Developing safe devices that work is the baseline for effective medtech design. FDA regulations help bring consistency to that process. But even guided by robust regulation, safety and functionality...
Why logistics are important: 4 considerations for planning global research
One of the biggest hurdles to a smoothly-run global research project is the planning of logistics. Most research teams are aware that different customs need to be taken into account when conducting...
Two tips for successfully preparing research materials for global studies
Global user experience (UX) research comes with unique challenges that require planning and consideration. One area to focus on is how a study’s research materials and testing environments will be...
How to prepare products for global research
Twenty years of global research have taught us (sometimes the hard way) that challenges can arise when prepping devices or other products for international research. When not accounted for, these...
Webisode: Possible impact if in-person human factors research is not considered essential
As an industry, we’ve done a lot thinking about the impact of COVID-19 on research that informs the development and commercialization of safe and effective medical devices. In this webisode, Bold...
Human factors research in the times of COVID
How to continue to support development of safe and effective medical devices Many thought pieces are being pushed out around what remote research methods are available to replace research that would...
7 insights from the 2019 HFES Health Care Symposium
The Bold Insight team offers some key insights from the conference, most from the medical and drug delivery device track, but some general insights as well.
Recruiting methods and study logistics for human factors and user research
Minimizing bias and mitigating risks to validity Earlier this month we attended the 4th Annual Human Factors Excellence for Medical Device Design. We had a great time connecting with clients and...
FDA’s digital health precertification program emphasizes importance of post-market surveillance
Post-market surveillance is already an important component of human factors analyses that inform the development of any safe and effective medical device. For manufacturers of Software as a Medical...
5 takeaways for human factors practitioners from the HFES Health Care Symposium FDA workshops
Pre-Symposium U.S. Food and Drug Administration (FDA) workshops have become the norm over the past few years at the annual International Symposium on Human Factors and Ergonomics in Health Care....
In-vehicle UX research: Here’s one recommendation that hasn’t changed in 10 years
After recently conducting research on drivers’ experience with technology in their vehicles, I reflected on what has changed about that experience in the last 10 years…. and what hasn’t changed. The...
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.
How collaboration builds value in medical device human factors research
Developing safe devices that work is the baseline for effective medtech design. FDA regulations help bring consistency to that process. But even guided by robust regulation, safety and functionality are only as effective as the likelihood that patients will adhere to a prescribed therapy. What’s...
Why logistics are important: 4 considerations for planning global research
One of the biggest hurdles to a smoothly-run global research project is the planning of logistics. Most research teams are aware that different customs need to be taken into account when conducting global research, as certain cultures are more punctual than others or may expect different standards...
Two tips for successfully preparing research materials for global studies
Global user experience (UX) research comes with unique challenges that require planning and consideration. One area to focus on is how a study’s research materials and testing environments will be prepared. While most teams allocate for the translation of some study materials, there are other...
How to prepare products for global research
Twenty years of global research have taught us (sometimes the hard way) that challenges can arise when prepping devices or other products for international research. When not accounted for, these factors can threaten the validity of insights gleaned from the research, or at minimum introduce...
Webisode: Possible impact if in-person human factors research is not considered essential
As an industry, we’ve done a lot thinking about the impact of COVID-19 on research that informs the development and commercialization of safe and effective medical devices. In this webisode, Bold Insight’s Managing Partner Korey Johnson describes why at least some of this research must be...
Human factors research in the times of COVID
How to continue to support development of safe and effective medical devices Many thought pieces are being pushed out around what remote research methods are available to replace research that would have otherwise been conducted in person if not for COVID. We’ve published some ourselves (Three...
7 insights from the 2019 HFES Health Care Symposium
The Bold Insight team offers some key insights from the conference, most from the medical and drug delivery device track, but some general insights as well.
Recruiting methods and study logistics for human factors and user research
Minimizing bias and mitigating risks to validity Earlier this month we attended the 4th Annual Human Factors Excellence for Medical Device Design. We had a great time connecting with clients and colleagues (and gave away some awesome cooler backpacks). We also enjoyed the conference topics ranging...
FDA’s digital health precertification program emphasizes importance of post-market surveillance
Post-market surveillance is already an important component of human factors analyses that inform the development of any safe and effective medical device. For manufacturers of Software as a Medical Device (SaMD) that elect to participate in the FDA’s Digital Health Software Precertification...
5 takeaways for human factors practitioners from the HFES Health Care Symposium FDA workshops
Pre-Symposium U.S. Food and Drug Administration (FDA) workshops have become the norm over the past few years at the annual International Symposium on Human Factors and Ergonomics in Health Care. This year, both Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological...
In-vehicle UX research: Here’s one recommendation that hasn’t changed in 10 years
After recently conducting research on drivers’ experience with technology in their vehicles, I reflected on what has changed about that experience in the last 10 years…. and what hasn’t changed. The availability of customized, on-demand, and context-appropriate information in in-vehicle displays...
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.