Module - Design and Development (SPE301)

STP

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 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. 

Work-based Competencies


Learning outcome Title Knowledge
1 1

Competently use a CAD software package to produce design drawings

  • The process of project life cycle
  • Nomenclature in project documentation
  • Design methodologies
  • Methods of risk analysis
  • Safety test requirements and methods
  • How to specify, design and construct equipment to meet appropriate safety standards
  • Small-scale engineering manufacturing techniques and good manufacturing practice
  • Materials properties and fabrication methods
2 1

Specify manufacturing and machining for production tasks

  • The process of project life cycle
  • Nomenclature in project documentation
  • Design methodologies
  • Methods of risk analysis
  • Safety test requirements and methods
  • How to specify, design and construct equipment to meet appropriate safety standards
  • Small-scale engineering manufacturing techniques and good manufacturing practice
  • Materials properties and fabrication methods
3 1

Communicate technical information effectively with non-technical users

  • Effective verbal communication skills, eg language, signposting, listening, language, non-verbal behaviour
4 2

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

  • Identification of sources of appropriate literature relating to the technical, scientific and clinical basis of clinical measurements
  • Sources of other guidance on design and good manufacturing practice
  • Governance and approval policies and procedures within the organisation
5 3

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

  • Essential requirements of the Medical Devices Directive
  • Risk Classification Rules of the Medical Devices Directive
  • Technical standards underpinning the Medical Devices Directive
  • Experimental design
6 2,3

Identify performance and functional requirements for a design or an application

  • The requirements for equipment in the clinical environment, including clinical and research governance issues related to medical devices
  • The importance of the human/machine interface in the clinical environment
  • Materials properties and fabrication methods
7 2,3

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

  • Impact analysis as applied to new ideas
  • The framework for intellectual property protection and exploitation
  • Applications of technology in other fields
8 3,4

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

  • Safety test requirements and methods
  • Applicable qualitative and quantitative methods
  • Means of assessing clinical outcomes
9 4

Plan and perform a design review

  • Scientific and engineering principles applicable and appropriate in a particular situation
  • Scientific method
10 4

Plan and perform a validation study

  • Design of a validation plan and how this plan validates the project
  • Design of a verification plan and the difference between verification and validation
11 4

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

  • Appropriate statistical methods
  • Effective written communication, including presenting technical information for both technical and non-technical users
12 5

Critically evaluate their proposed methodology

  • Limitations of different methods
  • Evidence base underpinning the chosen method
  • Report writing
  • Referencing

Work-based assessment


Complete 1 Case-Based Discussion(s)
Complete 1 of the following DOPS and/or OCEs
Type Title
DOPS 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