Module information

Module details

Design and Development
Module code

Aim of this module

To introduce the trainee to the development life cycle, from user specification through to validation and verification. The trainee will apply the methodology to a small project or component of a larger project in clinical  measurement,  information  and  communication  technology  (ICT)  or  medical  device  design and development.

Work-based content


# Learning outcome Competency Action
# 1 Learning outcome 1 Competency

Competently use a CAD software package to produce design drawings

Action View
# 2 Learning outcome 1 Competency

Specify manufacturing and machining for production tasks

Action View
# 3 Learning outcome 1 Competency

Communicate technical information effectively with non-technical users

Action View
# 4 Learning outcome 2 Competency

Perform a literature search and extract, collate and present information in a structured way

Action View
# 5 Learning outcome 3 Competency

Translate informal description of a problem into a set of detailed user requirements

Action View
# 6 Learning outcome 2,3 Competency

Identify performance and functional requirements for a design or an application

Action View
# 7 Learning outcome 2,3 Competency

Identify different options for a design and assess merits of each separately

Action View
# 8 Learning outcome 3,4 Competency

Plan, set up and conduct bench experiments to validate concepts, components and systems

Action View
# 9 Learning outcome 4 Competency

Plan and perform a design review

Action View
# 10 Learning outcome 4 Competency

Plan and perform a validation study

Action View
# 11 Learning outcome 4 Competency

Apply statistical analyses to data and to draw conclusions Present the results and their discussion in a structured manner and written format

Action View
# 12 Learning outcome 5 Competency

Critically evaluate their proposed methodology

Action View


You must complete:

  • 1 case-based discussion(s)
  • 1 of the following DOPS/ OCEs:
Produce a design using CAD or other appropriate design tool. DOPS
Undertake a design review DOPS
Undertake a risk assessment, suggest mitigation measures and show how that reduces the risk DOPS
Set up and undertake a validation experiment. DOPS
Generate a list of performance and functional requirements from user requirements. DOPS
Generate a list of design specifications from the performance and functional requirements. DOPS
Conduct risk assessment on user, functional and performance requirements and modify to mitigate risks DOPS

Learning outcomes

  1. Produce a user specification from a user concept.
  2. Undertake a literature review to inform the design process.
  3. Translate the user specification into a design using CAD software. 
  4. Design and undertake verification and validation tests on a design. 
  5. Critically evaluate their proposed methodology. 

Academic content (MSc in Clinical Science)

Important information

The academic parts of this module will be detailed and communicated to you by your university. Please contact them if you have questions regarding this module and its assessments. The module titles in your MSc may not be exactly identical to the work-based modules shown in the e-portfolio. Your modules will be aligned, however, to ensure that your academic and work-based learning are complimentary.

Learning outcomes

  1. Discuss the basis of medical electronics and the medical device life cycle. 

Indicative content


  • Health and safety legislation specific to division
  • Risk assessment techniques
  • Chemical safety: COSHH, hazards, storage, use and disposal
  • Electrical safety: medical equipment, leakage currents, fault conditions, isolation and circuit protection; biological/physiological response to electric shock; treatment of electric shock; equipment testing
  • Mechanical safety: lifting gear; guards and operation of machine and hand tools, eye and ear protection; fumes, dusts, moving and handling
  • Biological safety: pathological and normal specimens; blood and other tissues; equipment contamination, cleaning, cross-contamination; handling procedures and protocols
  • Theatre safety:    anaesthetic   agents,    explosion   hazard,    waste    gas extraction, function checks, obstacles, sterility
  • Workshop safety


Innovation and Service Improvement

  • Role of Medical Physics and Clinical Engineering in innovation and service improvement
  • Project management
  • Process mapping
  • Equipment life cycle
  • Specification, procurement, installation and commissioning
  • Critical review of protocols, techniques and equipment
  • Health Technology Assessment
  • Horizon scanning


Medical Electronics

  • Electronic components
  • Basic circuit design (analogue and digital)
  • Microprocessor principles
  • Data acquisition techniques
  • Applied signal processing
  • Biopotential electrode amplifiers
  • Transducers and interfaces
  • Interfacing computers, principles of wired and wire-free networks
  • Telemetry
  • Opto-electronics
  • Electromechanical systems
  • Intelligent systems
  • Safety/reliability analysis of designs
  • Instrumentation for physiological measurement and control
  • Clinical applications of medical instrumentation system, e.g. electrophysiology, defibrillation, patient monitoring, drug delivery, endoscopy, life support, the operating theatre environment

Clinical experiences

Important information

Clinical experiential learning is the range of activities trainees may undertake in order to gain the experience and evidence to demonstrate their achievement of module competencies and assessments. The list is not definitive or mandatory, but training officers should ensure, as best training practice, that trainees gain as many of these clinical experiences as possible. They should be included in training plans, and once undertaken they should support the completion of module assessments and competencies within the e-portfolio.


  • Review an ongoing or completed project within the organisation and discuss the clinical and scientific background to the project and the intended positive impact on patient care. 
  • For a novel medical device, novel software application or novel clinical measurement, undertake key steps in the project life cycle, including working with users to develop a user specification.