Autorentext

Dr. Ilkka Juuso, DSc, has 25-plus 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 principal regulatory engineer at the medical-device quality consultancy Kasve, and a post- doctoral researcher with the University of Oulu in Finland. Today he works as a lead auditor at the European notified body SGS Fimko (NB 0598) 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 in 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 secretary for its WGII on technology and applications. He is a member of the CEN/ CENELEC Strategic Advisory Group on Healthcare and a member of the RAPS Nordic LNG leadership team. 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) - and approximately 3,500 film reviews, which probably explains some of the film references in this book.

Ilpo Pöyhönen has 30-plus years of experience working on medical device research, development, testing, and safety and 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.Today 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, cyber security, 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).

Klappentext

This book simplifies the process regarding the application of usability to medical devices for new developers by providing a thought-out walkthrough of what is involved and how the expectations from the essential standards affect their work and why. Based on the authors' experiences, the information in the book provides other more seasoned experts with a wealth of insight and nuggets of new perspectives on addressing the usability of medical devices, particularly medical software.

The discussion in the book is rooted in recent real-world experiences from both the manufacturer and assessment body sides-the authors provide a novel high-level "roadmap" to using usability engineering to guide development activities from initial conceptual design to research, development, and ultimately release of a medical device. They build toward this map throughout the book and ultimately present the full model. This roadmap is the result of the authors' experiences of taking a research project and launching both a medical device and a medical device business after obtaining all the necessary regulatory approvals.

The book helps product developers to understand the usability requirements around their own work, and to also better understand their users and to present the expected usability information in a way that is readily understood by the auditors. Managers of such work will also greatly benefit from the discussion of the required deliverables and the goals of the usability activities.

Finally, the authors ease the divide between manufacturers and healthcare professionals using medical devices. By simultaneously showing the requirements for the manufacturer's development process and also discussing the realities of work on the healthcare side, the authors facilitate collaboration.

Inhalt

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