Presentation
Medical Devices for Home Health – Considerations Beyond HE-75, Lessons From the Field
SessionPoster Session 2
DescriptionAs the country grapples with increased healthcare challenges - staffing shortages, fragmented care, and funding cuts - it will push more medical diagnostics and treatments to patients and caregivers. Most Human Factors professionals are familiar with ANSI/AAMI HE-75, a comprehensive document which describes usability-related design considerations and recommendations for medical device design, most of which are for medical devices used by clinical users in clinical use environments. However, a lesser known chapter of this document pertains to home medical devices, and it highlights important characteristics of lay users in non-clinical use environments.
Although this presentation will not reiterate the content of HE-75 and other similar literature in detail, it is important to keep the descriptions of the potential users and environments in mind because they intersect with the lessons from the field discussed here. As a quick, non-comprehensive refresher, lay users - especially older ones - may not have the same vision, hearing, tactile, strength, or cognitive abilities of younger users in a clinical setting. Additionally, non-clinical use environments may not be optimized to promote proper use. Lighting, background noise, lack of work surfaces, etc. may all contribute to use problems or use errors. Even if the human factors practitioner is intimately familiar with these design principles and implements mitigations into their designs to accommodate, we have encountered numerous home use medical device-related design challenges that would have been difficult to predict prior to seeing and hearing them in the field. We would like to share some examples with this community.
One unanticipated usability challenge pertains to discretion. For multiple products in different spaces, we have heard the importance of discretion from end users. This ranges from checking a diagnostic level (i.e. blood glucose), to injecting themselves with a drug, to using a urinary incontinence product. Although there has been some movement by the public in not gawking or questioning the use of a medical device like a visible continuous glucose meter, it is not universal. In practice, this means the end user might try to interact with the device in a way that is suboptimal and not anticipated. For instance, they might try to make a dose adjustment blind, while the controller is still in their pocket, thus relying entirely on tactile cues rather than visual cues. Although multimodal feedback is always recommended, in instances like this example, tactile cues may be more important than visual cues.
Another unanticipated use problem, with crossover to insurance and reimbursement, pertains to devices (and drugs) that are intended to be replaced on a set cadence, often weekly. The insurer typically only covers one device or treatment per week so, if the user loses that week’s device, they get distracted and don’t get the full dose from an autoinjector, they sweat too much because they exercise and their wearable falls off, or any other of the myriad reasons the perfect use of the product is perturbed, they have decisions to make. They could try to get the product replaced, they could use next week’s device or drug if it’s available, or they could go without. What this means, in the case of wearables, is people tend to alter their lifestyle to minimize the chances the adhesive fails prematurely, or they reinforce the adhesive in ways that the designer might not anticipate.
A third home use usability challenge that is becoming increasingly common is initial setup and connectivity to home Wi-Fi. This connectivity is important for broadcasting data to caregivers or clinicians and can also be important for downloading data, automatically reordering disposables, or any number of other reasons. If one of the medical device interfaces is on a cellular phone, this typically is less of a usability challenge because, in the best case, the phone can automatically facilitate connectivity based on existing settings. But, if that isn’t the case, the user can make use of the native phone keyboard to set up device connectivity. However, if the end user’s cellular phone is not a device interface, often the native device interface is not designed to easily enter alphanumeric values. In our experience, the interface is often optimized for the primary use cases of the device itself, possibly viewing a diagnostic value or trend, step adjusting a dose, or viewing alerts and alarms. It may have a limited number of buttons, or a small touchscreen not optimized for alphanumeric data entry. Whereas phone manufacturers have maximized touchscreen keyboard usability with optimized touch targets, predictive modeling, and other strategies, typically embedded medical device touchscreens do not have this luxury. Initial setup and alphanumeric data entry becomes increasingly difficult for older adults, those not technologically savvy, or those with hand ailments. If the end user is unable to set up the device and configure connectivity, it is possible the device is completely inoperable or is at least limited in its functionality.
In summary, a combination of end user experience and ability levels, unanticipated use cases and user motivations, and interfaces not designed for rare interactions have all influenced emerging home use medical device designs. Like most design considerations, uncovering these challenges early in the design process minimizes the time and cost burden of mitigating for them later on.
Although this presentation will not reiterate the content of HE-75 and other similar literature in detail, it is important to keep the descriptions of the potential users and environments in mind because they intersect with the lessons from the field discussed here. As a quick, non-comprehensive refresher, lay users - especially older ones - may not have the same vision, hearing, tactile, strength, or cognitive abilities of younger users in a clinical setting. Additionally, non-clinical use environments may not be optimized to promote proper use. Lighting, background noise, lack of work surfaces, etc. may all contribute to use problems or use errors. Even if the human factors practitioner is intimately familiar with these design principles and implements mitigations into their designs to accommodate, we have encountered numerous home use medical device-related design challenges that would have been difficult to predict prior to seeing and hearing them in the field. We would like to share some examples with this community.
One unanticipated usability challenge pertains to discretion. For multiple products in different spaces, we have heard the importance of discretion from end users. This ranges from checking a diagnostic level (i.e. blood glucose), to injecting themselves with a drug, to using a urinary incontinence product. Although there has been some movement by the public in not gawking or questioning the use of a medical device like a visible continuous glucose meter, it is not universal. In practice, this means the end user might try to interact with the device in a way that is suboptimal and not anticipated. For instance, they might try to make a dose adjustment blind, while the controller is still in their pocket, thus relying entirely on tactile cues rather than visual cues. Although multimodal feedback is always recommended, in instances like this example, tactile cues may be more important than visual cues.
Another unanticipated use problem, with crossover to insurance and reimbursement, pertains to devices (and drugs) that are intended to be replaced on a set cadence, often weekly. The insurer typically only covers one device or treatment per week so, if the user loses that week’s device, they get distracted and don’t get the full dose from an autoinjector, they sweat too much because they exercise and their wearable falls off, or any other of the myriad reasons the perfect use of the product is perturbed, they have decisions to make. They could try to get the product replaced, they could use next week’s device or drug if it’s available, or they could go without. What this means, in the case of wearables, is people tend to alter their lifestyle to minimize the chances the adhesive fails prematurely, or they reinforce the adhesive in ways that the designer might not anticipate.
A third home use usability challenge that is becoming increasingly common is initial setup and connectivity to home Wi-Fi. This connectivity is important for broadcasting data to caregivers or clinicians and can also be important for downloading data, automatically reordering disposables, or any number of other reasons. If one of the medical device interfaces is on a cellular phone, this typically is less of a usability challenge because, in the best case, the phone can automatically facilitate connectivity based on existing settings. But, if that isn’t the case, the user can make use of the native phone keyboard to set up device connectivity. However, if the end user’s cellular phone is not a device interface, often the native device interface is not designed to easily enter alphanumeric values. In our experience, the interface is often optimized for the primary use cases of the device itself, possibly viewing a diagnostic value or trend, step adjusting a dose, or viewing alerts and alarms. It may have a limited number of buttons, or a small touchscreen not optimized for alphanumeric data entry. Whereas phone manufacturers have maximized touchscreen keyboard usability with optimized touch targets, predictive modeling, and other strategies, typically embedded medical device touchscreens do not have this luxury. Initial setup and alphanumeric data entry becomes increasingly difficult for older adults, those not technologically savvy, or those with hand ailments. If the end user is unable to set up the device and configure connectivity, it is possible the device is completely inoperable or is at least limited in its functionality.
In summary, a combination of end user experience and ability levels, unanticipated use cases and user motivations, and interfaces not designed for rare interactions have all influenced emerging home use medical device designs. Like most design considerations, uncovering these challenges early in the design process minimizes the time and cost burden of mitigating for them later on.
Author
Event Type
Poster Presentation
TimeTuesday, March 244:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices