When developing medical devices that support remote care, user-centered design is essential. These devices have been developed explicitly for patients outside of the clinical setting. They are greatly enhanced with digital technologies and innovative features that benefit both payers and providers. It is essential to consider the benefits of end-users when designing medical devices. This includes considering environmental factors such as planning for the elderly, infirm, and other inexperienced users. This could include increased battery life, fall detection, other risk-mitigating sensors, and innovative applications that trigger an emergency response.
Apps that track your fitness and basic statistics have become more popular on intelligent devices. This has increased patient acceptance. This allows for a more straightforward introduction of devices that enable complex diagnostics and therapeutic self-care options. These connected technologies can provide better drug delivery options and make it easier for patients to get their medication.
A qualitative approach to user-centered design
User-centered design methods look for confirmatory patterns to identify design opportunities and problems that can be solved. Iterative usability testing is necessary to maximize these opportunities for meeting unmet needs.
The designer can identify potential problems for patient end-users through user studies. Consider the following:
- Personas and specific needs of potential users
- Demographics (including size and economic variation)
- Cultural and psychographic differences
- Environments (the device is unlikely to be placed in an aseptic environment).
- Possible or actual comorbidities
- Discipline (to blend in with their environment or, if possible, on their attire).
Designers of devices need to plan how the device will arrive at the end-user. Temperature and humidity control are possible considerations. It is vital to answer and support questions about shelf life, long-term storage requirements, and management of biohazardous substances.
The Evolution of Distance Care
Patient-operated healthcare is now commonly called “distance health care.” This market segment includes in-home and wearable devices that monitor, manage pain, and deliver chronic drugs. These devices often feature secure data collection and transmission to professional healthcare providers for supervision and interaction. These devices include sophisticated embedded intelligence that simplifies operator interaction and transmits vital data to remote databases for analysis and optimization. Patients with multiple comorbidities, such as cognitive impairments or physical limitations, will find it easier to operate.
Patients’ lives are made more accessible by minimalism and simple interactions like voice and gesture commands. Many modern wearables and mobile devices can be styled to match the patient’s outfit. They often look like consumer appliances or entertainment products. Many devices can interact with smartphones, allowing for greater use of computer processing and photo and telemetric technology. This reduces the cost of distance care. Modern low-power electronics provide hours of uninterrupted operation in smaller and lighter devices.
Requirements for Usability
Device manufacturers must address usability issues that do not apply to clinician-operated devices. Patients have a vastly different demographic and psychographic profile than highly-trained healthcare professionals. These devices pose many design challenges that must be overcome to achieve interaction limitations. Eyesight, dexterity, strength, cognitive deterioration, and social/cultural/anthropomorphic variability conspire to complicate operability and use safety.
Design teams must consider the entire lifecycle of these devices. The drug-delivery product combination products that transport drugs from their point of manufacture to the patient might require special environmental and physical conditions to preserve the drug. If a patient requests a sample, how can it be held from the patient to its destination? As part of the design brief, packaging and environmental specifications (shock vibration, material leaching, and climate control) should be carefully constructed. Ideally, they should not add to the burden on the end-user.
This category includes administering and managing insulin delivery to people with diabetes. It is crucial for chronic and acute drug delivery to be precise by volume and delivered on time to avoid shelf-life limits. It is essential to have real-time glucose measurements to calculate the optimal insulin dose. Patients used to draw blood multiple times per day and check for sugar levels. This could lead to multiple-use errors and potentially dangerous outcomes. Continuous glucose monitoring, a mature and stable technology, can be used in conjunction with insulin delivery pumps (artificial pancreas) to significantly reduce the patient’s workflow. These semi-automated systems offer greatly improved treatment and outcomes for millions of people with this chronic condition.
Authentication and user identification
These devices are also needed to ensure proper operational compliance and patient adherence to meet reimbursement and health requirements. Authentication measures are essential to document the correct practices and ensure that devices and recording methods interact reliably.
Are they using the device as intended? It is also possible to require user identification, a significant part of reimbursement. Device designers may also consider using a smartphone, camera, or video recording to ensure proper usability. Therapy monitoring using time, data, and bolus quality is crucial.
To prove that the vaccine was given correctly to the patient, governing authorities may require a vaccine delivery device. A smartphone software application can be used to record the process and generate QR codes that allow batch recognition via video with an associated date-stamp. This information can be uploaded to a database autonomously for verification and traceability. To verify specific actions, the smartphone app may need to be able to read the data from the device. To ensure that the contents of the package are compatible with the QR code database and that the sample collection is not compromised in transit, it may be necessary to use tamper-resistant packaging.
Distance Care is Transforming Procedural Paradigms
The next decade will see significant advances in technology and data processing, including telemetry, cyber security, device and sensor technology, and data processing. This will allow distance healthcare to revolutionize healthcare procedures. As device operators, patients will become more familiar with and accept technology in their daily lives. This will result in higher levels of device functionality and acceptance. These self-administered devices present a more significant challenge than conventional clinical-use devices. They also require a thorough user-centered design methodology to ensure patient safety and effectiveness. As critical drug delivery and sample collection become more common, reliable authentication techniques will be essential.
As resources are decreasing to train future doctors to care for an aging population, it makes sense that patients should be more involved in their healthcare. These connected devices will be able to make safe and optimized real-time decisions using massive online biostatistical information. This is possible in our own homes or as part of our daily lives.