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...
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 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...
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...
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...
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...
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.
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...
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...
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....
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...
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.
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...
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...
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...
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...
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...
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...
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.
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...
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...
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...
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...
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.