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 https://www.intellus.org/Events-Webinars/Summit-2019

 

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 y9qch.hosts.cx or email hello@y9qch.hosts.cx 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 hfes.org.

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. https://boldinsight.com/human-factors

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

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

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BOLD INSIGHT

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.

5 takeaways for human factors practitioners from the HFES Health Care Symposium FDA workshops

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 Health (CDRH) were represented.

As in previous workshops, a significant portion of the content presented was a summary of various FDA guidance documents related to the application of human factors engineering to the development of medical and drug-delivery devices. While the bulk of that information is publicly available, it is valuable to take advantage of the forum and get some clarification and elaboration directly from the agency on current human factors (HF)-related topics.

As we have come to expect, there are some similarities in how CDER and CDRH expect human factors to be applied, but also some differences. This summary is simply my interpretation of key topics discussed, and is in no way meant to be comprehensive, nor an endorsed statement of FDA policy. While many of these points were couched in the context of designing, executing, and analyzing a human factors validation study, the implications apply more broadly.

Takeaway 1: User groups

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BOLD INSIGHT

When validating safe and effective use of a pre-filled syringe, relying on existing data for HCPs rather than including them alongside (e.g., adult patients) in the human factors validation test may be a viable option.
On both sides of the fence (CDER/CDRH), the importance of validating safe and effective use for all intended user groups was emphasized, as it has been many times before. CDRH cited failure to account for all intended user groups (and/or use environments) as one of the most common defects in human factors validation reports. CDER did not disagree with this common pitfall but did highlight one use case specific to combination products that may not require inclusion in human factors validation tests. For “standard” pre-filled syringes, health care practitioners (HCPs) (e.g., nurses) need to be acknowledged as a user group, but their inclusion in the actual HF validation test is likely not necessary given the well-documented practices and post-market data supporting this group’s safe and effective use of such products.

The point was made that of course not all pre-filled syringes are “standard” and that there are exceptions… but my takeaway was that when validating safe and effective use of a pre-filled syringe, relying on existing data for HCPs rather than including them alongside (e.g., adult patients) in the human factors validation test may be a viable option.

Takeaway 2: Critical tasks

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BOLD INSIGHT

While documenting all your human factors-related activities during product development is a must, for medical devices, those activities may not necessarily include a human factors validation study.
There exists a documented difference between the CDER and CDRH definitions of a critical task.

From CDER Draft Guidance:

Critical tasks are user tasks that, if performed incorrectly or not performed at all, would or could cause harm to the patient or user, where harm is defined to include compromised medical care.

From CDRH Guidance:

[A critical task is] A user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care.

This is not a new difference, but it was discussed during the workshops, and CDRH emphasized that they were “serious about the word serious.” More interesting than the rehashing of this difference was a related discussion about how a manufacturer should handle validation of safe and effective use of their product if their use-related risk analysis (URRA) determines that no critical tasks exist for their product. There are several rabbit holes one can go down when considering this question, but one interesting difference between the CDER and CDRH responses did emerge.

From CDER’s perspective, even if there is no immediate harm associated with (e.g.) a failed injection, that failed injections may occur is still important, so “no critical tasks exist” is not an argument a manufacturer can make in support of a decision to not conduct a human factors validation study.

From the CDRH perspective, if you complete all of your preliminary analyses and determine that there are no critical tasks associated with use of your device, you still have to complete Sections 1-7 of your human factors engineering report, describing all the activities leading up to that determination. If the agency agrees with your determination, you would not be required to conduct a human factors validation study.

Regardless of whether your product is a drug/combination product or a medical device, documenting all your human factors-related activities during product development is a must. However, for medical devices, those activities may not necessarily include a human factors validation study.

Takeaway 3: Training and support in simulated environments

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BOLD INSIGHT

There is an increasing willingness on the part of the agency to consider realistic simulations of training and support mechanisms available to medical device and combination product users.
The point was still made that training all participants in a validation study, particularly when evaluating a product to be used by laypersons, is very often not representative of operational context of use, and therefore not acceptable. However, a few specific examples were given that indicate the FDA’s commitment to consider reasonable arguments for providing more realistic (first-time) use simulations:

Help line

Historically, incorporating the opportunity for a research participant in a validation study to call a (simulated) help-line to get the support they need to complete a task has been a contentious practice. In my experience, this is mostly because it has been implemented with varying degrees of care. Simulating a help line by having the “support representative” role played by an observer directly behind the glass is not realistic, and likely to be met with justifiable criticism. However, the FDA did grant that when simulated properly, this can be a reasonable simulation of operational context of use. In these cases, a participant in a validation study independently choosing to call the help line and receiving the support they need to complete a task successfully does not necessarily constitute a critical task failure (though it likely constitutes a difficulty that would require further analysis).

Online support

It was encouraging to hear the agency acknowledge that online resources are increasingly becoming the first point of reference when users of a product (medical device or otherwise) need a tutorial. Whether a product website, online manual, or YouTube demo – these resources are very much a part of operational context of use for a significant portion of the population. As with the help line, the way in which these resources are incorporated into the simulated use environment is key to validity of the resulting data. “Here’s an injection device, go watch this YouTube video and then attempt a simulated injection…” not realistic, and likely to be met with justifiable criticism. But implementing protocols to understand how a specific research participant tends to learn about using a new injection device and making them aware that all those resources are available to them as a part of the research they are participating in can be a reasonable approach. It was good to hear the FDA acknowledge that a case can be made for this.

Train the trainer

Consistent with the underlying message in the previous two examples, when discussing the extent to which it is necessary to implement “train the trainer” protocols in simulated-use research, the FDA stressed the importance of achieving a reasonable simulation of operational context of use. For some types of devices, this question becomes less important than the question of whether any degree of consistent training can even be expected, in which case the data resulting from a trained arm of a study may be all but disregarded in favor of an assessment of untrained use. But for other types of devices, use without some degree of training is simply not realistic. In these cases, how the training is implemented becomes more important. If, for example, the expected practice is that groups of clinicians receive one in-service training from a manufacturer representative and then use the device themselves in a clinical setting and/or train patients on how to use the device themselves, then this is the sequence of events that should be simulated for validation of safe and effective use.

Takeaway 4: Communication with the agency

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BOLD INSIGHT

Of every 100 submissions that the CDRH human factors team receives to review, where they were NOT provided an opportunity to review the HF validation protocol in advance, maybe one of them makes it through without a request for additional information.
A common message from CDER/CDRH in just about every public forum I have heard them speak – communicate with us early and often. This can be frustrating for manufacturers to hear because for some types of interactions the response time from the agency is not as quick as they would like, but not every interaction has to be a full-fledged meeting and review. There are guidance documents available describing the various mechanisms by which the agency can be engaged (e.g., Guidance Document UCM311176) and given that some of the most important questions may be answered in a more formal meeting, that stresses the importance of having a robust human factors plan in place long before you’re gearing up for your validation study.

CDRH cited a high degree of communication with the agency as a key best practice, and backed this up with an observation that of every 100 submissions that the human factors team receives to review where they were NOT provided an opportunity to review the HF validation protocol in advance, maybe one of them makes it through without a request for additional information (e.g., another validation study).

Takeaway 5: Digital Health Software Precertification Program

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BOLD INSIGHT

The Digital Health Software Precertification Program represents an opportunity to incentivize not just the proper execution of a human factors validation study, but the advancement of safer and more effective medical devices (including software) through institutionalization of best practices in human factors engineering.
As a follow up to our previous piece on digital therapeutics, we started exploring the extent to which the Digital Health Software Precertification Program might in the future impact the regulation of medical and drug-delivery devices, or at least the software-based contingents of those devices. This is a very large and multi-faceted initiative coming out of CDRH, that seeks to “develop a tailored approach toward regulating digital health and software technologies. The new approach aims to look first at the software developer and/or digital health technology developer, rather than primarily at the product, which is what we currently do for traditional medical devices.”

The same, or at least very similar, topic has come up more and more frequently in recent years when considering how to assess and regulate the application of human factors engineering to the development of software as a medical device (or at least the software components of medical and drug-delivery devices). Given this, I expected to hear at least a mention of collaboration with the CDRH human factors team when listening in on the FDA-hosted public workshop focused on this program earlier this year. I was surprised to hear no such mention, and then thought maybe during the HFES workshops the CDRH human factors team would be able to share some insight to how human factors is being considered in the institutional precertification of developers and manufacturers. Unfortunately, the CDRH team was not able to share any insights to this when asked during the workshop (nor was CDER).

I hope that the Digital Health Software Precertification Program leadership has actively engaged their in-house human factors experts, and that the human factors team’s inability to share insights was simply due to some limitation in their ability speak publicly on the topic. If that is not the case, it would seem a missed opportunity to incentivize not just the proper execution of a human factors validation study, but the advancement of safer and more effective medical devices (including software) through institutionalization of best practices in human factors engineering.

Did you attend the Pre-Symposium FDA workshops? What additional takeaways do you have? Comment below!

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