Podcasts about human factors engineering

Send us a Text Message.In this episode, I sit down with UX expert Satyam Kantamneni to uncover the secrets of user experience design. From his journey in Human Factors Engineering to leading UX Reactor, we discuss the critical role of user-centric design, the evolving collaboration between product managers and designers, and share real-world examples of stellar and subpar UX.Discover how exceptional UX can drive business success, reduce costs, and why a strong company culture is essential. Tune in for insightful tips and strategies to enhance your product's user experience.You can find Satyam on LinkedIn.

Guests: Julie Haney, Computer scientist and Human-Centered Cybersecurity Program Lead at National Institute of Standards and Technology [@NISTcyber]On Linkedin | https://www.linkedin.com/in/julie-haney-037449119/On Twitter | https://x.com/jmhaney8?s=21&t=f6qJjVoRYdIJhkm3pOngHQDr. Calvin Nobles, Ph.D., Portfolio Vice President / Dean, School of Cybersecurity and Information Technology, University of Maryland Global Campus [@umdglobalcampus]On LinkedIn | https://www.linkedin.com/in/calvinnobles/____________________________Host: Sean Martin, Co-Founder at ITSPmagazine [@ITSPmagazine] and Host of Redefining CyberSecurity Podcast [@RedefiningCyber]On ITSPmagazine | https://www.itspmagazine.com/sean-martinView This Show's Sponsors___________________________Episode NotesIn a recent episode of Human-Centered Cybersecurity Series on the Redefining CyberSecurity podcast, co-hosts Sean Martin and Julie Haney dive into the intriguing world of human-centered cybersecurity with their guest, Dr. Calvin Nobles, Dean of the School of Cyber Security and Information Technology at the University of Maryland Global Campus. The episode provided a wealth of knowledge, not only about the significance of human factors in cybersecurity but also about how organizations can better integrate these considerations into their cybersecurity strategies.The conversation illuminated the critical role of human factors, a field born out of experimental psychology and foundational to related subfields such as human-computer interaction and usability. Dr. Nobles' insights shed light on the need for cybersecurity systems to be designed with human limitations and strengths in mind, thus optimizing user performance and reducing the risk of errors. It's a call to move from technology-centered designs to ones that place humans at their core. A significant point of discussion revolved around the common misunderstandies surrounding human factors in cybersecurity. Dr. Nobles clarified the definition of human factors, pointing out its systematic approach towards optimizing human performance. By fitting the system to the user, rather than forcing the user to adapt, cybersecurity can become more intuitive and less prone to human error.The episode also touched on the concerning gap in current cybersecurity education and practice. Dr. Nobles and Haney highlighted the sparse incorporation of human factors into cybersecurity curricula across universities, stressing the urgency for integrated education that aligns with real-world needs. This gap points to a broader issue within organizations—the lack of focused human factors programs to address the human element comprehensively.Practical advice was shared for organizations aspiring to incorporate human factors into their cybersecurity efforts. Identifying 'human friction areas' at work, such as fatigue, resource shortages, and a lack of prioritization, can guide initiatives to mitigate these challenges. Moreover, the suggestion to provide cybersecurity professionals with education in human factors underlines the need for a well-rounded skillset that goes beyond technical expertise.This episode serves as a beacon for the cybersecurity community, emphasizing the necessity of integrating human factors into cybersecurity education, practice, and policies. By doing so, the field can advance towards a more effective, human-centered approach that enhances both security and user experience.Top Questions AddressedWhat is the definition of human factors in cybersecurity?How can organizations integrate human factors into their cybersecurity strategies?What role does education play in bridging the gap between current cybersecurity practices and the need for a human-centered approach?___________________________Watch this and other videos on ITSPmagazine's YouTube ChannelRedefining CyberSecurity Podcast with Sean Martin, CISSP playlist:

Guests: Julie Haney, Computer scientist and Human-Centered Cybersecurity Program Lead at National Institute of Standards and Technology [@NISTcyber]On Linkedin | https://www.linkedin.com/in/julie-haney-037449119/On Twitter | https://x.com/jmhaney8?s=21&t=f6qJjVoRYdIJhkm3pOngHQDr. Calvin Nobles, Ph.D., Portfolio Vice President / Dean, School of Cybersecurity and Information Technology, University of Maryland Global Campus [@umdglobalcampus]On LinkedIn | https://www.linkedin.com/in/calvinnobles/____________________________Host: Sean Martin, Co-Founder at ITSPmagazine [@ITSPmagazine] and Host of Redefining CyberSecurity Podcast [@RedefiningCyber]On ITSPmagazine | https://www.itspmagazine.com/sean-martinView This Show's Sponsors___________________________Episode NotesIn a recent episode of Human-Centered Cybersecurity Series on the Redefining CyberSecurity podcast, co-hosts Sean Martin and Julie Haney dive into the intriguing world of human-centered cybersecurity with their guest, Dr. Calvin Nobles, Dean of the School of Cyber Security and Information Technology at the University of Maryland Global Campus. The episode provided a wealth of knowledge, not only about the significance of human factors in cybersecurity but also about how organizations can better integrate these considerations into their cybersecurity strategies.The conversation illuminated the critical role of human factors, a field born out of experimental psychology and foundational to related subfields such as human-computer interaction and usability. Dr. Nobles' insights shed light on the need for cybersecurity systems to be designed with human limitations and strengths in mind, thus optimizing user performance and reducing the risk of errors. It's a call to move from technology-centered designs to ones that place humans at their core. A significant point of discussion revolved around the common misunderstandies surrounding human factors in cybersecurity. Dr. Nobles clarified the definition of human factors, pointing out its systematic approach towards optimizing human performance. By fitting the system to the user, rather than forcing the user to adapt, cybersecurity can become more intuitive and less prone to human error.The episode also touched on the concerning gap in current cybersecurity education and practice. Dr. Nobles and Haney highlighted the sparse incorporation of human factors into cybersecurity curricula across universities, stressing the urgency for integrated education that aligns with real-world needs. This gap points to a broader issue within organizations—the lack of focused human factors programs to address the human element comprehensively.Practical advice was shared for organizations aspiring to incorporate human factors into their cybersecurity efforts. Identifying 'human friction areas' at work, such as fatigue, resource shortages, and a lack of prioritization, can guide initiatives to mitigate these challenges. Moreover, the suggestion to provide cybersecurity professionals with education in human factors underlines the need for a well-rounded skillset that goes beyond technical expertise.This episode serves as a beacon for the cybersecurity community, emphasizing the necessity of integrating human factors into cybersecurity education, practice, and policies. By doing so, the field can advance towards a more effective, human-centered approach that enhances both security and user experience.Top Questions AddressedWhat is the definition of human factors in cybersecurity?How can organizations integrate human factors into their cybersecurity strategies?What role does education play in bridging the gap between current cybersecurity practices and the need for a human-centered approach?___________________________Watch this and other videos on ITSPmagazine's YouTube ChannelRedefining CyberSecurity Podcast with Sean Martin, CISSP playlist:

Today, we're exploring human factors engineering, a fascinating field that impacts everything from your office chair to the airplane cockpit.

In this conclusive installment we explore the intricacies of AAMI HE75:2009 and its implications for medical device development. As you know, the FDA, AAMI, and the entire medical device development community are steadfast in their commitment to prioritizing usability research, human factors, and device ease-of-use. This commitment has led to the continuous evolution of standards and guidance documents, with AAMI HE75:2009 standing as a cornerstone in this landscape. During Episode 4, we meticulously dissect this guidance document, offering invaluable insights into its usability research and development methodologies. Our aim is to empower medical device developers with the knowledge they need to craft well-designed, safe, and effective medical devices that align with FDA regulations. This episode provides an opportunity to gain a deeper understanding of the principles and practices that underpin human factors engineering, ultimately driving innovation and enhancing patient outcomes.

Naveen Agarwal, PhD and Nate Blazei discuss the QMSR and the relationship to ISO 13485:2016 and how Risk Management is the cornerstone to success.  The new Quality Management System Regulation (QMSR) from the FDA represents a significant shift in expectations for how medical device companies manage their quality systems. At its core, QMSR requires companies to take a more process-based and risk-based approach that fully integrates risk management activities throughout the entire product lifecycle and organizational processes.This episode features:Naveen Agarwal, Ph.D. - Principal and Founder, Let's Talk Risk!Nathan Blazei, Senior Director, Regulatory Affairs, Kymanox with your host Shannon Hoste, Vice President of Human Factors Engineering at Kymanox Key Points:- Risk management can no longer be a separate activity but must be embedded into all quality processes under QMSR.- Process mapping and understanding information/data flows is critical for building an integrated risk management system.- A lifecycle approach to continually updating risk assessments based on real-world data is expected, not just a one-time activity.- The two-year transition period allows companies to identify gaps, update processes, and make a plan to implement QMSR's risk-based expectations.- While not mandating ISO 14971 specifically, the FDA acknowledges it provides an excellent model for risk management that most companies should leverage.About the Factor:The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry. About Kymanox:Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product's life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/.The Factor is edited and produced by Earfluence.

Tufts University Professor James Intriligator, PhD '97, a human factors engineer, says that GPT is not a search engine, although many of us use it that way. It's more like a glider. It can take us to great knowledge and help us explore new territory. But we need to steer it smartly to get where we want to go. In these journeys, our own curiosity is the wind beneath ChatGPT's wings, the force that unlocks AI's almost limitless potential. In this episode of Colloquy, James Intriligator maps out a flight plan for GPT glider pilots. He says the questions we ask the large language model can take us through transversal spaces that cross many different areas of knowledge. And he's got some important advice for steering it through these domains to get better answers. 

In this episode, titled "Understanding FDA Perspectives on Medical Device Development" we embark on a comprehensive exploration of FDA perspectives alongside Greg Montalbano, Co-Founder of MIDI. Greg takes us on a comprehensive journey through FDA perspectives on Human Factors and Device Development, covering essential topics such as: - The FDA's concern regarding Human Factors Engineering and Usability - Expectations for medical device developers from the FDA - Real-world examples of medical device Human Factors Engineering relative to hazards, risks, and user-related causes This episode provides listeners with invaluable insights into the significance placed by both the FDA and MIDI on Usability Research and HFE quality processes. By understanding these crucial aspects, developers can ensure the creation of safe and effective medical devices that align with regulatory standards. Listen to MIDI's HFE MedTech Podcast Episode 2! Don't miss out on this enlightening discussion—tune in now to gain a comprehensive understanding of FDA perspectives and the importance of Usability Research in medical device development!

Dive into the realm of innovation with us in our inaugural episode. Our expert, Greg Montalbano, unfolds an insightful, executive-level narrative, spotlighting the pivotal role of Human Factors & Usability Research in medical device development. Discover why Human Factors Engineering (HFE) and Usability Research aren't just buzzwords, but essential pillars in medical device creation, especially under the meticulous eye of the FDA. We delve into the intricate dance of balancing the three major components of medical device development: the Device Users, their Use Environments, and the User Interfaces.   But that's just the beginning!

Episode 81. Ashley Ruba is the founder of After Academia and a Human Factors Engineer at Arthrex. Ashley did her PhD in developmental psychology at the University of Washington and her  undergrad degree at Duke University.  Show Notes: Infant language and emotional development lab  [02:00]NIH NRSA Institutional Postdoc Training Grant (T32) [03:48]Ashey's academic story [01:45]Leaving academia [07:12] Human Factors Engineer [9:35]Arthrax [10:37]Working in augmented reality  [10:43]Attachment styles [13:10]How do you get your first job out of academia [16:05] Pivoting into UX research and Human Factors Engineering and the process of making the change [24:21]Mutually Exclusive, Collectively Exhaustive  [28:44]Pivoting from big tech for stability and more growth opportunities  [29:40]Career coaching [32:22] Getting over self doubt, internal roadblock, and imposter syndrome [34:39]How do I get recruiter to look at my resume [38:32]Tactical tips on how to structure a resume [40:08]Motivating factors beyond salary and benefits [44:22]Being honest with yourself [47:11] Core values - growth  [48:21]Most unexpected change and realization [49:37]Listen to yourself [52:57]What advice would you give to your younger self? [54:09]The myth of being stuck in academia [57:06]

Sarah Nolet is a co-founder of Tenacious Ventures, a venture firm focused on agriculture's role in addressing climate change. With her co-founder J Matthew Pryor, Tenacious Ventures backs early stage start-ups who are building tomorrow's agri-food system.  We love their open and empathetic approach to sharing their journey of building Tenacious Ventures through their blogs and podcasts making Sarah a perfect guest for our Transparent VC podcast. Tribe has a co-investment with Tenacious in SwarmFarm, a Queensland headquarters autonomous farming robot that is scaling internationally, and we've very much enjoyed our interactions.  Sarah holds a Masters in System Design and Management from MIT, and a Bachelor of Science in Computer Science and Human Factors Engineering from Tufts University. Sarah is also the host of the AgTech...So What? podcast, telling the stories of the innovators building the food system of the future.  On the back of their successful raising and deployment of their first fund, Tenacious are currently raising their second fund with a $70 Millon target and we think are well worth a chat for sophisticated investors looking for agtech exposure. In this episode you'll hear Sarah's deep passion and expertise for the sector and we hope you enjoy this episode as much as we enjoyed the discussion. 

Products are designed and created for their users right? Well at least they should be. A 2021 McKinsey Global Digital Sentiment Insights survey sites that 56% of users of digital services state they are dissatisfied by the user experience.  Today, we are joined by Satyam Kantamneni, a master of design thinking to shed some light on why this might be and to share his insights on how we can create user-centric organizations that leave users delighted while also driving business growth through the practice of User Experience Design. Satyam has a Bachelors in Electronics and Communication Engineering from Osmania University, an MS, of Human Factors Engineering from Wright State University, has attended Stanford, the School of Design Thinking, and received his Executive MBA from Harvard Business School.  He is currently the Managing Partner and Chief Experience Officer at UX Reactor. He has developed and curated the PragmaticUX framework, which is a scalable, consistent, replicable, and measurable approach to innovation in a digital world.  A subset of the framework is captured in his book:  User Experience Design: A Practical playbook to Fuel Business Growth. As our guest says Good Design is Good Business. Connect with Satyam: LinkedIn Website Email Sponsor: Get Space: Do you know if your developer's user experience is a good one? Install Get Space's real-time survey iteration tool now with code "buildwithpeople" and get 20% off your first year to get real insights in your your engineers experience Show notes and helpful resources: User Experience Design: A Practical Playbook to Fuel Business Growth Bv.d = m.p.p.e; Business value by design = Mindsets, Process, People and Environments The Experience Value Chain The 5 Mindsets Design is Business - Google Design Presentation by Satyam Collaboration Trinity - Magic happens when you have an Experience Strategist, a Product Owner, and an Engineering Architect As apart of Experience Transformation, everyone in your organization should be able to tell you four things: 1. Who are your top users; 2. What their top 5 pain points are; 3. What the org is doing to solve these pain points; 4. Knowing how the organization measures outcomes You should be collecting 3 research Insights: formative, sensorial and validation Formative: collecting insights on biggest user pain points Sensorial: collecting continuous real-time data about my users so I can adjust in real time Validation: collecting insights around where I have solved my top user pain points The power is knowing your user, tracking their journey, and constantly delivering user delight Building something cool or solving interesting problems? Want to be on this show? Send me an email at jointhepodcast@unfilteredbuild.com Podcast produced by Unfiltered Build - dream.design.develop.

Ever wondered how neuroscience and physical therapy intersect to tackle pain management? Unearth new learnings about your body's response to pain and its complex nature as we engage in a thought-provoking conversation with Dr. Natalia Sikaczowski , a passionate advocate for individualized patient treatment and founder of Symmetry Physical Therapy, and Dr Raymond Butts, an expert in investigating central mediated aspects of chronic pain. Explore the multifaceted dimensions of peripheral and central pain, and how the brain can be rewired to lower pain levels.From the mystery of immediate relief after spinal manipulation to the workings of McKenzie progression for extension-based work, the journey through the labyrinth of pain treatment is as complex as it is fascinating. Natalia and Raymond help us unravel the potential causes of pain, such as hypertonicity, hypoxia, and inflammation. Tune in to learn about the debate surrounding spine manipulation and the use of visual analog scales and numeric pain rating scores to effectively gauge pain.Timeline3:03 What is pain?7:42 By the joint? Muscle? Is it movement-based pain?15:52 How is pain measured? Is the VAS good enough?25:31 How does spinal manipulation diminish pain?29:00 Why do patients feel good after chiropractic manipulation?35:40 I think one of the biggest problems with physical therapy is we are not efficient – Drs. Butts and Sikaczowski; they want to feel better asap!37:58 Disc, Facet, and Multifidus39:39 Dry needling – what is it? How does it work?42:07 What makes dry needling work is mechanotransduction49:14 Blood flow restriction training – why PTs need to use itDr. Natalia Sikaczowski, PT, DPT, CSCS, Cert. DN, BFR-CDr. Natalia Sikaczowski founded Symmetry Physical Therapy in 2014 with the fundamental belief that patients should be treated on an individual basis. Dr. Natalia believes patients should be given a diverse array of treatment modalities and techniques, along with progressive and varied exercises and manual intervention to ensure maximum recovery. This all-encompassing approach, along with Dr. Natalia's strong background in strength and conditioning has led to Symmetry's successful treatment programs for patients looking to get back into sport, recover from injury, or beat chronic pain.Dr. Raymond Butts, PT, DPT, PhD, MS, FAAOMPT, Dip. Osteopractic, Cert. SMT, Cert. DN, MAACP(UK)Dr. Butts graduated with honors from the United States Military Academy at West Point with a Bachelor of Science in Human Factors Engineering and served as a 1 st Armored Division Army officer in Bosnia-Kosovo and Iraq. He also received a post-graduate, International Masters of Neuroscience from the University of Tubingen, Germany, where he investigated central mediated aspects of chronic pain with magnetoencephalography and fMRI. In addition, Dr.  Butts completed a Doctorate in Physical Therapy and a Doctorate of Philosophy in motor  rehabilitation from the University of South Carolina. His PhD thesis explored the use of transcranial magnetic and direct current stimulation to disinhibit the motor cortex and facilitate plasticity-dependent, motor recovery. He is one of 300 physical therapists in the U.S. to have earned a Diploma in Osteopractic. In 2022, he also became a Fellow of the American Academy of Orthopaedic Manual Physical Therapy, a title earned by only 2% of the physical therapy  profession.About the ShowWe cover all things related to sports science, nutrition, and performance. The Sports Science Dudes represent the opinions of the hosts and guests and are not the official opinions of the International Society of Sports Nutrition (ISSN), the Society for Sports Neuroscience, or Nova Southeastern University. The advice provided on this show should not be construe

Large language models, such as ChatGPT are poised to change the way we develop, research, and perhaps even think. But how do we best understand LLMs to get the most from our prompting?Thinking of LLMs as deep neural networks, while correct, is not very useful in practical terms. It doesn't help us interact with them, rather as thinking of human behavior as nothing more than the result of neurons firing won't make you many friends. However, thinking of LLMs as search engines is also faulty — they are notoriously unreliable for facts.Our guest this week is James Intriligator. James trained as a cognitive neuroscientist at Harvard, but then gravitated towards design and is currently Professor of the Practice in Human Factors Engineering and Director of Strategic Innovation at Tufts University. James proposes viewing ChatGPT not as a search engine, but as a "glider" that journeys through knowledge. By guiding it through diverse domains, it learns your interests and customizes better answers. Dimensional prompts activate specific areas like medicine or economics. I like this playful way of thinking of LLMs. Maybe gliding (LLMs) is the new surfing (of the web). Links: James' home page Multiverses website

Today, Susan Neadle and Stephanie Canfield are back for part two. If you haven't listened to part one, do that first and then come back to this episode. Susan and Stephanie chatted about Susan's new book, The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems. And how it brings clarity of understanding for global Combination Products guidance and regulations. Today, they continue the conversation, diving into risk management plans, control safety in the United States, and the polarizing viewpoints of ICH Q9 vs. ISO 14971.Today's episode is hosted by Shannon Hoste, President of Agilis by Kymanox, and Assistant Professor in the Quality Education Program at Pathway for Patient Health. She's joined by Susan Neadle, an internationally recognized Combination Products expert, and Stephanie Canfield, a Senior Consultant in Human Factors Engineering.About The Factor:To err is human. That's where we come in. The Factor is your trusted podcast for the global medical market. We are highlighting various topics and viewpoints within our industry. Our goal is to create dialogue that promotes best practices in creating safer medical products for the end user.  It is brought to you by Agilis by Kymanox, and is produced by Earfluence.

Episode: 2704 Muscle memory, perfect pitch, typewriters, and engineering design.  Today, muscle memory and engineering design.

Tony Luczak a Golf PRofessional and the Director of the Professional Golf Management Program at the University of Central Oklahoma. Formerly at Mississippi State, Tony earned his PhD in Human Factors Engineering and focuses on Sports Engineering and Science to Improve Performance. Tony joins #OntheMark to share his research and insights on Performance, and the Observation that "How golfers learn is more important that the information provided." Along those lines, he shares his methodology of "Thinking, Training and Practicing" for quicker learning. He also elaborates on his "ABC's of the Golf Swing": Swing Path Quantifiables vs Clubface Alignments, The Dangers of the "Gorilla" Golf swing, The Importance of Smoothness in the Golf swing, The use of Analogies for Success, Feedback and Feedforward systems, "Intent" for Success, and The use of Drills for improved learning and application. This podcast is also available as a Vodcast on YouTube. Search Mark Immelman.

We have fabulous guests this episode sharing their expertise about a skin condition called Bullous Pemphigoid: patient advocate Dr. Naomi Bishop and argenx's Associate Director of Global Patient Advocacy Shelley Gerson.    Naomi Bishop, M.D. (she/her) is a physician-medical writer/editor with a rich background in the arts. Following a career in dance and graphic design, she pivoted to medicine, where she channeled her fascination with human physiology and commitment to helping others achieve optimal health. With a young family in tow, Dr. Bishop completed the required preparatory courses and attended medical school, where she graduated as valedictorian of her class. She completed her post-graduate training at New York-Presbyterian Hospital, Columbia-Cornell, and has cared for children in Pediatric Intensive Care Units (PICUs) in several top New York hospitals. Her passion for understanding systems failures led her to seek formal training in Quality Improvement and she served as director of PICU Quality and Performance Improvement for six years. She was recognized by the Solutions for Patient Safety group for her poster summarizing the impact of adding Human Factors Engineering principles to central line-associated bloodstream infection (CLABSI) prevention strategies. After witnessing the tragic death of an infant with Alveolar Capillary Dysplasia, Dr. Bishop was awarded a large CDC grant for her project designed to increase awareness of this rare, fatal lung disease. Her research produced what is still the most cited State of the Art Review on the subject. In November 2019, Dr. Bishop pivoted to a career in freelance medical writing and editing, disciplines that combine her insatiable appetite for perusing the medical literature with a dedication to improving communication between healthcare providers, their peers, and the public. Dr. Bishop remains deeply committed to patient-centered, empathic, and ethical care. As a proponent of Design Thinking and Human-Centered Healthcare Design, she strives to leverage her insights and experience to create content that is compelling and instructive.  In November 2021, Dr. Bishop was diagnosed with Bullous Pemphigoid, an event that rocked her world and changed her understanding of what it means to be a patient with a rare, chronic disease. Her search for the latest treatments led her to the IPPF, an organization to which she owes boundless gratitude for supporting her journey through treatment and recovery. As of April 2023, her BP is in remission. Dr. Bishop currently shares an empty nest in New York City with her five sun-loving plants. She is a voracious reader and fitness enthusiast and savors her close relationships with her adult son and daughter. She would insist that the Atlantic, New Yorker, New England Journal of Medicine, and a beeline to the IPPF be within reach if she found herself stranded on a desert island.  Our second guest is Shelley Gerson. Shelley is the Associate Director of Global Patient Advocacy at argenx. Shelley leads the advocacy efforts for alternative treatments for people living with autoimmune dermatological and hematological diseases. Previously, she worked as a patient advocate at Sanofi and Biogen. Prior to working in the biotech industry,  Shelley was a licensed counselor and a private practice therapist. Shelley lives with a severe form of Hemophilia, called Hemophilia A, so she also has a personal perspective of being a patient advocate herself.    During the episode both Dr. Bishop and Shelley recommended the International Pemphigus and Pemphigoid Foundation and the Facebook group, Bullous Pemphigoid Warriors.   Stay tuned for the next new episode of It Happened To Me! In the meantime, you can listen to our previous episodes on Apple Podcasts, Spotify, streaming on the website, or any other podcast player by searching, “It Happened To Me”.    It Happened To Me is created and hosted by Cathy Gildenhorn and Beth Glassman. DNA Today's Kira Dineen is our executive producer and marketing lead. Amanda Andreoli is our associate producer. Ashlyn Enokian is our graphic designer.  See what else we are up to on Twitter, Instagram, Facebook, YouTube and our website, ItHappenedToMePod.com. Questions/inquiries can be sent to ItHappenedToMePod@gmail.com.

In part one, we chatted about the overarching risk management process for medical device development. Today we continue the conversation, digging into the complexities of medical devices, including AI and other MedTech. Can risk management keep up with the evolving medical tech landscape? What about complex systems? Let's find out.Today's episode is hosted by Denise Wagner, Senior Director of Human Factors Engineering and Usability Engineering at Agilis Consulting Group.  Today's guests are Shannon Hoste, President of Agilis by Kymanox, and Edwin Bills, who teaches the AAMI Risk Management course and is involved in the standards development for ISO 14971. Documenting medical device risk management through the risk traceability summary Implementation of risk management principles and activities within a Quality Management System Medical devices — Guidance on the application of ISO 14971 About The Factor:To err is human. That's where we come in. The Factor is your trusted podcast for the global medical market. We are highlighting various topics and viewpoints within our industry. Our goal is to create dialogue that promotes best practices in creating safer medical products for the end user.  It is brought to you by Agilis by Kymanox, and is produced by Earfluence.

Today we discuss the current developments and trends surrounding risk management in the medical device industry. Our guests are Edwin Bills and Shannon Hoste, and they touch upon the challenge of consolidating numerous standards and documents while ensuring the consideration of overall residual risk, encompassing aspects like AI, cybersecurity, and biocompatibility. The conversation explores the need for manufacturers to embrace comprehensive risk management, focusing not only on individual risk analysis but also on evaluating the overall risk of complex systems. We also review ISO 14971, the expansion of guidance documents, and the importance of putting patient safety at the forefront of the risk management process. Join us as we uncover the intricacies and advancements in medical device risk management.Today's episode is hosted by Denise Wagner, Senior Director of Human Factors Engineering and Usability Engineering at Agilis Consulting Group.  Today's guests are Shannon Hoste, President of Agilis by Kymanox, and Edwin Bills, who teaches the AAMI Risk Management course and is involved in the standards development for ISO 14971.About The Factor:To err is human. That's where we come in. The Factor is your trusted podcast for the global medical market. We are highlighting various topics and viewpoints within our industry. Our goal is to create dialogue that promotes best practices in creating safer medical products for the end user.  It is brought to you by Agilis by Kymanox, and is produced by Earfluence.

Shannon Clark is the founder and principal of UserWise, a consultancy that helps medical device manufacturers and startups to design safe and easy-to-use medical devices. In this episode, Shannon discusses her experience founding her company, the importance of human factors engineering, her love of history, and why she's so happy about her recent "demotion." Guest link: www.UserWiseConsulting.com Charity supported: Equal Justice Initiative Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 006 - Shannon Clark Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to the Leading Difference Podcast. I'm your host Lindsay, and I am excited to introduce you to my guest today, Shannon Clark. Shannon is founder and principal of UserWise, a consultancy that helps medical device manufacturers and startups to design safe and easy to use medical devices. Before founding UserWise in 2014, Shannon was a human factors engineer at Intuitive Surgical and Abbott Laboratories. Shannon graduated from UCLA with a BS in Mechanical Engineering and a technical breadth in technology management. Shannon is additionally a certified professional industrial engineer, holds two patents and has written and published three books. Clearly an absolute rockstar, thank you so much for being here, Shannon. Shannon Clark: Yeah, thanks for having me. Lindsey Dinneen: Of course. Well, I would love, if you don't mind just sharing a little bit about your background and maybe how you got to where you are. I know, you've gotten to do some really amazing things. You have an amazing company. I would just love to hear a little bit of that backstory. Shannon Clark: How far back should we go? I think it's interesting that on my application to USC, I ended up going to UCLA, but I did apply and get into USC, just for the record, and on my application. I said that my dream job, I was 17 years old, would be to run a product design firm in Spain. It's pretty interesting that I kind of ended up there and I kind of had that idea so early on, but I didn't really fall in love with human factors or even know about it until I was working at Abbott Laboratories and I had this unique opportunity to apprentice one of the world's leading experts in human factors named Ed Israelski. He was the Director of Human Factors for Abbott for many years, and laid all the groundwork for the international standards and it informed the FDA guidances around human factors, so it was a really unique opportunity to work for him. And from there I was able to really dive into human factors with that practical experience at Abbott. And I knew that I wanted to run my own company basically. And I think I, I finally made it there in 2014 when I saw some great opportunities to help fledgling companies out of Stanford Biodesign and Fogerty Institute for Innovation. And I started out with just myself consulting, and then from there built a practice and pretty soon it was 30 human factors engineers, recruiters, and operational staff as of 2022. Lindsey Dinneen: Wow. That is amazing. Congratulations. That's, that is no small accomplishment. That is amazing. So human factors engineering specifically wasn't necessarily, it sounds like, the first intention that you may have had going into school. So it's awesome to hear that having that experience is what sort of led you into your career path, but I'm kind of curious, were you always very technically minded, kind of interested in user experience growing up or what was, even going back a little further, what was the spark that interested you in that field in general? Shannon Clark: Well, I had actually never heard of engineering. My mom's a lawyer, my dad's an accountant. So I didn't know what engineering was going into college, and so I was gonna, study Latin or Spanish or something. But then I thought I don't really know what I'm gonna do after college if I study that. And I had an uncle who was an engineer who said, "you really should check this out." So I took some coursework and I thought I could probably do this. And to be honest, mechanical engineering was a big struggle for me, having not taken any of the AP courses. I took AP Latin, AP Music Theory, all the APs that you don't need for engineering. So I came into school pretty behind and feeling behind, but I made it through and I kind of had my eye on this goal of making user experiences easier for people. I was going back even further, I was really inspired by my uncle Peter Skillman, who's now with Phillips I think in their Design Center of Excellence. And he worked at IDO at the time and he was 35 years old and contributed to this project that was featured on 60 Minutes to redesign a shopping cart. And it was really inspiring to me at the age of 10 or seven or however old I was, to watch someone take something so mundane as a shopping cart and uncover all these issues that exist with shopping carts everywhere, and then completely rethink the design and improve it. And rewatching that video I can now kind of see with another lens that they even started on the basis of safety and designed for safety, which I believe is so important when prioritizing design efforts to think about, " well, how many injuries are there to toddlers every year in shopping carts and how can we address this and how can we make it better?" And then just a month ago, I actually had my toddler in a shopping cart and she got stuck because the seatbelt wouldn't unlatch. And then it made me think that's interesting, full circle. Lindsey Dinneen: Oh, that is interesting. Oh, the irony. Oh my gosh. Okay. Yeah. So designing for safety first. So I'd love to hear the evolution of you just starting this consultancy by yourself. And I mean, so you were literally doing all the things, you were marketing, you were doing the actual consulting, you were doing the accounting, I'm assuming. How did that all evolve and how did your leadership ability evolve as you've grown your business? Shannon Clark: Well, I started out with no management experience, quite young. I started out with just myself. I hired some contractors here and there in 2015 . 2016, hired my first employee and I gotta tell you, I was the worst manager. And she was like, patient zero, she's now at Intuitive Surgical. But I think overall it was a great step in her career, but good for her for getting through, I think, four years of reporting to me as I was learning to be a manager. And I think over time through trial and error, I became a better manager. That was sort of a learning experience for me. And something that people were always telling me as I was starting my company was, " you should learn on someone else's dime. Don't start a company and then learn these hard lessons on your own dime." But I'm happy that I didn't listen to them and sure there were a lot of really expensive life lessons, like the time we didn't expense $150,000 of expenses because I didn't realize that someone wasn't doing their job for four months. There's all kinds of things that happen as you're start a company. But you just have to learn from them and then embed processes to address any gaps that you uncover along the way. And so at this point, we're just such a strong company with so many internal processes and trainings and rigor, and it's really exciting to see how much it's matured over the past eight years. Lindsey Dinneen: Yeah, absolutely. Well, and correct me if I'm wrong, but it seems like you recently, in fact, had a bit of a transition even for yourself, for your role. Is that correct? Shannon Clark: Yes, we brought in a new CEO. I was able to secure significant private equity investment from a private equity firm called NaviMed. And so we're forming a new umbrella organization called ClariMed. And so that's sort of a broader quality by design thesis where we're bringing together a bunch of like-minded organizations to help support product development, specifically in the medical space. And we're starting that organization with two human factors consultancies. So it started with UserWise, my company, which was acquired in August of 2022. And then in January this year, 2023, we acquired Harvey Medical, which is a seven or eight person human factors consultancy in the UK and the Netherlands. So, that's where we're at today and I'm thrilled. I, I probably put on LinkedIn that I'm thrilled about this quote- unquote "demotion" to Principal Human Factors Engineer, 'cause previously I was Director of Human Resources, CFO, CEO, and Principal Human Factors Engineer, and it was a lot. Yeah. Let's just say I didn't get a maternity leave. But now I'm just really excited for the future and I have a CEO with 17 years experience running and growing a regulatory consultancy. So I, I'm just really excited to report to her and she's an inspiration to me every day, Kelly Kendall. Lindsey Dinneen: Awesome. That's fantastic. How has the transition been for you? Did it take a lot of transition or did it come easily? How was it for you? Shannon Clark: It's been a huge transition, cuz Kelly runs the business based on data and I think when you have investors involved, you have to really present a lot of data to them. Whereas before I didn't have to report to anyone or speak to anyone or ask anyone any questions about what I'm doing, which I think we're a lot better off now cause I'm not just making decisions as I go along. I have a, a whole support system to help me through all the decisions on a day-to-day basis. So, that's been really relaxing to share the responsibility and, and have support. But yeah, it's been a lot of work to try to come up with the data. We're trying to integrate Salesforce. We're just kind of like a small company, quickly growing, so there's a lot there to work on. Lindsey Dinneen: Yeah. Absolutely. I'm curious, is there a particular moment that stands out to you because it kind of clearly confirmed that this was the right career path for you or the correct industry? Shannon Clark: It just immediately clicked. Back when I was working for Ed Israelski at Abbott and contributing to standards committees and submitting feedback to the FDA and draft guidances on behalf of Abbott, all of that work really created a spark within me, I'd say. And I think I would pinpoint it on one project I worked on, which was to review all recalls of medical devices by the FDA over the course of time that were due to human error. So, for example, an automated external defibrillator that was on the market, I think this was 2009, where there was a low battery indicator that would blink and falsely cause individuals to cease use of the device unnecessarily. So the idea that they were confusing this red indicator light to mean, "oh, this is broken, don't use it," versus "it's just low battery. Change the battery when you have a chance, but you could have resuscitated the patient." And I wrote this 80 page internal report. All these events that had happened and it really brought to life the importance of the then new FDA focus on human factors. And the fact that you need to really intentionally bake safety into the design of products from the get-go. It's not something you can just add on post-market or even figure out through human factors validation at the end of the process. It's something that you need to think about constantly throughout design, and again, prioritize those design efforts according to risk and safety and according to patient harm and user harm so that you can, at the end, have a product that doesn't result in a recall like that. So when I saw all that data, it really centered my focus and brought clarity to me that this is something that I wanna do for the rest of my life, 10 years, 20 years. I don't know. I guess I wouldn't say for the rest of my life. But I really was super inspired to do something about it cuz I also read that there were half a million deaths every year due to preventable medical errors in hospitals alone, just in the United States. So we basically have a whole pandemic happening every year in hospitals. And some of that is due to medication errors and hospital processes. But that figure doesn't even capture instances where they amputated the wrong leg. I mean, these are deaths. And so I'm, I'm really dedicating my career to reducing that number of half a million to something lower. Lindsey Dinneen: Wow. Yeah. That's amazing. I'm so thankful for people like you that are doing that research and like you said, safety first, building it into the design from the very get-go. That's fantastic. Yeah. Shannon Clark: And I love what Velentium's doing with regards to cybersecurity. I think that definitely follows the same kind of premise of protecting users and ensuring safety. Lindsey Dinneen: Yeah, absolutely. Yeah. There is so much that goes into it. So any angles that we can take to help protect people is absolutely worth it. So, how would you define leadership or what does leadership mean to you? Shannon Clark: I think leadership to me is inspiring others to be their best selves and fulfill their own missions, whatever it may be. So sometimes I can spark someone to be inspired to follow my footsteps and become a human factors engineer. Or maybe someone wants to pursue something a little bit different and just letting them uncover their own truths and pursue their dreams. That's probably the main thing I ask in interviews, " what is your dream job?" Because I wanna make sure that you're in your dream job, whatever that may be. So I guess that's what leadership means to me. Lindsey Dinneen: I love that. Yeah, absolutely. And then what would be your best piece of advice for someone interested in obtaining a leadership role, either within the medtech industry, or very specifically following a similar career path to what you've done? What would you say to someone who that's a goal of theirs? Shannon Clark: Well, my specific path, I believe, can in fact be replicated, in that, I saw an opportunity to uniquely become an expert in a field that was emergent. And there's many emerging fields that result from regulatory shifts. And in this case, UserWise, came out of the 2011 draft guidance about human factors issued by the Food and Drug Administration that was later published as final in 2016. And so there from my position at Abbott in 2010, 2011, I was able to see that coming down the pike and I saw the huge amount of opportunity at hand, and I saw where industry was and where it would be going. And out of that, I was able to found my consultancy. So I worked tirelessly to transform myself into an expert, not only by working 12 hour days at Abbott and giving them everything I had, but also reading all the textbooks on the syllabus for human factors master's degrees at various universities and had a stack of 20 books that I was working through. So it was all sort of self-taught, but ultimately I saw this opportunity due to a shifting regulatory landscape and things like that happen all the time in all industries. And there's all these opportunities that exist that are just a great opportunity to create a new business around it whether it's consulting or software as a service. Yeah, tons of opportunities out there. Lindsey Dinneen: So sort of being open to maybe opportunities that you wouldn't have originally pinpointed for yourself, but being aware of various trends and kind of responding to the situation. Is that part of it? Shannon Clark: Yeah. I mean, ultimately, I guess I'd describe my business model, if it were to be replicated, if you wanted to have success in this manner is to uncover regulatory trends and then find an opportunity, a business opportunity within that. But I guess more generally, if you're looking for a leadership position in the medtech field, I think that expertise certainly is highly valued. And engineering abilities is also highly valued. So, I think you need to go deep before you go broad. I think I do see a lot of like marketing experts, that maybe haven't gone scientifically deep, end up as CEOs of these companies, but I think the best background of all the CEOs that I work with, I always enjoy working with CEOs that have a technical background cuz they can truly understand the ins and outs. And I, I see limitations among some of these CEOs that maybe just have sales backgrounds. Lindsey Dinneen: Sure. Yeah, that, that makes a lot of sense to me. I can understand that. Shannon Clark: I think I'm talking to a salesperson right now, so I hope I haven't offended you. Lindsey Dinneen: Not at all. I am more on the marketing engagement side of things, but I wouldn't be offended regardless, because you're right, you need both to be successful. So, absolutely. Shannon Clark: Go deep first and then go broad. That's kind of the advice that was given to me as well and I followed that advice. Lindsey Dinneen: I like it. I like that a lot. Yeah. Well, so I know from your bio that you are a published author three times. Right? I would love to hear about that and what have you written about and how did that all come about? Shannon Clark: Well, nothing too impressive, and it's quite off topic, but I really enjoy history. So I authored a history of a local neighborhood, which is actually where UserWise is located in San Jose. And so I wrote this 150 page history book and we sold I think 3000 copies. And all the funding went to fund local farmer's markets as well as ultimately the annual 4th of July parade for San Jose. So I wrote that book and then wrote a follow on, a sequel about parades in the Bay Area, California. Have you ever heard of the Pasadena Tournament of Roses? Lindsey Dinneen: I have. Shannon Clark: So, we used to have one of those in Northern California. There's a whole Northern California, Southern California rivalry. That was huge when I went to UCLA. But we used to have our parade and our parade died out with the Great Depression, and we tried to resurrect it in 1960, but it didn't work out. So it was just kind of an interesting forgotten history that I wanted to capture in a book before it got lost forever. Lindsey Dinneen: Yeah. That is awesome. Very cool. Shannon Clark: And then the third book is how to get a job in management consulting. It's called "College2Consulting." It's a silly book, but I think it's pretty helpful if you wanna get a job at LEK or some management consultancy. I didn't come up with all the material for that, but I was the ghost writer. Lindsey Dinneen: Oh, so cool. That's awesome. So what are some interesting industry trends that you are looking forward to as you continue on with UserWise and beyond? Shannon Clark: I guess when I think of industry trends, I immediately think of what's happening with Europe, with MDR, and where's the FDA headed specifically with regards to human factors cuz that's ultimately what's gonna guide where UserWise is going next. With the FDA, there's been a lot of turnover with their human factors review team over the past five years, and it's created a shift towards requiring more and more. I think that's always the story with regulations where before maybe we didn't submit a full 60 page human factors engineering submission report for a lower risk device and just submit a protocol. These days they're just rejecting a protocol if there's no full backup for all the elements found in a human factors engineering submission report. So I think overall, I guess as always there's just more and more regulations. I do hope to make some progress. I'm headed to the International Standards Committee later this month in Germany, and I hope that I can kind of start socializing some ideas around reducing the burden from an international standards standpoint for human factors. So, I guess another industry trend that's a little more specific is that we just finished our multi-year study on training decay, whereas in collaboration with the Food and Drug Administration. And to date for combination products, so drug delivery devices, you're basically required to conduct human factors testing with untrained users. And it's created a context where there's some drug delivery devices where if they were pure medical devices, they would easily get clearance. But since they're a combination product, they have a drug, they're reviewed by DMEPA, CDER, a different human factors team. They're just unapprovable because untrained users are not capable of using them successfully. So I'm hopeful that with our research, we can further promote the concept of trained usability testing and invite more devices to the table instead of requiring perfect use for combination products. That's a hope of mine. But again, with more and more regulations we'll see if that comes to fruition. Lindsey Dinneen: Yeah, of course. Yeah, that sounds like a really good path forward. So it'll be interesting to see, like you said, how the landscape changes over time. So how do you prioritize your own continued learning and growing as a leader these days? I know you mentioned having stacks of textbooks, which I love, but nowadays, how do you continue to develop your own skills and knowledge? Shannon Clark: Well, I think I mentioned earlier that I am thrilled to report to Kelly Kendall, CEO of our company. And so I learned from her every week by watching the way she runs the company, the way she makes decisions. I've just learned a ton. It's been drinking through a fire hose with regards to key performance indicators and everything to do with running a business in a more formal manner. Cuz I ran my business based purely on intuition and not really on data. And when you really get a grasp of all the data associated with a business, like she says, it's about turning knobs up and down and adjusting and fine tuning once you know what the knobs are. And so, I feel like myself professionally, I've grown so much just having a mentor continuously working with me. I have in the past had executive coaching, but that, that, pales in comparison to what I'm now able to experience having a seasoned and experienced CEO to report to. Lindsey Dinneen: Yeah, and it's completely a hundred percent relevant to you and your business, which is awesome that you get that experience. Very cool. Okay, so just for fun, imagine that someone were to offer you a million dollars to teach a masterclass on anything you want, doesn't have to be in your industry. What would you choose to teach and why? Shannon Clark: Well, I think the answer that I might be supposed to say is moderating. So I have a lot of experience moderating usability testing and minimizing bias for participants so that you can extract truth. So basically, as a moderator, you don't wanna get in the way of the truth of what a participant is experiencing or feeling or demonstrating through their interaction with a product. So we just launched a moderator course, which I'm really excited about. But I guess after having done all that work for the past months to launch that course, I need a break. So if I could teach a masterclass, I guess it would be on the history of the Maya, which right now I'm trying to learn Mayan hieroglyphs. And I have an interest in archeology. And to be honest, I know nothing about the Maya, but maybe I have a kind of a crazy overconfidence going on where I feel that I wanna learn everything about it. And I, I feel like I've done this in a couple of areas of my life where I'll learn everything about a subject and then kind of become like an expert. And so that's kinda my next side hobby. I have some ideas there about what I'm gonna do. Lindsey Dinneen: Oh, that's awesome. So what sparked your interest specifically in that? Shannon Clark: I think in part it's because I've been to Mexico a number of times. I speak Spanish. And then I have an aunt who's Mayan who was involved in kind of raising me at an early age. So, that definitely sparked my interest. And then I've been honestly, like watching a lot of TV about Ancient Apocalypse and all those shows. I don't know if you've seen them, but I was just like, oh yeah, this is so cool. Lindsey Dinneen: I love it. Yes. Isn't it great to have something outside of your main, day-to-day job life focus that just kind of brings you this other level of passion and joy-- I'll just put it, put it that way. Shannon Clark: Yeah. This is certainly, it really stems out of being able to share the burden of running a company with others namely my boss Kelly, and it opens up my time to actually think about other things. And that has been a focus for me since the transaction in August. It's something I'm excited about just to have some extra hours in my week to think about things that aren't related to work. Lindsey Dinneen: Yeah. That's fantastic. So what is the one thing you wish to be remembered for after you leave this world? Shannon Clark: I guess being a good mom and that's really all I care about. I have one daughter, her name is Emily, and she is 22 months old. And she's great. So that's definitely my focus to be a great mom. And it'd be cool to be remembered as a good contributor to the industry of human factors, but I think more importantly, I wanna be a good mom. Lindsey Dinneen: Yeah. Yeah. Absolutely. Aww. Oh my gosh. I love it. What is one thing that makes you smile every time you see or think about it? Shannon Clark: Well, my daughter Emily, obviously, lemme try to come up with a different answer. Lindsey Dinneen: Ok, it's a great answer though. Shannon Clark: Yeah, that's gotta be my answer, sorry. Lindsey Dinneen: No, that's fantastic. Well, I just want to say thank you so much for sharing a little bit about your background, about your company, about the industry, where you think things are going, and your advice. I just really appreciate your time today, and I love hearing the why behind how you got into this and what makes you tick. So, thank you. And plus, it's really fun to hear about your hobbies outside of work too. And Emily, and course Emily. So, we are honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So Shannon, thank you so much for picking that organization to support today. Thank you so much for your time. We wish you continued success as you work to change lives for a better world. Shannon Clark: Thanks so much. Thanks for having me. Lindsey Dinneen: Of course. And thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love if you'd share this episode with a colleague or two, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

About Kimberly O'Loughlin:Kimberly joined HRS in March 2022, bringing with her more than 30 years of experience in leveraging talent and technology to drive growth, innovation, and improved business performance and customer experiences across health tech and other industries.  At HRS, her portfolio includes award-winning Remote Patient Monitoring (RPM) and telehealth solutions and services that address increasingly important healthcare needs – lowering the cost of care, and improving health outcomes, while delivering better experiences for both consumers and clinicians. Prior to HRS, Kimberly was CEO of Therapy Brands where she was responsible for serving the mental, behavioral, and physical therapy market providers with a broad portfolio of software and services including specialty-specific EHR/PMS platforms, patient engagement, telehealth, e-prescription solutions, and revenue cycle management services.  Before this, she was President at Greenway Health; prior to that, she ran two global healthcare businesses at Philips in Connected Care and Health Informatics.  She had solutions for monitoring and supporting the safety, health, and connectedness needs of seniors in the home as well as in long-term and post-acute care settings.  She also expanded access to healthcare in emerging global markets with low-cost continuous monitoring, vital signs monitoring, cardiology, oncology, and women's health solutions.Prior to working at Philips, Kimberly held senior leadership roles within AIG, AT&T Wireless, and AT&T. She has demonstrated excellent results in growing revenue and profitability, launching innovative products, transforming operations to six sigma and best-in-class performance, and building stellar teams.Over the years, Kimberly and her teams have earned a variety of awards including Best Company Culture, Best Company for Diversity, Frost and Sullivan Award for Product Line Innovation, Best in KLAS for RCM, Best in KLAS Most Improved Ambulatory EHR, and Stevie's People's Choice Award for Best Customer Service. In 2012 she was inducted into the Executive Women of New Jersey, and in 2013 she was featured in Executive Profile magazine on the Top 25 executive profiles list. In 2019, she was named the number 3 woman in Healthcare by Modern Healthcare, and in 2021 she earned top CEO ratings by Comparably.Kimberly has a Bachelor of Science degree in Electrical Engineering and Computer Science from Princeton University and a Master of Science degree in Applied Psychology with a concentration in Human Factors Engineering from Steven's Institute of Technology. She served as class president at Princeton where she currently serves on the Alumni Schools Committee. She lives in New Jersey with her husband, Jerry, and their dog Harley.  They have three children and enjoy the beach, skiing, sports, and time with family and friends. Things You'll Learn:Health Recovery Solutions is the leading provider of remote care delivery.Patients are becoming more active in their healthcare.Individually tailored care plans with inpatient and virtual care will become more common in the coming years.HRS has clinical advisory services. HRS sets up the remote care technologies providers need.Promising healthcare industry trends include value-based care, lower-cost care settings, health equity focus, interoperability, the use of AI and ML, and hospital-at-home functionalities.HRS provides patients with hardware and software to connect to their caregivers and clinicians with a portal that monitors and supports the patient.AI technologies can help harness data to design different treatment pathways and predict which patients will need intervention. Resources:Connect with and follow Kimberly O'Loughlin on LinkedIn and Twitter.Follow Health Recovery Solutions on LinkedIn.Discover the Health Recovery Solutions Website!Reach out to Kimberly at KOLoughlin@HealthRecoverySolutions.com!

Sign up here for updates on impactinvestor.ioThanks to all the Causeartist Partners - Check them out here.Subscribe to our Causeartist newsletter here.This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice.----------------------------------------In Episode 56 of the Investing in Impact podcast, we speak with Sarah Nolet, Co-Founder & Managing Partner at Tenacious Ventures, on backing early-stage Agtech companies to tackle climate change.Sarah is the co-founder of Tenacious Ventures, a specialized agrifood tech venture firm that operates with a high-support, high conviction approach. Throughout her career, Sarah has played a pivotal role in cultivating the early-stage agtech ecosystem.Her contributions range from advising numerous startups and designing accelerator programs to consulting established agribusinesses. Additionally, Sarah has worked closely with industry, universities, and government bodies to develop and implement forward-thinking initiatives that drive food system innovation.Beyond her entrepreneurial pursuits, Sarah also hosts the highly acclaimed AgTech...So What? podcast. Through this platform, she shares captivating stories of innovators who are actively shaping the future of the food system, offering insights and inspiration to her audience.She holds a Masters in System Design and Management from the Massachusetts Institute of Technology (MIT), where she gained a deep understanding of complex systems and their management. Prior to that, she completed her Bachelor of Science degree in Computer Science and Human Factors Engineering at Tufts University, equipping her with a strong foundation in technology and its human-centered applications.Sarah Nolet's multifaceted expertise, combined with her extensive experience and academic qualifications, position her as a prominent figure in the realm of food systems innovation. Her contributions to the agtech ecosystem and her commitment to driving positive change have established her as a respected leader in the industry.In an era of increasing environmental challenges and the urgent need for sustainable solutions, Tenacious Ventures has emerged as a leading force in supporting early-stage companies that are revolutionizing the food and agriculture industry.With a strong commitment to driving carbon neutrality and resilience in the face of climate change, Tenacious Ventures is actively investing in innovative startups that are transforming the way we produce, distribute, and consume food.In 2019, Tenacious Ventures embarked on its journey and successfully raised A$35 million for its inaugural fund in 2021. This achievement was made possible through significant cornerstone commitments of A$8 million each from two influential entities: the Clean Energy Finance Corporation and Grok Ventures, the private investment firm owned by Mike and Annie Cannon-Brookes.Since then, Tenacious Ventures has been actively deploying its funds and supporting a diverse range of innovative companies that are driving positive change in the food and agriculture sector.The firm has recently initiated the fundraising process for its second fund. The firm aims to raise a total of A$70 million ($47 million; €47 million) for this fund, demonstrating its commitment to supporting innovative startups in the agricultural technology sector.Among the notable investments made by Tenacious Ventures from its first fund, Fund I, are: Cecil: An innovative natural capital platform that enables sustainable management and restoration of ecosystems. Cecil's unique approach aligns economic incentives with environmental outcomes, promoting the conservation and enhancement of natural resources. Goterra: A pioneering waste management start-up that revolutionizes the processing and conversion of organic waste. Goterra's innovative technology provides sustainable solutions for waste management while simultaneously creating valuable outputs such as nutrient-rich compost and livestock feed. SwarmFarm Robotics: A cutting-edge autonomous agricultural vehicle platform that streamlines and optimizes farming operations. By harnessing advanced robotics and artificial intelligence, SwarmFarm Robotics enhances efficiency, productivity, and sustainability in the agriculture industry. Nori: A US-based carbon marketplace that offers a unique platform for the exchange and monetization of carbon credits. Nori empowers farmers and landowners to earn revenue by implementing sustainable land management practices that sequester carbon dioxide from the atmosphere. Vow: A pioneering cellular agriculture company that focuses on producing high-quality, sustainable, and cruelty-free animal products without the need for traditional farming. Vow's innovative approach leverages cellular technology to cultivate meat, dairy, and other animal products, minimizing the environmental impact of conventional livestock farming. RapidAIM: A digital crop protection platform that employs advanced technologies, including sensors and data analytics, to enable early detection and monitoring of pest infestations in crops. By providing real-time insights, RapidAIM empowers farmers to make informed decisions and implement targeted pest control strategies, reducing the reliance on chemical pesticides. Nowadays: A forward-thinking sustainable protein company that leverages plant-based sources to create delicious and nutritious alternatives to traditional animal products. Nowadays focuses on developing sustainable protein options that are both environmentally friendly and meet the growing demand for plant-based food choices. These investments reflect Tenacious Ventures' commitment to driving innovation, sustainability, and positive environmental impact within the food and agriculture industry. Through strategic partnerships and financial support, Tenacious Ventures is playing a vital role in shaping a more sustainable and resilient future for the sector. ----------------------------------------Sign up here for updates on impactinvestor.ioThanks to all the Causeartist Partners - Check them out here.Subscribe to our Causeartist newsletter here.

Join us as we speak with Yakir, Yaniv, who is the CEO of a leading Israeli human factors engineering firm, ED&U. In this episode we discuss some of the projects that Yakir has worked on, ranging from machine design, to medical robots, to tanks for the Israeli Defence Forces. We also discuss the design process, some of the nuances of Human Factors Engineering, User Experience Design, and Ergonomics and the "cool" things we get to do at work. If you represent a business that needs human factors engineering, please check out www.ednu.net If you enjoyed this episode and want to see / hear more like it please subscribe to Collaborative With Spencer Krause Today. You'll get notified every time a new episode releases and it's the best way to support the channel!

Join us as we speak with Yakir, Yaniv, who is the CEO of a leading Israeli human factors engineering firm, ED&U. In this episode we discuss some of the projects that Yakir has worked on, ranging from machine design, to medical robots, to tanks for the Israeli Defence Forces. We also discuss the design process, some of the nuances of Human Factors Engineering, User Experience Design, and Ergonomics and the "cool" things we get to do at work. If you represent a business that needs human factors engineering, please check out www.ednu.net If you enjoyed this episode and want to see / hear more like it please subscribe to Collaborative With Spencer Krause Today. You'll get notified every time a new episode releases and it's the best way to support the channel!

Try Acres for free: https://www.acres.co/Agtech - So What? Podcast: https://www.agtechsowhat.com/Tenacious Ventures: https://tenacious.ventures/Today's episode features a conversation on the future of fertilizer with Sarah Nolet. Both of us have been exploring the future of fertilizer on our respective podcasts, and we thought it would be fun to do a joint episode to talk about what we've learned. So you're going to get not only Sarah and I's thoughts, but also some highlights from episodes that provide insights into the future of fertilizer.Sarah Nolet is an internationally recognized food systems innovation expert and co-founder of Tenacious Ventures, a high-support, high conviction, sector-specific agrifood tech venture firm. Sarah has been instrumental in building the early stage agtech ecosystem - from advising dozens of startups, designing accelerator programs and consulting to established agribusinesses, to helping industry, universities and government develop and implement forward-looking initiatives in food system innovation. Sarah is also the host of the AgTech...So What? podcast, telling stories of innovators building the food system of the future.Sarah holds a Masters in System Design and Management from MIT, and a Bachelor of Science in Computer Science and Human Factors Engineering from Tufts University.

Moira Larsen, MD, MBA, FCAP and Ethan Larsen, PhD discuss the Human Factors Engineering (HF) course they are leading at the 2023 Pathologists Leadership Summit. They explain how HF methods streamline processes, despite resource limitations, allowing laboratory practices to “Do More with Less.” For more information, visit https://pathologistsleadershipsummit.org/.

Revered basketball coach John Wooden once said, “A good coach can change a game. A great coach can change a life.” In this episode, guest host David Costello talks with human performance expert and coach James Merlo about how human factors engineering can help utilities, organizations, and individuals to not only improve efficiency and reliability, but also greatly reduce the frequency and severity of errors.  

It is an extra special episode this week with 2 great investors sharing their passion for agtech and the specialist fund they co-founded Tenacious Ventures. The first half of today's duo is Sarah Nolet, an internationally recognized food systems innovation expert who has been instrumental in building the early stage agtech ecosystem in Australia - from advising dozens of startups, designing accelerator programs and consulting to established agribusinesses, all the way to helping industry, universities and government develop and implement forward-looking initiatives in food system innovation. Sarah is also the host of the AgTech...So What? podcast, telling stories of innovators building the food systems of the future. Sarah holds a Masters in System Design and Management from MIT, and a Bachelor of Computer Science and Human Factors Engineering from Tufts University in the US. Matthew Pryor is the other half of the co-founder team at Tenacious Ventures and a Partner at AgThentic. He was previously co-founder of Observant, an Australian agtech pioneer acquired by Jain in 2017. He was the founding chair of Rocket Seeder, a food & agriculture innovation accelerator, and having achieved multiple significant exits himself, Matthew is dedicated to promoting Australian agri-food innovation globally. Both Sarah and Matthew are passionate about helping Australia take its rightful place as a leader in the technologies which will solve global food and environmental challenges. Its such an important mission. Companies Geora - https://www.geora.io/ Simple and secure technology for farmer networks to track and finance global agri-supply chains. Founder Bridie Ohlsson Rapid Aim - https://rapidaim.io/ A precision pest management tool for today's farmer. Founder Nancy Schellhorn, PhD Goterra - https://goterra.com.au/ Modular, autonomous waste management units using insects to consume food waste, directly where waste is produced or at a central site. Founder Olympia Yarger Resources Never Split the Difference: Negotiating as if Your Life Depended on It by Chris Voss & Tahl Raz Thinking in Bets: Making Smarter Decisions When You Don't Have All the Facts by Annie Duke Angel: How to Invest in Technology Startups-Timeless Advice from an Angel Investor Who Turned $100,000 into $100,000,000 by Jason Calacanis Triggers: Creating Behavior That Lasts--Becoming the Person You Want to Be by Dr Marshall Goldsmith & Mark Reiter Other 20 minute VC podcast Heavyweight podcast

An interview with Dr. Sarita Dara, an Aerospace physician and a space medicine and human factors consultant and occupational medicine physician for Humane Factors Exponential Limited.  She currently also works as a Senior Medical Officer with Civil Aviation Authority of New Zealand.Her training, qualifications and experience span Aviation and Space Medicine, Occupational Medicine, Public Health Medicine and Human Factors Engineering. She graduated with a Master of Space Sciences from the International Space University, in Strasbourg, France and has an MD in Aerospace Medicine and a PhD in Human Factors Engineering from the school of Mechanical and Aerospace Engineering, Nanyang Technological University, Singapore. She has worked in various capacities as a physician, educator and researcher in India, USA, Singapore and New Zealand. Prior to coming to New Zealand, she worked as Head, Aerospace Physiology and Human Factors at Singapore Aeromedical Centre where she was actively involved in aeromedical education and simulator training for aircrew and was also a medical examiner for Civil Aviation Authorities of Singapore, New Zealand and Australia.  In this interview, we are going to learn how Sarita's passion for medicine and human factors engineering has led her to a career at the intersection of commercial human spaceflight and safety needs Resources:Kings College Aerospace Medicine -Aerospace Medicine ProgrammeSpace.com - News outletSpacebase.co - social enterprise catalizing UNOOSA - United Nations Office of Outer Space AffairsWorld Space WeekNASAESARocket LabWomen in space AotearoaInternational Space UniversityHosted by: Emeline Paat-Dahlstrom, Co-Founder and CEO, SpaceBaseMusic: reCreation by airtone (c) copyright 2019 Licensed under a Creative Commons (3.0)If you like our work, please consider donating to SpaceBase through The Gift Trust or RSF Social Finance (for US charitable donations) and indicate "SpaceBase" gift account.Support the show

Happy Holidays everyone! On this episode of the Combinate Podcast, we had Sara Waxberg McNew, Chief Scientific Officer at Design Science. Sara and I talk about her interest in Human Factors and her career, we discuss who is a user and how to get close to them, how to read the ANSI/AAMI HE75:2009 (R2018) and IEC 62366-1:2015 standards, the design validation process and how human factors formative and summative evaluations fit in, human factors considerations for combination products, and figuring out what users need vs. want. Sara Waxberg McNew is the Chief Scientific Officer at Design Science, a human factors firm that specializes in healthcare. Sara has held roles previously in user centered design leadership at Eli Lilly and Company, Philips Healthcare, and Baxter Healthcare. Throughout these experiences, she has led cross functional teams, selected and managed human factors consultants (and now is one), interacted with the FDA and international regulatory agencies, and executed on created corporate level strategic plans for human factors. At each of these organizations, she was accountable to ensure intended end-users are effectively represented and their needs are considered throughout the product lifecycle in order to reduce the potential for use error, satisfy target customers, and comply with regulatory requirements. Sara has a B.S. in Human Factors Engineering and Biomedical Engineering Design from Tufts University, where she has also completed her M.S. course work. She is an active member of the Association for Advancement of Medical Instrumentation (AAMI) where she has contributed to the development and revision of human factors technical information reports and international standards.  Design Science is retained by the world's leading companies to assure that their products fit user needs. Design Science conducts rigorous research and design user interfaces to optimize usability, safety, and customer appeal of products. Founded in 1991, Design Science was one of the first consultancies to focus on the person/product interface. They have deep roots in those product categories where usability is mission critical—particularly medical devices, but also other products that are tools: commercial, industrial, or consumer.

**TRIGGER WARNING** This episode covers sensitive subject matter and is not suitable for all listeners. If this topic could be a trigger for you, listen to this episode with a friend, a sibling, a loved one or a parent so you can talk about any emotions that come up for you. The contents of this episode are not intended to replace therapy and should not be taken as such. If you need immediate help, please call the crisis hotline listed below in our resources.   As we continue our series speaking with young people who are biracial and identify as part of the LGBTQ community, on this episode, I speak with Jalen Little.   Jalen is a junior at Tufts University studying Human Factors Engineering. He grew up in Waterbury, Connecticut. Jalen is biracial, with two mixed-race parents and currently identifies as a black and Hispanic queer person.   Jalen tells us his painful story of growing up in an abusive home, and how he rebuilt his life after facing years of objectification, self-harm, and more.   Listen in as we talk about: How Jalen's sexual identity has changed over the years The difference between Queer and Non-binary in Jalen's opinion How coming out to friends differed from coming out to his parents The abuse Jalen faced from his dad partially because he was queer How that abuse led to self harm and a lack of self-confidence  The correlation between race and sexuality, and the objectification of Jalen's “blackness”   Youth Hotlines:  https://www.crisistextline.org   Connect with Jalen here: Instagram TikTok   Connect with Susan Instagram Facebook http://susanecasey.com/  TikTok

On this intermission, I interview Megan McCray, who moved to South Dakota to study Human Factors Engineering.  Learn about human factors, a dog with excessive toe fur, and more about Megan and her studies in the USD graduate school.

In this episode, HFIG talks to Dr. Caroline Cao, a Professor in the Department of Computer Science at IMT Atlantique in France and a Professor of Biomedical, Industrial and Human Factors Engineering at Wright State University, and Dr. Barrett Caldwell, a Professor of Industrial Engineering at Purdue University. We talked about the role of human factors in the design process, how we can educate engineering students and industry professionals about the importance of human factors, and how we should raise awareness among the public about the value of human factors in their everyday lives. Additional resources: Paper by Dr. Caldwell which discussed some of the issues mentioned in the episode: Caldwell, B. S. (2018, September). Considering the future of land grant ergonomics education. In Proceedings of the Human Factors and Ergonomics Society Annual Meeting (Vol. 62, No. 1, pp. 359-363). Sage CA: Los Angeles, CA: SAGE Publications. (link) Paper on the importance of human factors in software design: Meister, D. (1992, October). Relevance of human factors to design of computer software. In [Proceedings] 1992 IEEE International Conference on Systems, Man, and Cybernetics (pp. 218-221). IEEE. (link) Fun fact: SIGCHI history page refers to the first CHI conference in 1982 as “Conference on Human Factors in Computing Systems” in 1982. Episode music: The Happiest Side Of Science by MusicLFiles Link: https://filmmusic.io/song/6905-the-happiest-side-of-science License: http://creativecommons.org/licenses/by/4.0/

Glenn Gonzales joins The Innovation Cookbook to speak with Andrew about innovation in the skies. Glenn is the Founder and CEO of private jet company, Jet It. He served in the United States Air Force as an F15 flight commander before working as a regional sales manager for the Honda Aircraft Company, where he loved the small but mighty Honda Jet so much that he started a company around it. He has an MBA, a Masters in aeronautical science, and a BS in Behavioral Science with a concentration in Human Factors Engineering. He's also a speaker, a spokesman for Make a Wish, and the founder of a military community outreach organization, The 71st Fighter Squadron Iron Foundation, and now the Regional Entrepreneur of the Year for Ernst & Young.

Glenn Gonzales is the founder and CEO of Jet It LLC, a disruptor in the provision of private transportation. Prior to forming Jet It, Glenn provided transportation solutions as the Regional Sales Manager for the Eastern United States for Honda Aircraft Company. Glenn began his aviation career in the USAF, as a T-38A Instructor Pilot and his military career culminated as an F-15C Flight Commander and 4-Ship Flight Lead. He has a MBA from the Darla Moore School of Business at the University of South Carolina, and a Masters in Aeronautical Sciences from Embry-Riddle Aeronautical University. He completed his undergraduate studies at the United States Air Force Academy earning a B.S. degree in Behavioral Sciences with a concentration in Human Factors Engineering. Glenn has served as a spokesman for Make a Wish, founded a military community outreach organization, the “71st Fighter Squadron Iron Foundation”, and served as Program Coordinator for Special Olympics, Area 22 regional competition. He has spoken at countless universities, corporations, primary schools and community organizations sharing his career experiences, and the business of private aviation. Glenn continues his community outreach and through Jet It has helped raise just shy of $1M for charities and non-profit organizations. Mr. Gonzales is a Lieutenant Colonel in the USAF Reserves, and is married to his wife of 18 years, the former Tanika Archer. Where to Find Glenn Website: https://gojetit.com (https://gojetit.com) Twitter: https://twitter.com/gojetit_ (@GoJetIt_) Instagram: https://www.instagram.com/gojetit/ (@gojetit) Facebook: https://www.facebook.com/gojetit (Jet It) Youtube: https://www.youtube.com/channel/UCh8QaaDBUw4Vbx-2lgVlVsg/featured (The Jet It Experience) LinkedIn: https://www.linkedin.com/company/gojetit/ (Jet It) SPONSOR This episode is sponsored by http://www.entireproductions.com/ (Entire Productions)- Creating events (both in-person and virtual) that don't suck! and http://www.entireproductionsmarketing.com/ (Entire Productions Marketing)- carefully curated premium gifting and branded promo items.  PLEASE RATE, REVIEW, & SUBSCRIBE on APPLE PODCASTS “I love Natasha and the Fascinating Entrepreneurs Podcast!”

In this episode we explore the tragic failure in human factors engineering on the Boeing 737 MAX and why early incorporation of the user's needs and limitations is key to developing better, safer products. Dr. Mica Endsley, former Chief Scientist of the Air Force and founder of SA Technologies, joins us to discuss Human Factors Engineering and what we can learn from the 737 MAX tragedies.  Human Factors & Ergonomics Society: www.hfes.org

Today we welcome Dr. Mindy Howard, a renowned personality in the space industry and one of the few astronaut trainers in the world. From wanting to become an astronaut since she was 6 years old to now training commercial astronauts to cope better in space, Mindy's story is of perseverance and hard work. She has had a successful professional career of 25 years with leadership roles in Commercial Space Applications, Human Factors Engineering, and Psychology. She was elected by NASA as a “Highly Qualified Astronaut Candidate” and has spoken at TED conferences. Tune in to this interview and learn more about Mindy's journey of training astronauts psychologically and emotionally, commercial astronaut training, and her learnings along her journey of chasing her dream. Find us on: Facebook - http://facebook.com/followtbcy/ Twitter - http://twitter.com/followtbcy/ Instagram - http://instagram.com/followtbcy/ --- Support this podcast: https://anchor.fm/tbcy/support

In this episode, Rob is joined by Human Factors Engineer, Monica Philippart. Monica and Rob explore the definition and importance of human factors, how human factors should be integrated into both process design and incident investigation, and how organizations might improve their consideration of human factors beyond just a simple checklist. To learn more, find Monica on LinkedIn here. --- Send in a voice message: https://anchor.fm/amplifyyourprocesssafety/message

In Episode 4, titled Recommended Principals and Practices of Human Factors Engineering: The Deep Dive into AAMI HE75 and Methods for Human Factors Usability Research, we discuss and distill down this guidance documents usability research and development methods as related to what medical device developers need to know in order to generate well designed, safe and effective medical devices that will be recognized by the FDA.

In this episode, Greg Montalbano, Co-Owner of MIDI takes us on a deep dive into the details as related to the FDA Perspectives on Human Factors and Device Development. We cover topics related to understanding Regulatory Requirements and Methods for Human Factors Usability Testing such as: • Why is FDA concerned about Human Factors Engineering and Usability • What is expected of medical device developers from the FDA • Specific medical device Human Factors Engineering example relative to hazards, risks and the use related causes.

In this episode, we define User Centered Design, including the three major disciplines in a UCD team: UX / UI Design, Industrial Design, and Human Factors Engineering. We discuss how a combined structure like this can help organizations be more effective with a holistic approach to the user experience of your product.

The much anticipated Series 3 podcast is now available! Join MIDI's principal, Gregory Montalbano, in this series as he shares his deep understanding of the importance, requirements, and methods of Human Factors Engineering (HFE) and Usability Research during the design innovation process of medical devices. This new series will cover the role of human factors engineering in medical device development and explore specific methods, techniques, and examples of implementation. We begin with Episode 1 of the Series, Human Factors & User Interface Design for Medical Devices: The Overview. In this episode, Greg kicks-off the series with an executive-level discussion of the importance and benefits of MIDI's Human Factors & Usability Research quality process as related to medical device development programs. Greg continues his deep dive into why HFE and Usability Research are critical elements and what is expected by the FDA. Additionally, we discuss HFE and Usability considerations' specifics involving the three major development components of a medical device: the Device Users, Device Use Environments, and Device User Interfaces. In the remainder of this series, Greg affords the listeners full detailed access to his deep and diverse knowledge within specific verticals of Human Factors Engineering related to Medical Devices.

 In this episode, we discuss tips that will enable you to work effectively with your (User Centered Design) UCD consultants. Medical device companies believe that UCD consultants - Human Factors Engineering, UX/UI Design, Industrial Design - offer significant value for their projects. However, many of these companies are not fully prepared to build a working relationship that leverages the UCD consultant's strengths and expertise. We dive into aspects of building a schedule that supports iterative design, fostering a collaborative relationship with your UCD consultants, how to be strategy focused and scaling project work. 

Meet Tiffany McIntire, a senior Human Factors Engineer in the healthcare space. Learn what that is and likely ways to enter into that kind of career. Watch on YouTube: https://youtu.be/810TYGuoLoU

Ask Win is a podcast where you are a VIP. It’s a friend, family, and international show. Win wants to focus and teach people more and Cerebral Palsy. You’re welcome to ask questions about anything that you want. CP questions but mainly life questions on how to deal with CP or not. Win can ask you base questions if you want. Please let us know or there will be no base questions. If you have any questions for Win please email her at askingwkelly@gmail.com. Ask Win Podchaser: https://www.podchaser.com/podcasts/ask-win-22507. Please donate to Ask Win by going to https://www.paypal.me/WCharles. Patron Checkout: https://www.patreon.com/join/Askwin?. Simplecast's Brand Ambassador Program: http://refer.smplc.st/rtTvG. Check out Win's books at https://www.amazon.com/Win-Kelly-Charles/e/B009VNJEKE/ref=sr_tc_2_0?qid=1538951782&sr=1-2-ent. To buy Win’s new book, Smile with Dictation, go to https://bookhttps://books.apple.com/us/audiobook/i-win-hope-and-life/id1476934916s2read.com/Win. I, Win: http://books2read.com/Iwin. I, Win audiobook in iBooks:. I, Win audiobook in Google Pay: https://play.google.com/store/books/category/audiobooks?hl=en. I, Win audiobook in kobo: https://www.kobo.com/us/en/audiobook/i-win-5. I, Win audiobook in Nook: https://www.nookaudiobooks.com/audiobook/1005661/i-win. I, Win audiobook in Scibd: https://www.scribd.com/book/275801773/I-Win. I, Win audiobook in Beek: https://www.beek.io/libros/i-win. Check out Danielle's books at https://www.amazon.com/Danielle-Coulter/e/B00OFIOY3C/ref=as_li_ss_tl?qid=1483655853&sr=8-2&linkCode=sl2&tag=paradimarket-20&linkId=8490a064c62cededb762ed5b949ed144. Check out Win’s YouTube channel at https://www.youtube.com/channel/UCGN0mfJdlpKG8IdJTBjKTow. Please read Outsource Your Book to a Wall Street Journal Bestselling Press: https://leaderspress.com. Born with Cerebral Palsy author of I,Win | podcaster| by win charles: https://www.podchaser.com/creators/win-charles-107a4S3520. 5 Secrets for a Successful Podcast: https://youtu.be/eUTXwrx2ZIc. Apple Podcast on Amazon Smart Speaker: https://apps.apple.com/us/story/id1491094491. Podcast voice coaching: https://www.fiverr.com/share/kLrbLw.   On Ask Win today (Monday, March 23, 2020), Best-Selling Author, Win C welcomes Hank Scott. Retired Australian Naval Aviator/Officer. Currently founder of Molon Labe Aircraft Seating. Hold 3 Masters degrees in Aerospace field including Human Factors Engineering and Ergonomics, part time engineering Professor at CU Boulder. To learn more about Hank visit www.airlineseats.aero.

One of the highlights of this episode was hearing Irwin’s favorite quote; “If you cannot risk, you cannot grow. If you cannot grow, you cannot become your best. If you cannot become your best, you cannot be happy. If you can’t be happy, then what else matters.” - Viscott Irwin was born and raised in Starkville, MS and received a Bachelor’s Degree in Computer Engineering from Mississippi State University in 1991. He then obtained his Master’s from the University of Central Florida in Modeling & Simulation in 2013, and his Ph.D. in Human Factors Engineering from the University of Central Florida in December of 2016. Irwin currently works for the US Army Futures Command as a Science and Technology Manager, however, basketball is his passion! Teaching and training players how to physically and mentally play the game is what he does best. He's trained several thousands of players ranging from age 6 to All-stars in the NBA. He has had some pretty notable clients, including Dwight Howard, Chandler Parsons, Austin Rivers, Nick Calathes, Deshawn Stevenson, Tacko Falls, AJ Davis, and Phil Pressey. He served as Head Boys Varsity Coach for 2 years at Trinity Prep and 3 years at Bishop Moore Catholic High School and Assistant Coach for 8 years at Lake Howell High School, 2 years at Oakridge High School, & 2 years at Seminole State. He officially incorporated OrlandoHoops, Inc. in 1999, founding his company on the principles of hard-work, dedication and a willingness to do whatever it takes to improve talent and skill of each and every participant. Whether he’s coaching, counseling, teaching, or leading a training session Irwin’s passion and knowledge shines through whenever he is on the court. For the past 20 years he has been making players better in Orlando, the state of Florida, and across the world - including USA, Brazil, Greece, Russia, France and Canada. He is the very proud husband to Mrs. Phuong Hudson and father to daughters Olivia Joyce Hudson and Audrey Grace Hudson. It is crystal clear in this episode that Irwin is one of the most kind and dedicated coaches you could find. His wisdom for players and parents alike is invaluable. He and Kathy talk talent, focusing on the kind of support and dedication that prepares an athlete for the field of play and life off the court, and dissect the principles of focus and attention and their impact in an athlete’s success. He also offers guidance for parents in separating the activity of parenting from coaching, especially when working with young athletes, and how to put the emphasis on their choice to play and keep their love of the sport alive. You can find more from Dr. Coach’s at http://www.ohoops.com, as well as stay in the loop on his upcoming book release!

Shriya Nevatia joins Subversion with 1517 to discuss how startups and founders can do customer discovery research and UX research. Shriya studied Computer Science at Tufts University and got into UX Design through Human Factors Engineering, the General Assembly UX Design course, and the social entrepreneurship program Project Breaker. She did UX Research at the Tufts Center for Engineering Education and was a UX Intern at Pegasystems. She was the first employee at TenXList, later called Assembled, where she led UX Design for 4 product launches. Over the past 3 years, she's taught a 1-hour "Intro to UX Design" workshop at 10 hackathons for high school and college students.

Sarah Nolet is the Founder and CEO of AgThentic, a company that helps ag businesses and their entrepreneurs and innovators build the food systems of the future. She is a renowned food systems innovation expert and is the reason behind Australia’s early stage agtech ecosystem. Sarah holds a degree in System Design and Management from the Massachusetts Institute of Technology and a B.S. in Computer Science and Human Factors Engineering.   Sarah joins me today to share her insight regarding the future of ag businesses and how she seeks to help expand them faster. She shares the story behind AgThentic, how it started, and how it helps farmers and agbusinesses bridge the gap between agtech and traditional agriculture techniques to create innovative solutions for various problems throughout the industry. She also defines the concept of business accelerators and incubators and how they help agtech startups gain the traction they need to succeed in the agtech industry.   “If connecting to a big company is of strategic importance to your startup, then an accelerator or incubator program can be a good way to do that.” - Sarah Nolet   This Week on The Future of Agriculture Podcast:   What inspired her to start AgThentic. Her experience regarding farmers who don't adapt to the latest technologies. Do a lot of farmers need help when it comes to using basic software? What agtech accelerators are and how they help agtech startups. The criteria your agtech startup must meet to join an accelerator program. The difference between agtech accelerator programs and agtech incubators. The transformation that happens when an agtech startup goes through an effective accelerator program. Budding countries in the agtech startup space. How AgThentic helps improve the agtech ecosystem between agriculture and agtech.   Sarah Nolet’s Key Takeaways:   There is potential in combining technology and entrepreneurship that can solve a lot of problems. There's a gap between ag and agtech, and it needs to be filled to push innovation.   Connect with Sarah Nolet:   AgThentic AgThentic Resources Tool Bushtech Podcast Twitter Email: sarah@agthentic.com   Check Out Our Sponsor for the “Sustainability at Scale” Series Have you ever heard of Marrone’s BIO WITH BITE? Marrone Bio Innovation offers crop pest protection for the modern organic and conventional production systems. To make sure every grower using their products realize the best possible return on investment, Marrone invests time and resources to thoroughly test and demonstrate the efficacy of those new state of the art products. With serious trial data to back it up! You can see more and connect directly with Marrone by visiting them at www.marronebio.com Marrone is very proud to support The Future Of Agriculture blog series on sustainability in agriculture with Tim Hammerich.   We Are a Part of a Bigger Family!    The Future of Agriculture Podcast is now part of the Farm and Rural Ag Network. Listen to more ag-related podcasts by subscribing on iTunes or on the Farm and Rural Ag Network Website today.      Share the Ag-Love!    Thanks for joining us on the Future of Agriculture Podcast – your spot for valuable information, content, and interviews with industry leaders throughout the agricultural space! If you enjoyed this week’s episode, please subscribe on iTunes and leave your honest feedback. Don’t forget to share it with your friends on your favorite social media spots!    Learn more about AgGrad by visiting:  Future of Agriculture Website AgGrad Website AgGrad on Twitter  AgGrad on Facebook  AgGrad on LinkedIn  AgGrad on Instagram   

Welcome to Episode 8 of Software Tech Talks – How the Pro’s Build Reliable Products! Today’s Featured Guest is Ella Cozmi, a Master of Human Factors Engineering whose passion & expertise make her the ‘Go To’ Expert when you’re designing a Medical Device for use in the US or around the Globe. Ella has over 15 years HFE experience, and her specialties include Regulatory, Medical & Clinical development, Clinical Trials & Clinical Evaluations, Usability Studies, Product Usability and User Interface Design. Ella is a Consultant, and her agency, Human Factoring Rx, brings decades of experience to any Biotech project – and as a Registered Nurse with over 20 years of bedside nursing experience – Ella knows first hand what a successful product design looks like. So she can help you avoid product release failures – because she knows what users want!

Sarah Nolet is a start-up adviser, speaker, and writer. She is a food systems innovation expert who’s known globally because of the cause she pursues, the experts and companies she works with, and her role as the founder of AgThentic. She has a Master’s degree in System Design and Management from MIT and a Bachelor’s degree in Computer Science and Human Factors Engineering from Tufts University. Keep Reading >> Sarah joins me today to share the two significant concerns she tries to resolve through her consulting company and how to successfully launch a consulting business in STEM. She also explains how you can quickly develop a solid brand and how to set up your systems and organization in a way that scalability and expansion are possible.   “Follow your gut even if it’s something that defies conventional wisdom. It’s worth taking that chance” - Sarah Nolet   Today on the Fierce Feminine Leadership Podcast: What a consulting project looks like for her firm Where entrepreneurs can get started to start their agri-tech involvement How she realized the contributions she wanted to make in the industry The connection between early participation in competitive sports and future career success The most significant turning point in her career Why scalability is one of the biggest challenges she faced How she works with experts and leaders remotely Tools for effective communication Strategies for doing business with larger organizations Overcoming challenges of being a woman in the agri-tech industry   Sarah’s Advice for Fierce Feminine Leaders: Take things one step at a time. Don’t be afraid to reach out to people to build your network.   Resources Mentioned: Whatsapp Slack Skype Hootsuite Google Drive Apple Calendar Clocker   Connect with Sarah Nolet: AgThentic Sarah Nolet on Twitter     Dial Up Your Impact, Influence, and Income in 2018 Are you ready to take your leadership and influence to the next level in 2018? Join the Impact & Influence Leadership Lab for Women with Eleanor Beaton – the world’s premier leadership training and implementation program designed specifically for female leaders! This is an 8-week mentoring program for professional, ambitious women in business who are ready to take their leadership skills to the next level and truly step into their power. Visit the Leadership Lab for Women website to see all of the amazing content, tools, and services you will receive by registering today to claim your seat at the table!   Love the show? Let us know!  Are you a fan of the Fierce Feminine Leadership Podcast? If the tips and interviews we share in each episode have helped you gain the confidence and inspiration to become a better, more powerful leader, head on over to iTunes, subscribe to the show and leave your honest review to let us know! Each month, one lucky podcast reviewer will be selected to receive a free coaching session with me – Eleanor Beaton!   What are you waiting for? Head on over to iTunes, subscribe and leave a review to enter your name into this month’s drawing!    And, if you really want to ramp up your fierceness… Reach out to us for a free 30-minute Bold Women in Business Makeover Session with me or one of the fabulous coaches on my team! Explore your path and discover how you can be the fiercest lady-boss possible. Visit EleanorBeaton.com/Discover.