MEEN40600 Medical Device Design

Academic Year 2023/2024

Medical Device Design requires an understanding of clinical, technical and legal/regulatory needs and requirements.
This module is project and research led and will focus on developing a prototype and plan for medical device translation and commercialisation. Using the Stanford Biodesign model, in collaboration with clinical advisors, we use a stepwise approach to (1) identify a clinical need associated with a medical procedure, (2) invent a suitable device to address this need and (3) propose a suitable implementation strategy for its clinical translation.
The module will be delivered through a combination of lectures, required reading, guest speakers, based around a group design project. Students must complete regular project presentations and assessment exercises. Working in teams, the students compile a report and presentation pitch on their medical device technological solution.

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Curricular information is subject to change

Learning Outcomes:

On completion of the module, students will:
(a) Demonstrate an ability to derive, analyse and apply potential design solutions within the medical device design process
(b) Demonstrate an understanding of the core requirements and of legal and ethical issues, including the circular economy, within regulatory frameworks
(c) Be able to define core user needs for a given medical device application area
(d) Be able to capture and define core issues relating to intellectual property within a device design
(e) Be able to identify and rank clinical needs and potential medical device design solutions
(f) Development project management skills related to medical device development
(g) Be cognisant of the commercial challenges in clinical translation of medical device technology

Indicative Module Content:

The module follows a condensed version of the Biodesign Approach to Medical Device Development through team-based projects aimed at identifying and addressing real clinical needs:
(1) Clinical Need Identification - Figure out strategic focus, learn how to observe and identify clinical problems, construct and rank clinical need statements
(2) Invent Device Solutions - Ideation & Brainstorming, Prototyping and concept development
(3) Implementation Plan - Developing IP, Regulatory and Clinical Strategies, Stakeholder Analysis and Business Development Plan

Student Effort Hours: 
Student Effort Type Hours
Specified Learning Activities

24
Autonomous Student Learning

48
Lectures

24
Small Group

12
Conversation Class

24
Total

132
Approaches to Teaching and Learning:
A combination of lecture content (delivered through pre-recorded presentations when required), live and pre-recorded student team presentations as project updates (in person, with Zoom access as a backup, where feasible), end of trimester student project pitches, in-class quizzes, team meetings with project mentors. Access to 3D printing and other prototyping facilities through teaching assistants will be reviewed continuously throughout the trimester.
Efforts will be made to make content available to students who are unable to be physically located on the UCD Belfield campus.
 
Requirements, Exclusions and Recommendations
Learning Requirements:

Stage 3 complete.

Learning Recommendations:

Engineering or science background.


Module Requisites and Incompatibles
Incompatibles:
MEEN40100 - Biomechanics

Equivalents:
Medical Device Design (EEME40460)


 
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Group Project: Group Project Report in the form of an Enterprise Ireland Grant Application to develop your technology Coursework (End of Trimester) n/a Graded No

23
Presentation: Project Update Presentations & Final Presentation Grade Varies over the Trimester n/a Graded No

33
Attendance: Grade based on Attendance, Interaction with the Module, Individual, Mentor and Peer-Assessment Reports Coursework (End of Trimester) n/a Graded No

15
Multiple Choice Questionnaire (Short): In-class MCQ / Short Answer Questions Quiz Varies over the Trimester n/a Graded No

30

Carry forward of passed components
Yes
 
Resit In Terminal Exam
Spring Yes - 1 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
• Group/class feedback, post-assessment
• Self-assessment activities

How will my Feedback be Delivered?

Weekly feedback on group work is provided through the online tool DEFT

Biodesign : The Process of Innovating Medical Technologies - 2nd Edition

Online and Physical version available through UCD Library
Name Role
Dr Nicolas Aristokleous Lecturer / Co-Lecturer
Dr Irina Khaydukova Lecturer / Co-Lecturer
Mr Ryan Paetzold Lecturer / Co-Lecturer
Gang Shen Lecturer / Co-Lecturer
Timetabling information is displayed only for guidance purposes, relates to the current Academic Year only and is subject to change.
 
Autumn
      
Lecture Offering 1 Week(s) - Autumn: All Weeks Fri 15:00 - 15:50
Lecture Offering 1 Week(s) - 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12 Mon 11:00 - 11:50
Tutorial Offering 1 Week(s) - Autumn: All Weeks Tues 14:00 - 15:50
Autumn