Design and Development

Module details

Title

Design and Development

Type

Rotation

Module code

SPE301

Credits

10

Requirement

Compulsory

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.

Competencies

#	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

Assessments

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. 

Learning outcomes

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

Indicative content

Safety

• 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

Activities

• 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.