A workaround is often a design requirement that has not been recognized yet.
A workaround is often a design requirement that has not been recognized yet.
Principal Human Factors Engineer
Horacio M Pace-Bedetti, PhD
Human Factors, risk management and regulatory strategy that stand up to scrutiny, and to real use.
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.
For teams putting Human Factors work into practice, Human Factors Hub (HFhub) provides a structured place to organise the work and collaborate.
What I work on
- Human Factors engineering, use-related risk management and regulatory strategy
- Medical devices and drug-device combination products, including products for home use
- Use-related risk analysis, formative evaluation and Human Factors validation
- Regulatory evidence shaped by FDA, EU, China, IEC 62366-1 and ISO 14971
Topics
Latest insights
All insightsSimulated vs. Actual Use Testing
Most human factors validation testing happens under simulated use conditions. Actual use validation is possible, and sometimes necessary, when simulated environments cannot replicate critical user int…
Probability of occurrence. Risk vs HFE interpretation
Probability of occurrence is a common fight between risk management and human factors.
New FDA guidance Human Factors Medical Devices
Human Factors is having a surprisingly active summer at FDA.
Category 2 might expose your lifecycle HF problems
One of my favorite messages from the FDA town hall was this: “Human Factors and usability are aspects of a holistic medical device risk management process.”
The URRA is becoming even more important
One thing that became very clear to me during the recent FDA town hall is that the URRA is going to matter even more under the new submission framework.
Speaking & advisory
Available for events and select engagements
I speak at conferences, panels and in-house events, and take on a limited number of advisory engagements each year. Larger programmes and team workflows run through Human Factors Hub (HFhub).