This book offers a clear and accessible guide to applying usability principles to medical devices, particularly for new developers. It provides a thoughtful walkthrough of the development process, explaining how essential standards shape expectations and influence design decisions, and why these standards matter. Drawing on the authors' extensive experience, the book also delivers valuable insights for seasoned professionals, offering fresh perspectives on usability challenges in both hardware and medical software.
Grounded in recent real-world experiences from both manufacturers and assessment bodies, the book introduces a high-level roadmap for integrating usability engineering throughout the product lifecycle, from initial concept and research to development and final release. This roadmap, built progressively throughout the book, reflects the authors' journey from research project to fully approved medical device and business launch.
The book helps product developers understand usability requirements in the context of their own work, deepen their understanding of end users, and present usability documentation in a format that auditors can readily interpret. Managers will also benefit from detailed discussions on required deliverables and the strategic goals of usability activities.
Finally, the authors bridge the gap between manufacturers and healthcare professionals by addressing both the regulatory demands of development and the practical realities of clinical use. This dual perspective fosters collaboration and mutual understanding -- essential for creating safe, effective, and user-centered medical devices.
Sprache
Verlagsort
Zielgruppe
Für Beruf und Forschung
Professional Practice & Development
Produkt-Hinweis
Broschur/Paperback
Klebebindung
Illustrationen
55 s/w Zeichnungen, 12 s/w Tabellen, 55 s/w Abbildungen
12 Tables, black and white; 55 Line drawings, black and white; 55 Illustrations, black and white
Maße
Höhe: 254 mm
Breite: 178 mm
ISBN-13
978-1-041-08505-8 (9781041085058)
Copyright in bibliographic data is held by Nielsen Book Services Limited or its licensors: all rights reserved.
Schweitzer Klassifikation
Dr. Ilkka Juuso, DSc, has more than 25 years of experience working on multidisciplinary R&D projects in both industry and academia. He is one of the founders of the medical-device startup Cerenion, a former Senior Advisor and the Principal Regulatory Engineer at the medical-device quality consultancy Kasve, and a post-doctoral researcher with the University of Oulu in Finland. Currently, he works as a Lead Auditor at the European notified body SGS Fimko on conformity assessments according to the EU 2017/745 ("MDR") and international standards. His main interests are international regulatory affairs, standardization, and healthcare business development. He has successfully led the development of an ISO 13485, ISO 14971, and IEC 62304 compliant Quality Management System (QMS) from the ground up, its subsequent day-to-day operation, and certification by a notified body. He has had a key role in the launch of a CE-marked Class IIb medical device based on artificial intelligence. He has repeatedly served as a committee member and the head of the Finnish national delegation on key committees of the International Organization for Standardization (ISO). He is a member of the management team for CEN TC 251 on health informatics, and the secretary for its WGII on technology and applications. He is an active member of the Finnish Standards Association (SFS) and the industry forum Healthtech Finland, and a frequent visitor to International Medical Device Regulators (IMDRF) meetings. He is also the author of the books Developing an ISO 13485-Certified Quality Management System (Routledge 2022) and Medical-Grade Software Development (Routledge 2024).
Ilpo Poeyhoenen has 30-plus years of experience working on medical device research, development, testing, and safety & performance evaluation, including in the context of an accredited certification body. During that time, he has performed approximately 200 software evaluations according to IEC 60601-1-4, IEC 60601-1 Clause 14, IEC 62304, and IEC 82304-1. His particular areas of interest in this work have been the role of programmable database systems and the development of test equipment for diverse needs. The work has taken him across the globe and even to the edge of space. Currently, his main interests are international regulatory affairs, standardization, and the intelligent control of medical device design processes to continuously meet the requirements imposed by, for example, cybersecurity, usability engineering, risk management, and agile development models. The use of emerging technologies, such as artificial intelligence, also holds special appeal to him. He has been active in research initiatives that have, for example, examined the software development documentation required in a regulated environment, the impact of risk management, the performance of risk analysis itself as part of the software development life cycle, and the reliability factors involved in the supply of complex software systems. He is a long-time committee member of SFS/SR301 on healthcare IT and a sought-after lecturer on topics such as medical device software, risk management, usability, mHealth apps, and cloud services in the context of medical devices. He is also the co-author of the book Medical-Grade Software Development (Routledge, 2024).
Chapter 1: What to know before getting started Chapter 2: Usability engineering Chapter 3: Usability toolbox Chapter 4: Medical-device documentation Chapter 5: Clinical environment Chapter 6: Benefit management Chapter 7: Practical transparency Chapter 8: Listening to the user Chapter 9: Integration with quality management Chapter 10: The metro map Chapter 11: Seeing into the future Chapter 12: Conformity assessment Chapter 13: Business as usual Chapter 14: Conclusions
