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...
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...
4 make-or-break considerations for health IoT ecosystems
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...
3 reasons to conduct ethnographic research during medical device development
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...
Accessibility and medical human factors research: 3 questions to ask your product teams
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...
Improve medical device safety with these packaging design tips
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 to present on global medical device testing, in-person research logistics during COVID at HFES Health Care Symposium
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...
3 UX Trends Shaping Healthcare in 2021
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...
5 tips to mitigate use-related risk for pre-filled syringes and other injection devices
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...
What we’ve learned from six months of in-person research during COVID
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...
Bold Insight’s Gavin Lew to present at Intellus Worldwide Fall vForum
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.
Physicians and specialists weigh in on telehealth improvements
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...
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,...
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...
Is FMEA inadequate for human factors analyses?
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...
Care to share? UX considerations of the sharing economy for ridesharing, hospitality, and healthcare
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...
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...
Reclassifying diabetes: 3 implications for product design
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...
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....
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.
3 crucial aspects of submitting a successful human factors engineering package to the FDA
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...
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...
4 make-or-break considerations for health IoT ecosystems
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...
3 reasons to conduct ethnographic research during medical device development
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...
Accessibility and medical human factors research: 3 questions to ask your product teams
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...
Improve medical device safety with these packaging design tips
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 to present on global medical device testing, in-person research logistics during COVID at HFES Health Care Symposium
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...
3 UX Trends Shaping Healthcare in 2021
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...
5 tips to mitigate use-related risk for pre-filled syringes and other injection devices
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:...
What we’ve learned from six months of in-person research during COVID
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...
Bold Insight’s Gavin Lew to present at Intellus Worldwide Fall vForum
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.
Physicians and specialists weigh in on telehealth improvements
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...
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 collaborations with the talented UX...
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...
Is FMEA inadequate for human factors analyses?
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...
Care to share? UX considerations of the sharing economy for ridesharing, hospitality, and healthcare
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,...
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...
Reclassifying diabetes: 3 implications for product design
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...
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...
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.