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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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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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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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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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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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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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!

The time for a better UX in digital therapeutics is now

The time for a better UX in digital therapeutics is now

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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.
Over the last few years, health technology presence at the Consumer Electronics Show (CES) has grown. This year, not only was this true on the exhibition floor, but also in the conference sessions contemplating the future of the healthcare industry. One track of sessions focused on disruptive innovations in healthcare was particularly interesting and highlighted an important takeaway for medical device and med tech manufacturers; the digital therapeutics industry is ripe for the user experience (UX) of these devices to define the market leaders.

What are digital therapeutics?

I would be remiss not to acknowledge that there is some vagueness around what constitutes a digital therapeutic. One presentation in this conference track put forth a definition that essentially described digital therapeutics as any therapy with a digital component – from a VR simulator used for a type of immersion therapy to treat PTSD, to a companion mobile app that diabetics use to track their insulin intake. While useful to get a general grasp of the proliferation of digital therapeutics, this definition does lump together two very different types of therapies, each with unique considerations from both a regulatory and user experience perspective. An article from the MIT Review last year defined digital therapeutics in two categories, “medication augmentation” and “medication replacement,” and further described how the devices differentiate themselves from wellness tech. There is typically clinical testing conducted to demonstrate efficacy, and sometimes even regulatory approval sought with a digital therapeutic.

The lack of clarity around what constitutes a digital therapeutic does have the potential to, for example, hinder prescribing behavior if all manner of digital enhancements are perceived to be “alternative-to-drug” therapies facing the same barriers to adoption. Regardless of which definition the industry ultimately settles on one thing is clear – whether as standalone therapies or a component of a broader care program, digital and digitally augmented therapies are on the rise.

Current barriers to adoption

The same session that put forward the broad definition of digital therapeutics reported some descriptive statistics around patient populations most likely to adopt these therapies successfully with respect to their demographics, online behavior, technology usage, etc. Not surprisingly, those more receptive to use of technology in general are also more likely to adopt a digital therapeutic to manage their condition. Also not surprisingly, payer reluctance to reimburse for new digital and digitally augmented therapies was at the top of the list of prescribing barriers. The UX afforded by the digital therapeutics currently on the market however, was also very near the top of that list.

Interestingly, physicians who have experience prescribing digital therapeutics were much more likely to cite “lack of innovative and user-friendly solutions” as a key barrier to more widespread prescription and adoption. There was a huge jump – from 8% of those without experience prescribing digital therapeutics to 30% of those with experience citing this reason as a barrier. So – those who have exposure to these types of therapies recognize that in order for them to succeed, the end user experience needs to receive a greater focus.

Implications of reaching critical mass

It would be easy to see payer willingness to reimburse for digital therapeutics (or lack thereof) as a sufficiently large barrier such that most effort would be dedicated to navigating this challenge. However, in another session focused on the positive future of value-based healthcare, it was pointed out that history has shown us that payer behavior tends to shift once a critical mass is established for a therapy or therapy category. Attention was called to recent legislation outlining a change in Medicare reimbursement rules for 2018. For the first time in history, physicians will be reimbursed for time they spend monitoring Medicare patients’ health remotely. As this remote monitoring capability is one key benefit of many digitally enhanced therapies, it is not much of a stretch to view this as an important step closer to a fundamental shift in payer mindset. With reimbursement practices shifting, manufacturers of digital therapeutics can benefit from looking to the next horizon of how they will differentiate themselves in a rapidly growing market.

Spend the time now to get the UX right and win the market

Aside from reimbursement, lack of user-friendly solutions was cited as one of the largest barriers to more favorable prescribing behavior for digital therapeutics. With extensive experience conducting research to inform the design of digital interfaces both from within and outside of healthcare, we know that safe and effective use of these digital products is fundamentally tied to their design – not just their functionality. There is a tendency to focus on usability and UX as a confirmatory or validation-based activity (ok, we’ve built it as we planned, now let’s test it to make sure people can use it). In fact, there is much more value and ROI to be gained from incorporating user feedback early and often in the development process. Doing so helps shape early concepts for product and interface design, leading to the kind of best-in-class UX that wins market share. It also prepares manufacturers to successfully navigate regulatory requirements for the application of human factors engineering to the development of medical devices for products that are so regulated.

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. Regardless of whether the digital asset in question is a standalone therapy in its own right (medication replacement), or a component of a broader care management program (medication augmentation), now is the time for manufacturers to turn more attention to developing useful, usable, and engaging products to give patients and care providers alike the kind of best-in-class experience that will catapult digital therapeutics into the mainstream.

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