Discover why implementing knowledge tasks is essential for evaluating user comprehension of critical safety information in medical device validation. Learn how to effectively assess these tasks to enhance product safety and effectiveness in your healthcare UX research.
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Archive: medical devices
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.
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.
What medtech design teams need to know about AI regulations
China and the European Union are regulating AI ethics. The mandate for medtech design teams: build AI-powered products that meet ethics standards and inspire user trust.
Improve medical device safety with these packaging design tips
Safe and effective medical device use starts with designing packaging that considers the unique needs of its users.
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...
Webisode: Possible impact if in-person human factors research is not considered essential
Conducting research to inform development of safe and effective medical devices is essential and with modifications and precautions, in-person research can be conducted safely and effectively.
Is FMEA inadequate for human factors analyses?
A “traditional” risk assessment does not meet the needs of FDA-required human factors analyses.
Reclassifying diabetes: 3 implications for product design
Recent research suggests that reclassifying diabetes may allow for the development of more targeted diabetes treatments. This could present opportunities to design these treatments to maximize patient safety and experience.
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.