Module Overview

Medical Device Design 1

This module develops a knowledge of the engineering design process, encompassing specification, analysis, creative thought, and methods of selection from design alternatives. Students will be equipped with the knowledge to write basic design specifications for a product or task. They will undertake analytical calculations to design and/or select machine elements from a stand alone and system wide perspective, and apply selection methodologies to compare different design proposals. Students will also be tutored in the requirements for safety, ergonomic and environmental issues. They will expand their concurrent engineering knowledge into the areas of design for manufacturing, and assembly etc.

Module Code

MDDS H3000

ECTS Credits


*Curricular information is subject to change

Medical Device Design and Manufacture:

Introduction to Medical Device design, Medical device classifications, Health Products Regulatory Authority, importance of ethics in medical design relevant approval processes, device standards,prototyping & application performance testing, medical assessment techniques in respiration, cardiac, surgical noninvasivedevices. Good Manufacturing Practice.

Barriers to creative thought:

Definition of mental barriers. Classification of mental barriers. Puzzles which highlight barriers.

Approvals Process:

European medical device directives, 21CFR800, FDA applications and approval processes, importance of ethics in device testing, management and assessment of medicaltechnology, risk factors, safety, quality and management of medical equipment. Impact of product recalls.

Concept selection:

Concept screening, selection matrices, concept rating, concept ranking.

Design process review:

General structure of design specifications. Statement of problem, “must requirements”, “want” requirements, criteria for excellence.Setting target and final specifications, needs-metrics matrix.

Design Selection:

Requirements for engineering design calculations, industrial standards, safety factors, sizing structural elements, sizing welded joints. Component selection: threaded fasteners, locking devices, bearings, seals. Using web based supplier data

Specification and selection of system elements:

Analysis of electro-mechanical or electro-hydraulic systems. Effects of element efficiencies. System component selection and specification.

Safety requirement:

Protection of personnel, mechanical hazards, non-mechanical hazards, risk assessment. Protection of equipment, mechanical safety devices, thermal and electrical safety devices. EU machinery directive, US OSHA requirements, safety standards and compliance.


Deifinition of ergonomics, the human-machine relationship, human factors, instrumentation and control layouts, machine construction, anthropometric data.

Design for manufacturing and assembly:

The DFM method, minimising costs, use of standard components, redesign to minimise processing, integration of parts, minimisation of assembly directions, self-aligning and self locating parts, minimising complexity. Design for Environment (DFE).

Module Content & Assessment
Assessment Breakdown %
Formal Examination70
Other Assessment(s)30