor.

We recommend, but do not require, the book "Medical Device Design: Innovation from Concept to Market". This book is available electronically (free to students) through the library.

Health & Safety

Students must ensure they are familiar with their Health and Safety responsibilities, as described in the university's Health and Safety policy.

Workshop facilities will be available for device prototyping. Students should complete the relevant induction activities before using any workshop, which will outline any training and PPE usage required. These facilities are supervised by professional staff who will ensure that students follow the appropriate procedures to minimise risk.

Students will be designing and prototyping medical devices. To minimise risk, these devices are not to be tested on human participants as part of this course, and no other experiments are to be performed on human participants as part of this course. Any other experiments will be reviewed for risk prior to their commencement.

Student Feedback

At the end of every semester students will be invited to give feedback on the course and teaching through a tool called SET or Qualtrics. The lecturers and course co-ordinators will consider all feedback and respond with summaries and actions.

Your feedback helps teachers to improve the course and its delivery for future students.

Class Representatives in each class can take feedback to the department and faculty staff-student consultative committees.

In response to 2024 student feedback, for 2025 the marking rubrics will be clarified, as will the overall project requirements.

Other Information

Students are required to purchase a standard type 2B8 lecture book for use as a project notebook.

Academic Integrity

The University of Auckland will not tolerate cheating, or assisting others to cheat, and views cheating in coursework, tests and examinations as a serious academic offence. The work that a student submits for grading must be the student's own work, reflecting their learning. Where work from other sources is used, it must be properly acknowledged and referenced. A student's assessed work may be reviewed against electronic source material using computerised detection mechanisms. Upon reasonable request, students may be required to provide an electronic version of their work for computerised review.

Students can use generative artificial intelligence text and art generation software, such as ChatGPT and DALL.E 2, on their assessments in this course, but only with prior permission from the instructor. Without permission, you are expected to complete assessments without substantial assistance, including from automated tools. If you are given permission to use such tools, you must acknowledge this. Please include information alongside any assessment that uses AI explaining what you used the tool for and what prompts you used to get the results.

Class Representatives

Class representatives are students tasked with representing student issues to departments, faculties, and the wider university. If you have a complaint about this course, please contact your class rep who will know how to raise it in the right channels. See your departmental noticeboard for contact details for your class reps.

Inclusive Learning

All students are asked to discuss any impairment related requirements privately, face to face and/or in written form with the course coordinator, lecturer or tutor.

Student Disability Services also provides support for students with a wide range of impairments, both visible and invisible, to succeed and excel at the University. For more information and contact details, please visit the Student Disability Services’ website http://disability.auckland.ac.nz

Special Circumstances

If your ability to complete assessed coursework is affected by illness or other personal circumstances outside of your control, contact a member of teaching staff as soon as possible before the assessment is due.

If your personal circumstances significantly affect your performance, or preparation, for an exam or eligible written test, refer to the University’s aegrotat or compassionate consideration page https://www.auckland.ac.nz/en/students/academic-information/exams-and-final-results/during-exams/aegrotat-and-compassionate-consideration.html.

This should be done as soon as possible and no later than seven days after the affected test or exam date.

Learning Continuity

In the event of an unexpected disruption we undertake to maintain the continuity and standard of teaching and learning in all your courses throughout the year. If there are unexpected disruptions the University has contingency plans to ensure that access to your course continues and your assessment is fair, and not compromised. Some adjustments may need to be made in emergencies. You will be kept fully informed by your course co-ordinator, and if disruption occurs you should refer to the University Website for information about how to proceed.

Student Charter and Responsibilities

The Student Charter assumes and acknowledges that students are active participants in the learning process and that they have responsibilities to the institution and the international community of scholars. The University expects that students will act at all times in a way that demonstrates respect for the rights of other students and staff so that the learning environment is both safe and productive. For further information visit Student Charter https://www.auckland.ac.nz/en/students/forms-policies-and-guidelines/student-policies-and-guidelines/student-charter.html.

Disclaimer

Elements of this outline may be subject to change. The latest information about the course will be available for enrolled students in Canvas.

In this course you may be asked to submit your coursework assessments digitally. The University reserves the right to conduct scheduled tests and examinations for this course online or through the use of computers or other electronic devices. Where tests or examinations are conducted online remote invigilation arrangements may be used. The final decision on the completion mode for a test or examination, and remote invigilation arrangements where applicable, will be advised to students at least 10 days prior to the scheduled date of the assessment, or in the case of an examination when the examination timetable is published.