Medical-Device UsabilityEdition 1

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.