In 2023, we celebrated a milestone year, bidding farewell to our founder Patricia Patterson, a trailblazer in instructional design and human factors. Following Pat's retirement, we announced our acquisition by Kymanox, the year brought a global presence, podcast excellence, quality assurance, training innovation, and strategic leadership.
Read MoreThis blog post discusses three common pitfalls in determining the root cause of use errors in the context of human factors analysis for medical devices. Root cause analysis is vital for improving the safety and functionality of medical devices. It requires awareness of potential pitfalls and a willingness to adapt human factors strategies. When done correctly, RCA provides valuable insights into UI design modifications and ensures safer product use.
Read MoreAs a platform committed to fostering discussions and exploring a wide range of viewpoints, we invite you to engage with this thought-provoking content and contribute to the ongoing conversation about application of risk management in your product development lifecycle.
Read MoreIFU usability should be prioritized along with the medical device or combination product it supports. In this article we will discuss 4 key elements of the Human Factors process and how they apply to the development of usable, engaging and effective IFUs.
Read MoreWe review a presentation from HFES Healthcare Symposium, “Cross-Industry Trends in FDA Feedback”, presented by a panel of Human Factors consultants. In this newsletter, we discuss trends they have identified based on the feedback the US Food and Drug Administration (FDA) has provided a variety of medical device and pharmaceutical manufacturers.
Read MoreThis month’s newsletter will provide an overview of the many updates in the healthcare field with respect to regulatory oversight of SaMD, cybersecurity, and medical device implementation of artificial intelligence.
Read MoreThe Agilis team recently flew out to Orlando, Florida for the 2023 International Symposium on Human Factors and Ergonomics (HFES) in Health Care and wanted to share some of our insights. In the ever-changing world of human factors, it’s important to keep up to date on practical applications of HF techniques.
Read MoreModerating usability studies is a skill that is developed with practice and by observing experienced moderators. There are little, if any, training courses or in-depth guides on how to become an effective moderator. Moderating itself is multi-pronged; you need to be unbiased and observant, yet a leader who is neutral and approachable. The following are 4 tips and practices for moderating usability studies.
Read MoreA task analysis and use related risk analysis (URRA) are dependent tools which are the foundation of a successful human factors program. Both tools are important to understanding and analyzing user interactions with your device, which is critical to developing safe and effective product user interfaces.
Read MoreWhat does it mean to lean into MedTech in 2023. As president of Agilis, a global medical device consulting firm in a growing industry that is becoming more and more competitive every year, there are certain questions to consider.
Read MoreKeeping abreast of regulatory and industry trends is a priority for Agilis Consulting Group. This year we participated in 10 industry events, upgrading our knowledge as well as extending knowledge to the industry. We also held our first Summit, launched a podcast, drank 8,000 cups of coffee and had fun helping our clients navigate regulatory guidelines in human factors.
Read MoreRisk mitigation. Human Factors engineers want risk mitigations to be added into the device design. Device engineers want the mitigations to be added to the Instructions for Use (IFU). Which is the preference? Which is best? Which is correct?
Read MorePast Agilis newsletters have addressed the importance of integrating the human factors engineering process activities and deliverables into the new product development process. This newsletter will address the important role HFE/UE can serve in system integration of complex medical technology. Complex systems require multiple layers of risk and requirements analysis that correspond to multiple layers of testing.
Read MoreHealthcare product development has increasingly utilized tools like Artificial Intelligence (AI) and Machine Learning (ML) to inform and guide medical care. Learn more about available options to ensure your device is user friendly and transparent to the end user.
Read MoreDesign changes are expected to occur throughout the product lifecycle. Many manufacturers know to address impacts on the physical design or manufacturing process but may not be as familiar with how to evaluate the impact on their human factors and usability efforts. In this newsletter, we discuss four tips to consider when evaluating post-validation (or post-market) design changes from a human factors engineering perspective.
Read MoreThere is an increasing rate of popularity in the concept of platform drug delivery systems to reduce the amount of Design Verification testing. The concept of platform systems and identifying which tests can be applied across a platform system seems easy enough to strategize, but how can we apply this to human factors (HF) activities?
Read MoreThe human factors process may seem complex or an additional step. I’d like to challenge that thought. In this newsletter, I share my own experience and learnings while in industry to convey the importance of integrating human factors into the product development process.
Read MoreIn this newsletter we highlight our presentation on understanding the spectrum of perspectives that human factors consultants see and assist clients with. This includes the risk tolerance of sponsors, evolution of regulatory perspectives, and identifying alternative human factors strategies when necessary.
Read MoreLearn in this newsletter: why human factors validation does not have pass fail criteria, how the post validation study process should work, and what questions need to be answered to ensure regulatory submission success after a validation study.
Read MoreAre protective measures creating a gap between simulated-use and actual use environments? In this newsletter, we provide an Agilis’ guide to conducting in-person HF studies that can enhance the fidelity of simulated use during the ongoing COVID-19 pandemic.
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