中国国际医疗器械设计与制造技术展览会(Medtec China)2021

Dedicated to design & manufacturing for medical device

August 31-September 2 2022 | SWEECC H1&H2

Recent Trends in Self-Administration Drug Delivery Systems

2022-04-13

Drug delivery is changing, and with that the patient experience has evolved. Now, Distance Care is maximizing diagnostic and therapeutic self-care outside of the hospital environment. Patients are no longer tethered to the nurse, clinic, or other healthcare professional/setting to receive a drug infusion or another treatment.

New technologies provide better mechanisms for drug delivery and patients can request a safer and more convenient way to receive their medications. Connected technology is often a part of this, as the care provider has visibility into the patient’s regimen and medication timing.

User-Centered Methodologies for Distance Care Device Design

User-centered design is vital 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 feature 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.

The Usability Engineering Process

In user-centered design, user studies enable the designer to identify any potential challenges for patient end-users. The following must be considered:

Potential user personas and their needs
Demographics, including user size and economic variations
Psychographics and cultural differences
Intended environment, since the device will not be in an aseptic environment
Potential comorbidities
Discreet appearance to blend in with environment, or in the case of a wearable, on their attire

Device designers must 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 or biohazardous materials?

Authentication is essential. Is the patient using the device at all, or as often and in the right way as they should be? User identification can assist with this and is often a large part of reimbursement. Device designers can also consider utilizing a smartphone, camera, or video recording to ensure correct usability. Therapy monitoring with time, data, bolus quantity, and/or anatomical placement is also important.

Why Self-Care Devices?

The last decade has seen shifting healthcare practices to reduce costs by deploying a sliding scale of provider proficiency to match the level of competence required for the specific task. A GP used to provide first order of healthcare evaluation before specialists were involved, but today it is common to first see a nurse practitioner or physician’s assistant before the GP is involved. Similarly, 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 for diabetics, dialysis patients, and others to perform many tasks from the comfort of home and it’s no surprise patient-administered healthcare is one of the fastest growing segments in the medtech industry, with an estimated 12.5 percent CAGR through 2030, according to Transparency Market Research.

Distance Care

Patient-operated healthcare 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 healthcare 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 that minimizes operator interactions while feeding vital data to remote databanks for analysis and functional optimization.

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.

Usability Challenges

Regarding 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, 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 Workflows

Design teams must consider these devices’ entire work/lifecycle. 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 the drug during 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.

Authentication

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 done, done correctly, 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 was administered correctly to the right patient on the right date. One method to provide this authentication is to utilize a smartphone software application that can record the process and QR codes for batch recognition via video, 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.

Continuing advancements in device and sensor technology, telemetry, cybersecurity, and data processing will enable distance-care to transform healthcare 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 critical 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 healthcare. 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 home and as part of the everyday lifestyle.

Philip Remedios is principal and design director at BlackHägen Design, an R&D consultancy focused on medical device innovation. With a combined design and engineering background, Remedios has spent most of his 34-year career in executive consulting roles, developing project plans, and managing integrated technical teams, schedules, and budgets.

Article source: Medical Product Sourcing