Health Technology Innovation —
Training activity: 5

Details

Plan and perform verification and validation of a prototype or simulation developed to address a service need

Type

Developmental training activity (DTA)

Evidence requirements

Evidence the activity has been undertaken by the trainee​.

Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.

An action plan to implement learning and/or to address skills or knowledge gaps identified.

Considerations

• CAD/electronic simulation
• Health economics
• Cost effectiveness
• Process for development
• Medical device regulation
• Standards and guidance
• Difference between verification and validation activities

Reflective practice guidance

The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.

Before action

• What are the key performance indicators or acceptance criteria for your prototype or simulation?
  • What is the difference between verification and validation in this context?
• What testing methodologies are appropriate for your prototype or simulation?
  • What data will you need to collect and analyse?
  • Are there any relevant standards or guidelines for verification and validation?
• What insights do you hope to gain about the importance of rigorous testing and evaluation in the development process?
  • What do you already know about verification and validation principles?
• Will you develop a test plan outlining your approach, including the tests you will perform and the data you will collect?
  • Will you identify the tools or equipment needed for testing?
  • Have you discussed your verification and validation plan with your training officer?

In action

• When planning verification and validation, what specific tests or evaluations are you deciding to perform and why are these appropriate?
• As you perform the tests, how are you observing and recording the outcomes?
  • Are you noticing any unexpected behaviours or results?
• If the prototype or simulation fails a verification or validation step, what immediate decisions are you making about how to address the issue?

On action

• Summarise the verification and validation activities you planned and performed, and the key outcomes.
• What did you learn about the principles of verification and validation?
  • How did you plan appropriate tests or evaluations?
  • How did you assess whether the prototype or simulation met the required specifications and addressed the service need?
  • Were there any unexpected results or difficulties during the verification and validation process?
  • Why are verification and validation important in the development of healthcare technology?
• What aspects of planning and performing verification and validation could be improved?
  • How will you approach future verification and validation tasks?
  • What are your next steps in learning more about quality assurance and testing methodologies?
  • What resources (e.g., testing protocols, quality standards) would be beneficial?

Beyond action

• Have you planned or performed other verification and validation activities since this DTA?
  • Have you compared the verification and validation methods used in this activity with other approaches?
  • Have you considered the outcomes of your verification and validation in relation to the performance of the prototype/simulation in other contexts?
• How has this experience influenced your understanding of the importance of verification and validation?
  • Have you applied the skills of planning and performing testing in other areas of your work?
  • Has your understanding of quality assurance and testing processes evolved?
• What skills related to planning, testing, data analysis, and quality assurance did you develop?
  • How has this experience shaped your understanding of the role of verification and validation in ensuring the safety and effectiveness of healthcare technology?
  • What actions will you take to further develop your skills in verification and validation methodologies?

Relevant learning outcomes

#	Outcome
# 7	Outcome Use suitable tools for measurement and analysis.
# 8	Outcome Plan and perform verification and validation of solutions.