Bold Insight’s Korey Johnson featured in AAMI’s latest BI&T journal focusing on early use-related research for medical devices

Bold Insight’s Korey Johnson featured in AAMI’s latest BI&T journal focusing on early use-related research for medical devices

A roundtable of experts was featured in the July/August 2019 issue of the Association for the Advancement of Medical Instrumentation (AAMI) bimonthly journal, Biomedical Instrumentation & Technology (BI&T). The discussion, Early Research into the Operational Context of Device Use Is Needed, highlighted trends, value, and various roles of early use–related research of medical devices. Bold Insight’s Managing Director Korey Johnson, a frequent presenter and active member in the human factors research community, was asked to lend his expertise to the dialog.  

 “It was a great experience to connect and discuss with my peers a topic we are all passionate about,” said Johnson. “Most of us are involved in developing standards and defining best practices for this type of research, so we appreciate any opportunity to answer questions and share our perspectives with members of the healthcare technology management community who are tasked with executing this research. Our goal, as human factors practitioners in healthcare, is to do more than ensure safe and effective use at the conclusion of the product development process. We aim to make humans and the human experience central to the entire development process. AAMI is a respected resource for furthering industry standards and best practices. Convening this roundtable discussion on early use-related research is a great example of the organization helping to push the industry in the right direction.” 

 AAMI members can access the full article by visiting  

 Connect with Korey Johnson on Linked In, Twitter, or email (korey.johnson [at] 

 About Bold Insight 

Bold Insight is user experience (UX) and human factors (HF) research agency based in Chicago. Our team offers clients the expertise and professionalism of a large agency, with the imagination and agility of a startup; specializing in medical device research, human factors validation, and large-scale global testing. 

 About AAMI and BI&T publication 

The Association for the Advancement of Medical Instrumentation (AAMI) publishes BI&T (Biomedical Instrumentation & Technology) a bimonthly peer-reviewed journal dedicated to the developers, managers, and users of medical instrumentation and technology. Twice each year, AAMI also publishes the award-winning Horizons series. Each issue focus on a single topic of  interest to the medical technology community.  

Founded in 1967, AAMI is a unique alliance of nearly 7,000 members united by the common goal of increasing the understanding and beneficial use of medical instrumentation. Members include clinical engineers, biomedical equipment technicians, manufacturers, sterile processing professionals, researchers, quality assurance and regulatory affairs experts, and other healthcare technology professionals.  Visit to learn more.

Bold Insight’s Gavin Lew to highlight medical devices and human factors at Intellus Worldwide Summit

Bold Insight’s Gavin Lew to highlight medical devices and human factors at Intellus Worldwide Summit

*Gavin Lew, Managing Director of Bold Insight, will present at the 2019 Intellus Worldwide Summit Insights Evolution in Philadelphia, Pennsylvania on May 20, 2019. In his talk, Medical Devices & the Human Factors of Health, Lew will describe the regulatory environment for new product development involving medical device delivery. He will also detail how human factors research can be applied to advance product design and improve success.

“Because regulatory agencies, such as the FDA, now require human factors research on the design of a medical device to ensure safe and effective use, there is an opportunity for market research to support this effort during the early exploratory phase of a product lifecycle,” commented Lew.

With a deep expertise in medical device research, the Bold Insight team frequently presents at healthcare-related events and contributes to industry standards. Read our latest health news.

Connect with Gavin on Linked In and Twitter.


About Intellus Worldwide

Formed in 2018, Intellus Worldwide unified renowned industry associations The Pharmaceutical Business Intelligence and Research Group (PBIRG) and Pharmaceutical Marketing Research Group (PMRG) bringing together healthcare insights professionals and global pharmaceutical and medical device manufacturers and service providers. For more information about the event, visit


About Bold Insight

Bold Insight is user experience (UX) research agency based in Chicago. The team offers clients the expertise and professionalism of a large agency, with the imagination and agility of a startup. This dynamic offering results in responsiveness, sense of pride and ownership, and flexibility to exceed project expectations. Find out more at or email to discuss your next project. *


Bold Insight’s Korey Johnson co-presents human factors training to members of FDA’s DMEPA

Bold Insight’s Korey Johnson co-presents human factors training to members of FDA’s DMEPA

Representatives from the Human Factors and Ergonomics Society (HFES) provided a two-day training course on human factors science, user-centered design principles, and root cause analysis on September 25-26, 2018 at the Food and Drug Administration’s (FDA) White Oak Campus in Silver Spring, Maryland. This course was attended by representatives of the Division of Medication Error Prevention and Analysis (DMEPA) from the Center for Drug Evaluation and Research (CDER). Korey Johnson, Managing Director of Bold Insight, along with Dr. Anthony Andre, and Michael Wiklund were the three experts selected by HFES to provide this training course.

The training was intended to provide attendees with deeper knowledge of and appreciation for the scientific roots of human factors research and user-centered design. Training drew on seminal research and literature from the fields of psychology, engineering, and product design, and leveraged a wide range of practical examples of both good and bad application of human factors science.

“There are many reviewers within CDER tasked with assessing the extent to which submissions adequately support a decision indicating that a product can be used safely and effectively. Many of those reviewers have abundant experience assessing human factors and user-centered design related shortcomings. With this training we hoped to provide a bit more of the scientific underpinnings of our practice – on one hand to amplify instances where requests for additional research are warranted, and on the other hand to provide the scientific context for when that additional research may not be warranted,” said Johnson.

For more information about the Human Factors and Ergonomics Society (HFES), visit

Connect with Korey Johnson on Linked In, Twitter, or email.

Bold Insight is a user experience (UX) research agency based in Chicago. Our team offers clients the expertise and professionalism of a large agency, with the imagination and agility of a startup; specializing in medical device research, human factors validation, and large-scale global testing.

Bold Insight’s Gavin Lew to highlight medical devices and human factors at Intellus Worldwide Summit

Bold Insight to exhibit at Human Factors Excellence for Medical Device Design conference

Bold Insight will exhibit at the 4th Annual Human Factors Excellence for Medical Device Design on August 1-2, 2018 in Minneapolis, Minnesota. Bringing together human factors engineering and user experience (UX) professionals, the conference will highlight emerging trends in the field of human factors and usability as it relates to compliance, testing strategies, training, new technologies, and submission requirements. Bold Insight Managing Directors Korey Johnson and Gavin Lew will be on hand to showcase the latest approaches to medical device research.

“Every time I have attended this conference, I have enjoyed discussing extremely relevant topics with my clients and human factors colleagues,” said Johnson. “It’s important for the medical device industry and human factors and UX leaders to have a place to connect and collaborate to advance the safety, efficacy, and efficiency of medical devices. Lately, as digital therapeutics and connected devices become more ubiquitous, we take opportunities like this conference to discuss ecosystem-level considerations and best practices to ensure engaging and satisfying overall experiences as much as safe and effective use of a single component alone.”

Be sure to visit Bold Insight’s booth throughout the conference for special giveaways and lively discussion about the latest research technology, the FDA’s human factors engineering guidance, and the future of digital therapeutics.


About Bold Insight

Bold Insight is a UX and human factors research agency. From user research informing early product design to global human factors validation, we specialize in applying human factors engineering to all phases of product development. We have the expertise of a large agency, with the imagination and agility of a startup. Learn more

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Reclassifying diabetes: 3 implications for product design

Reclassifying diabetes: 3 implications for product design



Recent research suggests that reclassifying diabetes may allow for the development of more targeted diabetes treatments. This could present opportunities to design these treatments to maximize patient safety and experience.
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 of the key potential benefits of such a reclassification is that it could result in more personalized treatment opportunities for patients, based on the unique symptom or disease profile. If this research gains traction in the medical community, it could present an opportunity for manufacturers to tailor and design treatments to improve the patient experience and reduce medication errors.

Potential for more customized treatment

Recognizing that there are multiple proposed reclassification schemes, I will focus primarily on the proposed 5-type model. For background, in the 5-type model, the proposed types of diabetes are:

  1. severe autoimmune diabetes
  2. severe insulin-deficient diabetes
  3. severe insulin-resistant diabetes
  4. mild obesity-related diabetes
  5. mild age-related diabetes

There is literature describing the differences between these five types and the potential for targeted treatments that may result in improved health outcomes for patients. It appears that there is still a way to go from a research perspective before it is determined that those improved outcomes would be recognized by treating patients in each of these five categories differently. But for the purposes of this blog, let’s assume that there IS clinical benefit to customized treatment based on a more granular classification when treatment is administered and adhered to as intended.

Implications for product design

If diabetes were reclassified from two primary types to five or more, there would be all kinds of implications ranging from treatment efficacy to health insurance coverage and more. Let’s consider just a few use-related implications associated with increasing the variability in diabetes-related therapies, and the underlying opportunity for manufacturers of those therapies to solve for the implications through product design.

1. More delivery system options could make differentiation between delivery systems more difficult

What does this mean for differentiation between an increasing number of (e.g.) options for insulin types or delivery systems? It is not clear whether this reclassification would lead to an increase in the variety of insulin-based therapies, but it might. Assuming it could, consider the challenges that had to be addressed with increased prevalence and usage of concentrated-dose insulin (e.g., U-500) and variable syringe types (U-100, U-500, tuberculin). Introducing this concentrated dose insulin to the market provided a portion of the diabetic population with a useful treatment option, but it also made possible a dangerous error. If a diabetic patient intends to administer a 10mL dose of standard U-100 but instead administers 10mL of U-500, they would get five times the amount of insulin they intended.

One way to mitigate such a risk is by designing the two therapies (including the delivery devices, packaging, labeling, etc.) such that they can be easily differentiated. What additional therapy types or possible combinations of administration methods might result from the reclassification of diabetes? Which of these might be similar enough such that the potential for and clinical impact of confusion is high? What can be done from a design perspective to mitigate this confusion?

2. Treatments could be designed to improve patient experience

The increased granularity with which we could describe the “typical” diabetes patient in each of these more refined categories also presents an opportunity for the design of other diabetes-related therapies beyond insulin. Take oral therapies as an example – some have complex dosing procedures, and for many diabetes patients, comorbidities dictate what can be an overwhelming regimen of various pills, tablets, and capsules. This new research suggests that reclassifying those with similar disease progression and projected outcomes could help tailor treatment more effectively. For example, diabetics currently being treated with the same approach could be treated differently according to their more unique symptoms, e.g. someone more prone to blindness would be categorized (and treated) differently from those more prone to developing kidney disease.

If we are better able to predict what other health-related issues one type of diabetic patient is likely to experience compared to another, we will also be able to predict what other pills, tablets, etc. each of those two patients are likely to have in their medicine cabinet. For one type of diabetic patient, a certain color, shape, or size of pill might be easily confused with some other pill commonly prescribed to that patient population. For another patient type, a certain dosing procedure might not be advisable because it could be easily confused with others (do I take two of the red pills in the morning and one of the blue pills at night… or two of the blue pills in the morning and one of the red pills at night?). Being able to anticipate the makeup of oral treatment regimens for diabetics at a more granular level due to this proposed reclassification provides an opportunity to tailor the design of the oral treatments themselves to reduce medication errors and further improve outcomes.

3. Increased treatment customization could create space for more digital innovation

As digital innovation continues to impact healthcare, the opportunity in new, targeted treatment approaches may also lead to increased development of digital patient tools, including dosing calculators, symptom or treatment trackers, and many others. These of course already exist, but with a refined classification of diabetes and more robust information available describing each “new” type, existing concepts for digital support can be reimagined with the specific needs and constraints of each patient type.

One could argue that even if some of these use-related considerations are not addressed, the worst-case scenario is no worse than we have today –diabetics are diagnosed and treated as just Type 1 or Type 2 (oversimplification but illustrative). However, acknowledging the use-related implications of introducing new treatments or new treatment regimens for diabetics early on will help guide the design of packaging, labeling, instructions for use, training, diagnostics, or even insulin delivery systems themselves such that patients and health care providers can clearly see and understand the difference between “their” treatment regimen and those of “other” types of diabetics. And further, that their adherence to that regimen is supported by the design of its components.

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