Reviewing: S-CE-S5-1

Health Technology Innovation

Information:

Module information

Details

Title
Health Technology Innovation
Type
Specialist
Module code
S-CE-S5-1
Credits
15
Requirement
Compulsory

Aim of this module

This module will prepare the trainee for identifying, developing and implementing healthcare technology innovation. It provides experience in identifying opportunities for improvement and development, eliciting and specifying customer requirements and producing real world solutions whilst developing an understanding of the strategic planning and wider organisational requirements for the introduction of new technology into the healthcare pathway.

Work-based content

Competencies

# Learning outcome Competency Action
# 1 Learning outcome 1,2,7 Competency

Create a detailed functional specification for a healthcare technology development through discussion with the clients/users, e.g., clinicians and/or patients and their carers.

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# 2 Learning outcome 1,2 Competency

Use Computer Aided Design to generate a prototype and apply an appropriate methodology to simulate its functionality.

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# 3 Learning outcome 1,2,5 Competency

Perform and document a feasibility study for a healthcare technology development from a functional specification.

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# 4 Learning outcome 1,3,6 Competency

Develop technical documentation for the development of a healthcare technology, applying the requirements of the Medical Device Regulations and appropriate standards and legislation.

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# 5 Learning outcome 1,3,6 Competency

Perform a risk assessment for a healthcare technology development and propose a risk management strategy.

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# 6 Learning outcome 1,4,5 Competency

Plan and perform a verification study for a healthcare technology realisation.

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# 7 Learning outcome 1,4,5 Competency

Plan and perform a validation study for a healthcare technology realisation.

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# 8 Learning outcome 1,3,6,7 Competency

Commission a newly developed healthcare technology; produce protocols for its safe and effective introduction into service.

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# 9 Learning outcome 1,6,7 Competency

Train and familiarise the client/user in the use of the  healthcare technology, including the development of user instructions.

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# 10 Learning outcome 5 Competency

Critically review the introduction of a new medical technology, or a mass equipment replacement programme, within the organisation.

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# 11 Learning outcome 1 Competency

Outline the pathway of translation for a proposed medical device innovation from conceptualisation and clinical investigation, through to the adoption of use within a healthcare organisation.

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# 12 Learning outcome 5 Competency

Identify a development for a service based on a recent innovation or national initiative which impacts the patient pathway. Map the development to local service needs. Consider the strategic change required for adoption, identifying the impact on department/local service practice.

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# 13 Learning outcome 5 Competency

Appraise the evidence base for a new model of service delivery or practice, to improve the patient pathway.

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# 14 Learning outcome 1,5,7 Competency

Present a solution to address a service delivery need and lead an appraisal against requirements with stakeholders

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# 15 Learning outcome 1,5,6,7 Competency

Draft an outline business case, including formal options appraisal, for a new model of service delivery, practice or novel technology to improve the  patient pathway. Draft a plan for implementation.

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Assessments

Complete 3 Case-Based Discussions

Complete 3 DOPS or OCEs

Direct Observation of Practical Skills Titles

  • Perform a verification or validation activity.
  • Demonstrate an electrical circuit including live measurement.
  • Perform a mechanical test on a component and compare with CAD simulation.
  • Demonstrate the influence of filter design on circuit performance.

Observed Clinical Event Titles

  • Lead requirements generation or solution selection exercise with other stakeholders
  • Discuss the production of a prototype with the stakeholders.
  • Train users for a newly developed medical device.
  • Discuss an outline business case with a senior manager.
  • Present a service development need to the multidisciplinary team.
  • Demonstrate a CAD and simulation solution to stakeholders

Learning outcomes

# Learning outcome
1

Engage in the translation pathway for healthcare technology developments.
2

Generate a specification, develop a design and prototype, and assess the feasibility of a healthcare technology development.
3

Apply legislative and risk management frameworks to the development of healthcare technology.
4

Plan and perform verification and validation of solutions.
5

Critically evaluate changes and solutions to address service needs, considering the impact on patient care and safety and the wider healthcare system,
6

Support safe and effective introduction of healthcare technology developments into service.
7

Employ and adapt communication skills to effectively engage stakeholders in the design, development, and introduction of solutions to address service needs.

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. Apply integrative knowledge of the principles of design in the operational and technical domains.
  2. Identify and compute the appropriate statistics to quantify the dynamics of an operational, clinical or technical process.

Indicative content

  • Principles and practice of good design:
    • Engaging with users.
    • Design in health care technology.
    • Exploration of design opportunities.
    • Developing design solutions.
    • Verification and validation.
    • Managing and executing the design process.
  • Modelling and simulation of operational systems in healthcare:
    • Issue maps.
    • Discrete event simulations.
    • Activity diagrams.
    • Influence diagrams.
    • System dynamics.
    • Introduction to simulation tools for operational systems.
  • Modelling and simulation of mechanical systems in health care:
    • Mechanics refresher.
    • Physical and biological behaviours of clinical materials.
    • Introduction to CAD.
    • Introduction to finite element analysis (FEA).
  • Routes to market for medical device innovation:
    • Intellectual property.
    • Clinical investigations.
    • Commercialisation
    • Post-market surveillance.
  • Manufacturing technologies:
    • Principles of 3D printing.
    • Principles of CNC milling.

 

 

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.

Activities

  1. Visit a Clinical Engineering service involved in the introduction of new technology into clinical services.
  2. Visit a stakeholder service to fully appreciate the development opportunity and service impact of potential solutions.
  3. Attend a corporate level meeting at which decisions regarding the introduction of new technologies are made to appreciate the decision-making process.
  4. Attend and participate in stakeholder project meetings for the introduction of new technology.
  5. Spend time in a clinical engineering service that designs and produces medical devices to understand how project management and quality management systems support design and development in healthcare technology innovation.
  6. Attend an end of project review meeting for both a device development project and the introduction of new technology into clinical use.
  7. Spend time in the stakeholder service for a device analysed to appreciate how device performance affects clinical use and patient outcome.

Module assigned to

Specialties

Specialty code Specialty title View
Specialty code SPE3-4-27 Specialty title Clinical Engineering [2027] Action View
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