Development
How to scope, structure, and align instructional development with usability, risk management, and regulatory activities.
YOUR GUIDE TO MAKING
CLEAR, SAFE, & EFFECTIVE
INSTRUCTIONS
Everything you need to plan, design, test, and deliver clear, compliant instructions for medical products
Pre-order today at
MOST INSTRUCTIONS ARE TREATED AS AN AFTERTHOUGHT
Well-designed instructions
make good medical products great
WHO SHOULD READ THIS BOOK?
Anyone involved in designing, developing, or marketing medical products. Whether you're a regulatory professional, human factors specialist, technical writer, designer, or product developer, this book will show you how to plan, design, and evaluate instructions that make medical products safer, clearer, and easier to use. It's for anyone who believes that well-designed instructions are not just documentation, but an essential part of good product design.
WHY SHOULD YOU READ THIS BOOK?
Clear, well-designed instructions can transform how users experience your product, but many teams don't know where to start. This book teaches you how to make instructions a strategic part of product development rather than an afterthought. You'll learn practical methods for conceptualizing, designing, writing, testing, and refining instructional materials that not only meet regulatory expectations but also make products safer, easier to use, and more trusted by its users.
Who shouldn't read this book?
This book is not for those who see instructions as a regulatory burden or a task to hand off at the end of product development. If you're unwilling to rethink how instructions fit into product design, or to put in the work to make them genuinely clear, useful, and safe, this book isn't for you.
In this book, the authors share practical methods and insights refined through decades of designing, testing, and evaluating instructions for a wide range of medical devices and combination products. The approaches presented here come from real-world experience, shaped by what has worked, what hasn't, and what consistently leads to safer, clearer, and more effective use of medical products.
The book provides proven, practical guidance in five key areas:
Design
How to organize and present content in ways that make complex information clear, navigable, and easy to act on.
Writing
How to craft precise, user-focused language that supports correct, confident use.
Illustration
How to create visuals that clarify actions, reduce cognitive load, and work seamlessly with text.
Production
How to bring everything together into cohesive, compliant, and durable instructional materials ready for real-world use.
This book is a must-read if…
You want your medical product to be safer, easier, and more trusted in use.
You want to create instructions that truly support users—not just meet regulatory requirements.
You're developing or improving a product and need a clear, structured approach to designing effective instructional materials.
You've struggled with unclear, inconsistent, or compliance-driven instructions and want to replace them with guidance that genuinely improves usability and outcomes.
About the Authors
Michael Wiklund
Michael Wiklund is an internationally recognized human factors engineering expert with more than 40 years of experience. He has authored several books about designing products for safe, effective, and satisfying use. He co-founded and serves as a Principal Consultant in the human factors practice at Emergo by UL, is a Professor of the Practice at Tufts University, and frequently speaks at industry events focused on safety.
Jonathan Kendler
Jonathan Kendler is a user interface designer and human factors engineer with more than 20 years of experience. He has designed user interfaces for various safety-critical products, including dialysis machines, robotic surgical systems, and infusion pumps.
Katelynn Larson
Katelynn Larson received a Bachelor of Arts in English/Communications from Massachusetts College of Liberal Arts. She is currently a technical writer with Emergo by UL.