ENGGEN 771 : Medical Device Industry Practice
Engineering
2022 Semester Two (1225) (15 POINTS)
Course Prescription
Course Overview
- Introduction to standards and regulations
- Medical Device Design -- Risk management throughout the product life cycle According to ISO 14971
- Usability & Human Factors Engineering -- Understanding and controlling risks associated with the use of medical devices through the application of IEC 62366
- Programmable Electrical Medical Systems -- Controlling risks associated with software in medical devices through the application of IEC 62304 and Programmable Electrical Medical Systems requirements of IEC 60601-1
- Medical device product standards as a source for identification of hazards and controlling the risk and application of IEC 60601-1
- Workshop on Human Centred Design
- Commercialization -- how devices make it to the market
Capabilities Developed in this Course
| Capability 1: | Disciplinary Knowledge and Practice |
| Capability 2: | Critical Thinking |
| Capability 3: | Solution Seeking |
| Capability 4: | Communication and Engagement |
| Capability 5: | Independence and Integrity |
| Capability 6: | Social and Environmental Responsibilities |
Learning Outcomes
- Understand the origin and importance of laws and regulations pertaining to medical devices (Capability 1, 5 and 6)
- Understand the medical device development and production processes (Capability 1, 2 and 3)
- Explain the importance of medical device risk management, identifying its 5 key steps (Capability 1, 2, 4, 5 and 6)
- Estimate risks, and how to effectively mitigate risk to an acceptable level (Capability 1, 2, 3, 5 and 6)
- Understand and analyse risks associated with the use of medical devices through the application of international standard IEC 62366 (Capability 1, 2, 3 and 6)
- Understand and analyse risks associated with software in medical devices through the application of international standards IEC 62304 and Programmable Electrical Medical Systems requirements of IEC 60601-1 (Capability 1, 2 and 6)
- Understand and explain the importance of user-centric design, and how to extract and identify the needs of the user (Capability 1, 2, 3 and 4)
- Understand the role, responsibility, and authority of several key regulatory agencies in the process of gaining and maintaining commercialization of medical devices in key global markets (Capability 1 and 6)
Assessments
| Assessment Type | Percentage | Classification |
|---|---|---|
| Project | 60% | Group Coursework |
| Test | 40% | Individual Coursework |
| 2 types | 100% |
| Assessment Type | Learning Outcome Addressed | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | |||
| Project | ||||||||||
| Test | ||||||||||
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 2 hours of lectures, 2 hours of reading and thinking about course content, and 6 hours of work on assignments and/or test preparation per week.
Delivery Mode
Campus Experience
Attendance is expected at scheduled activities including, and required for group-work activities, to receive credit for components of the course.
Lectures will be available as recordings.
Attendance on campus is required for the test.
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.
Health & Safety
Students are expected to adhere to the guidelines outlined in the Health and Safety section of the Engineering Undergraduate Handbook.
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.
Academic Integrity
The University of Auckland will not tolerate cheating, or assisting others to cheat, and views cheating in coursework 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. This requirement also applies to sources on the internet. A student's assessed work may be reviewed against online source material using computerised detection mechanisms.
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 course assessment continues to meet the principles of the University’s assessment policy. Some adjustments may need to be made in emergencies. You will be kept fully informed by your course co-ordinator/director, 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 students may be asked to submit 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. In exceptional circumstances changes to elements of this course may be necessary at short notice. Students enrolled in this course will be informed of any such changes and the reasons for them, as soon as possible, through Canvas.