Department of Materials Science &
Engineering
Module Description 2012/13
Module Code: MAT3410
Module Title: Design of Medical Devices
and Implants
Module Convenor: Dr C K Chong
Module Links: MAT6307
Credits: 10
Semester: 2
Pre-requisites:
Co-requisites:
Brief Description (including aims of the course):
This module targets the solution of clinical problems by use of implants and medical
devices and underlines the role a BM engineer can play. Topics include a survey of
clinical problems and the need of solutions in developed, developing and
underdeveloped countries; the principles of medical device and implant design;
design parameters and specifications involving biomaterials and regulations;
engineering analysis in the design process; preclinical testing for safety and efficacy,
including risk/benefit ratio assessment evaluation of clinical performance and design
of clinical trials. Case studies are used to aid further understanding of specific topics.
Team Design Project is included to enhance the process and experience of
developing a solution for existing clinical problems.
This unit aims to provide the necessary background for students to adopt rational
approaches to the development of medical devices and implants for solving clinical
problems.
Course Objectives:
By the end of this course, you will be able to:
•Demonstrate an understanding of the paradigm for design of medical
devices/implants
•Demonstrate the ability to perceive a clinical problem (including the failure of
present solution) and formulate a solution;
•Demonstrate the capability for drawing on conceptual design skill, knowledge
obtained in BME lab and lecture modules, literature (including patent search);
•Demonstrate an appreciation of the interdisciplinary nature and requirement of
broad knowledge in solving medical/clinical problems;
•Demonstrate an understanding of international regulations and standards of
medical devices/implants;
•Demonstrate the process from idea creation through to commercialisation and
marketing of medical devices/implants;
•Demonstrate the ability to work in a team;
•Demonstrate to peers, faculty, and future employees that they are qualified BME and
prepared to enter the work force and make a difference in their discipline.
Assessment:
Exam: 30% (Quiz)
Individual Report: 50% Other: Team Design Project Presentation 20%
Booklist (A) Core Test; (B) Secondary Text; (C) Peripheral Reading:
(A) S Zenos, J Makower, P Yock, “BIODESIGN – The Process of Innovating Medical
Technologies”, Cambridge University Press, 2010
(B) R Richards-Kortum, “Biomedical Engineering for Global Health”, Cambridge University
Press, 2010
(B) S Mehta, “Commercializing Successful Biomedical Technologies”, Cambridge University
Press, 2008
(C) P King, R Fries, “Design of Biomedical Devices and Systems”, CRC Press, 2009
UK-SPEC Learning Outcomes
Please insert an 'x' in the table below against all learning outcomes that are delivered
in the module. N.B. The suffix 'm' indicates learning outcomes that are characteristic
of the enhanced outcomes expected of MENG graduates.
LEARNING
OUTCOME
DESCRIPTION
US1
Knowledge & understanding of scientific
principles & methodology necessary to
underpin their education in their
engineering discipline, to enable
appreciation of its scientific and
engineering context, & to support their
understanding of the historical, current &
future developments and technologies
Underpinning Science & Mathematics
US1m
A comprehensive understanding of the
scientific principles of own specialisation &
related disciplines
US2
Knowledge & understanding of
mathematical principles necessary to
underpin their education in their
engineering discipline and to enable them
to apply mathematical methods, tools &
notations proficiently in the analysis &
solution of engineering problems
US2m
An awareness of developing technologies
related to own specialisation
US3
Ability to apply & integrate knowledge &
understanding of other engineering
disciplines to support study of their own
engineering discipline
US3m
A comprehensive knowledge &
understanding of mathematical & computer
models relevant to the engineering
discipline, and an appreciation of their
limitations
BENG MENG
US4m
An understanding of concepts from a range
of areas including some outside
engineering, and the ability to apply them
effectively in engineering projects
E1
Understanding of engineering principles
and the ability to apply them to analyse key
engineering processes
E1m
An ability to use fundamental knowledge to
investigate new & emerging technologies
E2
Ability to identify, classify and describe the
performance of systems & components
Engineering Analysis
through the use of analytical methods &
modelling techniques
E2m
Ability to apply mathematical & computerbased models for solving problems in
engineering, & the ability to assess the
limitations of particular cases
E3
Ability to apply quantitative methods &
computer software relevant to their
engineering discipline, in order to solve
engineering problems
E3m
Ability to extract data pertinent to an
unfamiliar problem, & apply in its solution
using computer-based engineering tools
when appropriate
E4
Understanding of & ability to apply a
systems approach to engineering problems
D1
Investigate & define a problem & identify
constraints including environmental &
Design
sustainability limitations, health & safety &
risk assessment issues
D1m
Wide knowledge & comprehensive
understanding of design processes &
methodologies & the ability to apply &
adapt them in unfamiliar situations
D2
Understand customer & user needs & the
importance of considerations such as
aesthetics
D2m
Ability to generate an innovative design for
products, systems, components or
processes to fulfil new needs
D3
Identify & manage cost drivers
D4
Use creativity to establish innovative
solution
D5
Ensure fitness for purpose for all aspects of
the problem including production,
operation, maintenance & disposal
D6
Manage the design process & evaluate
outcomes
S1
Knowledge & understanding of commercial
& economic context of engineering
processes
S1m
Extensive knowledge & understanding of
Economic, Social & Environmental Context
management & business practices, & their
limitations, & how these may be applied
appropriately
S2
Knowledge of management techniques,
which may be used to achieve engineering
objectives within that context
S2m
The ability to make general evaluations of
commercial risks through some
understanding of the basis of such risks
S3
Understanding of the requirement for
engineering activities to promote
sustainable development
S4
Awareness of the framework of relevant
legal requirements governing engineering
activities, including personnel, health,
safety, & risk (including environmental risk)
issues
S5
Understanding of the need for a high level
of professional & ethical conduct in
engineering
P1
Knowledge of characteristics of particular
materials, equipment, processes, or
products
P1m
A thorough understanding of current
practice & its limitations, & some
appreciation of likely new developments
P2
Workshop & laboratory skills
P2m
Extensive knowledge & understanding of a
Engineering Practice
wide range of engineering materials &
components
P3
Understanding of contexts in which
engineering knowledge can be applied (e.g.
operations & management, technology
development, etc)
P3m
Ability to apply engineering techniques
taking account of a range of commercial &
industrial constraints
P4
Understanding use of technical literature &
other information sources
P5
Awareness of nature of intellectual property
& contractual issues
P6
Understanding of appropriate codes of
practice & industry standards
P7
Awareness of quality issues
P8
Ability to work with technical uncertainty