Work-based content
Competencies
| # | Learning outcome | Competency | Action |
|---|---|---|---|
| # 1 | Learning outcome 1 |
Competency
Devise a plan using an appropriate project management methodology to successfully deliver an innovation and development project controlling the quality, timing and costs of activities |
Action View |
| # 2 | Learning outcome 2,4 |
Competency
Work with users to develop a detailed specification of requirements for an innovation and development project |
Action View |
| # 3 | Learning outcome 3,4 |
Competency
Design a solution to meet the previous point by formulating various options and critically appraising them, taking into account the requirements specification, appropriateness of development tools and sustainability in the proposed operational environment |
Action View |
| # 4 | Learning outcome 5 |
Competency
Develop and critically evaluate the solution, establishing its appropriateness and limitations, including signal processing, decision support, mathematical modelling and choice of development platform |
Action View |
| # 5 | Learning outcome 5 |
Competency
Develop and undertake a validation plan |
Action View |
| # 6 | Learning outcome 5 |
Competency
Develop and undertake a verification plan |
Action View |
| # 7 | Learning outcome 5 |
Competency
Develop user documentation and training |
Action View |
| # 8 | Learning outcome 5 |
Competency
Develop technical documentation |
Action View |
| # 9 | Learning outcome 5 |
Competency
Follow the requirements of an appropriate development standard (eg EN13485, SSADM) |
Action View |
| # 10 | Learning outcome 1,5 |
Competency
Manage a project within the framework of a formal project management methodology |
Action View |
| # 11 | Learning outcome 5 |
Competency
Manage security, safety and business risk throughout the development, including the use of ALARP principles |
Action View |
| # 12 | Learning outcome 5 |
Competency
Apply risk analysis iteratively to improve and redefine a design |
Action View |
| # 13 | Learning outcome 5 |
Competency
Perform end-stage review |
Action View |
Assessments
You must complete:
- 4 case-based discussion(s)
- 3 of the following DOPS/ OCEs:
| Produce user documentation and training | DOPS |
| Produce technical documentation | DOPS |
| Review an ongoing project and identify the lifecycle of the project and ways of taking it forward | DOPS |
| Undertake vigilance and end of life procedures | DOPS |
| Develop a specification of requirements | DOPS |
| Design a solution to respond to a specification of requirements | DOPS |
| Develop a formal project management plan for a project lifecycle | DOPS |
| Undertake a risk analysis of a project | DOPS |
| Produce an implementation plan to manage the risks of medical device | DOPS |
| Apply lifecycle process to a project and undertake validation | DOPS |
| Undertake a risk analysis to support the improvement and redefinion of a design | DOPS |
| Present technical information for both technical and non-technical users | OCE |
| Review a completed project, understand the clinical and scientific background, and explain to colleagues the development lifecycle, suggesting alternatives and/or improvements | OCE |
| Present information about a project to a range of users and purposes including providing information, training and general reference | OCE |
| Advise colleagues on health and safety issues relevant to a development project or a medical devise | OCE |
| Contribute at a professional level to clinical teams and communicate scientific material effectively to professional colleagues | OCE |
| Obtain a patient history from a normal volunteer or typical patient referred to your service and present the findings to a colleague or peer. | OCE |
Learning outcomes
- Manage an innovation and development project within the context of a formal project management methodology
- Agree the clinical need with other scientists and/or clinicains
- Evaluate the current state of the art and limitations of existing solutions
- Develop a specification of requirements
- Develop, critically evaluate and deliver novel solutions to clinical measurement, information and communication technology (ICT) and/or medical device requirements through the full project life cycle