Let’s revisit the Human Factors/Usability Engineering process for Medical Device products. This overview is a good reminder of how our human factors work integrates into product development and regulatory submission.
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Keeping abreast of regulatory and industry trends is a priority for Agilis Consulting Group. Here are some key takeaways from the conferences, webinars, and workshops we attended in 2021.
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A task analysis is a critical aspect to understanding and analyzing user interactions with a medical device. Prioritizing and completing a thorough task analysis is advantageous to a successful human factors approach.
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We are excited to announce that Shannon Hoste has been named President of Agilis Consulting Group. Her vision allows Agilis to create a more robust offering for our clients through strategic partnerships, expanded services and product solutions.
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Study design is key to obtaining usable data from a formative evaluation. To ensure your data is usable, it’s important to consider that testing the user interface at once might not be the best strategy.
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One of the largest in person healthcare conferences, since the COVID-19 pandemic lockdowns, started this week. The HIMSS Global Health Conference & Exhibition kicked off Monday, August 9 to Friday, August 13 in Las Vegas.
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When to incorporate human factors into your regulatory strategy can have a serious impact on the product development timeline and budget, planned submission date, and submission success rate.
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Deciding if usability studies need oversight by an IRB can be a source of confusion or delay, but this does not necessarily need to be the case. In this newsletter we review the benefits of working with an IRB.
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The Agilis team attended all four days of the 2021 Annual HFES International Symposium on Human Factors and Ergonomics in Health Care and participated in both poster and panel presentations. In this newsletter, we summarize some of the important regulatory updates provided by FDA presenters.
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As connected medical devices become more pervasive in our healthcare repertoire, device users will need to play a more active role to protect them. Ensuring users are aware of cybersecurity measures, how to implement them, and what to do in case of a hack is critical to safe and effective use. Make sure your human factors strategy incorporates assessments of use-related cybersecurity tasks to protect users and their data.
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Medication error can be deadly, costly, and unfortunately common. But what does the data say? Agilis looked into the available human factors and labels/labeling reviews from the FDA Novel Drug Approvals list from 2016-2020 to determine trends in recommendations provided by DMEPA to mitigate residual risk of medication error.
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In this newsletter, we discuss common pitfalls of URRAs as well as the Agilis approach to URRA and critical task identification. Agilis understands how interconnected HF and URRA processes must be to create a successful medical product submission.
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Shannon Hoste joins Agilis and invites all Clients and Colleagues in the healthcare, medical device, pharmaceutical and life science industries to answer this question: What services/support you would like from Agilis. What can we do to better serve you and your needs?
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As this year ends, we reflect on how the events that unfolded in 2020 have impacted Agilis and our partners, while we continue to think optimistically towards the future.
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Wearables have been valuable tools for anyone that’s worn a hearing aid or used an insulin pump. As the technology advances so do the applications. It is crucial to consider a user centered design approach to maximize the impact of these advancements. Read considerations for human factors testing in the wearable space.
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As 2021 looms on the horizon, we are thinking ahead toward how human factors activities will proceed in the next year. Agilis has successfully navigated the pandemic over the past several months in ways that are unique to our company’s remote structure and expertise.
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Let’s consider alternative HF strategies if in-person testing is not feasible due to local coronavirus rates and/or federal or state guidelines. Our thoughts on remote studies.
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Determine how you can adapt your HF strategy during the pandemic and align your goals with the best type of HF activity and study. Look for ways to plan ahead so that your HF programs keep moving forward and users can ultimately benefit from your new products as quickly as possible.
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Using platforms across devices or products can streamline development and enhance user experience. Platforms help to bridge the data from one product to another. Learn how to design effective human factors studies to be leveraged across products.
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A successful human factors submission is the result of a safe and effective user interface design, thorough risk assessment, and well-designed validation study. In this newsletter, we present some insights by FDA during the 2020 Virtual HFES Healthcare Symposium for consideration when designing a study and planning for a submission.
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