Have a mid-development question about medtech regulation? Chances are – no matter the size or scale of the manufacturer you work for – you probably can’t just pick up the phone and ask the FDA for...
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...
All too often, medical device manufacturers roll out Internet of Things (IoT) devices that struggle to satisfy users and be adopted at scale. That’s in part because health IoT doesn’t exist in a...
Conducting ethnographic research is one of the best ways to understand and anticipate users’ needs. In systems as complex and personal as those in healthcare, it is especially important dive deep...
One of the best parts of my job as a human factors researcher is interacting with participants during studies. Early medical device studies generally have bare-bones definitions of intended user...
Packaging is often one of the last pieces to come together in R&D activities, yet it is often the first experience users have with a new product. The design of a product’s packaging can set the...
Bold Insight will feature two trending topics during the 2021 International Symposium on Human Factors and Ergonomics in Health Care. Sharing lessons learned when managing in-person research with...
The healthcare industry continues to evolve its use of smart devices, ranging from wearable technology to remote monitoring, but with innovation brings new obstacles in meeting patients’ needs. As...
With years of experience conducting human factors research with injection devices, we wanted to share some data-driven insights to those involved in the product development for these devices. We...
When COVID-19 first reared its ugly head, the global UX community was one of many that reacted in despair as we considered the future of our work: How were we going to work in these unprecedented...
Like many conferences, the shift to a virtual format will apply to this year’s Intellus Worldwide Summit. The Fall vForum will extend over four days and highlight topics that are top of mind for the healthcare insights and analytics community.
Both patients and clinics have had to rapidly adopt to telehealth due to safety concerns associated with in-person visits. Last summer, we published a blog post highlighting common areas of concern...
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,...
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...
As part of the overall human factors effort associated with the development of a medical device, critical tasks1 must be determined and evaluated. To support testing of critical tasks related to a...
Millions of people, by choice or circumstance, take advantage of the sharing economy, an economic model based on peer-to-peer sharing of goods and services. Some of the largest contributors and most...
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...
Currently, diabetes is diagnosed as either Type 1 or Type 2 (setting aside gestational diabetes). Research has suggested that diabetes should be reclassified into multiple separate diseases; a group...
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....
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.
Have a mid-development question about medtech regulation? Chances are – no matter the size or scale of the manufacturer you work for – you probably can’t just pick up the phone and ask the FDA for an answer. Most often, the process is instead slow and bureaucratic, which can make it all seem not...
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...
All too often, medical device manufacturers roll out Internet of Things (IoT) devices that struggle to satisfy users and be adopted at scale. That’s in part because health IoT doesn’t exist in a void. Each device fits into a broader ecosystem that includes other products, user contexts, user...
Conducting ethnographic research is one of the best ways to understand and anticipate users’ needs. In systems as complex and personal as those in healthcare, it is especially important dive deep into the context of use to identify gaps and nuances during the product development cycle. The...
One of the best parts of my job as a human factors researcher is interacting with participants during studies. Early medical device studies generally have bare-bones definitions of intended user groups that become more defined throughout the product development life cycle, but every time, even the...
Packaging is often one of the last pieces to come together in R&D activities, yet it is often the first experience users have with a new product. The design of a product’s packaging can set the tone for the entire user experience. Within the medical device space, considering the human factors...
Bold Insight will feature two trending topics during the 2021 International Symposium on Human Factors and Ergonomics in Health Care. Sharing lessons learned when managing in-person research with vulnerable populations during COVID, Michelle Jahn Holbrook, Senior UX Researcher at Bold Insight, and...
The healthcare industry continues to evolve its use of smart devices, ranging from wearable technology to remote monitoring, but with innovation brings new obstacles in meeting patients’ needs. As UX researchers and designers, we have played a key role in helping design solutions to these complex...
With years of experience conducting human factors research with injection devices, we wanted to share some data-driven insights to those involved in the product development for these devices. We have pulled together five research and design tips to mitigate use-related risk for injection devices:...
When COVID-19 first reared its ugly head, the global UX community was one of many that reacted in despair as we considered the future of our work: How were we going to work in these unprecedented times? How could we work safely with people when we were advised to not be around one another? As a...
Like many conferences, the shift to a virtual format will apply to this year’s Intellus Worldwide Summit. The Fall vForum will extend over four days and highlight topics that are top of mind for the healthcare insights and analytics community.
Both patients and clinics have had to rapidly adopt to telehealth due to safety concerns associated with in-person visits. Last summer, we published a blog post highlighting common areas of concern that healthcare professionals (HCPs) have when using telehealth. We suspected a gap between...
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 collaborations with the talented UX...
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...
As part of the overall human factors effort associated with the development of a medical device, critical tasks1 must be determined and evaluated. To support testing of critical tasks related to a device, it is necessary to have a clear understanding of the hazards associated with use of the...
Millions of people, by choice or circumstance, take advantage of the sharing economy, an economic model based on peer-to-peer sharing of goods and services. Some of the largest contributors and most well-known players in this game are companies that offer ridesharing, short-term accommodation,...
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...
Currently, diabetes is diagnosed as either Type 1 or Type 2 (setting aside gestational diabetes). Research has suggested that diabetes should be reclassified into multiple separate diseases; a group of scientists in Scandinavia argues for 5 (where others argue for as many as 11). Either way, one...
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...
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.