As the field of human factors continues to evolve, so must our approaches to testing and study design. While the FDA’s 2013 guidance laid the groundwork for study design and methodology, recent discussions and conference presentations have prompted a shift in how we approach OTC HF testing, leading to more comprehensive and realistic assessments of these products.
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Archive: human factors
What the history of human factors tells us about the future of our industry
Look back at the rich history of human factors engineering, from its roots in anthropometry to the advanced field of ergonomics and beyond. These developments have shaped technologies and design, enhancing everyday life by making experiences safer and more intuitive.
The FDA’s PCCP: A game changer for AI-enabled medical device software
Learn how incorporating human factors principles in developing the PCCP approach can improve the chances of successfully implementing a PCCP.
Human factors optimization: How to leverage HF researchers in your medtech team
As a medtech professional, you can enhance your team’s capabilities by engaging human factors researchers to create front-end documentation, alleviate research workloads, and provide regulatory guidance.
Integrating AI with care: FDA reveals focus areas for forthcoming guidance on AI products
As AI technology use expands within the healthcare industry, FDA focus areas will play an important role in ensuring safe implementation.
Follow this framework to ensure your SaMD conforms to HF standards post-release
Navigate regulatory nuances for your SaMD by following a structured approach to maintain compliance post-release.
New Blog Series: Bold Insight and Orthogonal share insights about getting medical devices to market faster
Given the multidisciplinary nature of MedTech and connected health, we have the opportunity to work with a wide variety of professionals including engineers of many stripes, scientists, researchers, designers, experts in regulatory, and quality management. Our...
Rethinking experiences: UX and human factors research can help companies develop safe, contactless designs
Explore early opportunities to create and refine a truly functional contactless experience for your customers, addressing new expectations in a changing world.
Human factors research in the times of COVID
Human factors research in the support of medical and drug delivery device commercialization is essential and we should be planning on a return to in-person research as soon as is possible by applying all available and practical protective measures.
Is FMEA inadequate for human factors analyses?
A “traditional” risk assessment does not meet the needs of FDA-required human factors analyses.
FDA’s digital health precertification program emphasizes importance of post-market surveillance
Finding efficient ways to leverage post-market surveillance data to inform product development at an institutional level will be key for SaMD manufacturers seeking FDA precertification.
5 takeaways for human factors practitioners from the HFES Health Care Symposium FDA workshops
Healthcare symposium provides clarity for interpretation of FDA guidance documents related to human factors engineering.
The time for a better UX in digital therapeutics is now
If history has shown that payer behavior tends to shift once a critical mass has been achieved, and we are on the precipice of achieving that critical mass for digital therapeutics, having a “user friendly solution” is about to replace “having a reimbursable solution” as the #1 factor affecting physician prescribing behavior.