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Human Factors: Real Life Testing for Real Life Experiences

Operating room with monitor

Published:

June 25, 2024

RAQA Café

A podcast series that tackles trending Regulatory Affairs and Quality Affairs (RAQA) topics within the MedTech industry.

In this episode of the RAQA Café podcast, our host explores the rapidly expanding field of human factors testing with two renowned experts—Dr. Caoimhe Duffy (Assistant Professor, Anesthesiology and Critical Care) from the the Perelman School of Medicine of the University of Pennsylvania and Dr. Victoria Barnosky (Clinical Outcomes Consultant) from SUAZIO, now part of NAMSA. Tune in to learn about the vital importance and the intricate challenges involved in assessing how users interact with medical devices.

“We all know that processes or workflows we’re doing here in the US are very different in other areas. There might be different ways that users are using devices in certain countries…and so that’s one of those challenges of performing human factor testing in a real-world environment is being able to prove that these users are a subset or a simulation of what you would be seeing in real life.” – Dr. Victoria Barnosky

Key Discussion Topics:

  • The future of human factors testing
  • How to identify and analyze use risks
  • Standardization vs. unique device requirements
  • Disconnect between manufacturers and users

 

*Please note that the opinions discussed throughout the podcast are their own and do not reflect those of their current or former employers.

Richard M. Granquist

Richard M. Granquist

In 2014, Rich joined NAMSA as a Quality Systems Consultant and has now been with the company for eight years. Over his 16 years in the industry, he has participated in numerous AAMI ISO standards committees and currently sits on the committees for ISO 14971, ISO 13485 and ISO 15223. Rich’s medical device industry experience also includes extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management. Rich started in the medical device industry as a Microbiologist focusing on aseptic technique and terminal sterilization at Cook Medical. During his 8-year career at Cook, he expanded his responsibilities to include coordination of preclinical testing, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices.

Dr. Caoimhe Duffy

Dr. Caoimhe Duffy

Dr. Caoimhe Duffy serves as the Director of the Perioperative Care Unit and co-director of the anesthesia resident quality improvement module at the Hospital of the University of Pennsylvania. She earned her medical degree and Bachelor of Medical Science from the Royal College of Surgeons in Ireland, where she also completed her anesthesia residency and specialist training in Airway and Healthcare Simulation. She holds a Master’s of Science in Human Factors in Patient Safety. In 2020, she joined the University of Pennsylvania as a Perioperative Safety Fellow, obtained a yellow belt in Six Sigma process improvement, and became a Certified Professional in Patient Safety from the Institute of Healthcare Improvement. Dr. Duffy sits on the University of Pennsylvania Health System’s Airway Safety Committee. Her research focuses on human factors engineering and safety science in the perioperative setting. She has led multidisciplinary research projects to enhance communication and relationships within the perioperative care team.

Dr. Victoria Barnosky

Dr. Victoria Barnosky

Dr. Victoria Barnosky has over twenty years of experience in healthcare operations and research. She has successfully directed many clinical, quality improvement, and patient satisfaction research studies dedicated to quantifying and measuring clinical outcomes. Victoria’s educational background includes a PhD with focus on healthcare operations and a master’s degree in Healthcare Administration. She holds the credentials of Registered Technologist in Radiology, Computed Tomography, and Quality Management, is a Certified Radiology Administrator, a Certified Imaging Informatics Professional, and a Fellow of the AHRA.

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