| Category |
Assignment |
Subject |
Mnagement |
| University |
Griffith Collage Dublin |
Module Title |
Medical Device Measurement and Analysis |
On successful completion of this module, learners will be able to:
- Research and critically evaluate the range of medical devices and their associated instrumentation and measurement systems.
- Critically assess and evaluate current techniques for human physiological, anatomical, biological, and electrochemical measurement and analysis.
- Appropriately assess a range of data collection systems in the management of medical device data.
- Analyse, appraise and evaluate the challenges with data storage, data security and data management relating to medical device data.
- Critically assess the ethical considerations in the data collection and analysis of medical device information.
Assignment Overview
Select one example of a human body system, organ, region, or body part (excluding the heart and pancreas). Conduct in-depth research into its anatomical and physiological characteristics and critically evaluate an existing smart medical device that measures, collects, analyses, and interprets data related to its health and performance.
Your assessment must be critical and evaluative, demonstrating an understanding of the technical, clinical, regulatory, ethical, and innovative aspects of medical devices in healthcare. Additionally, propose potential technological improvements and discuss the impact of AI/ML, digitalization, and smart medical devices on future healthcare delivery.
Task 1: Critical Analysis of the Selected Human Body System/Organ/Region
- Describe and critically analyse the anatomical and physiological characteristics of the selected body system/organ/region.
- Identify the physiological parameters that must be measured.
- Discuss the clinical significance of measuring these parameters for healthcare decisionmaking.
- Compare different methods used to measure these parameters e.g. invasive/non-invasive (point out advantages and limitations of each)
Task 2: Evaluation of a Smart Medical Device
- Identify and discuss a current, commercially available medical device designed to measure these physiological parameters.
- Critically assess its technical and operational aspects, including:
- Measurement technology: What sensors, algorithms, or analytical techniques does the device use?
- Data acquisition and processing: How is the data measured, stored, analysed, and communicated?
- Security and transmission: How is the data secured and transmitted to healthcare
providers? Discuss cybersecurity risks.
- Integration with digital health ecosystems: Does the device connect with cloud platforms, EHRs, or mobile health apps?
- User experience and adoption: Evaluate usability, accessibility, and cost implications.
- Regulatory and compliance considerations: Discuss FDA / EU MDR approvals and how regulatory challenges impact device adoption.
Task 3: : Risk, Safety, and Ethical Considerations
- Analyse the risks associated with the device, including:
- Accuracy and reliability concerns
- Privacy and cybersecurity risks
- Safety considerations (biocompatibility, device failures, patient safety concerns)
- Regulatory and legal issues (GDPR, HIPAA compliance, data governance).
- Compare these risks to at least one alternative medical device measuring similar
parameters.
Task 4: Innovation and Future Advancements
- Evaluate how AI/ML integration enhances the accuracy, personalisation, and predictive capabilities of the selected device.
- Identify potential biases in AI algorithms that could impact data reliability.
- Propose specific technological advancements that could improve the device’s performance (e.g., improved AI/ML models, better connectivity, enhanced user interfaces, integration with wearable technology).
- Discuss how the implementation of AI/ML algorithms can impact on the
function/performance of medical devices with measuring attributes.
Task 5: Presentation & Synthesis of Findings:
- Prepare a 5-minute video recorded presentation summarising your approach, key findings, and proposed innovations.
- Summarise the real-world clinical adoption challenges and how these devices contribute to healthcare transformation.
- Reflect on the role of AI/ML, digitalisation, and smart medical devices in shaping the future of healthcare.
- Include an evaluation of the quality and reliability of sources used in your research.
Task 6: References – Provide a reference section outlining your sources. Embed your references in the body of the assignment - Use Harvard referencing.
