As AI technology use expands within the healthcare industry, FDA focus areas will play an important role in ensuring safe implementation.
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Archive: human factors
Fostering collaboration between HF practitioners and interdisciplinary teams
Discover how integrating human factors expertise drives success in product design and learn the steps to foster collaboration through interdisciplinary teamwork.
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.