MTE-40051 - Medical Devices Design: Quality by Design
Coordinator: Peter Ogrodnik Tel: +44 1782 674996
Lecture Time: See Timetable...
Level: Level 7
Credits: 15
Study Hours: 150
School Office:

Programme/Approved Electives for 2024/25

None

Available as a Free Standing Elective

No

Co-requisites

None

Prerequisites

None

Barred Combinations

none

Description for 2024/25

This module aims to develop advanced engineering design skills required in order to be able to design components and products successfully within the context of medical devices and healthcare technologies. It will include a critical evaluation of models and tools used in creative engineering design. Particular emphasis will be placed on Quality By Design within a highly regulated environment. You will receive essential training on risk management and auditing. Working in teams is an essential aspect of design, you will be given the opportunity to work in teams and reflect on team performance throughout the module.

Aims
The main focus of this module encompasses Quality by Design methodologies. The aim of this module is to develop a student's formal engineering design ability in order that they could undertake a design project, either as an individual or as a part of a design team, within the context of medical devices / healthcare technology.

Intended Learning Outcomes

Evaluate and appraise design inputs and outputs using formal selection methods, Design for X(D4X), Quality in Design tools, risk analysis and Failure Mode and Effects Analysis (FMEA) and Design of Experiments: 2
Evaluate, formulate and defend a project plan within the context of engineering design: 2
Evaluate and synthesise concepts of Intellectual Property and summarise them in context: 1,2
Evaluate and critically appraise performance within a team within the context of quality by design: 1

Study hours

Nominal 1-2 hours per week (18 hours) containing a mix of
lectures, seminars and group work but this may vary dependent on the planned activity.
Examination: 2 hours
Guided independent study: 130 hours

School Rules

None

Description of Module Assessment

1: Coursework weighted 25%
Personal Reflection: IP


2: Exam weighted 75%
Examination