660-2015/01 – Preclinical usability testing of the prototype (PTPP)
| Gurantor department | Centre for Advanced Innovation Technologies | Credits | 4 |
| Subject guarantor | Ing. Lukáš Peter, Ph.D. | Subject version guarantor | Ing. Lukáš Peter, Ph.D. |
| Study level | undergraduate or graduate | Requirement | Compulsory |
| Year | 2 | Semester | summer |
| | Study language | Czech |
| Year of introduction | 2024/2025 | Year of cancellation | |
| Intended for the faculties | FMT | Intended for study types | Bachelor |
Subject aims expressed by acquired skills and competences
The objective of the preclinical usability testing course is to teach students to identify and address any potential risks or problems with a medical device before its use on human subjects. This may include identifying design flaws that could lead to device failure, testing the device for compatibility with different types of tissues and body fluids, and assessing its overall performance in a number of different scenarios.
Teaching methods
Lectures
Seminars
Summary
The aim of preclinical testing of the usability of medical devices is to evaluate the safety, effectiveness, and user-friendliness of the device before it is approved for use in humans. This type of testing is typically conducted on animals or in simulated laboratory conditions, and it involves testing the device's design, functionality, and ease of use by users with varying levels of experience. By conducting preclinical testing of the usability of medical devices, researchers can help ensure that these devices are safe, effective, and user-friendly when they are ultimately approved for use in clinical trials and medical practice. This can help to minimize the risk of harm to patients and improve the overall quality of care in the healthcare industry.
Compulsory literature:
IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices
PE, M. E. W., Kendler, J., & Strochlic, A. Y. (2015). Usability testing of medical devices. CRC press.
Recommended literature:
1. IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
2. Wiklund, M. E. (Ed.). (1995). Medical device and equipment design: Usability engineering and ergonomics. CRC Press.
3. REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Presentation from lectures
Way of continuous check of knowledge in the course of semester
Minimum 90% participation in exercises
Elaboration and submission of measurement protocols
E-learning
Other requirements
No further student requirements are required
Prerequisities
Subject has no prerequisities.
Co-requisities
Subject has no co-requisities.
Subject syllabus:
1. Introduction to usability testing, definition of usability testing
2. The importance of usability testing in the development of medical devices
3. Overview of the usability testing process
4. Regulatory requirements for usability testing in the development of medical devices
5. User needs and requirements, understanding user needs and requirements
6. Methods of gathering user feedback and input, incorporating user needs into device design and development
7. Usability testing methods, data collection methods (e.g. observation, surveys, interviews)
8. Types of usability testing (e.g. formative, summative, heuristic evaluation)
9. Usability testing protocols and procedures
10. Performing usability testing, preparing for usability testing
11. Testing on simulated users or in real-world environments, usability testing with special populations, performing usability testing with elderly or disabled individuals, considerations for pediatric usability testing
12. Identifying and solving potential usability problems, analyzing and interpreting data
13. New trends and technologies in usability testing
14. Usability testing as part of technical documentation, potential impact of new developments on the development of medical devices and usability testing
Conditions for subject completion
Occurrence in study plans
Occurrence in special blocks
Assessment of instruction
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