Patient-operated medical devices — such as those used in insulin delivery — require a focus on the usability requirements of the less-experienced end user.
Philip Remedios, BlackHägen Design
User-centered design is critical when developing new medical devices to support distance care. Medtech companies are now specifically designing devices for patient use outside of clinical settings. Digital technologies and ingenious benefits for providers and payers have enabled the shift.
However, it is imperative to focus on benefits to end-users in the design process. Device creators must consider environmental factors and design for elderly, infirm or inexperienced users. It may also include issues such as increased battery life, fall detection and other risk-mitigating sensors like innovative applications to trigger emergency responses.
Smart devices have gained traction with apps that track fitness goals and basic statistics, increasing patient acceptance. This trend simplifies the introduction of devices for more complex diagnostics and therapeutic self-care options. These connected technologies can now provide better, safer and more convenient drug delivery mechanisms for patients to receive their meds.
A qualitative approach to user-centered design
User-centered design methodologies look for confirmatory patterns to identify design innovations and issues. Incorporate iterative usability testing to optimize opportunities to provide unmet needs.
User studies enable the designer to identify potential challenges for patient end-users. Consider potential user personalities and their specific needs. Keep in mind demographics (including the size of the user and economic variations), psychographics and cultural differences, environments (the device likely will not be in an aseptic environment), and potential or actual comorbidities. Can users have the discretion to blend the device in with the environment or, if wearable, on their attire?
Device designers also need to identify how the device will be packaged and handled before reaching the user. For example, consider temperature and humidity control, shelf life, long-term storage needs and management of biohazardous materials.
The evolution of distance care
Patient-operated healthcare has become known as “distance care,” including wearable and in-home devices for real-time monitoring, pain management and chronic drug delivery. Many of these devices securely collect and transfer data to healthcare providers. They may also incorporate sophisticated embedded intelligence to simplify operator interactions while delivering vital data to remote databanks for analysis and functional optimization. Such features minimize the operational burden on patients with comorbidities that limit cognitive and physical capabilities.
Miniaturization and voice and gesture controls further enhance patient lifestyles. Wearables and portable devices are also being styled to blend with a patient’s attire and often resemble consumer products. In addition, many devices interact with smartphones to leverage processing, photographic and telemetric technology, reducing the capital cost of distance care. Modern device designs benefit from low-power electronics and dense battery chemistries that provide hours of continuous operation within smaller, lighter configurations.
With the patient-as-operator, device manufacturers must address significant usability requirements that have not been historically relevant with clinician-operated devices. The breadth of demographic and psychographic variation among patients is massive compared to highly trained healthcare professionals. As such, these devices present a slew of design challenges to overcome interaction limitations. Eyesight, dexterity, strength, cognitive deterioration, and social/cultural/anthropomorphic variability — all could complicate operability and use safety.
Design teams must consider the entire work/lifecycle for these devices. Drug-delivery combination products may require environmental and physical controls during transport, and the same is true for specimen samples sent by patients. Packaging and environmental specifications — shock, vibration, material leaching and climate control — must be well constructed as part of the design brief and ideally should not complicate the end-user burden.
A common scenario in this category is the administration and management of insulin delivery to diabetic patients. Both chronic and critical, it is necessary for drug delivery to be accurate by volume and timely in delivery to meet shelf-life limitations. Real-time blood glucose measurement is necessary to calculate the optimal insulin bolus. Patients previously drew their own blood to test for sugar levels multiple times a day, which could cause multiple-use errors and hazardous outcomes. Continuous blood glucose monitoring is now a stable and mature technology that substantially reduces the workflow burden to the patient when coupled with wearable insulin (and glucagon) delivery pumps (artificial pancreas). These semi-automated systems greatly improve therapy and outcomes for millions of patients.
Authentication and user identification
There is also a growing need for these devices to ensure appropriate operational compliance and adherence by the patient to support efficacy, safety and reimbursement requirements. Authentication measures are important to document correct practices and require that devices and recording methods interact reliably.
Is the patient using the device as often as they should and in the right way? User identification may also be necessary and is often a large part of reimbursement. In addition, designers can consider utilizing a smartphone, camera or video recording to ensure correct usability. Finally, therapy monitoring with time, data, bolus quality, and/or anatomical placement is important.
A vaccine delivery device may be required by governing authorities to prove correct administration to the patient on a specific date. One method is to utilize a smartphone app that video records the process and QR codes for batch recognition with a date-stamp. It could be possible to upload the information autonomously for verification and traceability. This may require the device to provide visual markers or electronic sensing to the app for verification. Tamper-resistant packaging ensures the contents are consistent with the QR code database and that the sample collection has not been compromised during transit.
Distance care is transforming procedural paradigms
Advancements in device and sensor technology, telemetry, cybersecurity and data processing are transforming healthcare procedural paradigms. Patients as device operators will grow more familiar with and accepting of this technology, propagating higher levels of device and functional capability.
However, usability requirements for self-administered devices are vastly more challenging than clinical-use devices and require thorough user-centered design methodologies to maximize safety and efficacy. Reliable authentication techniques will be required as critical drug delivery and sample collection become widely adopted.
With fewer future clinicians to care for an ever-aging population, we as patients need to become more involved in our healthcare. AI coupled with massive online biostatistical data will inform these connected patient-operated devices to make optimized and safe real-time decisions with little end-user involvement in the comfort of our homes and as part of our everyday lives.
Philip Remedios is principal and design director at BlackHägen Design, an R&D consultancy focused on medical device innovation. He has a background in design and engineering and is a named inventor on over 35 patents.
The opinions expressed in this post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.