Top 3 Ways Usability Is Replacing Compliance as the Competitive Edge
From Compliance to Confidence: The New Rules of Usability
By Anthony Andre, PhD, CPE, Director and Founder, and Carson Whitaker, Associate Director, Interface Analysis Associates
Medication adherence remains one of healthcare’s most persistent challenges, with more than one‑third of therapies not taken as prescribed. While compliance has traditionally been treated as a regulatory requirement, usability is increasingly shaping both patient outcomes and market success.
Here are three ways usability is redefining competitive advantage in drug‑delivery systems.
1. Confidence Drives Adherence More Than Instructions
Many use errors stem not from lack of information, but from uncertainty—patients wondering whether they performed a step correctly or completed a dose successfully. Anxiety, dexterity limitations, vision challenges, and forgotten steps all undermine adherence.
Designs that guide, reassure, and confirm actions help users feel confident, which directly supports consistent use.
2. Human Factors Validation Is a Business Strategy
Regulatory expectations for human factors engineering continue to rise, but validation is no longer just a checkbox. Devices that demonstrate intuitive, first‑time use reduce downstream risks such as redesigns, customer complaints, and post‑market scrutiny.
High usability supports faster submissions, lower risk, and stronger real‑world performance.
3. Connected Design Enables Data‑Driven Care
Beyond usability, modern designs increasingly support automatic data capture and real‑world evidence generation. Eliminating paper diaries, enabling real‑time adherence data, and supporting decentralized trials allows organizations to move faster while improving safety and insight.
Conclusion: The goal is no longer just error prevention; it’s about building confidence through human factors. And confidence is what ultimately drives adherence, loyalty, and long‑term success.
To learn more about Interface Analysis Associates’ human factors services, please contact us.
Anthony Andre, PhD, CPE, is a world-recognized thought leader in healthcare human factors. He is Director of Interface Analysis Associates LLC, a leading healthcare human factors consultancy in business since 1993. He is a recently retired Professor of Human Factors/Ergonomics at San Jose State University, the Founding Chair of the International Symposium on Human Factors and Ergonomics in Healthcare and the Founding Editor-in-Chief of the journal “Human Factors in Healthcare.”
Dr. Andre and his staff have been at the forefront of the combination drug product and medical device Human Factors movement, having managed and executed hundreds of HF validation programs for pharma, biotech, and medical device sponsors all over the world. IAA’s 33 years of healthcare human factors experience is incomparable. Dr. Andre has provided human factors training to the FDA reviewers, and for 10 years moderated an annual FDA-Industry human factors workshop.
Carson Whitaker earned his Master of Science degree in Human Factors and Ergonomics from San Jose State University. He previously completed a Bachelor of Science in Psychology with a Certificate in Human Factors from the University of Utah. While at the University of Utah, Carson managed a team in the Applied Basic Cognition Lab, gaining hands-on experience in research and leadership. He is a strong advocate for user-centered design, emphasizing correct design principles, creative problem-solving, focused research, and data analysis. Carson joined IAA in 2013. Outside of work, he enjoys building projects with his hands and spending quality time with his family.
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