Horacio M Pace-Bedetti, PhD

I am a Principal Human Factors Engineer working at the intersection of Human Factors, use-related risk management and regulatory strategy for medical devices and drug-device combination products. For the past 15 years, Human Factors has been central to my professional development and practice, from early research and design through use-related risk analysis, formative evaluation, Human Factors validation and regulatory submission.

Most of my work is about turning Human Factors and regulatory expectations into decisions development teams can act on. That includes identifying and controlling use-related risks, building defensible use-related risk analyses, designing formative evaluations that change the design, planning Human Factors validation, and developing the evidence needed to support regulatory decisions.

I have supported international regulatory submissions for medical devices and drug-device combination products, with much of my regulatory experience focused on the US, EU and China. I have also discussed complex Human Factors and validation strategies directly with FDA and other health authorities.

My background includes work with surgical equipment and instruments, including during my research. In recent years, most of my work has focused on combination products intended for use at home. Moving between those settings has made the difference between trained professionals and lay users especially clear: one brings established techniques and expectations to a device, while the other may bring very different levels of experience, health literacy, dexterity and confidence.

Alongside project work, I contribute to the AAMI Human Factors Standards Committee and the Combination Products Coalition. I previously served as an editor for the Human Factors in Healthcare. These roles keep me close to the standards, regulatory thinking and practical questions shaping Human Factors practice.

I write publicly because too much Human Factors practice is still passed on as folklore. I want to make the connection between Human Factors, risk management, design and regulatory review clearer, and to share practical, standards-grounded explanations for the teams building devices people depend on.

I lead larger Human Factors programmes through Human Factors Hub (HFhub) (opens in a new tab), and take on speaking engagements and select advisory work directly.