660-2017/01 – Management and design of medical devices (MDZP)
| Gurantor department | Centre for Advanced Innovation Technologies | Credits | 5 |
| Subject guarantor | Ing. Lukáš Peter, Ph.D. | Subject version guarantor | Ing. Lukáš Peter, Ph.D. |
| Study level | undergraduate or graduate | Requirement | Compulsory |
| Year | 3 | 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 aim of the subject management and design of medical devices is to summarize the complexity of the requirements for skills and knowledge needed for the development, production and marketing of safe and effective medical devices. Topics such as regulatory requirements, risk management, quality assurance, product design and development and market analysis are covered in this course. Overall, the course aims to provide students with a comprehensive understanding of the medical device development process, from idea to commercialization, and equip them with the skills and knowledge necessary to navigate the complex regulatory and commercial environment of the medical device industry.
Teaching methods
Lectures
Seminars
Summary
The subject will deepen and consolidate knowledge of quality assurance and control procedures and their use in the development and production of medical devices. This subject will promote an understanding of the importance of user-centred design principles in the development of medical devices, promote the use of best practices in project management, including project planning, resource allocation and risk mitigation. The course will focus on a deeper understanding of interdisciplinary collaboration in the design and development of medical devices, such as communication between engineers, physicians, regulatory experts and other stakeholders involved in the development and commercialization of medical devices. The course will emphasize understanding the importance of innovation and creativity in the development of medical devices, to think critically and creatively about the design and development process in relation to the use of new technologies and materials. Students' communication and presentation skills will also be developed, including the ability to effectively communicate technical information to a variety of audiences such as investors, regulatory authorities and healthcare providers.
Compulsory literature:
1. ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
2. 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
Recommended literature:
1. Fries, R. C. (2012). Reliable design of medical devices. CRC Press.
2. Prutchi, D., & Norris, M. (2005). Design and development of medical electronic instrumentation: a practical perspective of the design, construction, and test of medical devices. John Wiley & Sons.
3. Weinger, M. B., Wiklund, M. E., & Gardner-Bonneau, D. J. (Eds.). (2010). Handbook of human factors in medical device design. CRC Press.
Way of continuous check of knowledge in the course of semester
At least 90% participation in exercises, written credit test
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. Principles of user-centered design, ideation, prototyping, testing, and commercialization.
2. Overview of quality management systems, risk management and regulatory requirements, including US FDA regulations and the EU Medical Device Regulation.
3. Overview of regulations governing medical devices in major international markets, including China, Japan and Australia. Strategies for obtaining regulatory approval and ensuring compliance in global markets.
4. Overview of business and financial aspects of medical device development, including market analysis, intellectual property and commercialization strategies.
5. Strategies for entrepreneurship and innovation in the medical device industry, including how to identify market opportunities, secure funding and bring product to market
6. Definition and evaluation of the supply chain for medical devices, including outsourcing, manufacturing, logistics and distribution. Considerations for supply chain risk management and quality and safety assurance.
7. Overview of design controls used in medical device development, including design input, design output, design verification, design verification, and design transfer.
8. Overview of health literacy and its role in the development of medical devices, including designing medical devices that are easy to understand and use by patients with different levels of health literacy.
9. Strategies for effective collaboration and teamwork in the development of medical devices, including project management, team dynamics and communication.
10. Overview of patient involvement in medical device development, including the importance of involving patients in the design process, understanding their needs and preferences, and incorporating their feedback into the development process.
11. An overview of project management principles and best practices, including planning, scheduling, budgeting, risk management, and stakeholder management.
12. Overview of the impact of medical devices on the environment and strategies for designing ecologically sustainable medical devices.
13. User interface design – user awareness, user manuals, signage
14. Overview of new areas in the development of medical devices, such as wearable medical devices, mobile medical applications and digital health technologies. A discussion of their impact on the medical device industry and their potential to improve patient care.
Conditions for subject completion
Occurrence in study plans
Occurrence in special blocks
Assessment of instruction
Předmět neobsahuje žádné hodnocení.