Safe and Effective Human Factors Cast

Join us in our latest episode of Safe and Effective, where we welcome back our good friend Dr. Albert Boquet to talk about using an existing framework, such as HFACS, to develop a unified use error classification system and database to add as a tool to the human factors engineering process in the medical device and combination product (development) industry.
In our discussion we shed light on the nuances between not only use errors and their identification and classification, but also how such is a data driven system that requires building on. We get into the complexities of how humans are not engineered, but instead bio-psycho-social systems, and how therefore, their behaviors and actions can not be evaluated using methods and thinking originally derived and intended for engineered systems. We end our discussion with exploring the idea of implementing such a use error classification system, where to start, and how ultimately it could enable an elevated capacity of prioritization and mitigation of risks associated with such and increase device safety and effectiveness overall.
Additionally, we provide a sneak preview of what all we have in store for you during the upcoming Safe and Effective Instagram Live events streamed directly from the HFES 2024 International Symposium on Human Factors and Ergonomics in Health Care in Chicago, Illinois, from March 24-26th, 2024.
Instagram: safeeffectivepodcast
The Human Factors Analysis and Classification System (HFACS) FrameworkHFES HCS Poster, March 26th, 2024: Determining When and How to Include Multiple Users in Human Factors Testing - Case Study ExamplesHFES 2024 International Symposium on Human Factors and Ergonomics in Health Care, March 24 - 27, 2024 at the Hilton Chicago Hotel Host: Heidi MehrzadHFUX Research | Medical Human FactorsGuest: Albert BoquetApplying Human Factors and Usability Engineering to Medical Devices | FDAComparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for IndustryFDA Draft Guidance (December, 2022): Content of Human Factors Information in Medical Device Marketing Submissions

Join us in our latest ‘Let’s Get Real’ episode of Safe and Effective, where we delve into a nuanced and multi-faceted conversation with Rebecca Grier, a behavioral science expert in human factors and UX in the tech industry, discussing the broader issues of inequities and inequalities faced by women in the workplace, with a focus on behavioral sciences in the Tech and MedDev industries, particularly in the realms of human factors (HF) and user experience (UX).
Together, we explore topics such as biases, advantages and disadvantages, the perception of HF and UX, their interrelationship, historical context, and their application across various industries and organizations. Drawing from our professional and personal experiences, we share insights into the challenges encountered by women in our careers, how the science of human factors has evolved and continuously reinvented itself over the past century, and how our mutual love for data and statistics allows us to embrace our inner data geeks and have fun our own ‘scientist-y’ way. 
In a moment of candid reflection, we address the realities of misogyny and sexism, both subtle and overt, that we have encountered throughout our careers and lives, how we confronted them and prevailed, and how we remain hopeful for a future where the next generation of women can thrive in a genuinely gender-equal society.
The 'Pause Life by Dr. Mary Claire Haver - Demystifying MenopauseWomen are better leaders – and it's backed by science!Men or Women: Who’s the Better Leader? | Pew Research CenterResearch: Women Are Better Leaders During a CrisisResearch: Women Score Higher Than Men in Most Leadership SkillsNew Research: Women More Effective Than Men In All Leadership MeasuresGestalt Psychology, Gestaltism, or ConfigurationismLillian Moller Gilbreth 'Efficiency Engineer'Guest: Rebecca GrierHost: Heidi MehrzadHFUX Research | Medical Human Factors

In today’s episode of Safe and Effective we are featuring an excerpt of the previously recorded Human Factors Cast show in which Nick Roome and our host Heidi Mehrzad shared their personal experiences living with ADHD and AuDHD/ASD and discussed the various ways in which their neurodiversity impacts their lives. From professional to personal relationships to day to day tasks and lives, as well as how they see the world through their neurodivergent eyes.
Of course, as ADHDer’s would, they go off on many side tangents discussing ADHD and parenting, AuDHD in social interactions, and even take a sharp left turn and dive into the deeper meaning of unconditional love, how they personally define it, and how they have learned and experienced it throughout their lives.
Our vision for today’s episode is simple: sit back, relax, enjoy their chaotic and often times, let’s face it, hilarious conversation about anything and everything, and know that you are not alone in your neurodivergent mind. 
And please remember, you are worthy of love, you are enough, and your neurodivergent mind does not make you a burden.
And for all the neurotypicals listening out there, we hope you enjoy their beautiful zig zag conversation about how their minds work and process the world around them, and maybe, who knows, you learn something today that will allow you to gain a new or changed perspective and enable you to connect deeper with the neurodivergent people in your lives. 
Enjoy a very typical ADHD-all-over-the-place-wonderfully-and-deeply-amusing-chat on their very own, deeply personal, daily neurodivergent experience in a world made for neurotypicals.  
HFES HCS Poster, March 26th, 2024: Determining When and How to Include Multiple Users in Human Factors Testing - Case Study ExamplesHost: Heidi MehrzadCo-Host: Nick RoomeHFUX Research | Medical Human FactorsSafe and Effective The Medical Human Factors Podcast
Holiday Note from our Host:
During this time of year many people struggle, especially the ones in the neurodivergent community. When everyone’s focus is to come together and travel to where we belong during the holidays, it is easy to get lost and feel alone and isolated. 
It is therefore all the more important that we take care of and show grace to ourselves and the people around us.
Be kind to yourself and one another.
We know from research that kindness and our mental health are deeply connected. The research shows that kindness is an antidote to isolation and creates a sense of belonging. It helps reduce stress, brings a fresh perspective and deepens friendships and connections.
Empathy, grace, gratitude, and kindness aren’t just some fashionable trends to engage in, they can be the reason someone makes it through the most difficult time of year, the reason someone doesn’t lose all hope, the reason someone finds their smile and joy again and is reminded that in fact they are not alone and love is indeed all around us after all.
Be that reason for someone.
Be someone’s sunshine.
Happy Holidays to everyone.

Join us in our latest episode of Safe and Effective, in which we launch our newest segment ‘Let’s Get Real’ - where we drop all filters and stop masking and get real about special and sometimes sensitive topics and issues. 
In our first ever Let’s Get Real segment we talk with Christy Harper, usability expert and co-founder of End-to-End User Research, a usability and research consulting firm in Houston, Texas, about Failure as a Path to Innovation and Resilient Outcomes.
Together, we venture into the often avoided topic of failure (and vulnerability) and how its multifaceted definitions and the perception of such across cultures and individual thinking play a crucial role, not just in device innovation, research, and design and development, but also in our personal and professional lives and growth. We dig deep into how our often limited view and definition of failure (and vulnerability) can sneak into our lives very subtly, but then influence every aspect of it full on. From personal relationships to work relationships, from life aspirations to career ambitions, from innovation to product and medical device research and development, failure and how we define it will nearly always dictate our outcomes.
For a moment we get real, real uncomfortable - we promise it won’t hurt - talking about failure and how our definitions and thinking around it limits not just innovation, but our entire lives. 
HFES 2024 International Symposium on Human Factors and Ergonomics in Health Care, March 24 - 27, 2024 at the Hilton Chicago Hotel Guest: Rebecca GrierHFES Panel, October 27th, 2023 in the Georgetown West Room: Failure as a Path to Innovation and Resilient OutcomesHost: Heidi Mehrzad
Mentioned in this episode:
Human Factors Minute
https://www.humanfactorsminute.com
Human Factors Cast Podcast Network Patreon
https://www.patreon.com/humanfactorscast
Human Factors Cast
https://www.humanfactorscast.media

Join us in our fourth episode of Safe and Effective, where we dive deep with Helene Quie, regulatory and clinical expert, and founder and CEO of Qmed Consulting A/S in Copenhagen, Denmark. 
Together, we explore the pivotal role of a collaborative approach between clinical and human factors teams in order to align with regulatory requirements as well as provide for more robust device safety and performance data. Helene sheds light on the criticality of controlled testing environments and how invaluable insights from real-world scenarios are not just fed back into device design and development to achieve improved usability, safety and, effectiveness, but instead also play a crucial role in MDR clinical evaluation requirements and reporting of such. Additionally, we touch on the ever-evolving landscape of FDA and European MDR regulation and requirements and their respective adaptations and adjustments to improve clinical, safety, and usability requirements. We conclude our thought-provoking discussion on the topic of an early use-related risk analysis and its integral purpose and most optimal place in the research and development process. Listen in for an enlightening conversation that bridges the gap between theory and practice of applying a more collaborative approach between human factors and clinical teams in the world of medical device development.
In this episode we also provide a little sneak preview of our newest segment, 'Let's Get Real' - where we drop all filters and stop masking and get real about special and sometimes sensitive topics and issues. In our inaugural segment, we venture into the often-avoided topic of failure. Join us as we discuss failure as a path to innovation and resilient outcomes and how its multifaceted definitions and the perception of such across cultures and individual thinking play a crucial role, not just in device design and development, but also in our personal and professional lives and growth.
Failure as a Path to Innovation and Resilient OutcomesBest Practices for Use-Related Risk Analysis Through Collaboration of Human Factors and ClinicalREGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILGuest: Helene QuieHost: Heidi MehrzadApplying Human Factors and Usability Engineering to Medical Devices | FDAHuman Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development | FDA

In our third episode of Safe and Effective, we talk to Bert Boquet about the intricacies of the ever-present data debate of qualitative vs. quantitative in the sphere of medical human factors summative (validation) studies. In our discussion we shed light on the complexities of choosing the right data type and formulating an effective experiment design for validation studies, whilst also discussing the nuances of such between medical devices and combination products. Together, we tackle the myriad of challenges human factors researchers confront regarding not just formulating an effective experiment design, but also identifying a potential unified approach for validation data collection between medical device and combination product approaches to ensure cohesive measures and robust data sets for both.
Additionally, we provide a sneak preview of our next episode in which we address the integration of a collaborative approach between clinical and human factors teams, and it's necessity due to the evolution of the MDR and its "new" usability requirements within. 
Guest: Albert BoquetHost: Heidi MehrzadApplying Human Factors and Usability Engineering to Medical Devices | FDAHuman Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development | FDAComparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry | FDA