Medical Device Design Clinical Measurement

Details

Title

Medical Device Design Clinical Measurement

Type

Stage One

Module code

HPE300

Requirement

Compulsory

Module objective

By the end of this module the Clinical Scientist in HSST will be able to analyse and synthesise their understanding of the application of engineering design principles to novel clinical measurement, software and electronic design solutions device risk management. The Clinical Scientist in HSST will be expected to apply their knowledge whilst using software engineering techniques on projects in the workplace and to specify, design, implement, validate and verify a novel clinical measurement, software or electronic design solution in the workplace. The Clinical Scientist in HSST will be expected to work within project management methodologies and to evaluate their own response to both normal and complex situations using the professional attributes and insights required of a Consultant Clinical Scientist.

Knowledge and understanding

By the end of this module the Clinical Scientist in HSST will be able to analyse, synthesise and critically apply their expert knowledge with respect to clinical measurement and device design including:

Software Engineering

• the importance of engineering discipline in developing software.
• process models and their importance.
• comparison of process models.
• structured development methods (eg SSADM).
• the software development cycle including:
  • requirements
  • specification
  • design
  • implementation
• language selection
• software coding and coding management
• procedural, object oriented and functional programming.
  • real time system programming
  • validation and verification.
• embedded system programming
• Networking and large data set management

Clinical Measurement

• detection of physiological signals.
• normal ranges and abnormal results.
• processing physiological signals.
• safety issues relating to transducers and associated equipment.
• sources of artefacts.
• stimulation and evoked response techniques.
• instrumentation and signal processing.
• measurements in organ systems e.g. cardiovascular, respiratory, neurological, urological.
• audiological and ophthalmological measurements.
• ambulatory monitoring.
• clinical validation and verification of developed systems.

Medical Engineering Design

• the design process, and description of the problem to be solved, including standards and requirements, prototyping and testing, technical communication, project monitoring and outcome evaluation.
• bring new items of equipment, systems, facilities and protocols into service safely and effectively.
• identify the requirements for at least two pieces of equipment for  specific  patient use or for measurement/diagnosis.
• develop each requirement into a design brief and subsequently into a set of design specifications, suitable to allow the development of design  concepts.
• evaluate the design concepts using a appropriate scientific  methods.
• produce CAD drawings and/or circuit schematics, sufficiently detailed to allow the   development   of  costing   estimates   and  manufacture   by  an   external organisation.
• take the designs through manufacture and validate a  prototype.
• develop the required documentation as stipulated by the relevant  legislation.
• critically evaluate all stages of the project.
• specify, design, build and bring into service pieces of equipment, using formal design processes, to be used either (a) in a biomechanical or functional assessment, including validation against current clinical methods, or (b) to meet  a specific clinical need for a particular clinical  problem,  including  measurement of performance.
• develop and keep up to date the associated documentation, including those relating to technical construction and risk management according to established standards.

Software Quality Assurance

• configuration management and change control.
  • software tools.
  • standards.
  • documentation.

Technical and clinical skills

By the end of this module the Clinical Scientist in HSST will be able to demonstrate  a critical understanding of current research and its application to the performance and mastery of the following technical skills and will:

• manage an innovation and development project within the context of a formal project management methodology.
• develop a specification of requirements.
• develop and critically evaluate novel solutions to clinical measurement, Information & Communications Technology (ICT) and/or medical device requirements.
• design, plan and undertake validation and verification of a novel solution.
• write and evaluate user documentation and training.
• write technical documentation.
• write vigilance and end of life procedures for any developments.
• write adequate documentation demonstrating how risks have been managed.
• configure an Information & Communications Technology (ICT) hardware, software and network components, applying relevant safety standards and configuration control.
• implement server based applications, ensuring appropriate security, protective measures and routine housekeeping tasks.
• implement a novel Information & Communications Technology (ICT) and apply in the clinical environment in a controlled fashion.
• innovate and develop new clinical measurement solutions.
• provide scientific support to a novel or complex clinical investigation.
• provide reports on a novel or complex clinical measurement.

Attitudes and behaviours

By the end of this module the Clinical Scientist in HSST will be expected to evaluate their own response to both normal and complex situations demonstrating the professional attributes and insights required of a Consultant Clinical Scientist working within the limits of professional competence referring as appropriate to senior staff and will:

• present complex ideas in simple terms in both oral and written formats.
• consistently operates within their sphere of personal competence and level of authority.
• manage personal workload and objectives to achieve quality of care.
• actively seek accurate and validated information from all available sources.
• select and apply appropriate analysis or assessment techniques and tools.
• evaluate a wide range of data to assist with judgements and decision making.
• conduct procedures with due care for the safety of self and others.
• take restorative action within quality control/assurance requirements to address threats of performance deterioration.
• have a clear focus on effective patient centred service delivery, minimising risk and promoting patient safety
• work in partnership with colleagues, other professionals, patients and their carers to maximise patient care.