Instead of a top-down, one-size-fits-all approach to research, collaboration between manufacturers and human factors research teams can create trusted partnerships and a focus on designing valuable products.
A successful global project starts with understanding and planning for logistical challenges.
Prepare for a successful global study by allocating additional time to strategize localization and translation.
Understanding and accounting for common challenges is the first step in collecting high quality data during global research.
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.
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.
HFES healthcare symposium provides insight on FDA and regulatory perspectives, use of technology in research, interesting research methods employed, and cross-industry collaboration.
A stronger recruiting strategy that includes relationships with patient support groups and clinical treatment centers can provide better access to difficult-to-reach patient populations. Being intentional about how you plan the logistics of your human factors and user research can mitigate risks to validity introduced by biases.
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.
Healthcare symposium provides clarity for interpretation of FDA guidance documents related to human factors engineering.
I found myself discussing what can be done to increase the extent to which voice recognition systems are seen as a benefit rather than an annoyance with the research sponsors, and I said the same things as I said 10 years ago… improve the system to support and recognize more natural speech patterns.
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.
Instead of a top-down, one-size-fits-all approach to research, collaboration between manufacturers and human factors research teams can create trusted partnerships and a focus on designing valuable products.
A successful global project starts with understanding and planning for logistical challenges.
Prepare for a successful global study by allocating additional time to strategize localization and translation.
Understanding and accounting for common challenges is the first step in collecting high quality data during global research.
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.
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.
HFES healthcare symposium provides insight on FDA and regulatory perspectives, use of technology in research, interesting research methods employed, and cross-industry collaboration.
A stronger recruiting strategy that includes relationships with patient support groups and clinical treatment centers can provide better access to difficult-to-reach patient populations. Being intentional about how you plan the logistics of your human factors and user research can mitigate risks to validity introduced by biases.
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.
Healthcare symposium provides clarity for interpretation of FDA guidance documents related to human factors engineering.
I found myself discussing what can be done to increase the extent to which voice recognition systems are seen as a benefit rather than an annoyance with the research sponsors, and I said the same things as I said 10 years ago… improve the system to support and recognize more natural speech patterns.
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.