Training activity information
Details
Perform a risk assessment for a healthcare technology development and propose a risk management strategy.
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.
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 intended outcomes of the training activity?
- How have you reviewed the learning outcomes to ensure you are prepared to engage in the translation pathway and evaluate the safety profile of a developing healthcare technology?
- What essential knowledge have you identified as necessary regarding legislative and risk management frameworks (e.g., ISO 14971, Medical Device Regulations) before you begin identifying hazards?
- How do you plan to demonstrate that your proposed strategy will support the safe and effective introduction of the technology into clinical service?
What do you anticipate you will learn from the experience?
- What specific insights do you hope to gain regarding the interdependencies between technical design and patient safety within a complex healthcare system?
- In what ways do you expect this activity to improve your proficiency in quantifying technical risks and translating them into actionable clinical mitigations?
What actions will you take in preparation for the experience?
- What specific points have you prepared to discuss with your Training Officer to gain a clarity of understanding regarding the technical scope and safety-critical nature of the development?
- What possible challenges have you identified—such as managing conflicting technical and clinical requirements—and how do you plan to handle them?
- How have you identified your feelings about taking on the professional responsibility of performing a risk assessment that dictates future patient safety?
In action
What are you doing?
- How are you currently approaching the identification of hazards, and why have you chosen this specific methodology (e.g., FMEA, Fault Tree Analysis) for this technology?
- What logic-based decisions are you making right now as you determine the probability and severity of the risks identified?
- Which parts of the assessment feel intuitive, and which aspects—such as aligning with specific legislative clauses—require more conscious, focused effort?
How are you progressing with the activity?
- How effective are your current actions in building a robust risk management strategy that addresses all identified hazards?
- What technical challenges are you facing as the assessment unfolds, and what are you learning about the device’s potential failure modes in real-time?
- How does this activity connect to your existing knowledge of quality management systems and clinical safety standards?
How are you adapting to the situation?
- Are there alternative mitigation strategies you should consider mid-process to better balance safety with technical feasibility?
- What immediate support or guidance might you need from a senior engineer or clinical lead right now to resolve an interpretative ambiguity regarding a specific risk?
- How are you ensuring that your assessments remain strictly within your professional scope of practice regarding legal and clinical safety?
On action
What did you notice?
- How would you summarise the key points of the risk assessment, specifically detailing the high-priority risks identified and your proposed control measures?
What did you learn from the activity?
- What specific skills or knowledge did you develop regarding the ability to apply legislative frameworks to a practical development project?
- In what ways did your reflection-in-action—such as questioning a safety assumption—influence the final risk management strategy?
- How does the experience of ensuring regulatory compliance relate to the requirements for your future post-programme practice as a Clinical Scientist?
What will you take from the experience moving forward?
- What specific areas for continued development in forensic engineering or strategic risk appraisal have you identified as a result of this activity?
- How can you apply the learning from this risk assessment (e.g., more rigorous hazard identification) to your routine practice in the department?
- What are the specific ‘next steps’ you will now take, such as mastering a new risk-analysis tool, to support the assimilation of what you have learned?
Beyond action
Have you revisited the experiences?
- How have you re-evaluated your initial risk estimations in light of subsequent technical findings or peer feedback?
- Comparing this experience with your Observed Training Activities (OTAs), what specific observable behaviours in technical precision and professional critique have you now fully assimilated?
- In what ways has discussing this experience with peers regarding your risk management strategies changed your view on how to navigate the translation pathway?
How have these experiences impacted upon your current practice?
- How has this risk assessment activity supported your development in wider areas, such as writing interpretative technical reports or presenting safety cases to the MDT?
- How have you developed your skills in evaluating clinical safety since the original experience?
- In what ways has the cumulative learning from this activity supported your preparation for ‘in-person’ assessments, such as Case-based Discussions where you must justify safety decisions?
How might these experiences contribute towards your future practice?
- What transferable skills in strategic planning and system exploration have you developed that will help you evaluate and adopt new technologies in the future?
- How will your mastery of supporting safe and effective technology introductions help you lead future service improvements or innovations as a Clinical Scientist?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Engage in the translation pathway for healthcare technology developments. |
| # 3 |
Outcome
Apply legislative and risk management frameworks to the development of healthcare technology. |
| # 6 |
Outcome
Support safe and effective introduction of healthcare technology developments into service. |