In this article, we present considerations for choosing a human factors partner, along with a case study involving Agilis’ conduct of a human factors validation in the early days of the COVID-19 pandemic and key steps to follow when addressing emergencies and other challenges during study conduct.
Read MoreAgilis would like to send our sincerest gratitude to all the healthcare workers, emergency responders, and essential personnel in the front lines of this global pandemic. Agilis is a leader in medical instructional design and training, we are prepared to offer support to our industry during the evolving pandemic and challenges we face.
Read MoreDoes the U.S. have a literacy and/or health literacy problem? Data suggests we do; well designed instructional materials and human factors studies that include users with low health literacy is paramount to a successful FDA regulatory submission.
Read MoreWhen is the right time to implement Human Factors into your regulatory process? What are the best practices to ensure you have a successful regulatory submission? Agilis makes this a priority in the latest newsletter
Read MoreAs you prepare for you next human factors submission, you might feel you need superhuman skills. After spending years, millions of dollars and other resources on device development, are you ready to submit your regulatory human factor results?
Read MoreAs we take some time to reflect upon our human factors and instructional design endeavors in 2019 and look forward to a productive 2020, we want to highlight some notable industry and regulatory accomplishments from the year. Click on the title above to read the Agilis’ 2019 recap of 12 key human factors, regulatory, and industry highlights from the U.S. and abroad.
Read MoreIf your organization is currently conducting or will conduct a human factors validation study in the future, here are some tips to consider. Following these tips while you plan and execute the validation study will put your organization one step closer to a successful validation.
Read MoreSponsors often ask us, “Can we do a threshold analysis instead of submitting human factors validation data to the agency?” The short answer is: It depends! Sponsors hope for this outcome, but findings from a threshold analysis may or may not support this conclusion.
Read MoreHow can we best develop medical devices for use at home? For home use devices, including combination devices, over the counter (OTC) products, and many others, it is expected that users will engage with their devices in their homes and other non-clinical environments. Read 2 of our case studies on these types of results.
Read MoreA company has conducted several formative human factors studies and there are still use errors and difficulties associated with the IFU or instructional materials. The instructions have been tested and iterated several times by different people but still the issues persist. What could be going wrong?
Read MoreCombination products often pose unique design challenges and regulatory authorities have specific expectations regarding human factor submissions. Thus, HF engineering is a critical part of the product development lifecycle and market success.
Read MoreIf you want to mess up a human factors test, mess up the task analysis. A poorly written task analysis is a recipe for use errors and bad data collection. Six steps to writing a successful task analysis
Read MoreUnderstanding how patients interpret instructions can help manufacturers design better labeling and improve customer performance and satisfaction.
Read MoreThere have been significant changes in both the US and global regulatory environments affecting human factors for medical devices and combination products. While done with good intent, many of these changes have added complexity and, in some cases, confusion about how to ensure a successful human factors submission.
Read MoreThe prevailing message from the workshop was that while there are many barriers to the development of pediatric-specific devices, the FDA and community in attendance is committed to developing innovative pathways and solutions to promote bringing pediatric devices to market.
Read MoreThis article provides two regulatory leaders insight on human factors engineering considerations for helping manufacturers optimize user interfaces and successfully meet regulatory expectations to bring safe, effective and usable medical devices to market.
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