Advancements in patient-operated delivery systems offer safety and convenience
Consequently, the pharma industry is seeing an uptick in the use of self-administered drug delivery systems. The patient monitoring devices market is estimated to reach $44.86 billion by 2027, registering a CAGR of 4.4% from 2020 to 2027 according to Allied Market Research.
New technologies are providing better mechanisms for drug delivery and today, patients can request a safer and more convenient way to receive medications. Connected technology can enhance distance-care, as the care provider has visibility into the patient’s regimen and medication timing. Drugmakers in the space must keep pace with these trends in order to optimize the delivery of their drugs.
Designing for usability
User-centered design is crucial in this new distance-care setting because it ensures the device designer considers designing it for ‘untrained’ users. User-centered design is a qualitative design approach that examines emerging features and workflow preference patterns so potential design issues can be resolved and ease-of-use maximized. Iterative usability testing can be incorporated to optimize design solutions.
Patient-operated drug delivery systems — such as those used in insulin delivery — require a focus on the usability requirements of the less-experienced lay end user.
In user-centered design, user studies enable the designer to identify any potential challenges for patient end users. The following must be done:
- Assess potential user personas and their needs
- Evaluate demographics, including anatomical, psychographics and cultural differences
- Review intended workflows and surroundings, since the device will not be in an aseptic environment
- Anticipate potential comorbidities
- Provide discreet appearances in order to blend in with environment, or in the case of a wearable, on attire
It is important to also consider packaging and handling of the device before it gets to the end user. Temperature and humidity control may be a consideration. What is the shelf life and are there long-term storage needs?
Authentication may also be necessary for reimbursement. Is the patient using the device as often as intended and in the correct way? User identification can assist with this and is often a large part of reimbursement. Therapy monitoring with time, data, bolus quantity, and/or anatomical placement is also important.
Patient-operated and wearable devices
The last decade has seen health care practices shift to reduce costs. Outpatient services have replaced convalescence and post-therapy recovery outside of the hospital to reduce overhead expense. Patients can also provide routine self-diagnostic and chronic non-skilled therapies — never more so than in post-COVID-19 times — to avoid infection and reduce operational burden in clinical settings.
The proliferation of patient-operated and wearable devices for vital signs monitoring, sample collection, and regimented drug delivery has never been greater. Add to this the convenience of performing many tasks from the comfort of home for diabetics, dialysis patients, and others and it’s no surprise patient-administered health care is one of the fastest growing segments in the medtech industry, with an estimated 12.5% CAGR through 2030, according to Transparency Market Research.
Patient-operated health care has become so prevalent the term ‘distance-care’ has been coined to include all categories associated with this market segment. This includes wearable and in-home devices for real-time monitoring and chronic drug delivery devices, with many featuring connected secure data transfer to professional health care providers for oversight and interaction.
In an effort to minimize the operational burden on patients who may suffer from multiple comorbidities which limit cognitive and physical capabilities, modern distance-care devices incorporate surprisingly sophisticated embedded intelligence. Many chronic drug delivery devices feature connected secure data transfer to professional health care providers for oversight and interaction. The design of these distance-care devices further enhances patient lifestyles through miniaturization and simplistic interaction like voice and gesture controls.
Modern wearables and portable devices are styled to blend with the patient’s attire and home devices resemble appliances and entertainment products. Many interact with consumer smartphones to leverage available computer processing, photographic, and telemetric technology, reducing the capital cost of distance-care. Portable and wearable device designs benefit from modern low-power electronics and dense battery chemistries that provide hours of continuous operation in smaller, lighter configurations.
Regarding the patient-as-operator, device and drug 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 health care professionals, and these devices challenge the design process to overcome interaction limitations. Eyesight, dexterity, strength, cognitive deterioration and social/cultural/anthropomorphic variability conspire to complicate operability and use-safety.
Distance-care devices are philosophically a blend of clinical and consumer products and must provide superior user experience solutions to ensure safe and effective use.
Product life cycle
Design teams must consider these devices’ entire work/life cycle. Drug delivery combination products that transport the drug from its point of manufacture to the patient may require maintaining environmental and physical conditions to preserve drug integrity during storage and transport. If a specimen sample is also required, what is necessary to preserve the resultant sample from patient to its end-destination?
Packaging and environmental specifications (shock, vibration, material leaching, climate control) must be well constructed as part of the design brief and shouldn’t complicate the end-user burden. A well-established example is 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.
Real-time blood glucose measurement is necessary to calculate the optimal insulin bolus. Until recently, patients needed to draw blood and test current sugar levels multiple times a day, setting up a viable scenario for multiple use-errors and potential hazardous outcomes. Stable and mature continuous blood glucose monitoring technology coupled with wearable insulin (and glucagon) delivery pumps (‘artificial pancreas’) substantially reduces the patient’s workflow burden. These semi-automated systems provide far improved therapy for millions of diabetic patients.
In parallel with the technology advancements of modern distance-care devices is the need to ensure appropriate operational patient compliance and adherence to support efficacy and safety, as well as economic reimbursement requirements. Is the task being correctly accomplished and according to protocol?
Authentication measures are becoming increasingly important to document correct practice and require devices and recording methods to interact reliably. Governing authorities may require proving a vaccine delivery device administered the proper dosage correctly, to the right patient, and on the right date.
One method to provide this authentication is to utilize a smartphone application software that can record the process and QR codes for batch recognition via video complete with a date stamp, and upload the transaction autonomously to a database for verification and traceability. The device may therefore need to provide visual markers or electronic sensing to the smartphone app to verify certain actions have been successfully completed.
Tamper-resistant packaging may also be required to ensure the contents are consistent with the QR code database and/or sample collection has not been compromised during transit.
Consistent improvements in device and sensor technology, telemetry, cybersecurity and data processing will enable distance-care to transform health care procedural paradigms over the next decade.
Patients as device operators will mature in their familiarity and acceptance of technology, which will in turn propagate higher levels of device and functional capability. However, usability requirements for these self-administered devices are vastly more challenging than traditional clinical-use devices and require thorough user-centered design methodologies to maximize patient safety and effective use.
Reliable authentication techniques will be a requirement as society widely adopts self-administered drug delivery and sample collection. The people willing to train as clinicians to care for an ever-aging population are dwindling, so it’s logical patients must become more involved in their health care. Artificial intelligence 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 patients’ homes.